Current Status of Lower Extremity Arterial
Revascularization of Occlusive Disease

Albert G. Hakaim, M.D., M.Sc., FACS,  Associate Professor of Surgery, Mayo Clinic Jacksonville, Director, Endovascular Surgery, Section of Vascular Surgery

 
Introduction

Arterial reconstruction for atherosclerosis of lower extremity arteries continues to provide a significant challenge for vascular surgeons. Recently, the indications for such procedures have been analyzed and outcomes reported. In addition, the results of technical modifications in the performance of autogenous venous reconstruction have been documented. Endovascular approaches to inflow and lower extremity disease have also been reported. Analysis of the intensity of post-operative non-invasive surveillance, and their efficacy will be reviewed. Lastly, the efficacy of post-operative medical therapy is reviewed.

Indications and outcomes

Critical limb ischemia represents the primary indication for infra-popliteal arterial reconstruction. The alternative to such reconstructions is usually amputation. Until recently, little has been reported regarding the cost of such interventions. Panayiotopoulos et al, prospectively analyzed 109 limbs between 1991-5. Mean follow-up was 12 months. At 3 years, primary patency was 27%, and limb salvage reached 54%. Cost analysis were as follows: successful bypass, $ 8,640.00; failed bypass resulting in amputation $34,132; primary amputation $ 25,460. Therefore, cost analysis provides further justification for an aggressive approach to critical ischemia.1 Critical limb ischemia in patients with diabetes mellitus (DM) and/or end-stage renal disease (ESRD) have been the subject of several recent studies. Hakaim, et al analyzed 83 femoro-tibial or peroneal in situ reconstructions in 76 patients. Operative mortality was 1.2%. Patients with DM+ESRD had a significantly decreased 1 year cumulative graft patency of 53%, versus 82% in patients with DM alone. However limb salvage rates were 63% versus 84% for patients with DM + ESRD or DM alone, respectively. More importantly, 1 year survival for DM+ESRD was 52%, compared to 90% for DM alone.2

Recently, Korn,et al have reported a small series of similar patients. 33 procedures were performed on 31 limbs of 23 patients with ESRD. 57% required a digital or transmetatarsal amputation. Primary patency was 65% at 2 years, while limb salvage was 67% at 1 year. Patient survival was 47% at 2 years. Cost analysis was determined to be $44,308 per year of limb salvage.3

The results of arterial reconstruction to the pedal vessels in patients with ESRD have been reported. Leers, et al performed 41 procedures in 34 such patients. All procedures were performed for limb salvage. Primary patency and limb salvage at 2 years was 62% and 56%, respectively. However 16 amputations (63%) were required within 6 months of surgery. In addition, limb salvage lagged behind patency due to continued necrosis in spite of a functional bypass. Such a negative outcome was predicted by heel necrosis.4

Claudication has not been a common indication for arterial reconstruction to tibial vessels, largely due to the benign natural history of this condition. However, the results of such reconstructions in highly selected patients have been reported. Conte, et al reported the results of 57 tibial reconstructions in 53 patients, performed over a 16 year period. All were performed using autogenous vein as the arterial conduit. Primary patency at 5 years was 84%, significantly superior compared to patients bypassed for critical ischemia. Therefore, in selected patients such procedures appear justified.5

Conduits for arterial reconstruction

It is well established that autogenous Greater saphenous vein, either in situ, reversed, or transposed provided superior longterm graft patency. Alternative conduits seem to be increasingly required, as myocardial revascularization is frequently required in patients with surgically correctable periphreal vascular disease. Alternative prosthetic conduits include polytetrafluoroethylene (PTFE), Dacron, or composite grafts consisting of a prosthetic with a distal venous segment. The patency of prosthetic conduits for above the knee arterial reconstructions has recently been analyzed. A multicenter prospective trial over a 5 year period compared PTFE to Dacron for such reconstructions. There was no difference in 5 year cumulative patency between conduits; 43% at 5 years. In addition, patency was not influenced by smoking, diabetes, hypertension, number of run-off vessels, or post-operative aspirin or warfarin therapy.6

Similarly, a 5 year patency of 43% for 128 above the knee PTFE reconstructions has also been reported.7

Prosthetic conduits for below the knee arterial reconstructions have not achieved similar patency rates. A recent retrospective review compared greater saphenous vein and PTFE conduits to tibial vessels. In this series, 635 procedures were performed in 518 patients over a 24 year period. Primary patency at 1 year was 63% and 48% for vein and PTFE, respectively. At 2 years, primary patency for vein was 54% compared to 31% for PTFE.8

Composite conduits represent an alternative when autogenous vein of sufficient length is not available, and critical ischemia is the operative indication. Twenty-five composite grafts to the below knee popliteal or tibial arteries were compared to 144 saphenous vein and 45 PTFE bypasses. At 4 years, cumulative primary patency was 81%, 76%, and 67%, for saphenous vein, composite, and PTFE, respectively.9

Technical modifications for in-situ Greater Saphenous vein bypasses

Utilization of the Greater saphenous vein as an in situ arterial conduit requires valvulotomy and side branch ligation. The in-situ technique allows for utilization of the saphenous vein without the long medial incision required to procure the vein, when the reversed vein technique is performed. However, when several side branches are present, several small incisions are required for individual ligation. The result can sometimes be multiple incisions with a length nearly equivalent to the incision required for vein procurement.

