Published online before print November 13, 2003, doi: 10.1161/01.STR.0000098903.93992.49
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(Stroke. 2003;34:2941.)
© 2003 American Heart Association, Inc.
Original Contributions |
Durability of Carotid Endarterectomy
From the Departments of Neurosurgery (R.D.E., M.A.P., F.B.M.) and Neurology (I.M.), Mayo Clinic and Foundation, Rochester, Minn.
Correspondence to Fredric B. Meyer, MD, Department of Neurosurgery, Mayo Clinic, 200 First St SW, Rochester, MN 55905. E-mail meyer.fredric{at}mayo.edu
 |
Abstract |
|---|
 Top Abstract IntroductionSubjects and MethodsResultsDiscussionReferences |
|---|
Background and Purpose— We sought to determine the incidence of recurrent stenosis after carotid endarterectomy.
Methods— One thousand consecutive carotid endarterectomy patients were followed prospectively. The surgery was performed in a standard fashion. Cerebral protection was provided with intraoperative electroencephalographic monitoring and selective shunting. All arteriotomies were repaired with a patch graft. Each patient was seen 3 months after surgery and then yearly, with a duplex ultrasound obtained at each visit. Evidence for new ischemic events or recurrent stenosis of 
70% was recorded.
Results— The 30-day combined minor and major stroke and death rate was 1.9%. At 7.1-year follow-up, 0.1% of patients had recurrent stenosis 70%, the majority of which were asymptomatic.
Conclusions— Carotid endarterectomy is a low-risk procedure for the treatment of carotid occlusive disease, with excellent long-term durability. Although less invasive, carotid angioplasty must demonstrate equal robustness in long-term follow-up before it is considered a routine alternative to surgery.
Key Words: carotid endarterectomy • stenosis • stroke
|
Introduction |
|---|
|
TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
|---|
It is well established that carotid endarterectomy is a low-risk intervention that reduces the risk of stroke in patients who harbor both symptomatic and asymptomatic hemodynamically significant carotid stenoses.1–3 It is now generally agreed on in the surgical community that an acceptable perioperative risk should be no greater than 3.0% in typical surgical patients who do not have significant medical comorbidities.4 An ample number of independent surgical series support this contention.5–12 In addition to a low perioperative complication rate, the risk of recurrent stenosis or late postoperative stroke is favorable.13–16
Recently, carotid angioplasty has emerged as a potential alternative treatment for extracranial carotid occlusive disease. Many small published series chronicle a wide range of risks.17–26 Currently, there are no completed prospective randomized controlled studies with sufficient power to determine significant differences between carotid endarterectomy and carotid angioplasty/stenting in the typical patient evaluated for treatment.27,28 Some data suggest that in high-risk surgical patients, angioplasty may be a good alternative.22,29
Most importantly, only a few outcome studies consider the long-term success regarding stroke reduction and patency after carotid angioplasty/stenting.14–16 Although the literature suggests that angioplasty may have a higher risk of recurrent stenosis, there are no large, long-term surgical studies with sufficient patient numbers and years of follow-up to establish benchmarks for comparison. Accordingly, the purpose of this investigation is to determine the robustness of carotid endarterectomy by analyzing long-term follow-up data.
