title: Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA™): 6-month outcomes.
abstract: OBJECTIVE
  The ACURATE TA(™) Aortic Bioprosthesis and Delivery System (Symetis S.A., Ecublens, Switzerland) is a new transcatheter aortic valve designed for transapical implantation. The six-month results from the completed first-in-man study are reported.
  
  
  METHODS
  The Symetis ACURATE TA(™) is composed of a porcine biological tissue valve attached to a self-expandable nitinol stent. It allows for anatomical orientation and facilitates intuitive implantation providing tactile feedback. Since November 2009, a total of 40 high-risk elderly patients have been treated.
  
  
  RESULTS
  The mean age of enrolled patients was 83.2 ± 4.0; 60.0% were female, with a mean logistic EuroSCORE of 21.2 ± 10.8% and a mean Society of Thoracic Surgeons (STS) score of 9.0 ± 4.7%. All implants were delivered successfully in the intra-annular and subcoronary position. One patient was converted to conventional surgery due to coronary impingement (after valve-in-valve implantation). One additional patient received valve-in-valve treatment (SAPIEN THV TA(™)). Five patients expired within 30 days and two additional patients expired during the 6-month follow-up due to non-valve-related causes resulting in a mid-term survival rate of 82.5%. Two patients suffered a stroke and another three required new onset pacemaker implantation. The mean aortic gradient significantly improved and remained stable throughout the follow-up (baseline: 51.9 ± 14.3 mmHg, 30 days: 12.3 ± 5.1 mmHg, 6 months: 11.9 ± 5.8 mmHg). At the 6-month follow-up, 96.7% of patients demonstrated either none/trace or mild (1+/4) paravalvular leakage only. According to the Valve Academic Research Council the device's success rate was 92.5%, with a 30-day safety profile of 25%.
  
  
  CONCLUSIONS
  At the 6-month follow-up, the ACURATE TA(™) device showed stable valve function with low rates of paravalvular leakages. The cohort of high-risk patients demonstrated good clinical outcomes and 6-month survival.
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim,  Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kempfert
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.forename: Ardawan J
authors.initials: AJ
authors.lastname: Rastan
authors.forename: Markus
authors.initials: M
authors.lastname: Schönburg
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
authors.forename: Stefan
authors.initials: S
authors.lastname: Sorg
authors.forename: Friedrich-W
authors.initials: FW
authors.lastname: Mohr
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D002423:Cause of Death; D005260:Female; D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation*; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome