Abstract
In 2009 the Society for Vascular Surgery (SVS) developed Objective Performance Goals (OPGs) to assess the safety and efficacy of endovascular treatments of critical limb ischemia (CLI). We evaluated Laser-assisted angioplasty (LAA), using the OPGs All patients that underwent LAA to treat CLI between January 2006 and May 2010 were analyzed. The 30 day safety endpoints of Major Adverse Cardiac Event (MACE) (i.e. Postoperative Death (POD), Myocardial Infarction (MI ) and Cerebrovascular Accident (CVA), Amputation rate and Major Adverse Limb Event (MALE) rate (i.e. thrombosis, thrombectomy, and bypass) were calculated. The efficacy endpoints were calculated using Kaplan-Meier life table analysis. These included MALE + POD, Amputation Free Survival (AFS), and any Re-intervention or above ankle Amputation and Stenosis /occlusion (RAS) calculated at one year. Subsequently, a comparison with the SVS OPGs was made using the student T test. : Laser assisted angioplasty was used to treat 82 limbs with CLI. The mean age was 72.8 years, with a mean follow up of 19 months. Tissue loss and gangrene were the most common indications, in 67 (81.2%) of the limbs. Safety endpoints were: mortality rate 2.6%, MACE rate 3.9%, amputation rate 2.4%, and MALE rate of 9.7%. Efficacy endpoints were MALE + POD 84.1%, Amputation Free Survival 84.1%, and RAS 39%.Our study cohort was compared to the SVS OPGs using the Student T test; MACE 3.9% vs. 5.1% (P = .72), 30 day amputation rate 2.4% vs. 1.3% (P = .43), MALE 9.7% vs. 4.6% (P = .06). One year outcomes: MALE+POD 84.1% vs. 76.9% (P = .14), AFS 84.1% vs. 76.5% (P = .14), RAS 39% vs. 46.5% (P = .21). No statistically significant difference was noted. Our study demonstrates that the OPGs are attainable in clinical practice. Moreover, LAA meets the safety and efficacy OPGs for endovascular treatment of CLI.
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