Department of Veterans Affairs

Health Services Research & Development Service Evidence-based Synthesis Program

Effectiveness of Intermittent 

Pneumatic Compression Devices 

for Venous Thromboembolism 

Prophylaxis in High-risk Surgical 

and Medical Patients

June 2015

Prepared for:

Department of Veterans Affairs

Veterans Health Administration

Quality Enhancement Research Initiative

Health Services Research & Development Service

Washington, DC 20420

Prepared by:

Evidence-based Synthesis Program (ESP) Center

Durham Veterans Affairs Healthcare System

Durham, NC

John W. Williams, Jr., MD, MHSc, Director

Investigators:

Principal Investigators: 

Juliessa M. Pavon, MD

John W. Williams, Jr., MD, MHSc

Co-investigators: 

Soheir S. Adam, MD

Zayd A. Razouki, MD

Jennifer R. McDuffie, PhD

Paul F. Lachiewicz, MD

Andrzej S. Kosinski, PhD

Christopher A Beadles, MD

Thomas L. Ortel, MD, PhD

Research Associate:

Avishek Nagi, MS

NOTE: This publication is for internal use of the Department of 

Veterans Affairs and should not be distributed outside the agency.

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Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

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i 

PREFACE

The VA Evidence-based Synthesis Program (ESP) was established in 2007 to provide timely and 

accurate syntheses of targeted healthcare topics of particular importance to clinicians, managers, and 

policymakers as they work to improve the health and healthcare of Veterans. QUERI provides funding 

for four ESP Centers, and each Center has an active University affiliation. Center Directors are 

recognized leaders in the field of evidence synthesis with close ties to the AHRQ Evidence-based 

Practice Centers. The ESP is governed by a Steering Committee comprised of participants from VHA 

Policy, Program, and Operations Offices, VISN leadership, field-based investigators, and others as 

designated appropriate by QUERI/HSR&D.

The ESP Centers generate evidence syntheses on important clinical practice topics. These reports help: 

Develop clinical policies informed by evidence;

Implement effective services to improve patient outcomes and to support VA clinical practice

guidelines and performance measures; and

Set the direction for future research to address gaps in clinical knowledge.

The ESP disseminates these reports throughout VA and in the published literature; some evidence 

syntheses have informed the clinical guidelines of large professional organizations. 

The ESP Coordinating Center (ESP CC), located in Portland, Oregon, was created in 2009 to expand the 

capacity of QUERI/HSR&D and is charged with oversight of national ESP program operations, program 

development and evaluation, and dissemination efforts. The ESP CC establishes standard operating 

procedures for the production of evidence synthesis reports; facilitates a national topic nomination, 

prioritization, and selection process; manages the research portfolio of each Center; facilitates editorial 

review processes; ensures methodological consistency and quality of products; produces “rapid response 

evidence briefs” at the request of VHA senior leadership; collaborates with HSR&D Center for 

Information Dissemination and Education Resources (CIDER) to develop a national dissemination 

strategy for all ESP products; and interfaces with stakeholders to effectively engage the program. 

Comments on this evidence report are welcome and can be sent to Nicole Floyd, ESP CC Program 

Manager, at Nicole.Floyd@va.gov. 

Recommended citation: Pavon JM, Williams JW Jr., Adam SS, Razouki ZA, McDuffie JR, 

Lachiewicz PF, Kosinski AS, Beadles CA, Ortel TL, Nagi A. Evidence Report: Effectiveness of 

Intermittent Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis in High-Risk 

Surgical and Medical Patients. VA ESP Project #09-010; 2015.

This report is based on research conducted by the Evidence-based Synthesis Program (ESP) Center located at 

the Durham VA Medical Center, Durham, NC, funded by the Department of Veterans Affairs, Veterans Health 

Administration, Office of Research and Development, Quality Enhancement Research Initiative. The findings and 

conclusions in this document are those of the author(s) who are responsible for its contents; the findings and 

conclusions do not necessarily represent the views of the Department of Veterans Affairs or the United States 

government. Therefore, no statement in this article should be construed as an official position of the Department 

of Veterans Affairs. No investigators have any affiliations or financial involvement (eg, employment, consultancies, 

honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties) that 

conflict with material presented in the report. 
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

ABSTRACT

Context: Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) 

and pulmonary embolism (PE), is a serious potential complication in hospitalized patients. 

Thromboprophylaxis regimens include pharmacological and mechanical options such as 

intermittent pneumatic compression devices (IPCDs). There are a wide variety of IPCDs 

available, but it is uncertain if they vary in effectiveness or ease of use. 

Objective: To systematically review the literature on the comparative effectiveness of IPCDs for 

selected outcomes (mortality, VTE, symptomatic or asymptomatic DVT, major bleeding, ease of 

use, and adherence) in post-operative surgical and high-risk medical patients. 

Data Sources and Study Selection: We searched MEDLINE (via PubMed), Embase, CINAHL, 

and Cochrane CENTRAL from January 1, 1995, to October 30, 2014, for peer-reviewed, 

English-language randomized controlled trials (RCTs). All searches used terms for IPCDs and 

the conditions of interest, along with validated search terms for RCTs. We also used terms to 

identify relevant observational studies on ease of use and adherence. Bibliographies of identified 

articles were further reviewed. To assess for possible publication bias, we searched 

ClinicalTrials.gov to identify completed but unpublished studies meeting our eligibility criteria.

Data Synthesis: Eighteen RCTs and 3 observational studies were eligible; most were conducted 

in patients undergoing joint replacement surgery. Our review considered 3 types of evidence: 1) 

head-to-head comparisons of IPCDs; 2) indirect comparisons of IPCDs to a common comparator 

(eg, foot vs calf devices, each compared to anticoagulation); and 3) data on ease of use or 

adherence from patients or staff. The methodological quality of the included studies was variable 

and generally suboptimal. The most commonly studied devices were the Kendall SCDTM and 

A-V Impulse SystemTM. Only 3 trials compared different IPCDs directly. One showed lower 

VTE rates for a VenaFlow® compared to the Kendall SCD, but 2 other studies showed no 

difference between the PlexiPulse® and the Kendall SCD. IPCDs were comparable to 

anticoagulation for major clinical outcomes (VTE: risk ratio [RR] 1.39; 95% confidence interval 

[CI], 0.73 to 2.64). Limited data suggest that concurrent use of anticoagulation with IPCD may 

lower the risk of VTE compared to anticoagulation alone (RR 0.27; 95% CI 0.05 to 1.64) and 

that IPCD compared to anticoagulation may lower the risk of major bleeding (RR 0.33; 95% CI 

0.07 to 1.51). Subgroup analyses did not show significant differences by device location, mode 

of inflation, or risk of bias elements. Overall, there were no consistent associations between 

specific brand-name IPCDs or sleeve location and ease of use or adherence. Chief limitations of 

the literature were the paucity of head-to-head comparisons between IPCDs in surgical and 

medical patients, and the identification of primarily asymptomatic DVTs of uncertain clinical 

importance.

Conclusions: IPCDs are appropriate for VTE thromboprophylaxis when used in accordance with 

current clinical guidelines. The current evidence base to guide selection of a specific device or 

type of device is limited. When choosing a specific IPCD, focusing on device flexibility, 

acceptability by nursing staff and patients, and the most frequently studied devices, as well as on 

cost, can help direct selection of appropriate IPCDs. Comparative effectiveness studies are 

urgently needed to address current gaps in evidence. 

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ABBREVIATIONS TABLE

ACCP American College of Chest Physicians

CECT Continuous enhanced circulation therapy

CI Confidence interval

DVT Deep vein thrombosis

ECRI Emergency Care Research Institute

ESP Evidence-based Synthesis Program

HSR&D Health Services Research & Development

IPCD Intermittent pneumatic compression device

ISTH International Society on Thrombosis and Haemostasis

KQ Key question

LMWH Low molecular weight heparin

MeSH Medical Subject Heading

n Number

PE Pulmonary embolism

PICOTS Population, intervention, comparator, outcomes, timing, and setting

PTT Partial thromboplastin time

QUERI Quality Enhancement Research Initiative

RIAC Rapid inflation asymmetrical compression

RCT Randomized controlled trial

RD Risk difference

RR Risk ratio

SCD Sequential compression device

THA Total hip arthroplasty

TKA Total knee arthroplasty

VA Veterans Affairs

VHA Veterans Health Administration

VISN Veterans Integrated Service Networks

VTE Venous thromboembolism

V/Q Ventilation/perfusion

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TABLE OF CONTENTS

INTRODUCTION......................................................................................................................... 1

High-Risk Patient Populations .................................................................................................... 1

Intermittent Pneumatic Compression Devices ............................................................................ 1

Objectives of the Report ............................................................................................................. 2 

METHODS .................................................................................................................................... 3

Topic Development ..................................................................................................................... 3

Search Strategy ........................................................................................................................... 3

Study Selection ........................................................................................................................... 4

Data Abstraction ......................................................................................................................... 5

Quality Assessment ..................................................................................................................... 5

Data Synthesis ............................................................................................................................. 6

Rating the Body of Evidence ...................................................................................................... 6

Peer Review ................................................................................................................................ 7 

RESULTS ...................................................................................................................................... 8

Literature Flow............................................................................................................................ 8

Key Question 1: In hospitalized surgical patients at high risk for venous thromboembolism 

(VTE), what is the comparative effectiveness of VTE prophylaxis with intermittent pneumatic 

compression devices versus VTE prophylaxis with pharmacologic agents for VTE events, 

VTE-related mortality, and adverse events? ............................................................................. 13

Key Question 2: In hospitalized medical patients at high risk for VTE, what is the comparative 

effectiveness of VTE prophylaxis with IPC devices versus VTE prophylaxis with 

pharmacological agents for VTE events, VTE-related mortality, and adverse events? ........... 19

Key Question 3: In hospitalized surgical and medical patients at high risk for VTE, what is the 

comparative effectiveness of different IPC devices when compared to one another for 

preventing VTE events? ............................................................................................................ 20

Key Question 4: When used for VTE prophylaxis, do different IPC devices differ in ease of 

use or adherence? ...................................................................................................................... 21 

SUMMARY AND DISCUSSION .............................................................................................. 23

Summary of Evidence by Key Question (KQ) ......................................................................... 25

Clinical and Policy Implications ............................................................................................... 26

Framework for Selecting IPC Devices ..................................................................................... 27

Limitations ................................................................................................................................ 28

Research Gaps/Future Research ............................................................................................... 28

Conclusions ............................................................................................................................... 29 

REFERENCES ............................................................................................................................ 30

TABLES

 Table 1. Inclusion and Exclusion Criteria ................................................................................4 

 Table 2. Devices Evaluated in Included Studies ....................................................................10 

Table 3. Strength of Evidence for ICPD Effectiveness in Reducing VTE Events ................23 

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 Table 4. Evidence Gaps and Future Research Needs.............................................................29 

FIGURES

Figure 1. Literature Flow Chart ...............................................................................................9 

 Figure 2. Numbers of Comparisons between Interventions (RCTs only, n=18) ...................10 

 Figure 3. Risk for VTE Events with IPCD versus Anticoagulation Prophylaxis in Joint

Replacement Patients .............................................................................................................14 

 Figure 4. Risk for any DVT Events with IPCD versus Anticoagulation Prophylaxis in

Joint Replacement Patients ....................................................................................................16 

 Figure 5. Risk for Major Bleeding Events with IPCD versus Anticoagulation 

 Prophylaxis in Joint Replacement Patients ............................................................................18 

APPENDIX A. Search Strategies ...............................................................................................36 

APPENDIX B. Quality (Risk of Bias) Assessment of RCTs—Criteria Used and 

Detailed Ratings ...........................................................................................................................39 

APPENDIX C. Peer Review Comments/Author Responses ....................................................44 

APPENDIX D. Study Characteristics ........................................................................................48 

APPENDIX E. Technical Features of Named Devices Evaluated in Included Studies .........54 

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EVIDENCE REPORT 

INTRODUCTION 

Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) and 

pulmonary embolism (PE), is a serious potential complication in hospitalized patients. In highrisk groups, such as post-operative surgical patients and acutely ill medical patients,

1-5 VTE is a 

leading cause of morbidity and mortality.

6-8 VTE prophylaxis is recommended for approximately 

60% of high-risk surgical patients and for the 40% of hospitalized medical patients at risk for 

VTE.9,10 

Clinical practice guidelines generally recommend either pharmacological or mechanical VTE 

prophylaxis. Pharmacological options include anticoagulation (eg, low molecular weight heparin 

[LMWH], new oral anticoagulants, or warfarin) and aspirin, but these may increase the risk of 

bleeding.11,12 Mechanical prophylaxis with intermittent pneumatic compression devices (IPCDs) 

is recommended, particularly in populations at high risk of bleeding,

13-16 due to the decreased 

risk of major bleeding and surgical site bleeding associated with IPCDs.

17-19 Although IPCDs can 

offer protection against VTE,20-22 compliance is often suboptimal,23,24 and efficacy may vary 

importantly across various devices. 

HIGH-RISK PATIENT POPULATIONS

In hospitalized medical patients, risk factors for VTE include trauma, malignancy, stroke, prior 

VTE, and congestive heart failure.25 In surgical populations, lower limb joint replacement 

surgery in particular is associated with an increased risk of VTE.25 Without prophylaxis, the 

incidence of 35-day symptomatic VTE events following orthopedic surgeries is high, with an 

estimated baseline rate of 4.3%.16 While the risk of symptomatic VTE is highest in the first 6 

weeks following surgery, this risk can remain elevated for up to 2 to 3 months following 

surgery.26 Given this natural history, it is important to examine the effects of VTE prophylaxis 

beyond the period of hospitalization. 

INTERMITTENT PNEUMATIC COMPRESSION DEVICES

It is hypothesized that IPCDs prevent DVT formation through 2 mechanisms, namely, by 

decreasing venous stasis and activating fibrinolysis.27-29 These effects can be achieved by 

mechanical compression of the foot or calf alone, or by sequential compression of either the foot 

and calf, or the calf and thigh. 

