12 Months Registry Results of a Newly Approved Transapical Aortic Bioprosthesis - ACURATE TA
Joerg Kempfert1, Hendrik Treede2, David Holzhey3, Steffen Hoffmann4, Evaldas Girdauskas5, Holger Schroefel6, Matthias Thielmann7, Shahram Lofti8, Christoph Huber9, Andreas Holzamer10, Nicolas Doll11, Klaus Matschke12, Thorsten Wahlers13, Anno Diegeler14, Carlo Savini15, Nalian Schnelle16, Carla Agatiello17, Hermann Reichenspurner18, Friedrich W. Mohr3, Thomas Walther1.
1Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany, 2University Heart Center Hamburg, Hamburg, Germany, 3Heart Center University of Leipzig, Leipzig, Germany, 4Heart Center Bad Rothenfelde, Bad Rothenfelde, Germany, 5Clinic for Cardiac Surgery Bad Berka, Bad Berka, Germany, 6Clinic for Cardiac Surgery Karlsruhe, Karlsruhe, Germany, 7West German Heart Center University of Essen, Essen, Germany, 8University Clinic Aachen, Aachen, Germany, 9University Clinic Bern, Bern, Switzerland, 10University Clinic Regensburg, Regensburg, Germany, 11Sana Clinic Stuttgart, Stuttgart, Germany, 12Heart Center University of Dresden, Dresden, Germany, 13Heart Center University of Cologne, Cologne, Germany, 14Clinic for Cardiac Surgery Bad Neustadt, Bad Neustadt, Germany, 15University Clinic Bologna, Bologna, Italy, 16University Clinic Mainz, Mainz, Germany, 17Hospital Italiano, Buenos Aires, Argentina, 18Heart Center University of Hamburg, Hamburg, Germany.
OBJECTIVE: A novel, innovative transapical aortic valve implantation (TA-TAVI) system received CE Mark approval in September 2011 and to date almost 300 commercial implants have been performed. The ACURATE TA device (Symetis, Switzerland) is composed of a self-expanding nitinol stent covered by an anti-PV leak skirt with a surgical quality porcine tissue valve sewn within. Following CE-mark approval of the device, a post-market registry was performed to include the first 250 patients implanted with this new TA-TAVI system. The patients were treated between November 2011 and November 2012.
METHODS: The registry was conducted at 17 sites in Germany, Argentina and Italy to treat 250 high-risk elderly patients suffering from severe symptomatic aortic stenosis. This all-comers population presented pre-operatively with a mean aortic gradient of 43.3 ± 17.4 mmHg and a mean AVA of 0.7 ± 0.2 cm2. The patients were considered high-risk due to advanced age and multiple co-morbidities. Mean age of treated patients was 80.9 ± 6.3 years with a mean STS Score of 8.0 ± 5.9% and mean Logistic EuroSCORE I of 22.3 ± 12.7%. The majority of patients (90.8%) presented preoperatively in NYHA Class III/IV and 48.4% are female. All patients were treated within a multi-disciplinary Heart Team.
RESULTS: The procedural success rate was 98.4% (n=246) with two valve-in-valve procedures and two conversions to conventional surgery. The implantations were performed using small, medium and large bioprostheses covering an annular range of 21mm to 27mm. 30-day mortality rate was 4.8%. Post-implant echocardiography revealed only two patients with +2 (moderate) paravalvular leak. All other patients (99.2%) demonstrated either none/trace or a 1+ leak only. At 30-days two patients had suffered a stroke (0.8%). The mean gradient was 12.8 ± 5.2mmHg with a mean EOA of 1.4 ± 0.3 cm2. The new pacemaker implantation rate was 4.8% (n=12) and 88% of returning patients presented in NYHA Class I/II.
CONCLUSIONS: These real world results using this new TA-TAVI device are promising and compare well to longer approved devices. At ISMICS 2013, the 12 months results from the first 100 patients in the registry will be presented for the first time.
Back to Cardiac Track Program Overview