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

Abstract

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). Safety and efficacy of a true percutaneous approach in transfemoral-TAVI has not been described in a large prospective cohort. 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. 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. 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.