Abstract 17569: Transapical Aortic Valve Implantation With the 2nd Generation Self-Expandable Symetis Acurate TA™ TAVI System - First Clinical Experience and 1-Year Follow-up Results
Introduction: We report our first clinical experience and 1-year outcome of transapical transcatheter aortic valve implantation (TAVI) with the use of the 2nd generation self-expandable ACURATE TA™ device.
Methods: The Symetis (Symetis S.A., Ecublens, Switzerland) ACURATE TA™ system is composed of a porcine bioprosthesis attached into a self-expandable nitinol stent. This 2nd generation system enables anatomical orientation and facilitates intuitive implantation providing tactile feedback. Between 08/2010 and 06/2014 a total of 85 high-risk patients with symptomatic aortic stenosis were enrolled. All patients gave written informed consent. Clinical and hemodynamic data were prospectively recorded. Hemodynamic performance was evaluated by transthoracic echocardiography including mean pressure gradients (MPG) at baseline, discharge, 30-days, 6 and 12 months after surgery.
Results: Patients mean age was 79±7years (mean ±SD) and 55% were female. Logistic EuroSCORE was 32.6±10.7% and STS-score 6.8±3.0% on average. All but one valve could be implanted successfully. This single patient was converted to conventional surgery due to intra-procedural device embolization. Intra-procedural re-ballooning after deployment was performed in 28% of the patients. Mean aortic gradient was 43.6±19.3 mmHg preoperatively and significantly decreased to 13.0±6.6mmHg at 30 days postoperatively and remained stable with 10.3±5.8mmHg at 12 months. Thirty-day mortality was 2%. Survival was 89% at 6 and 12-months, and 78% at two and three years. During follow-up, three (3.5%) patients suffered from stroke and five (5.9%) patients required new pacemaker implantation. MPGs were 43.6±19.3mmHg at baseline, 12.5±7.0mmHg at discharge, 13.0±6.6mmHg at 30-days, 11.2±2.9mmHg at 6-months and 10.3±5.8mmHg at 12-months. At 30 days paravalvular regurgitation was ≤ mild in 95.3% and no patient had severe regurgitation. At 12 months follow-up all (100%) patients showed either none/trace or mild paravalvular leakage.
Conclusions: The present single-center study proves good hemodynamic performance with low paravalvular leakages and good clinical outcomes for transapical TAVI, using the ACURATE TA™ prosthesis over a 1 year follow-up period.
Author Disclosures: S. Pasa: None. D. Wendt: None. P. Kahlert: None. K. El-Chilali: None. F. Al-Rashid: None. P. Patsalis: None. M. Eißmann: None. R. Erbel: None. H. Jakob: None. M. Thielmann: None.
- © 2014 by American Heart Association, Inc.