Two Hundred Consecutive Implantations of the Sutureless 3f Enable Aortic Valve: What We Have Learned.

Background: In this article we present a consecutive single-center experience of implantation of the Medtronic 3f Enable aortic valve (Medtronic Inc, Minneapolis, MN).

Methods: Between March 2011 and October 2014, 200 consecutive patients (mean age, 76.4 ± 5.9 years; logistic EuroScore, 7.8% ± 7.0%) in our unit received the 3f Enable valve. This is a retrospective analysis of this prospective monocentric cohort.

Results: The 3f Enable valve could be implanted in all the scheduled 141 isolated aortic valve replacement (AVR) procedures (14 full sternotomies, 73 ministernotomies, 44 minithoracotomies, and 10 thoracoscopic approaches) and 59 combined procedures (all using full sternotomy). Reclamping was necessary in 7 (3.5%) patients (paravalvular leakage [PVL] was ≥ grade 1 because of undersizing or prosthetic misalignment); mean cross-clamp and cardiopulmonary bypass (CPB) times were 65 ± 31 and 91 ± 39 minutes, respectively. Sixteen (8%) patients required early implantation of a pacemaker (PM). At a mean follow-up of 12.6 ± 8.1 months, mean transvalvular gradient and effective orifice area (EOA) were 9.8 ± 4.4 mm Hg and 1.87 ± 0.6 cm(2), respectively. Mild PVL was present in 7 (3.5%) patients and moderate PVL was present in 5 (2.5%) patients. No device migration was registered, and no moderate PVL was detected in the last 100 patients of the cohort. Overall, 3-year survival was 78%.

Conclusions: The 3f Enable valve shows excellent results regarding PVL but in our experience required a learning curve and a refinement of the technique of implantation. Use of the prosthesis was possible in various less invasive approaches.