title: First registry results from the newly approved ACURATE TA™ TAVI system†.
abstract: OBJECTIVE
  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.affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany kempfertj@gmail.com.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kempfert
authors.affiliation: Department of Cardiac Surgery, Heart Center University of Leipzig, Leipzig, Germany.
authors.forename: David
authors.initials: D
authors.lastname: Holzhey
authors.affiliation: Department of Cardiac Surgery, Schüchtermann-Schillersche Kliniken, Bad Rothenfelde, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Hofmann
authors.affiliation: Department of Cardiac Surgery, Zentralklinik Bad Berka, Bad Berka, Germany.
authors.forename: Evaldas
authors.initials: E
authors.lastname: Girdauskas
authors.affiliation: Department of Cardiac Surgery, Heart Center University of Hamburg, Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.affiliation: Department of Cardiac Surgery, Clinic for Heart Surgery Karlsruhe, Karlsruhe, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Schröfel
authors.affiliation: Department of Cardiac Surgery, West German Heart Center University of Essen, Essen, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods / Q000401:mortality; D006801:Humans; D008297:Male; D012042:Registries / Q000706:statistics & numerical data; D016896:Treatment Outcome
keywords: Aortic valve implantation; Minimally invasive; Transapical