The long-term value of composite limb salvage

Transcription

1 The long-term value of composite limb salvage grafts for John B. Chang, MD, and Theodore A. Stein, PhD, Roslyn, N.Y. Purpose: We determined the long-term efficacy of composite grafts for limb salvage when autogenous vein grafts were not available. Methods: After arterial bypass, the 8-year primary and secondary patency, limb salvage, and mortality rates were compared by life-table analysis. One hundred twenty-five patients had 130 composite grafts for 27 femoropopliteal bypasses, 48 femorotibial bypasses, and 55 sequential femoropopliteotibial bypasses. Three hundred forty patients had autogenous vein grafts for 247 femoropopliteal bypasses and 114 femorotibial bypasses. Seventy-two patients had 82 femoropopliteal prosthetic grafts. Results: Eight-year primary and secondary patency rates were 56% and 62O/o for femoropopliteal procedures with composite grafts, respectively, and 53% and 59% for autogenous vein grafts, respectively. The secondary patency rate for polytetrafluoroethylene grafts was 35% and was less (p < 0.05) than the rate for the vein grafts. Secondary patency rates for femorotibial procedures were 66% for the vein grafts, 56% for single outflow composite grafts, and 52% for dual outflow composite grafts. Limb salvage rates for femoropopliteal procedures were 73% for composite grafts, 63% for polytetrafluoroethylene, and 82% for vein grafts, and for femorotibial procedures were 53% for single outflow composite grafts, 65% for dual outflow composite grafts, and 86% for vein grafts. Conclusions: Composite grafts achieve long-term preservation ofischemic limbs in patients who are facing limb loss because of poor run-off and have insufficient autogenous vein for a graft. (J VASC SURG 1995;22:25-31.) Most vascular surgeons consider that the autogenous vein is the best conduit for distal lower extremity arterial revascularization to prevent loss of the limb.l,2 The greater and lesser saphenous veins, however, may be absent because the vessels have been used in previous bypass procedures or are inadequate for achieving a suitable graft. After multiple graft failures, the long-term outcome of another bypass has been only minimally satisfactory with other autogenous veins or a prosthesis? -6 Restoration of an adequate blood flow to save the limb not only requires detailed attention and technical precision to the performance of the bypass but also necessitates choosing the best graft for these patients. Thus to preserve the lower extremity, alternate grafts have been used and have been comprised of either other autogenous veins, polytetrafluoroethylene (PTFE), or compos- From the Long Island Vascular Center, Roslyn. Reprint requests: }'ohn B. Chang, MD, Long Island Vascular Center, 1050 Northern Blvd., Roslyn, NY Copyright 1995 by The Society for Vascular Surgery and International Society for Cardiovascular Surgery, North American Chapter /95/$ /1/64716 ites of vein and PTFE. 7q The poor results with prosthetic grafts for long bypasses with below-the-knee outflow indicate that it is probably not the best choice for these operations, nqs Composite grafts may be a better option, because graft patency and limb salvage appear to be better with composites of vein and PTFE for popliteal and infrapopliteal bypasses. 9 Patency rates for these grafts have been reported to be 65% at 1 and 2 years after femorotibial bypasses, 12 and at 5 years they have ranged from 28% to 53%. 8,14 In this study the long-term value of composite grafts with single or dual outflow below the knee for fimb salvage have been compared with the PTFE and autogenous vein grafts, and their usefulness for a repeat bypass was evaluated. METHODS Between 1975 and 1994, 482 patients had 573 arterial revascularizations for limb salvage with the proximal anastomosis at the femoral artery level and the distal anastomosis below the knee. The senior author (~. B. C.) performed all bypasses. Patients were monitored from 0 to 13 years. In 125 patients, 130 composite grafts were used for 27 femo- 25

