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Long-term results of semiclosed endarterectomy of the superficial femoral artery and the outcome of failed reconstructions
Long-term results of semiclosed endarterectomy of the superficial femoral artery and the outcome of failed reconstructions F r a n k H . W. M. van der Heijden, M D , Bert C. Eikelboom, M D , PhD, R a n W. H. van R e e d t Dortland, M D , P h D , Yolanda van der Graaf, M D , PhD, Jaap J. F. Steijling, M D , D i n k A. Legemate, M D , PhD, T h e o d o r e Theodorides, M D , P h D , and Theo J. M. V. van Vroonhoven, M D , P h D , Utrecht, The Netherlands Purpose: The optimal method of treatment of superficial femoral artery occlusive disease has yet to be established. Therapeutic options include percutaneous transluminal angioplasty for short lesions and reversed or in situ autologous saphenous vein bypass for long lesious. Currently, staged revascularization with polytetrafluoroethylene as an initial condtfit and autologous vein for secondary procedures is suggested. An alternative to these procedures is endarterectomy of the occluded superficial femoral artery, followed by a femoropopliteal bypass in cases ofendarterectomy failure. Our results with this procedure are reviewed in this article. Methods: From 1980 until 1990, 259 endarterectomies of the superficial femoral artery were attempted, 231 of which were successfifllyperformed in 197 patients (145 men and 52 women), with an average age of 64 years (range 40 to 82 years). The indication for successfully performed endarterectomy was claudication in 186 patients (80%), rest pain in 21 (9%), and gangrene in 24 (11%). The postoperative mortality rate was 0.8% with a complication rate of 10%. Results: Eighty-two failures occurred during follow-up, of which 33 were treated with peripheral bypass. Five additional bypasses were performed because of occlusions distal from the endarterectomized segment. The 5-year primary overall patency rate of successfillly performed endarterectomy was 71% (SE 3.6). The 5-year overall secondary bypass patency rate was 61% (SE 11.3). The combined endarterectomy and bypass patency rate (tertiary patency) was 79% (SE 3.3) after 5 years and 45% (SE 7.6) after 10 years. The overall amputation rate was 5.6% and the amputation rate was 1.6% in patients treated for clandication. Conclm'ions: The combination ofendarterectomy and peripheral bypass provides a valuable alternative to the current treatment of superficial femoral artery occlusive disease. (1 VAsc Si3RG 1993;18:271-9.)
The treatment of lesions of the superficial femoral artery remains a subject of discussion. For short s:tenotic lesions percutaneous transluminal angloFrom the Department of Surgery, Section of Vascular Surgery, UniversityHospital Utrecht and the Department of Epidemiolog7 (Dr. van der Graaf), Universityof Utrecht, Utrecht. Reprint requests: Professor B. C. Eikelboom, Department of Surgery,UniversitT HospitalUtrecht, PO Box85500, 3808 GA Utrecht, The Netk~erlands. Copyright © 1993 by The Society for Vascular Surgery and International Societyfor CardiovascularSurgery,North American Chapter. 0741-5214/93/$1.00 + .10 24/1/44588
plasty is widely used. For long stenotic lesions or long occlusions, the current treatment of choice is a femoropopliteal bypass, by either the reversed or the in siva technique. Several authors ~,2 have proposed the primary use of prosthetic materials such as polytetrafluoroethylene or human umbilical vein in patients requiring above-knee femoropopliteal bypass, and the autologous vein can be preserved for a repeat procedure if it is required. Because of this reason, we have favored the use of endarterectomy of the superficial femoral artery as introduced by Dos Santos a and later modified by Vollmar. 4 In this article 271
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Table I. Extent of femoropopliteal tract obstruction before endarterectomy Endarterectomies Extent of obstruction
No.
%
1-10 cm occlusion 11-30 cm occlusion > 30 cm occlusion Single stenosis Multiple stenosis Unknown
52 14 82 21 28 34
23 6 35 9 12 15
we report the long-term results of superficial femoral artery endarterectomy and address the problem of occlusion of such an endarterectomized artery and the outcome of secondary (autologous) vein reconstruction. PATIENTS A N D M E T H O D S
Technique. During the last decade endarterectomy was the procedure of choice in our hospital in cases of superficial femoral artery occlusive disease. The primary procedure consisted of a femoropopliteal bypass only when the preoperative anglogram showed extensive calcification or involvement of the middle or distal popliteal segments. In our department the usual method of endarterectomy is the semiclosed technique with a ring stripper. 5 The superficial femoral artery is approached through a groin and a medial suprainguinal 5-6 incision. The ring stripper is introduced via arteriotomy in the distal end of the superficial femoral artery or the proximal popliteal artery and is advanced through the artery up on to the groin. An arteriotomy is made at the femoral bifurcation, and the intima core is cut at the origin of the superficial femoral artery, after which the entire core is removed via the distal arteriotomy. The intima in the distal arteriotomy is fixed with tacking sutures. Both arteriotomies are closed with a venous patch. Completion angiography was not performed. An extensive description of our technique has recently been published. 6 Patient population. Between 1980 and 1990, 231 open or semiclosed endarterectomies of the superficial femoral artery were successfully performed. Open endarterectomy was performed in 12 limbs and semiclosed endarterectomy was performed in 219 limbs. A total of 197 patients (145 men and 52 women), with a mean age of 64 years (range 40 to 82 years), underwent operation. Both limbs were treated in 34 patients. Claudication was the indication for endarterectomy in 186 (80%) of the operations. Rest pain was the indication in 21 (9%)
