title: Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes.
abstract: OBJECTIVE
  The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) remains uncertain. In this analysis, we sought to evaluate the impact of varying degrees of PVR on both mortality and changes in ventricular geometry and function.
  
  
  RESULTS
  Clinical and echocardiographic outcomes of patients who underwent TAVR from the randomized cohorts and continued access registries in the PARTNER trial were analysed after stratifying by severity of post-implant PVR, which was graded as none/trace in 52.9% (n = 1288), mild in 38.0% (n = 925), and moderate/severe in 9.1% (n = 221). There were significant differences in baseline clinical and echocardiographic characteristics. After TAVR, all the patients demonstrated increase in left ventricular (LV) function and reduction in the LV mass index, although the magnitude of mass regression was lower in the moderate/severe PVR group. The 30-day mortality (3.1 vs. 3.4 vs. 4.5%, P = 0.56) and stroke (3.4 vs. 3.7 vs. 2.3%, P = 0.59) were similar in all groups (none/trace, mild, and moderate/severe). At 1 year, there was increased all-cause mortality (15.9 vs. 22.2 vs. 35.1%, P < 0.0001), cardiac mortality (6.1 vs. 7.4% vs. 16.3%, P < 0.0001) and re-hospitalization (14.4 vs. 23.0 vs. 31.3%, P < 0.0001) with worsening PVR. A multivariable analysis indicated that the presence of moderate/severe PVR (HR: 2.18, 95% CI: 1.57-3.02, P < 0.0001) or mild PVR (HR: 1.37, 95% CI: 1.14-1.90, P = 0.012) was associated with higher late mortality.
  
  
  CONCLUSIONS
  Differences in baseline characteristics in patients with increasing severities of PVR may increase the risk of this complication. Despite these differences, multivariable analysis demonstrated that both mild and moderate/severe PVR predicted higher 1-year mortality.
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, NY 10032, USA sk2427@columbia.edu.
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.affiliation: Laval University, Quebec, QC, USA.
authors.forename: Philippe
authors.initials: P
authors.lastname: Pibarot
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, NY 10032, USA.
authors.forename: Mathew
authors.initials: M
authors.lastname: Williams
authors.affiliation: Cardiovascular Research Foundation, New York, NY, USA.
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.affiliation: Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Vinod
authors.initials: V
authors.lastname: Thourani
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: Charanjit S
authors.initials: CS
authors.lastname: Rihal
authors.affiliation: Washington University School of Medicine, Saint Louis, MO, USA.
authors.forename: Alan
authors.initials: A
authors.lastname: Zajarias
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, NY 10032, USA.
authors.forename: Darshan
authors.initials: D
authors.lastname: Doshi
authors.affiliation: Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Davidson
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: William
authors.initials: W
authors.lastname: Stewart
authors.affiliation: Medstar Health Research Institute, Washington, DC, USA.
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Lars
authors.initials: L
authors.lastname: Svensson
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Greason
authors.affiliation: Washington University School of Medicine, Saint Louis, MO, USA.
authors.forename: Hersh
authors.initials: H
authors.lastname: Maniar
authors.affiliation: Baylor Healthcare System, Plano, TX, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Saif
authors.initials: S
authors.lastname: Anwaruddin
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, NY 10032, USA.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, NY 10032, USA.
authors.forename: Rebecca T
authors.initials: RT
authors.lastname: Hahn
mesh_terms: D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000401:mortality / Q000473:pathology; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D004452:Echocardiography; D005260:Female; D016127:Heart Valve Prolapse; D006801:Humans; D008297:Male; D008944:Mitral Valve Insufficiency / Q000209:etiology / Q000401:mortality / Q000473:pathology; D009929:Organ Size; D012086:Reoperation / Q000706:statistics & numerical data; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
keywords: Aortic stenosis; Paravalvular regurgitation; Transcatheter aortic valve replacement