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

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

doi:10.1016/j.jtcvs.2009.10.041

« Previous Next »The Journal of Thoracic and Cardiovascular Surgery
Volume 140, Issue 2 , Pages 313-316, August 2010

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

Thierry Aymard, MD
- Department of Cardiovascular Surgery, University Hospital Berne, Berne, Switzerland
Alexander Kadner, MD
- Department of Cardiovascular Surgery, University Hospital Berne, Berne, Switzerland
Nazan Walpoth, MD
- Department of Cardiology, University Hospital Berne, Berne, Switzerland
Volkhart Göber, MD
- Department of Cardiovascular Surgery, University Hospital Berne, Berne, Switzerland
Lars Englberger, MD
- Department of Cardiovascular Surgery, University Hospital Berne, Berne, Switzerland
Mario Stalder, MD
- Department of Cardiovascular Surgery, University Hospital Berne, Berne, Switzerland
Friedrich Eckstein, MD
- Department of Cardiovascular Surgery, University Hospital Berne, Berne, Switzerland
Claudia Zobrist, MD
- Institute of Anesthesiology, University Hospital Berne, Berne, Switzerland
Thierry Carrel, MD
- Department of Cardiovascular Surgery, 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.

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.

CTSNet classification: 28, 35

Abbreviations and Acronyms: AVR, aortic valve replacement, CPB, cardiopulmonary bypass