of the endarterectomies, and ulceration or gangrene was the indication in 24 (11%) procedures. Walking distance in the 186 patients with claudication could be divided as follows: less than 50 m, 39 patients (21%); 51 to 100 m, 58 patients (31%); 101 to 250 m, 35 patients (I9%); more than 250 m, 35 patients (19%); and unknown, 19 (10%) patients. Table I lists the extent of the femoropopliteal occlusive disease before endarterectomy. A stenosis was defined as a diameter reduction of more than 50% as determined by monoplane angiography. Follow-up. Before surgery, evaluation consisted of Doppler measurement of ankle/brachial index, treadmill exercise to determine walking distance, and angiography. Routine follow-up after surgery consisted of an outpatient clinic visit every 3 months during the first postoperative year, wherein patient history, popliteal pulses, and anlde/brachial index were registered. After the first year an annual checku~ at our outpatient clinic was usually done. Angiograplay was performed when failure was suspected and repeat operation was mandatory. For the purpose of this study, patients were asked to come to our outpatient clinic if insufficient follow-up data were present. These patients were evaluated by means of patient history, physical examination, anlde/brachial index, and duplex scanning. The criteria used to determine the degree of stenosis in duplex scanning are those defined by Legemate et al. 7 Definitions. In this study, only the results of successful intraoperative endarterectomies are included. In the context of this study, Fontaine stage II is defined as claudication, Fontaine stage III as rest pain, and Fontaine stage IV as ulceration or gangrene. Early complications are considered complications immediately after operation or within the first 30 days after surgery. Endarterectomy failure was defined as absence of popliteal pulse, decline ankle/brachial index of more than 0.i5 compared with postoperative level, or recurrence of claudication. In cases where duplex scanning detected occlusion of the endarterectomized artery that did not have any clinical symptoms, the endarterectomy was regarded as a failure. The clinical consequences of endarterectomy failure were analyzed. The conditions of patients were considered improved if their ischemic manifestations after failure of the endarterectomy were less marked than they had been before operation. The conditions of patients whose ischemic symptoms were as severe as before the endarterectomy were classified as unchanged. The conditions of patients
JOURNAL OF VASCULAR SURGERY Volume 18, Number 2
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were classified as worse if endarterectomy failure led to more advanced ischemia or limb loss. The clinical outcome of failed endarterectomies will be discussed in the Results section, as will the results of repeat procedures after endarterectomy failure (secondary bypass procedures). The Kaplan-Meier method was used for calculation of the cumulative patency rate and for graphic comparison of endarterectomy and bypass. 8 The log rank test was used to test differences between subgroups. Only the primary patency of endarterectomy is mentioned. Of secondary bypass Jrocedures, primary and secondary patency as defined by the Ad Hoc Committee on Reporting Standards 9 are :mentioned. Tertiary patency is considered to be the result of combined endarterectomy and secondary bypass procedures. Tertiary patency is calculated by use of the Kaplan-Meier method, time of entry is the date endarterectomy was performed, the end point was either time of occlusion of the secondary bypass or endarterectomy or the time of death. R_ESULTS Results o f endarterectomy. Two hundred thirty-one of the 259 attempted endarterectomies were successful. Failure resulted from perforation of
Table II. Overall patency rate of endartectomy (intention to treat) of the superficial femoral artery Interval (yr) No. at risk 0-1 l-2 2-3 3-4 4-5 5-6 6-7 7-8 8-9 9-10
259 175 147 128 109 95 63 43 36 17
Cumulative patency rate (%) 76 71 69 66 63 56 50 47 42 33
SE (%) Failed 2.3 2.9 3.2 3.4 3.7 3.8 4.5 5.2 5.3 6.6
61 11 4 5 5 9 7 2 3 3
the artery by the ring stripper in eight procedures, intraoperative occlusion in one procedure, incomplete removal of intima and inability to establish a deavage plane between indma and media in 18 procedures. Total intraoperativc failure rate of endarterectomy in this series was 1i%. Unsuccessful endarterectomies were treated with a femoropopliteal bypass in all cases in the same session. After endarterectomy the mean increase of aulde/brachial index was 0.28 (SE 0.034,p < 0.0001). Early complications after successful endarterec-
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Fig. 2. Life-table: clinical stages of patency of superficial femoral artery endarterectomy. tomy were encountered in 10% (n = 24) of the operations. Complications consisted of death in two patients, significant hemorrhage requiring repeat operation in 10 patients, amputation in two patients, occlusion in three patients, wound healing disturbances in six patients, and lymph leakage in two patients. During follow-up, 82 late failures of successfully performed endarterectomy were seen, furthermore, five occlusions distal from the endarterectomized segment were found. Failures resulted in a 5-year overall primary cumulative patency rate of 71% and a 10-year overall cumulative patency rate of 38%. Fig. 1 and Table II show the primary cumulative patency of all endarterectomies, including intention to treat. An association was found between patency and the preoperative stage of peripheral ischemia (Fig. 2) in successfully performed endarterectomies (p = 0.04), whereas there was no association between the degree of stenosis or occlusion of the superficial femoral artery and the subsequent patency (p = 0.6) (Fig. 3). Rate of failures. During the follow-up period 82 endarterectomy failures were seen (65 of these failures occurred in patients with preoperative dandication, and 17 occurred in patients with limbthreatening ischemia). The mean interval between
endarterectomy and failure was 40 months (range < 1 to > 100 months). After endarterectomy failure, 23 (35%) of the patients with preoperative clandication still had improvement of symptoms, 33 (51%) had the same symptoms, and 9 (14%) had worsening of symptoms. Thirty-four (52%) of the patients with endarterectomy failure did not require treatment, 24 (37%) were treated by means of a secondary bypass procedure, four (6%) underwent lumbar sympathectomy, and three (5%) underwent lumbar sympathectomy and secondary bypass. No amputations were necessav/in this group after failure of the endarterectomy. Among patients who had endarterectomy failure and were treated for limb-threatening ischemia, seven (41%) showed improvement of symptoms after occlusion, and 10 (59%) had the same symptoms. As a result, three of these failures did not require treatment, six were treated by means of a secondary bypass procedure (with or without lumbar sympathectomy), and eight were treated by means of amputation. In total, 37 (45%) of the 82 endarterectomy failures did not require treatment. Table III shows the treatment after failure of the endarterectomy and the stage of peripheral ischemia before the endarterectomy. Results o f secondary femoropopliteal bypass.
