Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein, jugular vein, and polytetrafluoroethylene: long-term follow-up.
ABSTRACT This study examines the long-term clinical outcome and the incidence of recurrent stenosis (> or = 50%) after carotid endarterectomy (CEA) with primary closure (PC) versus vein patch closure (VPC), saphenous (SVP), and jugular vein (JVP) and polytetrafluoroethylene patch closure (PTFE-P).
A total of 399 CEAs were randomized into the following groups: 135 PC, 134 PTFE-P, and 130 VPC (SVP alternating with JVP). Postoperative duplex ultrasound scans were performed at 1, 6, and 12 months and every year thereafter. The mean follow-up was 30 months with a range of 1 to 62 months, and demographic characteristics were similar in all groups. Kaplan-Meier analysis was used to estimate the risk of restenosis and the stroke-free survival.
The incidence of ipsilateral stroke was 5% (seven of 135) for PC, 1% (one of 134) for PTFE-P, and 0% for VPC (PC vs VPC, p = 0.008; PC vs PTFE-P, p = 0.034). Seven strokes occurred in the perioperative period. All three groups had similar mortality rates. The cumulative stroke-free survival rate at 48 months was 82% for PC, 84% for PTFE-P, and 88% for VPC (p < 0.01 for PC vs PTFE-P or VPC). PC had a higher incidence of recurrent stenosis and occlusion (34%) than PTFE-P (2%) and VPC (9%) (SVP 9%, JVP 8%) (p < 0.001). PTFE-P had a lower recurrent stenosis rate than VPC (p < 0.045). Restenoses necessitating a redo CEA were also higher for PC (11%) than for PTFE-P (1%) and VPC (2%) (p < 0.001). Women with PC had a higher recurrent stenosis rate than men (46% vs 23%, p = 0.008). Kaplan-Meier analysis showed that freedom from recurrent stenosis at 48 months was 47% for PC, 84% for VPC, and 96% for PTFE-P (p < 0.001). The SVP and JVP results were comparable. The mean operative diameter of the internal carotid artery was similar in patients with or without restenosis. Significantly more late internal carotid artery dilatations occurred in the VPC group compared with the PC group.
Patch closure (VPC or PTFE-P) is less likely than PC to cause perioperative stroke. Patching was also superior in lowering the incidence of late recurrent stenoses, especially in women.
- Stroke 08/2011; 42(8):e464-540. · 6.02 Impact Factor
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ABSTRACT: The purpose of this study was to examine 30-day and long-term outcomes after carotid endarterectomy (CEA) in a contemporary series and to identify variables associated with stroke and death after CEA. This was a retrospective review of patients undergoing an isolated CEA at a single institution between January 1989 and December 2005. Primary study end points were 30-day and long-term overall stroke, ipsilateral stroke, and death. Secondary end points were recurrent stenosis (>70% stenosis) and reintervention. Kaplan-Meier analysis was used to create survival curves for the long-term study end points. Multivariate models were created to identify variables associated with the study end points. During the study period, 3014 CEAs were performed on 2644 patients (mean age, 71.0 ± 8.9 years; 60.9% male; 33.5% symptomatic; 37% primary closure), with mean follow-up of 7.0 years. The 30-day ipsilateral stroke, death, and combined ipsilateral stroke/death rates were 1.3%, 1.1%, and 2.2%, respectively. Previous ipsilateral CEA or neck dissection for cancer (hazard ratio [HR], 3.68; P = .0081) and symptomatic disease (HR, 2.45; P = .0071) were predictive of 30-day ipsilateral stroke. Stroke-free survival was 93.8% at 4 years and 86.9% at 10 years. Diabetes (HR, 1.94; P < .0001), symptomatic disease (HR, 1.75; P < .0001), female gender (HR, 1.34; P = .035), and increasing age (HR, 1.02; P < .0001) were predictors of long-term overall stroke. Ipsilateral stroke-free survival was 97.6% at 5 years and 94.6% at 10 years, respectively. Contralateral occlusion (HR, 2.06; P = .025) and symptomatic disease (HR, 1.87; P = .003) were predictors of ipsilateral stroke, whereas antilipid therapy was protective (HR, 0.65; P = .049). Overall survival was 70.1% at 5 years and 42.2% at 10 years, with no difference between symptomatic and asymptomatic patients. Although a variety of comorbidities were associated with inferior late survival, as anticipated, female gender (HR, 0.89; P = .016) and lipid-lowering therapy (HR, 0.69; P < .0001) were protective. Reintervention was 3.4% at 5 years and 6.6% at 10 years, with primary closure (vs patch angioplasty/eversion) increasing the risk of reintervention (HR, 1.72; P = .007). CEA has favorable perioperative and long-term clinical and anatomic outcomes with respect to its goal of stroke prevention for symptomatic and asymptomatic patients. Adjuvant medical therapy (antilipid) has increased overall and ipsilateral stroke-free survival.Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 04/2014; 59(4):944-9. · 2.98 Impact Factor
- Stroke 08/2011; 42(8):e420-63. · 6.02 Impact Factor
Prospective randomized trial of carotid
endarterectomy with primary closure and
patch angioplasty with saphenous vein,
jugular vein, and polytetrafluoroethylene:
Ali F. AbuRahma, MD, Patrick A. Robinson, MD, S. Saiedy, MD, Jamal H.
Khan, MD, and James P. Boland, MD, Charleston, W.Va.
Purpose: This study examines the long-term clinical outcome and the incidence of recur-
rent stenosis (≥50%) after carotid endarterectomy (CEA) with primary closure (PC) ver-
sus vein patch closure (VPC), saphenous (SVP), and jugular vein (JVP) and polytetra-
fluoroethylene patch closure (PTFE-P).
Methods: A total of 399 CEAs were randomized into the following groups: 135 PC, 134
PTFE-P, and 130 VPC (SVP alternating with JVP). Postoperative duplex ultrasound
scans were performed at 1, 6, and 12 months and every year thereafter. The mean fol-
low-up was 30 months with a range of 1 to 62 months, and demographic characteristics
were similar in all groups. Kaplan-Meier analysis was used to estimate the risk of
restenosis and the stroke-free survival.
Results: The incidence of ipsilateral stroke was 5% (seven of 135) for PC, 1% (one of 134)
for PTFE-P, and 0% for VPC (PC vs VPC, p = 0.008; PC vs PTFE-P, p = 0.034). Seven
strokes occurred in the perioperative period. All three groups had similar mortality rates.
The cumulative stroke-free survival rate at 48 months was 82% for PC, 84% for PTFE-
P, and 88% for VPC (p < 0.01 for PC vs PTFE-P or VPC). PC had a higher incidence
of recurrent stenosis and occlusion (34%) than PTFE-P (2%) and VPC (9%) (SVP 9%,
JVP 8%) (p < 0.001). PTFE-P had a lower recurrent stenosis rate than VPC (p < 0.045).
