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

被引:94
作者
Hayashida, Kentaro [1 ]
Lefevre, Thierry [1 ]
Chevalier, Bernard [1 ]
Hovasse, Thomas [1 ]
Romano, Mauro [1 ]
Garot, Philippe [1 ]
Mylotte, Darren [1 ]
Uribe, Jhonathan [1 ]
Farge, Arnaud [1 ]
Donzeau-Gouge, Patrick [1 ]
Bouvier, Erik [1 ]
Cormier, Bertrand [1 ]
Morice, Marie-Claude [1 ]
机构
[1] Inst Cardiovasc Paris Sud, Massy, France
关键词
closure device; percutaneous approach; Prostar device; transcatheter aortic valve implantation; vascular complications; ENDOVASCULAR ANEURYSM REPAIR; SURGERY DEVICE; EDWARDS SAPIEN(TM); ACCESS SITES; HEART-VALVE; FOLLOW-UP; STENOSIS; EXPERIENCE; REPLACEMENT; PROSTHESIS;
D O I
10.1016/j.jcin.2011.09.020
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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
引用
收藏
页码:207 / 214
页数:8
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