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Fig. 3. Life-table: stenosis versus occlusion in patency of supertcial femoral artery endarterectomy. Thirty-three endarterectomy occlusions and five poplitcal artery occlusions distal from the endarterectomized superficial artery in 33 patients were treated with peripheral bypass with or without additional lumbar sympathectomy. The indication for secondary bypass was claudication in 27 (71%) patients, rest pain in six (16%) patients, and ulceration or gangrene in five (13%) patients. In patients with claudication, mean walking distance was 166 m and mean ankk:/brachial index was 0.6. The proximal anastomosis of the bypass was ocalized at the common femoral artery in 25 (66%) patients, the superficial femoral artery in 12 (32%), and the popliteal artery in 1 (2%). The distal ,anastomosis of the bypass was localized at the above-knee popliteal artery in 18 (47%) procedures, *he below-knee popliteal artery in 11 (29%), the tibiofibular trunk in 5 (13%), and a crural artery in 4 (11%) operations. The conduits used for bypass were reversed greater saphenous vein in 19 (50%) procedures, in situ greater saphenous vein in 8 (21%), homologous vein in 10 (26%), and polytetrafluoroethylene prosthesis in 1 (3%) procedure. Early complications after bypass were occlusion in three (8%) patients, significant hemorrhage requiring repeat operation in two (5%), progressive
Table III. Treatment after failure of the endarterectomy (N = 82) in relation to preoperative stage of peripheral ischemia Fontaine s~age
Treatment
N
Percentage (%)
II (n = 65)
Conservative Femoropopliteal bypass Sympathectomy Combination Conservative Femoropopliteal bypass Amputation Combination
34 24 4 3 3 5 8 1
52 38 6 4 18 29 47 6
III and IV (n = 17)
Combination stands for a combination of bypass procedures and sympathectomy.
gangrene with patent bypass requiring amputation in one (3%) patient, and minor complications in three (8%). All occlusions were treated with thrombectomy, two of which failed shortly after the procedure. No early postoperative deaths were seen. At the time of follow-up three (9%) of 33 patients had died. The cause of death was cardiovascular disease in two patients and unknown in one. During the follow-up period after bypass, 14 failures were seen. Reason for failure was occlusion of bypass in 11
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38 29 21 18 15
Cumulative patency rate (%)
SE (%)
Failed
79 73 66 66 61
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8 2 2 0 1
(79%) patients, occlusion distal from bypass in two (14%) patients, and aneurysm formation in one (7%) patient. This resulted in a 5-year overall primary cumulative patency rate after bypass of 61%. The failures were primarily treated by thrombectomy in three (21%) patients, conservative therapy in two (15%), revision of either the proximal or distal anastomosis in three (21%) patients, bypass in four (28%), and amputation in two (15%) patients. The 5-year overall secondary cumulative patency rate after bypass is 61% (Table IV, Fig. 4). Six patients were unavailable for follow-up, 14 bypasses failed, three patients died, one patient with a patent bypass underwent amputation, and i 4 patients had bypasses that were still patent. The final treatment of failed secondary bypasses was conservative treatment in five patients, amputation in four, and bypass in five patients.
Combined results; "tertiary patency." The results of successfully performed endarterectomy and secondary bypass procedures are combined as "tertiary patency." The tertiary overall patency rate is 79% after 5 years and 45% after 10 years. Fig. 5 and Table V show the tertiary patency. The total number of-amputations was 13. Eight amputations were performed immediately after failure of the endarterectomy; the indication for endarterectomy in these cases was fimb-threatening ischemia. After secondary bypass, five amputations had to be performed, one because of progressive gangrene with a patent bypass and four because of bypass occlusion. Indication f ~ endarterectomy in the patients who finally underwent amputation was claudication in three patients and limb-threatening ischemia in 10. During follow-up, the total amputation rate for patients with stage II peripheral ischemia was 1.6% after endarterectomy and secondary bypass procedures. The average time between endarterectomy and amputation was 28 months (range 6 to 71 months). DISCUSSION The optimal method for treatment of superficial femoral artery occlusive disease has yet to be estabfished. Therapeutic options are percutaneous transluminal angioplasty, 1°12 reversed or in situ autologous saphenous vein bypass, or a staged infrainguinal
JOURNAL OF VASCULAR SURGERY Volume 18, Number 2
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revascularization with prosthetic materials as a primary bypass followed by an autologous saphenous vein bypass if a secondary vascular procedure is needed) ,2 We offer an alternative option: primary treatment of superficial femoral artery occlusive disease by means of endarterectomy. Recent studies have shown that endarterectomy is a valuable surgical technique for reopening the superficial femoral artery. 13q5 Complication rate, mortality rate, and patency rate of endarterectomy compare well with the results of autologous vein femoropopliteal bypasses. 16 Our study shows a morAiry rate of 1%, a complication rate of 10%, and a 5-year overall primary patency rate of 71% for successfully pedbrmed endarterectomies. In our stud), the intraoperative failure rate was 11%, which was always followed by a femoropopliteal bypass in the same session. Because patients do not suffer any adverse effects if endarterectomy casmot be performed, we reported only the results of successfully performed endarterectomies. Endarterectomy is a technically difficult operation; the developmenl: of a cleavage plane between the intima and media has to be performed with great care. Extensive calcifications of the arterial wall can make the establishing of a cleavage plane impossible and can cause perforation of the artery during passage of the ring stripper or inadequate removal of the
Table V. Superficial femoral artery endarterectomy patency; primary versus tertiary Interval (yr) Primary 0-1
No. at risk 231
1-2 2-3 3-4 4-5 5-6
177
6-7 7-8 8-6 9-10
65
Tertiary
149 111
130
97 44 36 17
0-1
231
2-3 3-4
157
1-2
4-5
5-6 6-7 7-8
8-9 9-10
187 137 116 101 70 50 39 19
Cumulative patency rate (%)
SE (%)
Failed
85 80 77 74 71 64 56 52 47 36
2.2 2.7 3.0 3.3 3.6 3.9 4.6 5.4 5.7 7.0
32 11 4 5 5 8 7 3 3 3
90 87 85 83 79 74 70 65 56 45
1.8 2.3 2.6 2.9 3.3 3.8 4.6 5.4 5.9 7.6
21 6 4 3 5 6 4 3 4 3
intima core. Inadequate removal of the entire intima core can cause early occlusion of the endarterectomized segment. Patency can be improved by extending the intraoperative control by means of an
278
