Transfemoral Aortic Valve Implantation New Criteria to Predict Vascular Complications

Objectives This study sought to evaluate the incidence, impact, and predictors of vascular complications in transcatheter aortic valve implantation (TAVI). Background Vascular complications increase morbidity and mortality in transfemoral TAVI; however, there remains a paucity of data describing these serious events. Methods We performed a prospective cohort study of 130 consecutive transfemoral TAVI recipients. Vascular complications were defined by the Valve Academic Research Consortium (VARC) criteria. The ratio of the sheath outer diameter (in millimeters) to the minimal femoral artery diameter (in millimeters) defined the sheath to femoral artery ratio (SFAR). Results In our cohort of elderly patients (83.3 +/- 5.9 years), the logistic Euro Score was 25.8% +/- 11.9%. The Edwards valve was used in 102 cases (18- to 24-F) and the Core Valve in 27(18-F). The minimal femoral artery diameter was 8.17 +/- 1.14 mm, and the calcification (0 to 3) and tortuosity scores (0 to 3) were 0.58 +/- 0.72 and 0.28 +/- 0.53, respectively. The mean sheath diameter was 8.10 +/- 0.82 mm, and the mean SFAR was 0.99 +/- 0.16. Vascular complications occurred in 27.6% (VARC major: 17.3%, minor: 10.2%), and major vascular complications predicted 30-day mortality (22.7% vs. 7.6%, p = 0.049). The SFAR (hazard ratio [HR]: 186.20, 95% confidence interval [CI]: 4.41 to 7,855.11), center experience (HR: 3.66, 95% CI: 1.17 to 11.49), and femoral calcification (HR: 3.44, 95% CI: 1.16 to 10.17) predicted major complications by multivariate analysis. An SFAR threshold of 1.05 (area under the curve = 0.727) predicted a higher rate of VARC major complications (30.9% vs. 6.9%, p = 0.001) and 30-day mortality (18.2% vs. 4.2%, p = 0.016). Conclusions Vascular complications in transfemoral TAVI are relatively frequent. VARC major vascular complications increase 30-day mortality and are predicted by experience, femoral calcification, and SFAR. Routine application of SFAR will improve patient selection for transfemoral TAVI and may improve outcome. (J Am Coll Cardiol Intv 2011;4:851-8) (C) 2011 by the American College of Cardiology Foundation