|
Subjects and Methods |
|---|
|
TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
|---|
One thousand consecutive carotid endarterectomies performed in 975 patients by a single surgeon (F.B.M.) during 1988–2000 were followed prospectively. Twenty-five patients underwent staged bilateral endarterectomies. All operations were performed on arteries with >70% stenosis. No operations for moderate stenosis were included in this study. When cerebral angiography was available, the degree of stenosis was determined with the use of North American Symptomatic Carotid Endarterectomy Trial (NASCET) methodology. However, carotid ultrasound and MR angiography (MRA) were the primary imaging modalities used in this study. MRA assessment of degree of stenosis has been shown to correlate well with traditional cerebral angiography in determining the presence of a hemodynamically significant lesion.30,31 Baseline and follow-up demographic data were entered into a long-standing departmental database. A Sundt risk classification grade was determined preoperatively for each patient. The Sundt grade determines anatomic, medical, and neurological risk factors and has been documented to be of value in predicting perioperative surgical morbidity and mortality (Table 1).4,32
|
All patients were given 325 mg of aspirin perioperatively. Before carotid artery clamping, 5000 U of heparin was administered, and the patient’s systolic blood pressure was elevated to approximately 150 to 170 mm Hg. The endarterectomy was performed in a standardized manner with the use of intraoperative electroencephalography.4 In cases in which the intraoperative electroencephalograph demonstrated ischemic changes during clamping of the carotid arteries despite induced hypertension (attenuation of faster frequencies of >4 Hz by >50% along with an increase in the amplitude of delta activity by 50%), a shunt was placed. After removal of the carotid plaque, the arteriotomy was closed with a patch graft. Early in this series the saphenous vein was utilized. However, because of the small risk of vein graft rupture,33 the vast majority of arteriotomies were repaired with a knitted, double-velour collagen impregnated graft (Hema-shield; Meadox).34
Patients were seen in follow-up at 3 months postoperatively and then yearly thereafter. Duplex carotid ultrasound was performed at each visit, and if a 70% stenosis was identified, this was confirmed by either carotid MRA or transfemoral cerebral angiography. Patients with a stenosis of 70% or evidence of new ischemic symptoms were cataloged.
|
Results |
|---|
|
TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
|---|
The study included 680 men and 320 women aged 69±8 years. The cataloging of patients by Sundt risk grade is listed in Table 1. Of note, 194 patients had concerning anatomic risk factors, including contralateral carotid occlusion, and 496 patients had concurrent significant medical risk factors, primarily coronary artery disease. In 59% of patients, the carotid stenosis was symptomatic.
The combined 30-day death and stroke rate was 1.9%. There were 9 deaths (0.9%) (3 fatal myocardial infarctions, 4 intracerebral hemorrhages, 2 strokes). All deaths occurred in Sundt grade 3 and 4 patients. Any patient in whom there was concern for a possible perioperative ischemic event was examined by a stroke neurologist. There were 10 documented strokes (1.0%). Of these 10 strokes, 1 occurred in a Sundt grade 1 patient, 2 in Sundt grade 2 patients, 4 in Sundt grade 3 patients, and 3 in Sundt grade 4 patients. At 3-month follow-up by the neurologist, 7 of 10 patients were functionally independent as defined by Rankin 2 scores. Other surgical morbidity included 1 infection and 7 cranial nerve palsies, 6 cases of transient vocal cord paresis, 1 permanent spinal accessory nerve injury, and 3 cases of mandibular facial nerve paresis, of which 2 resolved. There were no permanent significant twelfth nerve palsies.
Ten patients (0.1%) experienced a recurrent stenosis as defined by 70% stenosis on ultrasound, confirmed by either MRA or cerebral angiography. Of these, 2 were symptomatic. Five of the recurrences went on to reoperation, 3 were treated with carotid angioplasty/stenting, and 2 were left untreated. The time to recurrence was 4±2 years. The follow-up for this study was 7.1 (range, 2.0 to 11) years.
|
Discussion |
|---|
|
TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
|---|
This series of 1000 consecutive endarterectomies describes a combined 30-day minor and major stroke and death rate of 1.9% at a 7-year follow-up. These data are consistent with recent studies of >500 carotid endarterectomies that demonstrate 30-day major stroke and death rates ranging from 0.9% to 4% and a restenosis rate of 0.7% to 7.9% over an average of 3.5 years (Table 2).5–12 The present study demonstrating a 0.1% critical restenosis rate provides the longest follow-up data available to date and confirms that carotid endarterectomy is an extremely durable operation.
|
A meta-analysis of 714 patients in which 44% had both angioplasty and stenting revealed a stroke and death risk of 8%.35 Since the year 2000, 7 studies have been published with larger sample sizes (mean, 222 patients; range, 99 to 528) and 14.9-month follow-up (range, 11.2 to 20 months).36–41 The reported 30-day stroke and death rates range from 1% to 4%, with early restenosis rates of 0.5% to 14% (Table 3).36–41 Therefore, in experienced hands, the 30-day death and stroke rate for carotid angioplasty may be low. However, the available short-term follow-up data suggest that the durability of carotid angioplasty/stenting may be poor.
