Author + information
- Received September 9, 2011
- Revision received September 19, 2011
- Accepted September 21, 2011
- Published online February 1, 2012.
- Kentaro Hayashida, MD, PhD,
- Thierry Lefèvre, MD⁎ (, )
- Bernard Chevalier, MD,
- Thomas Hovasse, MD,
- Mauro Romano, MD,
- Philippe Garot, MD,
- Darren Mylotte, MD,
- Jhonathan Uribe, MD,
- Arnaud Farge, MD,
- Patrick Donzeau-Gouge, MD,
- Erik Bouvier, MD,
- Bertrand Cormier, MD and
- Marie-Claude Morice, MD
- ↵⁎Reprint requests and correspondence:
Dr. Thierry Lefèvre, Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, 91300 Massy, France
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.
- closure device
- percutaneous approach
- Prostar device
- transcatheter aortic valve implantation
- vascular complications
Dr. Hayashida is supported by a grant from Banyu Life Science Foundation International, Tokyo Japan. Dr. Lefèvre is proctor for transfemoral-TAVI for Edwards Lifesciences and is a consultant for Simetys and Directflow. Dr. Chevalier is a consultant for Abbott Vascular. Dr. Romano is proctor for transapical-TAVI for Edwards Lifesciences. Dr. Mylotte is supported by an educational bursary from Merck Sharp & Dohme. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 9, 2011.
- Revision received September 19, 2011.
- Accepted September 21, 2011.
- American College of Cardiology Foundation