The Artificial Heart: Costs, Risks, and

Benefits

May 1982

NTIS order #PB82-239971
THE IMPLICATIONS OF

COST-EFFECTIVENESS

ANALYSIS OF

MEDICAL TECHNOLOGY

MAY 1982

BACKGROUND PAPER #2: CASE STUDIES OF

MEDICAL TECHNOLOGIES

CASE STUDY #9: THE ARTIFICIAL HEART:

COST, RISKS, AND BENEFITS

Deborah P. Lubeck, Ph. D.

and

John P. Bunker, M.D.

Division of Health Services Research, Stanford University

Stanford, Calif.

Contributors: Dennis Davidson, M. D.; Eugene Dong, M. D.; Michael Eliastam, M. D.;

Dennis Florig, M. A.; Seth Foldy, M. D.; Margaret Marnell, R. N., M. A.;

Nancy Pfund, M. A.; Thomas Preston, M. D.; and Alice Whittemore, Ph.D.

OTA Background Papers are documents containing information that supplements

formal OTA assessments or is an outcome of internal exploratory planning and evaluation. The material is usually not of immediate policy interest such as is contained

in an OTA Report or Technical Memorandum, nor does it present options for Congress to consider.

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Library of Congress Catalog Card Number 80-600161

For sale by the Superintendent of Documents,

U.S. Government Printing Office, Washington, D.C. 20402
Foreword

This case study is one of 17 studies comprising Background Paper #2 for OTA’S

assessment, The Implications of Cost-Effectiveness Analysis of Medical Technology.

That assessment analyzes the feasibility, implications, and value of using cost-effectiveness and cost-benefit analysis (CEA/CBA) in health care decisionmaking. The major, policy-oriented report of the assessment was published in August 1980. In addition

to Background Paper #2, there are four other background papers being published in

conjunction with the assessment: 1) a document which addresses methodological

issues and reviews the CEA/CBA literature, published in September 1980; 2) a case

study of the efficacy and cost-effectiveness of psychotherapy, published in October

1980; 3) a case study of four common diagnostic X-ray procedures, published in April

1982; and 4) a review of international experience in managing medical technology,

published in October 1980. Another related report was published in September 1979: A

Review of Selected Federal Vaccine and Immunization Policies.

The case studies in Background Paper #2: Case Studies of Medical Technologies

are being published individually. They were commissioned by OTA both to provide

information on the specific technologies and to gain lessons that could be applied to

the broader policy aspects of the use of CEA/CBA. Several of the studies were specifically requested by the Senate Committee on Finance.

Drafts of each case study were reviewed by OTA staff; by members of the advisory panel to the overall assessment, chaired by Dr. John Hogness; by members of

the Health Program Advisory Committee, chaired by Dr. Frederick Robbins; and by

numerous other experts in clinical medicine, health policy, Government, and economics. We are grateful for their assistance. However, responsibility for the case studies remains with the authors.

Director
Advisory Panel on The Implications of

Cost= Effectiveness Analysis of Medical Technology

John R. Hogness, Panel Chairman

President, Association of Academic Health Centers

Stuart H. Altman

Dean

Florence Heller School

Brandeis University

James L. Bennington

Chairman

Department of Anatomic Pathology and

Clinical Laboratories

Children’s Hospital of San Francisco

John D. Chase

Associate Dean for Clinical Affairs

University of Washington School of Medicine

Joseph Fletcher

Visiting Scholar

Medical Ethics

School of Medicine

University of Virginia

Clark C. Havighurst

Professor of Law

School of Law

Duke University

Sheldon Leonard

Manager

Regulatory Affairs

General Electric Co.

Barbara J. McNeil

Department of Radiology

Peter Bent Brigham Hospital

Robert H. Moser

Executive Vice President

American College of Physicians

Frederick Mosteller

Chairman

Department of Biostatistics

Harvard University

Robert M. Sigmond

Advisor on Hospital Affairs

Blue Cross and Blue Shield Associations

Jane Sisk Willems

VA Scholar

Veterans Administration
OTA Staff for Background Paper #2

Joyce C. Lashof* and H. David Banta, **

Health and Life Sciences

H. David Banta’ and Clyde J. Behney, **

Assistant Director, 07’A

Division

Health Program Manager

Clyde J. Behney, Project Director

Kerry Britten Kemp,*** Editor

Virginia Cwalina, Research Assistant

Shirley Ann Gayheart, Secretary

Nancy L. Kenney, Secretary

Martha Finney, **” Assistant Editor

Other Contributing Staff

Bryan R. Luce Lawrence Miike Michael A. Riddiough

Leonard Saxe Chester Strobel***

OTA Publishing Staff

John C. Holmes, Publishing Officer

John Bergling Kathie S. Boss Debra M. Datcher Joe Henson

*Until December 1981.

● *From December 1981.

* ● *OTA contract personnel
Preface

This case study is one of 17 that comprise

Background Paper #2 to the OTA project on the

Implications of Cost-Effectiveness Anlalysis of

Medical Technology * The overall project was

requested by the Senate Committee on Labor

and Human Resources. In all, 19 case studies of

technological applications were commissioned

as part of that project. Three of the 19 were specifically requested by the Senate Committee on

Finance: psychotherapy, which was issued separately as background Paper #3; diagnostic Xray, issued as Background Paper #5; and respiratory therapies. The other 16 case studies were

selected by OTA staff.

In order to select those 16 case studies, OTA,

in consultation with the advisor-y panel to the

overall project, developed a set of selection

criteria. Those criteria were designed to ensure

that

●

●

●

●

●

●

●

as a group the case studies would provide:

examples of types of technologies by function (preventive, diagnostic, therapeutic,

and rehabilitative );

examples of types of technologies by physical nature (drugs, devices, and procedures);

examples of technologies i n different stages

of development and diffusion (new, emerging, and established);

examples from different areas of medicine

(such as general medical practice, pediatrics, radiology, and surgery);

examples addressing medical problems that

are important because of their high frequency or significant impacts (such as

cost ) ;

examples of technologies with associatecl

high costs either because of high volume

(for low-cost technologies) or high individual costs ;

examples that could provide informative

material relating to the broader policy and

methtodological issues of cost-effectiveness

or cost-benefit analysis (CEA/CBA); and

• examples with sufficient evaluable litera -

ture.

On the basis of these criteria and recommendations by panel members and other experts,

OTA staff selected the other case studies. These

16 plus the respiratory therapy case study requested by the Finance Committee make up the

17 studies in this background paper.

All case studies were commissioned by OTA

and performed under contract by experts in academia. They are authored studies. OTA subjected each case study to an extensive review

process. Initial drafts of cases were reviewed by

OTA staff and by members of the advisor y

panel to the project. Comments were provided

to uthors, along with OTA’S suggestions forrevisions. Subsequent drafts were sent by OTA

to numerous experts for review nd comment.

Each case was seen by at least 20, ad some by

40 or more, outside reviewers. These reviewers

were from relevant Government agencies, professional societies, consumer and public interest

groups, medical practice, and academic medicine. Academicians such as economists and decision analysts also reviewed the cases. In all,

over 400 separate individuals or organizations

reviewed one or more case studies. Although all

these reviewers cannot be acknowledged individually, OTA is very grateful for- their com -

ments and advice. In addition, the authors of

the case studies themselves often sent drafts to

reviewers and incorporated their comments.

These case studies are authored works

commissioned by OTA. The authors are responsible for the conclusions of their specific case study. These cases are not statements of official OTA position. OTA does

not make recommendations or endorse particular technologies. During the various

stages of the review and revision process,

therefore, OTA encouraged the authors to

present balanced information and to recognize divergent points of view. In two cases,

OTA decided that in order to more fullv

present divergent views on particular technologies a commentary should be added to

the case study. Thus, following the case

‘,1
studies on gastrointestinal endoscopy and

on the Keyes technique for periodontal disease, commentaries from experts in the appropriate health care specialty have been

included, followed by responses from the

authors.

The case studies were selected and designed to

fulfill two functions. The first, and primary,

purpose was to provide OTA with specific information that could be used in formulating

general conclusions regarding the feasibility and

implications of applying CEA/CBA in health

care. By examining the 19 cases as a group and

looking for common problems or strengths in

the techniques of CEA/CBA, OTA was able to

better analyze the potential contribution that

these techniques might make to the management

of medical technologies and health care costs

and quality. The second function of the cases

was to provide useful information on the specific technologies covered. However, this was

not the major intent of the cases, and they

should not be regarded as complete and definitive studies of the individual technologies. In

many instances, the case studies do represent excellent reviews of the literature pertaining to the

specific technologies and as such can stand on

their own as a useful contribution to the field. In

general, though, the design and the funding

levels of these case studies were such that they

should be read primarily in the context of the

overall OTA project on CEA/CBA in health

care.

Some of the case studies are formal CEAs or

CBAs; most are not. Some are primarily concerned with analysis of costs; others are more

concerned with analysis of efficacy or effectiveness. Some, such as the study on end-stage

renal disease, examine the role that formal

analysis of costs and benefits can play in policy

formulation, Others, such as the one on breast

cancer surgery, illustrate how influences other

than costs can determine the patterns of use of a

technology. In other words, each looks at evaluation of the costs and the benefits of medical

technologies from a slightly different perspective. The reader is encouraged to read this study

in the context of the overall assessment’s objectives in order to gain a feeling for the potential

role that CEA/ CBA can or cannot play in health

care and to better understand the difficulties and

complexities involved in applying CEA/CBA to

specific medical technologies.

The 17 case studies comprising Background

Paper #2 (short titles) and their authors are:

Artificial Heart: Deborah P. Lubeck and John P.

Bunker

Automated Multichannel Chemistry Analyzers:

Milton C. Weinstein and Laurie A. Pearlman

Bone Marrow Transplants: Stuart O. Schweitzer and C. C. Scalzi

Breast Cancer Surgery: Karen Schachter and

Duncan Neuhauser

Cardiac Radionuclide Imaging: William B,

Stason and Eric Fortess

Cervical Cancer Screening: Bryan R. Luce

Cimetidine and Peptic Ulcer Disease: Harvey V.

Fineberg and Laurie A. Pearlman

Colon Cancer Screening: David M. Eddy

CT Scanning: Judith L. Wagner

Elective Hysterectomy: Carol Korenbrot, Ann

B. Flood, Michael Higgins, Noralou Roos,

and John P. Bunker

End-Stage Renal Disease: Richard A. Rettig

Gastrointestinal Endoscopy: Jonathan A. Showstack and Steven A, Schroeder

Neonatal Intensive Care: Peter Budetti, Peggy

McManus, Nancy Barrand, and Lu Ann

Heinen

Nurse Practitioners: Lauren LeRoy and Sharon

Solkowitz

Orthopedic Joint Prosthetic Implants: Judith D.

Bentkover and Philip G. Drew

Periodontal Disease Interventions: Richard M,

Scheffler and Sheldon Rovin

Selected Respiratory Therapies: Richard M.

Scheffler and Morgan Delaney

These studies will be available for sale by the

Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

Call OTA’s Publishing Office (224-8996) for

availability and ordering information.

,’ 111
Case Study #9

The Artificial Heart:

Cost, Risks, and Benefits

Deborah P. Lubeck, Ph. D.

and

John P. Bunker, M.D.

Division of Health Services Research

Stanford University

Stanford, Calif.

AUTHORS’ ACKNOWLEDGMENTS

We would like to express our thanks to the following individuals who responded

to our requests for interviews and information on economic and technological aspects

of the artificial heart: Yuki NOSé and Ray Kiraly of the Cleveland Clinic; Don Cole of

the Department of Energy; Willem Kolff of the University of Utah; William Bernhard

of Boston Children’s Hospital; Victor Poirier of Thermoelectron Corp.; John Moise of

Aerojet General; Jack Chambers of Gould Measurement Systems; William Pierce of

Pennsylvania State University, and John Norman of the Texas Heart Institute. Diana

Dutton, Allen Ream, and Ralph Silber of Stanford University read drafts of the

material and provided valuable comments.

This work was carried out in conjunction with a grant entitled “Ethical Issues in

Biomedical Decision-Making: Four Cases Studies” (Diana B. Dutton, principal investigator) from the National Science Foundation under their program in Ethics and

Values in Science and Technology.
Contents

Page

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

History of the Artificial Heart. . . . . . . . . . . . . . . . . 4

Pool of Potential Recipients in the United States. 5

Sources of Candidates.. . . . . . . . . . . . . . . . . . . . 5

Estimates of Potential Candidates in the

United States, 1979. . . . . . . . . . . . . . . . . . . . . . 6

Patient Access to Implant Hospitals and

Patient Refusal . . . . . . . . . . . . . . . . . . . . . . . . . 8

Economic Aspects . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Artificial Cardiac Pacemaker. . . . . . . . . . . . . . . 8

Coronary Artery Bypass Grafts. . . . . . . . . . . . . 9

Heart Transplants . . . . . . . . . . . . . . . . . . . . . . . . . 9

Device Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Summary of Costs . . . . . . . . . . . . . . . . . . . . . . . . 11

Personnel and Facilities. . . . . . . . . . . . . . . . . . . . 12

R&D Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Parallel Costs of Hemodialysis . . . . . . . . . . . . . . . . 16

Estimates of the Potential Success of the

Artificial Heart . . . . . . . . . . . . . . . . . . . . . . . . . 18

LVAD Research and Clinical Trials. . . . . . . . . . 18

Instrument Reliability . . . . . . . . . . . . . . . . . . . . . 20

Quality of Life Parameters. . . . . . . . . . . . . . . . . . . 21

Hemodialysis and Kidney Transplants. . . . . . . 21

Cardiac Transplants. . . . . . . . . . . . . . . . . . . . . . . 22

Problems of a Nuclear-Powered Heart . . . . . . . . 22

Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Social Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Extension of Life. . . . . . . . . . . . . . . . . . . . . . . . . . 24

Return to Work. . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Social Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Increased Social Expenditures. . . . . . . . . . . . . . . 29

Distributional Issues. . . . . . . . . . . . . . . . . . . . . . . 31

Social Costs of a Nuclear Device.. . . . . . . . . . . 31

Opportunity Costs. . . . . . . . . . . . . . . . . . . . . . . . 31

Cardiac Disease Prevention . . . . . . . . . . . . . . . . . . . 32

Policy Recommendations. . . . . . . . . . . . . . . . . . . . 35

Program Administration . . . . . . . . . . . . . . . . . . . 35

Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Reimbursement and Distribution . . . . . . . . . . . . 37

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Appendix A: The Artificial Cardiac Pacemaker. . 41

Appendix B: Cardiac Transplant Costs . . . . . . . . . 44

Appendix C: NHLBI R&D Contracts and Grants. 45

Appendix D: Stanford Heart Disease

Prevention Program Materials . . . . . . . . . . . . . . 90

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

LIST OF TABLES

Table No. Page

1. Three Estimates of Major Items of Expense

Associated With Artificial Heart

Implantation and Use. . . . . . . . . . . . . . . . . . . . 11

2. Effect of Numbers of Implants unavailable

Societal Resources . . . . . . . . . . . . . . . . . . . . . . . 12

Table No. Page

3. NHLBI Devices and Technology Branch -

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

A-1. Pacemaker Longevity Excluding Causesof

B-1.

B-2.

D-1.

D-2.

Contract Funding, Fiscal Year;-1964-79. . . . . 14

Financial History of the Artificial Heart

Program at the Department of Energy, . . . . . . 15

Estimated Annual Costs for the ESRD

Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Fraction of Those With IHD in Each Age

Interval That Gets the Device—

Best and Worst Case. . . . . . . . . . . . . . . . . . . . . 25

Proportion of Those Obtaining the Device

That Dies Due to Device Failure at

Subsequent Ages-Best Case. . . . . . . . . . . . . . 26

Proportion of Those Obtaining the Device

That Dies Due to Device Failure at

Subsequent Ages-Worst Case. . . . . . . . . . . . 26

Age-Specific Death Rates Due to All

Causes, 1977..... . . . . . . . . . . . . . . . . . . . . . . . 26

Age-Specific Death Rates Due to IHD,1977. . 26

Increase in Life Expectancy in Years for

Randomly Selected Individuals of

Specified Ages Who Mayor May Not

Develop IHD—Best and Worst Case. . . . . . . . 27

Increase in Life Expectancy in Years for

Individuals of Specified Ages Who Will

Ultimately Develop IHD—Best and

Worst Case..... . . . . . . . . . . . . . . . . . . . . . . . . 27

Projected S-Year Sequence of Total

National Expenditures on Artificial Heart

Implantation and Patient Maintenance. . . . . . 30

SHDPP Expenses by Media Campaign.. . . . . 34

D-3.

D-4,

Failure Other Than Battery Exhaustion. . . . 41

Cardiac Transplant Hospitalization Costs,

1969-75 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Cardiac Transplant Outpatient Costs,

1969-75 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

SHDPP Three-Community Study Design.. 90

Demographic Characteristics and Survey

Response Rates in Each of the Three

Communities . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Risk Indicator and Knowledge Sources:

Percentage Change From Baseline at l, 2,

and 3 Follow up Surveys. . . . . . . . . . . . . . . . . 91

SHDPP Expenses By Media Campaign . . . . . 91

LIST OF FIGURES

Figure No, Page

l. Comparative Program Growth: NIH,

NHLBI, and the Artificial Heart Program,

Fiscal Years 1964-75. . . . . . . . . . . . . . . . . . . . . . . 14

2. Percentage Change in Risk of CHD After 1

and 2 Years of Health Education in Various

Study Groups From Three Communities. . . . . 33
.—

Case Study #9:

The Artificial Heart:

Cost, Risks, and Benefits

Deborah P. Lubeck, Ph. D.

and

John P. Bunker, M.D.

Division of Health Services Research

Stanford University

Stanford, Cal if.

INTRODUCTION

Current medical technology is often the result

of a convergence of clinical research and practice

with modern engineering. Advances in electronics, synthetic materials, pharmaceutical development, instrumentation, and computation result in important applications in diagnosis,

therapy, and rehabilitation. The artificial heart

program is an example of this convergence.

Cardiovascular diseases are still the leading

cause of death in the United States. According to

the National Center for Health Statistics, heart

attacks and strokes—the most lethal and wellknown manifestations of cardiovascular disease

—claim over 700,000 victims each year. In an effort to prevent some of the deaths, the National

Heart Advisory Council in 1963 recommended a

long-range program of research to develop a

permanently implantable artificial heart that

could be used to replace a failing natural heart.

At the time, there was considerable optimism

that the successful development of a permanently implantable artificial heart would provide a

means of treating serious cardiac disease by

IWO, well before biomedical advances were expected to produce appropriate preventive treatment (42). The success of cardiac pacemakers,

hemodialysis, and prosthetic joint replacement

underscored that optimism.

Today, after 15 years and over $180 million in

Federal expenditures, * however, a total implantable artificial heart is still a distant goal. This

case study, discusses the potential societal benefits, costs, and risks of continued investment in

this medical innovation. Many of our estimates

and forecasts are hampered by the fact that very

little research is directed toward the nature of

technical change in medicine and the supply side

of medical technology. We hope this case study

points to some useful areas of further research

on the relationship of public policy to the

development of new medical technologies. At a

minimum, an assessment of the artificial heart

program provides an opportunity to address

policy questions concerning the distribution of

research funds for treating heart disease, the

equitable distribution of medical technology,

and the potential costs to society before this lifesaving technology is available for therapeutic

use.

● These Federal expenditures include $134 million in National

Heart, Lung, and Blood Institute (NHLBI) contracts, approximately $30 million in NHLBI grants, and $17 million in Department of

Energy (DOE) funding.
4 ● Background Paper #2. Case Stud/es of Medical Technologies

HISTORY OF THE ARTIFICIAL HEART

The artificial heart program was created at the

National Heart Institute with special congressional approval in 1963. Its ultimate goal is to

develop a totally implantable mechanical heart

—including an implantable power source—

which can be used to replace a failing natural

heart. Since 1964, the program has had a succession of organizational names: Artificial

Heart/Myocardial Infarction Program, Medical

Devices Application Branch (1970), Division of

Technological Applications (1972), and Cardiovascular Devices Branch (1973) of the National

Heart and Lung Institute. The program is currently administered by the Devices and Technology Branch (1974), of the Division of Heart and

Vascular Diseases, of the National Heart, Lung,

and Blood Institute (NHLBI).

The effort to construct heart prostheses followed naturally from the successful design of

heart-lung pumps that could be used during

open-heart surgery to assume (for short periods

only) the functions of both the heart and lung.

Many medical and technical advances suggested

the feasibility of heart replacement: the implantation of artificial heart valves, the development

and widespread use of cardiac pacemakers, increasingly successful blood dialysis as a

mechanical replacement for kidney function,

and the achievement of kidney transplants in

humans and heart transplants in animals. The

success of the aforementioned surgical techniques demonstrated the possibility of prosthetic

replacement, while the immunological rejection

and shortage of donors associated with the

transplants helped demonstrate the need for a

mechanical heart. Other notable technological

achievements included the revolution in miniaturized engineering stimulated by the space

program, advances in energy technologies (e.g.,

the plutonium heat engine), and the development of synthetic materials (e.g., teflon and

lycra) with outstanding engineering specifications for wear and flexibility (45).

These developments helped set the stage for

the construction of prototype hearts by a

number of investigators—Adrian Kantrowitz,

Michael DeBakey, and Willem Kolff. Much of

the earliest work on the artificial heart was carried out, without Federal sponsorship, in academic and research centers.

The search for the large capital outlay necessary to finance the initial R&D for the artificial

heart was given impetus by nature of the medical and engineering problems that were encountered: finding hemocompatible materials able to

withstand continual wear and flexion, finding a

power supply, and developing sophisticated

miniaturized control systems. The magnitude of

these problems discouraged independent

development and created a demand for Government involvement.

The artificial heart program was launched in a

period of both economic growth and great faith

in the powers of science and technology. Heart

researchers, such as Michael DeBakey of Baylor

University, were enthusiastic about developing

an artificial heart and were optimistic that a successful device might take as few as 3 years but no

more than 10 years to achieve. By early 1965,

there was a 5-year plan for achieving the artificial heart: roughly 1 year to assess the “state of

the art,” 1 year to design, test, and develop the

system, 2 years to develop heart prototypes, and

1 year to test the model and determine standards

for mass production (40).

It was widely believed that the approach to

the space race (i.e., systems analysis) could be

used as a model for organizing technological

projects like the artificial heart. A similar approach, including a built-in rivalry among scientists, was therefore adopted by the National

Heart Institute. Several researchers worked on

parallel development of the separate subsystems

of the heart—energy systems, control systems,

blood interface materials—that were to be reintegrated into a working device at a later time

(33). The decision was also made, based on the

success of the space program, to use targeted

contracts to private firms to develop parts and

materials for the device, rather than the more

common research grant procedure (35). This targeted approach, reflecting the specificity of engineering, was based on the assumption that the
Case Study #9; The Artificial Heart: Cost, Risks, and Benefits ● 5

basic scientific knowledge necessary to develop

a device was available.

In the artificial heart program’s early years,

rapid growth in resources—from $500,000 in

1964 to $8 million in 1967—nurtured anticipation of early clinical results. Technical difficulties were greater than anticipated, however,

and the basic knowledge necessary to design and

produce the needed components was not available. There was no solution to two major technical problems: developing hemocompatible biomaterials and a power source. Researchers today

are still attempting to perfect an inner surface

material for the artificial heart that will not

cause adverse chemical reactions when in constant contact with blood, yet is sufficiently

durable to flex more than once a second over a

decade without cracking or chipping (41,69). A

compact, long-lived, and reliable power source

has still not been developed; permanently implanted nuclear energy sources, popular in the

1960’s, have been given a diminished priority,

and greater emphasis is now placed on electrical

engines that require a continuous energy supply

or recharging.

In 1974, in response to these problems, the artificial heart program was moved into NHLBI’s

Division of Heart and Vascular Diseases. There

it developed a more narrow focus, with an emphasis on the development of circulatory-assist

devices that would augment the left ventricle of

the heart by pumping blood from the left ventricle to the aorta. In 1975, authorization was

given to begin clinical trials of a left-ventricularassist device (LVAD) to be used temporarily in

patients unable to resume cardiac function at the

completion of open-heart surgery. Clinical trials

for a 2-year implantable LVAD are expected to

begin in an estimated 3 to 5 years. Targeted efforts beyond that include the development of a

5-year implantable LVAD and electrically energized engines. Researchers see the longer term

implantable LVAD as a significant step, possibly

a decade away. *

Parallel work on totally implantable artificial

hearts is still continuing. Willem Kolff, at the

University of Utah, has a number of calves in

which his prototype heart has been successfully

implanted. Nevertheless, the power source for a

totally implantable artificial heart remains a

continuing source of concern. Kolff’s calves are

on air-driven pumps, tethered to the wall; other

prototypes require that an external battery-pack

power an implanted motor. Estimates as to

when a totally implantable artificial heart

system capable of long-term support will be

achieved are uncertain. The most common

forecast is “many years away. ” Since the

achievement of a totally implantable artificial

heart depends on significant advances in basic

knowledge and in bioengineering, it remains

today a distant goal.

*LVAD research and clinical trials are discussed at greater

length in a separate section of this case study.

POOL OF POTENTIAL RECIPIENTS IN THE UNITED STATES

Sources of Candidates 10

The authors of this case study assume that in

order to be a candidate for heart replacement, a 2.

person must be in the hospital, with death imminent or highly probable, and must survive for 1 3.

hour after the “replacement” decision is made

(i.e., the amount of time needed to set up the

operating room and get the patient on cardiopulmonary bypass). .

survivors of recent myocardial infarction

(heart attack) and/or cardiac arrest with

worsening course,

persons with worsening chronic severe

heart disease, and

persons having open-heart surgery whose

heart after surgery is unable to reassume

the hemodynamic load from the cardiopulmonary bypass pump.

in order to be candidates, persons in the first

The following three groups are sources of group would have to survive their attack or car-

. . . . . potential candidates: diac arrest through the following phases: home/
6 ● Background paper #2: Case Studies of Medical Technologies

work (attack and replacement decision times),

transportation to hospital, treatment in the

emergency room, and initial stabilization in the

coronary care unit. Candidates in the first and

second groups would be primarily patients with

ischemic heart disease (IHD), but would also include some patients with rheumatic heart disease

(RHD).

The second group would include, in addition,

persons with severe cardiomyopathy (heart

muscle disease) which has rendered the heart incapable of supporting the body’s needs at any

level of exertion above absolute rest, and persons with severe electrical instability of the heart

which has been refractory to treatment with

medication. These individuals, we assume,

would have to survive at least 1 hour of hospitalization in order to be candidates.

The third group would consist of persons

whose heart is unable to reassume the body’s

hemodynamic load after the heart has been mechanically bypassed during open-heart surgery.

Such surgery includes operations for coronary

artery bypass, cardiac valve replacement, and

cardiac muscle resection in hearts with severe

mechanical or electrical dysfunction.

Our estimates of the number of potential recipients of an artificial heart are presented

below. These estimates are based on information

available from the Ad Hoc Task Force on Cardiac

ture

●

●

●

●

Replacement in 1969 (1) and recent literaregarding the following:

the percentage of persons experiencing

myocardial infarction or cardiac arrest who

die:

—at home or work,

—during transportation by mobile coronary units,

—in emergency rooms, or

—during stabilization in coronary care

units;

the distribution of “mobile coronary units”

(i.e., urban v. rural);

the total number and distribution of cardiac

deaths per year; and

the prevalence of severe, irreversible, potentially lethal noncardiac diseases in candidates (we assume no change from the

1969 task force estimate of 262/1,000).

