Vol 74, No 3 (2016)
Original articles - new methods
Published online: 2015-09-23

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Symetis Acurate Neo transfemoral aortic bioprosthesis — initial Polish experience

Michał Zembala, Michał Hawranek, Jacek Wacławski, Tomasz Niklewski, Paweł Nadziakiewicz, Rafał Koba, Roman Przybylski, Ryszard Walas, Jan Głowacki, Tomasz Jazwiec, Marcin Garbacz, Mariusz Gąsior, Marian Zembala
Kardiol Pol 2016;74(3):206-212.

Abstract

Background and aim: Transcatheter aortic valve implantation (TAVI) has proven to be a valuable alternative to conventional surgical aortic valve replacement in high-risk and surgically inoperable patients who suffer from severe symptomatic aortic stenosis. With the second generation of TAVI devices improvements in both handling and performance are highly demanded. This brief clinical communication reports the first Polish experience with the second generation of transfemoral TAVI device — Symetis Acurate Neo.

Methods: From November 19th 2014 until February 18th 2015 nine (n = 9) patients with severe symptomatic aortic stenosis have been operated on using the Symetis Acurate Neo. Patients were subject to seven-day evaluation and 30-day phone follow-up.

Results: The procedure was safely and successfully performed in all patients. A SMALL (S) valve (21–23 mm equivalent) was used in two patients, MEDIUM valve (M; 23–25 mm equivalent) in five patients, and a LARGE valve (L; 25–26 mm equivalent) in two patients. In three cases post-release balloon dilatation was required. There were no intraoperative complications and no major adverse events (as per VARC classification) during initial hospitalisation, including conduction or rhythm disturbances. In all cases, the mean gradient on the prosthetic valves was 7.8 mm Hg (10.2 mm Hg on the “S” valves). Rapid improvement in patients’ functional class was noted. Perivalvular leak was evaluated as “mild” in three cases, “trace” in one, and “not existing” in five.

Conclusions: This initial experience with the Symetis Acurate Neo demonstrates its good safety profile and excellent hae­modynamics. Low radial stress of the valve results in minimal incidence of atrioventricular rhythm disturbances, and a sealing crown for nearly non-existent paravalvular leak.




Polish Heart Journal (Kardiologia Polska)