Departent of Health and Human Servces


OFFICE OF


INSPECTOR GENERA


PEER REVIEW ORGANIZATION (PRO)


CRITIERIA FOR


CAROTID ENDARTERECTOMY


AUGUST 199 OEI-t3-91-O150 
EXECUTIVE SUMMAR 

PUROS 

Ths report (1) compares Peer Review Organitions' (PRO) preprocedure review 

criteria for caotid endarterectomy and (2) exaes how these criteria afect denial 

rates. A companon report entitled ''Preprocdure Review Costs for Caotid 

Endarterectomy" (OEI-03-91-O152) determed that preprocedure review for carotid 

endarterectomy was not cost effectie. Ths additional analysis was conducted to determe if PRO criteria afected these outcomes and whether selected criteria would 

result in higher denial rates. 

BACKGROUN 

Surgeons perform caotid endarterectomy when the carotid arteries leading to the 

brai are blocked and blood flow becomes restrcted. The procedure involves 

disecting the neck below the ears, cuttig the caotid arteries open lengthwise, and removing the accumulted plaque. 

The Health Cae Financing Admtration (HCFA) required preprocedure review for 

al carotid endarterectomies covered by Medicae until October 1, 1991, when all requied preprocdure reviews were eliated. However, a PRO may request to 

continue preprocedure review if it ca prove it is cost effective and would improve 

quality of cae. 

Under preprocedure review, each PRO developed review criteria and diagnostic 

indicators for approvig caotid endaerectomy. Criteria are general standards on 

which PRO approval is based; diagnostic indicators are measurements or test results 

which substatiate the criteria. 

There is no national consensus on when carotid endarerectomy is appropriate. 

Ongoing National Institutes of Health studies are addressing this issue. 

MEODOLOY 

We analyzed all PROs' 1991 preprocedure review criteria for caotid endarerectomy. 

We compared criteria by State and identied the criteria which PROs used most 

frequently. We analyzd the number of PRO preprocedure requests and denials by 

State, and compared denial rates for carotid endarerectomy among the different 

criteria tyes. 

FIINGS 

Two-thids of PROs use three priary medical criteria to evaluate carotid 

endarterectomy: syptomatic stenosis, asptomatic stenosis, and stroke 

history. 
Diagnostic indicators used to substatiate medica criteria var from PRO to 

PRO. 

The relationship between PROs' criteria selection and denial rates is uncertai. 

Statistically, stroke hitory had an impact on denial rates. However, this impact 

should be viewed with caution since it is skewed by one State s high denial rate. 

PROs in eight States accunt for 79 percent of al denial. Yet, they share the 

same criteria and diagnostic indicators as PROs with no denial. 

Except for patients with severe syptomatic stenosis, the benefits of caotid 

endaerectomy are unclear. 

CONCLUSION 

Under preprocedure review, the PROs alowed caotid endaerectomy surgery for a wide range of diagnostic indicators. Diferences among PROs may have resulted from 

the lack of objectie medica data outlg when caotid endaerectomy was

beneficial. It is difcult to develop crteria for preventig unnecess surgery when 

there is no clear data on when surgery is necessary or beneficial. 

When creatig criteria for surgica procedures where there is little objective medica 

data PROs have two choices. They ca alow surgery for a greater range of 

diagnostic criteria where the benefits from the surgery have yet to be proven. Or they 

ca deny surgery for al but a very select subset of crteria. 

However, there is no perfect choice. Under the fist option, there may be certai 

patients who have surgery that future research proves is unnecess and ineffective. 

The second option may exclude patients from havig surgery that is later found to be 

effective for their paricular circumstances.


When reviewig the PROs' criteria in light of the new research on caotid 

endarterectomy, most PROs seem to have selected crteria that would fall under the 

fist option. As of this time, research has proven caotid endaerectomy beneficial 

onl for patients with severe stenosis (70 percent or more). For th paricular crterion, the majority of PROs alowed surgery when there was stenosis of 50 percent 

or more. 

The PROs' caotid endaerectomy criteria did not have a clear effect on denial rates. Th conclusion provides further support for HCF A' s decision to eliate the 

preprocedure review requirement for carotid endarterectomies. 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ................. . . . . . . . . . . . . . .. . . . . . . . . . .. . . . . . . . . .. 

TABLE OF CONTENTS


EX S'y .......................................... i


INODUCfON 

FIINGS


Medca Cr1:ri . . . . . . . . . . . . . . . 6


DigI()tic Indicators .............................................. 6


Crteri and Deni Rat: .......................................... 8


Stat: with IIer Deni Rate .. 12


Benefits of Surery 

CONCLUSION 

APPENIX A: Deption of PRO Prprocure Revew Proc .......... AAPPENIX B: PRO Prprocure Reqests and Deni 

APPENIX C: Matr and Syop of State Crteri . . . . . . . . . . . . . . . . . . .. CB-1 
INTRODUCTION


PUROSE 

Ths report (1) compares Peer Review Organitions' (PRO) preprocedure review 

criteria for caotid endarterectomy and (2) examies how these criteria affect denial 

rates. A companion report entitled ''Preprocedure Review Costs for Carotid 

Endarterectomy" (OEI-03-91-00152) determed that preprocedure review for carotid 

endarterectomy was not cost effective. This additional analysis was conducted to 

determne if PRO criteria affected these outcomes and whether selected criteria would 

result in higher denial rates. 

BACKGROUN 

Cati Ar Occlun: Causes Riks an Treatm 

As shown in Ilustration I, two internal carotid arteries provide the brain's primary blood supply. Individuals often experience atherosclerosis of these arteries as they 

age. Atherosclerosis is the accumulation of plaque or lesions inside the arterial walls. 

Ilustration 1: Carotid Areries 

Internal carotid artery


Carotid bifurcation 

Right commn artery eft comn carotid artery 
. . , _. ?/.

:., \: ::;: /:.:?(. :: ::: . .,. , 

Atherosclerosis causes the caotid areries to narow in siz; thi narowng restrict 

blood flow to the brain producing potenti health riks (se Ilustrtion II). Individual usually can tolerate grdua oclusion or blockae of one caotid artery. However, serious occlusion of one or both areries ca caus masive strokes or traient ischemic attacks (TI). Tranient ishemic attacks are llmi-strokes . caused 

by a temporar decrease in the brai's bloo supply. 

Ilustration II: Constrcted Arety


Resultin from Atherosclerosis


Normal 

artery Constricted diameter 

artery 

diameter 

3; ' 

Artery Plaque Lumen


wall (clear space)
 lesions


Occlusion of the caotid areries ca be treated surgicay or non-surgicay. Caotid endaerectomy is the preferred surgica procdure. It involves disectg the neck 

below the ear cuttg the caotid areries open lengtwi, and removg the 

accmulated plaque. The procdure enta considerable riks and side effects. 

However, neurosurgeons and vascular surgeons clai high rates of success in restorig blood flow. 

The most common non-surgical treatment is anti-platelet medication, usually aspir. Clca studies show an aspirn every day reduces the rik of stroke. Other drug 

treatments are now being evaluated. 
In recent year, the frequency of caotid endaerectomy has not increased due to 

medica appropriateness questions surroundig the procedure. Concerns include the 

quacations of physician performg the surgery, surgica settings, post-surgica 

neurologica deficits, and high mortty rates. 

PRO Pr Rev 

In each State, HCFA contract with a Utiltion and Quaty Control Peer Review 

Organtion, commonly known as a PRO, to review the appropriateness and qualty 

of surgery performed on Medcae beneficiares. 

Prior to October 1991, HCF A required PRO preprocedure review for al carotid 

endarerectomies covered by Medicae. On October 1, 1991, HCF A eliated al 1 However, a PRO may request . requied preprocedure review.
 to contiue

preprocedure review if it ca prove it is cost effective and would improve qualty of 

cae. At th time, HCFA has not given approval for any PRO to perform preprocedure review for caotid endarterectomy. Pr Re Cr Il Dign IndCion 

Under preprocedure review, each PRO developed review criteria and diagnostic 

indicators for approvig caotid endaerectomy. Criteria are general stadards on 

which PRO approval is based; diagnostic indicators are measurements or test results 

which substatiate the criteri. 

Typically, PROs had commttees which developed criteria and diagnostic indicators in 

consultation with State medica asociations and a variety of individuals. In large 

States, specialty societies, such as vascular surgeons or neurosurgeons, were involved. 

In smaler States, the commttees solicited individual physician opinons. 

The PROs submitted the criteria and indicators to the HCF A regional offce, which 

reviewed and approved them before they could be implemented. Once HCF A 

approved the criteria, the PROs were requied to share them with providers. 

A description of the PRO preprocedure review process is in Appendix 

1 HCFA, Directed Change Order (DCC 91-13): Cesstion of Preadmision! 

Preprocedure Review. The HCFA does alow preprocedure review for approved 

objectives, interventions under the quality intervention plan and asistats at cataract 

surgery. 
Rean Stu 

The National Intitutes of Health (NIH) is supportg two large, multi-intitutional 

randomied tral. Both the Asymptomatic Caotid Atherosclerosis Study (ACAS) and 

the North America Symptomatic Caotid Endaerectomy Trial (NASCET) 

Collaborators examie the effectiveness of caotid endaerectomy in reducing arterial occlusion and preventing strokes.2 Effectieness of caotid endarerectomy is also 

being examed in the European Caotid Surgery Trial. 

In Februry 1991, the NI isued a Clca Alert detag the benefits of caotid 

endaerectomy for cert indidua. The Agency for Heath Cae Policy and Research with the Deparent of Health and Human Servces has alo issued 

report reviewig recent medica literature concerng caotid endarerectomy. 

MEODOLOY 

Da Coll 

We obtaied the PROs' prospective review criteria from HCFA We confed and 

updated the criteria with 47 PRO offcial representing al 50 States, the District of 

Columbia, Puerto Rico, and the Virgi Islands durig March 1991. In this report we refer to these 53 jursdictions as States. 

From the PROs we requested numerica data and a description of their review 

procedures. The data requested for caotid endaerectomies included the number of 

preprocedure requests and denial. We asked States to provide us with caenda 

year 199 data. However, some States supplied data from the Thd Scope of Work for contract year 199. Ths inormation is presented in Appendi B. 

North American Symptomatic Caotid Endaerectomy Trial Collaborators, 

Beneficial Effect of Caotid Endarerectomy in Symptomatic Patients with HighGrade Caotid Stenosis New England Journal of Medicine 1991;325:445-453. 

'MC European Caotid Surgery Trial: Interi Results for Symptomatic Patients with Severe (70-99 percent) or with Mild (0-29 percent) Caotid Stenosis (UK Medical 

Research Council), Lancet. June 25, 1991; 337(8752):1235-1243. 

S. Deparent of Health and Human Servces, Public Health Servce, Agency for Health Cae Policy and Research, Offce of Health Technology Asessment, 

Carotid Endarterectomy (revised1 AHCPR Health Technology Assessment Reports 

July 1991, Number SR. 

The PROs report that fial denial data could change as some denials were 

subject to reconsideration appeals. 
Da 

We analyzed al PRO criteria for caotid endarerectomy. We then identied the 

crteria which PROs used most frequently. Basd upon advce from our health care 

consultant, we narowed thi selection to three priar medca crteria. We clasifed 

inormation with the three criteria based on sim medica defitions. The PROs 

do not always use simar term to descrbe medica criteria. Therefore, we sometimes 

use one partcul term which is representative of the PROs' varous termologies. 

We categorid each PRO by the tyes of priar crteria it usd. The PROs fell into 

four categories dependig on the combination of the three crteria they used. To determe if PRO crteria afected denial we caculated the number of denials for 

each of the four categories. We then compared denial numbers and rates among the 

four groups. To test for dierences between the groups, we used a liear logitic 

analysis of categorical data. Each category of criteria was entered into the model and 

the signcace of the estiated coeffcients determed using Wald chi square 

statistics. 

Consultat servces were secured under contract from the Vilanova Uniersity College 

of Nursing. 

W. Hosmer and S. Lemeshow Applied Logistic Regression (New York: 

John Wiley and Sons, Inc., 1989). 
FINDINGS 

TWO-TI OF PROs USE 1H PRIY MEICA CR 

EVALUATE CAOT ENARTEMY. 

Six-six percent of the States (35 of 53) had PRO criteria which contaed all three 

priar medica criteria. The remaig 18 States did not have al three criteria but 

varous combinations of the medical crteria. The crteri were syptomatic stenosis, 

asptomatic stenosis and stroke hitory. Several States alo us criteria other than 

the three priar crteria. 

Symptomatic stenosis is a constrction of the caotid arery tht results in physica 

syptoms such as TI. Asptomatic stenosis is a constrcton of the caotid arery 

resulting in no outward syptoms. A patient's previous stroke experiences comprie 

the stroke hitory criterion. A matri and syopsis of indidua State criteria is 

presented in Appendi C. 

DIAGNOSC INICATORS USE TO SUBANTE MEICA 

VARY FROM PRO TO PRO. 

Even when States had the sae medica crteria, the diagnostic indicators they 

required to substatiate the criteria difered. 

Syto11 Ste 

Every State used syptomatic stenosis as a criterion for approvig carotid 

endaerectomy. The PROs' criteria generaly included (1) patient syptoms and (2) 

demonstrated stenosis. Accptable syptoms always included TI. Th-six States 

specifcally mentioned thi term. The other 17 States used more general defitions 

such as indicatig a patient must demonstrate cerebrovaular insuffciency syptoms. A common manestation of such inufcient circuation is a TI Some States also 

accpted other neurologica conditions as syptoms warrting consideration of 

caotid endarerectomy. 

States diered in their diagnostic indicators for syptomatic stenosis. Fort-three 

States used percentages which measured the amount of obstrction in the carotid 

arery as diagnostic indicators. Ten States did not specif stenosis percentages. These 

10 States general requied diagnostic test fidigs that confed an atherosclerotic 

lesion. 

For the 43 States using percentages, the percentage of stenosis required for surgery 

ranged from 50 to 95 percent. These States used 60 percentage indicators for 

syptomatic stenosis. Several States used more than one percentage indicator based 
on the severity of specifc physica syptoms. The lowest percentage accepted by each 

State is presented in the graph below. 

Variance in PROs' Lowest Acceptable Stenosis Percentages 

Symptomatic 

EB Aaymptomatlo 

r 20


30.. 50., 60., 70., 75., 80., 

Lowest Percentage Accepted for Approval 

43 States Use Symptomatic Percentage.


46 State. U.e "symptomatic Percentage.


pto11 Ste 

Diagnostic indicators for asptomatic stenosis vared widely. Fort-six States 

addressed asptomatic stenosis as a criterion. However, there was little commonalty 

among the diagnostic indicators. 

The 46 States had a tota of 109 diagnostic indicators for asptomatic stenosis. We 

found PROs representing 33 States used multiple indicators for thi term. For 

exaple, in Miesota, approval for asptomatic caotid endarterectomy required: 

80% stenosis, or greater than 70% stenosis with ulcerated plaque 

indicated by arteriogram or digita subtraction angiography (DSA), or 

less severe stenosis demonstrated by arteriogram or DSA with one of the 

followig: evidence of "silent-inarcts II on brai-afected side indicated by 

cr or MRI or cholesterol emboli to the eye. 
Of the 109 diagnostic indicators for asptomatic stenosis 83 included stenosis 

percentages representing the amount of caotid arery narowing. The lowest 

percentage accpted by each State is presented in the graph on the previous page. 

Some States used more than one percentage indicator, depending on other medical 

evidence. The 83 stenosis percentages vared from 30 to 90 percent. Most defitions 

(65 of 83) requied 70 to 90 percent stenosis, unless an ulcerative lesion was present. 

Strke His 

Diagnostic indicators for prevous stroke were often loosely defied or not addressed. Th-nie States addressd stroke hitory. Their diagnostic indicators for previous 

stroke fell into five general categories. 

Sixeen States requied a stroke patient to have signcat improvement but did 

not defie duration of the stroke.


Eleven States required a patient's stroke to last over one week with signcat improvement or recovery of neurologica function. 

Six States accepted strokes without further quacations. 

Five States defied strokes with multiple qualers (e.g., stroke in evolution and 

acute stoke). 

One State required strokes to have occurred withi a certain period of time 

before the review.


1H RETIONSH BET PROs' CR SE0N AN DEN 

RATE IS UNCETAI. 

Based on the tyes of priar crteria used, the PROs fell into four categories. The 

categories were: all thee priar criteria (syptomatic stenosis, asptomatic stenosis, and stroke history); syptomatic stenosis and asptomatic stenosis; 

syptomatic stenosis and stroke history; and only symptomatic stenosis. The PROs 

denied 90 caotid endaerectomies out of 53 528 preprocdure requests in 1990 

resulting in a national denial rate of 0.17 percent. Each of the four categories had a

dierent denial rate but al were under 1 percent, as shown in the table on the next 

page. 

The two PRO categories without stroke history had denial rates of 0.44 and 0. 

percent. Statisticay, the two categories have signcatly higher denial rates than 

those which included stroke hitory. Therefore, the decision to include or not include 

stroke history as a criteria seemed to impact a PRO's denial rates. However, the 

denials for one of the categories without stroke history cae from only one State 

(AZ). Th skewig of the data indicates that the effect of including stroke history in 

PRO criteria should be interpreted with caution. 
..:::

. ..... ... ... .... ......,....... .. ...::.., ..... .. ,,,,,.... ..... ... .... . ...... . :::..:::::::::: :.:.::::::..:..:. ...... ,. :///::: ..................................,. .... ... ........................, . ,...... ...., ..... .::::: ..... .... ... ....... ::.::::::::.:.:::::. :/::\..... . ::.:.:: . .... . .. ........................ ..... . ....... .. .. . ................. ::):::..

Denial Rates for the Four Criteria Categories 

. n. ..", _dr .Pf. I'.:. .SteoosIS\/?: t)):" oel8///? :neni8:(((. 

41, 

152 

::m:: 

The remaig two categories had denial rates relatiely close to the national average. 

States with al thee criteria had an average denial rate of 0. 11 percent and States with 

syptomatic stenosis and asyptomatic stenosis crteria had a denial rate of 0. 

percent. 

StI wi Sytoml Ste Astoml Ste an Strke IrlSry 

The 35 States using al 3 priary PRO criteria denied 47 of 41 633 requests. 

However, the majority of denial (34) were reported in just 6 States. Nearly hal the 

States (17 of 35) did not report any denial at 

As shown in the followig table, these 35 States had a collective denial rate of 0. 

percent (47 of 41,633) compared to the national average of 0.17 percent. The 47 

denials represented 52.2 percent (47 of 90) of all denial. 

Denial Rates for States with Symptomatic Stenosis, Asymptomatic Stenosis 

and Stroke History Criteria 

n.... . o.


\:::.:N8if6f' iSstM/Y'::'::' NO!f6f.:rmHiBi:/ :. ,n:.::, i.. hfb ri9d"': 

Alabama 1074 Not Available Not Available 

Alaska 

Arkansa 801 

Califomta 

Colorado 

Florida 

Geor la 291 

Idaho 133 

Kansas 132 

Maine 231 

Ma land 870 
..... ... ,.. .. .. .......... .... ,..........,.. ......:?)) . ................, . ,............. ....... . . ...... ...... . ... ............ \//

......... ...... .. ... ... ,......................... . . ........... . , ... ... .: . .. ..... ,.......... ........ . , ,... :::::::::p .. ,......... . . ... . ...

NoJdr. oeid: NO/d. 1818:'( ffijrt' Dijl 

Maschuse 762 

Michl an 

Minnesa 

Misslssi I 

Montana 161


New Je 139


New York 160


North Carolina 130


North Dakota 127


Ohio


Oklahoma


261 

Puerto Rico


South Caolina


South Dakota 164


Tenness 165


Texas


Vermont


1138


Wisconsin


Tbt i:2'35' StM 

Sta wi Sytoma Ste an Aqtoma Ste 

Eleven States had criteria that addressed syptomatic stenosis and asptomatic stenosis. Th group denied 31 of 7,005 requests. However, the denial rate in the 

States was afected by just 1 State, Arona, which reported al 31 denial. At 5. 

percent, Arona had the highest denial rate of all States. As shown below, Arona denial rate was more than 30 times the national average of 0. 17 percent. 

Denial Rates for States with Symptomatic and Asymptomatic Stenosis Criteria 

'::NaJ8fR':::::: ues/i j(NoHibeniai/) /\Percrtb&1i&f


Ariona 542


Connecicut


Delaware 130

:::::::)))

....................... ................. ... . . .. .............,.................. ,......,..,........... ... .....,,....................... . .................... ... .,... ..... ... ........ .......,................. ..,........................... . .... ... ................... ..................... .. )?).......... .:... . ..... .. .... . ...... ... . . .. . ............ ... ....... .. ............. .... ..... .............. ................ ................... .......... .... . ... ............... .... ............. ..... .. ............. ........... .............. ......./:::....... ..... ... ............................. ))).... .. /.... ....... . .... ... ............................... . ........ .. ......... . , ................. .. ,..............,...,..,.. ..,... .................... ,, .............. . .. . ... .......... .. .. .... .............. ........................................................ .. . ..................... ...... ....... ................. ........ ... .. .... ..... ............................. . . . ..... .. ......................... ..... ................. .. ..... .. . ........ . ....... ............. ... . ... ....

?,N()Bfff. esriF \iN6?bfDihiii:.'... n.... r.".p tditdjiH 

HawaII 102 

illinois 

Indiana 150 

Kentuc 

Nevada 

New Mexico 127 

674 ..... ..... n... 

::tr6tal(::::::t1 ittttt\tf1mrtmHrrf:: 

Sil wi Syto Ste an Str Hisry 

Four States with criteria addressing syptomatic stenosis and stroke history denied 4 

of 3,367 requests. The 4 denials represented 4.4 percent of all denials (4 of 90). 

Collectively, these States' denial rate of 0. 12 percent (6 of 3 422) was comparable to 

the national average of 0. 17 percent. 

Denial Rates for States wit Symptomatic Stenosis and Stroke History Criteria 

)m):.:)Statit?t::t.:tt.:::.)::?::.... ///N8HSfFf..OBtt')(:\ N8i6f'bii8''' :tttt'pircenFbenkKi'm?t:\):tt 

Louisiana 135 

Missuri 166 

New Ham hire 137 

Utah 214 

ff& F;;.4StMmr 

Sil wi Sypto11 Ste Crn On 

The three States with criterion addressing only syptomatic stenosis denied eight 

requests or 8.9 percent of all denials. Whe these three States had a collective denial 

rate of 0.53 percent (8 of 1 523), six of the eight reported denials occurred in one 

State (Iowa). 

Denial Rates for States wit Symptomatic Stenosis Criterion Only 

N6fbfi=f.. .N6J' 6fDenlahf. ':/(PercentDerl9a9 

Iowa 

Nebraka 

Rhode Island 130 

"TOtaV.' Sime.. 
PROs IN mGm STATE AaDUN FOR 79 PERCE OF AI DEN TI SH TH SA CR AN DIAGNOSC INICATORS 

AS PROs WI NO DEN 

The PROs in eight States reported more th thee-quars of al caotid 

endarterectomy denial in 199 (71 of 90). The caus of the higher denial rates in 

these eight States was not due to any parcular combintion of crteria or diagnostic indicators. In fact, other States with exactly the same crteri and diagnostic indicators 

as some of these eight States had much lower denial rates. 

These eight States had varous caotid endaerectomy crteria and diagnostic 

indicators. In six States (CA, CO, MI OR, TN, and VA), PROs addressed al three 

national medica crteria. The Arna PRO criteria addressd syptomatic and

asptomatic stenosis. The Iowa PRO criteria address onl syptomatic stenosis. 

Each of the eight States had four or more denial for caotid endarerectomy durig 

199. The 71 denial (out of 14,711 requests) resulted in a denial rate of 0.48 percent, 

alost 3 times the national average of 0.17 percent. These States, however, accunted 

for only 27.5 percent of al preprocedure requests. 

EXl.H1 FO PATI WI SEVE SYMATIC STOSIS 

EN.tTl OF CAOT ENARTEMY AR UNCL 

Two recent studies have concluded that caotid endaerectomy is beneficial for 

syptomatic patients with severe or high-grade stenosis (70 percent or more) of the internal caotid artery. However, no signcat boy of medica inormation shows 

that carotid endarerectomy is effective for lower-grade syptomatic stenosis or for 

asptomatic stenosis. 

Severe syptomatic stenosis is the one criterion where medical consensus exists. 

The Nort America Symptomatic Caotid Endaerectomy Trial Collaborators 

concluded that caotid endaerectomy is highy beneficial for patients with TI 

non-disablig strokes who have high-grade stenosis. The European Caotid Surgery Trial alo found that caotid endarerectomy was useful in treatig stoke patients with 

severe caotid stenosis. 

The benefits of caotid endaerectomy are not as clear for mid (0-29 percent) to 

moderate (30-9 percent) syptomatic stenosis or for asptomatic stenosis. 

However, the European trial found that for mid stenosis the results indicated that the 

riks of surgery outweigh the benefits. 

Among the 43 PROs who specifed syptomatic stenosis percentages, 2 States' lowest 

accptable percentage for surgery was 75 percent and for another 4 States it was 80 

percent. However, the majority of States allowed carotid endarterectomy for 50 

percent or greater syptomatic stenosis. 
CONCLUSION


Under preprocdure review, the PROs allowed caotid endarterectomy surgery for a 

wide range of diagnostic indicators. Diferences among PROs may have resulted from 

the lack of objective medica data outlinig when caotid endarterectomy was 

beneficial. It is dicult to develop criteria for preventing unecessary surgery when 

there is no clear data on when surgery is necessa or beneficial. 

When creating criteria for surgical procedures where there is little objective medical 

data, PROs have two choices. They ca alow surgery for a greater range of 

diagnostic crteria where the benefits from the surgery have yet to be proven. Or they 

ca deny surgery for all but a very select subset of criteria. 

However, there is no perfect choice. Under the fit option, there may be certai 

patients who have surgery that future research proves is unnecessary and ineffective. 

The second option may exclude patients from havig surgery that is later found to be 

effective for their particular circumstances. 

When reviewig the PROs' criteria in light of the new research on caotid 

endarterectomy, most PROs seem to have selected criteria that fal under the fist 

option. As of this time, research has proven caotid endarterectomy beneficial only 

for patients with severe stenosis (70 percent or more). For this particular criterion 

the majority of PROs allowed surgery when there was stenosis of 50 percent or more. 

The PROs' caotid endarterectomy criteria did not have a clear effect on denial rates. 

Ths conclusion provides further support for HCF A's decision to eliate the 

preprocedure review requirement for caotid endarterectomies. 
APPENDIX A


DESON OF PRO PREROCUR RE PROC 

The review procss does not vary signcatly among PROs. Physician usuay intiate 

the review procss prior to performg a caotid endaerectomy. However, the liethreatening nature of a stroke sometimes requies retrospective approva. 

Re for 

Typicay, the recommending surgeon, a sta member, or hospita sta telephones the 

PRO to review the patient s condition aI1d seek preprocedure approval. Most PROs 

also accept mai requests and a few accpt them via facsime machie. 

Ini Re by Re Nun 

Regitered nurses (RNs) review the intial preprocedure request, comparg the 

physician s diagnosis and the patient' s syptoms agait the PRO criteria for caotid 

endaerectomy. The RNs ca approve the request based on the inormation the 

physician (or physician s representative) provides. If the request does not meet the 

criteria, the RN refers the cae to the PRO physician advior for review. 

PRO Physi 

The PRO physician conducts a second review of the requests which have not met the 

criteria, often contacting the recommending surgeon to discuss the cae further. Afer 

the review, the PRO physician approves or denies the procdure. 

When a PRO approves a preprocdure request, it asigns the cae an approval 

number. When the PRO denies a request altogether, it tyically inorm both the 

surgeon and the patient of the decision, the rationale, and an explanation of appeal 

rights. 
... ...... :;

.. .. .. .........

APPENDIX 

1990 PRO PREPROCEDURE REQUESTS AND DENIAS


FOR CAOTID ENDARTERECTOMY


BY STATE


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ARZONA ARSA CAORNIA 5,

542

801

043 COLORA CONNECTCur DELAWAR 130 

ncFLORIDA 3,869

HAWAII GEORGIA 2,941

102 

nMO 

nuNO 2,no 

KECKY IOWA KASAS 1,

INDIAA 1,

726

325

504 

LOUISIAA 1,356 MAYLD MANE

870 MASACHUSETTS 762 

MISSOUR 1,

MINESOTA MISSISSIPPI 

MICHIGA 2,598

364

658 

NEBRAKA NEVADA 

MONTANA 161

667 

NEW HAPSHIR 137 

NEW MEXCO NEW JERSEY 1, 

127

390 

NEW YORK 1, 

NORTH CAOUNA 1,304 NORTH DAKOTA 127 

OKLOMA OHIO 2,922

552 

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:lj::f. i)fU HtpE\/ OREGON 786


PENNSYVANIA 2,6S1


PUERTO RICO


RHODE ISLAD 130


SOUTH CAOUNA 460


SOUTH DAKOTA 164


TENNESSEE 6S3


639


UTAH 214


VERMONT


VIRGINIA 943


VIRGIN ISLADS


WASHINGTON 138


WEST VIRGINIA 674


WISCONSIN 935


WYOMING


NADONA TOAL 53,528


AU data is diectly from PRO ins condte dug th inctn. Some PROs were able to provi da for cal year 199 as req oth choe to provi da for th Thir Scope of Work contract 

year 1990. 

. We use th degn n/a to inat tht data was not availe at th tie of OUT inter. 
::::::::::::::::::::::::::::::.:.:::://::: ......, :::::::. ,\::: (::::... ::, .... ....

APPENDIX 


MATRI OF STATE CRIRI FOR CAOTID ENDARTERECTOMY 

MA71q::::::) 

. n.. 

::(i ?J. ()Kl1)\ AL 

ALSKA . 

ARZONA 

ARSAS. 

CAFORNIA . 

COLORA. 

CONNECTICUT 

DELAWAR 

FLORIDA. 

GEORGIA . 

HAWAII 

IDAHO. 

ILLINOIS 

INDIAA 

IOWA 

KASAS. 

KENTCKY 

LOUISIAA 

MANE. 

MAYLD. 

MASACHUSETTS. 

MICHIGAN. 

MINNESOTA. 

MISSISSIPPI. 

MISSOUR 

MONTANA. 

NEBRASKA 

NEVADA 

NEW HAPSHIR 

NEW JERSEY


NEW MEXCO 

NEW YORK. 

NORTH CAOLINA.


NORrH DAKOTA. 

OHIO. 

OKLOMA . 

OREGON. 

PENNSYVANIA . 

PUERTO RICO.


C - 1

.. \::. ......

STT.H \SY77C\) :?JUMA77C( ?($TOKE: 

RHODE ISLAD 

SOUT CAOLINASOUT DAKOTATENESSEETESUTAH 

VERMONTVIRGINIA 

VIRGIN ISLADS 

WASHINGTONWEST VIRGINIA 

WISCONSINWYOMINGTOAL 

* INCLUDES ALL THREE CRIRI 

C - 2 
SYNOPSIS OF STATE CR FOR CAOT ENARTEMY 

AlIl 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have latera1d tranient neurological 

dysfuction involvig speech, reason, motor, or sensory function, stroke, or drop 

attacks (vertebral-basilar ishemia). And: 

Imagig: Angiography must demonstrate stenosis 70%, stenosis 60% with 

ulceration, deep ulceration related to TI or complete uniateral occlusion 

with stenosis 
 50% on the other side. 

ASYMOMATIC STENOSIS: The patient must have (1) a brut, ultrasonic stenosis 70%, and angiographic stenosis 
 70%; or (2) complete unilateral occlusion with stenosis 50% on the other side. 

STROKE: Stroke is defied as a recent stroke with goo to excellent recovery of
 fuction.


OTHR: Caotid-subclavian shunt warants carotid endarerectomy.


AIa* IdD d: Wasgtn


SYNTOMATIC STENOS 

Symptoms: Patient must have at least one TI amaurosis fugax stroke, or 

cholesterol emboli in the retinal arery. And: 

Imagig: Imagig must be positive for either an ulcerated plaque or 50% 

stenosis on the afected side. 

ASYMOMATIC STENOSIS: Noninvasive study, arteriograph, or digital subtraction angiography must demonstrated 
 80% stenosis or an ulcerated plaque. 

STROKE: Stroke (CVA) is not defined. 

OTHR: None. 

C - 3

&: 

Arna Hawai Nevad 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have amaurosis fugax tinglg libs of face 

(paresthesia), paresis (or paralysis), diess, diplopia (double vision), or 

vertigo. And: 

Imagig: Angiography must demonstrate 50% unateral stenosis of the common or internal caotid, 
 50% bilateral stenosis internal caotid occlusion 

asocated with 
 50% contralateral stenosis or an ulcerated plaque. 

ASYMOMATIC STENOSIS: Angiography must demonstrate 70% uniateral 

internal or common caotid stenosis, 50% stenosis in the presence of a contralateral 

internal or common caotid, or a total occlusion. 

STROKE: Not addressed. 

OTHR: None. 

SYMTOMATIC STENOSIS: 

Symptoms: The patient must have clasica TI with hemiparesis 

hemianesthesia, or dysphagia lastig c: 24 hours; amaurosis fugax (transient 

monocular blidness); unilateral deficits such as hemiparesis of hemianesthesia 

lastig 24 hours to 7 days; or stroke. And: 

Imagig: Angiography must conf 50% diameter reduction. 

ASYMOMATIC STENOSIS: Areriogram must show 80% diameter reduction. 

STROKE: Stroke is defied as lasting over one week with signifcant recovery of 

neurologica fuction.


OTHR: None. 

Clomi 

SYMTOMATIC STENOSIS: 

Symptoms: The patient must have clasical TI (with hemiparesis 

hemianesthesia, or dysphasia lasting c: 24 hours), amaurosis fugax (monocular 

blidness lasting 10 minutes), unilateral neurological deficits (such as 

C - 4 
hemiparesis, hemianesthesia, or monocul blidness) lasting 24 hours to 

several days (reversible ischemic neurological deficit or RIN), or stroke. And: 

Imagig: Angiography or DSA must demonstrate stenosis of 80% or carotid 

lesion with ulceration, or CAT sca or MRI must demonstrate silent inarction 

with stenosis of 80% or caotid lesion with ulceration. 

ASYMOMATIC STENOSIS: Angiography showig 80% stenosis referred for PA 

review. 

STROKE: Stroke is defied as a stroke lastig over one week with complete or 

nearly complete recovery of fuction. 

OTHR: Asptomatic caes in special HCFA study are automaticay approved for 

specifed practitioners and providers. 