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intraoperative angiogram ~7or by direct visual inspection by angioscopy. 18 In this study completion arteriography was not routinely performed; however, it is our opinion that intraoperative angiography should be performed to assess the quality of the arterial reconstruction. During follow-up we noticed that a number of patients had complete occlusion of the endarterectomized artery on duplex scanning without any complaints or decrease in ankle/brachial index. Thirtythree percent of the patients treated for claudication still showed improvement of symptoms after endarterectomy failure, and 48% did not require treatment. In studies by Brewster et al.19 and Blankensteijn et al.20 this percentage was 9% and 26%, respectively, after bypass failure. Cannon et al.21 also concluded in their study that the outcome of endarterectomy failure is better than the outcome of femoropopfiteal bypass failure. An explanation for these differences could be that collateral circulation is spared and occluded collateral vessels are reopened during endarterectomyY,23 This is in contrast to bypass wherein a harmful effect is seen regarding the extent of the collateral circulation. 24 If surgical treatment of endarterectomy occlusion was required, femoropopliteal bypass remained possible in 76% of the cases. Autologous vein could be used as a graft in 71% of these cases. In a large number of cases the ipsilateral saphenous vein could be used, which consequently reduced morbidity rate. If autologous saphenous vein could not be used, homologous vein was used as a conduit, z~ No deaths were seen after secondary bypass procedures, and the complication rate was 24%. Primary 5-year cumulative patency rate for all secondary bypass procedures was 61%. For secondary bypass procedures, other authors report 5-year cumulative patency rates of 0% to i8% for prosthetic grafts and 36% to 63% for venous grafts. 9,26 These studies and the study by Brewster et al. z7 show that the patency of secondary procedures is strongly influenced by the nature of the graft. Endarterectomy enables us to use autologous saphenous vein as a conduit for secondary vascular procedures. The final amputation rate after endarterectomy and secondary bypass occlusion in our study was 5.6% overall and 1.6% for patients treated for claudication. Brewster et al. 19 report an amputation rate of 7% after occlusion of a primary and secondary femoropopliteal bypass in patients treated for clandication. Walker et al.28 also report a low amputation rate after endarterectomy failure in their study. The technique of endarterectomy holds another major advantage; no prosthetic material is used in
this procedure. Therefore the risk of infection is minimized, and the outcome of infection is less severe than is encountered with infection of a vein or prosthetic graft. In fact, we have successfullyremoved infected grafts and restored patency with endarterectomy. Instead of a staged infrainguinal revascularization with prosthetic materials as a primary bypass as proposed by Rosen et al.2 and Cannon et al.,~ or primary reversed or in-situ autologous vein bypass, we propose primary treatment of superficial femoral artery occlusive disease by means of endarterectomy followed by bypass if necessary. In our series this policy resulted in a tertiary 5-year overall cumulative patency rate of 79%. The final proof of the value of staged infrainguinal revascularization with endarterectomy needs to come from randomized studies. Therefore, to judge the semiclosed endarterectomy in modern vascular practice, randomization betwee~ percutaneous transluminal angioplasty and endarterectomy for short stenotic lesions or occlusions and between autologous saphenous vein bypass and endarterectomy for long stenotic lesions and occlusions is necessary. REFERENCES
1. Cannon JA. A comparison of potential femoropopiiteai bypass grafting using different PTFE vs. vein grafting sequences. Int Vase Surg 1992;1:50-60. 2. Rosen RC, Johnson WC, Bush HL, Cho SI, O'Hara ET, Nasbeth DC. Staged infrainguinal revascularizarion: initial prosthetic above-knee bypass followed by a distal vein bypass for recurrent ischemia. Am J Surg 1986;152:224-9. 3. Dos Santos JC. Sur la desobstmction des thromboses arterielles anciermes. Mere Acad Clair 1947;73:409-11. 4. Vollmar J. Rekonstructive Chirurgie der Arterien. Stuttgart: George Thieme Verlag 1967;24-7,264-70. 5. Imparato AM, Bracco A, Rim GEB. Comparisons of three technics for femoral-popliteal arterial reconstructions. Ann Surg 1973;177:375-80. 6. Heijden FHWM van der, Eikelboom BC, Reedt D o r d ~ RWH van, et al. Endarterectorny of the superficial femoral artery: a procedure worth reconsidering. Eur J Vasc Surg 1992;6:561-8. 7. Legemate DA, Teeuwen C, Hoeneveld H, Ackerstaff RGA, Eikelboom BC. Spectral analysis criteria in duplex scanning of aortoiliac and femoropopliteal arterial disease. Ultrasound Med Biol 1991;17:769-76. 8. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations, l Am Stat Assoc 1958;53:22-7. 9. Ad Hoc Committee on Reporting Standards. Suggested standards for reports dealing with lower extremity ischemia. J VAsc SURG 1986;4:80-94. 10. Johnston KW, Rae M, Hogg-Iohnston SA, et al. 5-year results. of a prospective study of percutaneous transluminal angioplasty. Ann Surg 1987;206:403-13. 11. Adar R, Critchfield GC, Eddy DM. A confidence profile analysis of the results of femoropopliteal percutaneous trans-
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12. 13.
14.
15. 16.
17. 18.
19. 20.
luminal angioplasty in the treatment of lower extremity ischemia. J VAsc SURa 1989;10:57-67. Jeans WD, Murphy P, Hughes AO, Horrocks M, Baird RN. Randomized trial of laser-assisted passage through occluded femoro-popliteal arteries. Br J Radiol 1990;63:19-21. InaharaT, Scot CM. Endarterectomy for segmental occlusive disease of the superficial femoral artery. Arch Surg 1981;116: 1547-53. Vercellio G, Castelli P, Coletti M, Carlesi R, Agrifoglio G. Semiclosed thromboendarterectomy on femoro-popliteal tract revisited after a fourteen years experience of 595 cases. Int Surg 1986;71:59-61. Ouriel K, Smith CR, DeWeese JA. Endarterectomy for localized les~.ons of the superficial femoral artery at the adductor canal, l VAsc SURG 1986;3:531-4. Taylor LM, Edwards 5M, Porter JM. Present status of reversed vein bypass grafting: five-year results of a modern series. J Vase SURG 1990;11:193-206. Wylie EJ, Binkley FM, Albo RJ. Femoropopliteal endarterectomy; operative modifications and consideration of effects of outflow lesions. Am J Surg 1964;108:215-23. Vollmar JF, Loeprecht H, Hutschenreiter S. Advances in vascular endoscopy. Thorac Cardiovasc Surg 1987;35:33441. Brewster DC, LaSalle AJ, Robinson JG, Strayhorn EC, Darling RC. Femoropopliteal graft failures. Arch Surg 1983;118:1043-7. Blankensteijn JD, van Vroonhoven TJ. Consequences of failure of femoro-popliteal grafts for clandication. Eur l Vase Surg 1988;2:183-9.