2 26 Chang and Stein july 1995 Table I. Graft material used in bypass procedures Groups CFP CFT CFPT VFP VFT PFP Reversed GSV I78 (72) 36 (3I) - In sire GSV (20) 77 (68) - GSV + PTFE 21 (76) 29 (60) 42 (76) Other veins ~ 2 (8) 6 (12) 2 (4) 20 (8) 1 (1) - Other veins + PTFE 4 (16) 13 (28) 11 (20) PTFE (100) Total I4 82 CFP, Composite femoropopliteal bypass; CFT, composite femorotibial bypass; CFPT, composite femoropopliteotibial bypass; VFP, vein femoropopliteal bypass; VFT, vein femorotibial bypass; PFP, prosthetic femoropophteal bypass; GSV, greater saphenous vein. ~Cephahc, basilic, lesser saphenous, peroneal, anterior tibial, posterior tibial, and popliteal veins. Number in parenthesis is the percent of the total. For autogenous vein bypasses, 11 cephalic veins were used, six less saphenous veins, three basihc veins and one popliteal vein. Seven composite vein grafts were comprised of two GSV segments, two were composed of GSV and lesser saphenous vein, and one was composed of GSV and cephalic vein. Table II. Repeat arterial rcvascularizations with composite, composite-sequential, vein, and prosthetic grafts Repeat procedure None (%) First (%) Second or more (%) Femoropopliteal Composite PTFE Vein Total Femorotibial Composite Sequential Vein Total 11 (4.6) 3 (3.6) 13 (41.9) 42 (17.5) 28 (32.9) 12 (38.7) 187 (77.9) 54 (63.5) 6 (19.4) (8.0) 16 (47.1) 21 (45.7) 24 (17.5) 11 (32.3) 20 (43.5) 102 (74.5) 7 (20.6) 5 (10.8) ropopliteal bypasses, 48 femorotibial bypasses with a single outflow, and 55 sequential femoropopliteotibial bypasses with a dual outflow. In 340 patients, autogenous vein grafts were used for 247 femoropopliteal bypasses and for 114 femorotibia] bypasses. In 72 patients, PTFE grafts were used for 82 femoropoplitea] bypasses. A detailed description of the graft materials that were used in the bypasses are shown in Table I. The greater saphenous vein was our first choice for bypass grafts. Frequently, it was not available because it had been previously used for lower extremity bypasses or for coronary artery bypasses, it was too small ( < 3.0 mm diameter), or there was gross evidence of fibrosis. When the saphenous vein was inadequate to be used for the entire length of the conduit, composite grafts were usually made by use of a segment of the great saphenous vein. Most composite grafts were comprised of a proximal PTFE segment combined to a distal greater saphenous vein segment, which provided either single or double outflows. Other veins were combined with PTFE in approximately 25% of grafts. Composites of two vein segments were also used to construct two femo- ropopliteal and eight femorotibial grafts. The surgica] technique has been described, is Reversed greater saphenous vein segments were used for most (72%) vein femoropoplitea] procedures, and the in situ greater saphenous vein for most (68%) vein femorotibial grafts. Other veins were used less often. PTFE was used for femoropopliteal bypasses only when distal runoff was good. Femorotibia] bypasses with PTFE are not reported, because only a small number were done, and the outcome was poor, confirming reports by other investigators) In Table II the type of graft used for initial and repeat distal bypasses after graft failure is shown. For femoropopliteal bypasses, the autogenous vein was used in most cases for the initial bypass, and was available for most first repeat bypasses. Most patients requiring a second or greater repeat femoropopliteal bypass lackcd sufficient autogenous vein for another graft, and composite and PTFE grafts were used in 80% of these procedures. For femorotibial procedures, the autogenous vein was again used for most initial bypasses, but was available in only 20% of the first repeat bypasses, 10% of second repeats, and 0% for higher repeat procedures. Composite grafts were

3 Volume 22, Number 1 Chang and Stein 27 Table III. Life-table primary patency rates for femoropopliteal grafts Graft time (yr.) At risk Occluded Lost Patency SE VFP CFP PTFE VFP, Vein femoropopliteal bypass; CFP, composite femoropopliteal bypass. used for most repeat femorotibial bypasses with a single outflow for limbs with good distal runoff and with dual outflows to either bridge occlusions or to increase blood flow to the distal runoff beds. Patients who had an initial bypass with autogenous vein were given aspirin, 325 mg daily, and dipyridamole (Persantine), 25 mg four times daily. Patients who had other grafts or a redo bypass received warfarin (Coumadin) to increase clotting time to 1.5 of the control, and Persantine, 25 mg four times daily, to prevent graft occlusion. Patients Bypass procedures were done in 329 men and 208 women with a mean age of 69 _+ 10 years. Patients who had composite grafts were 2.6 years older than those with vein grafts. There were 189 (35.2%) patients with diabetes mellitus, 159 (30.0%) patients with hypertension, 140 (26.1%) patients with a prior myocardial infarction, 69 (13 %) patients with a prior cerebrovascular accident, and 297 (55.3%) patients who had a history of cigarette smoking. Preoperative symptoms of distal arterial disease were rest pain, which occurred in 55%, and gangrene or ischemic ulceration, which occurred in 78%. Surgery was indicated by limb-threatening ischemia, which was deter- mined by the criteria of the Society for Vascular Surgery and the International Society for Cardiovascular Surgery.16 Continuous-wave Doppler and segmental pressures were used to determine occlusion. The mean ankle-brachial systolic pressure index was 0.38, and 96% of patients had indexes of 0 to 0.9. Some patients with diabetes had incompressible arteries, and metatarsal and toe pressures and pulse volume recordings were obtained. Postoperative follow-up After operation, patients were routinely seen at 3, 6, and 12 months, and then at 1-year intervals. Some patients, however, stopped coming for their follow-up examinations, and we have lost contact with 180 patients. Mean follow-up times were 3.5 years for composite femoropopliteal grafts, 3.9 years for vein femoropopliteal grafts, 3.3 years for femoropopliteal PTFE grafts, 3.0 years for composite femorotibial grafts, 2.8 years for composite sequential grafts, and 3.3 years for vein femorotibial grafts. At each visit, a detailed history for symptoms of claudication, rest pain, or ischemia was taken and pedal pulses were determined. Segmental pressures and blood flow by Doppler sonography were measured at each visit by staffat the Long Island Vascular

4 28 Chang and Stein July 1995 Table IV. Life-table secondary patency rates for femoropopliteal grafts Gra~ time (yr.) At risk Occluded Lost Patency SE VFP CFP PTFE V/P, Vein femoropopliteal bypass; CFP, composite femoropopliteal bypass. Center, which is accredited by the Intersocietal Commission for the Accreditation of Vascular Laboratories. All surveillance methods followed the established guidelines of the Intersocietal Commission for the Accreditation of Vascular Laboratories. Segmental pressures and CW Doppler and plethysmographic waveforms were used to determine graft occlusion. Angiography was performed on patients who might require surgical revascularization. Statistical methods In this study, the results of the grafts with in situ vein were combined with those of the reversed vein segments. The mean patient age and standard deviation were calculated. Cumulative life-tables for primary and secondary graft patency, limb salvage, and survival rates were determined by the Kaplan-Meier method, and rates were compared by the Mantel- Haenszel test and the z test for endpoints. 17 The Fisher exact test was used to compare groups for the incidence of graft failure. A statistical difference was inferred with ap < RESULTS Primary patency rates for PTFE grafts were lower (p < 0.05) than those for femoropopliteal vein grafts from the third to the sixth year (Table III). The rates for femoropopliteal composite grafts were similar (p > 0.20) to PTFE grafts and to autogenous vein grafts (p > 0.80). In situ greater saphenous vein grafts had a primary patency rate of 72%. Early graft failure occurred within 30 days after operation and was most frequent with femoropopliteal composite grafts, but these were used for repeat bypasses. After the first year there was only one other occlusion and patency rates for composite and vein grafts became similar (p > 0.45). Secondary patency rates for PTFE grafts were also lower (p < 0.05) than those with femoropopliteal vein grafts from the fourth to the seventh year (Table IV). The rates with femoropopliteal composite grafts were similar (p > 0.29) to vein grafts. Limb salvage rates were 63% in patients with PTFE grafts, 73% in patients with femoropopliteal composite grafts and 82% in patients with vein grafts. Eight-year survival rates were 68% for patients with vein grafts, 59% for patients with PTFE grafts, and 48% for patients with femoropopliteal composite grafts. Patients with the vein grafts, however, were several years younger than those with the composite grafts. Most patients died of cardiac complications. Eight-year primary patency rates for femo-

