Preliminary six-month outcomes of LIMBSAVE (treatment of critical Limb IscheMia with infragenicular Bypass adopting in situ SAphenous VEin technique) registry

ObjectivesGuidelines recommend open bypass surgery for long occlusions of infrainguinal arteries. In situ saphenous vein bypass is a standardized technique. The aim of this study was to report preliminary six-month outcomes of a national, multicenter, observational, prospective registry based on the examination of treatment of critical Limb IscheMia with infragenicular Bypass adopting the in situ SAphenous VEin technique (LIMBSAVE).MethodsFrom January 2018 until October 2019, 428 patients from 41 centers were enrolled in the LIMBSAVE registry. Data were prospectively collected in a dedicated database, including demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative measures (including safety and effectiveness of the valvulotome during the surgical procedures), and 30-day follow-up data. Furthermore, estimated six-month outcomes according to Kaplan-Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated.ResultsPatients were predominantly male (n = 332, 77.6%) with a mean age of 73.3 years (range 39-95). Technical success, defined as bypass pulse after use of the valvulotome, was obtained in all cases. The proximal anastomosis could be reached by the valvulotome in all cases. The mean number of valvulotome uses was 2.5 (range 1-5). No vein perforation was reported. In nine cases (2.1%), a vein lesion with intramural hemorrhage occurred. The mean length of hospital stay was 11.1 days (range 1-60). At 30-day follow-up, the overall bypass patency rate was 97.4%, and the rate of open or endo reinterventions for failing bypass was 5.4%. At six-month follow-up, the estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 78.1%, 86.2%, 92.1%, and 94.7%, respectively.ConclusionsPreliminary intraprocedural outcomes of the LIMBSAVE registry show that the in situ technique with the valvulotome is safe and effective in disrupting v