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21. Cannon JA, Barker WF, Kawakami IG. Femoral popliteal endarterectomy in the treatment ofobliterative atherosclerotic disease. Surgery 1958;43:76-91. 22. Lerwick ER. Oscillating loop endarterectomy for peripheral reconstruction. Surgery 1985;97:574-84. 23. Cannon JA, Barker WF. Successfialmanagement of obstructive femoral atherosderosis by endarterectomy. Surgery 1955; 38:48-59. 24. Jacobsen IH, McAllister FF. The harmful effect of arterial grafting on existing collateral cir~lation. Surgery 1957;42: 148-55. 25. Reedt Dortland RWH van, Leeuwen MS van, Steijling ~JF, Theodorides Th, van Vroonhoven ThJMV. Long-term results with vein hornograft in femoro-distal arterial reconstructions. Eur J Vasc Snrg 1991;5:557-64. 26. Whittemore AD, Clowes AW, Couch NP, Mannick JA. Secondary femoropopliteal reconstruction. Ann Surg 1981; 193:35-42. 27. Brewster DC, LaSalle AI, Robinson JG, Strayhorn EA, Darling RC. Factors affecting patency of femoropopliteal bypass grafts. Surg Gynecol Obstet 1983;157:437-42. 28, Walker PM, Imparato AM, Riles TS, Mintzer R, Kopelman I. Long-term results in superficial femoral artery endarterectomy. Surgery 1981;89:23-9.
Submitted Sept. 8, 1992; accepted Nov. 29, 1992.
The treatment of lesions of the superficial femoral artery remains a subject of discussion. For short s:tenotic lesions percutaneous transluminal angloFrom the Department of Surgery, Section of Vascular Surgery, UniversityHospital Utrecht and the Department of Epidemiolog7 (Dr. van der Graaf), Universityof Utrecht, Utrecht. Reprint requests: Professor B. C. Eikelboom, Department of Surgery,UniversitT HospitalUtrecht, PO Box85500, 3808 GA Utrecht, The Netk~erlands. Copyright © 1993 by The Society for Vascular Surgery and International Societyfor CardiovascularSurgery,North American Chapter. 0741-5214/93/$1.00 + .10 24/1/44588
plasty is widely used. For long stenotic lesions or long occlusions, the current treatment of choice is a femoropopliteal bypass, by either the reversed or the in siva technique. Several authors ~,2 have proposed the primary use of prosthetic materials such as polytetrafluoroethylene or human umbilical vein in patients requiring above-knee femoropopliteal bypass, and the autologous vein can be preserved for a repeat procedure if it is required. Because of this reason, we have favored the use of endarterectomy of the superficial femoral artery as introduced by Dos Santos a and later modified by Vollmar. 4 In this article 271
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Table I. Extent of femoropopliteal tract obstruction before endarterectomy Endarterectomies Extent of obstruction
No.
%
1-10 cm occlusion 11-30 cm occlusion > 30 cm occlusion Single stenosis Multiple stenosis Unknown
52 14 82 21 28 34
23 6 35 9 12 15
we report the long-term results of superficial femoral artery endarterectomy and address the problem of occlusion of such an endarterectomized artery and the outcome of secondary (autologous) vein reconstruction. PATIENTS A N D M E T H O D S
Technique. During the last decade endarterectomy was the procedure of choice in our hospital in cases of superficial femoral artery occlusive disease. The primary procedure consisted of a femoropopliteal bypass only when the preoperative anglogram showed extensive calcification or involvement of the middle or distal popliteal segments. In our department the usual method of endarterectomy is the semiclosed technique with a ring stripper. 5 The superficial femoral artery is approached through a groin and a medial suprainguinal 5-6 incision. The ring stripper is introduced via arteriotomy in the distal end of the superficial femoral artery or the proximal popliteal artery and is advanced through the artery up on to the groin. An arteriotomy is made at the femoral bifurcation, and the intima core is cut at the origin of the superficial femoral artery, after which the entire core is removed via the distal arteriotomy. The intima in the distal arteriotomy is fixed with tacking sutures. Both arteriotomies are closed with a venous patch. Completion angiography was not performed. An extensive description of our technique has recently been published. 6 Patient population. Between 1980 and 1990, 231 open or semiclosed endarterectomies of the superficial femoral artery were successfully performed. Open endarterectomy was performed in 12 limbs and semiclosed endarterectomy was performed in 219 limbs. A total of 197 patients (145 men and 52 women), with a mean age of 64 years (range 40 to 82 years), underwent operation. Both limbs were treated in 34 patients. Claudication was the indication for endarterectomy in 186 (80%) of the operations. Rest pain was the indication in 21 (9%)
of the endarterectomies, and ulceration or gangrene was the indication in 24 (11%) procedures. Walking distance in the 186 patients with claudication could be divided as follows: less than 50 m, 39 patients (21%); 51 to 100 m, 58 patients (31%); 101 to 250 m, 35 patients (I9%); more than 250 m, 35 patients (19%); and unknown, 19 (10%) patients. Table I lists the extent of the femoropopliteal occlusive disease before endarterectomy. A stenosis was defined as a diameter reduction of more than 50% as determined by monoplane angiography. Follow-up. Before surgery, evaluation consisted of Doppler measurement of ankle/brachial index, treadmill exercise to determine walking distance, and angiography. Routine follow-up after surgery consisted of an outpatient clinic visit every 3 months during the first postoperative year, wherein patient history, popliteal pulses, and anlde/brachial index were registered. After the first year an annual checku~ at our outpatient clinic was usually done. Angiograplay was performed when failure was suspected and repeat operation was mandatory. For the purpose of this study, patients were asked to come to our outpatient clinic if insufficient follow-up data were present. These patients were evaluated by means of patient history, physical examination, anlde/brachial index, and duplex scanning. The criteria used to determine the degree of stenosis in duplex scanning are those defined by Legemate et al. 7 Definitions. In this study, only the results of successful intraoperative endarterectomies are included. In the context of this study, Fontaine stage II is defined as claudication, Fontaine stage III as rest pain, and Fontaine stage IV as ulceration or gangrene. Early complications are considered complications immediately after operation or within the first 30 days after surgery. Endarterectomy failure was defined as absence of popliteal pulse, decline ankle/brachial index of more than 0.i5 compared with postoperative level, or recurrence of claudication. In cases where duplex scanning detected occlusion of the endarterectomized artery that did not have any clinical symptoms, the endarterectomy was regarded as a failure. The clinical consequences of endarterectomy failure were analyzed. The conditions of patients were considered improved if their ischemic manifestations after failure of the endarterectomy were less marked than they had been before operation. The conditions of patients whose ischemic symptoms were as severe as before the endarterectomy were classified as unchanged. The conditions of patients