We differ from the 1969 task force as follows:

●

●

We do not consider that a patient’s prior

knowledge of cardiac disease alters the pattern of patient delays in seeking medical assistance, nor that it alters the candidacy

status once a patient has been hospitalized.

We do not concur with the task force’s category of “unexpected” deaths, neither with

the numerical estimates of such deaths nor

with the significance attributed to them. We

believe that cardiac deaths can be considered “instantaneous” (occurring in less than

1 to 2 minutes) or “sudden” (occurring in

less than 1 hour). The 1969 estimate of 42

percent (98/233) “unexpected” deaths seems

unreasonably high for “instantaneous”

deaths.

Further, the 1969 report does not appear

to exclude all persons who die within 1 hour

after onset of symptoms. As noted earlier,

at least 1 hour after the replacement decision is made will be required to prepare the

operating room and the patient for heart

replacement. We consider that if the patient

survives for 1 hour or more in a hospital

(avoids “sudden death”), he or she becomes

a potential recipient, as reflected in our

estimates below.

Finally, we assume that there will be no “elective” replacements, i.e., there will be no implantation in patents who are stable under medical

management, regardless of the severity of such

patients’ disease. This consideration might

change over time if the artificial heart proved

highly successful.

Estimates of Potential Candidates in

the United States, 1979

Group 1: Survivors of Recent Myocardial

Infarction and/or Cardiac Arrest

Three separate sets of figures from the medical

literature (23,44,61) are employed in our analysis of the number of potential candidates
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 7

among persons suffering acute myocardial infarction and/or cardiac arrest. Therefore, we

present three separate estimates below and then

use these to arrive at a pooled estimate.

Estimate A

1. Myocardial infarctions/year. . .............700,000

less those who survive uneventfully (50% ). –350,000

less those who die before hospitalization

(25%) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . –175,000

less those die “suddenly” in hospital (s%). . . –35,000

Subtotal . . . . . . . . . . . . . . . . . . . . . .........140,000

2. Cardiac arrests/year. . . . . . . . . . . . . . . . . . . . . .300,000

less those who die “at home”. . . . . . . . . . . . . . –80,000

less those who die before hospitalization. . . . –80,000

less those who die in hospital. . . . . . . . . . . . . . –80,000

less survivors (no mechanical damage

to heart). . . . . . . . . . . . . . . . . . . . . . . . . . . . . –60,000

Subtotal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0

Total estimate A. . . . . . . . . . . . . . . . . . . . . 140,000

Estimate B

Seventy-five percent of all cardiac deaths

are said to occur within 2 hours of symptom

onset. Thus, 25 percent of deaths occur after 2

hours; one-sixth of these deaths occur “without warning. ”

Cardiac deaths/year. . . . . . . . . . . . . . . . . . . . . . 684,000

less 75% who die within 2 hours. . . . . . . . . . –513,000

171,000

less 1/6 who die “without warning”. . . . . . . . –28,500

Total estimate B. . . . . . . . . . . . . . . . . . . . . ..142,500

Estimate C

Fifty percent of all cardiac deaths are said to

be “immediate” (time undefined). Of the rest,

so percent die before hospitalization, and

one-sixth die in the hospital “suddenly. ”

Cardiac deaths/year. . . . . . . . . . . . . . . . . . . . . . 684,000

less 50% whose deaths are “immediate”. . . –342,000

342,000

less 5070 who die before hospitalization. . ...171,000

171,000

less 1/6 who die in hospital “suddenly”. . . . . –28,500

Total estimate C. . . . . . . . . . . . . . . . . . . . . ..142,500

Pooled Estimate

Thus, in group 1 we estimate 140,000 to

142,500 candidates for artificial hearts. The

round figure of 140,000 will be used hereafter. *

Group 2: Persons With Worsening Chronic

Severe Heart Disease

Patients with severe cardiomyopathy and patients with severe electrical instability of the

heart are also prone to die instantaneously or

“suddenly.” The percentage of those persons

who survive 2 or more hours in the hospital, yet

have a worsening course, is estimated from

figures at Stanford University Medical Center,

which serves as a referral center for medical and

surgical treatment of patients in both categories.

We estimate 11,000 such patients per year.

Group 3: Persons Who Are Unable to Come Off

the Cardiopulmonary Bypass Pump Following

Open-Heart Surgery

Patients undergoing open-heart surgery occasionally survive the surgery but are “unable to

come off the pump, “ i.e., the patient’s heart will

not reassume the hemodynamic load when a

transfer is attempted from the artificial cardiopulmonary bypass machinery.

Approximately 100,000 coronary bypass

operations are performed yearly, as well as

other open-heart surgery. Of the patients

undergoing these procedures, we estimate that

no more than 1,000 patients a year would be

“unable to come off the pump. ”

All Groups

By combining the estimates presented above,

we estimate the total number of potential candidates for artificial hearts to be 140,000 +

*The figures used in the three estimates presented for this group

of potential candidates are compatible with data recently collected

in the area of Miami, Fla., which as of 1979 had not yet been published in manuscript form.
&3 ● Background Paper #2: Case Studies of Medical Technologies

11,000 + 1,000 =

152,000. Applying the 262/

1,000 estimated prevalence of severe, irreversible noncardiac disease (1) that would exclude

potential candidates from consideration, we

have 0.262 x 152,000 = 39,824, the latter being

the number of candidates who would be excluded. Their exclusion leaves 152,000 — 39,824

= 112,176, or approximately 112,000 candidates of all ages.

Maximum Age Considerations

According to the National Center for Health

Statistics (NCHS), the following percentages of

all cardiac deaths occur at the ages listed:

<80 years. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75%

<75 years. . . . . . . . . . . . . . . . . . . . . . ...........57.5

< 70 years. . . . . . . . . . . . . . . . . . . . . . . . . . .......42

<65 years. , , . . . . . . . . . . . . . . . . . . . . . . . .......30

From the application of cardiac deaths to the

112,000 candidates of all ages, we derive the

following numbers of candidates:

< 80 years. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84,000

< 75 years. . . . . . . . . . . . . . . . . . . . . ., . .......64,400

< 70 years. . . . . . . . . . . . . . . . . . . . . . .........47,000

<65 years. . . . . . . . . . . . . . . . . . . . . . .........33,600

Thus, our estimate is that there would be

33,600 artificial heart candidates each year

under the age of 65. Our estimate is not much

different from the 1969 Ad Hoc Task Force on

ECONOMIC ASPECTS

The economic costs of diagnosis, implantation, and postoperative care for artificial heart

recipients are not easily predictable from present

artificial heart prototypes, because there have

been only a few human implantations and none

of a totally implantable device. To provide a

range of estimates, therefore, in the discussion

that follows, we review the current cost information for three related medical technologies:

1) cardiac pacemakers, 2) coronary artery

bypass graft (CABG) surgery, and 3) cardiac

transplants. Data on projected device costs for

the artificial heart were obtained from letters

and interviews with manufacturers, as well as

NHLBI reports. Three estimates of the major

Cardiac Replacement’s estimate, based on different assumptions and calculations, that there

would be 32,168 candidates each year under the

age of 65(l).

Patient Access to Implant Hospitals

and Patient Refusal

We estimate above that 33,600 persons would

be candidates for artificial heart implantation

each year if all had access to hospitals capable of

implanting an artificial heart and if all agreed to

the replacement.

If the device is initially highly successful

and/or if the patient selection criteria are relaxed

overtime, as they have been for patients suffering from end-stage renal disease (ESRD), this

figure might increase substantially. To allow for

this possibility, we submit an “upper bound” of

twice this estimate, or approximately 66,000

candidates.

Conversely, if large and intractable technical

or other problems are encountered and/or if

many potential candidates choose not to accept

treatment with this device, the number of candidates might be substantially lower. Accordingly, we suggest a “lower bound” estimate of

16,000 candidates.

items of expense associated with artificial heart

implantation and use are presented in table 1 on

page 11. Following that are a discussion of personnel and facilities and a discussion of funding

for R&D.

Artificial Cardiac Pacemaker

The implantable cardiac pacemaker is a complex device that, like the artificial heart, joins

physicians with engineers and manufacturers.

The first totally implanted pacemakers were

reported in Sweden in 1959 and in the United

States in 1960 (17,37,78). Clearly, the pacemaker is a clinical success. It has been dramati-
Case Study #9; The Artificial Heart: Cost, Risks, and Benefits ● 9

cally lifesaving and has enormously improved

the quality of life for patients with heart block

and other abnormalities of conduction. For purposes of this analysis, however, we are concerned with the costs, reliability, and longevity

records of pacemakers. (For additional information, see app. A.)

From the outset, manufacturers of cardiac

pacemakers predicted that energy stored in the

battery would provide 5 years of pulse-generation function. This 5-year figure was based on

battery capacity and calculated discharge rates;

it did not include an allowance for the replacement of the pulse generator alone. Although

some investigators expressed reservations about

heightened expectations (78), there was a consensus that a 5-year pacemaker was at hand

(17,37). That projection proved overly optimistic. Early battery failure necessitated pacemaker

replacement in 60 percent of pacemaker recipients within 3 or 4 years. Even as late as a decade

after the therapy became accepted, many pulse

generators required replacement at 18 months.

In addition, wire fractures, high thresholds,

other component failures (e. g., self-discharge

within the battery, inward leakage of body

fluids), and infection required reoperation in

about 30 percent of pacemaker recipients within

3 years (55,56). The predicted longevity was not

achieved until 1975, with the availability of new

battery technology (lithium).

The unanticipated complications of systems

failures and recalls for recipients of cardiac

pacemakers meant greater than estimated continuing care costs. Although the expectation had

been for 3 to 5 years of fault-free system performance, the average system longevity during

the first 3 years of pacing was only about 6

months. Some patients had in excess of 15 operations in 3 to 5 years.

A 1976 study (74) analyzed the financial records of patients with more than 4 years (an average of 73 months) of cardiac pacing to establish

basic cost figures. A cost estimate of $7,500 includes an average of $3,500 for the initial implantation and $4,000 for continuing pacemaker

maintenance costs. Modern followup methods,

apart from complications requiring hospitalization and operative repair, are also costly. Electronic monitoring, directly or indirectly by

telephone, represents the best available means of

followup. Electronic monitoring by telephone

promises to reduce the number of emergency admissions, but the procedure is costly. Thirdparty payers, Blue Cross and medicare, now pay

$30 per telephone call; most patients are

monitored twice monthly, some as often as

weekly. Thus, the monitoring cost can approximate $1,560 per year.

Coronary Artery Bypass Grafts

The costs of CABGs have become an issue as

the number of procedures has grown—from

20,000 in 1971, to 50,000 in 1974 (75), to an

estimated 70,000 in 1977 (11), to 100,000 in 1978

(47). Figures from several studies analyzing

surgical costs of CABG patients (24,32,47,59,75)

were updated with assumptions about patient

care for artificial heart recipients to arrive at the

figures given in column A of table 1.

A study by Befeler (11) presents the range of

costs for 20 CABG patients. Hospital charges for

a 17-day average stay ranged from $6,525 to

$22,142, for an average of $10,103. This figure

includes charges for EKG analysis, cardiac

catheterization, blood flow rate measurements,

and other hospital fees that would be incurred

by artificial heart recipients. The professional

fees incurred by CABG patients provide the

most recent comparable cost information for

professional fees that might be incurred by artificial heart recipients. The surgeon’s fee for

CABG currently ranges from $2,000 to $2,400,

averaging $2,200; the anesthesiologist’s fee

averages $974; and the cardiologist’s fee averages $652. This brings the average professional

fees for CABG to $3,826. When these fees are

added to the hospital costs of CABG surgery,

the total charges are $13,929. Allowing for inflation and national variation, we estimate an average cost of $15,000 for CABG surgery.

Heart Transplants

Recent

Stanford

successes in cardiac transplantation at

University Medical Center provide a
IO ● Background Paper #.2: Case Studies of Medical Technologies

third cost comparison. Between 1969 and June

1979, Stanford completed 179 cardiac transplants, with 71 survivors (62). The survival rate

of patients who receive heart transplants now

rivals that of patients who receive kidney transplants from unrelated donors. About 70 percent

survive to 1 year, and 50 percent survive afters

years. The heart transplant patient selection

criteria at Stanford are very stringent. Selection

is based on factors that include the absence of infection, a psychological evaluation, and economic criteria. Patients must show they can provide transportation to and from Stanford during

postoperative monitoring and must document

that the patient’s family can provide financial

support during this period. Many of the recipients are young. Of 13 patients between 12 and

21 years old, 7 are still alive, with a 64-percent

survival rate to 4 years.

In February 1980, the former National Center

for Health Care Technology (NCHCT) recommended that the Health Care Financing Administration (HCFA) reimburse cardiac transplantation at Stanford under medicaid. Previously, a

substantial portion of the costs was underwritten by the National Institutes of Health (NIH). A

full recommendation on medicaid reimbursement for heart transplants is being prepared that

will include suggestions for cost containment incentives, “distributive justice” issues for patients

unable to afford the transportation to and from

Stanford, and a consideration of whether it is

necessary to regionalize (limit to four or five

centers) heart transplants. ’

Average costs for cardiac transplantation at

Stanford in 1977 are listed below (62):

Transportation and lodging. ... ... ... ... ..$ 5,600

Evaluation cost. . . . . . . . . . . . . . . . . . . . . ., ., 3,500

Hospital costs. . . . . . . . . . . . . . . . . . . . . . . . . . 62,000

Professional fees. . . . . . . . . . . . . . . . . . . . . . . . 30,000

Total. . . . . . . . . . . . . . . . . . . . . ... ... ... . .$101,100

These figures for cardiac transplantation do

not include fees for the heart donors, which

would not be encountered in artificial heart

surgery. The largest contributing factor to the

total cost of cardiac transplantation is the length

‘ The Blue Sheet, Feb. 20, 1980.

of hospital stay, which averages 65 patient days.

The average daily costs are between $400 and

$500 (not corrected for inflation). The first 30

days after surgery are spent by cardiac transplant patients in intensive care at the highest

service intensity and costs. Much of artificial

heart implantation would be emergency surgery,

according to our earlier patient selection pool,

and charges for transportation and lodging

would not be incurred. We have deducted these

charges and reduced the hospital charges for cardiac transplantation by one-half (to account for

the shorter hospital stay and fewer laboratory

tests required by artificial heart patients) to arrive at the figures given in column C of table 1.

The annual cost of followup care for heart

transplant patients at Stanford, after the first

year, is approximately $8,800 (62,71). Inpatient

followup care (medical surveillance, chest

X-rays, lab tests, and EKGs) costs about $7,300,

and outpatient followup care about $l,500. The

higher continuing care costs for the first year

and for those eight patients at Stanford who

have had second heart transplants are not included in the maintenance figure. (Tables summarizing the inpatient and outpatient costs at

Stanford are provided in app. B.)

Device Costs

Estimates of the cost of the artificial heart

itself vary, depending on the energy supply. The

following four energy supply systems are discussed in the report of the 1973 Artificial Heart

Assessment Panel (51): 1) electrically powered,

internal heat energy storage, 2) long-term internal secondary battery, 3) external secondary

battery, and 4) nuclear power.

Two of these energy systems are used on

LVADS that are undergoing testing and research

today. One is an electrical-energy converter

powered by an electrochemical battery. The

other is a thermal-energy converter powered by

an electrical or radioisotope-charged battery.

Recent estimates of the future cost of these

LVADs from NHLBI contractors provide the

best proxies for what the potential cost of the artificial heart may be when, and if, it is mass produced. According to representatives from Ther-
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits • 11

moElectron and Aerojet-General, an electromechanical LVAD designed for 2 years of

reliable use, at a production level of 5,000 per

year, will cost an estimated $10,000. A 5-year

device may cost $13,000 or $14,000. In addition,

the batteries for such a device will cost several

hundred dollars a year. An LVAD driven by a

thermal engine will cost an estimated $14,000,

with no additional costs expected for a 5-year

reliable form.

Willem Kolff, at the University of Utah, estimates that the first totally implantable artificial

hearts will be air-driven and will cost around

$14,000. However, many technical problems remain to be resolved (e.g., the development of

reliable biomaterials), and costly solutions

would increase these figures.

There is little potential for declining costs with

mass production of the devices because of the

high level of reliability demanded for the devices

and the expensive marketing structure. Theodore Cooper, former director of NHLBI, confirmed this point in a 1979 interview (22), stating

that he does not expect artificial hearts to be produced on a competitive basis; therefore, saturation and declining costs for the device are not

apt to be realized.

Summary of Costs

Table 1 contains three estimates of the major

items of expense incurred in the diagnosis, implantation, and recovery of patients undergoing

artificial heart implantation. These items have

been discussed in the preceding sections.

Our lower bound cost estimate (A in table 1)

is based on the CABG proxy, a low estimate for

the device of $10,000, and a low estimate for

continuing care of $1,500 based on the experience of cardiac pacemakers. * We do not expect

the technological and continuing surveillance

needs of artificial heart recipients to be less than

emergency medical treatment and monitoring

● There is a considerable difference of opinion about continuing

cost estimates. One reviewer felt that both the cardiac transplant

and pacemaker continuing costs were too high. Another reviewer

felt that there would be numerous mechanical problems, so that

even cardiac transplant estimates were too Zow. In table 1 we have

presented a range of estimates, with $8,000 as the upper bound.

Table 1.—Three Estimates of Major Items of

Expense Associated With Artificial Heart

Implantation and Use

A B c

Cardiac

CABG Calculated transplant

Item of expense prox y

a

fees prox y

b

Implantation

Hospital care. . . . . . .

Professional fees . . .

Device costsc

. . . . . . .

Total . . . . . . . . . . . .

Continuing costsd

Medical care . . . . . . .

Batteries. . . . . . . . . . .

Total yearly . . . . . .

$10,103

3,826

10,000

$10,822

5,300

12,000

$31,000

30,000

14,000

$23,929

$1,500

300

$1,800

$28,122

$2,000

300

$2,300

$75,000

$8,800 —

$8,800

a

CABG proxy for costs of hospital care and professional fees; cardiac pacemaker proxy for costs of continuing medical care.

b

Cardiac transplant proxy for costs of hospital care (adjusted), professional

fees, and continuing medical care.

cBased on estimates for electromechanical LVAD.

d Annua l costs subsequent to implantation.

SOURCE: Estimates are derived from information provided in the text.

costs of cardiac pacemakers. In addition to incurring these continuing medical costs, recipients will have to replace batteries yearly for the

2-year reliable LVADs that are being developed. * * These batteries will cost about $300 to

$500 annually.***

Our second cost estimate (B in table 1) is

based on our own calculations using current

hospital costs, professional fees, and a middle

estimate of $12,000 for the device. Consultations

with cardiac surgeons suggest that the nonemergency patient will need to be hospitalized for 5

to 7 days prior to artificial heart implantation.

Immediately after surgery, the patient will be

placed in an intensive care unit for extensive

monitoring and treatment for an anticipated

period of 7 days. Normal progression of the recovery processes would be expected to require a

hospital stay of about 21 days. Combining these

length-of-stay figures with current hospital

costs, we calculate that the recipient of an artificial heart would incur total hospital costs of

$10,822. That total includes $6,300 for 28 days

of care (7 days preoperatively, 21 days postoperatively) at $225 per day* and $4,522 for 7 days

of intensive care at $646 per day.** —.. —

**See section on LVAD research below for a description.

***Estimate from Thermoelectron.

*Cost figures from the American Hospital Association.

**The amount reimbursed by the Health Care Financing Administration (HCFA) for intensive care.
12 . Backgroimd Paper #2: Case Studies of Medical Technologies

We have added the professional fees stated for

CABG patients ($3,826) and applied them to the

surgical demands of artificial heart implantation. * The amount increases, because of the anticipated need for an associate surgeon (fee of

$500) and two anesthesiologists, to $5,300.**

When we add these fees to the hospital costs, we

arrive at estimated charges of $16,122, well

within the range of coronary bypass surgery.

(Many of our interviewees compared implantation costs to present bypass costs. ) Following

hospitalization and discharge, the artificial heart

recipient would presumably spend a reasonably

prolonged period of recovery. We anticipate

that during this recovery period the patient will

require frequent visits to the physician at the

hospital where the surgery was performed. For

this reason, we expect the first year’s costs to be

similar to those for cardiac transplant patients,

but we have chosen a lower continuing cost

figure of $2,000.

Our upper bound estimate (C in table 1)

employs the cardiac transplant figures described

earlier. The only addition is the device figure of

$14,000 for an air-driven heart, which would

not require batteries.

It must be noted that for all three estimates we

assume no surgical complications such as thrombosis, hemorrhage, and circulatory insufficiency. Such complications would require a longer

hospital stay and could easily double the hospital costs.

● In an experimental procedure, professional fees are not ordinarily charged. However, once the artificial heart is deemed to be

therapeutic, these fees will be incurred.

● *See discussion of personnel and facilities in the next section of

this case study.

In summary, the hospital and implantation

costs to the recipient of an artificial heart may

approach the present fees associated with cardiac transplants and will certainly be higher than

the present costs of CABG surgery. Table 2 lists

varying total societal costs for the range of

biologic or mechanical heart implants discussed

in the previous section of this case study and

also shows the impact on present facilities and

personnel. Even the best estimates project an expense that an individual recipient would not be

able to afford completely and that private insurance schemes would be expected to reimburse

only partially (as with dialysis and heart transplants). To meet these expenses, which could

easily reach $3 billion annually, the Government

will have to consider new concepts in insurance

or social security coverage.

Personnel and Facilities

An important consideration in planning for

the clinical application of the artificial heart is

the adequacy of present medical facilities and

surgical teams. The agonizing selection of patients associated with the early days of hemodialysis points up the problem that a shortage of

facilities and skilled personnel may create if

preparations for the artificial heart are inadequate.

John Watson, Chief of the Devices and Technology Branch of NHLBI, believes that existing

open-heart facilities should be adequate for artificial heart surgery and postoperative recovery

(77). The growth in emergency cardiac facilities

and personnel during the last decade and the

plans for mobile care units and coronary facilities throughout the United States should proTable 2.—Effect of Numbers of Implants on Available Societal Resources

Implants per surgeon per Implants per facility

Total costs per year (in millions) year with number of per year with number of

Replacements with implantation costs of: available surgeons: available facilities:

per year $24,000 $28,000 $75,000 800 1,000 1,200 600 800 1,000

16,000 . . . . . . . . . . . . $ 384.0 0 $ 448.0 0 $1,200.00 20.0 16.0 13.3 26.7 20.0 16.0

33,600 . . . . . . . . . . . . 806.40 940.80 2,520.00 42.0 33.6 28.0 56.0 42.0 33.6

47,000 . . . . . . . . . . . . 1,128.00 1,316.00 3,525.00 58.8 47.0 39.2 78.3 58.8 47.0

66,000 . . . . . . . . . . . . 1,584.00 1,848.00 4,950.00 82.5 66.0 55.0 110.0 82.5 66.0

SOURCE: Estimates are derived from information provided in the text.
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits . 13

vide a facilities base suitable for the transportation of candidates for artificial heart surgery. As

noted below, however, artificial heart implantations may severely strain existing personnel

resources.

Interviews with cardiac surgeons indicate that

the services of the current open-heart procedure

team plus an associate surgeon and an artificial

device engineer will be required for artificial

heart implantation. The estimated personnel requirements in the operating room are listed

below:

Hours

Chief surgeon. . . . . . . . . . . . . . . . . . . . . . .........4-5

Associate surgeon. . . . . . . . . . . . . . . . . . . . . . ......2-3

Anesthesiologists (2). . . . . . . . . . . . . . . . . . . . . .. ...7-8

Heart-lung machine operators (2). . .............7-8

Residents (3). . . . . . . . . . . . . . . . . . . . . . ..........7-8

Nurses (3). . . . . . . . . . . . . . . . . . . . . . .............7-8

Technicians (2). . . . . . . . . . . . . . . . . . . . . . . . .. ....7-8

Artificial device engineer. . . . . . . . . . . . . . . . . . . . . . 4-s

These personnel requirements are extensive

when superimposed on present needs for skilled

surgeons and nurses for heart-lung work, heart

transplants, arterial grafts, and pacemaker implantations. Artificial heart surgery, like heart

transplantation, is likely to disrupt any

hospital’s schedule. In addition, the surgery is

only a small part of the patient care process,

which requires the time and resources of nurses,

lab technicians, physicians, and engineers.

It is difficult to estimate the present number of

cardiac surgeons, because currently available

medical specialty statistics do not differentiate

between cardiac and noncardiac thoracic surgeons. In 1976, there were 2,020 thoracic surgeons (3). Approximately 39 percent (780) are

estimated to be active cardiovascular surgeons.

The supply of cardiac surgeons has been increasing at about 15 percent per year (59), so shortly

almost half of certified thoracic surgeons will be

active in cardiac surgery. Using these figures, we

have assumed that as few as 800 and probably

closer to 1,000 surgeons will be available to perform artificial heart surgery in the coming

decade.

In 1976, an estimated 600 hospitals were

engaged in open-heart surgery, an increase from

432 hospitals in 1972. Under the assumption that

no new facilities would be required for artificial

heart implantation, if one postulates a total of

33,600 implants a year* and 800 hospitals have

cardiac facilities, each hospital would average 42

implants per year. These centers will also have

subsidiary concerns, among them the blood requirements necessary to prime the heart-lung

machine for surgical bypass and emergency care

of hemorrhage, pump oxygenators, and an inventory of artificial hearts available for immediate use. With a product whose demand

could vary from 16,000 to 66,000 per year and

whose reliability, longevity, and maintenance

record still remain undocumented, accurate estimates of the major resource requirements are

still not feasible.

R&D Funding

The NHLBI-directed program for the development and assessment of circulatory-assist and

cardiac replacement devices is partially funded

through contracts (see app. C). This family of

contracts provides funds for researching blood

pumps, power sources, energy transmission and

storage, instrumentation, and biomaterials.

There is no single major recipient of contract

funds. As shown in table 3, the targeted contract

program of the Devices and Technology Branch

grew rapidly from $500,000 in fiscal year 1964 to

$8 million by fiscal year 1976. Since then, the

program has remained relatively stable at an

average of $10 million a year. Figure 1 compares

relative funding levels for NIH, NHLBI, and the

artificial heart program for fiscal years 1964

through 1975.

NHLBI has also supported basic research for

the artificial heart development program

through extramural grant programs. The extent

of these funds is difficult to delineate in the

overall Institute grant figures. The responsibilities of the Devices and Technology Branch

were broadened to include grants in 1975. Activities funded through regular and project

grants include intra-aortic balloons, biomaterials, and prosthetic heart valves (see app. C).

The branch also has unrelated grant activities on

*The manner of arriving at this estimate was discussed in the

previous part of this case study.
—.

