Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study.
Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study.
- 2014
Available online from MWHC library: 1994 - present, Available in print through MWHC library: 1999 - 2006
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.Copyright � 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved. 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. 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). 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.
English
0022-5223
*Aortic Valve Stenosis/su [Surgery]
*Aortic Valve/su [Surgery]
*Bioprosthesis
*Heart Valve Prosthesis
*Heart Valve Prosthesis Implantation/mt [Methods]
Aged
Echocardiography
Female
Follow-Up Studies
Hemodynamics
Humans
Longitudinal Studies
Male
Postoperative Complications/ep [Epidemiology]
Prospective Studies
Prosthesis Design
Sternotomy
Treatment Outcome
MedStar Heart & Vascular Institute
Available online from MWHC library: 1994 - present, Available in print through MWHC library: 1999 - 2006
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.Copyright � 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved. 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. 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). 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.
English
0022-5223
*Aortic Valve Stenosis/su [Surgery]
*Aortic Valve/su [Surgery]
*Bioprosthesis
*Heart Valve Prosthesis
*Heart Valve Prosthesis Implantation/mt [Methods]
Aged
Echocardiography
Female
Follow-Up Studies
Hemodynamics
Humans
Longitudinal Studies
Male
Postoperative Complications/ep [Epidemiology]
Prospective Studies
Prosthesis Design
Sternotomy
Treatment Outcome
MedStar Heart & Vascular Institute