title: Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) is a treatment option for high-risk patients with severe aortic stenosis. Previous reports focused on a single device or access site, whereas little is known of the combined use of different devices and access sites as selected by the heart team. The purpose of this study is to investigate clinical outcomes of TAVI using different devices and access sites.
  
  
  METHODS
  A consecutive cohort of 200 patients underwent TAVI with the Medtronic CoreValve Revalving system (Medtronic Core Valve LLC, Irvine, CA; n = 130) or the Edwards SAPIEN valve (Edwards Lifesciences LLC, Irvine, CA; n = 70) implanted by either the transfemoral or transapical access route.
  
  
  RESULTS
  Device success and procedure success were 99% and 95%, respectively, without differences between devices and access site. All-cause mortality was 7.5% at 30 days, with no differences between valve types or access sites. Using multivariable analysis, low body mass index (<20 kg/m(2)) (odds ratio [OR] 6.6, 95% CI 1.5-29.5) and previous stroke (OR 4.4, 95% CI 1.2-16.8) were independent risk factors for short-term mortality. The VARC-defined combined safety end point occurred in 18% of patients and was driven by major access site complications (8.0%), life-threatening bleeding (8.5%) or severe renal failure (4.5%). Transapical access emerged as independent predictor of adverse outcome for the Valve Academic Research Consortium-combined safety end point (OR 3.3, 95% CI 1.5-7.1).
  
  
  CONCLUSIONS
  A heart team-based selection of devices and access site among patients undergoing TAVI resulted in high device and procedural success. Low body mass index and history of previous stroke were independent predictors of mortality. Transapical access emerged as a risk factor for the Valve Academic Research Consortium-combined safety end point.
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.forename: Nadja
authors.initials: N
authors.lastname: Roth
authors.forename: Alexander
authors.initials: A
authors.lastname: Kadner
authors.forename: Stefan
authors.initials: S
authors.lastname: Stortecky
authors.forename: Bindu
authors.initials: B
authors.lastname: Kalesan
authors.forename: Fabienne
authors.initials: F
authors.lastname: Meuli
authors.forename: Lutz
authors.initials: L
authors.lastname: Büllesfeld
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Khattab
authors.forename: Christoph
authors.initials: C
authors.lastname: Huber
authors.forename: Balthasar
authors.initials: B
authors.lastname: Eberle
authors.forename: Gabor
authors.initials: G
authors.lastname: Erdös
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Thierry
authors.initials: T
authors.lastname: Carrel
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D015992:Body Mass Index; D017079:Exercise Tolerance; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D020521:Stroke / Q000453:epidemiology; D016896:Treatment Outcome