14. Background paper #2: Case Studies of Medical Technologies

Table 3.—NHLBI Devices and Technology Branch Contract Funding, Fiscal Years 1964-79

Programs

Energy Bioinstru- Special Physiological

Fiscal year Materials systems Blood pumps mentation programs Oxygenator s testing Total

1964 . . . . . . $ 209,085 $ 93,856 $ 278,183 $ 0 $ 0 $ 0 $ 0 $ 581,124

1965 . . . . . . 0 0 0 0 261,756 0 0 261,756

1966 . . . . . . 843,242 728,500 316,555 0 1,680,857 0 335,777 3,904,931

1967 . . . . . . 1,735,469 2,909,378 1,377,433 0 898,406 467,747 1,165,876 8,554,309

1968 . . . . . . 2,130,569 1,365,749 1,533,379 617,456 149,818 590,440 1,454,113 7,841,524

1969 . . . . . . 1,062,462 2,902,329 1,345,945 479,833 239,012 495,766 1,862,252 8,387,599

1970 . . . . . . 1,089,083 2,660,840 1,476,869 312,657 9,000 338,460 3,388,334 9,275,243

1971 . . . . . . 1,115,375 3,165,036 1,793,847 146,023 446,757 676,786 1,873,712 9,217,536

1972 . . . . . . 905,044 3,897,469 2,386,193 251,386 62,548 381,161 2,700,718 10,584,514

1973 . . . . . . 1,877,930 2,822,000 1,971,222 183,513 42,500 43,848 2,996,743 9,937,756

1974 . . . . . . 557,214 3,471,258 2,466,405 560,030 44,978 0 851,655 7,961,540

1975 . . . . . . 440,069 3,480)204 3,448,612 1,707,659 0 0 56,196 9,132,740

1976 . . . . . . 3,274,000 3,182,000 3,082,000 1,492,000 908,000 0 0 11,938,000

1977 . . . . . . 3,259,000 3,883,000 3,098,000 2,040,000 921,000 0 0 13,201,000

1978 . . . . . . 2,373,000 4,034,000 2,899,000 2,235,000 577,000 0 0 12,118,000

1979a. . . . . . 1,700,000 3,700,000 3,300,000 1,800,000 500,000 0 0 11,000,000

Total. . . . $22,571,542 $42,295,619 $30,773,643 $11,835,557 $6,741,63 2 $2,994,208 $16,685,376 $133,897,57 7

a

Estimated.

SOURCE: National Heart, Lung, and Blood Institute, Devices and Technology Branch, Bethesda, Md., 1979

Figure I.—Comparative Program Growth: NIH, NHLBI, and the Artificial Heart Program,

Fiscal Years 1964-75

250

200

150

100

50

1964 1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975

Fiscal yea r

SOURCE: National Heart, Lung, and Blood Institute, Bethesda, Md.
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits . 15

diagnostic instruments and

John Watson, of NHLBI,

grant spending since 1964

therapeutic devices.

has estimated total

at $30 million. For

fiscal years 1977 through 1979, the grants

specifically related to the development of the artificial heart were $10 million. Approximately

$3.5 million in grants were funded in fiscal year

1978.

The $164 million spent to date on the NHLBI

artificial heart program ($134 million in contracts, $30 million in grants) represents the bulk

of the total cost of developing an artificial heart,

but several research institutes and technology

firms have held Department of Energy (DOE)

contracts (totaling $17 million) to develop a

nuclear engine for an LVAD or totally implantable artificial heart. Contractors include the University of Utah, Westinghouse, Andros, Arco,

and Aerojet-General. We have estimates from

only one contractor on the size of these funds,

though we have contacted other recipients for

information. That firm has spent almost $7

million to date on thermal energy development.

The financial history of the artificial heart program at DOE is summarized in table 4.

In 1968, the Atomic Energy Commission

(AEC), now DOE, initiated a program at Los

Alamos Scientific Labs for the development of

plutonium-238 (Pu-238) fuel for the artificial

heart. In 1971, contracts were awarded to several university research centers (University of

Utah, Cleveland Clinic, University of Washington) to begin biomechanical and biomaterials

studies. According to Donald Cole of DOE’s Office of Health and Environmental Research (20),

DOE funding has recently ended.

It is by no means clear, however, that interest

in nuclear energy as a power source for the artificial heart has ended. In early 1979, NIH

solicited proposals for research into a clinical

thermal energy system, and in November 1979,

3-year contracts for $900,000 and $795,000,

respectively, were awarded to Aerojet-General

and the University of Washington. The thermal

engine to be designed can be driven by one of

two energy sources: thermal (e.g., lithium salts)

or nuclear (e. g., Pu-238). Of these two sources,

Pu-238 is acknowledged to be clinically the more

attractive, because lithium salts must be reheated at intervals not exceeding 4 to 8 hours.

Table 4.—Financial History of the Artificial Heart Program at the Department of Energy

Period of

Contractor performance

Westinghouse Electric Co. . . . . . . 4/19/71 - 6/30/78

Hittman Associates . . . . . . . . . . . . 3/74 - 3/75

Universities Center. . . . . . . . . . . . . 8/1/73 - 7/31/74

University of Washington . . . . . . . 6/15/71 - 9/14/78

TRW, Inc. . . . . . . . . . . . . . . . . . . . . . 4/19/71 - 6/30/75

Cleveland Clinic . . . . . . . . . . . . . . . 2/15/72 - 12/31/77

Cornell University. . . . . . . . . . . . . . 9/74 - 9/30/78

Sinai Hospital . . . . . . . . . . . . . . . . . 9/1/75 - 8/31/76

University of Utah. . . . . . . . . . . . . . 6/15/71 - 6/30/79

University of Utah. . . . . . . . . . . . . . 6/15/71 - 9/14/77

Westinghouse Electric Co. . . . . . . 5/1/72 - 4/30/73

Los Alamos Scientific Laboratory. 7/1/72 - 9/30/77

Mound Laboratory . . . . . . . . . . . . . 7/1/72 - 6/30/73

Pacific-Northwest Laboratory. . . . 7/1/72 - 6/30/74

Pacific-Northwest Laboratory. . . . 7/1/72 - 9/30/77

Pacific-Northwest Laboratory. . . . 7/1/73 - 10/1/76

Title Cumulative costs

Nuclear-powered artificial heart $10,005,103

Development of a radioisotope heat source 16,000

subsystem for heart devices

Artificial heart controls support 19,033

A program to evaluate the mechanical properties and 457,883

biocompatibility of materials for the ERDA

artificial heart

Radioisotope heat source for an artificial heart 527,499

Artificial heart supporting services 257,499

Biological effects of implanted nuclear energy 371,666

sources for artificial heart devices

ERDA artificial heart program review 9,874

Biomedical engineering support 1,719,880

Materials testing and requirements for the ERDA 357,208

nuclear-powered artificial heart

An investigation of high-performance thermal 132,421

insulation systems

Fuels and source development 2,083,000

Fuels and source development 59,000

Recipient radiation exposure 163,000

Population radiation exposure 145,000

Pu-238 from Am-241 315,000

SOURCE Information provided by the Department of Energy, Washington, DC.
16 ● Background Paper #2: Case Studies of Medical Technologies

In addition to Federal contracts and grants,

some private funding helps to support artificial

heart research. For example, the Cleveland

Clinic has an NHLBI contract to develop a pump

suitable for an implantable LVAD. Supplementing this contract, Parker-Hannifin Corp. provides a philanthropic gift that covers approximately 10 percent of the clinic’s heart device research. TRW Corp. produces at its own expense

components that are contributed to the clinic.

Goodyear Corp. contributes expertise and

manufactures the diaphragm for the pumps. It

also contributes one full-time employee who

works on the clinic’s heart device program. This

support is part of Goodyear’s Aid to Medical Research Program. The Cleveland Clinic is also

testing Medtronics’ LVADs with that firm’s

equipment, service, and expertise. Testing and

clinical trials of these devices are separate from

NHLBI funding.

Federal allocations for the artificial heart program have averaged $10 million since 1964, and

the present annual figure is approximately $15

million in contracts and grants. The growth in

allocations has not kept up with requests or inflation. Some researchers, such as Yuki Nosé of

the Cleveland Clinic, have estimated that a

clinically useful, totally implantable LVAD may

be ready in 1983, and that a totally implantable

artificial heart may possibly be available in

1986. Other contractors say these estimates are

optimistic, given present funding, and some

claim that a totally implantable artificial heart

may not be ready until the year 2000. It could

happen, then, that federally funded research will

be required for another 10 years. If annual

allocations are held at the present level for 10

years, this means an additional $150 million in

Federal R&D funds—and $300 million is a potential figure if research continues until the end

of the century.

PARALLEL COSTS OF HEMODIALYSIS

Hemodialysis and kidney transplantation

emerged as life-extending therapies for victims

of ESRD in the early 1960’s. Here we examine

the experience of hemodialysis financing and

distribution in order to draw lessons that have

potential for application to the artificial heart.

Systematic funding efforts by NIH on behalf

of the kidney program began in 1965 (64). At

that time, the artificial kidney-chronic uremia

program of the National Institute of Arthritis,

Metabolism, and Digestive Diseases (NIAMDD)

was founded with a contract research program

to build a better artificial kidney. The artificial

kidney program was mandated by the House

and Senate Appropriations Committees with the

1966 budget, 1 year after the artificial heart program was founded in the National Heart Institute. Though the artificial kidney was advanced

well beyond the artificial heart at the time,

advocates of the artificial heart (such as Michael

DeBakey) appear to have been more powerful.

Human kidney transplantation, which following occasional attempts in the 1940’s had begun

in earnest in the 1950’s, developed in parallel

with the artificial kidney. The availability of

hemodialysis helped the kidney transplantation

program by making available pools of potential

transplant recipients. NIH funding was available

for transplantation research, because the researchers who worked on the immunological

problem were well known as basic researchers

(64). Information concerning the total sums

spent on development of artificial kidney technology or kidney transplantation is not readily

available.

In 1960, cost estimates for hemodialysis were

made by Belding Scribner and his colleagues at

the University of Washington in Seattle (63,64).

Minus equipment, the cost per patient for onceweekly dialysis was estimated to be $5,533 annually. The later recognition that dialysis three

times weekly would be better medically greatly
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits . 17

increased per patient costs (63). In 1963, at a

joint finance meeting of the American Medical

Association and the National Kidney Disease

Foundation, costs were estimated to be about

$20,000 per patient per year. The moral questions involved in the availability of dialysis were

brought up at the same meeting. There was concern that 25 to 50 percent of those who needed

dialysis were not able to obtain it (43).

In 1964, the Federal Government recognized

its potential fiscal role in treatment of ESRD,

and the Senate Appropriations Committee said

that the Public Health Service (PHS) had the

authority to provide demonstration and training

funds for artificial kidney programs (but not for

patient care) (63). Scribner and his colleagues in

Seattle, through community fundraising and

private philanthropy, had developed a community treatment center in 1962. The first PHS

demonstration and training grant had been

given to that center in 1963 (63), to be phased

out in 3 years. Also in 1964, NBC television was

preparing a documentary that was aired in 1965

contrasting the millions the Government was

willing to spend on the space program to the

small amount spent for dying individual in need

of dialysis. A total of $3.4 million was allotted

for support of 14 community dialysis centers. In

1968 and 1969, PHS took action to gradually

stop funding these centers.

In 1967, despite these efforts, the Gottschalk

committee (an advisory group convened by the

Bureau of the Budget) recommended Federal

financing of patient care for ESRD through an

amendment to the medicare component of the

Social Security Act. One month prior to the

1972 election, Congress passed the Social Security Amendments including section 2991 which

extended medicare coverage to the treatment of

ESRD. Section 2991 was allotted less than 30

minutes of discussion on the Senate floor and

given only a few minutes of deliberation in the

joint House-Senate Conference Committee.

President Nixon signed it into law on October

30, 1972 (63). Senator Vance Hartke, who sponsored section 2991, stated that estimated annual

costs at the end of 4 years would be $250 million, with a first year cost of $75 million (63). *

Ronald M. Klar, in the Office of the Assistant

Secretary of Health at the Department of

Health, Education, and Welfare (HEW), immediately saw problems with this estimate.

Through information obtained from nephrologists, Klar made new projections of the costs of

the ESRD program based on a new cohort of patients entering the program each year. Each

cohort would include about 10,000 patients,

2,000 of whom would be transplanted; there

would be about a 20-percent annual mortality

rate; and the average annual cost of dialysis

would be $16,000. Thus, according to HEW in

1972, the cost in 5 years would be an estimated

$592.1 million for 40,000 patients. By the time

the program stabilized in 10 years, the cost

would be $1 billion annually (64). Table 5 summarizes the 1972 HEW and 1974 Social Security

Administration (SSA) estimates of the annual

costs for the ESRD program (64).

The House Ways and Means Committee, in

1975, estimated there would be 50,000 to 60,000

patients by 1984 at a cost of $1 billion, and

*The Senate amendment included a 6-month waiting period for

patients before benefits should begin, which the House Ways and

Means Committee was able to change to 3 months.

Table 5.—Estimated Annual Costs for the ESRD Program (dollars in millions)

SSA estimates of

Total patient medicare expenditures HEW estimates of total

Fiscal year population (1974) national costs (1972)

1974 . . . . . . . . . . . . 9,980 $135 $157.7

1975 . . . . . . . . . . . . 18,754 176 281.5

1976 . . . . . . . . . . . . 26,746 223 394.5

1977 . . . . . . . . . . . . 34,036 278 497.8

1978 . . . . . . . . . . . . 40,685 — 592.1

SOURCE: R. A. Rettig and T. C. Webster, “Implementation of the End-Stage Renal Disease Program: A Mixed Pattern of Subsidizing and Regulating the Delivery of Medical Services, ” 1977 (64),

94-283 c - 52 - 4
18 ● Background Paper #2: Case Studies of Medical Technologies

50,000 to 70,000 patients by 1990 at a cost of

$1.7 billion (64). According to Barnes (9), the

National Dialysis Registry estimates an annual

mortality rate of only 10.8 percent for patients

on dialysis during the first 4 years of care. Since

the highest mortality rate occurs in the first year,

this estimate is in marked contrast to the estimate of a 20-percent annual mortality rate of the

Office of the Actuary of the SSA noted above.

A number of problems have occurred with

regard to cost estimates for the ESRD program.

Both Barnes (9) and Rettig (64) address them

thoroughly. We summarize the most important

points below.

●

●

●

●

●

●

There has been persistent underestimation

of total costs.

The early hope of increased success with

cadaveric transplantation has not been

realized.

The increased problem of poor quality of

life for patients and the small proportion

rehabilitated was not anticipated. *

Cost-reducing innovations in therapy

through R&D have not occurred.

Prospects for disease prevention seem

remote.

The least expensive mode of treatment,

home dialysis, is not being used as exten-

‘Quality of life parameters are discussed below in another part

of this case study.

sively as expected. Some of this problem is

the result of taking marginal patients such

as the elderly and diabetics, as well as the

result of economic disincentives for home

dialysis by patients and physician providers.

The artificial heart program has received more

Federal research money than the hemodialysis

program did at equivalent stages of development. Early meetings of the American Society

for Artificial Internal Organs saw development

of an artificial heart as much more complex than

that of an artificial kidney, because a permanent, complete artificial heart must constantly

perform the full and precise function of the

human heart, whereas a kidney can function

part time and at a comparatively low capacity.

Anderton, et al. (4) have concluded that there

is no positive economic benefit for the treatment

of renal failure. In paying for such treatment,

society is tacitly agreeing to pay for the intangible” benefits of avoidance of pain, discomfort, grief, and premature loss of human life. For

the artificial heart program, the dialysis experience indicates that the allocation of scarce medical resources for the saving or prolonging of

lives deserves thoughtful deliberation.

**In economics, “intangibles” are those costs and benefits that

cannot be quantified or miced. .

ESTIMATES OF THE POTENTIAL SUCCESS OF

THE ARTIFICIAL HEART

LVAD Research and Clinical Trials

Since its inception, the artificial heart program has advocated simultaneous research on

both permanent heart replacement and temporary LVADs. Because of the obstacles encountered in developing a totally implantable artificial heart, however, the development of the

LVAD now takes priority. NHLBI funding since

1974 has been largely concentrated on the development of LVAD control systems, pump design,

biomaterials, and beginning in 1975, clinical

trials.

The goals of the LVAD program center at

present on developing a long-term (2- to 5-year)

implantable LVAD capable of taking over the

pumping function of the weakened left ventricle

of the heart and enabling its eventual recovery.

The development of a long-term assist device

will draw heavily on current experience with the

temporary (2-week) LVAD. Many models of the

temporary LVAD currently exist; these have

been funded largely through NHLBI,2 but partly

2

See Report of Cardiology Advisory Committee, ]ournal of

Artificial Internal Organs (}A1O), November 1977, for summary

of NHLBI devices.
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 19

through independent corporate investment (e.g.,

by Medtronics and Arco Medical Products).

Because of the recent emphasis on developing a

long-term implantable LVAD, explicit funding

of total artificial heart development has been

much less extensive; in 1978, NHLBI had only

four total artificial heart contracts, totaling $1

million.

In 1974, NHLBI convened a workshop to consider the desirability and feasibility of conducting LVAD clinical trials. Ruth Hegyeli and

Michael Machesko, 1974 workshop participants, reviewed in vitro and animal data on the

Thermoelectron LVAD (TECO models VII and

X) used by John Norman of the Texas Heart Institute and William Bernhard of Boston Children’s Hospital (34). They concluded that clinical trials would be in order once biomaterials

suitable for short-term use were developed, adequate provisions were made to protect patient/

subject rights, and criteria were established for

patient selection.

After meeting these criteria, Norman and

Bernhard received funding from NHLBI for

clinical trials of the short-term (2-week) LVAD.

Both the Texas Heart Institute and Boston

Children’s Hospital trials used the same patient

selection protocol, which sets forth a number of

conditions to be met by potential LVAD recipients. Only patients unable to resume cardiac

function at the conclusion of cardiac pulmonary

bypass were included. A total of 38 implants (23

Texas, 15 Boston) were performed in this program (58). Three patients were alive at this

writing (May 1980), 25, 24, and 18 months after

surgery; one patient survived 7 months. Of the

last 14 implants, 8 were successfully supported

for more than 40 hours (77). *

In addition to the NHLBI clinical trial contract

program, several other clinical trials of different

LVAD models have taken place.** William

Pierce, of Pennsylvania State University, has

used a smooth-surfaced, polyurethane-coated

pump in approximately nine patients and re-

*A summary of the clinical trial program is currently being developed by NHLBI.

* *For example, see articles in the 1978 issue of JAIO devoted exclusively to LVADS.

ported the first long-term survivor (57). Limited

clinical use of other LVADs in at least 11 patients has been reported, with 2 long-term survivors (57). The extent of use of commercially

developed pumps (e.g., Arco, Arothane) in

therapeutic settings is unknown, because data

from these implants are not formally reported.

Those who have conducted LVAD clinical

trials believe they have obtained much valuable

information that will contribute to the successful

development and use of future long-term devices. Such information includes confirmation

of the hypothesis that temporarily taking over

the left ventricle pumping function can, in some

patients, lead to partial recovery of the depressed ventricle and the observation that right

heart function is not always necessary during

LVAD implantation (52).

Major problems in device design and function

still exist, however. A primary challenge is the

development of biomaterials that do not encourage thrombogenesis (formation of blood clots)

and do not decompose over long-term use. Another challenge is the development of a portable,

reliable energy source. Current prototypes using

electric batteries have both mechanical and

operational liabilities; Pu-238-powered fuel cells

provide a compact energy source but pose severe

problems due to health risks from radiation.***

NHLBI has given top priority to further research in the areas of biomaterials and energy

sources (16). A special biomaterials task force

issued recommendations in 1977 calling for the

exploration of the comparative viability of

rough and smooth surfaces, the development of

operational and quantitative definitions of

blood compatibility, theories that correlate

blood compatibility with physiochemical characteristics of biomaterials, and adequate test and

evaluation methods. There has been progress in

these areas, and advances will increase as

NHLBI grants for basic research in biomaterials

expand. Because of the magnitude of the technical problems that must be solved in order to

develop a long-term (2-year) LVAD, estimates

for commencement of clinical trials of the long-

***The problems of a nuclear-powered heart are discussed

below in a separate section of this case study.
20 . Background Paper #.?: Case Studies of Medical Technologies

term LVAD range from 3 to 6 years. Industry

representatives (Thermoelectron and Aerojet

General) note that even the 6-year estimate may

be overly optimistic if the level of Federal funding does not increase.

Another factor complicating long-term device

development is the diversity of existing LVAD

programs and the difficulty of coordinating

research or clinical trial results. Although data

from NHLBI-sponsored LVAD programs have

been difficult to compile, the existence of

privately funded programs makes comprehensive data collection and coordinated research efforts even more difficult.

The experience of clinical trials of short-term

LVADs appears to be of only limited use in projecting the potential success of permanent devices, in part because the research protocols restricted potential recipients to very ill patients

who are likely to die regardless of the form of

treatment. Because the devices are implanted

temporarily, only short-term mechanical performance and negative side effects can be observed; medium- and long-term device performance and side effects cannot be evaluated. Since

most patients die on the operating table from

other causes, even potential complications due

to the short-term device cannot usually be identified.

Instrument Reliability

Instrument reliability is of utmost importance

in the effort to achieve a clinically successful

totally implantable artificial heart. With the patient’s natural heart removed, sudden instrument failure would lead to the patient’s death

within minutes unless corrected. Reliability is

different from durability. The durability of the

individual components of a device can be bench

tested and predicted with some confidence (e.g.,

materials that will flex with every stroke of the

heart pump can be tested for the enormous number of such flexions to which the materials will

be subjected over the anticipated instrument

life). The reliability of the assembled components under the conditions of use cannot be

predicted from bench tests alone, and testing has

not yet been done in animals. Testing, when

begun, will have to extend for at least as long a

period of time as the required life of the device

and, perhaps, twice as long. * Thus, if the target

is for a 5-year device, it will be necessary to wait

for 5 to 10 years before reliability can be established. ” Further, since the concept of reliability

is a statistical one, large numbers of trials may

need to be carried out.

Experience with other medical devices offers

some basis for expectation and for concern. The

cardiac pacemaker, an enormously less complex

instrument, has presented a series of serious difficulties which, after nearly 20 years of clinical

use, have only now been resolved with reasonable success. These include lead breaks, battery

failure, runaway pacemakers, electromagnetic

interference, and errors in manufacture as well

as errors and complications in clinical application. *** The cardiac pacemaker is a simple,

primarily electrical device with a low energy requirement. The artificial heart is a complex electromechanical device which has high energy and

mechanical requirements. Although pacemaker

failure is a serious complication, the patient

often survives long enough for replacement.

Failure of the artificial heart, however, would in

almost all imaginable circumstances lead rapidly

to death.

Our consultants express confidence that an

appropriate energy source (e.g., battery) with 5

to 7 years predictable life is currently feasible.

No such assurances have been offered for the

mechanical components or for the artificial heart

system as a whole. Opinions have been offered

that a system life as short as 60 days or as long as

a year may be encountered. Contributing to the

uncertainty is the existence of a number of identifiable problems that have yet to be resolved.

● Accelerated aging at increased temperatures can be used to

shorten the period of testing of implantable electronic devices but

would not be appropriate under the hemodynamic conditions of

the artificial heart. A method to shorten the test period for the artificial heart is urgently needed but cannot be counted on.

**In discussing this section, Kolff and others have pointed out

that a device of even as little as l-year reliability would be welcomed by many patients and physicians.

***See app. A by Dr. Thomas Preston for a summary of the introduction of the pacemaker and difficulties encountered; see also

testimony of Sidney M. Wolfe and Anita Johnson on medical

device legislation before the House Subcommittee on Health, July

28, 1975 and Oct. 23, 1973.
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 21

Such problems include permeability to moisture activated pump. It can be assumed that prob-

(undesirable) and to gases (desirable), and the lems that cannot be identified at present will also

need for volume and pressure compensation present themselves.

behind the moving pistons in a mechanically

QUALITY OF LIFE

The stated goal of every transplantation program is to return patients to active, productive

lives. The experience of heart transplants,

kidney transplants and. dialysis suggests that,

while for many patients the quality of life is considered good, the replacement of a vital organ

often produces unforeseen complications in

other parts of the body. It is impossible to

predict the spectrum of adverse outcomes that

will be encountered with the artificial heart.

Nevertheless, it may be possible to draw inferences concerning the chances for partial or

total rehabilitation after implantation of an artificial heart by examining related experience

with these other major surgical and medical interventions. Therefore, we examine that experience below. We also discuss the problems

that might be associated with a nuclear-powered

device.

Hemodialysis and Kidney Transplants

In general, short-term complications were expected very early in the use of dialysis. These included hemolysis, bleeding from heparinization,

calcium disturbances, and electrolyte disturbances, It was only after a few years that renal

bone disease, neuropathies, and hepatitis were

seen (9). Some progress has been made with

these problems, but accelerated atherosclerosis,

dialysis ascites, and dialysis dementia (an acute

deterioration of cerebral function) remain. In the

United States, 55 percent of dialysis patients and

34 percent of staff are carriers of hepatitis virus

B. Of those infected, 70 percent of patients and

15 percent of staff develop an anicteric hepatitis

(9). Depression and rapid mood swings are recurring or chronic problems and may be related

in part to electrolyte changes and other physiologic changes and in part to the psychic stress

of ESRD. Barnes (9) quotes studies indicating

that as many as 11 to 18 percent of deaths on

dialysis may result from progressive dialysis encephalopathy. This may be caused by excessive

aluminum in the

can result from

bind phosphates

aluminum in the

Family-related

central nervous system, which

aluminum hydroxide used to

in the intestine or even from

water supply.

problems occur frequently.

Sometimes there is a reversal of dependency

relations between spouses. Patients must restrict

their diet and fluid intake. Females are frequently anovulatory and develop amenorrhea. Many

males are impotent (59 percent at Mt. Zion

Hospital). Women, especially, have self-image

problems due to surgical scars from parathyroidectomies, splenectomies, sometimes nephrectomies, and transplant surgery (64). Levy

reported on a study of 15 children in six families

in which psychological assessment revealed that

all 15 were clinically depressed and showed

decreased academic achievement and some

psychomotor disorders (43). He also reported

that children whose parents were dialysed in

centers rather than at home did better and were

able to see the parent as more normal.

Serious dependence-independence conflicts

are reported by several authors (4,25,43). Patients who had been very independent initially

were forced to depend on other people and machines. Those who had always been dependent

tended to regress and become extremely passive,

refusing to participate in their care, attempt to

work, etc. Levy reports that staff, who are also

under constant strain of working with very ill,

irritable, depressed patients, often use the power

differential to meet their own emotional needs

and may contribute to forcing people to be even

more dependent (43). It is a rare patient and

family who are knowledgeable enough to overcome this.
—

,22 . Background Paper #2: Case Studies of Medical Technologies

A study on suicide by Abram, Moore, and

Westerfield (1971) is reported in Levy (43). That

study indicates that the rate of suicide by direct

action is similar among patients with ESRD to

the rate among persons with other chronic diseases—seven times greater than the rate for the

general population. If one includes “indirect”

suicide (e. g., that caused by ignoring dietary

limits, fluid overload, etc.), the rate is considerably greater.

Finally, cadaver transplants present another

problem. Patients often anticipate holiday weekends with joy, since the highway death toll

presents them with a chance for a better life.

Then they feel guilty for wishing for another

person’s death. For the patients who do not obtain a kidney, there is a “Christmas eve, no

Christmas morning” syndrome of disappointment and depression. Kidney transplantation is

still high-risk surgery. It also requires immunosuppression, with many complications, for the

rest of the person’s life. Physicians, themselves,

when suffering from ESRD almost never opt for

kidney transplants (43), and one physician has

described the agonies associated with treatment

(15).

Rettig reports that one of the major disappointments and cost contributing factors of the

ESRD program is that quality of life has remained poor (64). At this time, there are few

solutions to this. As older and sicker patients

(e.g., diabetics) are put on dialysis, this problem

is apt to worsen. Yet, in most centers, potential

and current patients are not routinely given an

option of not starting or of terminating treatment.