Restenoses necessitating a redo CEA were also higher for PC (11%) than for PTFE-P
(1%) and VPC (2%) (p < 0.001). Women with PC had a higher recurrent stenosis rate
than men (46% vs 23%, p = 0.008). Kaplan-Meier analysis showed that freedom from
recurrent stenosis at 48 months was 47% for PC, 84% for VPC, and 96% for PTFE-P (p
< 0.001). The SVP and JVP results were comparable. The mean operative diameter of
the internal carotid artery was similar in patients with or without restenosis. Signifi-
cantly more late internal carotid artery dilatations occurred in the VPC group compared
with the PC group.
Conclusions: Patch closure (VPC or PTFE-P) is less likely than PC to cause perioperative
stroke. Patching was also superior in lowering the incidence of late recurrent stenoses,
especially in women. (J Vasc Surg 1998;27:222-34.)
The type of closure after a carotid endarterecto-
my (CEA), primary closure (PC) versus patch angio-
plasty, remains controversial.1-14Selection of patch
material is also controversial, with supporters for the
use of both vein patch (saphenous or neck veins) and
synthetic patch materials (polytetrafluoroethylene or
Dacron). Proponents of vein patch angioplasty
(saphenous vein patch [SVP]) state that the theoret-
ic benefits include an increase in luminal size and
From the Department of Surgery, Robert C. Byrd Health Sci-
ences Center of West Virginia University, Charleston Area
Presented at the Fifty-first Annual Meeting of The Society for
Vascular Surgery, Boston, Mass., June 1–2, 1997.
Reprint requests: Ali F. AbuRahma, MD, 3100 MacCorkle Ave.,
SE, Suite 603, Charleston, WV 25304.
Copyright © 1998 by The Society for Vascular Surgery and Inter-
national Society for Cardiovascular Surgery, North American
0741-5214/98/$5.00 + 0
JOURNAL OF VASCULAR SURGERY
Volume 27, Number 2
AbuRahma et al.
provision of endothelialized tissue to the endarterec-
tomy site. Because of this benefit it is believed that
vein patch angioplasty reduces the risk of periopera-
tive stroke, recurrent carotid stenosis, or occlu-
sion.4,6,7Others cite that they prefer an autogenous
vein over prosthetic materials because the luminal
surface is less thrombogenic and more resistant to
infection.13The long saphenous vein is the most
common autogenous source for carotid vein patch
angioplasty, but it is also in demand for coronary
artery bypass grafting and lower extremity revascu-
larization. To save the saphenous vein for these pro-
cedures, the internal jugular vein has been proposed
as an alternative for carotid vein patch angioplasty.13
Although many authorities prefer vein patching, sev-
eral issues have been raised with respect to availabil-
ity, increased operative time, morbidity related to
harvesting, vein patch rupture, and late aneurysmal
dilatation.15,16Opponents to synthetic patches fear
bleeding through the patch material, intraluminal
thrombus formation, and infection.17Many believe
that inclusion of a patch prolongs the operative time
and clamp or shunt time, makes the procedure tech-
nically more demanding, and may be unnecessary in
Several etiologic factors have been deemed
responsible for recurrent carotid stenosis after a
CEA, for example smoking, hypercholesterolemia,
female sex, hypertension, and PC of the endarterec-
Although several studies have compared the
results of PC with SVP closure,2-4,6-8,10,11PC versus
polytetrafluoroethylene patch closure (PTFE-
P),7,9,12and PC versus jugular vein patch (JVP) clo-
sure,13,14no prospective randomized controlled tri-
als have compared the results of CEA with PC ver-
sus PTFE-P, SVP closure, and JVP closure in one
series. The purpose of this randomized prospective
trial was to study the long-term clinical outcome and
the incidence of recurrent stenosis (≥50%) after CEA
with PC versus vein patch closure (SVP and JVP),
PTFE-P, or both. We have previously reported the
early perioperative results (30 days) of this study.19
PATIENTS AND METHODS
Between October 1991 and November 1995,
399 CEAs (357 patients) were entered into this
study. This group included 315 patients with unilat-
eral procedures and 42 patients with bilateral proce-
dures. Patients were asked to participate in this
prospective randomized trial of CEA with PC versus
PTFE-P (W. L. Gore & Associates, Inc., Elkton,
Md.) versus vein patch closure (VPC, SVP alternat-
ing with JVP). Patients scheduled for a repeat CEA,
a CEA with concomitant coronary artery bypass
grafting, or patients with internal carotid artery
diameters of fewer than 4 mm were excluded (12
CEAs, 3%). This study was approved by the Institu-
tional Review Board of Charleston Area Medical
Center/Robert C. Byrd Health Sciences Center of
West Virginia University.
Before surgery all patients underwent carotid
color duplex ultrasound and angiographic studies to
determine preoperative stenoses. They also under-
went tests for baseline blood cholesterol and triglyc-
eride levels. Preoperative risk factors, including
hypertension, diabetes mellitus, coronary artery dis-
ease, and smoking, were determined for each
patient, along with the preoperative use of aspirin or
dipyridamole. Indications for surgery were catego-
rized into hemispheric transient ischemic attacks
(TIAs), amaurosis fugax, hemispheric cerebrovascu-
lar accident, nonhemispheric TIA, and asympto-
matic carotid bruit.
Randomization included 135 PCs, 134 PTFE-
Ps, and 130 VPCs (70 SVP and 60 JVP). In the vein
group seven assigned neck vein cases were not done.
Four of these were changed to PC by the assigned
surgeon for no specific reason, and these were con-
sequently excluded from the study. Three were
changed to SVP closure because of an unsuitable
jugular vein in two cases and a radical neck dissec-
tion in one case, and these were included in the
All patients were administered aspirin therapy
(325 mg daily) within 24 hours after the operation.
