148ONE-YEAR REGISTRY OUTCOMES OF THE RECENTLY APPROVED TRANSAPICAL ACURATE TAVI DEVICE

• Published in: Interactive cardiovascular and thoracic surgery 2014-10, Vol.19 (suppl_1), p.S46-S46
• Main Authors: Kempfert, J., Holzhey, D.M., Hoffmann, S., Girdauskas, E., Treede, H., Schroefel, H., Thielmann, M., Walther, T.
• Format: Article
• Language: English
• ISSN: 1569-9293; 1569-9285
• DOI: 10.1093/icvts/ivu276.148

Objectives: The ACURATE TA transcatheter transapical aortic valve system (Symetis, Switzerland) features a self-expanding nitinol stent including an anti-paravalvular leak skirt. After CE-mark approval 250 patients had been included within a first post-market multicentre registry. Methods: Overall, 17 sites in Germany, Argentina and Italy participated and included 250 high-risk elderly patients in an all-comers fashion. Mean age was 80.9 ± 6.3 years, mean STS-Score 8.0 ± 5.9% and mean logistic EuroSCORE 22.3 ± 12.7%. All patients were treated within multi-disciplinary heart teams. Results: Procedural success rate was 98.0% (n = 245) with two valve-in-valve procedures and three conversions to conventional surgery. All three available prosthesis sizes (small, medium, large) had been used. Thirty-day mortality rate was 6.8%, 30-day stroke rate was 2.8% and 10.0% of patients required a new pacemaker implantation. Initial functional results were excellent, with echocardiography revealing a relevant paravalvular leak (moderate 2+) in 2.7% only and a mean gradient of 12.5 ± 5.2 mmHg. During the 12-month follow-up no valve-related interventions were required. Three additional patients suffered a stroke (12-month stroke rate 4%). At 1 year, echocardiographic mean gradients remained stable with 12.9 ± 5.3 mmHg and 96.0% of patients presented with either none or mild (1+) paravalvular leak. One-year survival was 81.6%. Conclusion: One-year outcomes of this first registry demonstrate sustained excellent performance of the ACURATE TA prosthesis. The overall safety profile and 1-year survival is comparable to longer approved TAVI devices. This all-comers registry highlights excellent functional results, especially in regard to extremely low rates of relevant paravalvular leaks.