There are a wide variety of IPCDs currently available that differ in anatomical location of the 

sleeve garment, number and location of air bladders, patterns of compression cycles, and 

duration of inflation time and deflation time.30,31 In general, IPCDs can be categorized into either 

single-chamber or multi-chamber devices, constant pressure or sequential pressure devices, slowgradual or rapid inflation devices, and portable or non-portable devices. Portable IPCDs offer the 

potential advantage of continued use during ambulation in the early post-operative period.32 By

contrast, non-portable devices must be removed when the patient ambulates. Some devices also

include an hour meter that may facilitate adherence monitoring. Although some clinical 

guidelines recommend certain device features such as portability,

16 in general, guidelines do not 

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make recommendations for or against specific IPCDs or device categories. Therefore, it remains 

unclear which of these approaches works best for specific patient populations. Consequently, 

clinicians and health systems routinely struggle with the selection of IPCDs. 

OBJECTIVES OF THE REPORT 

This study was nominated by the Veterans Affairs (VA) National Surgery Office and Office of 

Nursing with the aim of evaluating IPCDs to inform best practice strategies, policy, and selection 

of devices for the VA Health System. The objective of this report is to evaluate the comparative 

effectiveness of IPCDs in post-operative surgical and high-risk medical patients of high interest 

to the Veterans Health Administration (VHA). There is a major gap in the existing literature on 

which specific populations will benefit from IPCD prophylaxis, and whether IPCDs vary 

importantly in VTE outcomes, adherence, and ease of use. This study addresses these gaps with a 

methodologically sophisticated systematic review.

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METHODS 

TOPIC DEVELOPMENT

The topic was nominated after a process that included a preliminary review of published peerreviewed literature and consultation with investigators, Veterans Affairs (VA) and non-VA 

experts, and key stakeholders (VA National Surgery Office, VA Office of Nursing). The VA 

Sequential Pressure Device Evaluation Committee nominated this project. The committee is 

interested in developing policy about the use of intermittent pneumatic compression devices 

(IPCDs), and specifically was interested in an evaluation to determine the comparative 

effectiveness of IPCDs. 

We followed a standard protocol for this review, and each step was pilot tested to train and 

calibrate study investigators. The PROSPERO registration number is CRD42014015157. The 

final key questions (KQs), developed in consultation with stakeholders, are:

KQ 1: In hospitalized surgical patients at high risk for venous thromboembolism (VTE), 

what is the comparative effectiveness of VTE prophylaxis with IPCDs versus VTE 

prophylaxis with pharmacological agents for VTE events, VTE-related mortality, and 

adverse events? 

a. Does effectiveness vary by surgical procedure?

b. Does effectiveness vary by type of IPCD? 

KQ 2: In hospitalized medical patients at high risk for VTE, what is the comparative 

effectiveness of VTE prophylaxis with IPCDs versus VTE prophylaxis with 

pharmacological agents for VTE events, VTE-related mortality, and adverse events? 

a. Does effectiveness vary by medical condition? 

b. Does effectiveness vary by type of IPCD? 

KQ 3: In hospitalized surgical and medical patients at high risk for VTE, what is the 

comparative effectiveness of different IPCDs when compared to one another for 

preventing VTE events?

KQ 4: When used for VTE prophylaxis, do different IPCDs differ in ease of use or 

adherence?

SEARCH STRATEGY 

In consultation with an expert librarian, we searched MEDLINE (via PubMed), Embase, 

CINAHL, and Cochrane CENTRAL from January 1, 1995, to October 30, 2014, for peerreviewed, English-language randomized controlled trials (RCTs). We used Medical Subject 

Heading (MeSH) terms and selected free-text terms for IPCDs and the conditions of interest, 

along with validated search terms for RCTs.33 For KQ 4, we also used terms to identify relevant 

observational studies. The exact search strategies used are provided in Appendix A. We further 

reviewed the bibliographies of included trials and systematic reviews20-22,30,34-40 for missed 

publications. 

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To assess for possible publication bias, we searched ClinicalTrials.gov (www.clinicaltrials.gov) 

to identify completed but unpublished studies meeting our eligibility criteria. 

All citations were imported into 2 electronic databases (for referencing, EndNote® Version X5, 

Thomson Reuters, Philadelphia, PA; for data abstraction, DistillerSR; Evidence Partners Inc., 

Manotick, ON, Canada). 

STUDY SELECTION

Using pre-specified inclusion and exclusion criteria, 2 trained investigators assessed titles and 

abstracts for relevance to the KQs. Full-text articles identified by either investigator as 

potentially relevant were retrieved for further review and examined by 2 investigators against the 

eligibility criteria. Disagreements on inclusion, exclusion, or the major reason for exclusion were 

resolved by discussion or by a third investigator. The criteria to screen articles for inclusion or 

exclusion at both the title-and-abstract and full-text screening stages are detailed in Table 1. In

addition, trials with 3 or more arms were examined for appropriateness of all arms for inclusion. 

For example, data from any active arm that did not include an IPCD or eligible anticoagulant 

were not abstracted for inclusion in the analysis. 

Table 1. Inclusion and Exclusion Criteria

Study 

Characteristic Inclusion Criteria Exclusion Criteria

Population Adults 18 years or older hospitalized for THA, 

TKA, hip fracture surgery, back surgery, bariatric 

surgery with surgical duration >1 hour, roboticassisted prostatectomy, or robotic-assisted 

hysterectomy (KQ 1, KQ 3, KQ 4); and 

hospitalized medical patients with active 

malignancy, stroke, trauma, critical illness, or 

high risk of VTE determined by a validated risk 

model (KQ 2, KQ 3, KQ 4)

Low risk of VTE

Mixed samples with fewer 

than 70% meeting 

eligibility criteria

Intervention IPCD used for ≥24 hours, with or without 

pharmacological prophylaxis

Graduated compression 

stockings

Devices that stimulate 

venous flow through ankle 

flexion and extension

Comparator KQ 1 and KQ 2: Pharmacological prophylaxis 

with LMWH, FXa inhibitors, direct thrombin 

inhibitors, adjusted-dose vitamin K antagonists, 

fondaparinux, or aspirin

KQ 3 and KQ 4: An IPCD

Placebo, antiplatelet drugs 

other than aspirin, 

graduated compression 

stockings, electrical calf 

stimulation devices, foot 

flexion/extension devices

Any comparator where the 

effect of the electronic 

aspect of the intervention 

could not be isolated

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Study 

Characteristic Inclusion Criteria Exclusion Criteria

Outcome Studies must report effects on at least one of the 

following relevant outcomes: 

KQ 1 and KQ 2: VTE events (DVT and/or PE), 

mortality, and adverse events

KQ 3: VTE events (DVT and/or PE)

KQ 4: Staff- or patient-reported ease of use or 

adherence

–

Timing Outcomes reported at ≥4 weeks from 

randomization or study enrollment*

Outcomes reported at <4

weeks

Setting Hospitalized patients in North America, the 

European Union, Australia, New Zealand, or 

Japan†

Outpatients or studies 

conducted in countries not 

listed as eligible

Design KQ 1, KQ 2, and KQ 3: RCTs

KQ 4: RCTs and quasi-experimental or cohort 

studies

–

Other Publication year 1995 or later‡

English-language publication

–

*Rationale was that approximately 15% of DVTs occur post-hospitalization.

†Rationale was to include economically developed countries with sufficient similarities in healthcare system and 

culture to be applicable to U.S. medical care.

‡Studies prior to 1995 were excluded because surgical procedures and post-operative care have changed 

substantially since then, and these changes affect the risk of VTE.

Abbreviations: DVT=deep vein thrombosis; FXa=factor Xa; IPCD=intermittent pneumatic compression device; 

KQ=key question; LMWH=low molecular weight heparin; PE=pulmonary embolism; RCTs=randomized controlled 

trials; THA=total hip arthroplasty; TKA=total knee arthroplasty; VTE=venous thromboembolism

DATA ABSTRACTION 

Data from included articles were abstracted into the final form by a trained investigator and 

confirmed by a second investigator. Data elements abstracted included patient descriptors; 

setting, features, and dose of the intervention (including timing and duration for IPCDs); 

characteristics of the comparator; outcomes; and risk of bias elements. All data abstractions were 

confirmed by a second investigator. Disagreements were resolved by consensus or by obtaining a 

third investigator’s opinion. When data were incomplete or missing, we contacted authors to 

request the data.

QUALITY ASSESSMENT

We assessed the quality (risk of bias) of each study and summarized the overall risk of bias for 

each study as low, moderate, or high. We used the key risk of bias criteria described in the 

Agency for Healthcare Research and Quality’s Methods Guide for Effectiveness and 

Comparative Effectiveness Reviews,

41 adapted to this specific topic (Appendix B). The key 

criteria for RCTs are: adequacy of randomization and allocation concealment; comparability of 

groups at baseline; blinding; completeness of follow-up and differential loss to follow-up; 

whether incomplete data were addressed appropriately; validity of outcome measures; and 

conflict of interest. Observational studies were evaluated using the following domains: basic 

study design, selection bias, performance bias, attrition bias, and detection bias. 

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DATA SYNTHESIS

We grouped studies into those that enrolled participants undergoing joint replacement, other 

surgery, and medical patients. 

When meta-analysis was feasible, we computed summary estimates of effect. We used R (R 

Foundation for Statistical Computing, Vienna, Austria) with the metafor package42 to calculate 

the summary estimates of treatment effect. Dichotomous outcomes were analyzed using 

summary risk ratios (RRs). We used a random-effects model and due to the relatively small 

number of studies we utilized the Knapp and Hartung method to adjust the standard errors of the 

estimated coefficients.43,44 We evaluated for statistical heterogeneity in treatment effects using 

Cochran’s Q and I2 statistics. We planned subgroup analyses to explore potential sources of 

heterogeneity, specifying a priori: foot, calf, or thigh location of the IPCD; concurrent use of 

anticoagulation; and risk of bias elements. In some instances, planned subgroup analyses could 

not be performed because subgroups did not meet the pre-specified minimum of 3 studies per 

subgroup. When there were at least 3 studies at low or moderate risk of bias, we performed 

sensitivity analyses to compute summary estimates after excluding studies at high risk of bias. 

Publication bias was assessed using findings from a search of ClinicalTrials.gov. Funnel plots 

were not used because analyses did not meet the minimum threshold of at least 10 studies for 

meaningful analysis.41

Where quantitative synthesis was not feasible, we analyzed the data qualitatively. We gave more

weight to evidence from higher-quality studies. We focused on identifying patterns in the 

efficacy and safety of the interventions and finding potential reasons for inconsistency in 

treatment effects.

RATING THE BODY OF EVIDENCE

In addition to rating the quality of individual studies, we evaluated the overall strength of 

evidence for selected outcomes (mortality, VTE, symptomatic or asymptomatic DVT, and major 

bleeding) as high, moderate, low, or insufficient using the domains: risk of bias, directness, 

consistency of treatment effects, precision of treatment effects, and risk of publication bias.

45

These domains were considered qualitatively, and a summary rating of high, moderate, low, or 

insufficient strength of evidence was assigned after discussion by 2 investigators. The 4-level 

rating scale consists of the following definitions:

High—We are very confident that the true effect lies close to the estimate of the effect.

Moderate—We are moderately confident in the effect estimate: The true effect is likely 

to be close to the estimate of the effect, but there is a possibility that it is substantially 

different.

Low—Our confidence in the effect estimate is limited: The true effect may be 

substantially different from the estimate of the effect.

Insufficient—Evidence on an outcome is absent or too weak, sparse, or inconsistent to 

estimate an effect.

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To evaluate the evidence for specific IPCDs or class of devices (eg, calf device), we considered 

head-to-head comparisons, indirect comparisons of IPCDs to a common comparator (eg, foot vs

calf devices, each compared to anticoagulation), and observational data about ease of use or 

patient comfort. We calculated risk differences (RDs) for outcomes with strength of evidence 

ratings of low or higher. We used the pooled estimate of effect and baseline event rates from the 

literature (VTE, 4.3%16) or from the event rate in the anticoagulation arms of the included 

studies (DVT). 

PEER REVIEW

A draft of this report was reviewed by technical experts and clinical leadership. A transcript of 

their comments and our responses is provided in Appendix C.

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RESULTS

LITERATURE FLOW

Our literature search (Figure 1) identified 1461 unique citations from a combined search of 

MEDLINE (n=959), Embase (n=393), CINAHL (n=15), Cochrane CENTRAL (n=84), and the 

bibliographies of included studies and review articles (n=10). After applying inclusion/exclusion 

criteria at the title-and-abstract screening level, 171 full texts were retrieved for further review. 

Of these, 21 unique studies (18 RCTs and 3 observational studies) were retained for data 

abstraction and grouped by key question (KQ).

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Figure 1. Literature Flow Chart 

*Two studies applied to both KQ 3 and KQ 4.

Abbreviations: KQ=key question; n=number of studies.

We attempted to contact 14 authors for additional study information; 5 could not be reached, and 

only 6 others supplied the requested data. A search of ClinicalTrials.gov to ascertain publication 

bias revealed no additional or completed but unpublished trials.

Eighteen RCTs (3666 subjects), conducted primarily in patients undergoing joint replacement 

surgery, compared the effectiveness of intermittent pneumatic compression devices (IPCDs) to 

anticoagulation (n=14) or other IPCDs (n=7) (Figure 2).

Records identified through 

databases searched 

(n=1611)

Additional records identified through 

other sources 

(n=10)

Records screened after 

duplicates removed 

(n=1461)

Records excluded 

(n=1290)

Full-text articles assessed 

for eligibility 

(n=171)

Full-text articles excluded 

(n=150)

-Not full publication: 16

-Not population: 39

-Not intervention: 13

-Not comparator: 47

-Not outcome: 5

-Non English/non-Western: 4

-Outcome <4weeks: 13

-Not study design: 13

Studies abstracted 

(n=21 unique*)

KQ 1

(surgical):

10 studies

KQ 2

(medical):

3 studies

KQ 3

(devices):

3 studies

KQ 4

(adherence):

7 studies

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Figure 2. Numbers of Comparisons between Interventions (RCTs only, n=18) 

Abbreviations: IPCD=intermittent pneumatic compression device; LMWH=low molecular weight heparin; 

UFH=unfractionated heparin

There were no RCTs comparing antiplatelet agents to IPCDs. Four RCTs and the 3 observational 

studies (1040 subjects) reported on adherence or ease of use (KQ 4). Devices from 7 different 

manufacturers were represented (Table 2); however, the brand name of the device and the name 

of the manufacturer were not always provided. The most commonly studied named devices were 

the Kendall SCDTM (7 studies) and the Novamedix A-V Impulse SystemTM (5 studies). Study 

characteristics are described in greater detail in Appendix D. Further characteristics of the 

devices are provided in Appendix E. 