|
A review of the carotid endarterectomy literature with respect to restenosis is methodologically challenging because of variations in definitions of restenosis, methods of measuring restenosis, length of follow-up, method of closure at the initial operation, initial lesion pathology, and study design. However, some general considerations regarding method of arteriotomy closure can be drawn from the literature, including those studies listed in Table 2. The preponderance of data indicates that restenosis rates are generally lower with patch closure of the arteriotomy than with primary closure, ranging from 0.1% to 5.8% and 1% to 14%, respectively.5–12
Conclusions
These data demonstrate that the risk of perioperative complications is low and that the durability of carotid endarterectomy is excellent. Although less invasive, carotid angioplasty/stenting must demonstrate equivalent robustness for this procedure to be considered a viable alternative to surgery. Clinical trials comparing these 2 treatments must incorporate sufficient years of follow-up after treatment to assess restenosis rates and long-term functional outcome.
Received June 3, 2003; revision received July 1, 2003; accepted July 23, 2003.
|
References |
|---|
|
TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
|---|
1. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991; 325: 445–453.[Abstract]
2. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. JAMA. 1995; 273: 1421–1428.
3. Corrigan J, Greiner A, Erickson SE. Fostering Rapid Advances in Health Care: Learning from System Demonstrations. Washington, DC: Institute of Medicine of the National Academies Press; 2002.
4. Meyer FB, ed. Sundt’s Occlusive Cerebrovascular Disease. Philadelphia, Pa: WB Saunders; 1994.
5. Archie JP Jr. A fifteen-year experience with carotid endarterectomy after a formal operative protocol requiring highly frequent patch angioplasty. J Vasc Surg. 2000; 31: 724–735.[CrossRef][Medline] [Order article via Infotrieve]
6. Biasi GM, Sternjakob S, Mingazzini PM, Ferrari SA. Nine-year experience of bovine pericardium patch angioplasty during carotid endarterectomy. J Vasc Surg. 2002; 36: 271–277.[CrossRef][Medline] [Order article via Infotrieve]
7. Cao P, Giordano G, De Rango P, Zannetti S, Chiesa R, Coppi G, Palombo D, Peinetti F, Spartera C, Stancanelli V, Vecchiati E. Eversion versus conventional carotid endarterectomy: late results of a prospective multicenter randomized trial. J Vasc Surg. 2000; 31: 19–30.[CrossRef][Medline] [Order article via Infotrieve]
8. Hertzer NR, Beven EG, O’Hara PJ, Krajewski LP. A prospective study of vein patch angioplasty during carotid endarterectomy: three-year results for 801 patients and 917 operations. Ann Surg. 1987; 206: 628–635.[Medline] [Order article via Infotrieve]
9. Lawhorne TW Jr, Brooks HB, Cunningham JM. Five hundred consecutive carotid endarterectomies: emphasis on vein patch closure. Cardiovasc Surg. 1997; 5: 141–144.[Medline] [Order article via Infotrieve]
10. Scavee V, Viejo D, Buche M, Eucher P, Louagie Y, Haxhe JP, De Wispelaere JF, Trigaux JP, Jamart J, Schoevaerdts JC. Six hundred consecutive carotid endarterectomies with temporary shunt and vein patch angioplasty: early and long-term results. Cardiovasc Surg. 2001; 9: 463–468.[CrossRef][Medline] [Order article via Infotrieve]
11. Shah DM, Darling RC III, Chang BB, Paty PS, Kreienberg PB, Lloyd WE, Leather RP. Carotid endarterectomy by eversion technique: its safety and durability. Ann Surg. 1998; 228: 471–478.[CrossRef][Medline] [Order article via Infotrieve]
12. Trisal V, Paulson T, Hans SS, Mittal V. Carotid artery restenosis: an ongoing disease process. Am Surg. 2002; 68: 275–280.[Medline] [Order article via Infotrieve]
13. Sundt TM Jr, Whisnant JP, Houser OW, Fode NC. Prospective study of the effectiveness and durability of carotid endarterectomy. Mayo Clin Proc. 1990; 65: 625–635.[Medline] [Order article via Infotrieve]
14. Cunningham EJ, Bond R, Mehta Z, Mayberg MR, Warlow CP, Rothwell PM, for the European Carotid Surgery Trialists’ Collaborative Group. Long-term durability of carotid endarterectomy for symptomatic stenosis and risk factors for late postoperative stroke. Stroke. 2002; 33: 2658–2663.
