title: A Comparison Between First-Generation and Second-Generation Transcatheter Aortic Valve Implantation (TAVI) Devices: A Propensity-Matched Single-Center Experience.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) is the treatment of choice for high-risk patients presenting with severe symptomatic aortic stenosis. The aim of this study was to investigate the impact of second-generation (2G) devices in comparison to first-generation (1G) devices with regard to procedural and short-term clinical outcomes.
  
  
  METHODS
  Between November 2007 and May 2015, a total of 449 patients treated with 1G TAVI devices (Edwards Sapien XT, Medtronic CoreValve) were propensity matched (1:1) to 179 patients treated with 2G TAVI devices (Edwards Sapien 3, Medtronic Evolut R, Boston Scientific Lotus, Direct Flow Medical). The primary endpoint was 30-day safety according to the Valve Academic Research Consortium 2 (VARC-2) definition.
  
  
  RESULTS
  Patients treated with 1G devices suffered more adverse events at 30-day follow-up (freedom of adverse events, 75.3% vs 88.8%; hazard ratio, 2.4; 95% confidence interval (CI), 1.4-4.0; P=.01) and a significantly greater number of minor vascular complications (31.8% vs 10.4%; P<.001) and major vascular complications (3.2% vs 0.6%; P<.001) compared with patients treated with 2G devices. The presence of residual aortic regurgitation ≥2 was also greater in the 1G group (17.5% vs 5.8%; odds ratio, 0.30; 95% CI, 0.13-0.69; P<.001). There were no differences between groups with regard to 30-day all-cause mortality (5.2% vs 3.2%; odds ratio, 0.61; 95% CI, 0.20-1.92; P=.40).
  
  
  CONCLUSIONS
  TAVI with contemporary 2G devices was associated with a significant safety benefit at 30 days and reduction of residual moderate or severe paravalvular leak. Longer-term follow-up in more patients is required to determine if these short-term benefits translate into improvements in long-term clinical outcomes.
authors.forename: Neil
authors.initials: N
authors.lastname: Ruparelia
authors.affiliation: EMO-GVM Centro Cuore Columbus, Via Buonarroti 48, 20145, Milan, Italy. info@emocolumbus.it.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Kawamoto
authors.forename: Nicola
authors.initials: N
authors.lastname: Buzzatti
authors.forename: Francesco
authors.initials: F
authors.lastname: Giannini
authors.forename: Filippo
authors.initials: F
authors.lastname: Figini
authors.forename: Antonio
authors.initials: A
authors.lastname: Mangieri
authors.forename: Damiano
authors.initials: D
authors.lastname: Regazzoli
authors.forename: Stefano
authors.initials: S
authors.lastname: Stella
authors.forename: Alessandro
authors.initials: A
authors.lastname: Sticchi
authors.forename: Akihito
authors.initials: A
authors.lastname: Tanaka
authors.forename: Marco
authors.initials: M
authors.lastname: Ancona
authors.forename: Eustachio
authors.initials: E
authors.lastname: Agricola
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Monaco
authors.forename: Pietro
authors.initials: P
authors.lastname: Spagnolo
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D004452:Echocardiography; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D057216:Propensity Score; D012189:Retrospective Studies; D012720:Severity of Illness Index; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*; D016896:Treatment Outcome