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 PS106. The Society for Vascular Surgery’s Objective Performance Goals: A Validation Study of Laser-assisted Angioplasty, A Safe and Effective Technique for the Management of Critical Limb Ischemia

​Jonathan A. Higgins, Joanne J. Kim, Samuel N. Steerman, Sadaf S. Ahanchi, Babatunde Almaroof, Jean M. Panneton
Vascular Surgery, Eastern Virginia Medical School, Norfolk, VA.

OBJECTIVES: 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.

METHODS: 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.

RESULTS: 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=0.72}, 30 day amputation rate 2.4% vs. 1.3 %{ p=0.43}, MALE 9.7% vs. 4.6% {p=0.06}. One year outcomes: MALE+POD 84.1% vs. 76.9% {p=0.14}, AFS 84.1% vs. 76.5% {p=0.14}, RAS 39% vs. 46.5 %{ p=0.21}. No statistically significant difference was noted.

CONCLUSIONS: Our study demonstrates that the OPGs are attainable in clinical practice. Moreover, LAA meets the safety and efficacy OPGs for endovascular treatment of CLI.

AUTHOR DISCLOSURES: S. S. Ahanchi, Nothing to disclose; B. Almaroof, Nothing to disclose; J. A. Higgins, Nothing to disclose; J. J. Kim, Nothing to disclose; J. M. Panneton, Spectranetics, Speaker’s bureau; S. N. Steerman, Nothing to disclose.

Posted April 2012

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