title: A prospective, non-randomized comparison of SAPIEN XT and CoreValve implantation in two sequential cohorts of patients with severe aortic stenosis.
abstract: OBJECTIVE
  Few data is available comparing Edwards SAPIEN XT - SXT (Edwards Lifesciences, Irvine, California) with Medtronic CoreValve - CoV (Medtronic Inc., Minneapolis, Minnesota) in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR).
  
  
  METHODS
  We selected consecutive patients undergoing transfemoral TAVR with SXT or CoV at our Institution. Main outcomes were Valve Academic Research Consortium (VARC)-combined safety endpoints.
  
  
  RESULTS
  A total of 100 patients (SXT, n=50 versus CoV, n=50) were analyzed. Both SXT and CoV showed good device success rates (98% versus 90%, p=0.20). SXT versus CoV reduced the occurrence of paravalvular regurgitation after TAVR (26% versus 90%, p<0.0001) though not affecting the rate of moderate/severe regurgitation (p=0.20). SXT versus CoV required less frequently a permanent pacemaker after TAVR (8% versus 38%, p<0.0001). In-hospital major vascular complications (8% versus 4%, p>0.99), life-threatening bleedings (2% versus 4%, p>0.99), stroke (4% versus 6%, p>0.99) and death (6% versus 2%, p>0.99) did not differ between SXT and CoV. However, safety endpoints favored SXT (17% versus 34.6%, p=0.01), due to a numerically higher incidence of ischemic stroke and Acute Kidney Injury Stage 3 after CoV. At multivariate analysis, TAVR with SXT (odds ratio=0.21, 95% confidence intervals [0.05-0.84], p=0.03) was predictive of fewer adverse events.
  
  
  CONCLUSIONS
  Transcatheter valve implantation with Edwards SAPIEN XT was associated with lower VARC-combined safety endpoints as compared with Medtronic CoreValve. More extensive cohorts are needed to confirm these results.
authors.affiliation: Klinik für Kardiologie und Intensivmedizin, Klinikum Bogenhausen Munich, Germany ; Deutsches Herzzentrum, Technische Universität Munich, Germany.
authors.forename: Albert Markus
authors.initials: AM
authors.lastname: Kasel
authors.affiliation: Deutsches Herzzentrum, Technische Universität Munich, Germany.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cassese
authors.affiliation: Klinik für Kardiologie und Intensivmedizin, Klinikum Bogenhausen Munich, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Ischinger
authors.affiliation: Klinik für Kardiologie und Intensivmedizin, Klinikum Bogenhausen Munich, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Leber
authors.affiliation: Klinik für Kardiologie und Intensivmedizin, Klinikum Bogenhausen Munich, Germany.
authors.forename: Diethmar
authors.initials: D
authors.lastname: Antoni
authors.affiliation: Klinik für Kardiologie und Intensivmedizin, Klinikum Bogenhausen Munich, Germany.
authors.forename: Gotthard
authors.initials: G
authors.lastname: Riess
authors.affiliation: Klinik für Kardiologie und Intensivmedizin, Klinikum Bogenhausen Munich, Germany ; Deutsches Herzzentrum, Technische Universität Munich, Germany.
authors.forename: Jayshree
authors.initials: J
authors.lastname: Vogel
authors.affiliation: Klinik für Kardiologie und Intensivmedizin, Klinikum Bogenhausen Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.affiliation: Klinik für Herzchirurgie, Klinikum Bogenhausen Munich, Germany.
authors.forename: Walter
authors.initials: W
authors.lastname: Eichinger
authors.affiliation: Klinik für Kardiologie und Intensivmedizin, Klinikum Bogenhausen Munich, Germany.
authors.forename: Ellen
authors.initials: E
authors.lastname: Hoffmann
keywords: Aortic valve stenosis; CoreValve; SAPIEN XT; TAVR