title: Worldwide experience with the 29-mm Edwards SAPIEN XT™ transcatheter heart valve in patients with large aortic annulus.
abstract: OBJECTIVE
  The feasibility of transcatheter aortic valve implantation is limited by the diameter of the aortic annulus. Patients with an annulus of >25 mm were previously unsuitable for transcatheter valve implantation using the Edwards SAPIEN™ bioprosthesis. The 29-mm Edwards SAPIEN XT™ bioprosthesis is a new device suitable for transapical aortic valve implantation in patients with a large aortic annulus. We report the worldwide experience in using this device.
  
  
  METHODS
  A total of 120 patients (age 80.3 ± 5.7 years, 2.5% female) underwent transapical aortic valve implantation using a 29-mm Edwards SAPIEN XT™ bioprosthesis between the period of December 2009 and February 2011. The mean values of the logistic EuroSCORE and the STS score were 23.4 ± 7.7 and 6.8 ± 4.0, respectively. A total of 20 centres participated in this study and all patients gave written informed consent.
  
  
  RESULTS
  There were two conversions to open heart surgery (1.7%) and four patients (3.3%) required a temporary cardiopulmonary bypass support. A mean of 131 ± 68.0-ml contrast dye was used. The procedural success, defined as one valve implanted, no aortic regurgitation (AR) >2+ and a transcatheter valve in the appropriate position, was achieved in 95.8% of patients. Early postoperative complications at ≤ 30 days included renal failure requiring temporary dialysis (n = 7, 5.8%), reopening for bleeding (n = 5, 4.2%), stroke (n = 2, 1.7%), respiratory complications requiring prolonged mechanical ventilation (n = 11, 9.2%) and postoperative pacemaker implantation (n = 15/12.5%). The Kaplan-Meier survival estimates were 95.8% at 30-day, 88.9% at 6-month and 79.8% at the 1-year follow-up. The controlled echocardiography data at 30 days (n = 95) revealed no/trivial AR in 79 (84.1%), mild AR in 12 (12.8%) and moderate in two (2.2%) patients. The univariable analysis of baseline characteristics revealed no predictor for 30-day mortality.
  
  
  CONCLUSIONS
  The 29-mm Edwards SAPIEN XT™ bioprosthesis provides an excellent outcome in patients with a large aortic annulus undergoing transapical aortic valve implantation. Using this larger transcatheter heart valve, a broader population of high-risk elderly patients with aortic stenosis can be treated by minimally invasive transapical implantation techniques.
authors.affiliation: Department of Cardiothoracic Surgery, King's College Hospital/King's Health Partners, London, UK. olaf.wendler@nhs.net
authors.forename: Olaf
authors.initials: O
authors.lastname: Wendler
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
authors.forename: Holger
authors.initials: H
authors.lastname: Schroefel
authors.forename: Ardawan
authors.initials: A
authors.lastname: Rastan
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.forename: Thorsten
authors.initials: T
authors.lastname: Wahlers
authors.forename: Walther
authors.initials: W
authors.lastname: Eichinger
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000002:abnormalities*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000379:methods*; D061887:Conversion to Open Surgery; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D061646:Operative Time; D011183:Postoperative Complications / Q000209:etiology; D016896:Treatment Outcome