Heart Transplants

There are a number of problems that all cardiac transplant patients must deal with after

surgery. After discharge from the hospital, each

patient must make frequent clinic visits, stay on

a special diet, maintain a good weight, and get

regular but moderate exercise. Most important,

patients must accustom themselves to a life-long

dose of immunosuppressant drugs to prevent rejection of the transplant. Artificial heart recipients would not encounter all of these problems,

but their quality of life maybe severely impaired

by sequelae (aftereffects) of surgery, many of

which may be unforeseen.

The family of the cardiac transplant patient

must also make adjustments. It is sometimes difficult for patients and their families to adjust to

the new roles in which they find themselves. The

sick role of the patient is no longer appropriate

or desirable after transplantation, but some patients find it difficult to give up. Other potential

problems include insecurities regarding selfimage, guilt feelings over the burden placed on

family or society, and severe depression triggered by their new status as a heart transplant

patient. Of those patients who survive more

than a year, 90 percent have been rehabilitated.

For some, this implies a return to previous

employment; for others, it means an active life

as students, homemakers, or retirees (19).

It has been possible to rehabilitate the majority of Stanford’s surviving cardiac transplant patients, in part because of the stringent patient

selection criteria which Stanford applies, and in

part because Stanford works intensively with a

small number of patients. * Medical criteria include the presence of end-stage heart disease,

absence of systemic disease, and minimal secondary organ damage. The psychosocial criteria

include a stable work history, a history of good

medical compliance, a supportive family, and a

reasonable expectation that additional life will

be gained by transplantation. Patients undergo

extensive evaluation for psychological problems

that would preclude good rehabilitation. The

fact that recipients are very carefully selected

and are attended closely by Stanford staff

before, during, and after surgery appears crucial

for the success of the Stanford program.

Problems of a Nuclear= Powered Heart

As mentioned earlier, Federal funding for research on a nuclear device has been ended—but

many researchers still believe that it is preferable

to other potential sources of power and continue

*Rehabilitation following heart transplantation is defined as

“restoration of physical and psychosocial capacity to a level at

which the patient has the options to return to employment or to an

activity of choice” (73).
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 23

to cite it as an alternative. One drawback to the

pneumatic systems that are currently being used

in clinical assist devices and experimental replacement devices is that the patient or experimental animal is literally tethered to a source of

compressed air. The associated noise and lack of

mobility would surely have profound psychological effects on the patient were such a device

to be used over a prolonged period. An additional major drawback is the risk of infection

along the track of the tubing passing through the

patient’s chest wall.

The risk of infection is also a serious

drawback to electrically powered systems that

depend on percutaneous electrical leads, but is

avoided by chemical batteries that can be recharged transcutaneously. Reliability, bulk, and

other physical limitations are other problems

with electrical and battery systems that remain

to be satisfactorily resolved.

The most advanced nuclear system depends

on the principle of heat generation by radioactive decay. The heat powers a miniature gas/

vapor engine, which in turn drives a blood

pump. Of several isotopes that might have been

selected, the isotope Pu-238 with a half-life of 87

years has been used most extensively. The design requires the system to respond to physiological demands; the waste heat of the energy

source must be dissipated from and by the body,

and the radiation exposure must be “tolerable. ”

The normal heart produces some 1.5 to 4

watts of mechanical pumping power. (These

power levels are over 10,000 times higher than

those required for cardiac pacemaking. ) Given a

system of 10-percent efficiency, approximately

50 watts of energy must be produced, and 45

watts of waste heat must be continuously rejected

to minimize a resultant rise of body temperature.* The proposal for the use of radioisotopes

in such devices arose when the concept of “maximal permissible dose” was prevalent. This

theory, postulating that there was a dose of

radiation below which there was no detectable

adverse biological effect, is now discredited (49).

*Current thermal engines use 25 watts of heat and have efficiencies of 13 percent or more (30).

Pu-238 was chosen as a power source on the

basis of its short half-life, relatively low radiation, containment technology, and costs. It is an

alpha-particle emitter that also has a spontaneous fission half-life of 4.9 X 1010 years,

which is a source of neutron and gamma radiation. Its decay scheme is complex and results in

the buildup of plutonium-236 (Pu-236), which in

turn decays to emit energetic gamma. All this

makes shielding the most serious problem;

shielding requirements need to be determined experimentally.

A Pu-238 heat source and shielded capsule

sufficient to produce 52 watts, as reported by

NHLBI in 1972, was found to produce 2.7 rads

per hour measured at the capsule surface and 0.6

millirem per hour measured 1 meter from the

surface. Simple calculations indicate that the patient would be exposed to 23,652 rads in 1 year.

The radiation dose for a spouse sharing the same

bed for 8 hours per night 1 meter distant would

be 1.752 rads in 1 year. To indicate the magnitude of these exposures, it should be noted that

natural background radiation is about 100 millirem per year—the doubling dose of genetic

mutation is estimated to fall in the range of 70 to

200 rem, and exposure of the U.S. population to

5 additional rem per 30 years could cause 3,000

to 15,000 cancer deaths annually (depending on

the assumptions made in the calculation).

Discussion

From the information presented above, it can

be seen that in the case of kidney and cardiac

transplant patients, there exist definite barriers

to posttransplant rehabilitation. Although the

greatest medical problem for these patients—the

host immune response to the implanted organ—

would not occur in artificial heart recipients

because the implanted organ would be completely artificial, the psychosocial barriers to posttransplant rehabilitation are numerous. While

many dialysis and cardiac transplant patients

have been able to return to work and lead active

lives, many more have had substantial difficulty

in doing so. If recipients of the artificial heart

fare no better than recipients of heart or kidney

transplants, then the claims regarding their
24 ● Background Paper #2: Case Studies of Medical Technologies

potential for health and economic productivity

will ring false.

It also should be noted that the artificial heart

will generate its own set of problems for patients. Psychological stress may characterize

recipients who have difficulty coping with their

total reliance on an implanted machine for life.

The inconvenience and anxiety related to recharging batteries, the potential for sudden

mechanical or electrical failure leading to death,

or risks of radiation would clearly reduce the

quality of life. The costs of implantation and

continuing medical care could cause financial

problems that would make adjustment harder

and induce guilt in recipients over depleting

SOCIAL BENEFITS

The development of emergency and temporary devices (such as the intra-aortic balloon

pump) en route to the artificial heart is a

technological benefit of the artificial heart program. Similarly, the successful fabrication of

biomaterials may help in the development of

other artificial organs, making the research expenses incurred in the development of the artificial heart less overwhelming. In the following

discussion, an effort is made to describe and estimate the social benefits that may result from a

successful implantation program. The focus is

on two of the most publicized potential benefits:

1) the potential gain in years of life that may

result among recipients of the device, and 2) the

potential for artificial heart recipients to return

to an active productive life.

Extension of Life

In the foregoing discussion of economic

aspects of the artificial heart program, it was

noted that there has already been a substantial

investment in R&D and that the costs of clinical

application can be expected to be enormous.

What will be the return on this investment? The

1969 Ad Hoc Task Force on Cardiac Replacement (1), while providing an estimate of the

number of prospective recipients which still appears today to be a realistic one, made no effort

family resources. How well patients deal with

these problems will be determined by individual

attitudes—and these will be shaped to some extent by how the rest of society receives the innovation, as well as by general concerns over

our growing dependence on technology. Because

so many factors affect the patient’s ability to

recover from implantation, adequate counseling

and psychiatric services should be a part of preimplantation and postimplantation procedures.

To the greatest extent possible, the decision

regarding implantation should actively involve

the patient so as to ensure the highest quality of

life possible.

to predict the success of replacement or how

long a recipient might expect to live. However,

the members of the 1973 Artificial Heart Assessment Panel (51) did make such an effort. This

panel assumed at the outset that the artificial

heart would be perfect—i.e., that the instrument

would not fail, that there would be no deaths

associated with its surgical implantation, and

that all deaths from heart failure would be

prevented for the subsequent 10 years. These unlikely assumptions led to equally unlikely calculations that the lo-year mortality of recipients

would be substantially less than that of members

of the general population of equal age. Thus, in

the 10-year period following artificial heart implantation in a cohort of 1,000 60-year-olds, the

panel estimated that there would be 135 deaths

—from cancer, stroke, and other conditions to

which we all are subject, but not from heart disease. The 10-year mortality for 1,000 60-yearolds in the general population, as reflected in the

U.S. Vital Statistics at that time, was 330, more

than twice that predicted for artificial heart recipients.

Though it appears that the estimates by the

1973 panel were unduly optimistic, there is no

way of knowing exactly how large an increase in

life expectancy among artificial heart recipients

can be reasonably anticipated. If a device of high
Case Study #9: The Artificial Heart Cost Risks and Benefits ● 25

reliability can be achieved, if the operation turns

out to be technically no more difficult than a

heart transplant, and if major complications

such as hemorrhage and thromboembolic phenomena are infrequent, it is possible that the life

expectancy of a recipient might be similar to that

of other patients who have undergone successful

heart surgery of equal magnitude (e.g., CABG

patients). If, on the other hand, instrument

reliability is as large a problem as some fear, and

if there are frequent and serious clinical complications, the life expectancy of a recipient

might more nearly approximate that of other patients undergoing major medical and surgical interventions (e.g., recipients of heart transplants,

patients with implanted pacemakers, patients

suffering from ESRD on hemodialysis, or recipients of kidney transplants). The recipient of an

artificial heart would not be subject to many of

the unique difficulties encountered by these

other groups, but it is not unreasonable to anticipate that they may encounter difficulties of

equal magnitude.

With full appreciation of the uncertainties involved, we make “best case” and’’ worst case”

assumptions that are described below. From

these assumptions and from relevant life tables,

we calculate the potential impact of an artificial

heart on the life expectancy of a randomly

selected member of the general population of a

given age, and its impact on the life expectancy

of a member of the general public of a given age

who is destined to suffer death from ischemic

heart disease (IHD) sometime in the future.

We have limited the analysis to potential recipients between the ages of 25 and 64. For our

“best case,” we have assumed that approximately one-sixth of patients dying of IHD will be candidates for artificial heart replacement (see table

6). * We also assume (see table 7) that 15 percent

of recipients between the ages of 25 and 34 will

die at the time of surgery or in the following year

(to these recipients we assign no added years of

life); we assume that an additional 30 percent

will die between the ages of 35 and 44, 30 percent more will die between the ages of 45 and 54,

and the remaining 25 percent will die between

*See discussion above on the pool of potential recipients.

Table 6.—Fraction of Those With IHD in Each Age

Interval That Gets the Device—Best and Worst Case

Best case Worst case

Age Fraction Age Fraction

0-4 . . . . . . . . . . 0 0-4 ....., . 0

5-14 . . . . . . . . . 0 5-14 . . . . . . . . . 0

15-24 . . . . . . . . 0 15-24 . . . . . . . . 0

25-34 . . . . . . . . 1/6 25-34 . . . . . . . . 1/1 2

35-44 . . . . . . . . 1/6 35-44 . . . . . . . . 1/12

45-54 ....... , 1/6 45-54 . . . . . . . . 1/12

55-64 . . . . . . . . 1/6 55-64 . . . . . . . . 1/12

65-74 . . . . . . . . 0 65-74 . . . . . . . . 0

75-84 . . . . . . . . 0 75-84 . . . . . . . . 0

85 or more . . . . 0 85 or more . . . . 0

SOURCE Calculations by A, Whittemore with the assistance of G Kelly, 1980

the ages of 55 and 64. We make parallel assumptions for recipients aged 35 to 44, 45 to 54, and

55 to 64 (see table 7).

For our “worst case, ” we assume that only

one-twelfth of patients dying of IHD will become candidates for replacement (see table 6).

We also assume higher initial mortality and a

higher failure rate (see table 8). Other observers

or investigators may choose to revise our calculations using different sets of assumptions.

Calculations:

Using the age-specific death rates due to all

causes (see table 9) and to IHD (see table 10), we

first estimated the “net” distribution of time to

occurrence of IHD. This is the distribution in

the hypothetical absence of all other causes of

death. We also estimated the net distribution of

time to death from other causes, in the absence

of death due to IHD. These computations were

done as described in Chiang (18).

To describe the impact of an artificial heart

device, we assumed that a fraction 7\, of those

who develop IHD in their ith age interval gets

the device (see table 6). We also supposed that a

proportion rji of those getting the device in interval j dies due to complications associated with

the device in a subsequent interval i, i >= j. The

proportions rji are shown in table 7 (best case)

and 8 (worst case).

We then computed a new net distribution of

death due to IHD, assuming that the device was

available. Note that in this case an individual

can die in the ith age interval from IHD in two

ways: Either the person developed IHD and fails

to receive the device, or the person dies as a re-
26 ● Background Paper #2: Case Studies of Medical Technologies

Table 7.—Proportion of Those Obtaining the Device That Dies

Due to Device Failure at Subsequent Ages—Best Case

Age at which device was obtained

Age at which device failed o - 4 5-1 4 15-2 4 25-3 4 35-4 4 45-5 4 55-6 4

0-4. . . . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0 0

5-14. . . . . . . . . . . . . . . . . . . . o 0 0 0 0 0 0

15-24 . . . . . . . . . . . . . . . . . . . O 0 0 0 0 0 0

25-34. . . . . . . . . . . . . . . . . . . O 0 0 0.15 0 0 0

35-44. . . . . . . . . . . . . . . . . . . o 0 0 0.3 0.2 0 0

45-54. . . . . . . . . . . . . . . . . . . 0 0 0 0.3 0.35 0.25 0

55-64. . . . . . . . . . . . . . . . . . . 0 0 0 0.25 0.35 0.4 0.3

65-74. . . . . . . . . . . . . . . . . . . 0 0 0 0 0.1 0.3 0.45

75-84. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0.05 0.25

850 or more. . . . . . . . . . . . . . . 0 0 0 0 0 0 0

SOURCE: Estimates by D. Lubeck and J. P. Bunker 1980.

Table 8.—Proportion of Those Obtaining the Device That Dies

Due to Device FaiIure at Subsequent Ages—Worst Case

Age at which device was obtained

Age at which device failed O-4 5-1 4 15-2 4 25-3 4 35-4 4 45-5 4 55-6 4

0-4. . . . . . . . . . . . . . . . . . . . . o 0 0 0 0 0 0

5-14. . . . . . . . . . . . . . . . . . . . o 0 0 0 0 0 0

15-24. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0 0

25-34. . . . . . . . . . . . . . . . . . . o 0 0.3 0 0

35-44. . . . . . . . . . . . . . . . . . . : o 0 0.6 0.4 0 0

45-54. . . . . . . . . . . . . . . . . . . 0 0 0 0.1 0.6 0.5 0

55-64. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0.5 0.6

65-74. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0 0.4

75-84. . . . . . . . . . . . . . . . . . . 0 0 0 0 0 0 0

85 or more . . . . . . . . . . . . . . . 0 0 0 0 0 0 0

SOURCE: Estimates byD. Lubeckand J. P. Bunker, 1980.

Table 9.—Age-Specific Death Rates

Due to All Causes, 1977

Table 10.—Age-Specific Death Rates

Due to lHD,1977

A g e Death rate

0-4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.000688

5-14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.000346

15-24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.001171

25-34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.001362

35-44 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.002475

45-54 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.006207

55-64 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.01434

65-74 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.030556

75-84 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.071819

85 or more . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.147259

A g e Death rate

o-4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0

5-14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0

15-24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.000004

25-34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.000042

35-44 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.000384

45-54 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.001683

55-64 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.004665

65-74 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.011164

75-84 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.028895

85 or more . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.064201

SOURCE: Mont/r/y Vita/StafisficsReport (Hyattsville, Md: National Center for SOURCE: Monf/r/y Vita/ Statistics Freport (Hyattsville, Md~ National Canter for

Health Statistics). Health Statistics)
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 27

suit of complications associated with a device

received in a previous interval j<= i. The probability of the first event is fi (l-~i), where fi is the

net probability of the occurrence of IHD in interval i. The probability of the second event is:

X fj ~j rjl

j<=i

Thus, the new net probability f'i of death due

to IHD in interval i is:

f '

i 

=

f i (l–Xi) + Z fj ‘Tj rji

j<=i

This new net distribution, together with the

net distribution for time to death due to other

causes, yielded a single distribution for time to

death, as described by Chiang (18), in the event

that the device is available. By comparing this

distribution with current death rates, we calculated the increase in life expectancy due to the

device that might be enjoyed by a randomly

chosen individual in the U.S. population. The

gains in life expectancy for individuals who ultimately develop IHD were also calculated. These

gains are shown in tables 11 and 12.

From table 11, we see that under our “best

case” assumptions, a randomly chosen 25-yearold gains 0.0966 of a year (or approximately 35

days) in life expectancy from the availability of

an artificial heart; under our “worst case”

assumptions, the gain is reduced to 0.0218 of a

year (or about a week). The gain in life expectancy will accrue only to those 25-year-olds

Table 11 .—Increase in Life Expectancy in Years for

Randomil Selected individuals of Specified Ages

Who May or May Not Develop IHD–

Best and Worst Case

Best case Worst case

Increase Increase

in life in life

A g e expectancy A g e expectancy

0-4 . . . . . . . . . . 0.096 0-4 . . . . . . . . . . 0.0214

5-14 . . . . . . . . . 0.0963 5-14 . . . . . . . . . 0.02146

15-24 . . . . . . . . 0.0966 15-24 . . . . . . . . 0.0215

25-34 . . . . . . . . . 0.0966 25-34 . . . . . . . . 0.0218

35-44 . . . . . . . . 0.0963 35-44 . . . . . . . . 0.02096

45-54 . . . . . . . . 0.0804 45-54 . . . . . . . . 0.0151

55-64 . . . . . . . . 0.0306 55-64 . . . . . . . . 0.0011

65-74a ., . . . . . – 0.0602 65-74a . . . . . . . . –0.019

75-84a . . . . . . . – 0.0137 75-84 . . . . . . . . 0.0

85 or more. . . . 0.0 85 or more. . . . 0.0

aNegative values in persons over age 65 reflect the impact on this age group of

patients who have received the artificial heart prior to age 65 and who bear the

added risk of death due to complications or disease.

SOURCE: Calculations by A. Whlttemore with the assistance of G. Kelly, 1960.

Table 12.—Increase in Life Expectancy in Years for

individuals of Specified Ages Who Will Ultimately

Develop IHD-Best and Worst Case

Best case Worst case

Increase Increase

in life in life

A g e expectancy A g e expectancy

0-4 . . . . . . . . . . 0.6025 0-4 . . . . . . . . . . 0.1343

5-14 . . . . . . . . . 0.6029 5-14 . . . . . . . . . 0.1344

15-24 . . . . . . . . 0.6033 15-24 . . . . . . . . 0.1345

25-34 . . . . . . . . 0.6049 25-34 . . . . . . . . 0.1348

35-44 . . . . . . . . 0.59085 35-44 . . . . . . . . 0.1285

45-54 . . . . . . . . 0.4925 45-54 . . . . . . . . 0.0925

55-64 . . . . . . . . 0.1935 55-64 . . . . . . . . 0.007

65-74a . . . . . . . . – 0.4925 65-74a . . . . . . . . – 0.1342

75-84a . . . . . . . -0.1430 75-84 . . . . . . . . 0.0

85 or more . . . . 0.0 85 or more . . . . 0.0

aNegative values in persons over age 65 reflect the impact on this age group of

patients who have received the artificial heart prior to age 65 and who bear the

added risk of death due to complications or disease.

SOURCE: Calculations by A. Whittemore with the assistance of G. Kelly, 1980.

destined to develop IHD. As shown in table 12,

the calculated increase in life expectancy for

these individuals, 0.6049 year (best case) and

0.1348 year (worst case), is considerably greater

than that for randomly selected 25-year-olds.

Comparable calculations are presented in

tables 11 and 12 for individuals in 10-year age

groups up to the age of 84. It should be noted

that at older ages the gain in life expectancy

becomes smaller, because older individuals have

a much shorter period of time in which to become candidates. It also should be noted that

there is a decrease in average life expectancy

among persons over age 65. This results from

the inclusion in this age group over time of individuals who received an artificial heart prior to

reaching age 65 (individuals age 65 and over are

themselves ineligible for the device). Such persons have a lower than average life expectancy

because of the risk of future complications associated with the artificial heart, so their inclusion

in this age group decreases the overall average.

In order to arrive at the average population

increase, the increase in life expectancy for a

randomly selected individual in each age group

is multiplied by the fraction of the population in

that age group and summed. Under the “best

case” conditions, the average increase is 0.0697

year (25 days). Under the “worst case” conditions, the average increase is 0.0106 year (4
28 . Background Paper #2: Case Studies of Medical Technologies

days). For those individuals destined to develop

IHD, the average increase for the “best case” is

0.4478 year (163 days). The average increase for

the “worst case” is 0.0926 year (34 days).

Return to Work

In order to estimate the possible effect of artificial heart surgery on return to work, we

reviewed the experience of patients undergoing

hemodialysis and CABG surgery. The findings

from the studies cited below indicate that each

intervention has considerable impact on the occupational situation of patients, especially in the

case of older individuals. The findings also cast

some doubt on the early predictions that the

artificial heart will be economically beneficial to

society by returning large numbers of individuals from their sickbeds to gainful activity.

Hemodialysis Patients

Though several authors discuss the return-towork issue for dialysis patients, all say that the

data are not very good (9,25,43,64). However,

McKegeny, cited in Levy (43), reported that

many dialysis patients could return to work part

time (20 hours per week), but do not do so

because they would lose all benefits for their

treatment. McKegney also comments that dialysis patients are still weak and anemic and have

intercurrent illnesses. Katz and Capron (39)

report better experience for dialysis patients in

the United Kingdom. There, 66 percent of patients are on home dialysis, which can be done

during sleep at night. Sixty-five percent of those

patients return to work full time.

CABG Patients

A study of 893 men at a median time of 14

months after CABG surgery was reported by

Rimm, et al. (65). Seventy-six of the men were

retired at the time of surgery, leaving 817 men of

all ages and occupational groups in the study.

The following six occupational groups were defined: 1) professionals; 2) administrators, managers, officials, and providers; 3) clerical and

sales workers; 4) skilled workers, foremen, and

tradesmen; 5) metal processors, machinery

workers and factory workers; 6) semiskilled and

unskilled workers.

Of the 817 men working before surgery, 52.9

percent stayed in the same occupational group,

31.1 percent changed occupational group, and

17 percent retired. In the subgroup of 510 patients less than 55 years of age who were working before surgery, 56.1 percent stayed in the

same occupational group, 32.5 percent changed

occupational group, and 11.4 percent retired. In

the subgroup of patients 55 years of age and

older, 47.6 percent stayed in the same occupational group, 26 percent changed occupational

group, and 26.4 percent retired. In the latter age

group, persons in occupational groups 4, 5, and

6 had only a 60- to 70-percent overall return to

work. The authors found that the observed

retirement rate in the study population was 7.5

times that of a comparable U.S. male population

for those 35 to 54 years of age and 11.3 times

that for those who were older.

Crosby, et al. (24) found that at an average of

18 months after surgery for left main coronary

artery disease, 62 percent of 70 patients returned

to work; 32 percent retired on disability; and 6

percent who were able to work chose to retire.

Information disaggregated by age categories was

not presented in this study.

A Toronto study (75) assessed the proximity

to retirement age and its effects on employment

patterns after CABG surgery. Of 329 patients

(men and women), 178 were employed before

surgery (54 percent). Of these 178, 122 were

under 55 years of age, and 56 were older. Two

years after surgery, 81 percent of those under

age 55 and 75 percent of those over age 55 were

employed. Overall, 79 percent of the 178 patients returned to work.

Finally, in a review of the effect of CABG surgery on work status, McIntosh and Garcia (47)

mention a study of patients at Emory University. The effect of CABG surgery on patients’

work status was less than its effect on their exercise tolerance levels. Its effect on work status

depended on individual economic considerations (especially retirement provisions). Although 90 percent of the patients observed at
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 29

Emory had symptomatic improvement, only 50

percent returned to work after surgery.

The evidence with regard to positive occupational rehabilitation as a result of CABG surgery

is conflicting. Studies of patients in randomized

trials show a lesser return to work for surgical

patients than for medical patients (59). It seems

that even if the procedure is successful, many

patients seize the opportunity to retire, which is

at that time socially acceptable and legitimate.

Factors that influence this choice are the duration of postoperative recovery and the availability of compensation or retirement benefits.

Artificial Heart Recipients

Thus, we have several proxies on which to

base estimates of probability of return to work

after artificial heart implantation. The percentage of cardiac transplant patients who return to

work is 20 to 25 percent (62). Because cardiac

transplantation leaves the recipient prone to infections and rejection from the body’s immune

system, however, we believe that this percentage

SOCIAL COSTS

A comparison of the costs of the artificial

heart must include not only the charges to the

consumer, but future economic effects on society as a whole. Below we discuss four prominent

issues that arise in connection with proposed

development of an artificial heart: 1) increased

social expenditures, 2) distributional issues, 3)

social costs of a nuclear device, and 4) opportunity costs.

Increased Social Expenditures

The extent of increased costs to society will

depend on the quality of the artificial heart in

clinical application. A highly effective device

could increase the productivity of midcareer recipients and greatly benefit society. An inadequate device, however, would mean, in addition

to losses in productivity, the loss to society of its

investment in R&D, and charges for implantation, continuing medical care, welfare and

rehabilitation programs.

is lower than might be expected among recipients of an artificial heart.

Patients with coronary artery disease amenable to surgery are often in much better medical

condition than those who would be receiving an

artificial heart. Thus, we believe that the returnto-work figures for the coronary bypass group

represent an upper limit. From the study by

Rimm, et al. (65), we note a return-to-work percentage of 70 to 80 percent for CABG patients

under age 55 and from so to 70 percent for

CABG patients between age 55 and 65. We also

note an approximate percentage of 60 percent of

persons with advanced kidney disease on home

dialysis who are able to maintain a normal

working condition.

Thus, we would suggest as the overall percentage of previously employed artificial heart

recipients who might return to work after

surgery a lower limit of 20 percent (based on the

experience of heart transplant patients) and an

upper limit of 60 percent (based on the experience of CABG patients).

The potential burden on social security and

other retirement programs is related not only to

the reliability and effectiveness of the artificial

heart, but also to the quality of rehabilitation

and the desire of recipients to return to active

lives. The experience of cardiac transplant patients emphasizes the importance of psychosocial and economic motivation for complete

rehabilitation. Likewise, the rapid diffusion of

CABG surgery, with its disappointing return-towork figures, suggests that considerable planning—with an eye toward comprehensive treatment, counseling and restricted development

—should precede clinical application of the artificial heart to ensure the best possible results.

Given the large number of patients who might

benefit from artificial heart surgery, the cost

could run into the billions, as predicted by

Sapolsky in 1978 (70). Yuki Nosé, of the Cleveland Clinic, has expressed the opinion that

societal costs will equal those of present dialysis
30 ● Background Paperr #2: Case Studies of Medical Technologies

payments by medicare (which

billion).

From our own assumptions,

cost of artificial heart surgery

33,600 implantations are done

now exceed $1

if the average

is $28,000 and

each year, the

yearly aggregate cost for the surgery alone

would be $941 million (see table 2). Added to the

cost of surgery are continuing care costs—estimated at $2,000 per patient per year—which will

increase incrementally as the number of procedures (and patients) accrues.