Operative technique. All CEAs were performed
with the patients under general anesthesia with sys-
temic heparin and routine shunting with the use of
a carotid Argyle shunt (C. R. Bard, Inc., Billerica,
Mass.). At the time of surgery the normal internal
carotid artery distal to the lesion was measured in
millimeters with calipers. Saphenous vein was har-
vested from the ankle. Other details of the operative
procedure were previously described by us.19
Surveillance protocol. Surviving patients
underwent clinical follow-up and underwent imme-
diate postoperative color duplex ultrasound scan-
ning, which was repeated at 30 days, 6 months, 12
months, and every year thereafter with an ATL
Ultramark 8 and 9 HDI system (Advanced Technol-
ogy Laboratory, Inc., Bellevue, Wash.). Reportable
complications including death, TIA, reversible
ischemic neurologic deficits (RINDs), or stroke
morbidity and asymptomatic occlusive events were
determined in accordance with the North American
JOURNAL OF VASCULAR SURGERY
224 AbuRahma et al.
Chapter of the International Society of Cardiovascu-
lar Surgery/Society for Vascular Surgery Ad Hoc
Committee Suggested Standards for Reports Deal-
ing with Cerebrovascular Disease.20
Duplex scanning was used to assess the presence
of residual or recurrent stenoses and aneurysmal
dilation. Peak systolic frequencies of the internal
carotid artery greater than 4.5 KHz (or a peak sys-
tolic velocity >140 cm/sec) with spectral broaden-
ing throughout systole and an increased diastolic
frequency were consistent with hemodynamically
significant stenosis (≥50% diameter reduction).21
Recurrent stenosis was considered to be present
only if the abnormality detected by duplex ultra-
sound was not detected on the first immediate post-
operative duplex examination and if it persisted for
at least two examinations done within 6 months of
the original duplex examination. Four patients had
residual stenosis of 50% or more (two in the PC
group, one in the PTFE-P group, and one in the
VPC group). These were not included in the recur-
rent stenosis cases. None of these patients pro-
gressed except for one patient with PC who pro-
gressed to 80% or more stenosis at 18 months, and
this patient refused further intervention. Patients
with duplex findings consistent with 80% or more
stenosis or occlusion had their diagnoses confirmed
by magnetic resonance angiography, conventional
arteriography, or carotid exploration. Duplex ultra-
sound was also used to measure the diameter of the
proximal common carotid artery (low in the neck)
and the maximum diameter of the distal common
carotid artery (just before the bifurcation). Similar-
ly, the proximal internal carotid artery diameter
near its origin and the distal internal carotid artery
diameter were measured. Significant postoperative
dilatation was defined as a dilatation of more than
twice the diameter of the adjacent normal artery.
Statistical methods. The primary null hypothe-
sis was that no difference would be seen in effect
(≥50% recurrent stenosis) among each of three com-
parisons: PC versus PTFE-P, PC versus VPC, and
PTFE-P versus VPC. Therefore the nominal proba-
bility for these comparisons was adjusted with the
Bonferroni method for multiple comparisons, and
the statistical significance for each of these primary
comparisons was defined as p < 0.0167. Other com-
parisons were designated as secondary or explorato-
ry, and no adjustment was made for multiple com-
parisons (i.e., p = 0.05).
The analyses were performed on the patients as
randomized to the specific closure except for the fol-
lowing modifications. All patients who underwent
the assigned closure procedure were to be moni-
tored until the end of the trial. If a surgeon with-
drew his patient from the study before starting the
surgery, the patient was not included in the trial.
These patients had no follow-up available to the
investigators and may have violated randomization.
For example, four patients who were randomized to
JVP were removed from the trial and treated with
PC by their surgeons. Three patients who were ran-
domized to JVP closure had to undergo closure with
SVP; these patients were analyzed “as treated” as
patients who underwent SVP closure. An intent-to-
treat analysis was also performed with these patients
analyzed as randomized (as patients who underwent
JVP). No substantial changes in results were
observed. All patients were monitored for clinical
events and death.
The time to the occurrence of events (e.g., time
to ≥50% recurrent stenosis, time to stroke, or death)
was calculated with the method of Kaplan and
Meier. Statistical comparisons were made with the
Wilcoxon rank sum test. Statistical comparisons of
continuous data were examined with the unpaired
Student’s t test, and discrete variables were com-
pared with χ or Fisher’s exact tests. Baseline vari-
ables were compared among treatment groups with
an analysis of variance.
Potential risk factors were examined for their
effects on clinical outcome or stenosis of the carotid
closure procedure. Univariate analyses were exam-
ined for possible association with outcomes. The fac-
tors most associated with clinical or stenosis out-
comes were examined by multivariate analyses with
multiple linear regression.
As in our previous study,19no statistically signif-
icant differences were seen between the demograph-
ic and clinical data in the various groups. The mean
follow-up of 30 months (range, 1 to 62 months) was
also similar in all groups. The perioperative morbid-
ity and mortality rates were reported previously.19
The combined early and late neurologic com-
plications are summarized in Table I. Ipsilateral
strokes were statistically significantly higher in
patients with PC in contrast to those in patients
with VPC (p = 0.008) or PTFE-P (p = 0.034).
Eight patients had ipsilateral strokes, seven of
which occurred during the perioperative period.
Six of the patients with perioperative strokes were
in the PC group, and one was in the PTFE-P
group. One of these patients awoke in the operat-
ing room with a neurologic deficit and underwent
JOURNAL OF VASCULAR SURGERY
Volume 27, Number 2
AbuRahma et al.
an immediate exploration, which showed an artery
with thrombosis. A thrombectomy was performed,
and the artery was closed with PTFE-P with signif-
icant neurologic improvement. Four other patients
had strokes in the recovery room, where an imme-
diate duplex ultrasound examination confirmed
carotid thrombosis in three patients who under-
went thrombectomy and PTFE patch angioplasty
with significant improvement of their neurologic
deficits. The other patient had a normal duplex
ultrasound result and was treated with anticoagula-
tion therapy with some improvement of the neuro-
logic deficit. The remaining two strokes occurred
at 24 and 48 hours after surgery, and both patients
had normal duplex ultrasound scan results; there-
fore they were treated with anticoagulation with
some neurologic improvement in one and none in
Overall, 15 patients had ipsilateral TIAs, nine of
which occurred in the perioperative period (Table I).
Of these nine patients, three had PC, three had
PTFE-P, two had SVP closure, and one had JVP clo-
sure. All nine patients had a normal postoperative
duplex ultrasound except for one patient with PC.
Table I.Perioperative complications and late neurologic events
(n = 135; %)
(n = 134; %)
(n = 130; %)
(n = 70; %)
(n = 60; %)
and late events
*PC versus all patching (vein and PTFE), p = 0.007; PC versus VPC, p = 0.0165; VPC versus PTFE-P, p = 0.51. For strokes and
RIND combined, PC versus all patching, p = 0.04; PC versus VPC, p = 0.037.
†PC versus all patching, p = 0.003; PC versus PTFE-P, p = 0.034; PC versus VPC, p = 0.008. For strokes and RIND combined, PC
versus all patching, p = 0.019; PC versus PTFE-P, p = 0.11; PC versus VPC, p = 0.021.