JOURNAL OF VASCULAR SURGERY Volume 18, Number 2
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were classified as worse if endarterectomy failure led to more advanced ischemia or limb loss. The clinical outcome of failed endarterectomies will be discussed in the Results section, as will the results of repeat procedures after endarterectomy failure (secondary bypass procedures). The Kaplan-Meier method was used for calculation of the cumulative patency rate and for graphic comparison of endarterectomy and bypass. 8 The log rank test was used to test differences between subgroups. Only the primary patency of endarterectomy is mentioned. Of secondary bypass Jrocedures, primary and secondary patency as defined by the Ad Hoc Committee on Reporting Standards 9 are :mentioned. Tertiary patency is considered to be the result of combined endarterectomy and secondary bypass procedures. Tertiary patency is calculated by use of the Kaplan-Meier method, time of entry is the date endarterectomy was performed, the end point was either time of occlusion of the secondary bypass or endarterectomy or the time of death. R_ESULTS Results o f endarterectomy. Two hundred thirty-one of the 259 attempted endarterectomies were successful. Failure resulted from perforation of
Table II. Overall patency rate of endartectomy (intention to treat) of the superficial femoral artery Interval (yr) No. at risk 0-1 l-2 2-3 3-4 4-5 5-6 6-7 7-8 8-9 9-10
259 175 147 128 109 95 63 43 36 17
Cumulative patency rate (%) 76 71 69 66 63 56 50 47 42 33
SE (%) Failed 2.3 2.9 3.2 3.4 3.7 3.8 4.5 5.2 5.3 6.6
61 11 4 5 5 9 7 2 3 3
the artery by the ring stripper in eight procedures, intraoperative occlusion in one procedure, incomplete removal of intima and inability to establish a deavage plane between indma and media in 18 procedures. Total intraoperativc failure rate of endarterectomy in this series was 1i%. Unsuccessful endarterectomies were treated with a femoropopliteal bypass in all cases in the same session. After endarterectomy the mean increase of aulde/brachial index was 0.28 (SE 0.034,p < 0.0001). Early complications after successful endarterec-
JOURNAL OF VASCULAR SURGERY
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endarterectomy and failure was 40 months (range < 1 to > 100 months). After endarterectomy failure, 23 (35%) of the patients with preoperative clandication still had improvement of symptoms, 33 (51%) had the same symptoms, and 9 (14%) had worsening of symptoms. Thirty-four (52%) of the patients with endarterectomy failure did not require treatment, 24 (37%) were treated by means of a secondary bypass procedure, four (6%) underwent lumbar sympathectomy, and three (5%) underwent lumbar sympathectomy and secondary bypass. No amputations were necessav/in this group after failure of the endarterectomy. Among patients who had endarterectomy failure and were treated for limb-threatening ischemia, seven (41%) showed improvement of symptoms after occlusion, and 10 (59%) had the same symptoms. As a result, three of these failures did not require treatment, six were treated by means of a secondary bypass procedure (with or without lumbar sympathectomy), and eight were treated by means of amputation. In total, 37 (45%) of the 82 endarterectomy failures did not require treatment. Table III shows the treatment after failure of the endarterectomy and the stage of peripheral ischemia before the endarterectomy. Results o f secondary femoropopliteal bypass.
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Fig. 3. Life-table: stenosis versus occlusion in patency of supertcial femoral artery endarterectomy. Thirty-three endarterectomy occlusions and five poplitcal artery occlusions distal from the endarterectomized superficial artery in 33 patients were treated with peripheral bypass with or without additional lumbar sympathectomy. The indication for secondary bypass was claudication in 27 (71%) patients, rest pain in six (16%) patients, and ulceration or gangrene in five (13%) patients. In patients with claudication, mean walking distance was 166 m and mean ankk:/brachial index was 0.6. The proximal anastomosis of the bypass was ocalized at the common femoral artery in 25 (66%) patients, the superficial femoral artery in 12 (32%), and the popliteal artery in 1 (2%). The distal ,anastomosis of the bypass was localized at the above-knee popliteal artery in 18 (47%) procedures, *he below-knee popliteal artery in 11 (29%), the tibiofibular trunk in 5 (13%), and a crural artery in 4 (11%) operations. The conduits used for bypass were reversed greater saphenous vein in 19 (50%) procedures, in situ greater saphenous vein in 8 (21%), homologous vein in 10 (26%), and polytetrafluoroethylene prosthesis in 1 (3%) procedure. Early complications after bypass were occlusion in three (8%) patients, significant hemorrhage requiring repeat operation in two (5%), progressive
Table III. Treatment after failure of the endarterectomy (N = 82) in relation to preoperative stage of peripheral ischemia Fontaine s~age
Treatment
N
Percentage (%)
II (n = 65)
Conservative Femoropopliteal bypass Sympathectomy Combination Conservative Femoropopliteal bypass Amputation Combination
34 24 4 3 3 5 8 1
52 38 6 4 18 29 47 6
III and IV (n = 17)
Combination stands for a combination of bypass procedures and sympathectomy.
gangrene with patent bypass requiring amputation in one (3%) patient, and minor complications in three (8%). All occlusions were treated with thrombectomy, two of which failed shortly after the procedure. No early postoperative deaths were seen. At the time of follow-up three (9%) of 33 patients had died. The cause of death was cardiovascular disease in two patients and unknown in one. During the follow-up period after bypass, 14 failures were seen. Reason for failure was occlusion of bypass in 11
JOURNAL OF VASCULAR SURGERY August 1993
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38 29 21 18 15
Cumulative patency rate (%)
SE (%)
Failed
79 73 66 66 61
5.8 6.9 8.2 9.0 11.3
8 2 2 0 1
(79%) patients, occlusion distal from bypass in two (14%) patients, and aneurysm formation in one (7%) patient. This resulted in a 5-year overall primary cumulative patency rate after bypass of 61%. The failures were primarily treated by thrombectomy in three (21%) patients, conservative therapy in two (15%), revision of either the proximal or distal anastomosis in three (21%) patients, bypass in four (28%), and amputation in two (15%) patients. The 5-year overall secondary cumulative patency rate after bypass is 61% (Table IV, Fig. 4). Six patients were unavailable for follow-up, 14 bypasses failed, three patients died, one patient with a patent bypass underwent amputation, and i 4 patients had bypasses that were still patent. The final treatment of failed secondary bypasses was conservative treatment in five patients, amputation in four, and bypass in five patients.