Table 2. Devices Evaluated in Included Studies

Manufacturer* Device Name† Device Characteristics;‡

Sleeve Location(s)§

Number of Studies

Kendall Kendall SCDTM Multi-chamber, sequential 

compression, slow inflation, 

portable and non-portable

options available, no hour 

meter

Sleeve location(s) available: 

Foot, calf, calf-thigh

7 studies:

Lachiewicz, 200446

Murakami, 200323

Pagella 200747

Robertson, 200048

Rokito, 199649

Stannard, 200150

Wood, 199751

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High-Risk Surgical and Medical Patients

Manufacturer* Device Name† Device Characteristics;‡

Sleeve Location(s)§

Number of Studies

Novamedix A-V Impulse SystemTM Single chamber, constant 

pressure, rapid inflation, 

non-portable, hour meter

Sleeve location(s) available: 

Foot

5 studies:

Blanchard, 199952

Pitto, 200418

Warwick, 200219

Warwick, 199853

Windisch, 201154

Huntleigh Flowtron® Single chamber, constant 

compression, slow inflation, 

portable and non-portable

options available, no hour 

meter

Sleeve location(s) available: 

Foot, calf, calf-thigh

3 studies:

Ginzburg, 200355

Pagella, 200747

Stone, 199656

NuTech PlexiPulse® Multi-chamber, constant 

compression, rapid inflation, 

non-portable, hour meter (1 

study) and no hour meter

(2 studies)

Sleeve location(s) available: 

Foot, calf, foot-calf

3 studies:

Robertson, 200048

Stannard, 200150

Wood, 199751

Aircast VenaFlow® Multi-chamber, sequential 

compression, rapid inflation, 

non-portable, hour meter

Sleeve location(s) available: 

Foot, calf, calf-thigh

2 studies:

Lachiewicz, 200446

Silbersack, 200457

Medical 

Compression 

Systems (MCS)

ActiveCare DVT® Multi-chamber, sequential 

compression, slow inflation, 

portable CECT, hour meter

Sleeve location(s) available: 

Foot, calf, calf-thigh

1 study: Edwards, 200858

ActiveCare+S.F.T.® Multi-chamber, sequential 

compression, slow inflation, 

portable CECT, hour meter

Sleeve location(s) available: 

Foot, calf, calf-thigh

1 study: Colwell, 201017

WizAir DVTTM CECT Multi-chamber, sequential 

compression, slow inflation, 

portable CECT, hour meter

Sleeve location(s) available: 

Calf

1 study: Murakami, 200323

Jobst Anthrombic Pump 

(System 2500)‖

Multi-chamber, sequential 

compression, slow inflation, 

non-portable, no hour meter

Sleeve location(s) available: 

Calf, calf-thigh

1 study: Pambianco, 199559

11
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Manufacturer* Device Name† Device Characteristics;‡

Sleeve Location(s)§

Number of Studies

Unnamed Unnamed – 3 studies (8 devices):

Bockheim, 200960

Greenfield, 199761

Proctor, 200162

*Manufacturers of the various IPCDs have changed over time. We report the manufacturer at the time of the study,

as accurately as we were able to ascertain this.

†Device names are given as reported in the study, sometimes revised/augmented to reflect trademarked device 

names at the time of the study, as accurately as we were able to ascertain these. 

‡Device characteristics are given as reported in the study, sometimes augmented to reflect the characteristics of 

trademarked devices at the time of the study, as accurately as we were able to ascertain these. Device characteristics 

may have changed over time. In particular, some devices that were non-portable at the time of the included studies 

may now be available in a portable form. Where more than one option was available for a given device

characteristic (eg, portable and non-portable, hour meter and no hour meter), the option(s) listed in bold font were 

used in the included studies.

§Sleeve locations in bold font were used in the included studies.

‖Specific information on this device was not provided in the published study report, but rather by Huntleigh, the 

company that most recently bought out Jobst. They sent us a copy of the manual for the specific Jobst model used in 

the Pambianco, 1995 study.59

Abbreviations: CECT=continuous enhanced circulation therapy device; DVT=deep vein thrombosis; 

SCD=sequential compression device; S.F.T.=Synchronized Flow Technology

As Table 2 indicates, the IPCDs evaluated in the included studies primarily used foot or calf 

sleeves. The mean age of patient samples ranged from 39.5 to 73 years old (median 53.7 years). 

On average, 47% (range, 24% to 91%) of samples were men. In 16 trials evaluating DVT, 

routine imaging (typically with ultrasound, 75% of studies) at 3 to 8 days was used for diagnosis, 

while evaluation for PE was normally triggered by symptoms and was diagnosed by 

ventilation/perfusion (V/Q) scan or computed tomography in only 44% of studies. Posthospitalization VTE was diagnosed by history, sometimes supplemented with medical records. 

Approximately 95% of VTE events were due to DVT. In the 13 studies reporting the distribution 

of DVT, 18.5% were proximal and 81.5% were distal. Most studies reported the combined rate 

of symptomatic and asymptomatic DVT, but when reported separately, only 3.2% of DVTs were 

symptomatic. Only 7 studies reported major bleeding, 5 of which17,18,52,55,56 conformed to the 

International Society on Thrombosis and Haemostasis (ISTH) definition.63 Studies were rated 

moderate (n=14) or high (n=7) risk of bias (Appendix B).

12
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

KEY QUESTION 1: In hospitalized surgical patients at high risk for 

venous thromboembolism (VTE), what is the comparative 

effectiveness of VTE prophylaxis with intermittent pneumatic 

compression devices versus VTE prophylaxis with pharmacologic 

agents for VTE events, VTE-related mortality, and adverse events? 

Description of Included Studies

Ten RCTs (1905 patients) evaluated IPCDs versus anticoagulation for VTE prophylaxis. Seven 

studies compared IPCDs alone versus anticoagulation,17-19,49,52,53,56 while 3 studies compared an 

IPCD in combination with anticoagulation versus anticoagulation alone.54,57,58 IPCDs were 

primarily evaluated in joint replacement patients. Only one study evaluated IPCDs in spinal 

surgery patients. The remaining 9 studies were conducted on patients undergoing total knee 

arthroplasty (TKA; 3 studies) or total hip arthroplasty (THA; 4 studies); 2 studies combined 

patient populations undergoing TKA and THA. One of the latter58 reported results separately for 

TKA and THA, resulting in a total of 11 comparisons. 

The following types of IPCDs were evaluated: foot devices (5 studies), calf devices (4 studies), 

and a calf-thigh device (1 study). All 10 studies reported the brand name of the devices studied; 

these were the A-V Impulse SystemTM foot device (5 studies), the ActiveCare® portable 

continuous enhanced circulation therapy (CECT) calf device (2 studies, possibly 2 slightly 

different models), the VenaFlow® rapid-inflation calf device (1 study), the Flowtron® calf device

(1 study), and the Kendall SCDTM calf-thigh device (1 study). Foot devices used rapid inflation 

modes, while all but one calf devices used gradual inflation modes. Devices were typically 

started intra-operatively or immediately post-operatively, and duration of use ranged from 5 to 

12 days or until hospital discharge. Anticoagulation included the LMWHs enoxaparin (7 studies) 

and nadroparin (2 studies), and the vitamin K antagonist warfarin (1 study). The duration of 

anticoagulation was less than 10 days in all included studies except for one, which reported use 

of 30 days or less.

57 Patients excluded from the trials were primarily those with a high risk of 

bleeding, a prior history of VTE, a history of malignancy, revision of surgery, or painful joints 

precluding the use of the foot device. 

The risk of bias was judged to be moderate in 8 studies17-19,49,53,54,56,57 and high in 2 studies.52,58

Appendix B provides details of the quality ratings for each study. 

Outcomes

Outcomes included VTE events (DVT and/or PE), any DVT (symptomatic or asymptomatic), 

symptomatic DVT, PE, all-cause mortality, and major bleeding adverse events. The duration of 

follow-up for all VTE outcomes and mortality was from 4 weeks to 1 year. We report VTE 

outcomes separately for joint replacement surgical patients and other surgical patients. Subgroup 

analyses were feasible only for VTE and DVT outcomes in studies of joint replacement. 

Additionally, we qualitatively synthesized data on IPCD adherence. 

13
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

VTE Outcomes in Surgical Joint Replacement Patients

VTE Events (DVT and/or PE)

Among patients undergoing joint replacement surgery, VTE events were identified in 163 

patients (11%). VTE events were more common in TKA patients (20%) than in THA patients 

(8%). Eight of the 10 RCTs in our sample examined the role of IPCDs alone (4 studies) or 

IPCDs used in combination with anticoagulation (4 studies) in preventing VTE events. One 

study reported results separately for TKA and THA patients, resulting in 9 comparisons for this 

analysis. In patients who underwent THA or TKA, there was no statistically significant 

difference between IPCDs and anticoagulation for VTE events (RR 0.80; 95% confidence 

interval [CI], 0.35 to 1.78; Figure 3), but intervention effects varied substantially across studies 

(Q=23.4; p=0.003; I2=66%). A sensitivity analysis restricted to studies at moderate risk of bias 

did not change the pooled estimate substantially (RR 0.78; 95% CI, 0.25 to 2.38). As noted 

above, the pooled estimate for this outcome was highly heterogeneous. Subgroup analyses 

separately evaluating IPCDs alone versus anticoagulation (RR 1.39; 95% CI, 0.73 to 2.64; 

I

2

=37%) and IPCDs plus anticoagulation versus anticoagulation alone (RR 0.27; 95% CI, 0.05 to 

1.64; I2

=16%) suggested that the combination of IPCDs plus anticoagulation may provide a large 

protective effect against VTE events, but the confidence interval included the possibility of a 

chance association (Figure 3). 

Figure 3. Risk for VTE Events with IPCD versus Anticoagulation Prophylaxis in Joint 

Replacement Patients

14
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Subgroup analysis of gradual versus rapid inflation devices showed consistent effects for gradual 

inflation devices (RR 0.61; 95% CI, 0.24 to 1.56; I2=0%), but inconsistent effects for rapid 

inflation devices (RR 0.80; 95% CI, 0.35 to 1.78; I2

=71%). We examined outliers qualitatively. 

Two small studies differed substantially from the pooled estimate. One study at high risk of 

bias52 found increased risk of VTE events in TKA patients with an AV Impulse foot device 

compared to LMWH (RR 2.26; 95% CI, 1.39 to 3.67). In contrast, a study by Silbersack and 

colleagues,57 judged to be at moderate risk of bias, found a protective effect against VTE events 

in a combined population of TKA and THA patients using a VenaFlow rapid inflation calf 

device plus LMWH versus LMWH alone (RR 0.03; 95% CI, 0.00 to 0.41). 

Any DVT Events (Symptomatic or Asymptomatic) 

Ten RCTs examined IPCDs alone (6 studies) or IPCDs plus anticoagulation (4 studies) versus 

anticoagulation alone and reported any DVT events. A total of 264 DVT events (15%) were 

identified; most DVTs were distal (81%). Proximal DVTs were more common in THA patients 

(53%) than in TKA patients (7%). There was no important difference in the risk of any DVT 

event between IPCDs and anticoagulation (RR 0.93; 95% CI, 0.51 to 1.71; Figure 4), but 

intervention effects varied substantially across studies (Q=23.0; p=0.006; I2=61%). A sensitivity 

analysis restricted to studies at moderate risk of bias did not change the pooled estimate 

substantially (RR 0.97; 95% CI, 0.53 to 1.78). Subgroup analyses separately evaluating IPCDs 

alone versus anticoagulation (RR 1.27; 95% CI, 0.81 to 2.00; I2

=46%) and IPCDs plus 

anticoagulation versus anticoagulation alone (RR 0.28; 95% CI, 0.04 to 1.79; I2=18%) suggested

that the combination of IPCDs plus anticoagulation may provide a large protective effect against 

VTE events, but the confidence interval included the possibility of a chance association (Figure 

4).

15
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Figure 4. Risk for any DVT Events with IPCD versus Anticoagulation Prophylaxis in Joint 

Replacement Patients

Additional subgroup analyses explain some but not all variability. Subgroup analyses by surgical 

site showed that heterogeneity was primarily driven by TKA studies. Among the TKA studies, 

one small study at high risk of bias52 was different from others in this group. This study found 

that the AV Impulse System foot device compared to LMWH increased the risk for any DVT 

(RR 2.26; 95% CI, 1.39 to 3.67). In this study, both lower limbs, as opposed to only the 

ipsilateral surgical limb, were assessed for DVT. THA studies showed consistent treatment 

effects and no difference between IPCDs and anticoagulation for risk of DVT events (RR 1.08; 

95% CI, 0.66 to 1.76; I2=0%). Because of the high correlation between device location and 

inflation mode, subgroup analyses by inflation mode yielded similar results to the analysis of calf 

versus foot location. 

Symptomatic DVT 

Although a clinically important outcome, few studies examined symptomatic DVT. Six RCTs (4 

studies IPCD alone, 2 studies combination IPCD plus anticoagulation) reported symptomatic 

DVTs in TKA and THA patients. A total of 6 (0.5%) symptomatic DVTs were identified 

(n=1143), 3 each in THA and TKA patients. There was no statistically significant difference in 

symptomatic DVT events when an IPCD was used instead of or in addition to anticoagulation 

(RR 1.02; 95% CI, 0.48 to 2.14; I2

=0%).

16
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Pulmonary Embolism (PE)

Eight RCTs evaluated IPCDs versus anticoagulation for the prevention of PEs. A total of 7 PEs 

(0.4%) were identified (n=1596); 5 were in THA patients, and 2 in TKA patients. IPCDs, either 

alone (4 studies) or in combination with anticoagulation (4 studies), offered no advantage in 

reducing PE events compared to anticoagulation in THA or TKA patients (RR 1.11, 95% CI 0.83 

to 1.49; I2=0%). We found consistent results, but analyses were limited by the small number of 

events. 

