title: PREVAIL TRANSAPICAL: multicentre trial of transcatheter aortic valve implantation using the newly designed bioprosthesis (SAPIEN-XT) and delivery system (ASCENDRA-II).
abstract: OBJECTIVE
  Transapical (TA) aortic valve implantation (AVI) has evolved as an alternative procedure for high-risk patients. We evaluated the second-generation SAPIEN XT™ prosthesis in a prospective multicentre clinical trial.
  
  
  METHODS
  A total of 150 patients (age: 81.6 ± 5.8 years; 40.7% female) were included. Prosthetic valves (diameter: 23 mm (n = 36), 26 mm (n = 57) and 29 mm (n = 57)) were implanted. The ASCENDRA-II™ modified delivery system was used in the smaller sizes. Mean logistic EuroSCORE was 24.3 ± 7.0%, and mean STS score 7.5 ± 4.4%. All patients gave written informed consent.
  
  
  RESULTS
  Off-pump AVI was performed using femoral arterial and venous access wires as a safety net. All but two patients received TA-AVI, as planned. The 29-mm valve showed similar function as the values of two other diameters did. Three patients (2%) required temporary cardiopulmonary bypass support. Postoperative complications included renal failure requiring long-term dialysis in four, bleeding requiring rethoracotomy in four, respiratory complication requiring reintubation in eight and sepsis in four patients, respectively. Thirty-day mortality was 13 (8.7%) for the total cohort and 2/57 (3.5%) for patients receiving the 29-mm valve, respectively. Echocardiography at discharge showed none or trivial aortic incompetence (AI) in 71% and mild-AI in 22% of the patients. Post-implantation AI was predominantly paravalvular and ≥ 2+ in 7% of patients. One patient required reoperation for AI within 30 days.
  
  
  CONCLUSIONS
  The PREVAIL TA multicentre trial demonstrates good functionality and good outcomes for TA-AVI, using the SAPIEN XT™ prosthesis and its second-generation ASCENDRA-II™ delivery system, as well successful introduction of the 29-mm SAPIEN XT™ valve for the benefit of high-risk elderly patients.
authors.affiliation: Department of Cardiac Surgery, Kerckhoff Heartcenter Bad Nauheim, Bad Nauheim, Germany. t.walther@kerckhoff-klinik.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
authors.forename: Joerg
authors.initials: J
authors.lastname: Kempfert
authors.forename: Holger
authors.initials: H
authors.lastname: Schroefel
authors.forename: Gerhard
authors.initials: G
authors.lastname: Wimmer-Greinecker
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.forename: Thorsten
authors.initials: T
authors.lastname: Wahlers
authors.forename: Olaf
authors.initials: O
authors.lastname: Wendler
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000379:methods*; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D016896:Treatment Outcome