Colo 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have one of the followig: tranient monocular 

blidness (amaurosis fugax) with ipsilatera stenosis or plaque with ulceration; TI involvg the anterior circulation with face, arm, hand, or leg numbness or weakess, aphasia, , or dysphasia for .c 24- hours traceable to the 

appropriate caotid; or recent CV A. Additionally, the medical record must 

document the neurologica deficit. And: 

Imagig: Areriogram or DSA must show a hemodynamcay signcat lesion

defied as at least 60% diameter stenosis 84% cross sectional area stenosis, or 

ulceration. Hemispheric symptoms alo require a cr scan or MRI. 

ASYMOMATIC STENOSIS: The patient must have a hemodynamcally signcat lesion, defied as at least 60% diameter stenosis 84% cross sectional area stenosis, or 

asptomatic severe, deep ulcerative plaque. 

STROKE: Stroke is defied as a recent CV A traceable to the extacranial carotid 

source where the patient made a with functional recovery, but would benefit from 

protection agaist a recurrent event in the ditn"bution of the stroke arery. It also 

includes stroke in progress or acute stroke with 6 hours followig carotid 

endarterectomy or neck trauma. 

OTHR: None. 

C - 5

Coti


SYMOMATIC STENOSIS: 

Symptoms: The patient must have a foc or neurological deficit (transient or 

permanent) compatible with a caotid lesion. Brai imagig must not reveal a 

lesion that could explai the clica fidigs. And: 

Imagig: Angiography must demonstrate 60% liear stenosis of the internal 

caotid arery, or signcat ulceration of the internal caotid arery with 

symptoms of cerebrovascular inuffciency compatible with the afected side 

whie on antiplatelet drgs. 

ASYMOMATIC STENOSIS: Angiography must demonstrate 90% stenosis of


internal carotid artery in the asymptomatic patient.


STROKE: None.


OTHR: None.


Dear d: Yug 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have cerebrovascular insuffciency symptoms. 

And: 

Imagig: Angiography must demonstrate 50% unilateral stenosis of the 

common or internal carotid, 50% bilateral stenosis, internal carotid occlusion 

with 50% contralateral stenosis, or an ulcerated atheromatous plaque. 

ASYMOMATIC STENOSIS: Angiography must demonstrate 80% uniateral 

internal or common carotid stenosis 50% stenosis in the presence of a contralateral 

internal or common carotid, or tota occlusion. 

STROKE: None.


OTHR: None.


Dit of Coluia d: Marla


SYMOMATIC STENOSIS:


Symptoms: The patient must have TI amaurosis fugax previous 

atherothrombotic stroke, stroke-in-evolution, crescendo TI, or recurrent 

C - 6 
global or non-specifc syptoms whie on antiplatelet or anticoagulant therapy. 

And: 

Imagig: For TI or amaurosis fugax angiography or duplex imagig must

fid ;: 50% diameter ipsilateral common or internal caotid arery stenosis. Or 

angiography must fid a large ulcerative lesion in the ipsilatera common or 

internal caotid artery. Or for repeated TI, angiogrphy must fid an 

ocluded ipsilateral internal caotid arery and ;: 50% diameter ipsilateral 

external caotid arery stenosis. Or for persistent focl TI despite 

anticoagut or antiplatelet therapy, angiography must fid c: 50% common or 

internal caotid arery stenosis, or a smal ulcerative lesion in the ipsilateral 

common or internal caotid arery. 

For previous atherothrombotic stroke, angiography or duplex imagig must fid 

;: 50% diameter ipsilateral common or internal caotid arery stenosis. Or 

angiography must fid a large ulcerative lesion in the ipsilateral common or 

internal caotid arery. On rare occions it would be appropriate to perform a 

caotid endaerectomy in a patient with an acute stroke if the operation is 

performed shortly after the stroke and angiography or duplex imagig fids :: 

70% diameter ipsilateral common or internal caotid artery stenosis. 

For stoke in evolution, angiography or duplex imagig must fid ;: 70% 

diaeter ipsilateral common or internal caotid arery stenosis. Or angiography 

must fid ;: 50% diameter common or internal caotid artery stenosis and a 

large multicentric ulcerative lesion in the ipsilateral common or internal caotid 

arery. 

For crescendo TI, angiography or duplex imagig must fid ;: 50% diameter 

common or internal caotid arery stenosis, or c: 50% diameter common or 

internal caotid arery stenosis on the side appropriate to the syptoms with :: 50% diameter common or internal caotid arery stenosis on the opposite side. 

Or angiography must fid a large ulcerative lesion in the ipsilateral common or 

internal caotid artery. 

For recurent global or nonspecifc syptoms whie on antiplatelet or 

anticoaguant therapy, angiography must fid ;: 50% diameter common or 

internal carotid artery stenosis, or a large ulcerative lesion in the common or 

internal caotid artery. 

ASYMOMATIC STENOSIS: Angiography or duplex imagig must fid :: 70% 

common or internal caotid artery stenosis. Or OPG-Gee must be positive for :: 50% 

diameter common or internal caotid artery stenosis. Or angiography must fid a 

large multicentric ulcerative lesion in the common or internal carotid artery. 

STROKE: Stroke includes a patient who has suffered an atherothrombotic stroke. 

The patient should not have an incapacitating or profound neurologic deficit but 

C ­

rather is a fuctional adult lig withi the communty. The neurologic symptoms 

should have fuy stabild. 

OTHR: None. 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have hemipheric and/or monocular TI with an 

appropriate lesion of the caotid bifcation, stroke, or global (die nonfoc) ischemic syptoms with multiple arerial oclusive lesions includig 

high grade stenosis of the internal caotid areries. And: 

Imagig: Nonivasive studies (duplex scag or other forms of ultrasonic 

imagig) or areriography must demonstrated either 50% carotid stenosis or a 

nonstenotic ulcerative plaque believed to be the source of cerebral emboli 

causing the patient' s syptoms. 

ASYMOMATIC STENOSIS: The patient must have 75-80% caotid stenosis or 

large caotid ulceration (complex multiple ulcerations) in selected better risk patients. 

STROKE: Stroke is defied as a hemipheric completed stroke with good recovery (mial to modest neurologica deficit). Stroke-in-evolution or waxg-and-wag deficit in the presence of an untable caotid lesion: 95% stenosis or a highy 

iregular ulcerated lesion not associated with high grade stenosis. 

OTHR: Acute caotid thrombosis followig areriography or caotid endarterectomy 

if surgery can be performed withi 1-2 hour after onset. 

Gerg 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have a clasical TI (with hemiparesis 

hemianesthesia, or dysphasia lastig c: 24 hour), amaurosis fugax (ophthalc arery uniateral inuffciency to retina due to internal carotid stenosis 

producig tranient loss of viion), uniateral neurologica deficits such as 

hemiparesis or hemianesthesia lastig 24 hour to 7 days (RIN), stroke, or 

vertebral basilar ischemia (drop attacks). And: 

Imagig: The areriogram must fid a 90% caotid lesion, or an 80% carotid 

lesion with signcat ulceration, or a brai CAT scan must indicate a silent 

inarct-with a 90% carotid lesion, or an 80% caotid lesion with ulceration. 

C - 8 
ASYMOMATIC STENOSIS: The patient must have a bruit with ultrasound 

evidence of 80% or greater caotid stenosis. 

STROKE: Stroke is defied as lasting over one week with complete or nearly 

complete neurologica function. 

OTHR: Preparatory procedure prior to performg a caotid subclavian shunt. 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have syptoms of caotid sytem inufciency (e.g., tranient monocular blidnes or amaurosis fugax hemipheric ischemia 

with weakess of numbness of the libs or face, or aphasia). And: 

Imagig: Angiogram or doppler sca must demonstrate one of the followig: 

50% uniateral stenosis of the common or internal caotid, 50% bilateral 

stenosis, internal carotid occlusion asociated with 50% contralateral stenosis 

or an ulcerated atheromatous plaque in the presence of cerebrovascular 

inufciency syptoms. 

ASYMOMATIC STENOSIS: The patient must have 70% unateral internal or 

common caotid stenosis, or 50% stenosis with a contralateral internal or common 

caotid tota occlusion. 

STROKE: Stroke is not addressed. 

OTHR: None. 

Ind 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have "focal" cerebrovascular inufciency 

syptoms, such as: amaurosis fugax tinglg libs or face (paresthesia), 

paresis or paralysis, hemianopia, or sensory deficit. Or the patient must have 

cerebrovascular insufciency syptoms. And: 

Imagig: For "focal" cerebrovascular inuffciency syptoms, angiogram must 

demonstrate an ulcerated atheromatous plaque. For cerebrovascular 

inuffciency syptoms, angiogram must demonstrate 50% uniateral stenosis 

of the common or internal caotid arery, 50% bilateral stenosis, or a 

severely ulcerated lesion c: 50% stenosis associated with syptoms. 

C - 9 
ASYMOMATIC STENOSIS: Angiogram must demonstrte 70% uniateral 

internal or common caotid stenosis, or 50% stenosis in the presence of a contralateral 

or common carotid lesion or occlusion. 

STROKE: Stroke is not addressed. 

OTHR: None. 