VTE Outcomes in Other Surgical Patients

IPCDs were compared to anticoagulation in only one other surgical population. A small RCT 

(n=110)49 performed in spinal surgery patients compared a Kendall SCD calf-thigh device to 

warfarin and found no significant difference in treatment effect for outcomes of VTE events

(DVT and/or PE), any DVT (symptomatic or asymptomatic), symptomatic DVT, or PE. The risk 

of bias was judged to be moderate. 

Mortality

A subset of 4 RCT studies (869 patients) examined all-cause mortality in patients undergoing 

joint replacement; the length of follow-up ranged from 4 weeks to 3 months. Only one of the 4 

RCTs reported any deaths (4 patients),19 finding no difference in mortality between the A-V 

Impulse System foot device and LMWH. The overall pooled effect estimate for the 4 RCTs 

found no difference in the risk of all-cause mortality between IPCDs and anticoagulation (RR 

1.57; 95% CI, 0.76 to 3.26; I2=0%), but the confidence intervals were wide and did not exclude a 

clinically important difference. 

Adverse Events

Adverse events were defined as clinically relevant major bleeding (defined using ISTH criteria 

for major bleeding in surgical patients), any bleeding, or skin or nerve damage. Meta-analysis

was performed only for the outcome of major bleeding. 

Major Bleeding 

Six RCTs evaluated major bleeding outcomes, but only 4 of these used ISTH criteria for major 

bleeding in surgical patients (total n=791). Major bleeding was reported in 22 (3%) joint 

replacement patients (19 patients randomized to anticoagulation versus 3 patients randomized to 

IPCD). Meta-analysis of these 4 studies suggest that IPCDs may reduce the risk of major 

bleeding events compared with anticoagulation (RR 0.33; 95% CI, 0.07 to 1.51; I

2

=0%; Figure 

5). The only individual study to find an IPCD protective against major bleeding events was 

conducted by Colwell et al,

17 who studied 392 THA patients and compared a portable CECT calf 

device (ActiveCare+S.F.T.®) versus LMWH. Risk of bias was moderate. Patients in both 

treatment groups were allowed to receive 81 mg aspirin daily. Patients in the IPCD group had a 

RR of developing a major bleed of 0.04 (95% CI, 0.0 to 0.72) compared with those who received 

LMWH. This was also the largest of the studies examining major bleeding outcomes, suggesting 

that smaller trials may have been underpowered to detect major bleeding outcomes. 

17
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Figure 5. Risk for Major Bleeding Events with IPCD versus Anticoagulation Prophylaxis in 

Joint Replacement Patients

Any Bleeding

Any bleeding was reported in 3 RCTs of patients undergoing joint replacement and one study of 

patients undergoing spine surgery (total n=710). Bleeding was reported in 83 (23.3%) patients 

randomized to IPCD and in 105 (29.6%) patients randomized to anticoagulation. 

Skin and Nerve Damage 

Skin and nerve damage was assessed in 3 studies; however, no patients were identified with this 

injury. 

IPCD Adherence

Adherence was described as rates of discontinuation and average duration of use per day of 

ICPDs. Four RCTs reported rates of discontinuation, all of which examined the A-V Impulse 

System foot device. This device was discontinued in 42 of 543 patients (8%). Average duration 

of use per day was examined in 6 RCTs, including the study by Edwards et al,

58 which reported 

results separately for TKA and THA patients, resulting in 7 total comparisons. IPCDs were worn

for an average of 14.5 hours per day (range 11 to 22). The ActiveCare portable CECT calf device

was worn for an average of 20 hours per day (range 19 to 20), whereas the non-portable A-V 

Impulse System foot device was worn for an average of 16 hours per day (range 11 to 22). 

18
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

KEY QUESTION 2: In hospitalized medical patients at high risk for 

VTE, what is the comparative effectiveness of VTE prophylaxis with 

IPC devices versus VTE prophylaxis with pharmacological agents for 

VTE events, VTE-related mortality, and adverse events? 

Description of Included Studies

Three eligible RCTs (n=855) compared IPCDs to anticoagulation in high-risk medical 

inpatients.

55,59,61 VTE prophylaxis was initiated within 24 to 48 hours post-admission in 2

studies;

55,61 time to initiation was not specified in the other study.59 All 3 trials continued VTE 

prophylaxis until hospital discharge or for 4 weeks, the entire study duration. The first study 

(n=360) compared a calf IPCD (Jobst Anthrombic Pump) to standard dose LMWH in stroke 

patients with lower extremity weakness.

59 The second study (n=442) compared a calf IPCD

(Flowtron) to unfractionated heparin, dose-adjusted to a therapeutic partial thromboplastin time

(PTT) level, in a high-risk, heterogeneous group of trauma patients.

55 The third study was a small 

feasibility study (n=53) that compared 4 study arms, 2 different IPCDs (calf compression devices 

and arteriovenous foot devices, manufacturers not specified) and 2 forms of heparin prophylaxis 

(unfractionated and LMWH) in a high-risk trauma sample.

61 Although this trial met eligibility 

criteria, it did not report outcomes separately for each study arm, precluding valid interpretation 

of results.

The risk of bias was judged to be moderate for 2 trials,55,59 mainly because of higher rates of 

attrition in the IPCD group and exclusion of these patients from analyses,

59 and because 

participants were excluded due to non-compliance with the assigned intervention.

55 The third 

study61 was judged to be at high risk of bias because of lack of clarity on key methodological 

criteria. Appendix B provides details of the quality ratings for each study. No eligible study 

examined other populations of interest with an elevated risk of thromboembolic complications,

such as medical intensive care unit patients or patients with malignancy.

VTE Outcomes

VTE Events (DVT and/or PE)

Two trials did not find a statistically significant difference in DVT incidence between IPCD and 

heparin treatment groups. For stroke patients, the incidence of proximal DVT events was 6.8% 

versus 4.2% with IPCDs versus heparin, respectively.59 For trauma patients, the overall incidence 

of DVT events (proximal and distal) was 2.7% versus 0.5% with IPCDs versus heparin, 

respectively.55 Neither study indicated whether DVT events diagnosed by ultrasound were 

symptomatic or asymptomatic, which limits the clinical usefulness of these results. Only one of 

the 2 trials reported PE events.

55 The incidence of PE events was similar: one event in the IPCD 

group compared to one in the heparin treatment group.

Mortality

Only one of the 2 trials reported mortality.

55 There were no deaths in this study. 

19
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Adverse Events

Only one study reported the rate of any bleeding or major bleeding.55 The incidence of bleeding 

did not differ significantly between the dose-adjusted heparin group (5.0%) and the IPCD group 

(3.6%; p=0.237). The incidence of major bleeding events was identical (1.8%) in the 2 study 

groups.

KEY QUESTION 3: In hospitalized surgical and medical patients at 

high risk for VTE, what is the comparative effectiveness of different 

IPC devices when compared to one another for preventing VTE 

events?

Description of Included Studies

Three RCTs (666 patients) directly compared 2 different IPCDs.46,50,51 Devices from 3

manufacturers, including those using foot, calf, and thigh sleeves, were compared in surgical 

populations undergoing joint replacement, spinal surgery, or repair of a traumatic acetabular or 

pelvic fracture. VTE prophylaxis was initiated intraoperatively46,51 or shortly following 

admission.

50 Only one study specified treatment duration,51 continuing the IPCD until the day of 

discharge. Risk of bias was moderate in 2 studies46,50 and high in the third.51 In 2 studies, 

outcome assessors were not blinded to the type of IPCD.46,51 Baseline risk profiles in the 2 

randomized groups were not comparable in one study.51

VTE Outcomes

VTE Events (DVT and/or PE)

A large study (moderate risk of bias) randomized 423 patients undergoing TKA to a calf rapid 

inflation asymmetrical compression (RIAC) device (VenaFlow) or to a calf sequential 

compression device (SCD) (Kendall SCD).46 The rate of VTE events was significantly lower in 

the Venaflow arm than in the Kendall SCD arm (6.9% vs 15%, respectively; p=0.007); all but 

one VTE events were DVTs, and it was not specified whether the DVTs were symptomatic. The 

study authors concluded that thromboprophylaxis using VenaFlow was associated with a 

significantly lower risk of VTE compared to the Kendall SCD.

Two studies compared a slow-gradual inflation SCD (Kendall SCD) to rapid inflation devices 

(PlexiPulse).50,51 In a study of 107 patients undergoing pelvic fracture surgery (moderate risk of 

bias), the overall rate of VTE events was 14%; all but one VTE events were DVTs, and it was 

not specified whether the DVTs were symptomatic.50 Patients received either a calf-thigh SCD 

(Kendall SCD) or a combination calf and foot rapid inflation device(PlexiPulse). The rate of 

VTE events in the Kendall SCD arm was not significantly different from that in the PlexiPulse 

arm (10 [19%] vs 5 [10%]; p=0.265). In another study (high risk of bias), 136 patients 

undergoing spinal surgery were randomized to receive either a calf-thigh SCD (Kendall SCD) or 

a sequential rapid inflation foot device (PlexiPulse).51 No patients randomized to the Kendall 

SCD were diagnosed with a VTE compared to 2 patients in the PlexiPulse arm (1 DVT and 1 

PE).

20
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Mortality

One study reported one death (0.2%) due to myocardial infarction, but no VTE-related 

mortality.46 The other studies did not report mortality outcomes.

Adverse Events

None of the included studies reported major bleeding events as an outcome. In one study, 36 

patients (26%) complained of redness, itching, or discomfort associated with IPCDs.51 Of these, 

18 (24%) were using the PlexiPulse system and 18 (31%) were using the Kendall SCD (p>0.5). 

In the TKA study,46 one patient with pigmented synovitis required post-operative aspiration. 

KEY QUESTION 4: When used for VTE prophylaxis, do different IPC 

devices differ in ease of use or adherence?

Description of Included Studies

Four RCTs (374 patients)23,47,50,51 and 3 observational studies (1724 patients)48,60,62 compared 

different IPCDs to one another and reported data on ease of use or adherence. All but one study 

were conducted in surgical populations. At least 5 devices were included, and specific device 

names were reported (or obtained through correspondence with study authors) for all but 2 

studies.60,62 Studies were judged to be at moderate (n=3)23,47,50 or high (n=4)48,51,60,62 risk of bias. 

Important limitations in the 3 observational studies were: sequential rather than 

contemporaneous comparisons of devices; analyses that did not adjust for potential confounders;

and use of unvalidated measures to assess comfort or ease of use.

Ease of Use

Four studies reported patient-rated comfort and 2 reported staff-rated ease of use. A PlexiPulse 

rapid inflation foot device was compared to a Kendall SCD calf-thigh device in 2 studies, one 

moderate-sized RCT finding no difference in comfort ratings,

51 and a larger observational study 

finding the PlexiPulse device rated more favorably.48 Another small RCT compared the Kendall

SCD calf and Flowtron calf devices.47 Patients rated the Flowtron breathable sleeve more 

comfortable than the Kendall SCD thick stiff plastic sleeve on 1 of 6 items. Staff rated the 

Flowtron device easier to use (by approximately 1 point on a 5-point Likert Scale) on each of 6 

different items. An observational study comparing 5 manufacturers with multiple different 

sleeves found differences in patient-rated comfort and staff-rated ease of use, but the devicesleeve combinations were not described in a manner that would allow the preferred devices or 

device type to be identified.62

Adherence

Six studies compared adherence for 2 or more IPCDs as reported by patients, staff observation, 

or counters installed on the devices. There were no consistent associations between specific 

named devices or location of the sleeve and adherence. Two observational studies found greater 

adherence with a foot device compared to other IPCDs.48,60 A small RCT found greater 

adherence with the portable WizAir DVT CECT calf device (77.7%), which includes a battery 

pack, compared to a Kendall SCD calf device (58.9%).23 Other studies found no important 

differences between a Kendall SCD using a thick plastic sleeve and a Flowtron device using a 

21
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

breathable plastic sleeve,47 did not identify the devices evaluated,62 or did not perform statistical 

analyses because of missing data.50

In KQ 1, we reported adherence in studies comparing an IPCD to anticoagulation. These studies 

also found longer use with a portable device (mean of 20 hours) compared to the A-V Impulse 

System foot device, a non-portable device.

22
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

SUMMARY AND DISCUSSION

We identified 18 RCTs and 3 observational studies in post-operative surgical and high-risk 

medical patients that evaluated the comparative effectiveness of IPCDs in reducing VTE events 

or that rated ease of use or adherence. Most studies compared IPCDs to anticoagulation. Only 3 

RCTs in high-risk surgical patients directly compared different IPCDs; there were no head-tohead comparisons in high-risk medical patients. IPCDs were comparable to anticoagulation for 

major clinical outcomes, but confidence intervals were typically wide and clinically important 

differences could not be excluded. Subgroup analyses did not show significant differences by 

device location or mode of inflation. The current evidence base to guide selection of a specific 

device or type of device is limited, and comparative effectiveness studies are needed to address 

this gap in evidence. This meta-message is consistent with the findings from another review.30

In Table 3 and sections below, we summarize the main findings and strength of evidence by key 

question (KQ). 