5 IOURNAL OF VASCULAR SURGERY Volume 22, Number 1 Chang and Stein 29 Table V. Life-table primary patency rates for femorotibial grafts Graft time (yr.) At risk Occluded Lost Patency SE VFT CFT CFPT VFT, Vein femorotibial bypass; CFT, composite femorotibial bypass; CFPT, composite femoropopliteotibial bypass. rotibial bypasses were 56% for the vein grafts and 35% for the sequential-composite grafts (femoropopliteotibial) with dual outflow (Table V). In situ greater saphenous vein grafts had a primary patency rate of 77%. All femorotibial composite grafts with a single outflow occluded within 6 years, and the primary patency rate was 38%. Secondary patency rates were 65% for vein grafts, 52% for composite femoropopliteotibial grafts, and 56% for composite femorotibial grafts (Table VI). The 8-year limb salvage rates were 86% for femorotibial vein grafts, 53% for single outflow composite grafts, and 65% for composite femoropopliteotibial grafts. Primary graft failure of initial bypasses occurred in 20% of grafts and at a rate of 7% per year for femoropopliteal and femorotibial vein grafts and 10% per year for all composite and PTFE grafts. After a repeat bypass, graft failure occurred in about 45% of the grafts and was an increase (p < 0.05) compared with the initial bypasses, but there was no difference (p > 0.55) by graft type. After multiple graft failures, 42% to 70% of the grafts occluded at an average of 33 months, but most grafts were salvaged by thromboendarterectomy or thrombectomy; secondary patency rates were similar (p > 0.29) for grafts. DISCUSSION It is clear from our study and those of other investigators that autogenous vein grafts are superior to prosthetic grafts for infrapopliteal arterial reconstruction. 1'2"13'1s Many of the failed PTFE grafts required a repeat bypass with a composite graft to salvage the lower extremity. Although point-to-point comparisons of patency rates for composite femoropopliteal grafts were done only up to 3 years, the long-term patency rates are slightly less than those of autogenous vein grafts. Composite grafts were used for 42% of bypasses after multiple bypass failures, but these had the highest early primary graft failure rates. It is known that graft failure occurs much more rapidly with the second bypass than with the initial procedure, 19 and during the early recovery period patients nced to be monitored closely to maintain the graft. Primary graft occlusion after repeat femoropopliteal bypasses was increased for all grafts. Poor 5-year patency rates of less than 30% and low limb salvage rates have been reported with repeat bypasses Other investigators have achieved 5-year primary patency rates of 37% to 57% with repeat bypasses. 3,6,24 A 4-year primary patency rate with predominantly autogenous vein grafts has been reported to be 80%, with a limb salvage rate of

6 30 Chang and Stein july 1995 Table VI. Life-table secondary patency rates for femorotibial grafts Graft time (yr.) At r#k Occluded Lost Patency SE VFT CFT CFPT VFT, Vein femorotibial bypass; CFT, composite femorotibial bypass; CFPT, composite femoropopliteotibial bypass. 70%. 19 Our 8-year primary and secondary patency rates for femoropopliteal composite grafts were 56% and 62%, respectively, and the limb salvage rate was 73%. These results indicate that composite grafts can be used to achieve a good outcome for femoropopliteal revascularizations when the greater saphenous vein is unavailable. With long distal bypasses, femorotibial composite grafts also preserved the lower extremity. Our 8-year secondary patency rates for these bypasses were 65% for autogenous vein grafts, 56% for composite grafts with a single distal outflow, and 52% for composite grafts with a double outflow. Other investigators have reported 5-year patency rates of 63% with autogenous vein grafts and 28% to 34% with composite grafts. 9'24 We believe that our results with femorotibial composite grafts have been good because we used double outflow sequential grafts to decrease the peripheral vascular resistance and increase blood flow to the distal runoff bed when blood flow to these beds was poor. Composite grafts with a single outflow were used when distal runoff was good. Early recognition of thrombosis and early treatment by thrombectomy or thromboendarterectomy also salvaged many of these femorotibial grafts, and the limb salvage rate was 53% with single outflow grafts and 63% with double outflow grafts. Because composite grafts for long distal bypasses salvaged many limbs in patients who had inadequate autogenous veins for a graft, composite grafts should be an option for these patients. Although