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

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• 作者：Ronald K. Binder ; MD^? ; Josep Rodé ; s-Cabau ; MD^&dagger ; ; David A. Wood ; MD^? ; Michael Mok ; MD^&dagger ; ; Jonathon Leipsic ; MD^? ; Robert De Larochelliè ; re ; MD^&dagger ; ; Stefan Toggweiler ; MD^? ; Eric Dumont ; MD^&dagger ; ; Melanie Freeman ; MBBS^? ; Alexander B. Willson ; MBBS^? ; John G. Webb ; MD^? ; ^{john.webb@vch.ca}
• 关键词：balloon-expandable ; SAPIEN 3 ; transcatheter aortic valve replacement ; transfemoral
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2013
• 出版时间：March, 2013
• 年：2013
• 卷：6
• 期：3
• 页码：293-300
• 全文大小：1302 K

文摘

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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 ¡À 0.4 cm², predicting 9.7 ¡À 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 ¡À 0.2 cm² to 1.5 ¡À 0.2 cm² (p < 0.001), and mean transaortic gradient decreased from 42.2 ¡À 10.3 mm Hg to 11.9 ¡À 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.