Abstract 17128: Transapical Aortic Valve Implantation (TA-AVI) Using the SYMETIS ACURATE TA™ Transapical Aortic Bioprosthesis - 1 Year Outcomes
OBJECTIVES: Transapical aortic valve implantation (TA-AVI) is a standard approach for high-risk elderly patients using the balloon expandable Edwards SAPIEN prosthesis. As an alternative we are evaluating a new self-expanding transapical bioprosthesis in a First-In-Man (FIM) study.
METHODS: This novel device (SYMETIS ACURATE TA™ Transapical Aortic Bioprosthesis), composed of a porcine biologic valve attached to a self-expandable nitinol stent, is unsheathed proximally towards the apex and is designed for anatomical orientation of the commissures and for subcoronary implantation. A unique two-step implantation procedure provides simple positioning and tactile feedback during implant.
RESULTS: 40 patients have been treated, patient age was 82.8±4 years, 60% were female, NYHA Class III/IV, logistic EuroSCORE was 21.5±10.9% and STS Score was 9.0±4.6%. All implants were delivered successfully in the intra-annular and subcoronary position. Two patients required a valve-in-a-valve (SAPIEN), one of which was followed with a conversion to conventional surgery. 95% of patients were treated off-pump. Two patients required a pacemaker implantation due to new onset AV-block post-implant. At 6 months post-procedure, this novel 2nd generation TA-AVI device highlights a PV leak rate of 0 - 1 in 97% of followed patients and functional improvement from baseline in 90% with a NYHA Class I/II. The pacemaker rate remains at 5%. Seven patients expired (respiratory complications=4, right heart failure=2, unclear=1). Two patients suffered a secondary stroke.
CONCLUSIONS: The ACURATE TA™ has demonstrated proof of concept with promising clinical results in this FIM study. The 1 year data will be available in October 2011.
- © 2011 by American Heart Association, Inc.