title: Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis.
abstract: BACKGROUND
  Little is known about the incidence of prosthesis-patient mismatch (PPM) and its impact on outcomes after transcatheter aortic valve replacement (TAVR).
  
  
  OBJECTIVE
  The objectives of this study were: 1) to compare the incidence of PPM in the TAVR and surgical aortic valve replacement (SAVR) randomized control trial (RCT) arms of the PARTNER (Placement of AoRTic TraNscathetER Valves) I Trial cohort A; and 2) to assess the impact of PPM on regression of left ventricular (LV) hypertrophy and mortality in these 2 arms and in the TAVR nonrandomized continued access (NRCA) registry cohort.
  
  
  METHODS
  The PARTNER Trial cohort A randomized patients 1:1 to TAVR or bioprosthetic SAVR. Postoperative PPM was defined as absent if the indexed effective orifice area (EOA) was >0.85 cm(2)/m(2), moderate if the indexed EOA was ≥0.65 but ≤0.85 cm(2)/m(2), or severe if the indexed EOA was <0.65 cm(2)/m(2). LV mass regression and mortality were analyzed using the SAVR-RCT (n = 270), TAVR-RCT (n = 304), and TAVR-NRCA (n = 1,637) cohorts.
  
  
  RESULTS
  The incidence of PPM was 60.0% (severe: 28.1%) in the SAVR-RCT cohort versus 46.4% (severe: 19.7%) in the TAVR-RCT cohort (p < 0.001) and 43.8% (severe: 13.6%) in the TAVR-NRCA cohort. In patients with an aortic annulus diameter <20 mm, severe PPM developed in 33.7% undergoing SAVR compared with 19.0% undergoing TAVR (p = 0.002). PPM was an independent predictor of less LV mass regression at 1 year in the SAVR-RCT (p = 0.017) and TAVR-NRCA (p = 0.012) cohorts but not in the TAVR-RCT cohort (p = 0.35). Severe PPM was an independent predictor of 2-year mortality in the SAVR-RCT cohort (hazard ratio [HR]: 1.78; p = 0.041) but not in the TAVR-RCT cohort (HR: 0.58; p = 0.11). In the TAVR-NRCA cohort, severe PPM was not a predictor of 1-year mortality in all patients (HR: 1.05; p = 0.60) but did independently predict mortality in the subset of patients with no post-procedural aortic regurgitation (HR: 1.88; p = 0.02).
  
  
  CONCLUSIONS
  In patients with severe aortic stenosis and high surgical risk, PPM is more frequent and more often severe after SAVR than TAVR. Patients with PPM after SAVR have worse survival and less LV mass regression than those without PPM. Severe PPM also has a significant impact on survival after TAVR in the subset of patients with no post-procedural aortic regurgitation. TAVR may be preferable to SAVR in patients with a small aortic annulus who are susceptible to PPM to avoid its adverse impact on LV mass regression and survival. (The PARTNER Trial: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
authors.affiliation: Québec Heart and Lung Institute/Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Québec, Canada. Electronic address: philippe.pibarot@med.ulaval.ca.
authors.forename: Philippe
authors.initials: P
authors.lastname: Pibarot
authors.affiliation: Medstar Health Research Institute, Washington, DC.
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
authors.forename: William J
authors.initials: WJ
authors.lastname: Stewart
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; The Cardiovascular Research Foundation, New York, New York.
authors.forename: Rebecca T
authors.initials: RT
authors.lastname: Hahn
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Brian R
authors.initials: BR
authors.lastname: Lindman
authors.affiliation: The Cardiovascular Research Foundation, New York, New York.
authors.forename: Thomas
authors.initials: T
authors.lastname: McAndrew
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; The Cardiovascular Research Foundation, New York, New York.
authors.forename: Susheel K
authors.initials: SK
authors.lastname: Kodali
authors.affiliation: Baylor Healthcare System, Dallas, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.affiliation: Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: Stanford University School of Medicine, Stanford, California.
authors.forename: D Craig
authors.initials: DC
authors.lastname: Miller
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; The Cardiovascular Research Foundation, New York, New York.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: Québec Heart and Lung Institute/Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Québec, Canada.
authors.forename: Josep
authors.initials: J
authors.lastname: Rodés-Cabau
authors.affiliation: University of British Columbia and St. Paul's Hospital, Vancouver, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Webb
authors.affiliation: University of Virginia Medical Center, Charlottesville, Virginia.
authors.forename: Scott
authors.initials: S
authors.lastname: Lim
authors.affiliation: The Cardiovascular Research Foundation, New York, New York.
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.
authors.forename: Irene
authors.initials: I
authors.lastname: Hueter
authors.affiliation: Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York; The Cardiovascular Research Foundation, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000503:physiopathology* / Q000628:therapy*; D001705:Bioprosthesis; D015331:Cohort Studies; D015150:Echocardiography, Doppler; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects*; D006801:Humans; D017379:Hypertrophy, Left Ventricular / Q000150:complications / Q000503:physiopathology; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011475:Prosthesis Failure; D012044:Regression Analysis; D013997:Time Factors; D016896:Treatment Outcome
keywords: Doppler echocardiography; aortic regurgitation; left ventricular mass regression; mortality