Combined results; "tertiary patency." The results of successfully performed endarterectomy and secondary bypass procedures are combined as "tertiary patency." The tertiary overall patency rate is 79% after 5 years and 45% after 10 years. Fig. 5 and Table V show the tertiary patency. The total number of-amputations was 13. Eight amputations were performed immediately after failure of the endarterectomy; the indication for endarterectomy in these cases was fimb-threatening ischemia. After secondary bypass, five amputations had to be performed, one because of progressive gangrene with a patent bypass and four because of bypass occlusion. Indication f ~ endarterectomy in the patients who finally underwent amputation was claudication in three patients and limb-threatening ischemia in 10. During follow-up, the total amputation rate for patients with stage II peripheral ischemia was 1.6% after endarterectomy and secondary bypass procedures. The average time between endarterectomy and amputation was 28 months (range 6 to 71 months). DISCUSSION The optimal method for treatment of superficial femoral artery occlusive disease has yet to be estabfished. Therapeutic options are percutaneous transluminal angioplasty, 1°12 reversed or in situ autologous saphenous vein bypass, or a staged infrainguinal
JOURNAL OF VASCULAR SURGERY Volume 18, Number 2
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revascularization with prosthetic materials as a primary bypass followed by an autologous saphenous vein bypass if a secondary vascular procedure is needed) ,2 We offer an alternative option: primary treatment of superficial femoral artery occlusive disease by means of endarterectomy. Recent studies have shown that endarterectomy is a valuable surgical technique for reopening the superficial femoral artery. 13q5 Complication rate, mortality rate, and patency rate of endarterectomy compare well with the results of autologous vein femoropopliteal bypasses. 16 Our study shows a morAiry rate of 1%, a complication rate of 10%, and a 5-year overall primary patency rate of 71% for successfully pedbrmed endarterectomies. In our stud), the intraoperative failure rate was 11%, which was always followed by a femoropopliteal bypass in the same session. Because patients do not suffer any adverse effects if endarterectomy casmot be performed, we reported only the results of successfully performed endarterectomies. Endarterectomy is a technically difficult operation; the developmenl: of a cleavage plane between the intima and media has to be performed with great care. Extensive calcifications of the arterial wall can make the establishing of a cleavage plane impossible and can cause perforation of the artery during passage of the ring stripper or inadequate removal of the
Table V. Superficial femoral artery endarterectomy patency; primary versus tertiary Interval (yr) Primary 0-1
No. at risk 231
1-2 2-3 3-4 4-5 5-6
177
6-7 7-8 8-6 9-10
65
Tertiary
149 111
130
97 44 36 17
0-1
231
2-3 3-4
157
1-2
4-5
5-6 6-7 7-8
8-9 9-10
187 137 116 101 70 50 39 19
Cumulative patency rate (%)
SE (%)
Failed
85 80 77 74 71 64 56 52 47 36
2.2 2.7 3.0 3.3 3.6 3.9 4.6 5.4 5.7 7.0
32 11 4 5 5 8 7 3 3 3
90 87 85 83 79 74 70 65 56 45
1.8 2.3 2.6 2.9 3.3 3.8 4.6 5.4 5.9 7.6
21 6 4 3 5 6 4 3 4 3
intima core. Inadequate removal of the entire intima core can cause early occlusion of the endarterectomized segment. Patency can be improved by extending the intraoperative control by means of an
278
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intraoperative angiogram ~7or by direct visual inspection by angioscopy. 18 In this study completion arteriography was not routinely performed; however, it is our opinion that intraoperative angiography should be performed to assess the quality of the arterial reconstruction. During follow-up we noticed that a number of patients had complete occlusion of the endarterectomized artery on duplex scanning without any complaints or decrease in ankle/brachial index. Thirtythree percent of the patients treated for claudication still showed improvement of symptoms after endarterectomy failure, and 48% did not require treatment. In studies by Brewster et al.19 and Blankensteijn et al.20 this percentage was 9% and 26%, respectively, after bypass failure. Cannon et al.21 also concluded in their study that the outcome of endarterectomy failure is better than the outcome of femoropopfiteal bypass failure. An explanation for these differences could be that collateral circulation is spared and occluded collateral vessels are reopened during endarterectomyY,23 This is in contrast to bypass wherein a harmful effect is seen regarding the extent of the collateral circulation. 24 If surgical treatment of endarterectomy occlusion was required, femoropopliteal bypass remained possible in 76% of the cases. Autologous vein could be used as a graft in 71% of these cases. In a large number of cases the ipsilateral saphenous vein could be used, which consequently reduced morbidity rate. If autologous saphenous vein could not be used, homologous vein was used as a conduit, z~ No deaths were seen after secondary bypass procedures, and the complication rate was 24%. Primary 5-year cumulative patency rate for all secondary bypass procedures was 61%. For secondary bypass procedures, other authors report 5-year cumulative patency rates of 0% to i8% for prosthetic grafts and 36% to 63% for venous grafts. 9,26 These studies and the study by Brewster et al. z7 show that the patency of secondary procedures is strongly influenced by the nature of the graft. Endarterectomy enables us to use autologous saphenous vein as a conduit for secondary vascular procedures. The final amputation rate after endarterectomy and secondary bypass occlusion in our study was 5.6% overall and 1.6% for patients treated for claudication. Brewster et al. 19 report an amputation rate of 7% after occlusion of a primary and secondary femoropopliteal bypass in patients treated for clandication. Walker et al.28 also report a low amputation rate after endarterectomy failure in their study. The technique of endarterectomy holds another major advantage; no prosthetic material is used in