Table II. Statistical comparisons of proportion of patients with combined neurologic complications* or
other major events
(n = 135; %)
(n = 134; %)
(n = 130; %)
(n = 70; %)
(n = 60; %)Event
events† and death
events‡ and ≥50%
events§ ≥50% recurrent
stenosis and death
eventsll, redo surgery,
32 (24)18 (13)18 (14)8 (11)10 (17)
52 (39)9 (7)20 (15) 8 (11)12 (20)
63 (47) 21 (16)31 (24)13 (19)18 (30)
38 (28)18 (13)20 (15)10 (14)10 (17)
*Includes TIA, RIND, and stroke (early and late combined).
†PC versus patching, p = 0.017; PC versus PTFE-P, p = 0.046; PC versus VPC, p = 0.058; PTFE-P versus VPC, p = 0.93; SVP versus
JVP, p = 0.54.
‡PC versus patching, p < 0.001; PC versus PTFE-P, p < 0.001; PC versus VPC, p < 0.001; PTFE-P versus VPC, p = 0.039; SVP ver-
sus JVP, p = 0.27.
§PC versus patching, p < 0.001; PC versus PTFE-P, p < 0.001; PC versus VPC, p < 0.001; PTFE-P versus VPC, p = 0.13; SVP versus
JVP, p = 0.188.
llPC versus patching, p = 0.0015; PC versus PTFE-P, p = 0.005; PC versus VPC, p = 0.018; PTFE-P versus VPC, p = 0.78; SVP ver-
sus JVP, p = 0.90.
JOURNAL OF VASCULAR SURGERY
226 AbuRahma et al.
This patient had more than 50% internal carotid
artery stenosis, but he refused further intervention
because he did not have any symptoms after the ini-
tial TIA, which lasted for a few minutes. The other
six patients had late TIAs, which were associated
with significant recurrent carotid stenoses in three
out of four patients with PC and less than 50%
stenosis in two patients with VPC.
Four patients had ipsilateral RIND, and all of
these situations occurred during the perioperative
period. Three of these patients had normal postop-
erative duplex ultrasounds, and one patient (with
PC) had postoperative carotid artery thrombosis.
This patient’s deficit was noticed 2 days after
surgery, and he was treated with anticoagulation
medication. The other three cases of RIND were
thought to be embolic in nature, and these patients
were treated with anticoagulation therapy.
When stroke, RIND, TIA, and death rates were
combined, patching (PTFE-P and VPC) was superi-
or to PC (p < 0.017; Table II). Patching was also
superior to PC in reducing all neurologic events
combined with 50% or more recurrent stenosis and
death (p < 0.001). Both VPC and PTFE-P were
superior to PC in this regard (p < 0.001). Similarly,
when all neurologic events, death, and redo carotid
surgery were combined, patching (PTFE-P, VPC, or
both) was better than PC (p = 0.0015; PTFE-P vs
PC, p = 0.005; VPC vs PC, p = 0.018) (Table II).
The Kaplan-Meier analysis showed that the
Fig. 1.Kaplan-Meier analysis shows cumulative stroke-free survival rates for PTFE-P,
VPC, and PC. Numbers at risk are shown at 6-month intervals.
Fig. 2. Kaplan-Meier analysis shows cumulative stroke-free survival rates for SVP and JVP.
JOURNAL OF VASCULAR SURGERY
Volume 27, Number 2
AbuRahma et al.
cumulative stroke-free survival rate at 48 months
was 82% for PC (number at risk, 63), 84% for PTFE-
P (number at risk, 75), and 88% for VPC (number
at risk, 60; p < 0.01 for PC vs PTFE-P or VPC, Fig.
1). No significant difference was found between
SVP and JVP (Fig. 2). A total of 37 deaths occurred
in the whole series, four of which occurred during
surgery, and none of the perioperative or late deaths
was stroke-related. Two of the perioperative deaths
were in the PC group and were the result of myocar-
dial infarction, and the other two were in the VPC
group, one respiratory arrest and one caused by car-
diopulmonary arrest. Overall, the causes of death in
this series were myocardial infarction in 21, conges-
tive heart failure in two, malignancies in three, renal
failure in three, respiratory complications in two,
suicide in one, complication of trauma in one, and
unknown causes in four. The late mortality rate was
similar among various groups.
Tables III and IV summarize the results of the
late carotid duplex ultrasound findings according
to the types of closure. PC had a statistically high-
er rate of significant recurrent stenoses and occlu-
sion (34%) compared with VPC (9%) or PTFE-P
(2%) (p < 0.001), and when all patching was com-
pared with PC, PC still had a higher recurrent
stenosis rate (34% vs 6%; p < 0.001). PTFE-P had
better recurrent stenosis rates than VPC (p =
0.045). No differences were seen in the recurrent
stenosis rates between JVP closure and SVP clo-
When combined recurrent tight stenoses
(>80%) and occlusions were analyzed, patching
was still superior to PC (PC vs PTFE-P, p < 0.001;
PC vs VPC, p < 0.001; PC vs patching, p < 0.001).
When only symptomatic recurrent stenoses
(≥50%) including symptomatic perioperative
thrombosis were compared, all patching, PTFE-P,
and VPC was superior to PC (0% vs 7%, p < 0.001,
0% vs 7%, p = 0.002, 1% vs 7%, p = 0.012, respec-
tively). If cases with perioperative carotid throm-
bosis were excluded, patching was still better than
PC (0% vs 3%, p < 0.049). The Kaplan-Meier
analysis showed that freedom from significant
recurrent stenoses at 48 months was 47% for PC
(number at risk, 41), 84% for VPC (number at
risk, 33), and 96% for PTFE-P (number at risk, 51;
p < 0.001, Fig. 3, Table V), with no significant dif-
ference between SVP and JVP closure (Fig. 4).
Table VI summarizes patients who underwent
a redo carotid surgery, including immediate post-
operative carotid exploration for carotid thrombo-
sis and redo carotid endarterectomy for significant
symptomatic recurrent carotid stenosis or asymp-
tomatic tight stenosis. The incidence of redo
carotid surgery was 11% for PC, 1% for PTFE-P,
and 2% for VPC (PC vs patch closure [PTFE-P
and vein], p < 0.001; PC vs PTFE-P, p < 0.001; PC
Table III. Late carotid duplex ultrasonographic results and type of closure
Duplex findingsclosure (%)closure (%)
0% to <20% stenosis
20% to <50% stenosis
50% to <80% stenosis
80% to 99% stenosis*
2 (5) (2)(3)
*p values for 80% to 99% stenosis and 100% occlusion combined: PC versus patching, p < 0.001; PC versus PTFE-P, p < 0.001; PC
versus VPC, p < 0.001; PTFE-P versus VPC, p = 0.95; SVP versus JVP, p = 0.69.
†This includes five immediate postoperative internal carotid artery occlusions, four in the PC group and one in the PTFE-P group.
Table IV. Statistical comparisons of stenosis ≥50% measured at last duplex examination according to opera-
PC versus patching, p < 0.001; PC versus PTFE-P, p < 0.001; PC versus VPC, p < 0.001; PTFE-P versus VPC, p = 0.045; JVP versus
SVP, p = 0.85.
