| | Long-term results of 442 consecutive, standardized carotid endarterectomy procedures in standard-risk and high-risk patientsPresented at the Twenty-fifth Annual Meeting of the Southern California Vascular Surgical Society, Coronado, Calif, May 4-6, 2007. Received 19 May 2007; accepted 25 June 2007. ObjectivesThe objectives of this study were to determine the results of a specific technique in the performance of carotid endarterectomy (CEA) and to compare results using this technique between standard-risk and high-risk patients eligible for Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) and between asymptomatic and symptomatic patients. MethodsA total of 391 patients underwent 442 consecutive CEA procedures under general anesthesia with the intent to shunt, patch, and perform intraoperative completion duplex ultrasound imaging. Indications included 272 asymptomatic patients (61.5%) with carotid stenoses ≥60% and 170 symptomatic patients (38.5%) with carotid stenosis ≥50%. Data were analyzed to determine the early (≤30 days) and long-term morbidity and mortality overall in standard-risk and high-risk procedures and in asymptomatic and symptomatic patients. The primary end points were the occurrence of all strokes or death or myocardial infarction (MI) in the first 30 postoperative days (100% follow-up) and the occurrence by life-table analysis of ipsilateral stroke or death or MI (SDMI) out to 93 months (mean, 31.4 months). ResultsA total of 441 (99.7%) procedures included shunting, 440 (99.5%) included patching, and 442 (100%) had completion duplex ultrasound imaging. Of these, 235 procedures were standard risk and 207 procedures were high risk. At the 30-day follow-up, there were two ipsilateral central neurologic deficits (1 major stroke, 1 minor stroke), no death, and one MI (0.45% for all strokes or death; 0.68% for all strokes or death or MI). After 30 days of follow-up, an additional 16 strokes (9 ipsilateral, 7 contralateral), eight MIs, and 38 deaths had occurred. No statistically significant difference was found between standard-risk and high-risk groups or between asymptomatic and symptomatic groups for stroke, death, MI, stroke or death, or stroke or death or MI at 30 days or during long-term follow-up at any interval up to 93 months. ConclusionCEA performed with intent to treat using general anesthesia, shunting, patching, and completion duplex scanning results in extremely low 30-day and long-term morbidity and mortality in asymptomatic, symptomatic, standard-risk and high-risk patients. These results are substantially superior to those reported in carotid stenting trials for both carotid stenting and CEA and do not support the contention that there is a high-risk group for CEA. Carotid endarterectomy (CEA) has been shown to be superior to medical therapy in the prevention of stroke in symptomatic patients with internal carotid artery stenosis of ≥50% (North American Symptomatic Carotid Endarterectomy Trial) and in asymptomatic patients with internal carotid stenoses of ≥60% (Asymptomatic Carotid Atherosclerosis Study).1, 2 It has been suggested that the good results obtained from CEA in these trials might have been due to the elimination of high-risk surgical patients and that unselected patients might not fare as well from the procedure.3 It has been further suggested that such high-risk patients might form a subset of patients appropriate for inclusion in carotid stenting studies. Almost all carotid stent trials, including the studies mandated by United States Food and Drug Administration after approval, have limited the patient cohort to high-risk patients. In addition, Medicare reimbursement has been approved only in high-risk patients. However, the concept that such high-risk patients experience more perioperative morbidity and mortality with CEA has been challenged in several previous studies.4, 5, 6, 7 In most studies comparing CEA with carotid stenting, the technique for the performance of carotid stenting and the devices to be used were defined, but the technique for CEA was the surgeon’s usual and customary approach. Thus, several different techniques of CEA were likely included in these studies. The current study was undertaken to assess the results of a specific CEA technique, on an intent-to-treat basis, in both high-risk and low-risk consecutive asymptomatic and symptomatic patients as defined in Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE), Table I. Methods  Patients From April 1999 through June 2005, 391 patients having 442 consecutive elective CEAs in a single institution private practice setting by four different vascular surgeons were entered into a vascular registry. All CEAs were done using