Using our figures (which are conservative

estimates) for the cost of implantation and the

pool of recipients, and applying these continuing

care costs ($2,000 per patient per year) to the

survival rates of heart transplant patients at

Stanford (i.e., 70-percent survival for the first

year and 5-percent attrition each succeeding

year, or 50-percent survival through 5 years)

yields the 5-year cost projections in table 13. As

can be seen in that table, first year costs for

33,600 implantations at $28,000 per procedure

would be about $941 million. Second year costs

would be $941 million for another 33,600 implantations (at $28,000 per procedure) plus

maintenance costs of about $47 million for the

23,520 survivors (at $2,000 per survivor), or a

total of about $988 million. Third year costs

would be $941 million for another 33,600 implantations plus maintenance costs of about $91

million for the survivors, or a total of about

$1,032 million. Fourth and fifth year costs,

calculated similarly, would be about $1,072

million and $1,109 million, respectively.

Even at these cost levels and projected patient

pools, the artificial heart (when distributed on a

large scale) will incur costs equivalent to present

dialysis payments within 1 year. If the implantation turns out to be more costly, then the program will rapidly approach $2 billion annually.

The decision to finance hemodialysis and the recent recommendation to finance cardiac transplants through medicare indicates that the costs

of artificial heart implantation will probably be

federally financed. If the experience of hemodialysis is typical of procedures supported by

public funds, then we can expect a progression

toward more relaxed patient selection criteria

for and widespread availability of the artificial

heart. Previously excluded candidates would

thus be included. As the recipient group is expanded, and more resources are invested, the

marginal quality-of-life improvements and longevity improvements will lessen.

Though the impact of the artificial heart on

total population growth may be small, an increase in the proportion of older citizens may

necessitate increased expenditures by social

security and medicare to cover rehabilitation

and early retirement. The present burden on

social security due to our expanding elderly

population is already well documented and of

fiscal concern. The burden of increased social

security expenditures will fall on all taxpayers. If

recipients of the device are substantially more

productive than they would have been without

it, costs of the program maybe made up through

increased tax revenue, as was predicted in the

1966 Hittman Report (35). Therefore, the development of a strong comprehensive rehabilitation

program is crucial if the artificial heart is designed for large-scale distribution.

Table 13.—Projected 5-Year Sequence of Total National Expenditures on Artificial Heart Implantation

and Patient Maintenance (dollars in millions)

First year Second year Third year Fourth year Fifth year

Implantation charges. . . . . . . . . . . . . . . . . . . . . . $940.80 $940.80 $ 940.8 0 $ 940.8 0 $ 940.8 0

Maintenance

Year 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — 47.04 47.04 47.04 47.04

Year2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — — 43.68 43.68 43.68

Year3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — — — 40.32 40.32

Year4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . — — — 36.96

Total costs . . . . . . . . . . . . . . . . . . . . . . . . . . $940.80 $987.84 $1,031 .52 –

$1,071.84 $1,108.80

SOURCE: D. Lubeck and J. P. Bunker, 19S0. See text for assumptions.
—

Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 31

Distributional Issues

In the experimental years of the artificial heart

program, strict patient selection criteria (similar

to those for cardiac transplantation) would limit

distribution and reimbursement problems. However, as the procedure becomes established for

therapy, and medical criteria are relaxed, there

will be fewer clinical reasons to deny the artificial heart to an individual able to benefit from it.

Thus, financial considerations will gain in significance.

Even the most conservative estimates of the

cost of the artificial heart project an amount that

would be a severe burden on many families. Insurance companies, particularly in the early

years of the artificial heart’s availability, maybe

unwilling to shoulder the high costs of such an

innovative treatment, just as they have been in

the case of cardiac transplants. Yet, in recent

years, Americans more and more have come to

see access to available modes of health care as a

basic right that should not depend on one’s ability to pay. The decision to cover hemodialysis

under medicare is the most notable illustration.

In the case of the artificial heart, the demand for

public financing would be strengthened by the

fact that the device came into existence only

because citizens’ tax dollars financed its development.

If artificial hearts do become available, the

Federal Government will be faced with a serious

dilemma—either to deny many citizens access to

a device sponsored by a Government research

program or to embark on a subsidization plan

that could run into billions of dollars annually.

Patient selection criteria and the mode of reimbursement will be the policy components that

establish the scope and equity of artificial heart

distribution. The challenge will be to design economically realistic financing and allocation arrangements that will not ration life on the basis

of the value of individual members to society.

Social Costs of a Nuclear Device

The social cost of a plutonium-fueled artificial

heart relates to the associated environmental

and social hazards. Plutonium is an extremely

toxic material. Each capsule (containing about

50 g of Pu-238) is the equivalent of many millions of lethal doses to a human being. From

manufacture through transportation and storage

to implantation, the materials would have to be

protected from accidents and thefts that might

result in breach of the capsule and release of the

Pu-238 into the environment. After a patient’s

death, the material would have to be quickly recovered and returned to the Government. Since

the basic premise of developing a device is that

the device will be widely distributed, it follows

that the safeguards associated with a nuclear

power source would also be widely applied. The

problems that could arise under conditions of

unexpected use, theft, terrorism, or accident are

dramatized by the estimate (with a very wide

range of variability) that if the 50 g of Pu-238 in

the artificial heart were to be distributed as an

ideally aerosolized particle, that particle would

be the equivalent of 1.7 billion doses of, lung

cancer (26).

In addition to these risks, another consideration is the capital costs. At the current price of

Pu-238 ($1,000 per g), each device (containing

50 g of Pu-238) would cost $50,000 for fuel

alone. At 50,000 devices per year, the initial

costs for fuel alone would be $2.5 billion. If this

were financed at lo-percent simple interest per

year, the finance charge would be $250 million

per year. These costs would be added on to the

other costs previously mentioned.

Opportunity Costs

In considering the costs of the artificial heart

program, one must also take into account potential gains that might have accrued from other

social expenditures precluded by the primacy of

artificial heart development. Although spending

on one project does not automatically preclude

spending on another program, the development

and promotion of an artificial heart is likely to

reemphasize the importance of alternative approaches to the treatment of heart disease, as

well as increase social costs.

As noted earlier, distribution of the artificial

heart may proportionately raise social expenditures financed through medicare and social secu-
32 ● Background Paper #2: Case Studies of Medical Technologies

rity, so funds will have to be diverted from other

programs. This will be especially true if social

security, in the future, is partially financed from

general funds. There are additional potential

tradeoffs in the area of biomedical research.

Thus, for example, the question may be asked

whether the research funds that support the

training of new heart surgeons and technicians

will deter or undermine research on heart disease

prevention or other forms of treating cardiovascular disease.

CARDIAC DISEASE PREVENTION

A perspective on heart replacement can be obtained by comparing replacement with alternative programs that have the same criteria of

effectiveness (i.e., increased life expectancy) and

represent present investments for the future.

One alternative is to try to prevent the occurrence of heart disease by altering individual and

institutional patterns of behavior.

Independent risk factors that contribute to

premature cardiac disease are elevated serum

cholesterol, cigarette smoking, and high blood

pressure. Much of the evidence supporting the

importance of these factors stems from the

Framingham study, epidemiological studies that

compare affluent, technology-based societies

with those less affluent, and collaborating

evidence from population studies.

The evidence establishing a constellation of

risk factors related to coronary heart disease

(CHD) led NHLBI in 1970 to fund several decade-long, community-based clinical trials designed to develop methods of risk reduction applicable to home, work, and community environments. The Stanford Heart Disease Prevention Program (SHDPP) was initiated in 1971 as

part of this NHLBI research.

To estimate the potential effectiveness of

modifying risk factors in preventing CHD in the

U.S. population, we have chosen to look at the

results of the SHDPP Three Community Education Study. This study, completed in 1975, has

demonstrated increased community awareness

of heart disease factors, changes in targeted

Completion of the artificial heart, as noted in

the introduction to this case study, was projected to occur long before an effective cardiac

disease prevention program. However, today

there are several prevention programs that hold

the potential for reaching more people and at

less cost than the artificial heart. The alternative

of cardiac disease prevention is discussed in

more detail below.

behavior (reductions in smoking and cholesterol

levels), and a decrease in risk factors. It indicates

the great potential of prevention in reducing

death from CHD, though conclusive evidence

on whether a population or an individual will

experience an actual decline in mortality is not

yet available (more information about the

SHDPP study is presented in app. D).

Three comparable communities were selected

for the study: one control town (Tracy) and two

experimental towns (Gilroy and Watsonville).

The experimental towns received health education through a mass campaign (radio, TV, newspaper, and direct mail) over 2 years. Additionally, high-risk individuals (those in the top quartile) were exposed to two different treatments:

media education only (Gilroy) and a media program enriched by face-to-face instruction (Watsonville intensive instruction). Data were

gathered through regular interviews of a random

sample of 35- to 59-year-old men and women,

which measured knowledge about behavior related to CHD, as well as daily dietary and smoking habits. After 2 years of intervention, a decrease in overall risks of 23 to 28 percent was realized in the two experimental communities.

There was a small increase in risk in the control

group (27). Figure 2 summarizes the changes in

risk for each community.

In order to determine the effectiveness of risk

reductions, one must evaluate the frequency of

CHD risk factors in the population and the

degree of concentration within categories. Data
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 33

Figure 2.— Percentage Change in Risk of CHD After

1 and 2 Years of Health Education in Various Study

Groups From Three Communities

Total participants

+ 3 0

I

c

I

T = Tracy

W-recon. = Watsonville reconstituteda

v>

g + 15

} i

.E + 10

x

.-(n e t

g

:

x

(n.-

.

c.-

al 0)

c

2

v

(0) (1) (2)

High-risk participants

(o) (1) (2)

awatsonville reconstituted = Watsonvllle group minus Watsonvllle Intensive

instruction group

bwatsonvllle randomized control = Watsonwlle high-risk grOuP minus Watson”

vine Intensive Instruct Ion group

cwatsonvllle intensive Instruct Ion = Watsonvllle h!gh+lsk intensive 9rouP

SOURCE: Stanford Heart Disease Prevention Proqram, Stanford, Calif.

from the National Cooperative Pooling Project

(2) indicate that 8 percent of 30- to 59-year-old

men have three or more risk factors elevated; 30

percent have two or more factors elevated; 45

percent have one; and 17 percent have no elevated risk factors. By combining risk factors

with their associated mortality, one finds that if

only 50 percent of those individuals in the category of having two or more elevated factors participated in a similar prevention program, there

would be a 23-percent reduction in new cases of

CHD. If all individuals in that category were to

participate, there would be as much as a

45-percent reduction in new cases.

Expected life extensions due to a directed

prevention program can only be very generally

estimated until more data are collected. Tsai

used multiple decrement and cause-reIated life

tables to estimate the improvement in life expectancy due to a reduction in new cases of CHD

(76). He found that if CHD is reduced by 20 percent, a member of the total population gains an

average of 1.26 years of life. However, if a

50-percent reduction in CHD is achieved (the

potential of a national program directed towards

those with two or more elevated risk factors),

the average gain is 3.7 years of life. These estimates far surpass any overall population life expectancy increases that might result from the

availability of the artificial heart. *

In order to estimate the costs of a similar

prevention program on a national scale, we have

evaluated the media and personnel costs of the

SHDPP Three Community Education Study

(27). A summary of program costs over the

period from 1972 to 1975 is given in table

14. The total cost for the three media campaigns

for the two experimental communities was

$515,477. SHDPP has estimated that a similar

program on a national level would cost approximately $1.5 billion.

We also reviewed another comprehensive

community program in Finland. The North Karelia Project was carried out from 1972 to 1977

in the county of North Karelia, an area of

Finland with exceptionally high CHD rates (60).

The objective was to reduce the mortality and

morbidity of CHD among middle-aged men

(ages 25 to 59), through reduction of smoking,

serum cholesterol levels, and elevated blood

pressure. More than 10,000 subjects were

studied, with a participation rate of around 90

percent. Program activities were integrated with

● See extension of life estimates discussed earlier.
34 ● Background Paper #2: Case Studies of Medical Technologies

Table 14.—SHDPP Expenses by Media Campaign

Campaign 1 Campaign 2 Campaign 3 Total

Media costs . . . . . . . . . . . . . . . . $120,150 $ 74,246 $33,93 0 $228,326

Personnel. . . . . . . . . . . . . . . . . . 87,960 57,958 69,153 215,071

Surveys and data. . . . . . . . . . . . 33,243 20,639 18,198 72,080

Total . . . . . . . . . . . . . . . . . . . . $241,353 $152,843 $121,281 $515,477

Number of months . . . . . . . . . .

Average/month . . . . . . . . . . . . . $8,045 $12,737 $10,107 $9,546

SOURCE: Stanford Heart Disease Prevention Program, Stanford, Cal if,

existing social service structures and the media.

The activities involved providing health services, advising individuals on changing personal

behavior, advising communities on environmental changes, training personnel, and providing

media information.

The results were evaluated by examining independent population samples at the start and at

the end of the project in North Karelia and in a

matched reference county. An overall mean net

reduction of 17.4 percent among all males was

observed in the estimated CHD risk in North

Karelia. Changes in individual risk factors were

greatest for hypertension (down 43.5 percent),

followed by smoking (down 9.8 percent), cholesterol levels (down 4.1 percent), and blood

pressure (down 3.6 percent). However, although

risk factors were reduced in North Karelia, the

change in mortality was statistically the same in

both communities in the study.

A precise economic comparison of the cost effectiveness of preventive programs v. the artificial heart is not feasible until more information

is available on the costs, risks, and benefits of

both approaches. The effectiveness of the artificial heart is still not known, since such a device

is not yet ready for clinical testing. By the same

token, the effectiveness of the SHDPP in reducing cardiac deaths remains to be documented,

though the program is effective in reducing certain CHD-related risk factors. An array of alternative programs (including heart transplants)

provides the context for decisions regarding

public funding of disease treatment.

The two programs—cardiac disease treatment

and prevention—could coexist in a beneficial

manner, as many of our consultants noted. John

Watson, of NHLBI, mentioned that the opportunity and incentive to improve cardiac prevention programs will continue, despite the advances due to the artificial heart. Yuki Nosé, of

the Cleveland Clinic, mentioned that expensive

treatment programs may also lead to better diagnostic equipment that may reverse or halt disease progression for those not improved by cardiac disease prevention. The distribution and

cost problems of the artificial heart might be reduced if a prevention program were judiciously

used to reduce CHD to a level where those persons in need of an artificial heart would have

easier access to it. Cost containment or private

health insurance program incentives could be

used to encourage this.

The data necessary for an economic evaluation of the two programs that would compare

the average cost per patient and the marginal

cost per additional patient are not available.

However, we can make some general statements. If the cost of an artificial heart will not

decline incrementally because it is a specialized

technology and production competition will not

be realized, then no cost savings will be realized

through mass production. In contrast, the types

of prevention programs undergoing clinical

trials now will have decreasing programing costs

as educational programs are standardized and

distributed more widely in classrooms and

through the mass media.

In assessing the cost effectiveness of a technology still in the R&D stage, one must consider the

chances of attaining the desired effects and at

what level. There are still great uncertainties to

be resolved in the development of the artificial

heart (e.g., biomaterials and energy sources) and

in prevention programs (e. g., their effect on

reduction of cardiac deaths). A useful way to
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits • 35

aim for future cost comparisons of these two approaches would be to collect information in a

central registry over the next decade on the

POLICY RECOMMENDATIONS

Artificial heart research represents the first

prototype of a comprehensive Federal Government program to develop a concrete medical

device. As such, its significance extends beyond

the pure success or failure of the research to include the lessons that affect future Federal commitment in applied health technology. In the following discussion, we address three areas of

public policy raised by artificial heart development: 1) program administration, 2) regulation,

and 3) reimbursement and distribution.

Program Administration

The Federal circulatory-assist devices program

has led to useful therapeutic inventions (such as

the intra-aortic balloon and temporary LVADs),

yet the development of a clinically effective artificial heart appears to be decades in the future.

The manner in which research priorities are established is of fundamental importance for the

artificial heart and alternative forms of treatment.

Previous allocation decisions led to a research

strategy in which many identical contracts were

assigned in order to hasten the proliferation of

technological options, rather than the usual system of investigator-initiated grants. Some consultants expressed the opinion that this approach

resulted in unnecessary duplication of research

effort, that it discouraged many talented researchers from becoming involved, and that the

resulting competition interfered with the full exchange of scientific information, thus compounding the magnitude of the biomaterials and

energy source problems discussed earlier. The

relative lack of dissemination of information

may have substantially slowed the program’s

progress.

NHLBI has moved to correct these shortcomings through annual meetings of contractors and

a larger emphasis on grants. A greater dialog beresults of clinical trials of the LVADs and on the

outcomes of prevention programs.

tween Federal program administrators and researchers should be encouraged early in any research program to ensure widespread consensus

about the appropriate level, distribution, and

direction of research effort. If a mission-oriented

approach is deemed appropriate, it will be necessary to have a careful evaluation of the knowledge base that is necessary to identify areas of

study that may require further basic research.

An adversarial proceeding that focuses organized “skepticism” on the potential for success

may best uncover such areas.

The major responsibility for the evaluation of

the program rests entirely with the community

of surgeons, engineers, and administrators who

are directly involved in the research. In the early

years, this led to an emphasis on technological

issues and little consideration of the larger

societal needs and projected impact of the

device. We certainly acknowledge the attempts

by NHLBI to assess a broader range of outside

opinion through the 1969 Ad Hoc Task Force on

Cardiac Replacement (2) and the 1973 Artificial

Heart Assessment Panel (51). However, these

bodies were charged only with advising NHLBI

on internal policy in areas limited by their

charges, and they had no authority to evaluate

alternative research strategies and weigh relative

priorities for the allocation of public funds.

It appears that the most comprehensive

evaluation of the costs and benefits of artificial

heart research came from the Artificial Heart

Assessment Panel (51), which did not stand to

benefit directly from the program in question.

That panel was the first to examine in depth the

costs to society of using a nuclear power source.

The panel’s recommendation that nuclear engine

development be reemphasized led to the cessation of nuclear research by NHLBI. In the case of

the nuclear-powered artificial heart, taxpayers

might have recognized savings from an inde-
36 ● Background Paper #2: Case Studies of Medical Technologies

pendent, broad-based analysis earlier in the program, and the electrical systems under research

might be considerably more advanced today.

Given the central role of such analyses in decisionmaking, it appears desirable to establish an

independent agency to consider the costs and

benefits—including the manifold social and economic implications—of medical innovations. To

ensure that potential societal impacts are considered early in the research process, analysis of

the costs and benefits of medical innovations

might take place before the initial allocation of

funds by Congress. In rapidly changing areas of

biomedical understanding, independent analysis

should also be undertaken at intervals during the

life of a program to avoid ongoing expenditures

when more viable alternative approaches exist.

The National Center for Health Care Technology (NCHCT) was established in 1978 to anticipate and evaluate the impact of health technologies and it represented a constructive step

toward such an independent authority. However, its responsibilities now belong to a study

section of the National Center for Health Services Research (NCHSR), since NCHCT’s appropriations were not renewed in 1982.

Regulation

The greatest Federal control over biomedical

innovation is currently through regulating the

introduction of new innovations through comprehensive legislation covering drugs and medical devices. A way to ensure that better information is available for making these regulatory

decisions is discussed below.

The process of developing a new medical technology involves several types of testing—animal

studies, clinical trials, and experimental clinical

use. Considerable controversy surrounded the

decision to use the 2-week LVAD in clinical

trials of patients unable to resume cardiac function after open-heart surgery in 1975. Completed LVAD implants in animals had been successful, but, as is true with most experiments in

animals, the results could not readily be translated to the clinical situation. At least one major

NHLBI contractor participated in the decision to

begin the clinical trials, raising serious questions

about conflict of interest.

Ultimately, clinical trials of 2- and 5-year versions of the LVAD are planned. Since each of

these longer term devices confronts the major

problems of the total artificial heart—energy

supply, actuator and engine design, durable and

hemocompatible materials—their testing can

provide an experimental model to assess the reliability, economic costs, and quality of life expected from a total artificial heart. Before clinical trials with these LVADs begin, adequate information on all LVADs under research should

be collected in order to select the best model for

testing. When clinical trials do take place, the

review process should set criteria and boundaries to confirm their safety and ensure the protection of human subjects. It is especially important that local institutional review boards be

fully involved in decisionmaking (i.e., that they

not be bypassed on the grounds that the device

constitutes “emergency therapy”). The larger

implications of such criteria might constructively be addressed by the National Commission for

the Protection of Human Subjects of Biomedical

and Behavioral Research.

The Food and Drug Administration (FDA)

was recently given authority by Congress

through the Medical Device Amendments to develop and enforce standards for the performance, efficacy, and safety of all medical devices.

No regulations have yet been written for the

LVAD or for the artificial heart. We recommend

that when FDA does develop regulations, it

coordinate efforts with NIH to develop a central

repository of all (private and NIH) data on

LVAD/artificial heart development, performance, and clinical results. In addition to data on

technical and protocol details, information

should be collected on patient status (i.e., socioeconomic status, age, race, sex) and details of informed consent measures. Submitting this information should be mandatory for all involved in

order to establish a knowledge base, and monitoring should take place to maintain quality control and compliance. This information should be

used in determining criteria or regulations for
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 37

commercial marketing and device distribution,

as well as R&D.

The 1973 report of the Artificial Heart Assessment Panel (51) called into question the active

search for a nuclear-powered artificial heart.

The panel expressed concern about the dangers

of walking-plutonium proliferation and of exposure of the patient and relatives to higher than

acceptable levels of radiation. While suggesting

that development might proceed pending more

complete evidence of risk, the panel specifically

recommended against any experimental implantation in humans.

The potential costs of a nuclear-powered

device may be very great. Aside from the health

risks to the individual, the strict safeguards

necessary to avoid theft or loss of plutonium

may well involve an unacceptable threat to the

quality of life of the recipient and raise many

thorny issues of civil liberties. However, there

remains to date no clear regulatory policy fully

excluding the possibility that a nuclear device

might be implemented in the future.

Meanwhile, the development of a clinically

acceptable energy alternative is progressing

slowly. The question arises, therefore, whether

research on the artificial heart is progressing

with the conscious or unconscious assumption

that a nuclear power source is still a viable alternative. Should we arrive on the brink of a successful device that lacks only an efficient power

source, it would be difficult to resist the pressure

to go ahead with a nuclear engine. For this reason, we believe it is important that a firm commitment against the use of nuclear-powered

devices be reached.

Reimbursement and

As noted earlier in this

Distribution

case study, the cost to

an individual for artificial heart implantation

and continuing care will be very great. These expenses will place access of the device out of the

hands of many needy patients, unless a plan for

socializing these costs is formulated. In the early

stages of availability, insurance companies

might well be expected not to assume the large

costs.

The prevailing trend already shows the Government assuming responsibility for ensuring

equitable access to expensive medical technologies even for those technologies initially developed without direct Government intervention

(e.g., the artificial kidney). When the Federal

Government underwrites the majority of research for an innovation, as it has with the artificial heart, the issue of access assumes greater

significance. In our opinion, in such an instance,

the responsibility for ensuring equitable distribution rests clearly on the Government. The

1973 Artificial Heart Assessment Panel noted

(51):

Particularly in view of the substantial commitment of public funds for development of the

artificial heart, implantation should be broadly

available, and availability should not be limited

only to those able to pay. This objective can be

accomplished through either private or government insurance mechanisms.

At the same time, a decision by the Federal

Government to assume this responsibility must

not be taken lightly. A decision to finance implantation federally may well commit the Government to an annual outflow of several billion

dollars for a single therapeutic modality that will

have relatively little impact on national life expectancy. Such a commitment is so great as to

dwarf all of the funds spent to date on the development of the artificial heart and other circulatory-assist devices. This commitment also implies planning and additional costs to ensure an

adequate inventory, facilities, and personnel for

implantation, continuing medical care, and rehabilitation. The specific details of any costsharing program will obviously affect the speed

and extent of clinical application. If there is no

incentive to centralize resources or to encourage

efficient use, the costs of application will rise as

the procedure diffuses throughout the country.

The absence of cost-containment incentives may

also result in a relaxation of medical criteria to

provide artificial hearts to patients not faced

with imminent death from cardiac disease.
.

38 ● Background Paper #2: Case Studies of Medical Technologies

Although the current situation with the artificial heart represents a great responsibility, it

also presents an opportunity. Whereas advances

such as the computed tomography scanner were

introduced by private industry and could not be

effectively influenced by post hoc regulation, the

introduction and distribution of circulatory

device technology could be carefully controlled

by the Government on its own terms. We

strongly believe that the time for discussing this

matter is now. At this point, a clinically effective

artificial heart is still many years away. From the

perspective of a member of society, investment

in artificial heart devices may contribute no

more to saving his or her life and health than

would a comprehensive, effective cardiac disease prevention program. This fact gives us considerable leeway in how we prefer to attack the

massive costs of heart disease in our society.

Calabresi and Bobbitt, in their book Tragic

Choices (13), introduce the concept of first and

second order decisions in the development and

allocation of lifesaving technologies. The first

order decision for the artificial heart is the decision about whether or not to proceed with its development. The second order decisions are who

should receive the device and who will pay for

it. As Calabresi and Bobbitt point out, it is easier

to stop or change direction at the first order decision level than at the second.

The point at which Federal Government intervention is most likely to have a real leverage

is at the first order decision level—whether to

continue to fund the research that might make

the artificial heart a clinical reality. If a

breakthrough were to occur that made a clinically acceptable device a reality, or even a strong

possibility, it is likely that the demand of heart

patients, their families, and physicians for this

potentially life-extending treatment would overwhelm even carefully constructed regulatory

SUMMARY

Research to develop a permanently implantable artificial heart that could be used to replace a

failing natural heart has been funded by NHLBI

and financial checks on device diffusion. The

dialysis case is instructive here—nobody wants

to be put in the position of saying we will not

save identifiable lives because a procedure is too

expensive. Consideration of regulatory and reimbursement issues is important, both because it

may be effective to some limited degree in making the diffusion of the artificial heart more rational and orderly and because it will heighten

awareness of the magnitude of the potential impact of an artificial heart on the health care

system.

In an era of limited resources, it is imperative

that such a potentially expensive innovation as

the artificial heart be carefully compared with

other social and medical programs designed to

extend life and improve its quality. Such a comparison will require a full and candid understanding of the likely costs and benefits of the

device. We have found that before a complete

understanding of the impact of an artificial heart

may be achieved, two very important questions

must be resolved. First, the Government must

decide whether it is willing and has the capability to ensure equitable access to the device—assuming this responsibility may substantially increase the perceived cost of the program. Second, the acceptance or rejection of a nuclear

power source should be made explicit—the nuclear heart device may substantially enhance the

attractiveness of the device from a clinical standpoint, but will also involve substantial social

costs and risks. These two decisions will have a

marked influence on the balance of costs and

benefits of the device, and they should be fully

debated and resolved before a final commitment

to artificial heart development is reached. Insofar as we may be faced with a $1 billion to $3

billion annual ‘commitment

time to make these decisions

in the future, the

is now.

since 1964. At the program’s inception, there

was considerable optimism that the successful

development of such a device would provide a

/
—

Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 39

means of treating serious cardiac disease by

1970—well before biomedical advances were expected to produce effective preventive treatment. But now, more than 15 years later, a totally implantable artificial heart is still a distant

goal. This case study has reviewed the potential

benefits, costs, and risks of continued investment in this medical innovation, as well as the

technological problems that remain to be solved.

