Transcatheter Aortic Valve Replacement With the SAPIEN 3 A New Balloon-Expandable Transcatheter Heart Valve

被引:171
作者
Binder, Ronald K. [1 ]
Rodes-Cabau, Josep [2 ]
Wood, David A. [1 ]
Mok, Michael [2 ]
Leipsic, Jonathon [1 ]
De Larochelliere, Robert [2 ]
Toggweiler, Stefan [1 ]
Dumont, Eric [2 ]
Freeman, Melanie [1 ]
Willson, Alexander B. [1 ]
Webb, John G. [1 ]
机构
[1] Univ British Columbia, St Pauls Hosp, Vancouver, BC V5Z 1M9, Canada
[2] Univ Laval, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
关键词
balloon-expandable; SAPIEN; 3; transcatheter aortic valve replacement; transfemoral; HIGH-RISK PATIENTS; IMPLANTATION; REGISTRY; STENOSIS; REGURGITATION; OUTCOMES;
D O I
10.1016/j.jcin.2012.09.019
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives The aim of this study was to demonstrate the first-in-human feasibility and short-term clinical outcomes with a new balloon-expandable transcatheter heart valve (THV). Background The SAPIEN 3 (S3) THV incorporates a paravalvular sealing system, an active 3-dimensional coaxial positioning catheter, and is compatible with a 14-F expandable sheath. Methods The S3 THV was implanted in 15 patients with symptomatic severe aortic stenosis via femoral arterial access. Multidetector computed tomography before and after valve implantation allowed assessment of a novel annular area sizing algorithm. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days. Results All 15 device implants were successful. Multidetector computed tomography estimated an aortic annular area of 4.9 +/- 0.4 cm(2), predicting 9.7 +/- 6.9% THV oversizing. Post-transcatheter aortic valve replacement multidetector computed tomography showed consistently symmetrical and circular THVs. Aortic valve area increased from 0.7 +/- 0.2 cm(2) to 1.5 +/- 0.2 cm(2) (p < 0.001), and mean transaortic gradient decreased from 42.2 +/- 10.3 mm Hg to 11.9 +/- 5.3 mm Hg (p < 0.001). No patient had more than mild paravalvular aortic regurgitation. Hospital discharge occurred at a median of 3 (range 2 to 12) hospital days. At 30 days there were no deaths, strokes, vascular complications, bleeds, or transfusions, although 1 patient (6.7%) required a new pacemaker. All patients were in New York Heart Association functional class I or II. Conclusions The S3 THV and delivery system might facilitate fully percutaneous implantation in a broader range of patients with the potential for more accurate positioning and less paravalvular regurgitation. (J Am Coll Cardiol Intv 2013; 6: 293-300) (C) 2013 by the American College of Cardiology Foundation
引用
收藏
页码:293 / 300
页数:8
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