Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study.
OBJECTIVE
Sutureless valves are designed to facilitate surgical implantation, including less-invasive techniques in aortic valve replacement, by maintaining surgical precision of implantation compared with transcatheter techniques. Long-term clinical experience with sutureless valves is lacking. We report the 5-year follow-up results of an international, prospective, multicenter study evaluating the clinical performance and safety of the 3f Enable valve (Medtronic Inc, Minneapolis, Minn).


METHODS
Between March 2007 and December 2009, 141 patients (54 male; mean age, 76.1±5.7 years) undergoing aortic valve replacement with the 3f Enable valve were enrolled in 10 European sites. The mean follow-up was 2.76 years (range, 2 days to 5.1 years; total, 388.7 patient-years). Echocardiographic valvular hemodynamic and morphologic analyses were performed by an independent core laboratory.


RESULTS
The mean systolic gradient was 10.4±4.4 mm Hg at discharge and 7.7±4.1 mm Hg at 5 years. The mean effective orifice area was 1.7±0.5 cm2 at discharge and 1.6±0.2 cm2 at 5 years. Freedom from all-cause and valve-related mortality was 87.6%±2.9% and 96.8%±1.6% at 1 year (113 patients at risk) and 77.0%±7.5% and 93.8%±4.8% at 5 years (24 patients at risk), respectively. Six patients underwent reoperation (4 because of major paravalvular leakage and 2 because of endocarditis). Freedom from reoperation was 95.4%±1.9% at 1 year and 95.4%±6.1% at 5 years. No structural valve deterioration occurred during the follow-up period.


CONCLUSIONS
The sutureless 3f Enable valve represents a safe and effective treatment for aortic valve stenosis, providing an excellent hemodynamic profile. This study represents the longest follow-up study for a sutureless bioprosthesis. Sutureless valves may become an option for all patients with indicated biological aortic valve replacement.
Department of Cardiovascular Surgery, University Hospital Bern, Bern, Switzerland. Electronic address: lars.englberger@insel.ch.
Lars
L
Englberger
Department of Cardiovascular Surgery, University Hospital Bern, Bern, Switzerland.
Thierry P
TP
Carrel
Department of Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe University, Frankfurt, Germany.
Mirko
M
Doss
Department of Cardiovascular Surgery and Transplantology, Jagiellonian University, Krakow, Poland.
Jerzy
J
Sadowski
Department of Cardiovascular Surgery and Transplantology, Jagiellonian University, Krakow, Poland.
Krzysztof
K
Bartus
Department of Cardiac Surgery, University Hospital Basel, Basel, Switzerland.
Friedrich F
FF
Eckstein
MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, DC.
Federico M
FM
Asch
Department of Thoracic and Cardiovascular Surgery, University Hospital Muenster, Muenster, Germany.
Sven
S
Martens
D000368:Aged; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006439:Hemodynamics; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011474:Prosthesis Design; D056346:Sternotomy; D016896:Treatment Outcome