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

Objective The 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. Methods In 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%. Results Most 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%. Conclusions The 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.