Cardiac disease kills over 800,000 persons

yearly. The number of people that might benefit

from total heart replacement depends on the

severity of concomitant illness, age restrictions,

access to emergency coronary care, and the

nature of the device itself. Our estimate of a pool

of 33,600 candidates yearly assumes that a prospective candidate’s death is imminent, that circulation can be supported long enough for transportation to an institution with appropriate facilities, that the patient does not suffer from serious or chronic noncardiac disease, and that he

or she is under 65 years of age. A lower estimate

of 16,000 candidates is defined on the likelihood

of inadequate mobile coronary care and surgical

facilities, at least initially, in some parts of the

country. If the device is highly successful, we

estimate that there might be as many as 66,000

candidates annually.

If the artificial heart is perfected, it will have a

substantial impact on those who suffer from cardiac disease now or in the future. We estimate

that the availability of the artificial heart may

extend the lives of such individuals, on the average, by 0.6 of a year (about 210 days). It might

extend the lives of randomly chosen 25-year-old

members of the population, on the average, by

about 0.0966 of a year (about 35 days). An optimistic estimate is that 60 percent of artificial

heart recipients employed prior to implantation

may return to work. The experience of patients

undergoing CABG surgery suggests that as few

as 50 percent of persons aged 55 to 65 years

would return to work; the experience of heart

transplant patients suggests that the lower limit

might be 20 percent. The range of estimates

varies with the reliability of the device and the

adequacy of rehabilitative care.

As the technology becomes available, it will

be nearly impossible to deny the demand for its

widespread use, as the recent history of hemodialysis demonstrates. Even the minimum estimates of the cost for an individual to receive an

artificial heart involve an amount that would be

a severe burden on most families. Our estimates

for the cost of manufacturing and surgically implanting an electrically powered device (not including previous development costs) range from

$24,000 to $75,000 per patient; these are initial

costs. Continuing medical and technological

care could range from $1,800 to $8,800 per patient per year. Insurance companies will probably be unwilling to cover the high costs of this

treatment without special premiums or other incentives. Thus, the Federal Government will be

faced with a serious dilemma—to allow those

who cannot afford to pay privately to do without a lifesaving device, or, alternatively, to devote up to an additional $1 billion to $3 billion

annually to this new medical technology. Such a

commitment is so great as to dwarf all of the

funds spent to date on the development of the

artificial heart and other circulatory-assist

devices.

A decision to finance artificial heart implantation with Federal funds must not be taken lightly. It involves additional costs and planning for

adequate facilities, training of personnel, and a

strong program to rehabilitate patients who

must deal with the inconvenience and anxiety

related to daily recharging of batteries, potential

mechanical or electrical failure, and total reliance on an implanted machine. Cost considerations must also take into account potential loss

of other social programs displaced by the development of the artificial heart. The artificial

heart may proportionately raise social expenditures financed through medicare and social

security that will have to come from other social

programs. Funds that support the training of

heart surgeons and technicians for a large-scale

implantation program may deter the urgency

with which research on cardiac disease prevention or alternative treatments is pursued. Recent

work in cardiac disease prevention at Stanford

University (27) and in Finland (60) indicates that
90 ● Background Paper #2: Case Studies of Medical Technologies

an effective prevention program definitely reduces the risk factors associated with CHD and

may have a greater potential to reduce death

from cardiac disease.

While artificial heart research has led to useful

therapeutic inventions and substantial advances

in understanding, the development of a clinically acceptable artificial heart seems unlikely to be

realized in the near future. As yet, neither a

hemocompatible material nor a portable power

source that can meet the specifications for a

long-term, implantable heart in laboratory testing has been developed. Current prototypes of

2- and 5-year LVADs use electrical battery systems that still have mechanical and operational

liabilities. In clinical trials projected for the

mid-1980’s, these devices will provide an experimental model to assess the reliability of the

engine under conditions of extended use, as well

as the quality of life that might be expected from

an artificial heart. Production and implantation

will also result in a more accurate picture of total

economic costs of the device and surgical procedure.

In addition to investment in battery-powered

devices, several million dollars of DOE funding

(primarily through the Energy Research and Development Agency) have been devoted to research on a nuclear power source. Should we arrive on the brink of a successful device that lacks

only an acceptable power source, it may be difficult to resist the pressure to go ahead with a

Pu-238 powered engine. The costs and risks of

such a device are enormous. Because of its dangerous qualities and its value ($1,000 per g for a

device using 50 g of Pu-238), the material would

have to be closely guarded from manufacture,

through transportation and storage, to implantation, until removal upon the death. Strict safeguards would have to be imposed on recipients

to protect them from health risks due to radiation, physical injury, or kidnapping. In light of

these considerations, we believe it is important

that a firm commitment against the use of nuclear-powered devices be made so that the ultimate

potential for a safe and acceptable heart device

may be evaluated.

The current situation with the artificial heart

represents a great responsibility, but also

represents an opportunity to control with care

the introduction of circulatory device technology. At this time, a clinically effective artificial

heart is still many years away. From the perspective of a member of society, investment in artificial heart devices may be no closer to saving his

or her life and health than a comprehensive, effective cardiac disease prevention program. This

fact gives us considerable leeway in how we prefer to attack the massive costs of heart disease in

our society. For this reason, we should compare

the benefits and costs of the artificial heart in

competition with other social and medical programs designed to extend life and improve its

quality. We must first decide whether to proceed

with development of the artificial heart, knowing that it will require a large commitment of

resources. If we assume this commitment, we

must then consider issues of who should receive

the device, who will absorb the costs of manufacture and implantation, and most importantly, what opportunities will be lost through an inability to fund other social programs.

In sum, we believe that two major issues involving the development of the artificial heart

must be resolved in order to comprehend fully

the device’s total impact. First, the Federal Government must decide whether it is willing and

has the capability to ensure equitable access to

the device—assuming this responsibility may

substantially increase the perceived cost of the

program. Second, the acceptance or rejection of

a nuclear power source should be made explicit

—the nuclear heart device may substantially

enhance the attractiveness of the device from a

clinical standpoint, but will also involve very

large social costs and risks. Because these two

decisions will have a marked influence on the

balance of costs and benefits of the device, they

should be fully debated and resolved before a

final commitment to artificial heart development

is made.
Case Study #9 The Artlflclal Heart Cost, Risks, and Benefits ● 41

APPENDIX A: THE ARTIFICIAL CARDIAC PACEMAKER

by Thomas Preston

The first totally implantable cardiac pacemaker

was implanted in Sweden in 1959. This was followed

by the development of implantable pacers by three

companies in the United States in 1960 (17,37,78).

Although animal investigations predicted a problem

with electrodes (rising excitation threshold), this

problem was considered manageable, and there were

widespread forecasts for a 5-year pacemaker longevity. The 5-year longevity prediction was based on

battery capacity and calculated discharge rate. The

first commercially available pacemakers were designed with the pulse generator and leads as one inseparable unit, i.e., there was no design allowance

for replacement of the pulse generator alone, without

disturbing the electrical connections (leads) to the

heart. Although some investigators voiced caution

about heightened expectations (78), in general there

was optimism that a 5-year pacemaker was at hand

(17,37).

Risks

The major risk of permanent pacing—operation

mortality—initially was about 7.5 to 10 percent due

to the requirement for thoracotomy and epicardial

electrode placement. That risk was deemed acceptable because of the poor prognosis of untreated patients and the dramatic relief of successfully paced

patients (see the section below on benefits). Other

risks that also usually meant pacemaker system failure included infection at any part of the operative

area (from epicardium with myocardial abscess to infection around the pulse generator) and dehiscence

(bursting) of the pulse generator. In its worst manifestation, the patient had an acquired abscess with

draining fistula. These complications were relatively

common initially (5 to 10 percent), but not unexpected. Improved surgical technique solved most of

these problems.

Complications peculiar to pacemakers that were

relatively or totally unanticipated are discussed

below.

● Wire (lead) break. Fatigue of the metal leads resulted in premature system failure at a high rate,

such that this was the primary limiting factor for

the first few years of permanent pacing. The

solution of this problem required engineering

analysis of fracture points and modes, followed

by multiple design changes. Although lead

breaks still occur, this complication was controlled to an acceptable incidence over a period

of 6 to 7 years.

High threshold of cardiac excitation. As noted

above, animal testing revealed this complication, which was medically unique to this technology. The biotechnical factors involved were

not well worked out until about 1967, and electrode evolution pertaining to this feature still

continues. In the first 5 years of permanent pacemakers, at least 10 percent of system failures

were from this cause.

Battery failure. The predicted battery longevity

did not materialize until about 1975 because of

defects with the batteries and current shunting

due to structural defects within the pulse generator. Excluding all other failure modes, pulse generator longevity as limited by battery exhaustion

is listed in table A-1. The dramatic increase in

pacemaker longevity from 1975 to 1979 reflects

the development of a new technology battery

(lithium).

“Runaway” pacemakers. Rarely, but dramatically, pulse generators can fail with an accelerated rate (up to 800 impulses per minute). In

some cases, this complication was fatal. Although design changes have made this complication quite rare, it still occurs (e.g., recall of

American Pacemaker Co., June 1979).

Electromagnetic interference. Interference

caused by extrinsic noncardiac signals can alter

pacemaker output signals. This problem was

greatly magnified by creation of the sensing (“on

demand”) pacemaker, which must sense cardiac

signals but reject all other electrical signals. This

complication (incorrect sensing) still occurs with

approximately 5 percent of implanted units.

Competition with natural heart beats. Although

this complication was anticipated, it was not

Table A. 1.—Pacemaker Longevity Excluding Causes 

of Failure Other Than Battery Exhaustion

Year pacemaker implanted Longevity (50%)

1961. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6to 12 months

1965. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 months

1970. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 months

1975. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 months

1979. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 years (est.)

SOURCES: S. Furman and D. Escher, Prirrc@es and Techniques of Cardiac

Pacing (New York: Harper and Row, 1970); and M. Bilitch, “Performance of Cardiac Pacemaker Pulse Generators,” PACE 2:259, 1979,
42 ● Background Paper #2: Case Studies of Medical Technologies

considered serious (78). Although it is an infrequent occurrence, pacemaker stimulation during

the vulnerable period of a preceding natural beat

can precipitate ventricular fibrillation and death

(59). proper sensing of natural depolarizations

(demand function) precludes this complication,

but inadequate sensing still occurs with about 5

percent of implanted units.

Surgical inexperience. The use of a prosthetic device posed new problems for surgeons. Many

complications—e. g., incorrect connection of

pulse generator to leads, improper positioning of

electrodes or pulse generator—are related to expertise in this particular operation. Furthermore,

normally functioning pacemaker systems have

been removed, because the surgeon and/or cardiologist did not understand the proper functioning of the system. Trauma to the device

through mishandling still occurs in the hands of

the inexperienced.

Manufacturing errors.

Sudden failure, From specifications and performance of the batteries (for the first 15 years,

virtually all batteries were the same type), the

expected failure mode was a slow but detectable

change in pacer rate. Unexpected, sudden failure

without prior detected rate change has occurred

and still does occur for a number of reasons

(lead break, component failure, short circuit,

etc. ). For a patient who is pacemaker dependent,

this mode of failure produces syncope (temporary suspension of circulation) or death. Sudden

unexpected failure is now uncommon (approximately 1 in 50 to 100 pulse generators), but occurred with 5 percent or more of pulse generators for the first 10 years of permanent pacing.

Benefits

● Survival. There never has been a well-controlled

study comparing survival of patients with and

without pacemakers, presumably because of the

apparent immediate and dramatic success of pacemakers. Analysis of survival benefit has always

been made by comparison of prepacing and postpacing groups. Patients with complete (or intermittent) heart block and syncopal episodes have a

l-year mortality of 50 percent (29,36), whereas

similar patients who are paced have a 2-year survival of 70 to 80 percent (68). Survival analysis of

patients paced for reasons other than complete

heart block is virtually impossible, as no “natural

history” data exist for other conditions. T h e

diagnoses of partial blocks and sick sinus syn-

●

●

●

drome appear to be a consequence of pacing, as

these disorders were relatively unknown prior to

permanent pacing, and investigations into these

disorders probably resulted from the innovation of

a treatment for them. Thus, the availability of

pacemakers led to investigation into nonheart

block causes of syncope. Pacemaker therapy was

applied to other presumed causes of syncope as

soon as a cause and effect relationship seemed to

exist, as in sick sinus syndrome. The universally

acknowledged success of pacing for heart block led

to an uncritical extension of the therapy to patients

with “preheart block” EKG patterns, and sinus

node dysfunction. Consequently, there are no data

(even uncontrolled) by which to judge the effect of

pacing on survival in these groups of patients.

Some believe that the widespread use of pacing for

preheart block syndromes does not increase survival (46). Of all patients receiving pacemakers,

about 55 to 60 percent now survive 5 years (31).

Treatment of symptomatic complete heart block.

The advent of pacing led to legendary tales of how

the moribund rose to walk. For those who remember the plight of patients with symptomatic complete heart block, the benefit in terms of decreased

syncopal episodes and increased activity level is

beyond question. For patients with other maladies,

however, the benefits are more questionable. Most

patients with light-headedness spells, or true syncope, and without evidence of heart block or sinus

arrest associated with syncope, end up with pacemakers. Many are not improved.

Treatment of symptomatic bradycardia, Availability of pacing has created the option of adjunct therapy (e. g., large doses of propranolol) with pacing

to avoid symptomatic bradycardia.

Treatment of tachyrhythmias. An unanticipated

new use of pacemakers is in treatment of tachyrhythmias, using overdrive or interruption techniques. This accounts for less than 1 percent of all

permanent pacing.

Capital Investment

• Initial cost. The cost of hospitalization and hardware was estimated easily and adequately at the

time of initiation of this technology.

● Followup care. The unanticipated complications of

systems failures meant greater than estimated followup costs. I know of no studies in 1960-61 estimating followup costs. Although the anticipation

was for 3 to 5 years of fault-free system performance, during the first 3 years of pacing, the average

system longevity was about 6 months. Some pa-
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 43

tients had in excess of 15 operations (some more

than 20) in 3 to 5 years, most of them thoracotomy

(surgical incision of the chest wall). During the

next 5 years, the average system failure (any

failure requiring surgical correction, e.g., wire

break, displacement of catheter, generator failure)

was about 1 in 12 months of pacing (or greater).

Exclusive of complications requiring hospitalization/operative repair, modern followup methods

now cost from $100 to $1,600 per year, depending ●

on the mode of followup. Office visits (minimum,

EKG; maximum, detailed pacemaker analysis at a

“pacemaker clinic”) vary from 2 to 6 years in

routine followup. Electronic monitoring (even interrogation of implanted units) has become widespread in this country during the last 10 years. It

can be done directly (with the patient present at a

clinic) or indirectly by telephone, with or without

automatic computer analysis. The availability of

such monitoring has made it mandatory in the

minds of most physicians, as this represents the

“best” means of followup. Indeed, there is now a

whole ancillary industry in this area. The artificial

heart, for which monitoring would be even more

necessary, will undoubtedly have more advanced

forms of electronic monitoring. Third-party payers

(Blue Cross/Blue Shield, medicare) now pay $30

per telephone call for pacemaker monitoring.

Many patients are monitored weekly (there is a

scale of allowable calls, as a function of the age of

the pacemaker), meaning a monitoring cost of

$1,560 per year. I anticipate a minimum of one call

per week for artificial heart patients.

Indirect cost (or gains), There are no data on

return to employment of paced patients, but for

those who were incapacitated from symptomatic

complete heart block, there is a return to normal

existence (excluding other limitations). Thus, for

the group heavily dependent on pacemakers, there

would appear to be a large net gain in return to

gainful employment. For others, the result is less

evident. To the degree that a patient is restored to

normal function, there should be an economic

gain. The countereffect, as seen with coronary

artery surgery, of legitimation of illness and retirement may also be present. I know of no data on

this subject.
44 . Background Paper #2: Case Studies of Medical Technologies

APPENDIX B: CARDIAC TRANSPLANT COSTS

Table B-1.–Cardiac Transplant Hospitalization Costs, 1969.75

Professional Blood Drug

Days Insurance Grant fees credit credit Written off Total Cost/day

Year 1. . . . 1,788 $87,923.57 $ 493,385.2 0 $3,109.53 $ 325.00 – $36,485.9 6 $ 621,229.26 $347.4 4

Year2. . . . 841 144,561.47 129,443.33 150.00 485.00 — 31,318.31 305,958.11 363.80

Year 3. . . . 942 267,677.56 106,956.45 1,001.47 712.98$ 18.4 0 796.85 377,163.71 400.39

Year4. . . . 869 122,962.32 235,811.89 10,062.83 73.05 — 44,380.79 413,290.88 475.59

Year5. . . . 922 360,158.01 186,294.45 12,177.33 834.00 211.8 4 326.17 560,001.80 607.3 8

Year 6. . . . 198 — 101,887.09 3,444.00 – – — 69,489.65 534.5 4

Total. . . 5,560 $983,282.93 $1,253,778.4 1 $29,945.16 $2,430.03$230.24 $113,308.0 8

Percent

of total — 4170 53% I % — — 5 %

Average/ $2,382,974.85 $428.59

person . . 69 $12,139.29 $15,478.75 $369.69 $30.00 $2.8 4 $1,398.87 100%

Average/ $29,419.44 $426..37

transplant 6 5 $11,433.52 $14,578.82 $348.20 $28.26 $2.6 8 $1,317.54 $27,709.01 $426.29

SOURCE: Stanford Cardiac Transplantation Program, Stanford, Cal if.

Table B-2.–Cardiac Transplant Outpatient Costs, 1969-75

Professional Blood Drug

Visits Insurance Grant fees credit credit Written off Total Cost/visit

Year 1. . . . 466 $ 580.1 0 $ 19,768.80 $1,095.00 – – $21,443.9 0 $46.02

Year2. . . . 224 854.50 12,802.89 1,170.00 — — $ 877.95 15,705.34 70.11

Year 3. . . . 112 74.85 8,434.04 – 8,508.59 75.97

Year4. . . . 468

—

7,774.72 41,269.30 632.64 851.95 50,528.61 107.97

Year5. . . . 523 5,970.50 48,956.87 1,620.90 — — 56,548.27 108.12

Year 6. . . . 110 —

—

9,306.10 786.00 — — — 10,092.10 91.75

Total. . . 1,903 $15,254.67 $140,538.00 $5,304.54 – – $1,729.90 $162,827.11 $85.56

Percent

of total — 9 % 86% 4% — — 1 % 100% —

Average/

person . . 23 $188.33 $1,735.00 $65.49 – – $21.36 $2,010.21 $87.40

Average/

transplant 2 2 $177.38 $1,634.16 $61.68 – – $20.12 $1,905.34 $86.61

SOURCE: Stanford Cardiac Transplantation Program, Stanford, Cal if,
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PAGE 11
5 ~ 09-79

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79
DEVICES AND TECHNOLOGY DIS!XLP 

DIVISION OF HEART AND VASCULAR DISEASES

OF THE

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

BETHESDA, mARYLAND 20205

RESEARCH AND DEVELOPMENT CONTRACTS

NOVEMBER, 1980

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH
POWER SOURCES - ELECTRICAL Dr. Altier i

Dr. John Moise

Aerojet Liquid Rocket

Aerojet-General Corp .

POB 13222, Dpt 2150

Sacramento, CA 95813

(916) 355-2018

NO1-HV-7-297 1

Implantable Electrohydraulic Left Heart Assist Device

Expired: 9/29/80

Dr. Peer H. Portner

Andros, Inc.

2332 Fourth St

Berkeley, CA9471 0

(415) 849-1377

NO1-HV-4-291 4

Implantable Controlled Solenoid LVAs

Expired: 9/2/80

.

?lr. Jack Chambera

Gould Meaauremnt Sys t

Statham Instr Di v

2230 Statham Blvd

Oxnard, CA 93030

(805) 487-8511

NO1-HV-8-2916

Electrical Energy Converter for Heart Assiat Devicea

Expired: 9/18/80

M. Victor Poirier

Thermo Electron Corp

101 Firat Ave

Waltham, MA 0215 4

(617) 890-8700

NO1-HV-7-2976

Electrical Energy Convertera for Heart Assist Devices

Expired: 9/29/8Q

Dr. Robert Jarvik

University of Utah

Inst. Biomedical Eng

Salt Lake City, UT 84112

(801) 581-6991

NO1-HV-7-297 5

Reversing ElectroHydraulic Energy Converter for Assist Devices

Expired: 9/29/80

●

I
Power SOURCES - RENEWAL Dr. Altieri

Dr. John Moise

Aerojet Liquid Rocket

Aerojet Gen Corp

POB 13222, Dpt 2150

Sacramento, CA 95813

(916) 355-2018

NO1-HV-9-2909

Develop, Evaluate Stirling Cycle Conversion System

FY 80: $893,176

Mr. Richard P. Johnston

Univ of Washington

100 Sprout Rd.

Richland, WA 99352

(509) 375-3176

NO1-HV-9-2908

Develop, Evaluate Codified Stirlin% Cycle Engine

FY 80: $792,306
CIRCULATORY ASSIST & ARTIFICIAL HEART DEVICES PROGRAM

Dr. Jeffrey L. Peters

Inst for Biomed Eng

University of Utah

Bldg 518

Salt Lake City, UT84112

(801) 261-3141

Single & Biventricular Cannulae Circulatory Support

5 RO1 HL 23279-02

Dr. William S. Pierce

Hershey Medical Ctr

Penn State University

500 University Dr

Hershey, PA 17033

(717) 534-8328

Development and Evaluation of an Artificial Heart

2 RO1 HL 20356-04

Dr. William S. Pierce

Hershey Medical Ctr

Penn State University

500 University Dr

Hershey, PA 17033

( 7

17) 534-

832 8

Left Ventricular Bypass for Myocardial Infarction

5 RO1 HL 13426-11

Dr. Andreas F. Von Recum

College of Eng

Clemson University

301 Rhodes Eng Blvd

Clemson, SC 29631

(803) 656-3052

Healing of Intestinal Mucosa to a Penetrating Conduit

5 RO1 HL 23646-02

Dr. Andreas F. Von Recum

College of Eng

Clemson University

301 Rhodes Eng Blvd

Clemson, SC 29631

(803) 656-3052

Treated Percutaneous Implants

1 RO1 HL 25438-01

Dr. Frederick J. Walburn

Dept of Medicine

Henry Ford Hospital

2799 W. Grand Blvd

Detroit, MI 48202

(313) 876-3221

Pulsatile Flow,Separation in Branching Tubes

1 R23 HL 25839-01
THERAPEUTIC INSTRUMENTATION & DEVICES PROGRAM

Dr. Stanley A. Briller

Allegheny-Singe r

Research Corp

320 E. North Ave

Pittsburgh, PA1521 2

(412) 237-3146

Syntactic Pattern Analysis of 24-hr Helter Records

1 RO1 HL 26066-01

Dr. K.B.Chandra n

Materials Eng Div

University of Iowa

College of Eng

Iowa City, IA 52242

(319) 353-4192

Pulsatile Flow Dynamics of Prosthetic Heart Valves

1 RO1 HL 26269-01

Dr. Richard E. Clark

Dept of Surgery

Washington Universit y

4960 Audubon Ave

St Louis,MO 63110

(314) 454-3457

Advanced Cardiac Valvular and Vascular Prostheses

5 RO1 HL 13803-07

Dr. Herman L. Falsetti

Dept of Internal Med

University Hospital s

Iowa City, IA 52242

(319) 356-3412

Fluid Mechanics of Heart Valve Prostheses

3 RO1 HL 20829-03S1

Dr. Leslie A. Geddes

Purdue University

Biomedical Eng Ctr

W. Lafayette, IN 47907

(317) 494-6151 X212

An Automatic Implantable Blood Pressure Controller

1 RO1 HL 25746-01

Dr. Howard C. Hughes

College of Medicine

Penn State University

Hershey, PA1703 3

(717) 534-8328

Elimination of Reoperative Cardiac Pacemaker Surgery

5 RO1 HL 13988-09

Dr. Janice L. Jones

School of Medicine

Case Western Univ

2119 Abington Rd

Cleveland, OH 44106

(216) 368-3487

Defibrillator Waveshape Optimizatio n

5 ROl HL 24606-02

Dr. Raymond J. Kiraly

Dept .of Art. Organs

Cleveland Clinic

9500 Euclid Ave

Cleveland, OH 44106

(216) 444-2470

Hexsyn Leaflet Valve

1 RO1 HL 25689-01
THERAPEUTIC INSTRUMENTATION & DEVICES PROGRAM

Dr. Victor Parsonnet

Dept of Surgery

Newark Beth Israel

Medical Center

Newark, NJ 07112

(201) 926-7330

Extending the Life of Implanted Pacemakers

5 RO1 HL 15247-07

Dr. Victor Parsonnet

Newark Beth Israel

Medical Center

201 Lyons Ave

Newark, NJ 07112

(201) 926-7330

Simulation of Pacemaker - ECG Interactions

5 RO1 HL 24567-02

Dr. Lester R. Sauvage

Providence Med Center

528 18th Avenue

Seattle, WA

(206)326-589 1

Prosthesis for Aorotocoronary Bypass

2 RO1 HL 18644-04AI

Dr. John C. Schuder

Surgery Department

Univ of Missouri

Columbia,MO 65212

(314) 882-8068

Waveform Dependency in Defibrillating 100 KG Calves

5 RO1 HL 18040-06

Dr. John C. Schuder

Surgery Departmen t

Univ of Missouri

Columbia, MO 65212

(314) 882-8068

Development of Automatic Implanted Defibrillator

5 RO1 HL 21674-03

Dr. William F. Walker

Dept Mech Eng

Rice University

PO BOX 189 2

Houston, TX 77001

(713) 527-8101 x3549

Cavitation Phenomena Near Prosthetic Devices

5 RO1 HL 17821-04
DIAGNOSTIC & MEASUREMENT INSTRUMENTATIOIN & DEVICES PROGRAM

Dr. Herbert L. Abrams

Dept of Radiology

Petr Bent Brighm Hosp

721 Huntington Ave

Boston, MA 02115

(617) 734-8000 X2542

Cineangiographic Studies of the Cardiovascular System

5 RO1 HL 20895-05

Dr. Donald W. Baker

Ctr for Bioeng

Univ of Washington

Seattle, WA 98195

(206) 543-6832

Noninvasive Cardiovascular Measurements

5 PO1 HL 07293-18

Dr. Dana H. Ballard

Dept of Computer Sci

Univ of Rochester

Rochester, NY 14627

(716) 275-3772

Anatomical Modela in Computer-Aided Image Analysis

5 R23 HL 21253-03

Dr. Joe D. Bourland

Biomedical Eng Ctr

Purdue University

West Lafayette, IN 47907

(317) 494-6151

Cardiac Output from the Pneumocardiogram

5 RO1 HL 22321-03

Dr. Ruben D.Bunag

University of Kansas

Medical Center

College of Health Sci

Kansas City, Kansas66103

(913) 588-7507

Non-Invasive Blood Pressure Measurement

5 RO1 HL 22854-02

Dr. David A. Chesler

Physics Research Lab

Mass General Hospital

Boston, MA 02114

(617) 726-3805

Gated Imaging with the MGH X-Ray Camera

5 RO1 HL 20274-03

Dr. B. Neil Cuffin

Mass Inst of Tech

170 Albany St

Cambridge, MA 02139

(617) 253-5562

Accuracy of Electric & Magnetic heart Measurements

2 R23 HL 24645-02

Dr. Cornelis J. Drost

Dept Physiology

NY State Vet College

Cornell University

Ithaca, NY 14853

(607) 256-2121

Accurate Transcutaneous Doppler Bloodflow Monitoring

5 RO1 HL 19019-05
DIAGNOSTIC & MEASUREMENT INSTRUMENTATION & DEVICES PROGRAM

Dr. Nancy C. Flowers

U of Louisville

School of Medicine

323 E. Chestnut St

Louisville, KY 40202

(502) 589-4668

Recording & Analysis of Low Level Cardiac Signals

2 RO1 HL 19768-04

Dr. Fred K. Forster

U of Washington

Dept of Mech Eng

Seattle, WA 98195

(206) 543-4910

Fluid Dynamic-Ultrasonic Aspects of Blood Turbulence

1 R23 HL 26706-01

Dr. Leslie A. Geddes

Biomedical Eng Ctr

Purdue University

West Lafayette, IN 47907

(317) 494-6151 x321

Indirect Mean Blood Pressure

2 RO1 HL 18947-03

Dr. Edward A. Geiser

Dept. of Medicine

University of Florida

Gainesville, FL 32610

(904) 392-3481

3-D Analysis of Ventricular Contractile Performance

1 R23 HL 25621-01

Dr. Don P. Giddens

Sch of Aerospace Eng

Georgia Inst of Tech

Atlanta, GA 30332

(404) 894-3044

Hemodynamics of Normal and Diseased Carotid Arteries

5 RO1 HL 22635-02

Dr. Raymond Gramiak

Univ of Rochester”

