(Stroke. 1999;30:1185-1189.)
© 1999 American Heart Association, Inc.
Original Contributions |
Prospective Randomized Trial of Bilateral Carotid Endarterectomies
Primary Closure Versus Patching
Presented at the 24th American Heart Association International Conference on Stroke and Cerebral Circulation, Nashville, Tenn, February 4–6, 1999.
From the Department of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston Area Medical Center, Charleston, and Virology/Clinical Research, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Conn (P.A.R.).
Correspondence to Ali F. AbuRahma, MD, 3100 MacCorkle Ave SE, Suite 603, Charleston, WV 25304.
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Abstract |
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Background and Purpose—Although several studies have compared the results of carotid endarterectomy (CEA) with primary closure (PC) versus patch closure, none have compared the outcome of bilateral CEAs with patch versus PC performed on the same patient. This prospective randomized study compares the clinical outcome and incidence of recurrent stenosis (
80%) for CEA with PC versus
patch closure in patients with bilateral CEAs.
Methods—This study includes 74 patients with bilateral CEAs with
PC on one side and patching on the other. Patients were randomized to
sequential operative treatment of either patching/PC or PC/patching.
Postoperative duplex ultrasounds and clinical follow-up were done at 1,
6, and 12 months and every year thereafter. A Kaplan-Meier
analysis was used to estimate the risk of significant
restenosis (80%).
Results—Demographic characteristics and the mean operative diameter of the internal carotid artery were similar for both PC and patching. The mean follow-up was 29 months (range, 6 to 65 months). The incidence of ipsilateral stroke was 4% for PC versus 0% for patching. PC had a significantly higher incidence of neurological complications (transient ischemic attacks and stroke combined) than patching (12% versus 1%; P=0.02). Operative mortality was 0%. PC had a higher incidence of recurrent stenosis (22% versus 1%; P<0.003) and total internal carotid artery occlusion (8% versus 0%; P=0.04) than patching. Restenoses necessitating a repeated CEA were also higher for PC (14%) than for patching (1%; P=0.01). The Kaplan-Meier analysis showed that patching had a significantly better cumulative patency rate than PC (P<0.01). This analysis also showed that freedom from recurrent stenosis at 24 months was 75% for PC and 98% for patching.
Conclusions—Patch closure is less likely than PC to cause ipsilateral stroke, transient ischemic attacks, and recurrent carotid stenosis. The higher rate of unilateral recurrent stenosis may suggest that local factors play a more significant role than systemic factors in the etiology of recurrent carotid stenosis.
Key Words: carotid endarterectomy • carotid stenosis • outcome
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Introduction |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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The type of closure after carotid endarterectomy (CEA), especially primary closure (PC) versus patch angioplasty, remains a controversial subject in the vascular literature.1 2 3 4 5 6 7 8 9 10 11 12 Selection of the type of patch material is also controversial, with the majority of surgeons using either vein patch (saphenous or neck vein) or synthetic materials (polytetrafluoroethylene [PTFE] or a synthetic polyester textile fiber [Dacron]). Those advocating vein patching cite the theoretical benefit of increased luminal size and the provision of endothelialized tissue to the operative site, thus providing a surface that is less thrombogenic and more resistant to infection.3 5 6 12 Disadvantages to vein patch angioplasty include increased operative time, availability, morbidity related to harvesting, and aneurysmal dilatation or rupture.13 14 Opponents of synthetic patches fear bleeding through the patch material, long hemostatic times, intraluminal thrombus formation, and infection.15 Still others believe that the routine use of patch angioplasty prolongs significantly the clamp and shunt time and the overall operative time, makes the procedure technically more demanding, and may be unnecessary in the majority of patients.1 7 16
Recent randomized prospective studies published from our institution have demonstrated the superiority of patch angioplasty in preventing both perioperative neurological events and recurrent carotid stenosis.17 18
A number of factors have been implicated in the pathogenesis of recurrent carotid stenosis. These include both "local" factors such as a small (<5 mm) internal carotid artery, culling or kinking of the internal carotid, long arteriotomy, the use of "tacking" sutures, wall irregularities, and technical problems, as well as "systemic" factors such as female sex, smoking, hyperlipidemia, young age (<60 years), diabetes mellitus, hypertension, and disseminated atherosclerosis.7 19 20 Although data previously published by Rossi et al20 suggested that local factors predominate, no randomized prospective study to date has examined the occurrence of recurrent carotid stenosis in a population who underwent bilateral CEA in which PC was performed on one side and patch angioplasty on the contralateral side. In this circumstance, each patient would literally serve as his/her own "control." Thus, both closure types would be subjected to identical systemic risk factors for recurrence. If patching continued to prove to be superior in this circumstance, then this would suggest that local factors related to the use of the patch itself were the primary reason for the differences in recurrence rates.
