True Percutaneous Approach for Transfemoral Aortic Valve Implantation Using the Prostar XL Device Impact of Learning Curve on Vascular Complications

Objectives The purpose of this study was to evaluate the incidence of vascular complications and the predictors of Prostar failure for a "true percutaneous approach" in transfemoral transcatheter aortic valve implantation (TAVI). Background Safety and efficacy of a true percutaneous approach in transfemoral-TAVI has not been described in a large prospective cohort. Methods Among 264 patients included in our prospective TAVI database (October 2006 to December 2010), transfemoral-TAVI was performed in 170 patients. True percutaneous approach was performed in 142 consecutive patients since March 2008. Successful closure with Prostar was defined as adequate hemostasis without Prostar-related vascular complications. We compared the incidence of vascular complications in our early and late experience. Results Patients were 83.0 +/- 7.2 years old and with a EuroSCORE of 24.0 +/- 11.6%. The Edwards valve (Edwards Lifesciences, Irvine, California) (18- to 24-F) was used in 109 cases and the CoreValve (Medtronic, Minneapolis, Minnesota) (18-F) in 31. The sheath outer diameter to minimal femoral diameter ratio (SFAR) was 0.96 +/- 0.14. Successful closure was achieved in 90.7%, and was significantly increased (95.7% vs. 85.7%, p = 0.047) in the late experience group. Cross-over to surgery was required in 3.6%. Vascular complications occurred in 20.0%, and were significantly lower in the late experience group (11.4% vs. 28.6%, p = 0.012). Major vascular complications (2.9% vs. 14.3%, p = 0.018) were decreased in the late experience group. Early experience (hazard ratio [HR]: 3.66, 95% confidence interval [CI]: 1.04 to 13.89, p = 0.047) and SFAR (HR: 110.80, 95% CI: 1.15 to 10,710.73, p = 0.044) predicted Prostar failure by univariate analysis. Conclusions Experience reduced major vascular complications in a true percutaneous approach for transfemoral-TAVI. Further application of this less invasive strategy is feasible and may be beneficial, in this high-risk patient cohort. (J Am Coll Cardiol Intv 2012;5:207-14) (C) 2012 by the American College of Cardiology Foundation