Evolving technology/basic science
Clinical performance of a sutureless aortic bioprosthesis: Five-year results of the 3f Enable long-term follow-up study

https://doi.org/10.1016/j.jtcvs.2014.03.054Get rights and content
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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.

CTSNet classification

35
35.2
35.3.3

Abbreviations and Acronyms

AVR
aortic valve replacement
EOA
effective orifice area
EOAi
indexed effective orifice area
NYHA
New York Heart Association
PPM
prosthesis–patient mismatch
PVL
paravalvular leak
TAVI
transcatheter aortic valve implantation
TTE
transthoracic echocardiography

Cited by (0)

This study was funded by Medtronic Inc, Minneapolis, Minn.

Disclosures: Lars Englberger reports consulting fees from Medtronic and lecture fees from Medtronic and St. Jude Medical. Mirko Doss reports consulting fees from Edwards Lifesciences. Jerzy Sadowski reports grant support from Medtronic. Krzysztof Bartus reports lecture fees from Medtronic. Sven Martens reports consulting and lecture fees from Medtronic. All other authors have nothing to disclose with regard to commercial support.