a specific technique that included general anesthesia, shunting, patch angioplasty, and intraoperative completion duplex scanning. Indications included asymptomatic patients with carotid stenosis of ≥60% and symptomatic patients with carotid stenosis of ≥50%. Patients underwent follow-up neurologic examinations by a vascular surgeon ≤24 hours of the surgery and had additional neurologic examinations at approximately 1 and 6 weeks postoperatively. Myocardial infarction (MI) testing was only performed for clinical symptoms. Postoperative duplex ultrasound scans were performed at 6 weeks postoperatively and every 6 months thereafter. Duplex criteria for percentage of stenosis are included in the Appendix Table I (available online only). Long-term follow-up was performed at every 6-month office visit by a vascular surgeon. Technique of carotid endarterectomy A standard vertical incision was used. The posterior auricular nerve was avoided whenever possible, and retraction against the jaw in the area where the marginal mandibular nerve courses was minimized as much as possible. Meticulous technique with minimal manipulation of the carotid artery was done during dissection of the artery. Cranial nerves were avoided but not purposely dissected out for identification. Heparin (7500 U) was administered before arterial clamping. The internal carotid artery was grasped and occluded distal to the plaque with a DeBakey forceps and clamped distal to the forceps with a Senning bulldog clamp before any other arterial clamping was performed. The external and then common carotid arteries were clamped. A Pruitt-Inahara (LaMaitre Vascular, Burlington, Mass) T-shaped shunt with a side arm with a stopcock was used. The shunt was first inserted into the internal carotid artery and the balloon inflated. Back bleeding from the internal carotid was allowed to flush the shunt. The shunt was then clamped on the internal carotid side of the T arm with a mosquito hemostat, after which the other end of the shunt was inserted into the common carotid artery and the balloon was inflated. Forward bleeding was then allowed to occur from the common carotid artery out the end of the T arm of the shunt. The stopcock on the end of the T arm was then closed and the mosquito hemostat removed, thus providing flow from the common carotid artery through the shunt into the internal carotid artery. A standard endarterectomy was then performed. The proximal end of the plaque was transected with Potts scissors. An eversion endarterectomy of the external carotid artery was performed during temporary external carotid artery clamp release. The internal carotid artery end point was achieved either through a natural break point or was created using a beaver blade scalpel. Tacking sutures were not used. All intimal and medial tissue was removed with the specimen. Copious heparinized flushing was performed to clean the endarterectomized surface and to check for any tissue flaps. The arteriotomy was closed with a bovine pericardial patch angioplasty with a continuous suture technique. Arterial hypoplasia and redundancy were treated with bypass and internal carotid artery segmental resection with patch, respectively. The patch was always extended distal to the distal end point of the endarterectomy in the internal carotid artery. The shunt was removed just before final patch closure. Shunt removal was accomplished by first clamping the main channel of the shunt on either side of the T arm. The internal carotid balloon was deflated first, and the distal end of the shunt was removed while allowing back bleeding from the internal carotid artery. The internal carotid artery was then reclamped. The common carotid artery was then controlled with finger compression while the common carotid artery balloon was deflated and the shunt was removed. Forward bleeding was then allowed from the common carotid artery, after which it was clamped. Back bleeding was then allowed from the external carotid artery. The artery was again flushed with heparinized saline. The remaining patch opening was then closed, with back bleeding from the internal carotid allowed just before the stitch was tied to again flush the artery and to allow any air to escape. The proximal internal carotid artery was occluded with a DeBakey forceps, and flow was first re-established from the common carotid artery into the external carotid artery, followed by removal of the DeBakey forceps and re-establishment of flow into the internal carotid artery. After hemostasis was obtained, an intraoperative duplex ultrasound scan was performed. If the scan revealed any defect the surgeon thought was significant, the artery was reopened and the defect was