15. Gray WA, White HJ Jr, Barrett DM, Chandran G, Turner R, Reisman M. Carotid stenting and endarterectomy: a clinical and cost comparison of revascularization strategies. Stroke. 2002; 33: 1063–1070.
16. Shawl FA. Carotid artery stenting: acute and long-term results. Curr Opin Cardiol. 2002; 17: 671–676.[CrossRef][Medline] [Order article via Infotrieve]
17. Ballotta E. Circulation. 2001; 104: E121–E122. Comment on: Roubin GS, New G, Iyer SS, Vitek JJ, Al-Mubarak N, Liu MW, Yadav J, Gomez C, Kuntz RE. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation. 2001; 103: 532–537.
18. Dietz A, Berkefeld J, Theron JG, Schmitz-Rixen T, Zanella FE, Turowski B, Steinmetz H, Sitzer M. Endovascular treatment of symptomatic carotid stenosis using stent placement: long-term follow-up of patients with a balanced surgical risk/benefit ratio. Stroke. 2001; 32: 1855–1859.
19. Guimaraens L, Sola MT, Matali A, Arbelaez A, Delgado M, Soler L, Balaguer E, Castellanos C, Ibanez J, Miquel L, Theron J. Carotid angioplasty with cerebral protection and stenting: report of 164 patients (194 carotid percutaneous transluminal angioplasties). Cerebrovasc Dis. 2002; 13: 114–119.[CrossRef][Medline] [Order article via Infotrieve]
20. Jordan WD Jr, Schroeder PT, Fisher WS, McDowell HA. A comparison of angioplasty with stenting versus endarterectomy for the treatment of carotid artery stenosis. Ann Vasc Surg. 1997; 11: 2–8.[CrossRef][Medline] [Order article via Infotrieve]
21. Naylor AR, Bolia A, Abbott RJ, Pye IF, Smith J, Lennard N, Lloyd AJ, London NJ, Bell PR. Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: a stopped trial. J Vasc Surg. 1998; 28: 326–334.[CrossRef][Medline] [Order article via Infotrieve]
22. New G, Roubin GS, Iyer SS, Vitek JJ, Wholey MH, Diethrich EB, Hopkins LN, Hobson RW II, Leon MB, Myla SV, et al. Safety, efficacy, and durability of carotid artery stenting for restenosis following carotid endarterectomy: a multicenter study. J Endovasc Ther. 2000; 7: 345–352.[CrossRef][Medline] [Order article via Infotrieve]
23. Roubin GS, New G, Iyer SS, Vitek JJ, Al-Mubarak N, Liu MW, Yadav J, Gomez C, Kuntz RE. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation. 2001; 103: 532–537.
24. Wholey MH, Wholey MH, Jarmolowski CR, Eles G, Levy D, Buecthel J. Endovascular stents for carotid artery occlusive disease. J Endovasc Surg. 1997; 4: 326–338.[CrossRef][Medline] [Order article via Infotrieve]
25. Wholey MH, Wholey M, Mathias K, Roubin GS, Diethrich EB, Henry M, Bailey S, Bergeron P, Dorros G, Eles G, et al. Global experience in cervical carotid artery stent placement. Cathet Cardiovasc Intervent. 2000; 50: 160–167.[CrossRef][Medline] [Order article via Infotrieve]
26. Wholey MH, Wholey MH, Tan WA, Toursarkissian B, Bailey S, Eles G, Jarmolowski C. Management of neurological complications of carotid artery stenting. J Endovasc Ther. 2001; 8: 341–353.[CrossRef][Medline] [Order article via Infotrieve]
27. Hobson RW II. Update on the Carotid Revascularization Endarterectomy versus Stent Trial (CREST) protocol. J Am Coll Surg. 2002; 194: S9–S14.[CrossRef][Medline] [Order article via Infotrieve]
28. Persell S. Carotid angioplasty and stenting versus endarterectomy: larger trials needed. JCOM. 2002; 9: 13–14.
29. Rothwell PM, Gutnikov SA, Warlow CP. Reanalysis of the final results of the European Carotid Surgery Trial. Stroke. 2003; 34: 514–523.