Iowa 

SYMOMATIC STENOSff: 

Symptoms: The patient must demonstrate ipsilateral caotid terrtory syptoms such as contralateral weakess clumines, paralysis contralatera numbness 

paresthesias, dysarhra, dysphasia, ipsilateral monoclar blidness (amaurosis fugax), or contralateral homonymous hemianopia (defective vision affecting the 

right halves or left hales of the visual fields). And: 

Imagig: Angiogram or duplex study must demonstrate 75% uniateral 

stenosis of the ipsilateral common or internal caotid, 50% stenosis of the 

ipsilateral common or internal caotid associated with contralateral internal 

caotid arery occlusion, or ulcerated atheromatous caotid bifcation plaque 

with asocated stenosis 50%. 

ASYMOMATIC STENOSIS: Asptomatic stenosis is Dot mentioned. 

STROKE: Stroke is not addressed. 

OTHR: None. 

SYMOMATIC STEOSIS: 

Symptoms: The patient must have (1) a symptom (transient speech dysfucton, altered body sensations, gait disturbance, dyhra, sudden 

blidness, tranient hemiparesis, or stroke), and (2) a sign (caotid bruit, neurological examiation confirmg deficits, or cholesterol plaques in the eye 

grounds). And: 

Imagig: Angiography must conf an atherosclerotic lesion in the 

appropriate caotid arery.


ASYMOMATIC STENOSIS: Areriogram must diagnose a 30% caotid lesion or a 

caotid lesion with ulceration, or brain CAT scan must demonstrate a silent infarct 

with a signcant caotid lesion. 

C - 10

STROKE: Stroke is defied as a stroke with complete or nearly complete recovery of 

neurologica function. 

OTHR: None. 

SYMTOMATIC STENOS 

Symptoms: The patient must have either foca cerebrovasular inuffciency 

syptoms such as amaurosis fugax tiglg libs or face (paresthesia), paresis 

or paralysis hemianopia, or sensry deficit; or general cerebrovascuar 

inufciency syptoms. And: 

Imagig: For foca cerebrovascular inufciency syptoms, angiogram or 

arerial DSA must demonstrates an ulcerated atheromatous plaque. For 

general cerebrovasular inuffciency syptoms, angiogram or arerial DSA must demonstrates an ulcerated atheromatous plaque, 
 50% uniateral 

stenosis of the common or internal caotid arery, 50% bilatera stenosis, or a 

severely ulcerated lesion with c: 50% stenosis. 

ASYMOMATIC STENOSIS: Angiogr or arerial DSA must demonstrate 

70% unateral internal or common caotid stenosis, or 50% stenosis in the presence 

of a contralateral or common caotid lesion or occlusion. 

STROKE: Stroke is not addressed. 

OTHR: None. 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have TI CV A, sycope; sudden onset of focal 

weakess, diorientation, dimg of viion, or monocular loss of vision; 

episodic senstion of or loss of consciousness or episodic confion or amnesia; 

sensory loss; or episodic dysarhra or dysphagia. And: 

Imagig: Radiography must evidence 70% stenosis 'of the caotid artery with 

or without an ulcerative plaque, or sonography must evidence sigIcant 

stenosis in patients with documented severe allergic reaction to iodinated dyes. 

ASYMOMATIC STENOSIS: Asptomatic stenosis is not mentioned. 

STROKE: Stroke is identifed as a CV 

C - 11

OTHR: None. 

Mai 

SYMTOMATIC STENOSff: 

Symptoms: The patient must have TI (motor or sensory), RIN (uniateral weakess lasting:; 24 hours and -c 48 hour with no fied neurological deficit 

and negatie CAT sca), amaurosis fugax CV A, or basilar-vertebral syptoms (at least two of diess, sycope, subclavian steal sydrome). And: 

Imagig: Doppler, angiography, or DSA must evidence a surgical carotid lesion 

in a suitable surgica rik patient. 

ASYMOMATIC STENOSIS: Doppler, angiography, or DSA must evidence 

bilateral severe (:; 75%) stenosis, severe (:; 75%) unateral stenosis with 

contralateral internal caotid arery occlusion, or severe (:; 75%) bilateral internal 

carotid arery stenosis in selected pre-operative patients. In addition, Doppler, 

angiography, or DSA must evidence a surgica caotid lesion in a suitable surgica rik 

patient. 

STROKE: Stroke is defied as CV A with recovery. 

OTHR: None. Mtl 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have amaurosis fugax (monocular transient loss 

of viion), CV A, TI RIN, or cholesterol emboli to the eye. And: 

Imagig: For amaurosis fugax CV A, TI or RIN, arteriography or DSA 

must demonstrates ulcerated plaque or :; 50% diameter stenosis on the brain 

affected side, or a duplex sca must demonstrate sytolic frequency 60 Hz or velocity 
 5 m/sec. For cholesterol emboli to the eye, areriography or 

DSA must demonstrates ulcerated plaque. 

ASYMOMATIC STENOSIS: Areriograph or DSA must demonstrate 90% 

diameter stenosis on the operative side or -c 2 Mm. residua lumen on the operative 

side, or duplex scan must demonstrate systolic frequency 60 Hz or velocity of 

1.5 m/sec, or the patient is preoperative for a coronar artery bypass graft and 

arteriography or DSA demonstrates:; 70% diameter stenosis on the operative side 

and 70-100% diameter stenosis on the non-operative side. 

STROKE: Stroke is defied as CV A (ischemic) with signcant functional recovery. 

C - 12

OTHR: Patient enrolled in Nl' s Asymptomatic Caotid Atherosclerosis Study


(Toole) or North America Symptomatic Caotid Endaerecomy Study Trial


(Barett) ia an automatic approva.


Mic 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have either (1) hemipheric syptoms (TI recovered stroke, stroke in evolution, loss of speech, confion, expressive or receptie languge problems, unateral lib weaes, or paralysis) or 

amaurosis fugax (unateral viion loss), or (2) non-hemispheric syptoms (dies; diplopia; blured viion; ata; drop attacks; or bilateral lib 

paralis, weakess, or numbness). And: 

Imagig: For hemipheric symptoms, angiography must evidence;: 50% 

stenosis in the ipsilateral internal caotid artery or common caotid arery, and/or untable ulcerated lesion. For non-hemipheric syptoms, angiogrphy must evidence ;: 75% stenosis of the common or internal caotid arery. 

ASYMOMATIC STENOSIS: Angiography must evidence ;: 80% stenosis of the 

common or internal caotid arery. 

STROKE: Stroke is defied as recovered stroke or stroke in evolution. 

OTHR: None. 

Mmnta 

SYMOMATIC STENOSff: 

Symptoms: The patient must have amaurosis fugax CV A, or TI. And: 

Imagig: Areriogram or digital subtraction angiography must indicate 

ulcerated plaque or ;: 50% stenosis on the brai-afected side. 

ASYMOMATIC STENOSIS: Areriogram or DSA must indicate 80% stenosis, or :: 70% stenosis with ulcerated plaque; or areriogr or DSA must demonstrate less 

severe stenosis with cr or MRI evidence of silent inarct on brain-afected side, or cholesterol emboli to the eye. 

STROKE: Stroke is defied as CV A (ischemic) with signcat functional recovery. 

OTIR: None. 

C - 13

MISpi 

SYNTOMATIC STENOSff: 

Symptoms: The patient must have stable, foc ischemic syptoms (T, amaurosis fugax RIN, and previous atherothombotic stroke); stable, dise 

ischemic syptoms; evolvg, foca ischemic syptoms (stroke in evolution or 

crescendo TI); or acute stroke. And: 

Imagig: For stable, foc, ischemic syptoms areriography or duplex imagig 

must judge promient plaque formation in the internal or common caotid 

artery appropriate to the syptoms; areriogrphy must judge a large ulcerative 

lesion in the internal or common caotid arery or areriography must judge an occluded internal caotid arery and promient plaque formation in the external 

caotid arery appropriate to the syptoms. For stable, die, ischemic 

syptoms, areriography or duplex must fid :; 50% diameter reduction in the 

common or internal caotid arery bilateraly. For evolvg, foc, ischemic 

syptoms areriography or duplex must judge promient formation in the 

internal or common carotid artery, or areriogrphy must judge a large 

ulceratie lesion in the internal or common caotid arery. For acute stroke 

areriography or duplex imagig must fid promient plaque formation in the 

internal or common caotid artery and the procedure must be done shortly 

afer the onset of stroke. 

ASYMOMATIC STENOSIS: Areriography or duplex imagig must fid an 

atherosclerotic lesion in the common or internal caotid arery producing:; 75% 

diameter reduction, or areriography must fid a large multicentrc ulcerative 

atherosclerotic lesion in the common or internal caotid arery. 

STROKE: Stroke is defied as stroke in evolution (which refers to the neurological 

deficit manested hours or days afer the intial event) and acute stroke (which is a 

stroke of onl several hours duration). 