corrected. Heparin was routinely reversed with 50 mg of protamine. The wound was closed over a drain placed to bulb suction. Statistical analysis Data were analyzed by procedure. Procedures were divided into high-risk and standard-risk groups as well as into symptomatic and asymptomatic groups by preoperative surgical indication. High-risk patients were defined as those who met the definition of high risk according to criteria used in the SAPPHIRE study (Table I).3 Standard-risk patients included all the remaining patients not included in the high-risk group. Data were analyzed to determine early (≤30 days) and late (>30 days) morbidity and mortality overall and in each risk group as well as for symptomatic vs asymptomatic patients. The primary end points were the occurrence of all strokes or death or myocardial infarction ≤30 postoperative days (100% follow-up) and the occurrence of ipsilateral stroke or death or MI (SDMI) out to 93 months (mean, 31.4 months). Results were analyzed using standard statistical methods, including χ2 test, the Fisher exact test, and Goodman-Kruskal τ test for 30-day results; Mann-Whitney test for hospital length of stay analysis; and life-table analysis and Kaplan-Meyer analysis (standard error <10%) using the log-rank test to compare survival curves for the risk and symptom groups for long-term follow-up. Statistical significance was set at an α level of 0.05. Data analysis was hierarchical. If a patient died and also had a stroke or MI, only the death was counted. If a patient had both an MI and a stroke but did not die, then both the stroke and MI were counted and the person was still coded as experiencing the event (ie, stroke or MI, or both). Statistical analysis was performed by Dale Glaser, PhD of Glaser Consulting, San Diego, California using SPSS software (SPSS Inc, Chicago, Ill). Results Procedure characteristics are shown in Appendix Table II (available online only). A total of 218 procedures were performed in men (49%) and 224 in women (51%). The overall mean age of patients was 73 years (range, 41 to 94 years), and 105 procedures (23.8%) were performed in patients aged ≥80 years. CEA was performed on the right side 216 times (49%) and on the left side 226 times (51%) for a total of 442 procedures. Patients were symptomatic before 170 procedures (38.5%) and asymptomatic before 272 procedures (61.5%). Preoperative symptoms consisted of amaurosis fugax in 19 patients, transient ischemic attack (TIA) in 84 (including 3 crescendo TIAs), ischemic stroke in 60, and miscellaneous in 7. Mean ipsilateral stenosis was 80% (range, 50% to 99%), and mean contralateral stenosis was 33% (range, 0% to 100%). There were 207 high-risk procedures (46.8%) and 235 standard-risk procedures (53.2%). Numerous additional risk factors beyond those defined in SAPPHIRE were identified (Appendix Table III, available online only). Patients were taking statins before 195 procedures (44%) and aspirin before 227 procedures (51%). All patients were prescribed aspirin postoperatively. Mean length of stay was 1.59 hospital days, with 355 discharges (80%) occurring the morning after surgery. There was no statistically significant difference in length of stay between high-risk and standard-risk patients (P = 0.675). Of 442 procedures, 439 (99.32%) were treated as intended. General anesthesia was used 442 times (100%), a shunt was used 441 times (99.8%), a patch was used 440 times (99.5%), and intraoperative completion duplex scanning was performed in 442 procedures (100%). Patch material was bovine pericardium in 438 procedures (99%). During 28 procedures (6.3%), the artery was reopened because of defects found on an intraoperative completion duplex scan and the defect was repaired. Defects consisted of 2 instances of missed residual disease in the more proximal common carotid artery, 6 intimal flaps, 7 thrombi, 9 stenoses, and 4 kinks. Three of the four kinked internal carotid arteries required carotid reconstruction. External carotid defects were repaired if they caused >30% stenosis. Follow-up was 100% at 30 days postoperatively. Early (≤30 days) adverse events included 1 TIA, 1 minor stroke, 1 major stroke, 1 MI, and no death. The 30-day all strokes or death rate was 0.45%, and the 30-day all strokes or death or MI rate was 0.68% (Table II). There were four (0.9%) temporary cranial nerve injuries (2 vagus, 2 hypoglossal). There were 20 temporary marginal mandibular nerve deficits and 13 temporary and permanent posterior auricular nerve deficits. An additional 23 procedures were followed by mild cervical numbness, indicating injury to small sensory cervical nerves. Hematomas developed after eight procedures, requiring four returns (0.9%) to surgery. Headache developed in 28 patients, five patients incurred wound infections, and one patient presented with a temporary, mild hyperperfusion syndrome manifesting as hypertension and headache. | | |  | Category | Standard risk | High risk | Total (%) | P | |
