First registry results from the newly approved ACURATE TA™ TAVI system†

TY - JOUR

T1 - First registry results from the newly approved ACURATE TA™ TAVI system†

AU - Kempfert, Jörg

AU - Holzhey, David

AU - Hofmann, Steffen

AU - Girdauskas, Evaldas

AU - Treede, Hendrik

AU - Schröfel, Holger

AU - Thielmann, Matthias

AU - Walther, Thomas

N1 - © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

PY - 2015/7

Y1 - 2015/7

N2 - 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.

AB - 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.

KW - Aged, 80 and over

KW - Aortic Valve/surgery

KW - Female

KW - Heart Valve Prosthesis/adverse effects

KW - Heart Valve Prosthesis Implantation/instrumentation

KW - Humans

KW - Male

KW - Registries/statistics & numerical data

KW - Treatment Outcome

U2 - 10.1093/ejcts/ezu367

DO - 10.1093/ejcts/ezu367

M3 - SCORING: Journal article

C2 - 25425552

VL - 48

SP - 137

EP - 141

JO - EUR J CARDIO-THORAC

JF - EUR J CARDIO-THORAC

SN - 1010-7940

IS - 1

ER -