OTHR: A patient may undergo a carotid endaerectomy prior to or in conjunction with another procedure for the purose of reducing the rik of further stroke. 

Misur 

SYMTOMATIC STENOSIS: 

Symptoms: The patient must have TI or CV A symptoms. And: 

Imagig: Radiographic evidence must show:; 50% carotid occlusion 

(diameter), or 70% reduction in the cross-sectional area, or ulcerated plaque 

or embolic phenomenon. 

C - 14

ASYMOMATIC STENOSIS: Asptomatic stenosis is not mentioned. 

STROKE: Stroke is defied as a CV 

OTHR: None. 

MOI d: JJg 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have classica TI with hemiparesis, 

hemianesthesia, or dyphasia lasting oe 24 hour; or amaurosis fugax; or 

unateral neurologica deficits such as hemiparesis or hemianesthesia lasting 24 

hours to 7 days (RIN); or stroke. And: 

Imagig: Angiography including DSA must conf an atherosclerotic lesion in 

the appropriate caotid artery. 

ASYMOMATIC STENOSIS: Areriogram must fid a 90% carotid lesion, or an 

80% carotid lesion with signcant ulceration; or brain CAT scan must fid a silent 

inarct with a 90% caotid lesion, or an 80% caotid lesion with ulceration. 

STROKE: Stroke is defied as a stroke lasting over one week with complete or 

nearly complete recovery of neurological fuction.


OTHR: None. 

Nebra 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have ipsilateral carotid terrtory syptoms 

includig contralateral weakess, clumsiness, paralis, contralateral numbness 

paresthesias includig loss of sensation, dysarthra, dysphasia, ipsilateral 

monocular blidness (amaurosis fugax), or contralateral homonymous 

hemianopia (defective vision affecting the right halves or left halves of the 

viual fields). And: 

Imagig: Angiogram or duplex study demonstrates 75% unateral caotid 

stenosis of the ipsilateral common or internal caotid artery, 50% stenosis of 

the common or internal caotid arery associated with contralateral internal 

caotid arery oclusion, or ulcerated atheromatous caotid bifrcation plaque 

with asociated stenosis of 50%. 

ASYMOMATIC STENOSIS: Asptomatic stenosis is not mentioned. 

C - 15

STROKE: Stroke is not addressed. 

OTHR: None. 

New Ham 

SYMTOMATIC STENOSff: 

Symptoms: The patient must have clasica TI with hemiparesis, 

hemianesthesia, or dysphasia lasting oe 24 hour; or amaurosis fugax; or unatera neurologica deficits such as hemiparesis or hemianesthesia lasting 24 

hour to 7 days (RI); CV A; or syptomatic caotid bruit. And: 

Imagig: Areriogrphy must fid a 90% caotid stenosis, or an 80% caotid 

stenosis with sigIcat ulceration. Nonivasive caotid examation must confed by areriography. 

ASYMOMATIC STENOSIS: Asptomatic stenosis is not mentioned. 

STROKE: Stroke is defied as a cerebrovascular accident lasting over one week with 

complete or parial recovery of neurologica function. 

OTH: None. 

New Jer 

SYMTOMATIC STENOSIS: 

Symptoms: The patient must have classica TI with hemiparesis 

hemianesthesia, or dysphasia; or amaurosis fugax or stroke. And: 

Imagig: Angiography including DSA must conf an atherosclerotic lesion in 

the appropriate caotid arery 

ASYMOMATIC STENOSIS: Areriogram must reveal 80% caotid stenosis 

(complex ulcerations with oe 80% stenosis require referral). 

STROKE: Stroke is defied as the patient havig complete or nearly complete 

recovery of neurological function. 

OTHR: None. 

C - 16

New Mer 

SYMOMATIC STENOS 

Symptoms: The patient must have a mid or flucttig neurological deficit 

with correspondence of syptoms/sign to the hemipheric distribution of the 

obstructed caotid arery. And: 

Imagig: Angiography or DSA must demonstrate 70% stenosis of the 

internal caotid artery, caotid bulb, or common caotid arery (or 50% with a 

large ulcer). 

ASYMOMATIC STENOSIS: Angiography or DSA must demonstrate 70% 

stenosis of the internal caotid arery, caotid bulb, or common caotid arery. 

STROKE: Stroke is not addressed. 

OTHR: Unle other PRO criteria, New Mexico lits the conditions that determe 

when the caotid endaerectomy is "usualy not indicated." Th surgica procedure is 

not indicated when there is c: 50% caotid stenosis without ulcerated plaque, or when 

a brai imagig procedure documents new, major inarction on the affected side. 

New York 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have clasica TI with hemiparesis 

hemianesthesia, or dysphasia; or amaurosis fugax or stroke. And: 

Imagig: Angiography includig DSA must conf an atherosclerotic lesion in 

the appropriate carotid arery. 

ASYMOMATIC STENOSIS: Areriogram must reveal 80% caotid stenosis 

(complex ulcerations with c: 80% stenosis require referr). 

STROKE: Stroke is defined as the patient havig complete or nearly complete 

recovery of neurological function. 

OTHR: None. 

C - 17

Nor Ca d: So 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have tranient speech dysfuncton, altered body senstion, gait disturbance, dysahra; or amaurosis fugax or tranient 

hemiparesis; or stroke. And: 

Imagig: Angiography must demonstrate caotid stenosis 75%; or ulcerated 

plaque refractory to conservative medica management; or caotid aneurym, or caotid dicton; or clica radiography must evidence a prior cerebral stroke 

in asation with an ipsilateral caotid stenosis 75%. 

ASYMOMATIC STEOSIS: Angiography must demonstrate caotid stenosis 

75%. In addition, the medica record must include a consenting opinon from a non­ afated second physician stating that the procedure is merited. 

STROKE: Stroke is defied as a stroke with complete or nearly complete recovery of 

neurologica function. 

OTHR: None. 

Nor Data 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have classica TI with hemiparesis 

hemianesthesia, or dysphasia lasting -c 24 hours; or amaurosis fugax; or 

uniateral neurologica deficits such as hemiparesis or hemianesthesia lasting 24 

hours to 7 days (RIN); or stroke. And: 

Imagig: Angiography including DSA must conf an atherosclerotic lesion in 

the appropriate carotid artery. 

ASYMTOMATIC STENOSIS: Areriogram must fid a 90% caotid lesion, or an 80% caotid lesion with signcant ulceration; or brai CAT scan must fid a silent 

inarct with a 90% carotid lesion, or an 80% caotid lesion with ulceration. 

STROKE: Stroke is defied as a stroke lasting over one week with complete or 

nearly complete recovery of neurological function. 

OTHR: None. 

C - 18

Ohi 

SYMTOMATIC STENOSIS: 

Symptoms: The patient must have cerebrovascul inuffciency syptoms (Le. TI, amaurosis fugax sensory or motor monoparesis or hemiparesis) And: 

Imagig: Angiogr DSA, or duplex imgig must demonstrate 50% 

uniateral cross-sectional stenosis of the common or internal caotid, 50% 

bilteral cross-sectonal stenosis, or complete ipsilteral internal caotid 

occlusion asiated with 50% contralateral cross-sectional stenosis (only the 

contralateral lesion should be considered for surgery), or a large ulcerated 

plaque. 

ASYMOMATIC STENOSIS: Angiogram, DSA, or duplex imagig must 

demonstrate 75% uniateral internal or common caotid cross-sectional stenosis, or 

50% stenosis in the presence of a contralateral internal or common carotid occlusion. 

STROKE: Stroke is defied as documented, ipsilateral stroke. 

OTHR: None. 

Oklma 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have amaurosis fugax (monocular or partial 

blidness lastig .c 10 miutes); or hemipheric TI with the past 12 months; 

or hemipheric stroke. And: 

Imagig: Angiography or DSA must document 50% stenosis and/or 

ulceration in an appropriate carotid artery (Le., the caotid supplying the 

cerebral hemiphere responsible for the symptoms). The percentage of stenosis 

must be specified. 

ASYMOMATIC STENOSIS: Angiography or DSA must document 75% 

stenosis, or lumen .c 2 mm in the common or internal caotid artery, or bilateral 

stenosis with 
 75% occlusion on the operative side. 

STROKE: Stroke is descn"bed as hemispheric stroke with documented good recovery 

or with 
 minimal to modest deficit. 

OTHR: None. 

C - 19

,. 

Orn 

SYMTOMATIC STENOS 

Symptoms: The patient must have amaurosis fuga hemipheric TI 

stroke. Or:


Imagig: The patient must have a hemodynamca signcat stenosis (50% 

diameter or 75% cross-sectional area), or an ulcerated plaque. 

ASYMOMATIC STENOSIS: The patient must have a hemodynamcally signcat stenosis (50% diameter or 75% cross-sectional area). 

STROKE: Stroke is defied as hemispheric stroke with docmented good recovery and with mial to modest deficit. 

OTHR: None. 