The following randomized prospective study compares the clinical outcome and the incidence of recurrent stenosis in patients undergoing bilateral CEA in which patients were randomized to receive PC on one side and patch angioplasty on the contralateral side.
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Subjects and Methods |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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This study includes 74 patients who had bilateral CEAs with PC on one side and patching on the other. Patients were randomized to sequential operative treatment of either patching/PC or PC/patching. This study was approved by the Institutional Review Board of the Charleston Area Medical Center, Robert C. Byrd Health Sciences Center of West Virginia University. Patients scheduled for a repeated CEA or a CEA with concomitant coronary artery bypass grafting or patients with an internal carotid artery diameter of <4 mm were excluded. Before surgery, all patients had carotid color duplex ultrasound and angiographic studies to determine preoperative stenoses. They also had tests for baseline blood cholesterol and triglyceride levels. Preoperative risk factors including coronary artery disease, smoking, hypertension, and diabetes mellitus were determined for each patient, along with the preoperative use of aspirin. Indications for surgery were categorized into hemispheric transient ischemic attacks (TIAs), amaurosis fugax, hemispheric cerebrovascular accidents (strokes), nonhemispheric TIAs, and asymptomatic carotid bruits. All patients were started on aspirin therapy (325 mg/d) within 24 hours postoperatively.
Operative Technique
All CEAs were performed with the patients under general
anesthesia with systemic heparin (100 U/kg body wt),
magnification x2.5, and routine shunting with a carotid Argyle shunt
(C. R. Bard, Inc). At the time of surgery, the normal
internal carotid artery distal to the lesion was measured in
millimeters with calipers. The arteriotomy was extended up the internal
carotid artery as far as necessary to get beyond the plaque to a normal
artery. The intimectomy plane was made between the diseased intima and
the internal elastic lamina, leaving the circular medial fibers
attached to the adventia. Tack-down sutures were not used in these
patients. Other details of the operative procedure were previously
described by us.17 Two types of patches were used in this
study: the long saphenous vein from the ankle level (34 patches) and
PTFE (40 patches; Gore-Tex, W. L. Gore & Associates, Inc).
Selection of the type of patch to be used was at the discretion of the
surgeon.
Surveillance Protocol
All patients were followed clinically and had an immediate
postoperative color duplex ultrasound, which was repeated at 30 days, 6
months, 12 months, and every year thereafter with the use of an ATL
Ultramark 9 HDI System (Advanced Technology Laboratory, Inc).
Postoperative complications, including death, TIA, reversible
ischemic neurological deficits, permanent stroke morbidity, and
asymptomatic occlusive events, were determined in
accordance with the North American Chapter of the International Society
of Cardiovascular Surgery/Society for Vascular Surgery
Ad Hoc Committee suggested standard for reports dealing with
cerebrovascular diseases.21
Duplex scanning was used to assess the presence of residual or
recurrent stenoses. A peak systolic velocity of >140
cm/s and an end-diastolic velocity of >140 cm/s were
consistent with stenosis of 80%.22
Recurrent stenosis was considered to be present only
if the abnormality detected by duplex ultrasound was not detected on
the first immediate postoperative duplex examination and if it
persisted for 2 examinations done within 6 months of the original
duplex examination. Patients with duplex findings consistent
with 80% stenoses or occlusion had their diagnoses confirmed
by MR angiography, conventional arteriography, or carotid
exploration.
Statistical Methods
Statistical comparisons of continuous data were examined with the
use of the unpaired Student's t test, and discrete
variables were compared with the 
2 or
Fisher's exact test. A Kaplan-Meier analysis was used to
estimate the rates of recurrent significant stenosis
(80%).