30. Huston J, Nichols DA, Luetmer PH, Rydberg CH, Lewis BD, Meyer FB, Brown RD, Schleck CD. MR angiographic and sonographic indications for endarterectomy. AJNR Am J Neuroradiol. 1998; 19: 309–315.[Abstract]
31. Huston J 3rd, Fain SB, Wald JT, Luetmer PH, Rydberg CH, Covarrubias DJ, Riederer SJ, Bernstein MA, Brown RD, Meyer FB, et al. Carotid artery: elliptic centric contrast-enhanced MR angiography compared with conventional angiography. Radiology. 2001; 218: 138–143.
32. Sundt TM Jr, Sandok BA, Whisnant JP. Carotid endarterectomy: complications and preoperative assessment of risk. Mayo Clin Proc. 1975; 50: 301–306.[Medline] [Order article via Infotrieve]
33. Yamamoto Y, Piepgras DG, Marsh WR, Meyer FB. Complications resulting from saphenous vein patch graft after carotid endarterectomy. Neurosurgery. 1996; 39: 670–676.[CrossRef][Medline] [Order article via Infotrieve]
34. Meyer FB, Windschitl WL. Repair of carotid endarterectomy with a collagen-impregnated fabric graft. J Neurosurg. 1998; 88: 647–649.[CrossRef][Medline] [Order article via Infotrieve]
35. Golledge J, Mitchell A, Greenhalgh RM, Davies AH. Systematic comparison of the early outcome of angioplasty and endarterectomy for symptomatic carotid artery disease. Stroke. 2000; 31: 1439–1443.
36. Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial. Lancet. 2001; 357: 1729–1737.[CrossRef][Medline] [Order article via Infotrieve]
37. Brooks WH, McClure RR, Jones MR, Coleman TC, Breathitt L. Carotid angioplasty and stenting versus carotid endarterectomy: randomized trial in a community hospital. J Am Coll Cardiol. 2001; 38: 1589–1595.
38. Gupta A, Bhatia A, Ahuja A, Shalev Y, Bajwa T. Carotid stenting in patients older than 65 years with inoperable carotid artery disease: a single-center experience. Cathet Cardiovasc Intervent. 2000; 50: 1–9.[CrossRef][Medline] [Order article via Infotrieve]
39. Henry M, Amor M, Klonaris C, Henry I, Masson I, Chati Z, Leborgne E, Hugel M. Angioplasty and stenting of the extracranial carotid arteries. Tex Heart Inst J. 2000; 27: 150–158.[Medline] [Order article via Infotrieve]
40. Henry M, Henry I, Klonaris C, Masson I, Hugel M, Tzvetanov K, Ethevenot G, Le BE, Kownator S, Luizi F, Folliguet B. Benefits of cerebral protection during carotid stenting with the PercuSurge GuardWire system: midterm results. J Endovasc Ther. 2002; 9: 1–13.[CrossRef][Medline] [Order article via Infotrieve]
41. Vitek JJ, Roubin GS, New G, Al-Mubarek N, Iyer SS. Carotid angioplasty with stenting in post-carotid endarterectomy restenosis. J Invasive Cardiol. 2001; 13: 123–125; comment 158–170.
This article has been cited by other articles:
 |
|
 |
|
  A. Schanzer, A. Hoel, C. D. Owens, N. Wake, L. L. Nguyen, M. S. Conte, and M. Belkin Restenosis After Carotid Endarterectomy Performed With Routine Intraoperative Duplex Ultrasonography and Arterial Patch Closure: A Contemporary Series Vascular and Endovascular Surgery, July 1, 2007; 41(3): 200 - 205. [Abstract] [PDF]
|
|
|
|
 |
|
 T. G. Brott, R. D. Brown Jr, F. B. Meyer, D. A. Miller, H. J. Cloft, and T. M. Sullivan Carotid Revascularization for Prevention of Stroke: Carotid Endarterectomy and Carotid Artery Stenting Mayo Clin. Proc., September 1, 2004; 79(9): 1197 - 1208. [Abstract] [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||