|---|
| All strokes | 1 | 1 | 2 (0.45) | .982 | | | Death | 0 | 0 | 0(0) | NA | | | MI | 1 | 0 | 1(0.23) | .347 | | | All strokes or death | 1 | 1 | 2(0.45) | .982 | | | All strokes or death or MI | 2 | 1 | 3(0.68) | .638 | | | | |
Mean long-term follow-up was 31.4 months (range, 1 to 93 months). After 30 days’ follow-up, 13 carotid arteries developed restenosis of >50%, and there were 16 strokes (9 ipsilateral), 38 deaths, and 8 MIs. Fig 1 shows the life-table plot for composite ipsilateral stroke or death or MI out to 93 months (SE, 0.07 at 93 months). Appendix Table IV (available online only) shows event-free status at selected intervals. At the 1-year follow-up, 96% were free of ipsilateral stroke or death or MI. A χ2 analysis of 30-day results demonstrated no statistically significant difference between high-risk and standard-risk groups for all strokes (P= .928), death (P= not applicable), MI (P = .347), all strokes or death (P = .928), or all strokes or death or MI (P = .638; Table II). There was no statistically significant difference between asymptomatic and symptomatic patients for all strokes (P = .737), death (P = NA), MI (P = .429), all strokes or death (P = .737) or all strokes or death or MI (P = .855; Table III). | | | | Category | Asymptomatic | Symptomatic | Total (%) | P | |
|---|
| All strokes | 1 | 1 | 2(0.45) | .737 | | | Death | 0 | 0 | 0(0) | NA | | | MI | 1 | 0 | 1(0.23) | .429 | | | All strokes or death | 1 | 1 | 2(0.45) | .737 | | | All strokes or death or MI | 2 | 1 | 3(0.68) | .855 | | | | |
Kaplan-Meyer analysis out to 93 months demonstrated no statistically significant difference between high-risk and standard-risk procedures for all strokes (P = .159), ipsilateral stroke (P = .350), death (P = 0.092), MI (P = 0.707), ipsilateral stroke or death (P = .107), or ipsilateral stroke or death or MI (P = .080; Table IV and Fig 2 [Raw Kaplan-Meyer data is shown in Appendix Table V (online only), Appendix Table VI (online only)]). Kaplan-Meyer analysis out to 93 months demonstrated no statistically significant difference between procedures performed in symptomatic vs asymptomatic patients for all strokes (P = .152), death (P = 0.658), MI (P = 0.083), ipsilateral stroke or death (P = .773), or ipsilateral stroke or death or MI (P = 0.483). Fewer ipsilateral strokes were encountered in the symptomatic group (P = .043; Table V and Fig 3 [Raw Kaplan-Meyer data is shown in Appendix Table VII (online only), Appendix Table VIII (online only)]). | | | | Event | High risk | Standard risk | P | |
|---|
| All strokes | 10 | 8 | .159 | | | Ipsilateral stroke | 6 | 5 | .350 | | | Death | 21 | 17 | .092 | | | MI | 4 | 5 | .707 | | | Ipsilateral stroke or death | 25 | 22 | .107 | | | Ipsilateral stroke or death or MI | 28 | 25 | .080 | | | | |
| | | | Event | Symptomatic | Asymptomatic | P | |
|---|
| All strokes | 4 | 14 | .152 | | | Ipsilateral stroke | 1 | 10 | .043 | | | Death | 16 | 22 | .658 | | | MI | 1 | 8 | .083 | | | Ipsilateral stroke or death | 17 | 30 | .773 | | | Ipsilateral stroke or death or mi | 18 | 35 | .483 | | | | |
During follow-up, eight carotid arteries required repeat ipsilateral CEA (target lesion revascularization [TLR]). The mean time between procedures was 27 months. Life-table analysis showed the incidence to be 1% at 1 year and 2% at 2 years. At 93 months, 97% of arteries were free of the need for TLR (Appendix Fig 1, available online only). Discussion The routine use of general anesthesia was associated with no death and only one MI (0.2%) within the first 30 days. In a series of 3382 CEAs, Rockman et al8 were unable to demonstrate any difference in morbidity and mortality when they compared general anesthesia with regional anesthesia. Although regional anesthesia may allow earlier intraoperative detection of cerebral ischemia, the routine use of shunting in the current series likely negated this potential advantage. Shunting clearly provides more cerebral blood flow than nonshunting, and the use of a T-style shunt allows for flushing of potential embolic debris that could result in an intraoperative neurologic deficit. In our series, no shunt required removal to facilitate exposure, and no embolization through the shunt was documented. The use of bovine pericardium for the patch material allows for excellent quality duplex scanning because both Dacron and polytetrafluoroethylene materials cause acoustical shadowing and prevent a complete