*This includes immediate postoperative and late internal carotid artery occlusion.
JOURNAL OF VASCULAR SURGERY
228 AbuRahma et al.
vs VPC, p = 0.0034). No differences were found
between the incidence of redo carotid surgery for
patients with VPC or PTFE-P, nor for JVP closure
and SVP closure.
Indications for redo carotid surgery (18 patients)
included 15 patients with PC (four with periopera-
tive carotid thrombosis, three with TIAs with 80% to
99% stenosis, eight with no symptoms with >80%
stenosis, one with PTFE-P with TIA and 40% to
<50% stenosis, and two with VPC [one with >80%
asymptomatic stenosis and one with TIA with 50%
to 79% stenosis]).
Eleven (61%) of 18 patients underwent their
redo surgery within 12 months, and five patients
(28%) underwent redo surgery between 12 and 18
months (i.e., 89%). The remaining two patients
(11%) underwent surgery after 2 years (one at 27
months and the other at 28 months after surgery).
Fig. 3. Kaplan-Meier analysis shows freedom from significant recurrent stenosis (≥50%) and
survival rates for PTFE-P, VPC, and PC. Numbers at risk are shown at 6-month intervals.
Fig. 4. Kaplan-Meier analysis shows freedom from significant recurrent stenosis (≥50%)
and survival rates for SVP and JVP.
JOURNAL OF VASCULAR SURGERY
Volume 27, Number 2
AbuRahma et al.
Risk factors and recurrent stenosis. With mul-
tiple linear regression analysis, the occurrence of
≥50% stenosis was associated more strongly with PC
(p < 0.0001) and female sex (p = 0.0051). Table VII
summarizes the effect of sex on the incidence of
recurrent stenoses and types of closure. Female sex
was associated with a 20% incidence of 50% or more
Table V. Life table analysis of risk for 50% or more stenosis/occlusion and recurrence-free rates
stenosis in contrast to 11% for male sex in the whole
series (p = 0.013). No correlation was found
between sex and recurrent stenosis of 50% or more
in patients with PTFE-P or VPC; however, women
with PC had a higher recurrent stenosis rate than
men (46% vs 23%; p = 0.008). Carotid artery diam-
eter at surgery was not significantly associated with
Table VI. Proportion of patients with redo surgery
*This includes four patients with immediate postoperative thrombosis who underwent thrombectomy and patch closure.
PC versus patching, p < 0.001; PC versus PTFE-P, p < 0.001; PC versus VPC, p = 0.0034; PTFE-P versus VPC, p = 0.489; SVP versus
JVP, p = 0.288.
JOURNAL OF VASCULAR SURGERY
230 AbuRahma et al.
the occurrence of recurrent stenosis, nor were patch
closures, coronary artery disease, serum triglycerides
or cholesterol concentrations, hypertension, dia-
betes mellitus, age, or the use of aspirin therapy.
The mean operative diameter of the internal
carotid artery was similar in patients with or without
restenosis (0.541 cm, SD = 0.07 for patients without
recurrent stenosis vs 0.528 cm, SD = 0.076 for
patients with ≥50% stenosis). The mean diameter of
the internal carotid artery was also similar in all
patient groups (0.538 cm, SD = 0.07 for the whole
series; 0.548 cm, SD = 0.08 for PC; 0.537 cm, SD
= 0.08 for PTFE-P; and 0.530 cm, SD = 0.07 for
Late internal carotid artery dilatation. The
incidence of late internal carotid artery dilatation
was 0% for PC, 5% for PTFE-P, 11% for VPC (11%
for SVP and 10% for JVP; PC vs PTFE-P, p = 0.113;
PC vs VPC, p = 0.0031). No evidence of early or late
VPC rupture or VPC or PTFE-P pseudoaneurysmal
formation was found in the whole series.
CEA closure remains controversial. It has been
suggested that the flow characteristics of patched
carotid arteries may be superior to those of PC arter-
ies in terms of preventing early thrombosis,2,22which
can be attributed to the fact that the endarterec-
tomized artery is thrombogenic for the first several
hours after CEA, during which time the carotid
artery is most vulnerable to acute thrombosis.23
Other authors have attributed this improvement to
widening of the artery with a corresponding reduc-
tion in the effect of intimal hyperplasia.1Opponents
of carotid patching cite the increased operative time
required for patch closure, risk of patch rupture,
potential for false aneurysm formation, thromboem-
bolism from dilated or aneurysmal carotid dilation,
and excellent results with PC.3,5,8,24
Most data on patch angioplasties have been
derived from retrospective or nonrandomized
prospective trials. A review of the English literature
detected only a few prospective randomized studies
comparing the results of CEA with PC versus patch-
This series is the first and largest prospective ran-
domized trial of CEA that compares PC versus
PTFE-P, SVP closure, and JVP closure in 399 con-
secutive CEAs. Our previous study19showed that
the perioperative permanent stroke rates were statis-
tically significantly superior in the patched group
compared with those in the PC group (4% for PC,
1% for PTFE-P, 0% for both SVP and JVP closure
The perioperative permanent stroke rates for
previous trials with PTFE-P or SVP ranged from 0%
to 2%.3,4,7,8,11,24Katz et al.12demonstrated no sig-
nificant difference in the perioperative morbidity
and mortality rates between PC and PTFE-P; how-
ever, their series included only 100 CEAs with 51
PCs versus 49 PTFE-P.
Similarly, Myers et al.24concluded that the use
of VPC did not produce superior results compared
with the use of PC; however, their series was selec-
tive because it excluded female sex and patients
with an internal carotid artery diameter of fewer
than 5 mm, and patients in that series who required
complex CEAs underwent obligatory vein patch.
The choice of patch material has been controver-
sial. Many authorities prefer using autologous mate-
Table VII. Correlation of sex, recurrent stenosis, and type of closure
All stenoses <50%
All stenoses ≥50%
Vein patch closure
p = 0.0132
p = 0.0084
p = 0.9140
p = 0.2606
PTFE-P (1%) and VPC (2%). Most of the recurrent
stenoses in our series occurred in the first 18 months
after surgery. Aldoori and Baird34have suggested
that all recurrent stenoses are detected within 6
months of surgery. Therefore in this study, with
more than 90% of the patients being monitored for
at least 1 year (a mean follow-up of 3 years), the vast
majority of significant stenoses that would have been
likely to develop would have been detected. The
incidence of 2% of recurrent significant carotid
stenosis in the PTFE-P in our group is comparable
with that in other reports.1,7,12,22,28VPC was asso-
ciated with a 9% incidence of significant recurrent
carotid stenosis in our series; however, only 2% had
significant stenosis that necessitated redo carotid
surgery. Other studies reported an incidence of 0%
to 13% after VPC.3,4,6-8,10,11,24
Many studies have advocated a selective approach
to the use of patch angioplasty for patients considered
at particular risk of restenosis or vessel occlusion, such
as those with small arteries or those undergoing
surgery for restenosis. The mean operative diameter of
the internal carotid artery in our series was similar in
patients with or without significant recurrent carotid
stenoses. Although women with PC had higher recur-
rent stenosis rates than men with PC (46% vs 23%),
men with PC had a higher incidence of recurrent
stenoses than men with patching.