Several studies have been reported using an endovascular approach to perform side branch occlusion; making multiple incisions for branch ligation unnecessary.

Using this approach, Cikrit et al performed 31 procedures using a single groin and lower leg incision. 12 branches were missed, and hospital length of stay (LOS) ranged from 2 to 6 days.10 A more recent series of 15 femoropopliteal bypass procedures resulted in a decrease in LOS to a mean of 35 hours. In addition, 1 year patency was 88%. Further refinements in devices appears to have decreased hospital LOS without affecting graft patency.11

Medical therapy following lower extremity revascularization

Since the majority of patients with peripheral vascular disease have some degree of coronary artery disease, aspirin therapy is not uncommon in this patient population. Since a prospective determination of the effect of aspirin on peripheral graft patency would require its elimination, such a study has not been undertaken.

In a series of 243 femoro-popliteal or tibial vein grafts, ticlopidine at a dose of 250 mg twice daily was compared to placebo. At 2 years, ticlopidine treated patients had a cumulative patency of 82%, which was significantly superior to 63% for the placebo group.12

Graft surveillance following arterial reconstruction

It is well known that patency following revision of a thrombosed autogenous vein graft is inferior to patency following revision of a stenosis prior to thrombosis. The optimal timing of duplex ultrasound (DU) to detect such stenoses has been investigated. Over a 9 year period, 615 autogenous vein bypasses underwent either intensive surveillance, consisting of ankle-brachial indices and DU or clinical surveillance (ie. return of pre-operative symptoms). Secondary or primary assisted patency at 2 years was 80% and 67% for the intensive vs clinical surveillance groups, respectively.13 A similar intensive vs clinical surveillance protocol was prospectively followed in a series of 159 patients. 79 patients underwent intensive while 77 patients underwent clinical surveillance. At 3 years, patency was 78% and 53% for the intensive and clinical surveillance groups, respectively. No benefit was demonstrated for intensive surveillance of prosthetic grafts.14

Endovascular approaches to lower extremity revascularization

Endovascular, or repair from within a blood vessel, has gained popularity as an alternative to open repair of abdominal aortic aneurysms. The impact of endovascular stent-grafting is illustrated by our institution performing 70 such procedures in the last year.

Endovascular procedures have been applied in 50 patients utilizing PTFE and Palmaz stents. In this series, 37 occlusions and 14 stenoses in 47 native arteries and 5 prior prosthetic lower extremity grafts were treated. While primary patency was 72%, in-hospital complications occurred in 33%. These results illustrate the feasibility of such procedures, and the importance of patient selection and refinement of technique.15

Superficial femoral artery stenoses and occlusions were initially approached with subintimal dissection to facilitate endovascular thromboendarterectomy. While these procedures reportedly resulted in 72% patency at 30 months, the procedure has not been easily introduced.16 Percutaneous transluminal angioplasty (PTA) has also been combined with intimal dissection for short segment superficial femoral artery stenoses. In an early series of 71 treated occlusions, technical success was achieved in 54 (76%) with major complications occurring in 5.6%. At 6 months average follow-up, 84% were asymptomatic or improved, based upon clinical assessment.17

In an attempt to improve longterm durability, PTA with stenting has been undertaken. In a recent study, 30 patients were evenly divided to receive PTA alone, or PTA+ stent. There was no operative mortality. Overall, there were 6 (15%) major complications. Re-stenosis was more common in those receiving a stent in addition to PTA, 50% vs 25%. Therefore, stenting may actually decrease the durability of infrainguinal PTA.18

Rather than angioplasty, endovascular removal of the offending plaque has recently been attempted. In a series of 14 such procedures, primary patency at 2 years was 61%.19 In an effort to improve patency, endoluminal prostheses have been placed following endovascular endarterectomy. In an initial series of 4 cases, 75% were patent at 6 months.20 In a second series of 14 patients, there were 2 (14%) technical failures. Cumulative primary patency at 1 year was 35.7%. In addition, 23 additional procedures were required to maintain this patency.21

These results must be compared to open surgical endarterectomy of superficial femoral artery disease. In a series of 94 patients over a 15 year period, primary patency at 3 years and 7 years was 66% and 57%, respectively.22 While technically feasible in the majority of cases, endovascular placement of endoluminal grafts for femoro-popliteal disease has not reached the results achieved by conventional femoropopliteal bypass or surgical endarterectomy.