examination. Patching clearly requires more time than primary closure but can prevent stenosis, especially at the end point of the endarterectomy, and patching has been shown in a series of 1972 procedures to be associated with a significant reduction in perioperative stroke compared with primary closure.9 The increased operative time caused by patching may be moot when a shunt is routinely used. In 6.3% of procedures in this series, reopening of the artery was required to correct technical defects found on intraoperative duplex scans. It is not possible to know if any or all of the defects would have led to morbidity if left uncorrected, but intuitively, it would seem prudent to complete surgery with the best technical result possible. A previous study attempted to define which defects require correcting and which do not.10 To be accurate, this determination would require a randomized study, but such a study would have ethical concerns. The surgeon has to use best judgment to decide which defects to repair because the reopening of a carotid artery may, in itself, pose an increased risk to the patient. In the current series, all patients left the operating room with either normal duplex scans or with duplex scans showing only minor defects, as previously described.10 We combined several surgical techniques previously shown to have benefit into one procedure yielding a 30-day composite stroke or death or MI rate of 0.68%. These results question whether the high-risk group, as defined in SAPPHIRE, truly represents high-risk patients for CEA. Four other large studies (2345 CEAs) have also failed to find increased morbidity and mortality for high-risk patients.4, 5, 6, 7 The SAPPHIRE study showed a combined stroke or death or MI rate of 4.8% for carotid stenting and 9.8% for CEA on an intention-to-treat basis.3 About 71% of patients in SAPPHIRE were asymptomatic. Two subsequent level 1 studies conducted on standard-risk symptomatic patients, the Stent-Protected Percutaneous Angioplasty Versus Carotid Endarterectomy (SPACE) and Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S) trials, yielded distinctly different results.11, 12 The SPACE trial failed to prove noninferiority of carotid artery stenting compared with CEA for ipsilateral stroke or death at 30 days (6.84% for stenting vs 6.34% for CEA). EVA-3S demonstrated a 30-day stroke or death rate of 3.9% for CEA and 9.6% for carotid stenting. In the 3500-procedure Carotid ACCULINK/ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) study of carotid stents mandated by the FDA, only 13.8% of the patients were symptomatic.13 In CAPTURE, the 30-day stroke or death or MI rate in the 482 symptomatic patients was 12.0%, whereas in Emboshield and Xact Post Approval Carotid Stent Trial (EXACT) and CAPTURE 2, both postmarket carotid stent studies subsequent to CAPTURE, that rate improved to 8.6% and 9.1%, respectively.13, 14, 15 Bond et al16 recently reviewed 103 reports published between 1980 and 2000 that stratified risk between symptomatic and asymptomatic patients who had carotid endarterectomy and found approximately a 5% stroke and death rate for symptomatic patients vs a 3% stroke and death rate in asymptomatic patients. In the current study, no such difference based on preoperative symptom status was observed. Stenting appears particularly hazardous in patients aged ≥80 years. In CAPTURE, the 30-day stroke or death or MI rate in symptomatic octogenarians was 17.1%. In the Carotid Revascularization Endarterectomy vs. Stent Trial (CREST) lead-in phase, including symptomatic and asymptomatic patients, octogenarians undergoing carotid stenting had 30-day stroke or death rate of 12.1%.17 None of the 105 octogenarians in the CEA study reported here sustained stroke, death, or MI at the 30-day follow-up. The Stroke Council of the American Heart Association advised that a surgeon’s surgical morbidity and mortality rate should not exceed 3% for asymptomatic patients or 6% for symptomatic patients.18, 19, 20 The pooled data collected by Bond et al16 indicate that the reported results are in line with or exceed those recommendations. The 3500 patients enrolled into the CAPTURE study showed vastly inferior results for carotid stenting, with a 30-day stroke or death rate of 4.9% in asymptomatic patients and 10.6% in symptomatic patients.13 The 30-day rate of 0.45% for all strokes or death in the current study for a specific CEA technique was vastly superior to that found in CAPTURE and in all of the other carotid stenting trials as well. The need for TLR was 3.1% at 2 years and 3.9% at 3 years in the ACCULINK for Revascularization of Carotids in High-Risk Patients (ARCHER) carotid stenting trial.13 In the