some vascular surgeons may believe that amputation should be performed in patients with multiple graft failure because the repeat bypass graft is likely to occlude, we believe that an attempt should be made to preserve the lower extremity in these patients. After amputation many patients become nonambulatory, their health and spirit decline progressively, and they die. 14,25 If meticulous attention is taken in the creation of the composite graft, in the technical placement of this graft with particular concern for the outflow, and in the management of early complications, composite grafts can be used for distal revascularization to successfully preserve the lower limb for an extended time. REFERENCES 1. Taylor LM, Edwards JM, Porter JM. Present status of reversed vein bypass grafting: five-year results of a modern series. J VASC SURG 1990;11: Veith FJ, Gupta SK, Ascer E, et al. Six-year prospective multicenter randomized comparison of autologous saphenous

7 Volume 22, Number 1 Chang and Stein 31 vein and expanded polytetrafluoroethylene graft in infrainguinal arterial reconstruction. J VASC SURG 1986;3: Ascer E, Collier P, Gupta SK, et al. Reoperation for polytetrafluoroethylene bypass failure: the importance of distal outflow site and operative technique in determining outcome. J VAse SURe 1987;5: Dennis JW, Littooy FN, Greisler HP, et al. Secondary vascular procedures with polytetrafluoroethylene grafts for lower extremity ischemia in a male veteran population. J VASC SURG 1988;8: Green RM, Ouriel K, Ricotta JJ, et al. Revision of failed infrainguinal bypass graft: principles of management. Surgery 1986;100: Whittemore AD, Clowes AW, Couch NP, et al. Secondary femoropopliteal reconstruction. Ann Surg 1981;193: EI-Masery S, Saad E, Sauvage LR, et al. Femoropopliteal bypass with externally supported knitted Dacron grafts: a follow-up of 200 grafts for one to twelve years. J VASC SURG 1994;19: Quifiones WJ, Colhurn MD, Ahn SS, et al. Very distal bypass for salvage of the severely ischemic extremity. Am J Surg 1993;166: Raithel D. Role of PTFE grafts in infrainguinal arterial reconstruction: a ten-year experience. In: Wang ZB, Becker H-M, Mishima Y, Chang JB, eds. The proceeding of the international conference on vascular surgery. New York: International Academy Publisher, 1993;1: Whittemore AD, Kent KC, Donaldson MC, et al. What is the proper role of polytetrafluoroethylene grafts in infrainguinal reconstruction? J VASe SuRG 1989;10: Bell PRF. Are distal vascular procedures worthwhile? Br J Surg 1985;72: Britton JP, Leveson SH. Distal arterial bypass by composite grafting. Br J Surg 1987;74: Veterans Administration Cooperative Study Group 141. Comparative evaluation of prosthetic, reversed, and in situ bypass grafts in distal popliteal and tibial-peroneal revascularization. Arch Surg 1988;123: Little JM. Successful amputation-by whose standards? Am Heart 1975;90: Chang JB. Popliteal and tibial artery revascularization. In: Chang JBC, ed. Vascular Surgery. New York: Spectrum Publications, 1985: Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery and the International Society for Cardiovascular Surgery. Standards for reports dealing with lower extremity ischemia. J VASC SURG 1986;4: Lagakos SW. Statistical analysis of survival data. In: Bailar JC III, Mosteller F, eds. Medical uses of statistics. 2nd ed. Boston: N Engl J Med Books, 1992: Michaels JM. Choice of materials for above-knee femoropopliteal bypass graft. Br J Surg 1989;76: De Frang RD, Edwards JiM, Moneta GL, et al. Repeat leg bypass after multiple prior bypass failures. J VASC SURG 1994;19: Burnham SJ, Flanigan DP, Goodrean II, et al. Nonvein bypass in below-knee reoperation for lower limb ischemia. Surgery 1978;84: Painton JF, Avellone JC, Plecha FR. Effectiveness of reoperation after late failure of femoropopliteal reconstruction. Am I Surg 1978;135: Tyson RR, Grosh JD, Reichle FA. Redo surgery for graft failure. Am J Surg 1978;136: Edwards JM, Taylor LM Jr, Porter JM. Treatment of failed lower extremity bypass grafts with new autogenous vein bypass grafting. [1 VASC SURG 1990;11: Londrey GL, Ramsey DE, Hodgson KJ, et al. Infrapopliteal bypass for severe ischemia: comparison of autogenous vein, composite, and prosthetic grafts. ]" VASC SURG 1991;13: Whittemore AD, Donaldson MC, Mannick JA. Infrainguinal reconstruction for patients with chronic renal insufficiency. J VASC SURG 1993;17: Submitted Dec. 28, 1994; accepted March 7, 1995.