Table 3. Strength of Evidence for ICPD Effectiveness in Reducing VTE Events

Outcome

Strength of Evidence Domains

Effect Estimate 

(95% CI)*

Strength 

of 

Evidence

No. of 

Studies 

(Patients)

Study 

Design/Risk 

of Bias

Consistency

Directness

Precision

Publication 

Bias

KQ 1: IPCDs vs Anticoagulation in Surgical Patients

Mortality 4 (869) RCT/High Consistent

Direct

Imprecise

None 

detected

RR 1.57

(0.76 to 3.26)

Insufficient

VTE

Events

8 (1528) RCT/

Moderate

Inconsistent

Indirect

Imprecise

None 

detected

IPCD alone:

RR 1.39

(0.73 to 2.64)

RD=23 

more/1000 (16 

fewer to 98 

more)

IPCD+LMWH: 

RR 0.27

(0.05-1.64)

RD=44 

fewer/1000 (57 

fewer to 38 

more)

Low

23
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Outcome

Strength of Evidence Domains

Effect Estimate 

(95% CI)*

Strength 

of 

Evidence

No. of 

Studies 

(Patients)

Study 

Design/Risk 

of Bias

Consistency

Directness

Precision

Publication 

Bias

Any DVT 10 (1716) RCT/

Moderate

Inconsistent

Indirect

Precise

None 

detected

IPCD alone:

RR 1.27

(0.81 to 2.00)

RD=5 

more/1000 (4 

fewer to 20 

more)

IPCD+LMWH: 

RR 0.28

(0.04 to 1.79)

RD=14

fewer/1000 (19 

fewer to 16 

more)

Low

Major 

bleeding

4 (772) RCT/

Moderate

Consistent

Direct

Imprecise

None 

detected

RR 0.33

(0.07 to 1.51)

RD=25

fewer/1000 

(34 fewer to 19 

more)

Low

KQ 2: IPCDs vs Anticoagulation in Medical Patients

Mortality 1 (442) RCT/High Consistent

Direct

Imprecise

None 

detected

No events Insufficient

VTE

Events

1 (442) RCT/High Consistent

Indirect

Imprecise

None 

detected

More events

with IPCD (7 vs

2) but p=NS

Insufficient

Any DVT 2 (679) RCT/High Consistent

Indirect

Imprecise

None 

detected

More events

with IPCD (14 vs

6) but p=NS

Insufficient

Major 

bleeding

1 (442) RCT/High Consistent

Direct

Imprecise

None 

detected

Equal number of 

events

Insufficient

KQ 3: Direct Comparisons of IPCDs in Surgical and Medical Patients

Mortality 1 (423) RCT/

Moderate

Consistent

Direct

Imprecise

None 

detected

1 death Insufficient

VTE

Events

1 (423)

2 (143)

RCT/

Moderate

RCT/High

Consistent

Indirect

Consistent

Indirect

Imprecise

None 

detected

Imprecise

None 

detected

Fewer VTE 

events with 

VenaFlow vs 

Kendall SCD* 

No difference 

between Kendall

SCD and 

PlexiPulse

Low

Insufficient

24
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Outcome

Strength of Evidence Domains

Effect Estimate 

(95% CI)*

Strength 

of 

Evidence

No. of 

Studies 

(Patients)

Study 

Design/Risk 

of Bias

Consistency

Directness

Precision

Publication 

Bias

Any DVT 1 (423)

2 (143)

RCT/

Moderate

RCT/High

Consistent

Indirect

Consistent

Indirect

Imprecise

None 

detected

Imprecise

None 

detected

Fewer VTE 

events with 

VenaFlow vs 

Kendall SCD* 

No difference 

between Kendall

SCD and 

PlexiPulse

Low

Insufficient

Major 

bleeding

None NA NA NA NA Insufficient

*Risk differences (RDs) were calculated for outcomes with pooled estimates of effect and strength of evidence 

ratings of low or higher.

Abbreviations: CI=confidence interval; DVT=deep vein thrombosis; IPCD(s)=intermittent pneumatic compression 

device(s); KQ=key question; LMWH=low molecular weight heparin; NA=not applicable; No.=Number; NS=not 

statistically significant; RCT=randomized controlled trial; RD=risk difference; RR= risk ratio; SCD=sequential 

compression device; VTE=venous thromboembolism

SUMMARY OF EVIDENCE BY KEY QUESTION (KQ)

KQ 1: IPCDs versus Anticoagulation in Surgical Patients

The majority of these studies were performed in patients undergoing joint replacement, with one 

study in other surgical populations. The A-V Impulse System foot device and the portable 

ActiveCare CECT devices were the IPCDs most commonly compared to anticoagulation. There 

was no difference between IPCDs and anticoagulation for the outcomes of VTE events, DVT 

events, and mortality, but confidence intervals were wide and did not exclude clinically 

important differences for some of these outcomes. There was also no clear pattern of differences 

in the studied outcomes by type or location of IPCD (foot, calf, thigh), surgical indication (TKA 

vs THA), or IPCD only versus combined therapy (IPCD plus anticoagulation), although some 

evidence suggests that combination of IPCD plus anticoagulation may be more effective than 

IPCD alone. IPCDs compared to anticoagulation may lower the risk of major bleeding. 

KQ 2: IPCDs versus Anticoagulation in Medical Patients

There are few studies examining IPCD performance for VTE prophylaxis in high-risk medical 

patients. We identified studies only in stroke and trauma patients, and calf IPCDs were the most 

commonly studied devices in these patients. Although there is limited evidence suggesting 

similar incidence rates of VTE events (DVT or PE) with IPCDs and anticoagulation, we judged 

the strength of evidence to be insufficient because of important risk of bias and wide confidence 

intervals that do not exclude clinically important differences in treatment effects.

KQ 3: Direct Comparison of IPCDs in Surgical and Medical Patients

There are few studies that directly compare IPCDs for VTE prophylaxis in surgical patients, and 

none meeting our inclusion criteria in medical patients. One large study (moderate risk of bias) in 

TKA patients found evidence that a rapid inflation calf device (VenaFlow) was associated with 

25
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

lower VTE risk compared to a gradual inflation calf device (Kendall SCD). Two other studies in 

pelvic fracture and spinal surgery patients, comparing rapid inflation foot or foot-calf devices 

(PlexiPlus) to gradual inflation thigh-high devices (Kendall SCD), did not show significant 

differences in VTE event rates. No VTE-related mortality or major VTE-related complications 

were reported in any of these studies. With few studies reporting on the direct comparison of 

IPCDs, and indirect comparisons infeasible due to variability in study designs, we considered the 

strength of evidence to be insufficient to low.

KQ 4: Ease of Use and Adherence in Surgical and Medical Patients

We examined RCTs and observational studies that compared IPCDs and reported data on ease of 

use or adherence in surgical and medical patients. One small RCT found greater adherence with 

use of a portable calf device (WizAir DVT CECT) compared to a non-portable calf device

(Kendall SCD). Another RCT found no difference in adherence between a rapid inflation foot 

device (PlexiPlus) compared to a calf-thigh gradual inflation device (Kendall SCD). 

Observational studies found that foot devices had greater adherence compared to other IPCDs. 

However, observational studies had important methodological limitations. Overall, there were no 

consistent associations between specific brand-name IPCDs or sleeve location and ease of use or 

adherence. 

CLINICAL AND POLICY IMPLICATIONS

The prevalence of total joint replacements in the United States is increasing rapidly. By 2030, it 

is projected that the number of primary THAs in the United States will grow 174% to 572,000, 

and primary TKAs by 673% to 3.48 million procedures per year.64 Similar growth in these 

procedures is likely in the VA Health System since it serves an older population with a high 

prevalence of orthopedic conditions. However, appropriate prophylaxis is suboptimal in this 

high-risk population, and there is a growing gap between consensus guidelines and clinical 

practice.65-67 Among medically ill hospitalized Veterans, missed opportunities for VTE 

prophylaxis are also frequent and often include inappropriate mechanical prophylaxis or 

inadequate use of anticoagulation.68

Suboptimal utilization of mechanical prophylaxis with IPCDs is a patient safety issue that has 

significant cost implications for health systems. Therefore, there is health system interest in 

improving the quality of mechanical VTE prophylaxis prescribing to ensure that all surgical and 

medically ill hospitalized patients receive the most appropriate, safe, and cost-effective VTE 

prophylaxis possible. In the next section, we summarize recommendations from the 2 major U.S. 

clinical guideline panels that have addressed this issue and then provide a framework for 

selecting IPCDs in the face of uncertain evidence. 

Clinical Practice Guidelines

Surgical Patients

Both the American Academy of Orthopaedic Surgeons and the American College of Chest 

Physicians (ACCP) have recently issued guidelines on thromboprophylaxis.14-16

Recommendations for thromboprophylaxis are related to the surgery, the risk of bleeding, and 

the risk of VTE. IPCD prophylaxis is recommended for orthopedic and non-orthopedic patients 

26
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

at high risk of bleeding. For non-orthopedic procedures in patients at low risk of bleeding, IPCD 

prophylaxis is recommended for patients who are also at low risk of VTE. For orthopedic 

procedures, portable battery-powered IPCDs and devices capable of recording wear time are 

recommended as an option for patients at low risk of bleeding, but pharmacological prophylaxis 

with or without IPCD is preferred.16 Overall, however, these clinical guidelines do not 

recommend for or against specific IPCDs for VTE prophylaxis and were based on low-quality 

evidence. Relevant to these guidelines are our findings that IPCDs, compared to anticoagulation, 

may have decreased risk of major bleeding complications, and that the combination of IPCD and 

anticoagulation may be more effective at preventing VTE than anticoagulation alone. 

Medical Patients

According to the 2012 ACCP guidelines, optimal use of mechanical thromboprophylaxis with 

IPCDs is recommended in acutely ill medical inpatients at increased risk for thrombosis, who are 

bleeding, or who are at high risk for major bleeding.

13 These are consensus-based 

recommendations. The VA patient population has more medical conditions than the general 

patient population,69 placing our patients at high risk for VTE and bleeding complications. Given 

the limited data on mechanical IPCD use in high-risk medical patients, we judged the strength of 

evidence to be insufficient to determine the effects on clinically important outcomes in this 

population. 

FRAMEWORK FOR SELECTING IPC DEVICES

Making clinical and policy recommendations in the face of uncertain evidence is challenging. 

Our review was structured to consider 3 types of evidence: 1) head-to-head comparisons of 

IPCDs; 2) indirect comparisons of IPCDs to a common comparator (eg, foot vs calf devices, 

each compared to anticoagulation); and 3) data on ease of use or adherence from patients or staff. 

An additional type of evidence is simply the frequency with which particular devices or device 

types have been evaluated. 

Although there are mechanistic differences between ICPDs, such as sleeve location (foot, calf, 

thigh) and inflation and compression cycle patterns, as well as conceptual differences, such as 

device portability, we did not find definitive evidence to suggest that any of these factors are 

associated with clinically important differences in VTE rates or patient- or staff-rated ease of 

use. When the strength of evidence from published studies is insufficient for confident decision 

making, other criteria may be applied. In 2007, the Emergency Care Research Institute (ECRI 

Institute) evaluated selected IPCDs and proposed the following evaluation criteria: safety 

features, patient comfort, performance (eg, inflate to specified pressure), quality of construction, 

battery life and other battery related features (if battery equipped), and ease of setup and other 

ease-of-use features.70 In addition, the guideline-recommended use of portable, battery-powered 

IPCDs with hour meters in joint replacement patients16 may be applicable to other surgical and 

medical populations, but further study of this is needed. Additional considerations are costs and 

flexibility. If a single device can be used in a variety of modes and with a variety of compression 

bladders, then that device may serve a broader range of clinical needs. An updated evaluation

that describes these features for devices currently on the market could inform decision making. 

27
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

LIMITATIONS

Limitations can be categorized broadly into those related to the methods of the review and those 

related to the included studies. Our review differs from prior reviews in important ways. We 

limited eligibility to studies reporting VTE outcomes at 4 weeks or greater, a period of clinically 

important elevated risk for VTE. By excluding short-duration studies, we prioritized the most 

clinically relevant time-point, but excluded trials that may have contributed some useful data.

We also imposed geographical limits to restrict the review to medical systems most similar to the 

United States, but this led to exclusion of at least 2 trials that would otherwise have been 

eligible.71,72 A sensitivity analysis (data not shown) that included these studies for the outcomes 

“any DVT” and “major bleeding” had no important effect on the estimates of effect. In other 

ways, our eligibility criteria were more expansive. We included surgical and medical populations 

at elevated risk of VTE and observational studies to better evaluate ease-of-use outcomes. We 

also conducted novel subgroup analyses by device characteristics to explore whether these 

characteristics could guide policymakers or health systems in device selection. The devices 

studied may, however, not be the same as those currently on the market; furthermore, in some 

instances, we do not know all the features of the devices studied. Our search of 

ClinicalTrials.gov did not identify any completed but unpublished studies, but statistical methods 

to evaluate publication bias were limited due to the relatively small number of studies. 

The chief limitations of the literature were the paucity of head-to-head comparisons of IPCDs 

and the focus on DVT assessed by screening imaging studies, resulting primarily in the 

identification of asymptomatic DVTs of uncertain clinical importance. Other limitations include 

important methodological limitations in both RCTs and observational studies. However, 

sensitivity analyses did not show important differences in pooled estimates when studies at high 

risk of bias were excluded. We also found important heterogeneity in treatment effects for VTE 

and DVT outcomes, heterogeneity that was only partly explained by subgroup analyses. This 

unexplained heterogeneity decreased our confidence in the strength of evidence. Finally, changes 

in manufacturers over time made it difficult to identify some devices and their characteristics 

accurately.

Despite these limitations, men and women were well-represented in the included studies, and the 

median average age was 54 years, somewhat younger than the average patient admitted to VA 

hospitals. Other than age, which is associated with risk for VTE, these results should be 

applicable to VA patients and VA hospitals. 

RESEARCH GAPS/FUTURE RESEARCH

We used the framework recommended by Robinson et al73 to identify gaps in evidence and 

prioritize future needs (Table 4). This approach considers PICOTS (population, intervention, 

comparator, outcomes, timing, and setting) to identify gaps. 

28
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Table 4. Evidence Gaps and Future Research Needs

Evidence Gap Reason Type of Studies to Consider

Patients

Effects of IPCDs in medically ill 

patients

Insufficient 

information

RCTs or multi-site observational studies

Effects of IPCDs in non-orthopedic 

high-risk surgical groups (bariatrics, 

gynecological, or robotic surgeries)

Insufficient

information

Large RCTs or multi-site observational studies

Interventions

Optimal IPCD type or category Insufficient 

information

RCTs or quasi-experimental studies of head-tohead comparisons of IPCD sleeve locations, 

compression patterns, and inflation times

Comparator

Effectiveness of IPCDs compared 

to newer oral anticoagulants

Insufficient 

information

RCTs or observational studies

Outcomes

Accuracy of treatment effects 

beyond 4 weeks

Insufficient 

information

Trials with more careful assessment of VTE 

rates at 1 month and beyond, outcomes 

assessed blinded to treatment assignment

Effects on clinically relevant 

outcomes

Insufficient 

information

Trials with proximal and symptomatic DVT 

outcome assessments, trials with standard 

approaches to assessing/reporting bleeding

Effects on adherence and 

patient/staff tolerability

Insufficient 

information

Trials using standard, validated questionnaires 

for patient/staff assessment of ease of use 

outcomes

Abbreviations: DVT=deep vein thrombosis; IPCD(s)=intermittent pneumatic compression device(s); 

RCTs=randomized controlled trials; VTE=venous thromboembolism

CONCLUSIONS

Although IPCDs differ in practical features and in effects on physiology, current evidence does 

not show a clear difference in effects on clinically important outcomes. As a strategy for 

thromboprophylaxis, we found that IPCDs may decrease the risk of major bleeding compared to

anticoagulation, and when used in combination with LMWH, may decrease the risk of VTE. We 

conclude that IPCDs are a viable option for VTE thromboprophylaxis when used in accordance 

with current clinical guidelines. When choosing a specific IPCD, focusing on device flexibility,

acceptability by nursing staff and patients, and the most frequently studied devices, as well as on 

cost, can help direct selection of appropriate IPCDs. Comparative effectiveness studies are 

urgently needed to address current gaps in evidence. 

