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

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• 作者：Jean Franç ; ois Fuzellier ; MD^a ; Salvatore Campisi ; MD^a ; Antoine Gerbay ; MD^b ; Benjamain Haber ; MD^b ; Vito Giovanni Ruggieri ; MD^a ; Marco Vola ; MD ; PhD^a ; ^{marco.vola@univ-st-etienne.fr" class="auth_mail" title="E-mail the corresponding author}
• 关键词：AVR ; aortic valve replacement ; BAV ; bicuspid aortic valve ; BMI ; body mass index ; EOA ; effective orifice area ; MS ; ministernotomy ; PM ; pacemaker ; PVL ; paravalvular leakage ; RAMT ; right anterior minithoracotomy ; SU ; sutureless ; TAVI ; transcatheter valve implantation ; TEAVR ; total endoscopic aortic valve replacement
• 刊名：The Annals of Thoracic Surgery
• 出版年：2016
• 出版时间：May 2016
• 年：2016
• 卷：101
• 期：5
• 页码：1716-1723
• 全文大小：644 K

文摘

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 cm², 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.