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Clinical experience with the second-generation 3f Enable sutureless aortic valve prosthesis

By Thierry Aymard, Alexander Kadner, Nazan Walpoth, Volkhart Göber, Lars Englberger, Mario Stalder, Friedrich Eckstein, Claudia Zobrist and Thierry Carrel

Abstract

ObjectiveThe 3f Enable aortic bioprosthesis (ATS Medical, Inc, Minneapolis, Minn) represents a new generation of equine pericardial self-expanding valve designed for sutureless implantation. This study evaluated technical aspects of implantation and safety and effectiveness of the valve in the short term.MethodsIn an outcome analysis of a consecutive series of 28 patients who underwent aortic valve replacement for aortic stenosis with the 3f Enable during an 18-month period, mean age was 75.7 ± 6.6 years, 18 patients were female (64.2%), and mean EuroSCORE was 7.1% ± 1.7%.ResultsMost implanted valves were 23 mm in diameter (19–27 mm). Mean aortic crossclamp time was 39 ± 15 minutes (29–103 minutes), mean cardiopulmonary bypass time was 58 ± 20 minutes (41–127 minutes), mean hospital stay was 11 days (7–22 days), and 30-day mortality was 3.5%. Mean and peak intraoperative transvalvular pressure gradients were 6.1 ± 2.6 and 18 ± 5 mm Hg, respectively. Trivial and mild paravalvular leaks were observed in 1 patient each. One patient underwent reoperative aortic valve replacement 4 months after initial surgery for severe valve-unrelated paravalvular leakage. Five patients (18.5%) required permanent pacemakers. No patients were unavailable for follow-up. One-year survival was 86.2%.ConclusionsThe 3-f Enable aortic bioprosthesis can be implanted safely with favorable early hemodynamics. The self-expanding stent allows sutureless implantation with a large valve area. The procedure was fast, although not as fast as expected. This experience has led to continued design and procedural enhancements to facilitate and accelerate future implantation

Publisher: The American Association for Thoracic Surgery. Published by Mosby, Inc.
Year: 2010
DOI identifier: 10.1016/j.jtcvs.2009.10.041
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