this procedure. Therefore the risk of infection is minimized, and the outcome of infection is less severe than is encountered with infection of a vein or prosthetic graft. In fact, we have successfullyremoved infected grafts and restored patency with endarterectomy. Instead of a staged infrainguinal revascularization with prosthetic materials as a primary bypass as proposed by Rosen et al.2 and Cannon et al.,~ or primary reversed or in-situ autologous vein bypass, we propose primary treatment of superficial femoral artery occlusive disease by means of endarterectomy followed by bypass if necessary. In our series this policy resulted in a tertiary 5-year overall cumulative patency rate of 79%. The final proof of the value of staged infrainguinal revascularization with endarterectomy needs to come from randomized studies. Therefore, to judge the semiclosed endarterectomy in modern vascular practice, randomization betwee~ percutaneous transluminal angioplasty and endarterectomy for short stenotic lesions or occlusions and between autologous saphenous vein bypass and endarterectomy for long stenotic lesions and occlusions is necessary. REFERENCES
1. Cannon JA. A comparison of potential femoropopiiteai bypass grafting using different PTFE vs. vein grafting sequences. Int Vase Surg 1992;1:50-60. 2. Rosen RC, Johnson WC, Bush HL, Cho SI, O'Hara ET, Nasbeth DC. Staged infrainguinal revascularizarion: initial prosthetic above-knee bypass followed by a distal vein bypass for recurrent ischemia. Am J Surg 1986;152:224-9. 3. Dos Santos JC. Sur la desobstmction des thromboses arterielles anciermes. Mere Acad Clair 1947;73:409-11. 4. Vollmar J. Rekonstructive Chirurgie der Arterien. Stuttgart: George Thieme Verlag 1967;24-7,264-70. 5. Imparato AM, Bracco A, Rim GEB. Comparisons of three technics for femoral-popliteal arterial reconstructions. Ann Surg 1973;177:375-80. 6. Heijden FHWM van der, Eikelboom BC, Reedt D o r d ~ RWH van, et al. Endarterectorny of the superficial femoral artery: a procedure worth reconsidering. Eur J Vasc Surg 1992;6:561-8. 7. Legemate DA, Teeuwen C, Hoeneveld H, Ackerstaff RGA, Eikelboom BC. Spectral analysis criteria in duplex scanning of aortoiliac and femoropopliteal arterial disease. Ultrasound Med Biol 1991;17:769-76. 8. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations, l Am Stat Assoc 1958;53:22-7. 9. Ad Hoc Committee on Reporting Standards. Suggested standards for reports dealing with lower extremity ischemia. J VAsc SURG 1986;4:80-94. 10. Johnston KW, Rae M, Hogg-Iohnston SA, et al. 5-year results. of a prospective study of percutaneous transluminal angioplasty. Ann Surg 1987;206:403-13. 11. Adar R, Critchfield GC, Eddy DM. A confidence profile analysis of the results of femoropopliteal percutaneous trans-
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12. 13.
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15. 16.
17. 18.
19. 20.
luminal angioplasty in the treatment of lower extremity ischemia. J VAsc SURa 1989;10:57-67. Jeans WD, Murphy P, Hughes AO, Horrocks M, Baird RN. Randomized trial of laser-assisted passage through occluded femoro-popliteal arteries. Br J Radiol 1990;63:19-21. InaharaT, Scot CM. Endarterectomy for segmental occlusive disease of the superficial femoral artery. Arch Surg 1981;116: 1547-53. Vercellio G, Castelli P, Coletti M, Carlesi R, Agrifoglio G. Semiclosed thromboendarterectomy on femoro-popliteal tract revisited after a fourteen years experience of 595 cases. Int Surg 1986;71:59-61. Ouriel K, Smith CR, DeWeese JA. Endarterectomy for localized les~.ons of the superficial femoral artery at the adductor canal, l VAsc SURG 1986;3:531-4. Taylor LM, Edwards 5M, Porter JM. Present status of reversed vein bypass grafting: five-year results of a modern series. J Vase SURG 1990;11:193-206. Wylie EJ, Binkley FM, Albo RJ. Femoropopliteal endarterectomy; operative modifications and consideration of effects of outflow lesions. Am J Surg 1964;108:215-23. Vollmar JF, Loeprecht H, Hutschenreiter S. Advances in vascular endoscopy. Thorac Cardiovasc Surg 1987;35:33441. Brewster DC, LaSalle AJ, Robinson JG, Strayhorn EC, Darling RC. Femoropopliteal graft failures. Arch Surg 1983;118:1043-7. Blankensteijn JD, van Vroonhoven TJ. Consequences of failure of femoro-popliteal grafts for clandication. Eur l Vase Surg 1988;2:183-9.
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21. Cannon JA, Barker WF, Kawakami IG. Femoral popliteal endarterectomy in the treatment ofobliterative atherosclerotic disease. Surgery 1958;43:76-91. 22. Lerwick ER. Oscillating loop endarterectomy for peripheral reconstruction. Surgery 1985;97:574-84. 23. Cannon JA, Barker WF. Successfialmanagement of obstructive femoral atherosderosis by endarterectomy. Surgery 1955; 38:48-59. 24. Jacobsen IH, McAllister FF. The harmful effect of arterial grafting on existing collateral cir~lation. Surgery 1957;42: 148-55. 25. Reedt Dortland RWH van, Leeuwen MS van, Steijling ~JF, Theodorides Th, van Vroonhoven ThJMV. Long-term results with vein hornograft in femoro-distal arterial reconstructions. Eur J Vasc Snrg 1991;5:557-64. 26. Whittemore AD, Clowes AW, Couch NP, Mannick JA. Secondary femoropopliteal reconstruction. Ann Surg 1981; 193:35-42. 27. Brewster DC, LaSalle AI, Robinson JG, Strayhorn EA, Darling RC. Factors affecting patency of femoropopliteal bypass grafts. Surg Gynecol Obstet 1983;157:437-42. 28, Walker PM, Imparato AM, Riles TS, Mintzer R, Kopelman I. Long-term results in superficial femoral artery endarterectomy. Surgery 1981;89:23-9.
Submitted Sept. 8, 1992; accepted Nov. 29, 1992.