601 Elmwood Ave

Rochester, NY 14642

(716) 275-2625

New Concepts in Cardiac Ultrasound Technology

5 RO1 HL 15016-09

Dr. Craig J. Hartley

Dept of Medicine

The Methodist Hosp

6516 Bertner

Houston, Tx 77030

(713) 790-3252

Ultrasonic Instrumentation for Cardiovascular Studies

5 RO1 HL 22512-03

Dr. Gabor T. Herman

Dept of Computer Sci

SUNY at Buffalo

4226 Ridge Lea

Amherst, NY 14226

(716) 831-1351

Computer Technology for Transaxial Tomography

5 RO1 HL 18968-05
DIAGNOSTIC & MEASUREMENT INSTRUMENTATION & DEVICES PROGRAM

Dr. Michael B. Histand

Dept of Mech Eng

Colorado State Univ

Fort Collins, CO 80523

(303) 491-5544

Noninvasive Measurement of Cardiac Output

5 RO1 HL 22326-03

Dr. Cecil J. Hodson

Yale University

333 Cedar Street

New Haven CT 06510

(203) 432-4364

Ultrasonic Monitoring of Visceral Blood Vessels

5 RO1 HL 19791-03

Dr. Adrian Kantrowitz

Dept Cardiovasc Surg

Sinai Hosp of Detroit

6767 West Outer Dr

Detroit, MI 48235

(313) 493-5775

Quantitating In-Series Effects in Cardiac Arrhythmias

5 RO1 HL 22274-02

Dr. Antti J. Koivo

School of Elec Eng

Purdue Univ

West Lafayette, IN47907

(317).493-9156

The Use of Microprocessors in Medical Applications

1 RO1 HL 22417-01

Dr. Paul C. Lauterbur

Dept of Chemistry

SUNY at Stony Brook

Stony Brook, NY 11794

(516) 246-5061

Cardiovascular NMR Zeugmatography

5 RO1 HL 19851-02

Dr. Richard L.Longini

Biotechnology Program

Carnegie-Mellon Univ

Pittsburgh, PA 15213

(412) 578-2528

An Optimal Fetal Heart Monitor

2 RO1 HL 20632-03

Dr. Roy W. Martin

Dept Anesthesiology

U of Washington

Seattle, WA

(206) 545-1883

Blood Flow Measurement by Ultrasonic Catheter Tip Method

5 RO1 HL 14645-09

Dr. William E. Moritz

Dept of Elec Eng

Univ of Washington

Seattle, WA 98195

(206) 543-6049

Ultrasonic Measurement of Cardiac Geometry and Flow

5 RO1 HL 16759-06
DIAGNOSTIC & MEASUREMENT INSTRUMENTATION & DEVICES PROGRAM

Dr. P. David Myerowitz

U of Wisconsin

Department of Surgery

600 Highland Ave

Madison, WI

(608) 263-5215

Noninvasive Computerized Fluoroscopic Cardiac Imaging

1 RO1 HL 26586-01

Dr. Charles P. Olinger

Dept of Neurology

Univ of Cincinnati

4305 Med Sci Bldg

Cincinnati, Ohio 45267

(513) 872-5431

Computer Aided Bioacoustic Arterial Diagnostics

5 RO1 HL 23671-02

Dr. T. Allan Pryor

Dept of Biophysics

Latter-Day Saint Hosp

325 8th Ave

Salt Lake City, UT 84143

(801) 322-5761 X255

Computer Controlled Two-Dimensional Echocardiography

2 RO1 HL 16487-06

Dr. John M. Reid

Inst of Applied

Physiology & Medicine

556 18th Avenue

Seattle, WA 98122

(206) 442-734o

Ultrasonic Scattering Studies for Tissue Characterization

5 RO1 HL 24805-02

Dr. Erick L. Ritman

Dept of Physiology

Mayo Foundation

200 First St. SW

Rochester, MN 55901

(507) 284-3495

Cardiovascular and Lung Dynamics

2 POl HL 04664-20

Dr. William P. Santamore

Temple University

Philadelphia, PA

(215) 221-4724

Ventricular Interdependence

1 RO1 HL 26592-01

Dr. Richard K. Shaw

School of Medicine

Yale University

333 Cedar Street

New Haven, CT 06510

(203) 436-8259

Long Term Assessment of Flow in Vascular Grafts

5 RO1 HL 22352-02

Dr. Richard J. Spears

Dept of Cardiology

USC Schl of Medicine

2025 Zonal Ave

Los Angeles, CA 90033

(213) 226-2152

3-D Analysis of Single Plane Coronary Cineangiograms

1 R23 25272-01

I

I

I
DIAGNOSTIC & MEASUREMENT INSTRUMENTATION & DEVICES PROGRAM

Dr. Donald E. Strandness

Dept of Surgery

Univ of Washington

Seattle, WA 98195

(206) 543-3653

Ultrasonic Evaluation in Direct Arterisl Surgery

2 RO1 HL 20898-03

Dr. Louis E. Teichholz

Dept of Med

Pit Sinai Schl of Med

1 Gustave L Levy P1

New York, NT 10029

(212) 650-7785

Pulse-Doppler Analysis of Left Ventricular Function

1 RO1 HL 25277-01

Dr. Fredrick L. Thurstone

Biomedical Eng Dept

Duke University

Durham, NC 27706

(919) 684-6185

Dynamic Cardiovascular Measurement Using Ultrasound

5 RO1 HL 12715-12

Dr. John G. Webster

Dept. of Elec. Eng.

U of Wisconsin

1500 Johnson Dr.

Madison, WI 53706

(608) 263-1574

Portable Arrhythmia Monitor

1 RO1 HL 25691-01

Dr. Mark L. Yelderman

Dpt of Anesthesia

Stanford University

Stanford, CA 94305

(415) 497-6411

A Continuous Cardiac Output Monitor

5 RO1 HL 24798-02
BIOMATERIALS PROGRAM

Dr. Clarence P. Alfrey

Dept of Internal Hed

Methodist Hospital

6516 Bertner

Houston, TX 77030

(713) 790-2155

Effects of Physical Forces on Blood

5 RO1 HL 16938-05

Dr. Harry R. Allcock

Dept of Chemistry

Penn State Univ

University Park, PA 16802

(814) 865-3527 “

Polydiaminophosphazenes

5 RO1 HL 11418-11

Dr. Joseph D. Andrade

Dpt of Bioengineering

University of Utah

Salt Lake City, U1’ 84112

(801) 581-8509

Synthetic Hydrogels as Blood Tolerable Materials

5 RO1 HL 16921-06

Dr. Joseph D. Andrade

Dpt of Bioengineering

University of Utah

Salt Lake City, UT 84112

(801) 581-8509

Albumin and Hemocompatibility

2 RO1 HL 18519-05

Dr. Joseph D. Andrade

Dpt of Bioengineering

University of Utah

Salt Lake City, UT 84112

(801) 581-8509

Blood Interactions of Triblock Polymers

5 RO1 HL 24474-02

Dr. Robert E. Apfel

Eng & Applied Sci Dpt

Yale University

New Haven, CT 06520

(203) 436-8674

Characterization of Biomaterials by Elastic Property

5 RO1 HL 22233-03

Dr. John Autian

College of Pharmacy

Univ of Tennessee

Ctr for Health Sci

Memphis, TN 38163

(901) 528-6020

Acute Toxicity Evaluation of Biomaterials

5 RO1 HL 24040-02

Dr. Sumner A. Barenberg

Dept of Chemical Eng

Univ of Michigan

Ann Arbor, Michigan 48109

(313) 764-7391

Polyorganophosphazenes ; Molecular Motion & Thrombosis

5 RO1 HL 23288-02
BIOMATERIALS PROGRAM

Dr. William E. Burkel

Dept of Anatomy

Univ of Michigan

4734 Medical Sci II

Ann Arbor, MI 48109

(313) 764-4379

Development of Cell-Lined Vascular Prostheses

3 RO1 HL 23345-02S1

Dr- Allan D. Callow

Dept of Surgery

New Eng Med Ctr Hosp

171 Harrison Ave

Boston, MA 02111

(617) 956-5596

Platelet-Fibrin Dynamics in Healing Arterial Surfaces

5 RO1 HL 24447-02

Dr. Hanson Y.K. Chuang

Dept of Pathology

University of Utah

School of Medicine

Salt Lake City, UT 84112

(801) 581-7773

Plasma Proteins Adsorbed to Artificial Organs

7 RO1 HL 25808-01

Dr. Hanson Y.K. Chuang

Dept of Pathology

University of Utah

Salt Lake City, UT 84112

(801) 581-7773

Interaction: Prothrombin, Thrombin, ATIII & Materials

1 RO1 HL 25807-01

Dr. Stusrt L. Cooper

Dept of Chem Eng

Univ of Wisconsin

1415 Johnson Dr

Madison, WI 53706

(608) 262-3641

Protein and Thrombus Deposition on Vascular Graft

5 RO1 HL 21001-03

Dr. Stuart L.Cooper

Dept of Chem Eng

Univ of Wisconsin

1415 Johnson Dr

Madison, WI 53706

(608) 262-3641

Transient Thrombotic Events at Polymeric Surfaces

5 RO1 HL 24046-02

Dr. W. Jean Dodds

Div of Lab & Research

NY St Dept of Health

Empire St Plaza

Albany, NY 12201

(518) 457-2663

Blood-Materials Interactions: The Bridge Problems

5 RO1 HL 24017-02

Dr. Robert C. Eberhart

Dept of Mech Eng

University of Texas

Eng Sci Bldg 610

Austin, TX 78712

(512) 471-7167

Analysis of Blood Trauma From Microporous Oxygenators

5 RO1 HL 19173-04
BIOMATERIALS PRO(WWbl

Dr. Eugene C. Eckstein

Biomedical Eng Dept

University of Miami

PO B OX 24829 4

Coral Gables, FL 33124

(305) 284-2442

Platelet Concentration in the Marginal Layer

2 RO1 HL 22455-03

Dr. L. Henry Edmunds

Dept of Surgery

University of PA

3400 Spruce St

Philadelphia, PA19104

(215) 662-2091

Platelet Function During Extracorporeal Perfusion

5 RO1 HL 19055-05

Dr. Suzanne Gaston Eskin

Dept of Surgery

Baylor College of Med

1200 Moursund

Houston, TX 77030

(713) 790-4567’

Response of Cultured Endothelial Cells to Flow

5 RO1 HL 23016-02

Dr. Evan A. Evans

Dept of Biomed Eng

Duke University

Durham, NC

(919) 684-5218

RBC Membrane Adhesion & Deformation Energies

1 RO1 HL 24796-01

Dr. John L. Glover

Purdue University

at Indianapolis

Indianapolis, IN

(317) 630-7491

Seeding of Endothelial Cells in Vascular Prostheses

1 RO1 HL 24247-O1A1

Dr. Donald E. Gregonis

University of Utah

Salt Lake City, UT

(801) 581-7899

Basic Studies on Blood-Polymer Interactions

1 RO1 HL 26469-01

Dr. Frederick Grinnell

Dept of Cell Biology

University of Texas

5323 HarryHines Blv

Dallas, TX 75235

(214) 688-2181

Blood-Material Interactions: Adsorption of Fibronectin

5 RO1 HL 24221-02

Dr. Jesse D. Hellums

Dept of Chem Eng

Rice University

PO Box 1892

Houston, TX 77001

(713) 527-3497

Effects of Physical Forces on Platelets

5 RO1 ill 18584-05
BIOMATERIALS PROGRAM

Dr. Anne P. Hiltner

Dept Macromolec Sci

Case Western Res Univ

University Circle

Cleveland, OH 44106

(216) 368-4186

Long Term Biodegradation of Elastomeric Biomaterials

1 RO1 HL 25239

Dr. Cornelis A. Hoeve

Dept of Chemistry

Texas A&M University

College Station, TX 77843

(713) 845-3243

Guidelines for Polymers Acting as Elastin Substitutes

5 RO1 HZ 18441-03

Dr. Allan S. Hcoffman

Bioengineering Ctr

Univ of Washington

Seattle, WA 98195

(206) 543-9423

Surface Thrombogenesis:Mechanisms and Prevention

5 PO1 HL 22163-03

Dr. Thomas A. Horbett

Dept of Chem Eng

Univ of Washington

Seattle, WA 98195

(206) 543-6419

Cellular Interactions with Foreign Materials

2 RO1 HL 19419-05

Dr. Ting-Cheng Hung

School of Medicine

U of Pittsburgh

Pittsburgh, PA 15261

(412) 624-5369

Study of Leukocyte Degradation Characteristics

1 RO1 HL 25814-01

Dr. Lucija Stacic Karic

Inst of Med Sciences

Pacific Medical Ctr

Clay & Webster Sts

San Francisco, CA 94120

(415) 563-2323 X2416

Extracorporeal Circulation & Protein Denaturation

5 R23 HZ 21271-03

Dr. Sung Wan Kim

School of Pharmacy

University of Utah

Skaggs Hall

Salt Lake City, UT 84112

(801) 581-6801

Initial Events in Thrombus Formation on Surfaces

5 RO1 HL 17623-07

Dr. Sung W. Kim

School of Pharmacy

University of Utah

Skaggs Hall

Salt Lake City, UT 84112

(801) 581-6801

A Novel Approach to Nonthrombogenic Polymer Surfaces

2 RO1 HL 20251-04
DEVICES AND TECHNOLOGY BRANCH

DIVISION OF HEART AND VASCULAR DISEASES

OF THE

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

BETHESDA, MARYLAND 20205

RESEARCH AND DEVELOPMENT GRANTS

NOVEMBER, 1980

U.S. DEPARTNENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH
CIRCULATORY ASSIST & ARTIFICIAL HEART DEVICES PROGRAM

Dr. William F. Bernhard

Childrens Hospital

Medical Center

300 Longwood Ave

Boston, MA 02115

(617) 734-6000 X3261

Evaluation of a Left Ventricular-Aortic Prosthesis

5 RO1 HL 20037-03

Dr. William F. Bernhard

Children’s Hospital

Medical Center

300 Longwood Avenue

Boston, MA 02115

(617) 734-6000 X3261

Clinical Left Ventricular Bypass Studies

1 RO1 HL 25882-01

Dr. Erich E. Brueachke

St. Lukes Medical Ctr

1753 W Congresa Pk

Chicago, IL 60612

(312) 942-7083

Development of a Transcutaneous Power Transfer System

5 RO1 HL 21632-03

Dr. John E. Chimoskey

Dept of Physiology

Michigan State Univ

East Lansing, HI 48824

(517) 355-9269

Left Heart Failure Model for Testing Assist Devices

5 RO1 HL 24503-02

Dr. C. Forbes Dewey

Dept Mechanical Eng

Mass Inst of Tech

Room 3-250

Cambridge, MA 02139

(617) 253-2235

Unsteady Flow in Arterial Bifurcations

5 RO1 HL 21859-03

Dr. William H. Dobelle

Dept of Surgery

Columbia University

630 West 168th St

New York, NY 10032

(212) 694-4198

Simple Cardiac Assist (TALVB) Devices in Man

5 RO1 HL 23941-02

Dr. Leonard A.R. Gelding

Dept Cardiothor Surg

Cleveland Clinic

4500 Euclid Ave

Cleveland, OH 44106

(216) 444-6915

Physiological Studies of Chronic Nonpulsatile Blood FlOW

1 RO1 HL 26267-01

Dr. Robert K. Jarvik

Inst Biomedical Eng

University of Utah

Bldg 518

Salt Lake City, UT84112

(801) 581-6991

Studies with Electric Total Artificial Hearts

5 RO1 HL 24338-02
CIRCULATORY ASSIST & ARTIFICIAL HEART DEVICES PROGRAM

Dr. Adrian Kantrowitz

Dept of Surgery

Sinai Hosp of Detroit

6767 W Outer Dr

Detroit, MI 48235

(313) 272-6000 X8205

Active Prosthetic Myocardium: Effects on LV Function

5 RO1 HL 22329-02

Dr. Willem Kolff

Inst for Biomed Eng

University of Utah

Bldg 518

Salt Lake City, UT 84112

(801) 581-6296

Intra Aortic Balloon Pumping in Small Animals

5 RO1 HL 20803-04

Dr. Willem Kolff

Inst for Biomed Eng

University of Utah

Bldg 518

Salt Lake City, UT 84112

(801) 581-6991

Studies Towards An Acceptable Artificial Heart for Man

2 PO1 HL 13738-09

Dr. Bayliss C. McInnis

Cullen College of Eng

University of Houston

4800 Calhoun

Houston, TX 77004

(713) 749-1574

Automatic Controls for the Artificial Heart

1 RO1 HL 25029-OIA1

Dr. J. D. Mortensen

Utah Biomed Test Lab

520 Wakara Way

Salt Lake City, UT 84108

(801) 581-6190

Chronic Total Cardiopulmonary Mechanical Substitution

5 RO1 HL 22661-02

Dr. Yukihiko Nose

Dept Artificial Orgns

Cleveland Clin Found

9500 Euclid Ave

Cleveland, OH 44106

(216) 444-2470

Biventricular Assist and Replacement Studies

5 RO1 HL 24286-02

Dr. Don B. Olsen

Div Artificial Orgns

University of Utah

Salt Lake City, UT 84112

(801) 581-6991

Artificial Heart Implant,Later Cardiac Transplant

1 RO1 HL 24419-02

Dr. Don B. Olsen

Div Artificial Orgns

University of Utah

Salt Lake City, UT 84112

(801) 581-6991

Studies of the Pneumatic Artificial Heart in Calves

1 RO1 HL 24561-01
BLOOD PUMPS - Dr. Watson

Dr. Peer M. Portner

Andros, Inc.

2332 Fourth Street

Berkley, CA 94710

(415) 849-1377

NO1-HV-7-2938

Development of a Left Heart Assist Blood Pump

Expired: 9/14/80

Dr. David Lederman

Avco Everett Res Lab

2385 Revere Bch Pkw

Everett, MA 02149

(617) 389-3000

NO1-HV-7-2937

Left Heart Assist Blood Pumps

Expired: 9/14/80

Dr. Yukihiko Nose

Cleveland Clinic Fndn

9500 Euclid Ave

Cleveland, OH 44106

(216) 444-2470

NO1-HV-4-2960

Development & Evaluation of Cardiac Prostheses

Expired: 9/29/80

Dr. John C. Norman

Texas Heart Inst

6720 Bestner St

Houston, TX 77030

(713) 521-3121

NO1-HV-7-2936

Left Heart Assist Device Development

Expired: 9/29/80

Mr. Robert L. Whalen

Thermo Electron Corp

101 First A v e

Waltham, MA 02154

(617) 890-8700

NO1-HV-7-2934

Development of a Left Heart Assist Blood Pump

FY 80: -ODr. Philip Litwak

Thoratec Labs Corp

2023 8th Street

Emeryville, CA 94710

(415) 658-7787

NO1-HV-7-2939

Develop and Evaluate Left Heart Assist Blood Pumps

FY 80: -O-
FABRICATION - Dr. Altier i

Mr. Victor Poirier

Thermo Electron Corp.

101 First Ave.

Waltham, MA 02154

(617) 890-8700

NO1-HV-9-2907

Fabrication of Cardiovascular Devices

FY 80: $292,156

Mr. Keith S. Buck

Thoratec Labs Corp.

4204 Hollis St.

Emeryville, CA 94608

(415) 658-7787

NO1-HV-9-2906.

Fabrication of Cardiovascular Devices

FY 80: $207,821 I
CLINICAL EVALUATION: LEFT VENTRICULAR ASSIST DEVICES - Dr. Watson

Dr. William F. Bernhard

Childrens Hospital

Medical Center

300 Longwood Ave

Boston, MA 02115

(617) 734-6000 X3261

NO1-HV-5-3007

Clinical Evaluation: Model X LVAD

FY 80: $23,068

Expired: 6/30/80

Dr. John C. Norman

Texas Heart Inst

6720 Bestner Street

Houston, TX 72025

(713) 521-3121

NO1-HV-5-3006

Clinical Evaluation: Model VII LVAD

FY 80: $32,053

Expired: 6/30/80

Mr. John M. Keiser

Thermo Electron Corp

101 First Ave

Waltham, MA 02154

(617) 890-8700 X409

NO1-HV-5-3008

LVAD: Clinical Evaluation of Temporary Assist

FY 80: $31,809

Expired: 6/30/80
IMPLANTABLE LEFT HEART ASSIST SYSTEMS - Dr. Altieri, Dr. Watson

Dr. John Moise

Dr. Yukihiko Nose

Aerojet General Corp

POB 1322.2 Dept 2150

Sacramento, CA 95813

(919) 355-2018

NO1-HV-O-291 1

Implantable Electrohydraulic Left Heart Assist Device

FY 80: $1,076,181

Dr. Peer Portner

Andros, Inc.

2332 Fourth St

Berkeley, CA 94710

(415) 849-1377

NO1-HV-O-290 8

Implantable Left Heart Assist Syatem

FY 80: $1,044,718

Dr. Param I.Sing h

Dr. David Lederman

Avco Everett Res Lab

2385 Revere Bch Pkw

Everett, MA 02149

(617) 389-300

NO1-HV-O-291 3

Implantable Left Heart Assist Device

FY 80: $1,038,454

Dr. John C. Norman

Mr. Jack Chambers

Texas Heart Institute

6720 Bestner St

Houston, TX 77030

(713) 521-3121

NO1-HV-O-291 5

Implantable Left Heart Assist Device

FY 80: $893,361

Mr. David B. Oernes

Dr. William F. Bernhar d

Thermo Electron Corp.

101 First A v e

Waltham, MA 02154

(617) 890-8700

NO1 NV-O-2914

Implantable Left Heart Assist Device

FY 80: $1,083,466

I
PHYSICAL TESTING - Dr. Watson

Dr. Carl R. McMillin

Monsanto Res Corp

1515 Nicholas Rd

Dayton, OH 45407

(513) 268-3411 x211

NO1-HV-7-2918

Physical Testing of Circulatory Assist Device Polymers

Expired: 8/31/80

Dr. Robert W. Penn

Natl Bureau of Stnds

Materials Res Inst

Gaithersburg, MD 20760

(301) 921-2116

YO1-HV-8-0003

Physical Testing of Circulatory Assist Device Polymers

Expired:9/30/80

Dr. John L. Kardos

Washington University

Linden & Skinker

St. Louis, MO 6313 0

(314) 863-0100 x4577

NO1-HV-7-2919

Physical Testing of Circulatory Assist Device Polymers

Expired: 8/31/80
PHYSICAL TESTING - Dr. Altieri

Dr. Carl R. McMillan

Monsanto Res Corp

1515 Nicholas Rd

Dayton, OH 45407

(513) 268-3411 x211

NO1-RV-O-2909

Physical Testing of Circulatory Assiat Device Polymers

PY 80: $208,762

Dr. John L. Kardoa

Washington University

Linden & Skinker

St Louis, MO 63130

(314) 889-6062

NO1-HV-O-291O

Physical Testing of Circulatory Assist Device Polymers

PY 80: $145,992
ENERGY TRANSMISSION - Dr. Berson

Dr. Peer M. Portner

Andros, Inc

2332 Fourth Street

Berkeley, CA 94710

(415) 849-1377

NO1-NV-7-2933

Electrical Energy Transmission Technique Development

FY 80: $219,323

Dr. Adrian Kantrowitz

Sinai Hosp of Detroit

6767 West Outer Dr

Detroit, MI 48235

(313) 493-5775

NO1-NV-8-2921

Percutaneous Energy Transmission Systems

FY 80: $116,263

Dr. Benedict D.T. Daly

St Elizabeth’s Hosp

736 Cambridge St

Boston, MA 02135

(617) 956-5589

NO1-HV-8-2919

Percutaneous Energy Transmission Systems

FY 80: $141,092

Dr. Freeman Fraim

Thermo Electron Corp

101 First Ave

Waltham, MA 02154

(617) 890-8700

NO1-HV-O-2903

Develop, Evaluate Transcutaneous Energy Transmission System

FY 80: $202,507
INSTRUMENTATION - Dr. Berson

Dr. Ralph W. Barnes

Bowman Gray

School of Medicine

300 Hawthorne Rd

Winston-Salem, N.C.27103

(919] 727-4504

NO1-HV-1-2902

Noninvasive Detection of Atherosclerotic Lesions

FY 81: $296,830

Dr. John D. Hestenes

Calif Inst of Tech

Jet Propulsion Lab

4800 Oak Grove Dr

Pasadena, CA 91103

(213) 354-2961

Imaging of Deep Arterial Lesions by Swept Ultrasound

Dr. William R. Brody

Stanford University

Dept of Radiology

Stanford, CA 94305

(415) 497-5226

NO1-HV-O-2922

Energy Selective Methods for Intravenous Arteriography

FY 80: $246,359

Dr. Donald Sashin

Univ of Pittsburgh

RC 406 Scafe Hall

Pittsburgh, PA 15621

(412) 647-3490

NO1-HV-O-2929

Noninvasive Detection of Atherosclerotic Lesions

FY 80: $181,251

Dr. Charles A. Histretta

Univ of Wisconsin

Clinical Science Ctr

600 Highland Ave

Madison, WI 53706

(608) 263-8309

NO1-HV 1-2905

Noninvasive Detection of Atherosclerotic Lesions

FY 81: $296,830
INSTRUMENTATION - Mr. Powell

Dr. Ralph W. Barnes

Bowman Gray

School of Medicine

300 S Hawthorne Rd

Winston Salem, N.C.27103

(919) 727-4504

NO1-HV-7-2925

Ultrasonic Imaging andArterial Measurements

Expired: 9/14/80

Dr. Frank E. Barber

Harvard Med School

44 Bimey St

Boston, MA 02115

(617) 732-3582

NO1-HV-7-2927

Ultrasonic Imaging and Tisaue Characterization

Expired: 9/29/80

Dr. John M. Reid

Institute of Applied

Physiology & Medicine

701-16th Ave

Seattle, WA 98122

(206) 442-7330

NO1-HV-7-2926

Ultrasonic Doppler I-ging with Automatic Line Scanning

Expired: 9/14/80

Dr. Titus C. Evans

Mayo Foundation

200 First Ave.

Rochester, MN 55901

(507) 282-2511

NO1-HV-7-2928

Ultrasonic Imaging with Flow Velocity Profiles

Expired: 9/17/80

Dr. David Wilson

SRI International

Bioengineering Res

333 Ravenswood*Ave

Menlo Park, CA 94025

(415) 326-6200 X4918

NO1-HV-2900

Duplex B-Scan Imaging System for Abdominal Arteries

FY 81: $346,130

Dr. Leon Kaufmann

Univ of Calif at SF

400 Grandview Dr

San Francisco, CA94080

(415) 952-1366

NO1-HV-O-2928

Noninvasive Detection of Atherosclerotic Lesions

N 80: $87,361

Dr. Charles P. Olinger

Univ of Cincinnati

Stroke Research Lab

4303 ?led Sci Bldg

Cincinnati, OH 45267

(513) 872-5431

NO1-HV-7-2924

Ultrasonic Imaging with Flow & Tissue Characterization

FY 80: $266,478

Expired: 9/1/80

Dr. Martin D. Fox

Univ of Connecticut

School of Eng

Storrs, CT 06268

(203) 486-4821

NO1-HV-7-2929

Crossed Beam Doppler and Sector Scans

Expired: 9/1/80
INSTRUMENTATION - Mr. Powell

Dr. David H. Blankenhorn

Univ of So. Cal.