A multiple linear regression analysis of our data
concluded that the occurrence of 50% or more recur-
rent stenoses was associated more often with PC (p <
0.0001) and female sex (p = 0.0051). The occurrence
of stroke was also significantly associated with PC only
(p = 0.0011). The carotid artery diameter was not
associated with the occurrence of significant recurrent
stenoses or neurologic complications, nor were patch
closures, coronary artery disease, serum triglyceride or
cholesterol concentrations, hypertension, diabetes
mellitus, or age.
The cumulative stroke-free survival rate at 48
months was 82% for PC, 84% for PTFE-P, and 88% for
VPC (p < 0.01 for PC vs PTFE-P or VPC). None of
the late deaths was attributed to ipsilateral or con-
tralateral strokes. A similar experience was reported by
This randomized prospective study confirms the
conclusions of several others that patching in general is
superior to PC in lowering the incidence of periopera-
tive stroke, acute postoperative internal carotid artery
thrombosis, or both. Both VPC and PTFE-P are supe-
rior to PC in this regard. Patching (PTFE-P or SVP) is
also significantly superior in reducing significant recur-
rent carotid artery stenosis over the long term. We also
JOURNAL OF VASCULAR SURGERY
Volume 27, Number 2
AbuRahma et al.
rial (saphenous or neck vein, e.g., internal jugular
vein), citing the advantages of using an intima-lined
patch with the potential for reduction of periopera-
tive thrombosis and infection.
An infrequent complication associated with SVPs
has been a blowout or rupture in the early postoper-
ative period.3,4,11,25No vein patch rupture occurred
in our series; however, significantly more late inter-
nal carotid artery dilatations occurred in the VPC
group compared with the PC group.
Satisfactory reports have been obtained with
neck veins including the internal jugular vein and
external jugular vein.13,14Similar perioperative
results were obtained in our series with a 0% periop-
erative stroke rate. However, significant late internal
carotid artery dilation was noted in 10% of the JVP
group in contrast to 0% of the PC group. Others26
reported no dilatation of the patch or aneurysmal
degeneration when an everted cervical vein was used
as a patch material for CEA.
Synthetic patches including Dacron and PTFE-P
have also been used for carotid angioplasty, and they
have the advantages of availability, resistance to
aneurysmal formation and patch rupture, and a
reduction in morbidity associated with vein harvest-
ing. Excessive intraoperative bleeding from needle
holes in the PTFE-P cardiovascular patches has been
reported.9,27However, other studies reported no
significant bleeding problems with PTFE-P in
CEA.7,11,28Reduction of such blood loss has been
found to be associated with a needle/suture diame-
ter ratio of 1:1.28,29In our series the use of PTFE
sutures (CV-6) and needles (TT-9) minimized the
hemostasis time; however, the mean hemostasis time
for PTFE-P was still significantly higher than for
both PC and VPC.19Although Dacron patches were
not used in this study, satisfactory results were
reported by others.11,17
Significant recurrent carotid artery stenosis
(≥50%) may have affected between 10% and 30% of
patients who had a CEA with PC within the first 2
years after surgery2-4,6,7,11,22,30,31; however, only a
small percentage of these patients will have a recur-
rence of symptoms from carotid restenosis.32,33In
our series the overall incidence rate of significant
recurrent stenoses and occlusion was 34% for PC, 2%
for PTFE-P, and 9% for VPC. The Kaplan-Meier
analysis showed that freedom from significant recur-
rent stenosis at 48 months was 47% for PC, 84% for
VPC, and 96% for PTFE-P (p < 0.001). Both SVP
and JVP results were comparable. The number of
patients with restenoses necessitating redo carotid
surgery was also higher for PC (11%) than for
JOURNAL OF VASCULAR SURGERY
232 AbuRahma et al.
conclude that for those who like to preserve the saphe-
nous vein, the preferential use of PTFE patching may
1. Deriu GP, Ballotta E, Bonavina L, et al. The rationale for patch-
graft angioplasty after carotid endarterectomy: early and long-
term follow-up. Stroke 1984;15:972-9.
2. Archie JP. Prevention of early restenosis and thrombosis-occlu-
sion after carotid endarterectomy by saphenous vein patch
angioplasty. Stroke 1986;17:901-5.
3. Katz MM, Jones GT, Degenhardt J, Gunn B, Wilson J, Katz S.
The use of patch angioplasty to alter the incidence of carotid
restenosis following thromboendarterectomy. J Cardiovasc
4. Hertzer NR, Beven EG, O’Hara PJ, Krajewski LP. A prospec-
tive study of vein patch angioplasty during carotid endarterec-
tomy. Ann Surg 1987;206:628-35.
5. Imparato AM. The role of patch angioplasty after carotid
endarterectomy. J Vasc Surg 1988;7:715-6.
6. Eikelboom BC, Ackerstaff RGA, Hoeneveld H, et al. Benefits
of carotid patching: a randomized study. J Vasc Surg
7. Lord RSA, Raj TB, Stary DL, Nash PA, Graham AR, Goh KH.
Comparison of saphenous vein patch, polytetrafluoroethylene
patch, and direct arteriotomy closure after carotid endarterec-
tomy. Part I: perioperative results. J Vasc Surg 1989;9:521-9.
8. Clagett GP, Patterson CB, Fisher DF, et al. Vein patch versus
primary closure for carotid endarterectomy. J Vasc Surg
9. LeGrand DL, Linehan RL. The suitability of expanded PTFE-
P for carotid patch angioplasty. Ann Vasc Surg 1990;4:209-12.
10. Holter JBMT, Ackerstaff RGA, Schwartzenberg GWST, Eikel-
boom BC, Vermeulen FEE, van den Berg ECJM. The impact
of vein patch angioplasty on long-term surgical outcome after
carotid endarterectomy: a prospective follow-up study with ser-
ial duplex scanning. J Cardiovasc Surg 1990;31:58-65.
