Purpose: To report the initial clinical experience with fully endovascular extra-anatomic femoro-popliteal bypass (FPB) for limb salvage in patients with critical limb ischemia (CLI) and no traditional endovascular or surgical revascularization options.
Methods: Between June 2013 and May 2018, endovascular procedure was proposed for limb salvage during multidisciplinary team meeting in fifteen hospitalized patients (median age 67 years; 73% men) with CLI and a high risk of major amputation. Primary outcome was amputation-free survival at 1 year. Secondary outcomes included mortality, cardiovascular (CV) events and major limb amputation at 1 year, primary/secondary bypass patency and wound healing at the last follow-up visit. Procedure-related complications (deaths, CV events, hemorrhages) were recorded through 30 days.
Results: Technical procedure success rate was 100%. Major peri-procedural outcomes occurred in two patients (13%): One patient died secondary to cardiogenic shock; one patient suffered acute coronary syndrome associated with iliopsoas bleeding. No major amputation occurred through 30 days. Median follow-up period was 21.5 (18.25-45.5) months (last follow-up visits on April 2019). Amputation-free survival at 1-year and at the last follow-up visit was 80% and 53%, respectively. Cumulative mortality at 1-year and at the last follow-up visit was 13% and 33%, respectively. Primary and secondary bypass patency was 27% and 60%, respectively. Complete wound healing was achieved in 11 patients (73%).
Conclusion: Endovascular extra-anatomic FPB represents an innovative approach for limb salvage in CLI with no traditional endovascular or surgical revascularization options. Our clinical experience highlights that this technique remains challenging because of frequent comorbidities and fragility of this patient population.
Level of evidence: Level 4, Case series.
Keywords: Critical limb ischemia; Endovascular revascularization; Femoro-popliteal bypass; Limb salvage.