29
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

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63. Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W. Definition of 

major bleeding in clinical investigations of antihemostatic medicinal products in surgical 

patients. J Thromb Haemost. 2010;8(1):202-204.

64. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip 

and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 

2007;89(4):780-785.

65. Amin A, Stemkowski S, Lin J, Yang G. Thromboprophylaxis rates in US medical 

centers: success or failure? J Thromb Haemost. 2007;5(8):1610-1616.

66. Tapson VF, Decousus H, Pini M, et al. Venous thromboembolism prophylaxis in acutely 

ill hospitalized medical patients: findings from the International Medical Prevention 

Registry on Venous Thromboembolism. Chest. 2007;132(3):936-945.

67. Schleyer AM, Schreuder AB, Jarman KM, Logerfo JP, Goss JR. Adherence to guidelinedirected venous thromboembolism prophylaxis among medical and surgical inpatients at 

33 academic medical centers in the United States. Am J Med Qual. 2011;26(3):174-180.

68. Herbers J, Zarter S. Prevention of venous thromboembolism in Department of Veterans 

Affairs hospitals. J Hosp Med. 2010;5(1):E21-E25.

69. Agha Z, Lofgren RP, VanRuiswyk JV, Layde PM. Are patients at Veterans Affairs 

medical centers sicker? A comparative analysis of health status and medical resource use. 

Arch Intern Med. 2000;160(21):3252-3257.

70. Anonymous. Intermittent pneumatic compression devices. Health Devices. 

2007;36(6):177-204.

71. Gelfer Y, Tavor H, Oron A, Peer A, Halperin N, Robinson D. Deep vein thrombosis 

prevention in joint arthroplasties: continuous enhanced circulation therapy vs low 

molecular weight heparin. J Arthroplasty. 2006;21(2):206-214.

72. Chin PL, Amin MS, Yang KY, Yeo SJ, Lo NN. Thromboembolic prophylaxis for total 

knee arthroplasty in Asian patients: a randomised controlled trial. J Orthop Surg (Hong 

Kong). 2009;17(1):1-5.

73. Robinson KA, Saldanha IJ, Mckoy NA. Frameworks for Determining Research Gaps 

During Systematic Reviews. Methods Future Research Needs Report No. 2. (Prepared by 

the Johns Hopkins University Evidence-based Practice Center under Contract No. HHSA 

290-2007-10061-I.) AHRQ Publication No. 11-EHC043-EF. Rockville, MD: Agency for 

Healthcare Research and Quality. June 2011. 

www.effectivehealthcare.ahrq.gov/reports/final.cfm.

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Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

APPENDIX A. SEARCH STRATEGIES

Database: MEDLINE (via PubMed)

Search date: 10/30/14 

Set # Search Terms Results

#1 Search "venous thrombosis"[MeSH Terms] OR venous thrombo*[tiab] OR deep-venous 

thrombo*[tiab] OR deep vein thrombo*[tiab] OR deep-vein thrombo*[tiab] OR 

phlebothrombo*[tiab] OR "Thromboembolism"[Mesh:NoExp] OR “thrombophlebitis”[tiab] 

OR thromboemboli*[tiab] OR "Venous Thromboembolism"[Mesh] OR venothrombolic 

event*[tiab] OR "VTEs"[tiab] OR "VTE"[tiab] OR "Thrombosis"[Mesh:NoExp] OR 

"Thrombosis"[tiab]

187,263

#2 Search "intermittent pneumatic compression devices"[MeSH Terms] OR compression 

device*[tiab] OR “intermittent compression”[tiab] OR “intermittent pneumatic”[tiab] OR 

foot pump*[tiab] OR foot-pump*[tiab] OR "Gravity Suits"[Mesh] OR "compression 

garment"[tiab] OR "inflatable garment"[tiab] OR "pneumatic pump"[tiab] OR "gradient 

pressure"[tiab] OR "Pneumatic compressor"[tiab] OR "pneumatic appliance"[tiab] OR 

“WizAIR”[tiab] OR “Flowtron”[tiab] OR “Phlebo”[tiab] OR “Kendall”[tiab] OR air 

massage*[tiab] OR “A-V impulse system”[tiab] OR “VenaFlow”[tiab] OR “Jobst”[tiab] OR 

“ArtAssist”[tiab] OR “Plexipulse”[tiab] OR “SC-2004 Sequential Circulator PCD”[tiab] OR 

“Walkcare”[tiab] OR “Venodyne”[tiab] OR “IPC”[tiab] OR “PIC”[tiab] OR “EPIC”[tiab] OR 

“IPEC”[tiab] OR "Bandages"[Mesh:NoExp] OR "Assisted Circulation"[Mesh:NoExp]

28,466

#3 Search #1 AND #2 1923

#4 Search #3 NOT (animals[mh] NOT humans[mh]) 1879

#5 #4 NOT (Editorial[ptyp] OR Letter[ptyp] OR Case Reports[ptyp] OR Comment[ptyp]) Sort 

by: Author Filters: Publication date from 1995/01/01; English

963

Database: Embase

Search date: 10/30/14 

Set # Search Terms Results

#1 'vein thrombosis'/exp OR 'thrombosis'/de OR thrombo*:ab,ti OR phlebothrombo*:ab,ti 

OR "venothrombolic event":ab,ti OR "VTE":ab,ti OR "VTEs":ab,ti

460,903

#2 'intermittent pneumatic compression device'/exp OR “A-V Impulse System”:ab,ti OR 

“ArtAssist”:ab,ti OR “Flexitouch system”:ab,ti OR “FLOWTRON”:ab,ti OR “intermittent 

pneumatic compression devices”:ab,ti OR “Plexipulse”:ab,ti OR “pneumatic intermittent 

impulse device”:ab,ti OR “SC-2004 Sequential Circulator PCD”:ab,ti OR 

“Walkcare”:ab,ti OR 'assisted circulation'/de OR 'bandage'/de OR 'mast suit'/exp OR 

'compression instrument'/de OR “compression device”:ti,ab OR “intermittent 

compression”:ti,ab OR “intermittent pneumatic”:ti,ab OR “foot pump”:ti,ab OR “footpumps”:ti,ab OR “foot-pump”:ti,ab OR "compression garment":ti,ab OR "inflatable 

garment":ti,ab OR "pneumatic pump":ti,ab OR "gradient pressure":ti,ab OR "Pneumatic 

compressor":ti,ab OR "pneumatic appliance":ti,ab OR “WizAIR”:ti,ab OR “Phlebo”:ti,ab 

OR “Kendall”:ti,ab OR “air massage”:ti,ab OR “air massages”:ti,ab OR “VenaFlow”:ti,ab 

OR “Jobst”:ti,ab OR “Venodyne”:ti,ab

25,460

#3 #1 AND #2 2519

#4 #3 AND ([embase]/lim OR [embase classic]/lim) NOT [medline]/lim 807

#5 #4 NOT ('case report'/exp OR 'editorial'/exp OR 'letter'/exp OR 'note'/exp) 735

#6 #5 AND [humans]/lim AND [english]/lim 437

#7 #6 AND [1995-2014]/py 425

36
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Database: CINAHL (Key Question 4 only)

Search date: 10/30/14 

Set # Search Terms Results

S1 (MH "Compression Garments") 1634

S2 (MH "Compression Therapy") 1673 

S3 (MH "Bandages and Dressings") 7649 

S4 TI ( “intermittent pneumatic compression device” or "A-V Impulse System" or "ArtAssist" 

or "Flexitouch system" or "FLOWTRON" or "intermittent pneumatic compression 

devices" or "Plexipulse" or "pneumatic intermittent impulse device" or "SC-2004 

Sequential Circulator PCD" or "Walkcare" or "assisted circulation" or "bandage" or 

"compression instrument" or "compression device" or "intermittent compression" or 

"intermittent pneumatic" or "foot pump" or "foot-pumps" or "foot-pump" or "compression 

garment" or "inflatable garment" or "pneumatic pump" or "gradient pressure" or 

"Pneumatic compressor" or "pneumatic appliance" or "WizAIR" or "Phlebo" or "Kendall" 

or "air massage" or "air massages" or "VenaFlow" or "Jobst" or "Venodyne" ) OR AB ( 

“intermittent pneumatic compression device” or "A-V Impulse System" or "ArtAssist" or 

"Flexitouch system" or "FLOWTRON" or "intermittent pneumatic compression devices" 

or "Plexipulse" or "pneumatic intermittent impulse device" or "SC-2004 Sequential 

Circulator PCD" or "Walkcare" or "assisted circulation" or "bandage" or "compression 

instrument" or "compression device" or "intermittent compression" or "intermittent 

pneumatic" or "foot pump" or "foot-pumps" or "foot-pump" or "compression garment" or 

"inflatable garment" or "pneumatic pump" or "gradient pressure" or "Pneumatic 

compressor" or "pneumatic appliance" or "WizAIR" or "Phlebo" or "Kendall" or "air 

massage" or "air massages" or "VenaFlow" or "Jobst" or "Venodyne" ) 

1187 

S5 S1 OR S2 OR S3 OR S4 10,761 

S6 TI ( thrombo* or phlebothrombo* or "venothrombolic event" or "VTE" or "VTEs" ) OR AB 

( thrombo* or phlebothrombo* or "venothrombolic event" or "VTE" or "VTEs" ) 

25,614 

S7 (MH "Venous Thrombosis+") OR (MH "Thromboembolism+") OR (MH "Thrombosis+") 21,952 

S8 S6 OR S7 36,538 

S9 S5 AND S8 841 

S10 S9 Limiters - English Language; Published Date: 19950101-20141231; Exclude 

MEDLINE records; Language: English; Search modes - Find all my search terms

309 

S11 (MH "Prospective Studies+") OR (MH "Cross Sectional Studies") OR (MH "QuasiExperimental Studies+") OR (MH "Retrospective Design") 433,714 

S12 S10 AND S11 18 

Database: Cochrane CENTRAL

Search date: 10/30/14 

Set # Search Terms Results

#1 deep vein thrombosis:ti,ab,kw (Word variations have been searched) 2205

#2 deep vein thromboses:ti,ab,kw (Word variations have been searched) 40

#3 thrombo* or phlebothrombo* or "venothrombolic event" or "VTE" or "VTEs":ti,ab,kw 

(Word variations have been searched)

22,495

#4 [or #1-#3] 22,495

37
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Set # Search Terms Results

#5 “intermittent pneumatic compression device” or "A-V Impulse System" or "ArtAssist" or 

"Flexitouch system" or "FLOWTRON" or "intermittent pneumatic compression devices" 

or "Plexipulse" or "pneumatic intermittent impulse device" or "SC-2004 Sequential 

Circulator PCD" or "Walkcare" or "assisted circulation" or "bandage" or "compression 

instrument" or "compression device" or "intermittent compression" or "intermittent 

pneumatic" or "foot pump" or "foot-pumps" or "foot-pump" or "compression garment" or 

"inflatable garment" or "pneumatic pump" or "gradient pressure" or "Pneumatic 

compressor" or "pneumatic appliance" or "WizAIR" or "Phlebo" or "Kendall" or "air 

massage" or "air massages" or "VenaFlow" or "Jobst" or "Venodyne":ti,ab

1984

#6 [and #4-#5] Publication Year from 1995 to 2014, in Cochrane Reviews (Reviews and 

Protocols) and Trials

205

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Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

APPENDIX B. QUALITY (RISK OF BIAS) ASSESSMENT OF 

RCTS—CRITERIA USED AND DETAILED RATINGS

General Instructions: Rate each risk of bias item listed below as Low risk/High risk/Unclear 

risk (see Cochrane guidance to inform judgements). Add comments to justify ratings. After 

considering each of the quality items, give the study an overall rating of “Low risk,” “Moderate 

risk,” or “High risk” (see below).

Rating of individual items: 

1. Selection bias:

a. *Randomization adequate (Adequate methods include: random number table, computergenerated randomization, minimization w/o a random element) Low risk/High 

risk/Unclear risk

b. *Allocation concealment (Adequate methods include: pharmacy-controlled 

randomization, numbered sealed envelopes, central allocation) Low risk/High 

risk/Unclear risk

c. Baseline characteristics (Consider whether there were systematic differences observed in 

baseline characteristics and prognostic factors between groups, and if important 

differences were observed, if the analyses controlled for these differences) Low 

risk/High risk/Unclear risk

2. Performance bias:

a. *Concurrent interventions or unintended exposures: (Consider concurrent intervention or 

an unintended exposure [eg, crossovers; contamination – some control group gets the 

intervention] that might bias results) Low risk/High risk/Unclear risk

b. Protocol variation: (Consider whether variation from the protocol compromised the 

conclusions of the study) Low risk/High risk/Unclear risk

3. Detection bias:

a. *Subjects Blinded?: (Consider measures used to blind subjects to treatment assignment 

and any data presented on effectiveness of these measures) Low risk/High risk/Unclear 

risk

b. *Outcome assessors blinded (hard outcomes): (Outcome assessors blind to treatment 

assignment for “hard outcomes” such as mortality) Low risk/High risk/Unclear risk

c. *Outcome assessors blinded (soft outcomes): (Outcome assessors blind to treatment 

assignment for “soft outcomes” such as symptoms) Low risk/High risk/Unclear risk

d. Measurement bias: (Reliability and validity of measures used-VTE) Low risk/High 

risk/Unclear risk

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Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

e. Measurement bias: (Reliability and validity of measures used- Ease of use/Acceptability

Low risk/High risk/Unclear risk

4. Attrition bias:

a. *Incomplete outcome data: (Consider whether incomplete outcome data were adequately

addressed, including: systematic differences in attrition between groups [differential 

attrition]; overall loss to follow-up [overall attrition]; and whether an “intention-to-treat” 

[ITT; all eligible patients that were randomized are included in analysis] analysis was 

performed) (Note – mixed models and survival analyses are in general ITT) Low 

risk/High risk/Unclear risk

5. Reporting bias:

a. *Selective outcomes reporting: (Consider whether there is any suggestion of selective

outcome reporting (eg, systematic differences between planned and reported findings)? 