11. Rosenthal D, Archie JP, Garcia-Rinaldi R, et al. Carotid patch
angioplasty: immediate and long-term results. J Vasc Surg
12. Katz D, Snyder SO, Gandhi RH, et al. Long-term follow-up for
recurrent stenosis: a prospective randomized study of expanded
polytetrafluoroethylene patch angioplasty versus primary clo-
sure after carotid endarterectomy. J Vasc Surg 1994;19:198-
13. Seabrook GR, Towne JB, Bandyk DF, Schmitt DD, Cohen EB.
Use of the internal jugular vein for carotid patch angioplasty.
14. Whereatt N, Burke K, Littooy FN, Greisler HP, Baker WH. An
evaluation of external jugular vein patch angioplasty after
carotid endarterectomy. Am Surg 1990;56:455-9.
15. Baker WH, Littooy FN, Hayes AC, Dorner DB, Stubbs D.
Carotid endarterectomy without a shunt: the control series. J
Vasc Surg 1984;1:50-6.
16. Thompson JE, Talkington CM. Carotid endarterectomy. Ann
17. Goldman KA, Su WT, Riles TS, Adelman MA, Landis R. A
comparative study of saphenous vein, internal jugular vein, and
knitted Dacron patches for carotid artery endarterectomy. Ann
Vasc Surg 1995;9:71-9.
18. Little JR, Bryerton BS, Furlan AJ. Saphenous vein patch grafts
in carotid endarterectomy. J Neurosurg 1984;61:743-7.
19. AbuRahma AF, Khan JH, Robinson PA, Saiedy S, Short YS.
Prospective randomized trial of carotid endarterectomy with
primary closure and patch angioplasty with saphenous vein,
jugular vein, and polytetrafluoroethylene: perioperative (30-
day) results. J Vasc Surg 1996;24:998-1007.
20. Baker JD, Rutherford RB, Bernstein EF, et al. Suggested stan-
dards for reports dealing with cerebrovascular disease. J Vasc
21. AbuRahma AF, Robinson PA, Khan S, Pollack JA, Richmond
BK, Alberts S. Effect of contralateral severe stenosis or carotid
occlusion on duplex criteria of ipsilateral stenoses: comparative
study of various duplex parameters. J Vasc Surg 1995;22:751-
22. Ranaboldo CJ, D’Sa AABB, Bell PRF, Chant ADB, Perry PM
for the Joint Vascular Research Group. Randomized controlled
trial of patch angioplasty for carotid endarterectomy. Br J Surg
23. Dirrenberger RA, Sundt TM Jr. Carotid endarterectomy: tem-
poral profile of the healing process and effects of anticoagula-
tion therapy. J Neurosurg 1978;48:201-19.
24. Myers SI, Velentine RJ, Chervu A, Bowers BL, Clagett GP.
Saphenous vein patch versus primary closure for carotid
endarterectomy: long-term assessment of a randomized
prospective study. J Vasc Surg 1994;19:15-22.
25. Archie JP, Green JJ Jr. Saphenous vein rupture pressure, rup-
ture stress, and carotid endarterectomy vein patch reconstruc-
tion. Surgery 1990;107:389-96.
26. Dardik H, Wolodiger F, Silvestri F, Sussman B, Kahn M,
Wengerter K, Ibrahim I. Clinical experience with everted cervi-
cal vein as patch material after carotid endarterectomy. J Vasc
27. McCready RA, Siderys H, Pittman JN, et al. Delayed postoper-
ative bleeding from polytetrafluoroethylene carotid artery
patches. J Vasc Surg 1992;15:661-3.
28. Rhodes VJ. Expanded polytetrafluoroethylene patch angioplas-
ty in carotid endarterectomy. J Vasc Surg 1995;22:724-31.
29. Miller CM, Sangiolo P, Jacobson JH II. Reduced anastomotic
bleeding using new sutures with a needle-suture diameter of
one. Surgery 1987;101:156-60.
30. Baker WH, Hayes AC, Mahler D, Littooy FN. Durability of
carotid endarterectomy. Surg 1983;94:112-5.
31. Piepgras DG, Sundt TM Jr, March WR, Mussman LA, Fode
NC. Recurrent carotid stenosis: results and complications of 57
operations. Ann Surg 1986;203:205-13.
32. Raj TB, Lord RS, Graham AR. Symptomatic carotid restenosis.
J Cardiovasc Surg 1988;29:682-6.
33. Das MB, Hertzer NR, Ratliff NB, O’Hara PJ, Beven EG.
Recurrent carotid stenosis. A five-year series of 65 reoperations.
Ann Surg 1985;202:28-35.
34. Aldoori MI, Baird RN. Prospective assessment of carotid
endarterectomy by clinical and ultrasonic methods. Br J Surg
Submitted June 3, 1997; accepted Aug. 13, 1997.
JOURNAL OF VASCULAR SURGERY
Volume 27, Number 2
AbuRahma et al.
Dr. G. Patrick Clagett (Dallas, Tex.). I thank the
authors for this excellent study. It is the largest random-
ized trial of its type, and it is well done and analyzed
appropriately. These results and conclusions are identical
to those of a well-done meta-analysis of all randomized tri-
als that was recently reported in the European Journal of
Vascular and Endovascular Surgery (Counsell CE, et al. A
systematic review of the randomized trials of carotid patch
angioplasty and carotid endarterectomy. Eur J Vasc
Endovasc Surg 1997;13:345-54).
Thus patching is better, but there remains a question as
to what is the ideal patch. I believe that most people using
prosthetic material prefer Dacron over PTFE because of bet-
ter handling and less bleeding, which translates into a savings
in time and less hematoma formation. However, Dacron has
a highly textured surface that is more thrombogenic than the
smooth surface of PTFE. Of course, vein should provide the
ideal flow surface and be the least thrombogenic patch mate-
rial. I am intrigued that the authors found that there was no
difference between PTFE and vein patch closure when all
events and end points were considered together. However,
in their earlier article there was a distinct trend for there to
be less thromboembolic events including ipsilateral stroke,
RIND, and TIA with saphenous vein patch closure in com-
parison to the other closure methods. I suggest that there
may be a type II statistical error, and I remain unconvinced
that prosthetic patch and saphenous vein patch closures are
This leads to the following questions. Now that you
have proved that patch is superior to primary closure,
would you consider proceeding with a randomized trial of
PTFE versus vein patch versus Dacron patch?
What was the preferred method of closure among sur-
geons participating in the trial before beginning the trial?
This is an important point, because if surgeons participat-
ing in the trial were trained and most comfortable with
patch closure, they may have been less comfortable and
competent in performing primary closure. My experience
in working with trainees is that a meticulous, well-done
primary closure is mastered only with considerable skill
and experience. If the surgeons participating in this trial
routinely performed patch closure before the trial, this
could have biased results against primary closure.
And finally, are there any candidates for primary closure?