2025 Zonal Ave

Los Angeles, CA 90033

(213) 224-7315

NO1-NV-7-2930

Enhanced X-ray Images and Ultrasonic Tissue Parameters

Expired: 9/29/80

Dr. Theron W. Ovitt

University of Arizona

Dept of Radiology

Tucson, AZ 85724

(602) 626-6007

NO1-HV-7-2931

Electronic X-ray Imaging & New Contrast Agents

Expired: 9/1/80

Dr. Theron W. Ovitt

Univ of Arizona

Dept of Radiology

Health Sciences Ctr

Tuscon, AZ 85724

(602) 626-6007

NO1-NV-1-2901

Noninvasive Detection of Atherosclerotic Lesions

FY 81: $257,159
BIOMATERIALS - Dr. Pitlic k

Dr. Peter Madras

Dr. Robert C.Cumming

Avco Everett Res Lab

2385 Revere Bch Pkw

Everett, MA 02149

(617)389-3000

NO1-HV-O-2912

Blood Compatibility of Circulatory Assist Devices

FY 80: $142,885

Dr. Edward W.C. Wong

Avco Everett Res Lab

2385 Revere Bch Pkw

Everett, MA 02149

(617) 389-3000 X765

NO1-HV-9-2932

Procurement of Standard Reference Materials

FY 80: $81,968

Dr. George Herzlinger

Avco Everett Res. Lab

2385 Revere Bch Pkw

Everett, MA 02149

(617) 389-3000 X305

NO1-HV-9-2901

Complement-Biomaterial Interaction

Expired: 3/31/80

Mr. Axel D. Haubold

Carbomedics

11388 Sorrento Vail

‘San Diego, CA 92111

(714) 452-8484

NO1-HV-4-2928

Carbon Film Composites for Prosthetic Devices

Expired: 4/30/80

Dr. G. C. Berry

Carnegie-Mellon Inst.

4400 Fifth Avenue

Pittsburgh, PA 15213

(412) 578-3131

NO1-HV-3-2949

Interpenetrating Polymer Networks for Biological Application:

Expired: 3/31/80

Dr. Paul Didisheim

Mayo Foundation

200 First St. , SW

Rochester, MN 55901

(507) 284-3049

NO1-HV-9-2915

Blood Compatibility of Circulatory Assist Devices

FY 80: $137,687

Mr. Robert S. Ward

Thoratec Labs.Corp.

2023 Eighth Street

Berkeley, CA 94710

(415) 658-7787

NO1-HV-9-2933

Procurement of Standard Reference Materials

FY 80: $237,248

●
f310MATERIALS - Mr. Powell

Mr. Michael Szycher

Thermo Electron Corp.

101 First Ave

Waltham, MA 02154

(617) 890-8700

N01-HV-3-2915

Development & Testing of Integrally Textured Blood Pump Bladders

FY 80: -O-
BIOMATERIALS PROGRAM

Dr. William W. Lee

Stanford Res Inst

333 Ravenswood Ave

Menlo Park, CA 94025

(413) 326-6200

Blood Compatible Benzamidine Containing Polymers

5 RO1 HL 21769-03

Dr. Robert I.Leininger

Battelle Mem Inst

Columbus Laboratories

505 King Avenue

Columbus,OH 43201

(614) 424-7138

An Evaluation of Blood-Surface Interactions

5 RO1 HL 24015-02

Dr. Jane B. Lian

Dept of Surgery

Childrns Hosp Med Ctr

300 Longwood Ave

Boston, MA 02115

(617) 734-6000 X3619

Blood-Material Interactions

5 RO1 HL 24029-02

Dr. Reginald G. Mason

Dept of Pathology

University of Utah

School of Medicine

Salt Lake City, UT 84112

(801) 581-7773

Endothelial Linings for Artificial Organs

7 RO1 HL 25805-01

Dr. Reginald G. Mason

Dept of Pathology

University of Utah

School of Medicine

Salt Lake City, UT 84112

(801) 581-7773

An Inhibitor of Platelet Adhesion to Artificial Organs

7 RO1 HL 25806-01

Dr. Larry V. McIntire

Dept of Chem Eng

Rice University

PO BOX 189 2

Houston TX 77001

(713) 528-4141 X41O

Perfusion Lung: Role of Traumatized Leukocytes

5 RO1 HL 17437-05

Dr. Syed Fazal Mohammad

Dept of Pathology

University of Utah

Salt Lake City, UT 8411 2

(801) 581-7773

Platelet Factor 3 and Blood-Material Interactions

1 RO1 HL 25804-01

Dr. John A. Penner

Dept of Medicine

College of Human Med

B220 Life Sciences

E. Lansing, MI 48824

(517) 353-6625

Control of Clotting on Biomaterials by Anticoagulants

7 RO1 HL 27042-01
BIOMATERIALS PROGRAM

Dr. Ronald P. Quintana

Dept Medicinal Chem

Univ of Tennessee

Center for Hlth Sci

Memphis, TN 38163

(901) 528-6085

Surface-Active Antithrombotic Agents for Prostheses

5 RO1 HL 22236-02

Dr. Ronald P. Quintana

U of Tennessee

Ctr for Health Sci

800 Madison Avenue

Memphis, TN 38163

(901) 528-6085

Moieties Affecting Platelet - Biomaterial Interactions

1 RO1 HLGM 25884-01

Dr. Robert Rodvien

Heart Research Inst

Inst of Medical Sci

2200 Webster St

San Francisco, CA 94114

(415) 563-2323 X2420

Blood-Material Interactions

5 RO1 HL 24018-02

Dr. Edwin W. Salzman

Mass Inst Technology

Bldg 16 Rm 522

Cambridge, MA 02139

(617) 735-2000

Thromboresistant Materials

5 RO1 HL 20079-04

Dr. Jerome S. Schultz

Dept of Chemical Eng

Univ of Michigan

2020 G.C. Brown Lab

Ann Arbor, MI 48109

(313) 764-2383

Effect of Flow on Fibrin Formation

1 RO1 HL 23379-01

Dr. Jerome S. Schultz

Dept of Chemical Eng

Univ of Michigan

2020 G C Brown Lab

Ann Arbor, MI 48109

(313) 764-2383

Blood Material Interface Interactions

5 RO1-HL 24039-02

Dr. Michael V. Sefton

Dept of Chemical Eng

University of Toronto

Toronto, Ontario MFS IA4

(416) 978-4019

Heparinized Material - Blood Interaction

5 RO1 HL 24020-02

Dr. Kenneth A. Solen

Dept of Chemical Eng

Brigham Young Univ

350 CB

Provo, UT 84602

(801) 378-1211 X2587

Pulsatile Pressures in Microemboli Filtrations

1 RO1 HL 25912-01
B1OMATER1ALS PROGRAM

Dr. Robert E.Sparks

Dept of Chemical Eng

Washington University

Linden & Skinker

St. Louis, MO 63130

(314) 889-6003

Biosorbable Thromboresistant Surfaces

5 RO1 HL 18764-05

Dr. Salvatore P. Sutera

Dept of Mech Eng

Washington University

BOX 118 5

St. Louis, MO 63130

(314) 863-0100 X4343

Blood Cells:Physical Properties,Structure & Function

5 RO1 HL 12839-11

Dr. Leo Vroman

Downstate Medical Ctr

450 Clarkson Ave

Brooklyn, NY 11203

(212) 836-6600 X223

Flow and Flexing at Blood/Biomaterial Interface

5 RO1 HL 23899-03

Dr. Alan G. Walton

Dpt Macromoleclr Sci

Case Western Res Univ

801 Olin Bldg

Cleveland, OH 44106

(216) 368-4166

Program Project in Biological Materials

5 PO1 HL 15195-04

Dr. Michael C. Williams

Dept of Chem Eng

Univ of California

Berkeley, CA 94720

(415) 642-4525

Hemolysis Induced by Shear Flow

5 RO1 HL 23274-02

Dr. Joseph E. Wilson

Dept of Chemistry

Bishop College

3837 Simpsn-Strt Rd

Dallas, TX 75241

(214) 372-8170

Development of Antithrombogenic Plastic Biomaterials

2 RO1 HL 21194-03

Dr. Ioannis V. Yannas

Dept of Mech Eng

MIT

77 Mass Ave

Cambridge, MA 02139

(617) 253-4469

Thrombogenic/Non-thrombogenic Collagen Fibers

5 RO1 HL 24036-02
—

90 ● Background paper #2: Case Studies of Medical Technologies

APPENDIX D: SHDPP MATERIALS

Table D-1.—SHDPP Three= Community Study Design

CommuniTY 1972 1973 1974 1975

Watsonville. . Baseline survey Media campaign Second survey Media campaign Third survey Maintenance

intensive instruc- intensive instruc- (Iow level)

t ion for 2/3 tion for 2/3 media campaign

Gilroy . . . . . . Baseline survey Media campaign Second survey Media campaign Third survey Maintenance

(low level)

media campaign

Tracy. . . . . . . Baseline survey Second survey Third survey

SOURCE: Stanford Heart Disease Prevention Program, Stanford, Calif.

Table D-2.—Demographic Characteristics and Survey Response Rates in Each of the Three Communities

Characteristics oft he community groups Tracy Gilroy Watsonville

Entire town (1970 census)

Population (total) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14,724

Population (35 to 59 years of age). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4,283

Mean age of 35-to 59-year-old group (years) . . . . . . . . . . . . . . . . . . . . . . 47.0

Male/female ratio of 35-to 59-year-old group . . . . . . . . . . . . . . . . . . . . . 0.96

Random sample (ages 35 to 59)

Original sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 659

Natural attrition (migration or death). . . . . . . . . . . . . . . . . . . . . . . . . . 74

Potential participants for all 3 surveys. . . . . . . . . . . . . . . . . . . . . . . . . 585

Percentage of original sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88.8%

Refusals and dropouts over 2 years. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

Participants completing first and third survey . . . . . . . . . . . . . . . . . . . . 418

Percentage of potential participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2 %

Mean age at October 1972 (years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46.9

Male/female ratio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.84

Spanish speaking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.170

Bilingual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.0 %

High school completed. . . . . . . . . . . . . . ., . . . . . . . . . . . . . . . . . . . . . . . 68.5%

Annual family income of $10,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68.9%

SOURCE: Stanford Heart Disease Prevention Program, Stanford, Cal if.

12,665

3,224

46.2

0.88

79

580

88.0%

183

427

7 4 %

45.8

0.78

8.370

17.970

63.5%

65.3%

14,569

4,115

47.6

0.86

833

107

726

87.1%

303

449

62%

48.4

0.75

7.8%

9.5%

64.7%

62.2%
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 91

Table D-3.—Risk Indicator and Knowledge Scores:

Percentage Change From Baseline at 1,2, and 3 Followup Surveys

Treatment

Watsonville: media plus Watsonville: media only Gilroy: media only Tracy: control

Measurement face-to-face (N= 67) (N= 37) (N= 85) (N= 90)

Risk score

Followup 1. . . . . . . . . .

Followup 2. . . . . . . . . .

Followup 3. . . . . . . . . .

Knowledge score

Followup 1. . . . . . . . . .

Followup 2. . . . . . . . . .

Followup 3. . . . . . . . . .

Dietary cholesterol (mg/day)

Followup 1. . . . . . . . . .

Followup 2. . . . . . . . . .

Followup 3. . . . . . . . . .

Dietary saturated fat (g/day)

Followup 1. . . . . . . . . .

Followup 2. . . . . . . . . .

Followup 3. . . . . . . . . .

Relative weight

Followup 1. . . . . . . . . .

Followup 2. . . . . . . . . .

Followup 3. . . . . . . . . .

Cigarette smokers (%)

Followup 1. . . . . . . . . .

Followup 2. . . . . . . . . .

Followup 3. . . . . . . . . .

– 27.8a

– 30.1 b

–29.OC

– 11.6b

–25.6b

– 23.1 b

– 8 1 b

–25.5 b

– 16.1

5.7

– 2.3

– 8.0

51 .6a

53.3a

57. 0

a

27. 4

b

27. 7

b

27. 9

b

16. 6

b

28. 0

b

33. 9

b

2.2

4.8

14.0

–40.7d

- 37.lb

–42.3b

– 26.1 b

–22.9b

–27.2b

–29.8b

–31.8b

–38.6b

– 10.1

– 6.5

– 13.4

–33.4b

–30.5b

–36.4b

–20.9b

– 17.0

–23.9b

–25.8b

– 30.1 b

–38.4b

– 11.1

– 5.1

– 7.0

– 3.6a

– 1.5

– 0.4

0.0

0.0

– 0.8

– 0.3

– 0.2

0.4

– 0.7

– 0.4

– 0.8

–32.5d

– 47.5a

–50.oa

0.0

O . O

b e

O . O

b e

– 15.1

– 15.1

– 11.3

– 6.4

– 10.6

– 14.9

NOTE: The treatment groups consist of individuals who attended baseline and all three annual followup surveys. Data are reproduced from Meyer, et al. aThe between.group, one-tailed t-test with each other group iS Significant: P <

005

The between-group, one-tailed t-test with Tracy is significant: p <0.05.

cThe betweefl-group, one-tailed t-test with Tracy and Gilroy is significant: P <005

dThe between-group, one.tailed t test with Watsonville Control and Tracy iS signifiLa,lt: P <0.05.

eBetween-group difference IS in the direction contrary to prediction.

SOURCE: Stanford Heart Disease Prevention Program, Stanford, Calif.

Table D-4.—SHDPP Expenses by Media Campaign

Campaign 1 Campaign 2 Campaign 3 Total

Media costs . . . . . . . . . . . . . . . . $120,150 $74,24 6 $33,93 0 $228,326

Personnel. . . . . . . . . . . . . . . . . . 87,960 57,958 69,153 215,071

Surveys and data. . . . . . . . . . . . 33,243 20,639 18,198 72,080

Total . . . . . . . . . . . . . . . . . . . . $241,353 $152,843 $121,281 $515,477

Number of months . . . . . . . . . .

Average/month . . . . . . . . . . . . . $8,045 $12,737 $10,107 $9,545

SOURCE. Stanford Heart Disease Prevention Program, Stanford, Cal if
92 ● Background Paper #2: Case Studies of Medical Technologies

REFERENCES

1,

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

Ad Hoc Task Force on Cardiac Replacement,

Cardiac Replacement: Medical, Ethical, Psychological, and Economic Implications (Washington, D. C.: U.S. Government Printing Office,

1969).

American Heart Association, “Intersociety Commission for Heart Disease Resources, ” Circulation, 42:A55, 1970.

American Hospital Association, Hospital Statistics (Chicago: AHA, published annually).

Anderton, J. L., et al., Living With Renal Failure

(Baltimore, Md.: University Park Press, 1978).

Annas, G., “Rationing Health Technology: Legal

and Ethical Issues, ” in Technology and the Quality of Health Care, R. H. Egdahl and P. M. Gertman (eds. ) (Germantown, Md.: Aspen Systems

Corp., 1978).

Arthur D. Little, Inc., Final Report: An Evacuation of Home Hemodialysis Systems (2 vols. ),

final report to Kidney Disease Control Program,

Health Services and Mental Administration,

Public Health Service, DHEW, Rockville, Md.,

1970.

Arthur D. Little, Inc., Financing Catastrophically Expensive Health Care (2 vols. ), contract No.

HSM 11o-71-197, final report to Health Resources Administration, Public Health Service,

DHEW, Rockville, Md., 1975.

Banta, H. D., and Sanes, J. R., “How the CAT

Got Out of the Bag,” in Technology and the

Quality of Health Care, R. H. Egdahl and P. M.

Gertman (eds.) (Germantown, Md.: Aspen Systems Corp., 1978).

Barnes, B. A., Harvard School of Public Health,

“Current Status of Home Dialysis and Related

Issues Based Upon Literature of 1977-1979, ” unpublished manuscript, 1979.

, “An Overview of the Treatment of EndStage Renal Disease and a Consideration of

Some of the Consequences,” in Costs, Risks, and

Benefits of Surgery, J. P. Bunker, et al. (eds.)

(New York: Oxford University Press, 1977).

Befeler, B., “Cost Analysis of Elective Myocardial Revascularization,” Chest, 72(4):548, 1977.

Bilitch, M., “Performance of Cardiac Pacemaker

Generators,” PACE, 2:259, 1979.

Calabresi, G., and Bobbitt, P., Tragic Choices

(New York: W. W. Norton & Co., 1978).

California State Department of Public Health,

The Feasibility of Chronic Hemodialysis in California (Berkeley, Calif.: State of California,

1966).

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

Calland, C., “Iatrogenic Problems in End-Stage

Renal Failure,” N. Eng. ). Med. 287:334, 1972.

Cardiology Advisory Committee, “Mechanically

Assisted Circulation” (Bethesda, Md.: National

Heart, Lung, and Blood Institute, May 1977).

Chardack, W., et al., “Correction of Complete

Heart-Block by Self-Contained Pacemaker,” J.

Thor. Cardio. Surg. 42:814, 1961.

Chiang, C. L., Introduction to Stochastic Processes in Biostatistics (New York: John Wiley &

Sons, 1968).

Christopherson, L. K., et al., “Rehabilitation

After Cardiac Transplantation, ” ]. A.M.A.

236(18): 2082, 1976.

Cole, D., Human Health and Assessments, Office of HeaIth and Environmental Research, Department of Energy, Washington, D. C., personal

communication, July 1979.

Comroe, J. H., University of California, San

Francisco, interview, Sept. 21, 1979.

Cooper, T., Cornell University, Ithaca, N. Y.,

personal communication, May 25, 1979.

Copley, D. P., et al., “Improved Outcome for

Prehospital Cardiopulmonary Collapse With Resuscitation by Bystanders, ” Circulation 56:901,

1977.

Crosby, I. K., et al., “Employment and Survival

After Left Main Coronary Surgery,” Circzdation

58:18, 1978.

Czaczkes, J. W., and De-Nour, A. K., Chronic

Dialysis as a Way of Life (New York: Brunner/

Mazel, 1978).

Dong, E., and Andreopoulos, S., Heartbeat

(New York: Coward, McGann & Geoghegan,

1978).

Farquhar, J. W., et al., “Community Education

for Cardiovascular Health,” L.ancet 1:1192, 1977.

Fox, R. C., and Swazey, J. P., The Courage to

Fail (Chicago: University of Chicago Press,

1974).

Friedberg, C. K., et al., “Non-Surgically Acquired Heart Blocks,” Ann. IV. Y. Acad. Sci.

11:835, 1964.

Frommer, P., National Heart, Lung, and Blood

Institute, Bethesda, Md., personal communication, March 1980.

Furman, S., and Escher, D., Principles and Techniques of Cardiac Pacemaking (New York:

Harper & Row, 1979).

Hammermeister, K. E., et al., “The Effect of Surgical Versus Medical Therapy of Coronary Disease on Return to Work, ” Amer. ]. Card. 41:409,

1978.
Case Study #9: The Artificial Heart: Cost, Risks, and Benefits ● 9 3

33.

34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

44.

45.

46.

47.

48.

49.

Hastings, F., in hearings on HEW Appropriations for 1968, Senate Subcommittee on Appropriations, 90th Cong., 1st sess. (Washington,

D. C.: U.S. Government Printing Office, 1967).

Hegyeli, R., and Machesko, M,, Report on the

Left Ventricular Assist Device: Teco Models VII

and X, DHEW publication No. (NIH) 75-626 (Bethesda, Md.: National Institutes of Health, January 1974).

Hittman Associates, Final Summary Report on

Six Studies Basic to the Consideration of the Artificial Heart Program (Baltimore, Md.: Hittman

Associates, 1966).

Johansson, B., “Longevity in Complete Heart

Block,” Arm. N.Y. Acad. Sci. 167:1031, 1969.

Kantrowitz, A., et al., “The Treatment of Complete Heart Block With an Implanted Pacemaker,” Surg. Gyn. Ob. 115:415, 1962.

Kaplan, A., “Artificial Heart Panel,” Hastings

Center Report 5:4I, 1975.

Katz, J., and Capron, A. M., Catastrophic Diseases: Who Decides What? (New York: Russell

Sage Foundation, 1975).

Knutti, R., in hearings on HEW Appropriations

for 1966, Senate Subcommittee on Appropriations, 89th Cong., 1st sess. (Washington, D. C.:

U.S. Government Printing Office, 1965).

Kolff, W. J., and Lawson, J., “Perspectives for

the Total Artificial Heart, ” Transplantation Proceedings 9(1):317, March 1979.

Lederberg, J., “The Heart Gap Will Cause Soul

Ache,” Washington Post, Washington, D. C.,

July 24, 1966.

Levy, N. B. (cd.), Living or Dying (Springfield,

111.: Charles C. Thomas, 1974).

Liberthson, R. R., et al., “Pre-Hospital Ventricular Defibrillation: Prognosis Follow-Up

Course,” N. Eng, ]. Med. 91:317, 1974.

Lindgren, N., “Artificial Heart—Examples of

Mechanical Engineering Enterprise, ” IEEE Spectrum, September 1967.

McAnulty, J. H., et al., “A Prospective Evaluation of Intrahislan Delay, ” Circulation 59:1035,

1979.

McIntosh, H. D., and Garcia, J. A., “Aortocoronary Bypass Grafting 1967-1977, ” Circulation

57(3):405, 1978.

Meyer, A., et al., Stanford Heart Disease

Prevention Program, Stanford, Calif., “Skills

Training in a Cardiovascular Health Education

Campaign,” unpublished manuscript.

National Academy of Sciences, Institute of Medicine, “The Effects on Populations of Exposure to

Low Levels of Ionizing Radiation” (Washington,

50.

51.

52.

53.

54.

55.

56,

57.

58.

59.

60.

61.

62.

63.

64.

65.

66.

D. C.: National Academy of Sciences, November

1972).

National Heart and Lung Institute, Totally Zmplantable Nuclear Heart Assist and Artificial

Heart Devices (Bethesda, Md.: National Institutes of Health, February 1972).

National Institutes of Health, The Totally Zmplantable Artificial Heart: Economic, Ethical,

Legal, Medical, Psychiatric, and Social Implications, NIH publication No. 74-191 (Bethesda,

Md.: National Institutes of Health, 1973).

Norman, J., Texas Heart Institute, Houston,

Tex., interview, January 1979.

“Mechanical Cloning, ” ]. Art. Znt. Org.

2:235, ~978.

NosE, Y., Cleveland Clinic, Cleveland, Ohio,

personal communication, 1979.

Parsonnet, V., “Appraisal and Reappraisal of

Cardiac Therapy, “ Am. Heart J. 94(5):658, 1977.

Parsonnet, V., and Manhardt, M., “Permanent

Pacing of the Heart, 1952 to 1976, ” Am. ], Card.

39:250, 1977.

Pierce, W., Pennsylvania State University, Hershey, Pa., personal communication, 1980.

Poirier, V., Thermoelectron Corp., Waltham,

Mass., personal communication, July 1979.

Preston, T., Coronary Artery Surgery (New

York: Raven Press, 1977).

Puska, P., et al., “Changes in Coronary Risk

Factors During Comprehensive Five-Year Community Programme to Control Cardiovascular

Diseases (North Karelia Project),” Br. Med. 1.

2:1173, 1979.

Raizes, G., et al., “Instantaneous Nonarrhythmic

Cardiac Death in Acute Myocardial Infarction, ”

Am. J, Card. 39(1):1, 1977.

Reiss, J. B., et al., Washington, D. C., “Issues in

the Cost and Regulation of New Medical Technologies and Procedures: Heart Transplants as a

Case Study,” unpublished paper, 1980.

Rettig, R. A., “The Policy Debate on Patient

Care Financing for Victims of End-Stage Renal

Disease,” Law Contemp, Pro6/. 40(4):196, 1976.

Rettig, R. A., and Webster, T. C., “Implementation of the End-Stage Renal Disease Program: A

Mixed Pattern of Subsidizing and Regulating the

Delivery of Medical Services, ” in Toward A National Health Policy, K. Friedman and S. Radkoff (eds. ) (Lexington, Mass.: Lexington Books,

1977).

Rimm, A., et al., “Changes in Occupation After

Aortocoronary Bypass, ” J. A.M.A. 236(4):361,

1976.

Russell, R. O., et al., “Changes in Work Status
94 . Background Paper #2: Case Studies of Medical Technologies

67.

68.

69.

70.

71.

72.

for Surgical Versus Medical Therapy,” Am. J.

Card. 43:383, 1979.

Salonen, J. T., et al., “Changes in Morbidity and

Mortality During Comprehensive Community

Programme To Control Cardiovascular Diseases

During 1972-7 in North Karelia,” Br. Med. J.

2:1178, 1979.

Samet, P., Cardiac Pacing (New York: Grune &

Stratton, 1973).

Sanders, H., “Artificial Organs,” Chem. & Eng.

N, 49:68, 1971.

Sapolsky, H. M., “Here Comes the Artificial

Heart,” The Sciences 13:26, 1978.

Schroeder, J., “Current Status of Cardiac Transplantation, 1978,” J, A.M.A. 241(19):2069, 1979.

Stanford Heart Disease Prevention Program,

Stanford, Calif., personal communication, 1980.

73.

74.

75.

76.

77.

78.

Stinson, E. B., “Current Status of Cardiac Transplantation,” in Heart Failure, A. P. Fishman

(cd.) (Washington, D. C.: Hemisphere Publishing

Co., 1978).

Stoney, W. S., et al., “Cost of Cardiac Pacing,”

Am. J. Card. 37:23, 1976.

Symmes, J. C., et al., “Influence of Aortocoronary Bypass Surgery on Employ merit,” CMA

Journal 118:268, 1978.

Tsai, S. P., et al., “Effect of Reduction in Leading

Causes of Death,” Am. J, Public Health

68(10):966, 1978.

Watson, J., National Heart, Lung, and Blood Institute, Bethesda, Md,, interview, June 1979.

Zoll, P. M., et al., “Long-Term Electric Stimulation of the Heart,” Ann. Surg. 154:330, 1961.

0