Penlvan 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have TI (speech dysfucton, altered boy senstion, gait diturbance, dysarhra, loss of motor cordiation of upper or 

lower extremity, hemiparesis, or uniparesis); or amaurosis fugax if ipsilateral to lesion; or stroke. And: physical exaation must suggest a caotid bifrcation 

atheroma or embolition by a cervcal brut; neurological deficits; or 

oculopneumoplethysmography, doppler spectral frequency analysis, or duplex

scag evidencing a signcat caotid lesion; ulcerated plaque; or ,. 70% 

stenosis. And: 

Imagig: Angiography alone, or angiography and doppler spectral scanng (or 

duplex scag), must conf 70% diameter stenosis. 

ASYMOMATIC STENOSIS: Angiography must indicate;: 70% bifurcation 

stenosis and the patient has no major operative rik factors which contraidicate 

surgery. If,. 70% stenosis on nonivasive studies, angiography must conf. 

STROKE: Stroke is defied as a stroke with complete or nearly complete recovery of 

neurologica function. 

OTHR: None. 

C - 20

Pu Ri 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have clasica TI with hemiparesis, speech dysfuction, altered boy sensations, gait diturbance, hemianesthesia, 

dyphasia lastig'" 24 hour; or amurosis fugax or unateral neurologica 

deficits such as hemiparesis or hemianesthesia lastig 24 hour to 7 days 

(RIN); or stroke. Physica exaation must fid caotid bruit, neurological 

deficits or cholesterol plaques in the eye grounds. And: 

Imagig: Angiography must conf an atherosclerotic lesion in the 

appropriate caotid artery. 

ASYMOMATIC STENOSIS: Areriogram must fid a 90% caotid lesion, or an 80% caotid lesion with signcant ulceration; or brai CAT sca must fid a silent 

inarct with a 90% carotid lesion, or an 80% caotid lesion with ulceration. 

STROKE: Stroke is defied as a stroke lasting over one week with complete or 

nearly complete recovery of neurologica function. 

OTHR: None. 

Rh 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have foc or neurological deficit (transient or 

permanent) compatible with caotid lesion. And: 

Imagig: Angiogram must demonstrte ulceration of the internal carotid arery 

compatible with the afected side whie on antiplatelet drugs. Brai cr sca 

must not reveal another lesion that could explai the symptoms. 

ASYMOMATIC STENOSIS: Asymptomatic stenosis is not mentioned. 

STROKE: Stroke is not addressed. 

OTHR: None. 

Sout Dakta 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have transient monocular blidness (amaurosis 

fugax) with ipsilateral caotid stenosis or plaque; or TI (involvng the anterior 

C - 21

circulation with face, ar, hand, or leg numbness or weakess; aphasia; or 

dysphasia) for c: 24- hours and traceable to the appropriate caotid, or 

stroke. The medica record must document neurologica deficit. And: 

Imagig: Areriogram or DSA must show a hemodamcay signcat lesion 

defied as at least 60% diameter stenosis or 84% cross sectional area stenosis 

or ulceration. Hemipheric syptoms (tranient foc motor sensory or 

aphasias) require a cr sc or MR. 

ASYMOMATIC STENOSIS: Imagig must demonstrate stenosis 60% diameter 

or 84% cross-sectional area, or a severe, deep ulceratie plaque. 

STROKE: Stroke is defied as a recent CV A traceable to the exta-cranial carotid 

source where the patient made a fuctional recovery but would benefit from 

protection agaist a recurent event. Additional stroke defitions include a stroke in 

progress or acute stroke with 6 hours followig caotid endarerectomy or trauma to 

the neck.


OTIR: None. 

Ten 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have classica TI with hemiparesis, 

hemianesthesia, or dysphasia lasting c: 24 hours; or amaurosis fugax (temporary 

loss of viion in one eye due to inufcient blood flow to the retina and lasting 

c: 10 miutes); or unateral neurological deficits such as hemiparesis or 

hemianesthesia lasting 24 hours to 7 days (RIN); or stroke. And: 

Imagig: Areriogram must fid 90% caotid lesion, or a 80% caotid 

lesion with significat ulceration; or brai sca must find a 90% carotid lesion 

or an 80% caotid lesion with ulceration. 

ASYMOMATIC STENOSIS: Imagig must fid a 90% caotid lesion, a 80% 

caotid lesion with signcant ulceration, silent inarct with a 90% carotid lesion, or silent inarct with a 80% caotid lesion with ulceration. 

STROKE: Stroke is defied as a stroke lasting over one week with complete or 

nearly complete recovery of neurologica function. 

OTIR: None. 

C - 22

Ter 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have defite TI or stroke involvg the 

ipsilateral hemiphere or ipsilateral retial circultion. And: 

Imagig: Imagig must fid :: 50% stenosis of the caotid arery or an 

ulcerated plaque. 

ASYMOMATIC STENOSIS: Imagig must fid signcat stenosis (:: 90%) in the 

common or internal caotid arery, or stenosis :: 50% in the common or internal 

caotid arery with the presence of an ulcerated plaque. 

STROKE: Stroke is defied as a non-disblig stroke involvg the ipsilateral 

hemisphere or ipsilateral retial circulation. 

OTIR: None. 

Uta 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have clasica TI with hemiparesis 

hemianesthesia, or dysphasia lasting c: 24 hours; or amaurosis fugax (tranient 

loss of viion); or uniateral neurologica deficits such as hemiparesis or 

hemianesthesia lasting 24 hour to 7 days; or stroke. And: 

Imagig: Angiography, including four-vessel intra and extracranial direct 

arteriogram, must conf the appropriate caotid lesion and lack of signcat dita obstructive disease. 

ASYMOMATIC STENOSIS: Asptomatic stenosis is not mentioned. 

STROKE: Stroke is defied as a stroke lastig over one week with complete or 

nearly complete recoery of neurologica function. 

OTIR: None. 

Vernt 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have clasica TI (i. , hemiparesis 

hemianesthesia, or dysphasia lasting c: 24 hours); or amaurosis fugax (transient 

C - 23 
monocular blidness); or unateral neurologica deficits such as hemiparesis or 

hemianesthesia lastig 24 hours to 7 days (RI); or stroke. And: 

Imagig: Angiography must fid 70% stenosis in the appropriate caotid 

arery. 

ASYMOMATIC STENOSIS: cr sca must fid silent inarct. Angiography must

fid at least 70% stenosis in appropriate caotid arery. 

STROKE: Stroke is defied as a stroke lastig over one week with complete or 

nealy complete recoery of neurologica fuction. 

OTHR: None. 

Vug 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have focal or global cerebrovascular insuffciency 

syptoms or sigI including amaurosis fugax (temporar, reversible loss of 

viion), unateral tranient tinglg in libs or face (paresthesias), paresis

paralis diplopia (double viion), vertgo, TI foc neurologica deficit that 

resolves in oe one hour, stroke, sycope, gait diturbance dyhra, tranient 

speech dyfuction, or altered body senstions. And: 

Imagig: Angiography must evidence;: 50% plaque stenosis of common or 

internal caotid arery; or plaque necrosis or ulceration (e.g., actiely embolic); 

or a totay occluded internal caotid arery with;: 70% stenosis in the external 

caotid arery. 

ASYMOMATIC STENOSIS: Angiography must evidence ;: 80% plaque stenosis. 

STROKE: Stroke is defied as a completed stroke over 6 weeks old or fewer than 18 

months old. 

OTHR: None. 

Vug Isla


SYMOMATIC STENOSIS: 

Symptoms: The patient must have cerebral vascular insuffciency syptoms. And: 

Imagig: Angiogram must demonstrate: ;: 50% uniateral stenosis of the 

common or internal carotid, or ;: 50% bilateral stenosis, or internal carotid 

C - 24 
occlusion associated with;: 50% contralateral stenosis or an ulcerated 

atheromatous plaque. 

ASYMTOMATIC STENOSIS: Angiogram must demonstrte;: 70% uniateral 

internal or common caotid stenosis, or ;: 50% stenosis in the presence of a 

contralateral internal or common caotid (occlusion), or total oclusion. 

STROKE: Stroke is not addressed. 

OTHR: None. 

WlS 

SYMOMATIC STENOSIS: 

Symptoms: The patient must have TI, or amaurosis fugax or RIN (e.g. 

tinglg libs, face paresthesias, paresis, or paralysis), or nonhemispheric 

syptoms (e.g., vertgo, syncope). The syptoms must be consistent with the 

lesion location. And: 

Imagig: Angiogram must conf caotid stenosis ;: 70% or an ulcerated 

atheromatous plaque. 

ASYMOMATIC STENOSIS: Angiogr must demonstrte;: 70% stenosis; and 

caotid duplex sca must document bloo velocty ;: 1.5 m.sec, or peak sytolic 

frequency ;: 12 kiohert or reversed periorbita flow. 

STROKE: A physician advior must review the patient s stroke (CV A) hitory. 

OTHR: None. 

C - 25