Low risk/High risk/Unclear risk

*Items contained in Cochrane Risk of Bias Tool

Overall study rating: 

Please assign each study an overall quality rating of “Low risk,” “High risk,” or “Unclear risk” based 

on the following definitions: 

A “Low risk” study has the least bias, and results are considered valid. A low risk study 

uses a valid approach to allocate patients to alternative treatments; has a low dropout rate; 

and uses appropriate means to prevent bias, measure outcomes, and analyze and report 

results. [Items 1a and 1c; 2a; 3b and 3c; and 4a are all rated low risk]

A “Moderate risk” study is susceptible to some bias but probably not enough to 

invalidate the results. The study may be missing information, making it difficult to assess 

limitations and potential problems (unclear risk). As the moderate risk category is broad, 

studies with this rating vary in their strengths and weaknesses. [Most, but not all of the 

following items are rated low risk: Items 1a and 1c; 2a; 3b and 3c; and 4a] 

A “High risk” rating indicates significant bias that may invalidate the results. These 

studies have serious errors in design, analysis, or reporting; have large amounts of 

missing information; or have discrepancies in reporting. The results of a high risk study 

are at least as likely to reflect flaws in the study design as to indicate true differences 

between the compared interventions. [At least one-half of the individual quality items are 

rated high risk or unclear risk] 

Conflict of interest: (Record but not used as part of Risk of Bias Assessment)

a. Was there the absence of potential important conflict of interest?: The focus here is

financial conflict of interest. If no financial conflict of interest (eg, if funded by

government or foundation and authors do not have financial relationships with

drug/device manufacturer), then answer “Yes.” Yes/No/Unclear

40
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

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Appendix Table B1. Detailed Risk-of-Bias Ratings for Included RCTs*

Study Individual Quality Assessment Criteria Ratings Overall 

Rating

COI 

1a 1b 1c 2a 2b 3a 3b 3c 3d 3e 4 5 Absent?

Blanchard,199952 UR LR UR LR LR LR UR UR LR UR LR LR High Yes

Colwell, 201017 LR HR LR UR LR HR LR UR LR UR LR LR Moderate No

Edwards, 200858 UR UR LR UR HR HR UR UR LR UR UR LR High No

Ginzburg, 200355 LR UR LR LR HR LR LR UR LR UR HR LR Moderate Unclear

Greenfield, 199761 UR UR UR LR LR LR UR UR LR UR UR UR High Unclear

Lachiewicz, 

200446 UR LR LR LR LR LR LR UR LR UR LR LR Moderate Yes

Murakami, 200323 LR HR LR LR LR HR UR UR LR LR LR LR Moderate Yes

Pagella, 200747 LR LR LR LR LR HR UR HR UR UR LR LR Moderate Unclear

Pambianco, 

199559 LR LR LR LR LR LR UR UR LR UR HR LR Moderate Yes

Pitto, 200418 LR UR LR LR UR LR LR HR LR UR HR LR Moderate No

Rokito, 199649 UR UR LR UR LR HR LR UR UR UR LR LR Moderate No

Silbersack, 200457 UR UR LR UR HR LR LR UR LR UR LR LR Moderate No

Stannard, 200150 LR UR LR UR UR UR LR UR LR UR HR LR Moderate No

Stone, 199656 UR UR LR LR UR LR UR UR LR UR UR LR Moderate Unclear

Warwick,200219 LR UR LR UR UR LR LR HR LR UR UR LR Moderate No

Warwick, 199853 LR UR LR LR HR HR LR HR LR LR LR LR Moderate No

Windisch, 201154 UR UR UR LR LR HR LR UR LR UR LR LR Moderate Unclear

Wood, 199751 UR UR HR UR UR HR LR HR LR UR UR LR High Unclear

*The quality rating criteria described above were not used for the 3 included observational studies.48,60,62 They were evaluated using the 5 domains of basic

design, selection bias, performance bias, attrition bias, and detection bias, and only the overall score is reported in the body of the report.

Abbreviations: COI=conflict of interest; HR=high risk; LR=low risk; RCTs=randomized controlled trials; UR=unclear risk

41
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

References to Appendix B:

1. Blanchard J, Meuwly JY, Leyvraz PF, et al. Prevention of deep-vein thrombosis after

total knee replacement. Randomised comparison between a low-molecular-weight

heparin (nadroparin) and mechanical prophylaxis with a foot-pump system. J Bone Joint

Surg Br. 1999;81(4):654-659.

2. Colwell CW, Jr., Froimson MI, Mont MA, et al. Thrombosis prevention after total hip

arthroplasty: a prospective, randomized trial comparing a mobile compression device

with low-molecular-weight heparin. J Bone Joint Surg Am. 2010;92(3):527-535.

3. Edwards JZ, Pulido PA, Ezzet KA, Copp SN, Walker RH, Colwell CW, Jr. Portable

compression device and low-molecular-weight heparin compared with low-molecularweight heparin for thromboprophylaxis after total joint arthroplasty. J Arthroplasty.

2008;23(8):1122-1127.

4. Ginzburg E, Cohn SM, Lopez J, Jackowski J, Brown M, Hameed SM. Randomized

clinical trial of intermittent pneumatic compression and low molecular weight heparin in

trauma. Br J Surg. 2003;90(11):1338-1344.

5. Greenfield LJ, Proctor MC, Rodriguez JL, Luchette FA, Cipolle MD, Cho J. Posttrauma

thromboembolism prophylaxis. J Trauma. 1997;42(1):100-103.

6. Lachiewicz PF, Kelley SS, Haden LR. Two mechanical devices for prophylaxis of

thromboembolism after total knee arthroplasty. A prospective, randomised study. J Bone

Joint Surg Br. 2004;86(8):1137-1141.

7. Murakami M, McDill TL, Cindrick-Pounds L, et al. Deep venous thrombosis prophylaxis

in trauma: improved compliance with a novel miniaturized pneumatic compression

device. J Vasc Surg. 2003;38(5):923-927.

8. Pagella P, Cipolle M, Sacco E, Matula P, Karoly E, Bokovoy J. A randomized trial to

evaluate compliance in terms of patient comfort and satisfaction of two pneumatic

compression devices. Orthop Nurs. 2007;26(3):169-174.

9. Pambianco G, Orchard T, Landau P. Deep vein thrombosis: prevention in stroke patients

during rehabilitation. Arch Phys Med Rehabil. 1995;76(4):324-330.

10. Pitto RP, Hamer H, Heiss-Dunlop W, Kuehle J. Mechanical prophylaxis of deep-vein

thrombosis after total hip replacement a randomised clinical trial. J Bone Joint Surg Br.

2004;86(5):639-642.

11. Rokito SE, Schwartz MC, Neuwirth MG. Deep vein thrombosis after major

reconstructive spinal surgery. Spine (Phila Pa 1976). 1996;21(7):853-858; discussion

859. 

42
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

12. Silbersack Y, Taute BM, Hein W, Podhaisky H. Prevention of deep-vein thrombosis after

total hip and knee replacement. Low-molecular-weight heparin in combination with

intermittent pneumatic compression. J Bone Joint Surg Br. 2004;86(6):809-812.

13. Stannard JP, Riley RS, McClenney MD, Lopez-Ben RR, Volgas DA, Alonso JE.

Mechanical prophylaxis against deep-vein thrombosis after pelvic and acetabular

fractures. J Bone Joint Surg Am. 2001;83-a(7):1047-1051.

14. Stone MH, Limb D, Campbell P, Stead D, Culleton G. A comparison of intermittent calf

compression and enoxaparin for thromboprophylaxis in total hip replacement. A pilot

study. Int Orthop. 1996;20(6):367-369.

15. Warwick D, Harrison J, Whitehouse S, Mitchelmore A, Thornton M. A randomised

comparison of a foot pump and low-molecular-weight heparin in the prevention of deepvein thrombosis after total knee replacement. J Bone Joint Surg Br. 2002;84(3):344-350.

16. Warwick D, Harrison J, Glew D, Mitchelmore A, Peters TJ, Donovan J. Comparison of

the use of a foot pump with the use of low-molecular-weight heparin for the prevention

of deep-vein thrombosis after total hip replacement. A prospective, randomized trial. J

Bone Joint Surg Am. 1998;80(8):1158-1166.

17. Windisch C, Kolb W, Kolb K, Grutzner P, Venbrocks R, Anders J. Pneumatic

compression with foot pumps facilitates early postoperative mobilisation in total knee

arthroplasty. Int Orthop. 2011;35(7):995-1000.

18. Wood KB, Kos PB, Abnet JK, Ista C. Prevention of deep-vein thrombosis after major

spinal surgery: a comparison study of external devices. J Spinal Disord. 1997;10(3):209-

214. 

19. Bockheim HM, McAllen KJ, Baker R, Barletta JF. Mechanical prophylaxis to prevent

venous thromboembolism in surgical patients: a prospective trial evaluating compliance.

J Crit Care. 2009;24(2):192-196.

20. Proctor MC, Greenfield LJ, Wakefield TW, Zajkowski PJ. A clinical comparison of

pneumatic compression devices: the basis for selection. J Vasc Surg. 2001;34(3):459-

463; discussion 463-454.

21. Robertson KA, Bertot AJ, Wolfe MW, Barrack RL. Patient compliance and satisfaction

with mechanical devices for preventing deep venous thrombosis after joint replacement. J

South Orthop Assoc. 2000;9(3):182-186.

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Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

APPENDIX C. PEER REVIEW COMMENTS/AUTHOR RESPONSES

Reviewer Comment Response

Question 1. Are the objectives, scope, and methods for this review clearly described?

1 Yes Acknowledged

2 Yes Acknowledged

3 Yes Acknowledged

4 Yes Acknowledged

6 Yes Acknowledged

Question 2. Is there any indication of bias in our synthesis of the evidence?

1 No Acknowledged

2 No Acknowledged

3 No Acknowledged

4 No Acknowledged

6 No Acknowledged

Question 3. Are there any published or unpublished studies that we may have overlooked?

1 No Acknowledged

2 No Acknowledged

3 No Acknowledged

4 No Acknowledged

6 Yes - Colwell report from 2014 JBJS of large cohort trial with 

IPCD

This article was identified in our search, but did not meet 

inclusion criteria at the comparator level. This Colwell study is a 

non-randomized registry trial that compares VTE events of an 

IPCD with published symptomatic rates for anticoagulants. This 

study, however, does not directly compare IPCDs with 

pharmacological prophylaxis, which is required for inclusion. 

Furthermore, this study did not report on outcomes of interest 

(such as ease of use or adherence) required for inclusion of nonrandomized trials in our review.

44
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

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Reviewer Comment Response

Question 4: Please write additional suggestions or comments below. If applicable, please indicate the page and line numbers from the 

draft report.

1 The purpose of the study that I had in mind when I asked for your 

assistance in evaluating pneumatic compression devices used to 

prevent DVT and PE in post-op surgical patients was for you to 

evaluate and critically compare the various devices used to 

provide compression. Since there were several different devices 

available using different modes of compression, my hope was 

that if one method was superior to the others we could identify it 

and direct the VA to use it preferentially. Your study was most 

helpful in that it shows, within the limits of the evaluation, that all 

of the devices provide similar prophylaxis for DVT and similar 

levels of comfort for the patient during their use. This was most 

helpful as it means that we should primarily select a device or 

pneumatic compression system on value which equals quality 

divided by cost.

Thank you. While the existing data do not allow any strong 

conclusions about differential effectiveness or ease of use, we 

noted other factors to consider: 1) Clinical guidelines from ACCP 

and AAOS, and 2) safety features, ease-of-use features, and 

most frequently studied devices. We have added a new table 

providing more details about the characteristics of the devices 

examined in the included studies (Appendix E). 

2 Word missing from line 14. "The committee is interested ____ 

developing policy...."

Thank you. This error has been corrected. 

3 [No comments submitted] –

4 Overall well done review and the reports in concise and 

transparent with appropriate methodology.

Search date (consider an update)

Thank you. 

An updated search is not part of the standard processes for the 

Evidence Synthesis Program.

4 English language restriction is problematic. At a minimum there 

should be a rationale provided for doing so.

We restricted eligible studies to those published in English 

because we did not have the resources to translate non-English 

publications. Although this restriction introduces the chance of 

publication bias, we were reassured that the risk was low after 

reviewing a recent study without this restriction (Ho 2013) and 

finding that it had not identified any eligible non-English language 

studies.

4 Agreement among reviewers is not reported or described (I 

apologize if I missed it).

Inter-rater agreement is not reported. However, in the methods 

section we specify, “All data abstractions were confirmed by a 

second investigator. Disagreements were resolved by consensus 

or by obtaining a third investigator’s opinion.”

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Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Reviewer Comment Response

4 Figure 1 (and other figures) that reference to the questions (KQ1, 

KQ2, etc) are hard to read. I suggest you add the question in a 

shortened format to remind readers. For example, you can say 

“KQ1-surgical patients”, etc.

Acknowledged. We modified the labels to reference the KQs in 

Figure 1, and we have clarified that the other figures reference 

surgical patients.

4 Major bleeding in KQ1 is clearly not precise: RD=25 fewer (34 

fewer to 19 more) and such direct evidence is clearly not 

moderate, but rather of low quality. Nonetheless, indirect 

evidence (from people treated with anticoagulation in other 

settings and conditions) tells us that bleeding risk increases with 

anticoagulation. So, in this case, the indirect evidence is probably 

better to use for the outcome of bleeding (you can list both in the 

evidence profile as two subsequent lines).

The denominator for this calculation was missing from the draft 

table and has been corrected to show a risk difference of 25 

fewer per 1000 patients (34 fewer to 19 more). However, this RD 

was based on few events and we agree that this is an imprecise 

result. We have re-rated the SOE as “Low”.

Although it is well established that long-term anticoagulation does 

increase the risk of bleeding, the SOE in Table 3 is based only on 

studies included in the current review.