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Results |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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The mean follow-up was 29 months (range, 6 to 65 months). There were no significant differences between the mean follow-up for the PC and patching groups. As noted in Table 1
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the demographic and clinical data were comparable for both groups. The
incidence of ipsilateral perioperative strokes was 4%
for PC versus 0% for patching. PC had a statistically higher incidence
of neurological complications (TIAs and strokes combined) than patching
(12% versus 1%; P=0.02; Table 2). Three patients with PC had
ipsilateral strokes secondary to perioperative carotid
artery thrombosis. One of these patients awoke in the operating room
with a neurological deficit and underwent an immediate exploration,
which showed a thrombosed artery. A thrombectomy was done, and the
artery was closed with a PTFE patch with significant neurological
improvement. Two other patients had strokes in the recovery room, where
an immediate duplex ultrasound confirmed carotid thrombosis, and both
patients underwent a thrombectomy and PTFE patch angioplasty with some
improvement of the neurological deficit in one and no improvement in
the other. As noted in Table 2, 6 others with PC had late
ipsilateral TIAs occurring between 6 and 42 months (mean, 19 months),
and 4 of these were associated with 80% stenoses, all of
whom underwent a repeated CEA with no complications. One other patient
had late internal carotid artery occlusion (at 6 months), and the
remaining patient had recurrent stenosis of 50% to 80% (at 12
months) and was treated medically. One patient with patching had a late
ipsilateral TIA occurring at 18 months and associated with a normal
carotid duplex ultrasound; this patient was treated medically.
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Table 3 summarizes the results of late
carotid duplex ultrasound findings according to the type of closure. PC
had a statistically significant higher incidence of recurrent
stenoses of 50%, 80%, and/or total occlusion. There were
16 patients (22%) with PC associated with 80% stenoses,
which included 6 occlusions (8%; 3 with perioperative
internal carotid artery thrombosis and 3 with late occlusions). Ten
patients had 80% stenoses; 4 of these had a repeated CEA for
ipsilateral TIA symptoms and 6 were asymptomatic (3 of whom
had repeated CEAs, 1 had carotid stenting, 1 refused surgery, and 1 was
medically unstable for reoperation). In contrast, there was 1
asymptomatic patient with 80% stenosis in the
patch group who underwent a repeated CEA. Restenoses and
perioperative thrombosis necessitating a repeated
carotid surgery were higher for PC (14%) than for patching (1%)
(P=0.01). Nine of 10 patients (90%) with PC had their
repeated surgery within 18 months, and the remaining patient had
repeated surgery at 26 months. Similarly, 1 patient in the patch group
had repeated surgery at 15 months.
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The Kaplan-Meier analysis
(Figure) shows that patching has a
significantly better cumulative patency rate than PC
(P<0.01). This analysis shows that freedom from
recurrent stenosis at 24 months was 75% for PC and 98% for
patching.
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When only symptomatic recurrent stenoses of >80%, including symptomatic perioperative thrombosis, were compared, patching was still superior to PC (0% versus 11%; P=0.0109).
Female sex was associated with a 24% incidence of 80% recurrent
stenosis in the PC group in contrast to 3% for the patch group
(P=0.0154); however, male patients also had a higher
incidence of recurrent stenoses in the PC group (19%) in
contrast to the patch group (0%; P=0.0189). Overall, there
were no significant differences between male (10%) and female (13%)
sex in the incidence of recurrent stenosis.
There were no significant differences in the results of PTFE patch closure and saphenous vein patch closure or between participating surgeons. Similarly, preoperative aspirin use had no effect on recurrent stenosis. Three patients had kinked internal carotid arteries beyond the arteriotomy (2 in the patch group and 1 in the PC group). None of these had significant recurrent stenosis.
There was no perioperative mortality in this series; however, 1 patient in the PC group had a perioperative myocardial infarction. There were 6 late deaths: 4 related to a myocardial infarction, 1 secondary to cancer of the bladder, and 1 due to kidney failure. None of these deaths were stroke related.
