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12 Month Post-Market Registry Results In An All-Comers Population Implanted With The ACURATE TA™ Transapical TAVI Device
Jörg Kempfert, MD1, Hendrik Treede, MD2, David Holzhey, MD3, Steffen Hoffmann, MD4, Evaldas Girdauskas, MD5, Holger Schröfel, MD6, Matthias Thielmann, MD7, Shahram Lofti, MD8, Christophe Huber, MD9, Michael Hilker, MD10, Nicolas Doll, MD11, Klaus Matschke, MD12, Thorsten Wahlers, MD13, Arno Diegeler, MD14, Carlo Savini, MD15, Nalian Schnelle, MD16, Carla Romina Agatiello, MD17, Hermann Reichenspurner, MD2, Friedrich Mohr, MD3, Thomas Walther, MD1.
1Kerckhoff-Klinikum, Bad Nauheim, Germany, 2University Heart Center, Hamburg, Germany, 3Leipzig Herzzentrum, Leipzig, Germany, 4Schüchtermann-Schillersche Klinik, Bad Rothenfelde, Germany, 5Zentralklinik, Bad Berka, Germany, 6Klinik für Herzchirurgie, Karlsruhe, Germany, 7Universitätsklinikum, Essen, Germany, 8Universitätsklinikum, Aachen, Germany, 9Universitätsklinik für Herz-und Gefäßchirurgie, Bern, Switzerland, 10Universitätsklinikum, Regensberg, Germany, 11Sana Herzchirurgie, Stuttgart, Germany, 12UniversitätsKlinik Herzzentrum, Dresden, Germany, 13Uniklinik Herzzentrum, Köln, Germany, 14Klinik für Kardiochirurgie, Bad Neustadt, Germany, 15Policlinico S. Orsola Malpighi, Bologna, Italy, 16Universitäts Medizin, Mainz, Germany, 17Hospital Italiano, Buenos Aires, Argentina.

OBJECTIVE: The novel ACURATE TA™ Transapical Aortic Valve (Symetis, Switzerland) is composed of a porcine tissue valve sewn within a self-expanding nitinol stent covered by an anti-PV leak skirt designed for transapical implantation. Following its CE-mark approval, a post-market multi-center registry collected safety and efficacy information from the first consecutive 250 treated patients with this new commercial device. METHODS: The registry was conducted at 17 sites in Europe and South America to treat 250 high-risk elderly patients. This all-comers population presented pre-operatively with a mean aortic gradient of 43.3±17.4 mmHg, mean age of 80.9±6.3 years, mean STS Score of 8.0±5.9% and mean Logistic EuroSCORE I of 22.3±12.7%. The majority of patients (92.7%) were in NYHA Class III/IV. All patients were treated at centers with a multi-disciplinary Heart Team. RESULTS: The procedural success rate was 98.0% (n=245) with two valve-in-valve procedures and three conversions to conventional surgery. The implantations were performed using small, medium and large bioprostheses covering an annular range of 21mm to 27mm. The 30 days mortality and stroke rate is 6.8% and 2.8%, respectively. Post-implant echocardiography revealed a mean gradient of 12.4±5.2mmHg with a moderate paravalvular leak (Grade 2) in only 2.5% (n=6) of patients - all other patients demonstrated either none/trace or a 1+ leak. A new permanent pacemaker was required in 10.0% (n=25) of patients and 84.9% returning for follow-up at 30 days exhibited in NYHA Class I/II. CONCLUSIONS: The short-term registry results show a safety and efficacy profile comparable, if not improved in some aspects, to earlier approved TAVI valves. The device's ease-of-use is illustrated by the negligible learning curve as seen in the high procedure success rate. These real world data highlight excellent functional outcome with 97.5% of patients without relevant leak (<2+) and a promising safety profile. The full 12 months results will be available early next year and will be presented at the Heart Valve Conference 2014.

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