Jörg Kempfert1, David Holzhey2, Steffen Hofmann3, Evaldas Girdauskas4, Hendrik Treede5, Holger Schröfel6, Matthias Thielmann7, Thomas Walther8. 1. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany kempfertj@gmail.com. 2. Department of Cardiac Surgery, Heart Center University of Leipzig, Leipzig, Germany. 3. Department of Cardiac Surgery, Schüchtermann-Schillersche Kliniken, Bad Rothenfelde, Germany. 4. Department of Cardiac Surgery, Zentralklinik Bad Berka, Bad Berka, Germany. 5. Department of Cardiac Surgery, Heart Center University of Hamburg, Hamburg, Germany. 6. Department of Cardiac Surgery, Clinic for Heart Surgery Karlsruhe, Karlsruhe, Germany. 7. Department of Cardiac Surgery, West German Heart Center University of Essen, Essen, Germany. 8. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
Abstract
OBJECTIVES: The novel ACURATE TA™ transcatheter aortic valve (Symetis, Ecublens, Switzerland) is composed of a self-expanding nitinol stent covered by an anti-paravalvular leak skirt designed for transapical implantation. Since Conformite Europeenne (CE)-mark approval, the first 250 patients implanted with the newly approved device have been included in this post-market, multicentre registry. METHODS: The registry was conducted at 17 sites in Germany, Italy, Switzerland and Argentina to treat 250 high-risk elderly patients. This all-comers population presented preoperatively with a mean aortic gradient of 43.2 ± 17.4 mmHg, mean age of 80.9 ± 6.3 years, mean society of thoracic surgeons risk score of 8.0 ± 5.9% and mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 22.3 ± 12.7%. The majority of patients (93%) were in New York Heart Association (NYHA) class III/IV. All patients were treated within a multidisciplinary Heart Team. RESULTS: The procedural success rate was 98% (n = 245) with two valve-in-valve procedures and three conversions to conventional surgery. The 30-day mortality rate was 6.8%. Postimplant echocardiography revealed a relevant paravalvular leak (moderate 2+) in 2.3% of patients, with all other patients demonstrating either none/trace or a 1+ leak. The 30-day stroke rate was 2.8% and the mean transvalvular gradient was 12.4 ± 5.8 mmHg. A new pacemaker implantation was required in 10.0% of patients and 85% of patients returning for the follow-up presented in NYHA class I/II. CONCLUSIONS: The short-term result of the registry shows a safety and efficacy profile comparable, if not improved in some aspects, with previously approved transcatheter aortic valve implantation devices. These 'real-world' data highlight an excellent functional outcome, especially in regard to a low rate of relevant paravalvular leak.
OBJECTIVES: The novel ACURATE TA™ transcatheter aortic valve (Symetis, Ecublens, Switzerland) is composed of a self-expanding nitinol stent covered by an anti-paravalvular leak skirt designed for transapical implantation. Since Conformite Europeenne (CE)-mark approval, the first 250 patients implanted with the newly approved device have been included in this post-market, multicentre registry. METHODS: The registry was conducted at 17 sites in Germany, Italy, Switzerland and Argentina to treat 250 high-risk elderly patients. This all-comers population presented preoperatively with a mean aortic gradient of 43.2 ± 17.4 mmHg, mean age of 80.9 ± 6.3 years, mean society of thoracic surgeons risk score of 8.0 ± 5.9% and mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 22.3 ± 12.7%. The majority of patients (93%) were in New York Heart Association (NYHA) class III/IV. All patients were treated within a multidisciplinary Heart Team. RESULTS: The procedural success rate was 98% (n = 245) with two valve-in-valve procedures and three conversions to conventional surgery. The 30-day mortality rate was 6.8%. Postimplant echocardiography revealed a relevant paravalvular leak (moderate 2+) in 2.3% of patients, with all other patients demonstrating either none/trace or a 1+ leak. The 30-day stroke rate was 2.8% and the mean transvalvular gradient was 12.4 ± 5.8 mmHg. A new pacemaker implantation was required in 10.0% of patients and 85% of patients returning for the follow-up presented in NYHA class I/II. CONCLUSIONS: The short-term result of the registry shows a safety and efficacy profile comparable, if not improved in some aspects, with previously approved transcatheter aortic valve implantation devices. These 'real-world' data highlight an excellent functional outcome, especially in regard to a low rate of relevant paravalvular leak.
Authors: Marcin Misterski; Mateusz Puślecki; Marek Grygier; Anna Olasińska-Wiśniewska; Maciej Lesiak; Aleksander Araszkiewicz; Barłomiej Perek; Aneta Choręziak; Jacek Lindner; Anna Komosa; Piotr Buczkowski; Marcin Ligowski; Sławomir Katarzyński; Marek Jemielity Journal: Wideochir Inne Tech Maloinwazyjne Date: 2017-04-27 Impact factor: 1.195