current series of CEA, TLR was 1% at 1 year and 2% at 2 years, and 97% were free from the need for TLR at 93 months. It is possible that the routine measurement of cardiac enzymes and the performance of routine postoperative electrocardiograms might have resulted in a higher detection rate for asymptomatic MI in this series. The 1-year death rate after carotid endarterectomy in SAPPHIRE was 13.5%, whereas in the current study it was 6% in the high-risk group, suggesting that any missed asymptomatic MIs in our study did not contribute to increased mortality. Routine neurologic examinations by neurologists, rather than vascular surgeons, might have led to increased detection of minor asymptomatic preoperative and postoperative neurologic deficits. The low event rate in this study could have masked differences between the risk groups, but the current cohort of 442 compares well with other studies, including SAPPHIRE (n = 151 CEAs). Because this study does not randomize our technique of CEA against other techniques, it is not possible to conclude with certainty that the good results achieved in this series are solely due to the surgical technique that was used. The current results of carotid stenting neither reach the level of those attained in this series with a specific technique of CEA nor those attained in other series of CEA using a variety of surgical techniques.16 Also, current results of carotid stenting suggest the procedure is too risky in octogenarians and in symptomatic patients. Nevertheless, carotid stenting most likely will have a role in specific patients with extracranial cerebrovascular disease, but those patients are yet to be defined. Future studies of carotid stenting should consider standardization of technique for both stenting and endarterectomy. It appears unnecessary to limit enrollment of patients into carotid stenting trials by using the concept of high surgical risk as previously defined. Liberalizing entry criteria into stenting trials should facilitate definition of the role of carotid stenting sooner by providing a larger data pool for analysis. Conclusions This study demonstrates that the application of a specific contemporary vascular surgical technique yields excellent short-term and long-term results for CEA and that the results differ neither between standard-risk vs high-risk patients (as defined in SAPPHIRE) nor between symptomatic vs asymptomatic patients. These data challenge the concept of a high-risk group of patients for CEA and suggest entry criteria into carotid stenting trials need not include high surgical risk as previously defined. Furthermore, this research supports other reports in questioning whether carotid stenting is appropriate at this time in symptomatic patients and octogenarians given the excellent results attained in these groups with CEA. Author contributions Conception and design: DF, TH, MR, JB Analysis and interpretation: DF, MF, TH, MR, JB Data collection: DF, MF, AD Writing the article: DF, MR, JB Critical revision of the article: DF, MF, AD, TH, MR, JB Final approval of the article: DF, MF, AD, TH, MR, JB Statistical analysis: DF, JB Obtained funding: Not applicable Overall responsibility: DF References 1. 1Barnett HJM, Taylor DE, Eliasziw M, Fox AJ, Ferguson GG, Haynes RB, et al. Benefit of carotid endarterectomy in patients with symptomatic moderate and severe stenosis. N Engl J Med. 1998;339:1415–1425. MEDLINE |
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18. 18Beebe HG, Clagett GP, DeWeese JA, Moore WS, Robertson JT, Sandok B, et al. Assessing risk associated with carotid endarterectomy (A statement for health professionals by ad hoc committee on carotid surgery standards of the Stroke Council, American Heart Association). Circulation. 1989;79:472–473. MEDLINE 19. 19Moore WS, Barnett HM, Beebe HG, Bernstein EF, Brener BJ, Brott T, et al. Guidelines for carotid endarterectomy: A multidisciplinary consensus statement from the ad hoc committee, American Heart Association. Stroke. 1995;26:188–201. MEDLINE 20. 20Biller J, Feinberg WM, Castaldo JE, Whittemore AD, Harbaugh RE, Dempsey RJ, et al. Guidelines for carotid endarterectomy: a statement for healthcare professionals from a special writing group of the stroke council, American Heart Association. Circulation. 1998;97:501–509. MEDLINE St. Joseph Hospital Vascular Institute, Orange, Calif.  Correspondence: D. Preston Flanigan, MD, The St. Joseph Hospital Vascular Institute, 1140 W La Veta Ave, Ste 850, Orange, CA 92868.
Competition of interest: none. PII: S0741-5214(07)01142-1 doi:10.1016/j.jvs.2007.06.045 © 2007 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. | |
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