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Discussion |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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The best method for arterial closure after CEA remains a controversial subject among vascular surgeons.1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 23 24 25 26 27 28 It has been suggested that the flow characteristics obtained by patching may be superior to those obtained with arteries closed primarily,2 23 which may account for the decrease in carotid thrombosis during the first few hours postoperatively, during which time the artery is most thrombogenic.29 Advocates of patching also believe that the improved flow and increased luminal diameter may decrease the amount of intimal hyperplasia and thus help to prevent recurrent carotid stenosis.19
A review of the English literature revealed only a few randomized prospective studies comparing the results of carotid patch angioplasty and PC.5 6 7 11 17 18 23 24 Recently, published data from our institution derived from 399 consecutive CEAs performed prospectively suggested that carotid patch angioplasty was effective in reducing the incidence of perioperative neurological events.17 Long-term follow-up data obtained from this population also demonstrated a decreased incidence of neurological events and of recurrent carotid stenosis in patched arteries.18
Our results in this present study population were supportive
of our previously published data, in which patching was superior to PC
in the incidence of perioperative strokes (0% versus
4%), overall neurological events (TIA/strokes, 1% versus 12%;
P=0.02), and 80% recurrent stenosis (1% versus
22%; P<0.003). Freedom from recurrent stenosis at
24 months was 75% for PC and 98% for patching.
Recently, Moore et al28 analyzed the incidence of recurrent stenosis in patients in the Asymptomatic Carotid Atherosclerosis Study who had undergone CEA and were prospectively followed with Doppler ultrasound for up to 5 years. Of the 825 patients randomized to the surgical arm, 720 underwent CEA, and 645 had complete ultrasound data. Early restenosis was found in 7.6% to 11.4%, and late restenosis occurred in 1.9% to 4.9%, depending on the positive predictive value confidence level desired. None of the traditional risk factors showed a statistically significant effect on recurrent stenosis. The use of patch angioplasty closure reduced overall risk of restenosis from 21.2% to 7.1%, from 16.7% to 4.6%, and from 27.4% to 8.2%, depending on the positive predictive value confidence level desired (P<0.001).
A variety of factors have been implicated in the etiology of recurrent carotid stenosis. Local factors implicated include a small (<5 mm) internal carotid artery, PC, a redundant or kinked internal carotid artery, long arteriotomy, use of tacking sutures, extensive proximal disease, an excessively deep plane of dissection, or failure to obtain precise arteriotomy closure. Systemic risk factors for recurrence have been proposed and include female sex, continued smoking, hyperlipidemia, diabetes mellitus, young age at endarterectomy, and the presence of disseminated atherosclerosis.7 19 20 In our recently published series of 399 endarterectomies, a multiple linear regression analysis revealed that the occurrence of >50% stenosis at 48 months was significantly associated with PC (P<0.001) and female sex (P=0.0051). The diameter of the internal carotid artery was not associated with recurrence, nor was patch closure, hyperlipidemia, presence of coronary artery disease, hypertension, diabetes mellitus, or patient age.18
Despite these data, it remains unclear whether local or systemic factors predominate in the pathogenesis of recurrent carotid stenosis. Although the demographics of the PC and patched groups did not vary significantly,17 18 it is still logical to presume that because each patient was different in terms of individual combination of specific risk factors for recurrence, conclusions are difficult to draw. The consideration of a group of patients undergoing bilateral CEA is interesting for this reason. Because each patient serves as his/her own control, unilateral recurrence would suggest that local factors predominate in that recurrence. Similarly, bilateral recurrence would suggest predominance of systemic factors.
This concept was explored initially by Rossi et al,20 in which 27 patients underwent bilateral CEA, 15 of whom received alternate methods of closure with PC on one side and vein patch on the other. Of the 27 patients, there were 6 recurrent stenoses in 5 patients (1 bilateral, 5 unilateral). Although the small number of subjects precluded meaningful statistical analysis, their study at least suggested a trend toward the predominance of unilateral recurrence, thus implicating local factors as the major culprit.
This study is therefore the first randomized prospective trial examining the results of alternate method closure with the use of PC on one side with patch angioplasty on the contralateral artery. Our results indicate that patching has a decreased overall incidence of ipsilateral strokes, combined neurological events (strokes and TIA), recurrent stenosis, and total internal carotid artery occlusion.
In summary, these data provide further evidence supporting patch angioplasty as the superior method of closure after CEA. In addition, the high incidence of unilateral recurrence with PC further supports the hypothesis that local factors play an important role in the etiology of recurrent carotid stenosis.
Received February 12, 1999; revision received March 25, 1999; accepted March 25, 1999.
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