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Endovascular-First Strategy in Patients with Critical Limb Ischemia

  • Fri, 9/5/08 - 3:36pm
  • 0 Comments
  • 2991 reads
Author(s): 

Hassan Tehrani, MD, Chris Otero, MD, Mariano Arosemena, MD, Eduardo Perez, MD, Kenneth Zelnick, MD, Cesar Mendoza, MD, Jose Yrizarry, MD, Kevin Stadtlander, MD, Gary Rothenberg, MD, Michael Cohen, MD, Karin Zachow, MD, Alan Schob, MD

Introduction
Surgical bypass is considered the gold standard for the treatment of patients with chronic severe lower extremity ischemia.1,2 However, the 5-year limb salvage rates reported as high as 80% in single center/surgeon series have not been reproduced in multicenter studies or national registries.1,3,4 Often, these are extensive surgeries being performed in a mostly elderly patient population with multiple comorbidities. This has an impact on functional outcome. Only 45% of patients under going infrainguinal bypass reported feeling “back to normal” at 6 months.5

Recent advances in endovascular technology, coupled with the perception of associated lower morbidity and mortality has made the percutaneous treatment of severe lower extremity ischemia more attractive in recent years. At our institution we adopted an “endovascular-first” strategy in the management of patients with chronic severe lower extremity ischemia regardless of their age or comorbidities. The goal of this study was to evaluate the treatment outcomes of this approach in all patients presenting to our institution with chronic severe lower extremity ischemia.

Materials and Methods
The study is a retrospective analysis of 29 consecutive patients with infrainguinal occlusive disease manifesting as severe chronic ischemia (33 limbs) who were treated with a combination of endovascular techniques over 26 months (October 2003 to December 2005). The decision to treat using endovascular techniques was based upon clinical examination, diagnostic imaging and at the discretion of the interventionalist. Patients who had treatment of isolated suprainguinal lesions were excluded. Also excluded were patients presenting with acute ischemia or a functionally useless limb.

Endovascular Techniques
All procedures were performed in a dedicated interventional suite or a hybrid endovascular operating room. Diagnostic imaging was performed either prior to the procedure using gadolinium-enhanced magnetic resonance angiography or at the same time as the intervention using iodinated contrast. TransAtlantic Inter-Society Consensus (TASC) classification was used to categorize the limbs’ morphologic arterial lesions. Either an antegrade or retrograde common femoral approach was used for arterial access. Heparin anticoagulation was used to obtain an activated clotting time of > 200 seconds throughout the procedure. Superficial femoral artery lesions were crossed using an angled 0.035 hydrophilic wires. Popliteal and infrapopliteal lesions were crossed using 0.014 hydrophilic wires. Superficial femoral artery lesions underwent angioplasty and primary stenting with either Smart Stents (Cordis, Warren, New Jersey) or Viabahn stent grafts (WL Gore & Assoc. Flagstaff, Arizona). Popliteal and infrapopliteal lesions underwent either balloon angioplasty, Clirpath Excimer laser angioplasty (Spectranetics, Colorado Springs, Colorado) or SilverHawk atherectomy (Foxhollow, Redwood, California) or a combination of the above. Intraprocedural angiographic data were recorded for later analysis. Post-procedure all patients were treated with 300mg clopidogrel if not previously prescribed, and maintained on 75 mg/day for a minimum of 6 weeks.

Follow-up. Follow-up consisted of gradation of symptoms, physical examination and non-invasive measurements including ankle brachial indices and pulse volume recordings. Patients were seen within one month of the procedure, then every 6 months thereafter.

Definitions. Technical success was defined as the ability to obtain in-line arterial flow into the foot with less than a 20% residual stenosis using percutaneous techniques. Clinical success was defined as the resolution of rest pain or healing of an ulcer or amputation site. Limb salvage was defined as the ability to avoid major level amputation (below or above knee).

Statistics. Data were entered into an Excel spreadsheet (Microsoft, Inc, Redmond, Washington). Data were transferred into SPSS software (SPSS, Inc, Chicago, Illinois) for statistical analysis.

References: 

1. Akbari CM, Pomposelli FB, Gibbons GW, et al. Lower extremity revascularization in diabetes: Late observations. Arch Surg 2000;135:452–456. 2. Pomposelli FB, Kansal N, Hamdan A, et al. A decade of experience with dorsalis pedis artery bypass: Analysis of outcome in more than 1000 cases. J Vasc Surg 2003;37:307–315. 3. Stonebridge PA, Prescott RJ, Ruckley CV. Randomized trial comparing infrainguinal polytetrafluoroethylene bypass grafting with and without vein interposition cuff at the distal anastomosis. The Joint Vascular Research Group. J Vasc Surg 1997;26:543–550. 4. Kantonen I, Lepantalo M, Luther M, et al. Factors affecting the results of surgery for chronic critical leg ischemia — a nationwide survey. Finnvasc Study Group. J Vasc Surg 1998;27:940–947. 5. Gibbons GW, Burgess AM, Guadagnoli E, et al. Return to well-being and function after infrainguinal revascularization. J Vasc Surg 1995;21:35–44. 6. Goshima KR, Mills JL, Hughes JD. A new look at outcomes after infrainguinal bypass surgery: Traditional reporting standards systematically underestimate the expenditure of effort required to attain limb salvage. J Vasc Surg 2004;39:330–355. 7. Tefera G, Hoch J, Turnipseed WD. Limb-salvage angioplasty in vascular surgery practice. J Vasc Surg 2005;41:988–993. 8. Varty K, Nydahl S, Nasim A, et al. Results of surgery and angioplasty for the treatment of chronic severe lower limb ischaemia. Eur J Vasc Endovasc Surg 1998;16:159–163. 9. Nydahl S, Hartshorne T, Bell PR, et al. Subintimal angioplasty of infrapopliteal occlusions in critically ischaemic limbs. Eur J Vasc Endovasc Surg 1997;14:212–216. 10. Adam DJ, Beard JD, Cleveland T, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): Multicentre, randomised controlled trial. Lancet 2005;366:1925–1934. 11. Laird JR, Zeller T, Gray BH, et al. Limb salvage following laser-assisted angioplasty for critical limb ischemia: Results of the LACI multicenter trial. J Endovasc Ther 2006;13:1–11.

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