Clinical experience with the second-generation 3f Enable sutureless aortic valve prosthesis
Received 13 August 2009; received in revised form 24 September 2009; accepted 15 October 2009.
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.
aDepartment of Cardiovascular Surgery, University Hospital Berne, Berne, Switzerland
bDepartment of Cardiology, University Hospital Berne, Berne, Switzerland
cInstitute of Anesthesiology, University Hospital Berne, Berne, Switzerland
Address for reprints: Thierry Carrel, MD, Professor and Chairman, Department of Cardiovascular Surgery, University Hospital Berne, CH-3010 Berne, Switzerland.
Disclosures: T. Carrel reports lecture fees from ATS and Edwards.
3f Enable is manufactured by ATS Medical, Inc, Minneapolis, Minn.
ABSTRACT