I believe that we have to be careful and not too rigid in rec-
ommending patch closure for all patients and all surgeons. I
would hate to see these recommendations ending up in the
hands of plaintiffs’ attorneys, some of whom will read your
article with great interest. I personally feel that in men with
large arteries, short arteriotomies confined to the bulb can
be safely closed without patches. I would also guess that
there are many experienced carotid surgeons in this audience
who almost routinely perform primary closure with excellent
and acceptable results.
I would again like to congratulate the authors and
emphasize the importance of this study. We are entering
an era when there will be competing endovascular thera-
pies for carotid disease. It is more important than ever to
reduce the morbidity and mortality of this operation to
the absolute lowest possible levels. I thank the authors for
helping us to achieve this goal.
Dr. Ali F. AbuRahma. Thanks, Patrick, for your con-
structive comments. As regards the possibility of a type II
statistical error in our study, my statistician, who is also an
MD, advised me that all applicable statistical points were
taken into consideration in our study.
In answer to your question number one, it would be
difficult to start a new randomized trial comparing PTFE
versus vein patch versus Dacron patch; however, we will
see what we can do.
In regard to question number two related to the pre-
ferred method of closure among surgeons participating in
the trial, the surgeons who participated in this trial were
selectively patching, that is, there were more primary clo-
sures than patching over the last 15 to 20 years of their
In regard to question number three regarding
whether there were would be any candidates for primary
closure, I understand your comments concerning male
patients with large arteries and short arteriotomies con-
fined bulb. I agree that, perhaps, these patients can be
safely closed without patches; however; I cannot scientifi-
cally answer this question because this selective group of
patients was not analyzed in our study.
Dr. Hassan Najafi (Chicago, Ill.). I would very much
like to compliment Dr. AbuRahma and Dr. Pat Clagett for
their respective excellent comments. Thanks to my men-
tors, Dr. Julian and Dr. Jarvis, who had started brachio-
cephalic surgery in Chicago in the mid 1950s. We have
had a very rich experience with brachiocephalic arterial
reconstruction, in particular carotid surgery. I imagine if
we were to count our cases, it might exceed some 4000
A few years ago, Dr. Yao from Chicago asked me to
discuss their article on “patching of the carotid artery.” I
looked at some 900 patients during a 5- to 6-year period
and noted that we had patched only 10% of the cases. We
follow our patients very closely. Dr. Clagett is absolutely
right. Those of us in the audience who grew up with pri-
mary closure of the internal carotid artery or arteriotomy
have managed to achieve excellent results. This is not to
say that your article does not stimulate me to patch more
arteries than I have in the past, but nevertheless I want to
say that we will continue to consider primary closure espe-
cially with sizable arteries as the best technique for carotid
One minor technical point. If you are going to use
PTFE or PTCA, I would recommend you consider using
JOURNAL OF VASCULAR SURGERY
234 AbuRahma et al.
Charles C. Miller III (Houston, Tex.). I am a bio-
statistician, and I applaud your fortitude in conducting a
clinical trial of this ambitious scale on this important topic.
I was also impressed with your ability to get 97% follow-
up in these patients. Since the experience of the primary
closure group appeared to be quite different from that of
the patched groups, I was wondering whether any differ-
ence in follow-up was present between the groups that
might explain some of the results?
Dr. AbuRahma. My statistician, who happened to be
an MD, believed we followed all the rules, so I did not see
any difference in that.
Dr. Herbert Dardik (Englewood, N.J.). As a corol-
lary to Dr. Clagett’s discussion, I would also urge that in
your next randomized prospective study you include as
well the everted cervical vein. We have recently reported
our 10 years of experience with this material. And
although the results are comparable to all other materials,
it has the distinct advantage of being a vein, and you do
not have to use the saphenous and you certainly do not
have problems with bleeding at suture lines.
Dr. Edward V. Kinney (Louisville, Ky.). When I was
a fellow with Dr. Towne in Milwaukee, I reviewed our
results of intraoperative duplex scanning on carotids and
the outcome. It is a similar group of patients, follow-up
for a similar length of time, similar data analysis. We found
the number one predictor of restenosis-free survival was a
normal intraoperative duplex study. and that was a
stronger predictor of the patches. Now, most of those
patients were patched, and it certainly was not random-
ized. Do you have any data that refutes that or supports
Dr. Benjamin F. Gibbs, Jr. (Rapid City, S.D.).These
arguments about patching always presuppose that the clas-
sical method of carotid endarterectomy, extending the
arteriotomy well up into the internal carotid artery, is
being used. There are many of us who limit the distal arte-
riotomy, using an eversion technique to get the end point.
And so I simply rise to mention that this distinction
should be made in these arguments because I personally
believe that the eversion technique has results that are at
least equal and perhaps better than those with patching.
Dr. AbuRahma. Thank you for your comments.
4 mm or 6 mm PTFE graft. The way to do it is to hold it
taut and use a #11 blade and remove a portion of the side
of the graft to use in a separate flat patch. This is because
the graft has the memory of being cylindric. I have noticed
an elliptic piece of tube graft produces a much better end
result than can be obtained with a flat patch.
Dr. AbuRahma. I appreciate your comment. The
only thing that I might add is that we used to use the
patch as you described before the endarterectomy trial;
however, the company was not encouraging us to use that
type of patching. Therefore we used the CV patch as I
indicated in my discussion.
Dr. Ronald J. Stoney (San Francisco, Calif.). I
enjoyed the paper very much, and I think the data that
you have are quite interesting. I have been an advocate of
primary closure during my career, and I have had a chance
to follow a large number of these patients, looking at
recurrent carotid stenosis. I am assuming from the dura-
tion of this study that the recurrent lesions that you found
were actually myointimal hyperplasia rather than athero-
sclerosis in large part.
Dr. AbuRahma. That’s correct.
Dr. Stoney. What were the diagnostic criteria that you
used for that? We have reported on several occasions on
the incidence of recurrence. The operative incidence has
ranged from 1.8% to as high as 3% when following patients
over long periods of time (5 to 15 years). Since you
reported a higher incidence of recurrent stenosis, I won-
dered whether these are diagnosed by ultrasound evalua-
tions. Are they symptomatic recurrences? Or, in fact, are
they defined by arteriography?
Dr. AbuRahma. Thank you, Dr. Stoney, that’s an
excellent point. We used the duplex criteria that was pub-
lished by us in the Journal of Vascular Surgery more than
2 years ago to report recurrent stenosis, and it was defined
as follows: ≥50% stenosis was defined as the presence of a
peak systolic frequency greater than 4.5 kHz or a peak sys-
tolic velocity greater than 140 cm/sec. The overall accu-
racy of these criteria when compared with angiography
was in the range of 90% or so. You made an excellent point
regarding asymptomatic versus symptomatic lesions, since
most of these recurrences were asymptomatic stenoses in