Thorac Cardiovasc Surg 2013; 61 - OP111
DOI: 10.1055/s-0032-1332350

First 100 commercial TAVI implants using the new transapical ACURATE™ TA device

J Kempfert 1, D Holzhey 2, H Treede 3, H Möllmann 4, H Schröfel 5, S Hofmann 6, M Czesla 7, M Thielmann 8, E Girdauskas 9, C Huber 10, J Babin-Ebell 11, S Lotfi 12, R Di Bartolomeo 13, M Wohlhöfer 14, T Walther 1
  • 1Kerckhoff Klinik, Herzchirurgie, Bad Nauheim, Germany
  • 2Herzzentrum Leipzig, Leipzig, Germany
  • 3Herzzentrum Universität Hamburg, Hamburg, Germany
  • 4Kerckhoff Klinik, Kardiologie, Bad Nauheim, Germany
  • 5Klinik für Herzchirurgie Karlsruhe, Karlsruhe, Germany
  • 6Herzzentrum Bad Rothenfelde, Bad Rothenfelde, Germany
  • 7Herzzentrum Stuttgart, Stuttgart, Germany
  • 8Westdeutsches Herzzentrum Essen, Essen, Germany
  • 9Herzzentrum Bad Berka, Bad Berka, Germany
  • 10Inselspital Bern, Bern, Switzerland
  • 11Herzzentrum Bad Neustadt, Bad Neustadt, Germany
  • 12Universitätsklinikum Aachen, Aachen, Germany
  • 13Hospitale Malpighi di Bologna, Bologna, Italy
  • 14Universitätsklinikum Mainz, Mainz, Germany

Objective: A novel, innovative transapical aortic valve implantation (TA-TAVI) system (ACURATE™ TA, Symetis) received CE approval in September 2011. The valve is composed of a porcine biologic valve attached to a self-expanding nitinol stent designed for a simple 2-step implantation technique characterized by controlled positioning with a self-seating mechanism. This report is on the first 100 commercial implantations within a post-market registry (SAVI).

Methods: Mean age of patients was 81.5 ± 5.9 years (49% female) with 86.0% presenting in NYHA Class III or IV. The mean STS-Score was 9.5 ± 7.9% and the mean logistic EuroSCORE I 22.0 ± 12.8%. The mean transvalvular gradient prior to implant was 44.1 ± 18.4 with a mean AVA of 0.68 ± 0.21 cm2. The implantations were performed at 13 sites in Europe.

Fig. 1: Symetis ACURATE TA

Results: The device was successfully implanted in 99.0% of patients (n = 99). Valve sizes were distributed equally: n = 37 small (23 mm), n = 34 medium (25 mm) and n = 29 large (27 mm) valves. One patient was converted to surgery after the valve was implanted too low with embolization into the LV. 30-day mortality rate was 5.0% (respiratory n = 3, sepsis n = 1, MOF n = 1) and 30-day stroke rate was 2% (n = 2). New pacemaker implantation was necessary in 5.0% (n = 5) of patients by 30-days post-implant. Mean echocardiographic gradient post-implant was < 10 mmHg in 88% of patients. Rate of paravalvular leaks were as following: none/trace: 62%, mild (1+): 36%, moderate (2+): 2%.

Conclusion: These post-market, real-world data confirm the very safe profile of this new TA-TAVI system. The ACURATE™ TA device has proven excellent hemodynamical outcome with very promising low rates of relevant paravalvular leaks.