References

  1. Panayiotopoulos YP, Tyrrell MR, Owens SE, Reidy JF, Taylor PR. Outcome and cost analysis after femorocrural and femoropedal grafting for critical limb ischemia. Br J Surg 1997;84:207-12.
  2. Hakaim AG, Gordon JK, Scott TE. Early outcome of in situ femorotibial reconstruction among patients with diabetes alone versus diabetes and end-stage renal failure: analysis of 83 limbs. J Vasc Surg 1998;27:1049-54.
  3. Korn P, Hoenig SJ, Skillman JJ, Kent KC. Is lower extremity revascularization worthwhile in patients with end-stage renal disease. Surgery 2000;128:472-9.
  4. Leers SA, Reifsnyder T, Delmonte R, Caron M.Realistic expectations for pedal bypass grafts in patients with end-stage renal disease. J Vasc Surg 1998;28:976-80.
  5. Conte MA, Belkin M, Donaldson MC, Baum P, Mannick JA, Whittemore AD. Femorotibial bypass for claudication: do the results justify an aggressve approach. J Vasc Surg 1995;21:873-80.
  6. Green RM, Abbott WM, Matsumoto T, Wheeler JR, Miller N, Veith FJ, Money S, Garrett HE. Prosthetic above-knee femoropopliteal bypass grafting: five-year results of a randomized trial. J Vasc Surg 2000;31:417-25.
  7. Allen BT, Reilly JM, Rubin BG, Thompson RW, Anderson CB, Flye MW, Sicard GA. Femoropopliteal bypass for claudication: vein vs PTFE. Ann Vasc Surg 1996;10:178-85.
  8. Sayers RD, Raptis S, Berce M, Miller JH. Long-term results of femorotibial bypass with vein or polytetrafluoroethylene. Br J Surg 1998;85:934-8.
  9. Bebedetti-Valentini F, Gossetti B, Irace I, Martinelli O, Gattuso R. Composite grafts for critical ischemia. Cardiovasc Surg 1996;4:372-6.
  10. Cikrit DF, Dalsing MC, Lalka SG, Fiore NF, Sawchuk AP, Ladd AP, Solooki B. Early results of endovascular-assisted in istu saphenous vein bypass grafting. J Vasc Surg 1994;19:778-85.
  11. Nelson PR, Arous EJ. Endovascular in situ bypass decreases morbidity and hospital stay following infrainguinal arterial reconstruction . J Endovasc Ther 2000;7:309-14.
  12. Becquemin JP. Effect of ticlopidine on the long term patency of saphenous vein bypass grafts in the legs. N Engl J Med 1997;337:1726-31.
  13. Bergamini TM, George SM, Massey HT, Henke PK, Klamer TW, Lambert GE, Miller FB, Garrison RN, Richardson JD. Intensive surveillance of femoropopliteal-tibial autogenous vein bypasses improves long-term graft patency and limb salvage. Ann Surg 1995;221:507-15.
  14. Lundell A, Lindblad B, Bergquist D, Hansen F. Femoropopliteal-crural graft patency is improved by an intensive surveillance program: a prospective randomized study. J Vasc Surg 1995;21:26-33.
  15. Diethrich EB, Papazoglou K. Endoluminal grafting for aneurysmal and occlusive disease in the superficial femoral artery: early experience. J Endovasc Surg 1995;2:225-39.
  16. Wagenmann W, Heinrich P, Hoffmann P. Thromboendarterectomy of the femoro-popliteal region for chronic occlusion. Zentralbl Chir 1981;186: 1360-8.
  17. Bolia A, Miles KA, Brennan J, Bell PR. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol 1990;13:357-63.
  18. Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribble E, Thorne J, Norgren L. Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions. A randomized controlled study. Int Angiol 1999;18:251-5.
  19. Ho GH, Moll FL, Nolthenius RP, van den Berg JC, Overtoom T Th C, Endovascular femoropopliteal bypass combined with remote endarterectomy in SFA occlusive disease: Initial experience. Eur J Vasc Endovasc Surg 2000;19: 27-34.
  20. LoScudo LS, Mascellari L, Dompe G, Di Crisci D, Platone A, Falappa PG. Thromboendarterectomy of the superficial femoral artery with a femoro-popliteal endoprosthesis. Technical note on a preliminary experience. Minerva Cardioangiol 1997;45:541-6.
  21. Tisi PV, Cowman AR, Morris GE. Endoluminal femoropopliteal bypass for intermittent claudication. Eur J Vasc Endovasc Surg 2000;19:481-8.
  22. Ouriel K, Smith CR, DeWeese JA. Endarterectomy for localized lesions of the superficial femoral artery at the adductor canal. J Vasc Surg 1986;3:531-4.
Jacksonville Medicine / December, 2000

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