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Transapical aortic valve implantation using the SYMETIS ACURATE TA™ device - Clinical experience to date
Joerg Kempfert1, Hendrik Treede2, Ardawan Rastan3, David Holzhey3, Markus Schönburg1, Matthias Thielmann4, Holger Schroefel5, Arnaud van Linden1, Johannes Blumenstein1, Friedrich W. Mohr3, Thomas Walther1.
1Kerckhoff Clinic, Bad Nauheim, Germany, 2Heartcenter University of Hamburg, Hamburg, Germany, 3Heartcenter University of Leipzig, Leipzig, Germany, 4Heartcenter university of Essen, Essen, Germany, 5Clinic for Cardiac Surgery Karlsruhe, Karlsruhe, Germany.
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 high-risk patient population.
METHODS: This novel device (SYMETIS ACURATE TA™ Transapical Aortic Bioprosthesis), composed of a porcine biologic valve attached to a self-expandable nitinol stentis designed for anatomical orientation of the commissures and for subcoronary implantation. A unique two-step implantation procedure with ventricular unsheathing provides simple positioning and tactile feedback during implant.
RESULTS: 90 patients have been treated to date, patient age was 83.4 ± 4.1 years, 69% were female, all in NYHA Class III/IV, logistic EuroSCORE was 20.3±8.7% and STS Score was 8.6±6.4%. All implants were delivered successfully in the intra-annular and subcoronary position. Two patients required a valve-in-a-valve (SAPIEN) due to central leak after inadequate post-ballooning in one and after initial device misplacement in another patient. Three patients were converted to surgery, two after coronary obstruction and one following annular dissection post dilatation. Ten patients required a pacemaker post-implantation.
97% of patients had none or 1+ aortic incompetence only. and 90% of patients had functional improvement to NYHA class I or II. . At30 days seven patients (7.8%) expired (respiratory complications = 4, right heart failure = 2, unclear = 1). Three patients suffered a secondary stroke.
CONCLUSIONS: The ACURATE TA™ has demonstrated promising results in this high-risk patient cohort, comparable to the SAPIEN experience. The Symetis valve proved good functional outcomes with relatively low rates of relevant aortic incompetence. CE approval has been granted recently. 
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