6 The report concludes that IPCD prophylaxis is equivalent to 

anticoagulation in prevention of VTE and that the risk of bleeding 

from using chemoprophylaxis is higher. Because ACCP 

guidelines recommend that IPCD devices be portable, battery 

powered and record compliance and because the ACCP 

guidelines have always been the gold standard for VTE 

prophylaxis recommendations in orthopaedics, a comparison of 

various IPCD devices can be done by just comparing 

characteristics of each of the devices as to whether they all 

conform to these recommendations (only one device is portable, 

battery-powered and records compliance). Also, this device has 

documented efficacy in prevention of symptomatic VTE in a very 

large (>3000 total hip and knee patients) multicenter study that is 

similar (non-inferior) to that of LMWH. Also, several studies have 

been published indicating a higher rate of readmission in patients 

treated with chemoprophylaxis compared to IPCD, this fact 

should be presented in the study.

Our conclusions states, “Although IPCDs differ in practical 

features and in effects on physiology, current evidence does not 

show a clear difference in effects on clinically important 

outcomes.”

In the discussion, we cite the ACCP guidelines and note that “for 

orthopedic procedures, portable battery powered IPCDs and 

devices capable of recording wear time are recommended as an 

option for patients at low risk of bleeding, but pharmacological 

prophylaxis with or without IPCD is preferred.” We give 

characteristics of devices evaluated in the studies included in this 

review (Table 2 and Appendix E)) but note that this is not a 

comprehensive listing of all the devices on the market.

We believe the multicenter study cited by the reviewer is Colwell 

et al, Journal of Bone and Joint Surgery, 2014;96: 177-83. This 

study was identified by our search and excluded because it is a 

non-randomized trial reporting VTE outcomes. It also does not 

report any outcomes required for inclusion of non-randomized 

studies. 

Readmission was not an outcome identified by our content

experts or stakeholders. Further, it is a potentially problematic 

outcome because many factors contribute to rehospitalization.

46
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Reviewer Comment Response

Extra comments

1 Extra comments from an email from Reviewer 1 on 05/18/15 (he 

turned in comments via the form on 05/27/15, so the comments 

below precede those):

“I have read and re-read the results of your research into the 

effectiveness of the various types of pneumatic compression 

devices for DVT/PE prophylaxis in high risk surgical and medical 

patients. It is a truly excellent document - clearly written with 

easily comprehendable study objectives and outcomes. I was 

amazed to see how few studies out of the 1500+ total actually 

provided meaningful information. You have out done yourselves 

in providing me (and other clinicians, I suspect) with very useful 

information. It will help our team understand that most of the 

pneumatic compression devices perform well and with the 

exceptions you identify, we can recommend that the VA use 

competitive price for the basis for acquisition of these devices.

My sincere thanks for all you effort and dedication. I will send any 

thoughts for improvement in the publication as I find them - if I 

can note any.”

Acknowledged. Thank you.

47
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

APPENDIX D. STUDY CHARACTERISTICS 

Study Information

Author, year

Number randomized

Risk of bias

KQ(s)

Population

Country

Procedure

Sex (mean % men)

Age (mean [range])

Intervention (IPCD)

Device

Location

Initiation

Duration

Comparator

Name

Dosage or location

Initiation

Duration

Adjunctive Therapy*

ASA

GCS

Other

Blanchard, 199952

130

High

KQ 1

Switzerland

TKA

23.8%

73 (49-88)

A-V Impulse SystemTM

Foot

12 hours pre-op

8-12 days

LMWH (nadroparin)

2850-5700 IU daily

12 hours pre-op

10-12 days

NR

No

Acenocoumarol after 8-

12 days over 6-8 weeks

Bockheim, 200960

150

High

KQ 4

United States

Trauma

51%

62 (NR)

SCD

Calf

NR

NR

Venous pump

Foot

NR

NR

NR

NR

NR

Colwell, 201017

386 or 392

Moderate

KQ 1

United States

THA

45%

63 (20-88)

ActiveCare+S.F.T.®

Calf

Intra-op

10 days post-op

LMWH (enoxaparin)

30 mg per 12 hours to 

discharge, then 40 mg 

daily

1 day post-op

10 days post-op

81 mg/day allowed

No

NR

Edwards, 200858

277

High

KQ 1

United States

TKA, THA

42.5%

68 (32-88)

ActiveCare DVT®

Calf

Intra-op

To discharge

LMWH (enoxaparin)

30 mg per 12 hours

1 day post-op

8 days post-op

NR

No

Intervention: Enoxaparin 

30 mg per 12 hours until 

8 days post-op

Ginzburg, 200355

442

Moderate

KQ 2

United States

Trauma

74.0%

41.5 (NR)

Flowtron®

Calf

Post-op within 24 hours

30 days, discharge, or 

death

LMWH (enoxaparin)

30 mg per 12 hours

Post-op within 24 hours

30 days, discharge, or 

death

NR

No

NR

Greenfield, 199761

53

High

KQ 2

United States

Trauma

60.4%

44 (NR)

IPCD

Calf

Post-admission

Up to 4 weeks

Low dose unfractionated 

heparin

5000 U SC twice daily

Post-admission

Up to 4 weeks

NR

NR

Intervention: AV foot 

pump

Comparator: LMWH

48
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Study Information

Author, year

Number randomized

Risk of bias

KQ(s)

Population

Country

Procedure

Sex (mean % men)

Age (mean [range])

Intervention (IPCD)

Device

Location

Initiation

Duration

Comparator

Name

Dosage or location

Initiation

Duration

Adjunctive Therapy*

ASA

GCS

Other

Lachiewicz, 200446

423

Moderate

KQ 3

United States

TKA

35.5%

66.8 (23-94)

VenaFlow®

Calf

During surgery

NR, probably discharge

Kendall SCDTM

Calf

During surgery

NR, probably discharge

325 mg pre-op; 650 mg 

twice daily, post-op

Yes

Continuous passive 

movement machine, 1 

hour, 3 times daily

Murakami, 200323

33

Moderate

KQ 4

United States

Trauma

60.6%

48.4 (NR)

WizAir DVTTM CECT

Calf

Immediately postrandomization

NR

Kendall SCD

Calf

Immediately postrandomization

NR

NR

NR

Addition of heparin at 

the discretion of the MD

Pagella, 200747

65

Moderate

KQ 4

United States

THA or TKA

41.5%

57.6 (NR)

Kendall SCD

Calf

NR

NR

Flowtron

Calf

NR

NR

NR

Allowed

Warfarin, LMWH, 

unfractionated heparin, 

and IVC filters also 

allowed

Pambianco, 199559

360

Moderate

KQ 2

United States

Stroke patients

41.5%

71.4 (NR)

Anthrombic pump 

(Jobst)

Calf

Post-admission

Discharge or day 28

Adjusted dose heparin; 

5000-10,000 U SC 

every 8 hours

Post-admission

Discharge or day 28

NR

Yes

NR

Pitto, 200418

216

Moderate

KQ 1

New Zealand

THA

31%

57.7 (NR)

A-V Impulse System

Foot

Post-op, in recovery 

room

NR

LMWH (nadroparin)

NR

Post-op, in recovery 

room

Until discharge

NR

Yes

LMWH given to both 

groups at 12 hours preop

Proctor, 200162

1350

High

KQ 4

United States

Surgical & medical

NR

54.3 (NR)

NR

Foot, calf, or calf-thigh

Admission

Discharge or 30 days

NR

Foot, calf, or calf-thigh

Admission

Discharge or 30 days

NR

Allowed

Heparin allowed

49
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Study Information

Author, year

Number randomized

Risk of bias

KQ(s)

Population

Country

Procedure

Sex (mean % men)

Age (mean [range])

Intervention (IPCD)

Device

Location

Initiation

Duration

Comparator

Name

Dosage or location

Initiation

Duration

Adjunctive Therapy*

ASA

GCS

Other

Robertson, 200048

224

High

KQ 4

United States

THA or TKA

NR

NR

Kendall SCD

Calf-thigh

NR

NR

PlexiPulse®

Foot

NR

NR

NR

Yes with Intervention, 

NR with Comparator

Enoxaparin and warfarin 

allowed per MD

Rokito, 199649

110

Moderate

KQ 1

United States

Spinal surgery

39.5%

44.5 (22-77) 

Kendall SCD

Calf-thigh

Intra-op (“at surgery”)

5-7 days post-op

Warfarin

10 mg

Day before surgery

5-7 days post-op

NR

Yes

No

Silbersack, 200457

131

Moderate

KQ 1

Germany

THA or TKA

35.7%

64 (29-90)

VenaFlow

Calf

Immediately post-op

NR

LMWH (enoxaparin)

40 mg daily

Evening prior to surgery

30 days 

Allowed

Yes (Comparator only)

Intervention: Enoxaparin 

40 mg daily until 30 

days

Stannard, 200150

107

Moderate

KQs 3 and 4

United States

Trauma

NR

NR

Kendall SCD

Calf-thigh

<72 hours from injury

NR

PlexiPulse

Calf-foot 

<72 hours from injury

NR

No

NR

NR

Stone, 199656

50

Moderate

KQ 1

United Kingdom

THA

NR

NR

Flowtron

Calf

Immediately post-op

NR

LMWH (enoxaparin)

40 mg daily

Evening prior to surgery

Until discharge

No

NR

NR

Warwick, 200219

229

Moderate

KQ 1

United Kingdom

TKA

40%

72 (NR)

A-V Impulse System

Foot

In recovery room

Until discharge

LMWH (enoxaparin)

40 mg daily

12 hours pre-op

Until discharge

Allowed

Yes

NR

Warwick, 199853

290

Moderate

KQ 1

United Kingdom

THA

62.5%

68 (NR)

A-V Impulse System

Foot

In recovery room

7 days post-op

LMWH (enoxaparin)

40 mg daily

12 hours pre-op

7 days post-op

Allowed

Yes

NR

50
Effectiveness of IPCDs for VTE Prophylaxis in Evidence-based Synthesis Program

High-Risk Surgical and Medical Patients

Study Information

Author, year

Number randomized

Risk of bias

KQ(s)

Population

Country

Procedure

Sex (mean % men)

Age (mean [range])

Intervention (IPCD)

Device

Location

Initiation

Duration

Comparator

Name

Dosage or location

Initiation

Duration

Adjunctive Therapy*

ASA

GCS

Other

Windisch, 201154

80

Moderate

KQ 1

Germany

TKA

NR

68.9

A-V Impulse System

Foot

Immediately post-op

8 days post-op

LMWH (enoxaparin)

40 mg daily

24 hours pre-op

8 days post-op

Yes

NR

Intervention: Enoxaparin 

40 mg daily until 8 days 

post-op

Wood, 199751

136

High

KQs 3 and 4

United States

Spinal surgery

59%

39.5 (NR)

PlexiPulse

Foot

Intra-op or at surgery

Until discharge

Kendall SCD

Calf-thigh

Post-op

Until discharge

NR

Yes

No

*Adjunctive therapies (ASA, GCS, or Other) apply to both Intervention and Comparator groups unless otherwise noted.

Abbreviations: ASA=acetylsalicylic acid (aspirin); AV=arteriovenous; CECT=Continuous Enhanced Circulation Therapy; GCS=graduated compression 

stockings; IPCD=intermittent pneumatic compression device; IVC=inferior vena cava; KQ(s)=key question(s); LMWH=low molecular weight heparin; NR=not 

reported; PCD=pneumatic compression device; SC=subcutaneously; SCD=sequential compression device; S.F.T.=Synchronized Flow Technology; THA=total 

hip arthroplasty; TKA=total knee arthroplasty

51
Effectiveness of IPCDs for VTE Prophylaxis in

High-Risk Surgical and Medical Patients

Evidence-based Synthesis Program

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56
Effectiveness of IPCDs for VTE Prophylaxis in

High-Risk Surgical and Medical Patients 

Evidence-based Synthesis Program

APPENDIX E. TECHNICAL FEATURES OF NAMED DEVICES EVALUATED IN 

INCLUDED STUDIES 

Manufacturer Device Name Sleeve 

Location

Single vs

Multiple 

(Bladder 

Position)

Average 

Cycle 

Duration

Average 

Compression 

Duration

Pressure Pattern 

(Constant vs

Sequential) and 

Amount

Inflation 

Rise Time 

(Rapid vs

Slow)

Portable? Hour 

Meter?

Aircast VenaFlow® Calf* Multiple 60 sec 6 sec Sequential; 52 mm Hg 

(distal), 45 mm Hg 

(proximal)

Rapid No Yes

Huntleigh Flowtron® Calf* Single 60 sec 12 sec Constant; 30-60 mm 

Hg

Slow No† No

Jobst Anthrombic Pump 

(System 2500)‡

Calf§ Multiple 60 sec 7-8 sec Sequential; 30-50 mm 

Hg

Slow No No

NuTech PlexiPulse® Foot, 

foot-calf‖

Multiple Varies:

20-60 sec 

2.5 sec Constant; 160 mm Hg Rapid No Yes (1 

study)

No (2 

studies)

Kendall Kendall SCDTM Calf, calfthigh#Multiple Varies; 

20-60 sec

11 sec Sequential; 30-45 mm 

Hg

Slow No† No

Medical 

Compression 

Systems

ActiveCare DVT® or 

ActiveCare+S.F.T.®

CECTs

Calf* Multiple Varies; 

30-60 sec

10 sec Sequential; 

Average maximum 50 

mm Hg

Slow Yes Yes

WizAir DVTTM CECT Calf Multiple 60 sec 8 sec Sequential; average 

maximum 50 mm Hg

Slow Yes Yes

Novamedix A-V Impulse SystemTM Foot Single (sole 

of foot)

Varies: 

20-50 sec

3 sec Constant; 60-200 mm 

Hg

Rapid No Yes

*Sleeves also available for foot and calf-thigh locations.

†Device available in both portable and non-portable options; answer given here is for the specific devices evaluated in the included studies.

‡Specific information on this device was not provided in the published study included in our report, but rather by Huntleigh, the company that most recently 

bought out Jobst. 

§Sleeve also available for calf-thigh location.

‖Sleeve also available for calf location.

#Sleeve also available for foot location.

Abbreviations: CECT(s)=continuous enhanced circulation therapy device(s); DVT=deep vein thrombosis; SCD=sequential compression device; 

S.F.T.=Synchronized Flow Technology 

57