Author + information
- Received April 6, 2014
- Revision received June 3, 2014
- Accepted June 8, 2014
- Published online September 30, 2014.
- Philippe Pibarot, DVM, PhD∗∗ (, )
- Neil J. Weissman, MD†,
- William J. Stewart, MD‡,
- Rebecca T. Hahn, MD§,‖,
- Brian R. Lindman, MD, MSCI¶,
- Thomas McAndrew, MS‖,
- Susheel K. Kodali, MD§,‖,
- Michael J. Mack, MD#,
- Vinod H. Thourani, MD∗∗,
- D. Craig Miller, MD††,
- Lars G. Svensson, MD, PhD‡‡,
- Howard C. Herrmann, MD§§,
- Craig R. Smith, MD§,‖,
- Josep Rodés-Cabau, MD∗,
- John Webb, MD‖‖,
- Scott Lim, MD¶¶,
- Ke Xu, PhD‖,
- Irene Hueter, PhD§,
- Pamela S. Douglas, MD## and
- Martin B. Leon, MD§,‖
- ∗Québec Heart and Lung Institute/Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Québec, Canada
- †Medstar Health Research Institute, Washington, DC
- ‡Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
- §Columbia University Medical Center/New York–Presbyterian Hospital, New York, New York
- ‖The Cardiovascular Research Foundation, New York, New York
- ¶Washington University School of Medicine, St. Louis, Missouri
- #Baylor Healthcare System, Dallas, Texas
- ∗∗Emory University School of Medicine, Atlanta, Georgia
- ††Stanford University School of Medicine, Stanford, California
- ‡‡Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio
- §§Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- ‖‖University of British Columbia and St. Paul’s Hospital, Vancouver, Canada
- ¶¶University of Virginia Medical Center, Charlottesville, Virginia
- ##Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina
- ↵∗Reprint requests and correspondence:
Dr. Philippe Pibarot, Québec Heart and Lung Institute, 2725 Chemin Ste-Foy, Québec QC G1V-4G5, Canada.
Background Little is known about the incidence of prosthesis-patient mismatch (PPM) and its impact on outcomes after transcatheter aortic valve replacement (TAVR).
Objectives 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 cm2/m2, moderate if the indexed EOA was ≥0.65 but ≤0.85 cm2/m2, or severe if the indexed EOA was <0.65 cm2/m2. 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)
The PARTNER trial was funded by Edwards Lifesciences Corporation. The current analysis was carried out by academic investigators and at the Cardiovascular Research Foundation under the auspices of the PARTNER Publications Office. Dr. Pibarot holds the Canada Research Chair in Valvular Heart Diseases, Canadian Institutes of Health Research, Ottawa, Ontario, Canada; and has received research grant support from Edwards Lifesciences Corporation. Dr. Weissman has received grant support from Boston Scientific Corporation. Dr. Lindman was supported by K23 Grant HL116660 from the National Institutes of Health, Washington, DC. Dr. Kodali is a member of the PARTNER Trial Steering Committee and a consultant for Edwards Lifesciences Corporation; a member of the steering committee for the Portico Trial (St. Jude Medical Inc.); and a member of the scientific advisory board of Thubrikar Aortic Valve Inc. Dr. Mack has received travel reimbursements from Edwards Lifesciences Corporation relating to his participation as an unpaid member of the PARTNER Trial Executive Committee. Dr. Thourani is a member of the PARTNER Trial Steering Committee; and a consultant for Edwards Lifesciences Corporation, Sorin Medical, St. Jude Medical Inc., and DirectFlow. Dr. Miller is supported by an R01 research grant from National Heart, Lung, and Blood Institute No. HL67025; has received travel reimbursements from Edwards Lifesciences Corporation related to his work as an unpaid member of the PARTNER Trial Executive Committee; and has received consulting fees/honoraria from Abbott Vascular, St. Jude Medical Inc., and Medtronic Inc. Dr. Svensson has received travel reimbursements from Edwards Lifesciences Corporation related to his work as an unpaid member of the PARTNER Trial Executive Committee; holds equity in Cardiosolutions and ValvXchange; and has Intellectual Property Rights/Royalties from Posthorax. Dr. Herrmann has received grant support from Abbott Vascular, Boston Scientific Corporation, Edwards Lifesciences Corporation, Medtronic Inc., Siemens, and W. L. Gore & Associates Inc.; and has received consulting fees/honoraria from Paieon and W. L. Gore & Associates Inc. Dr. Smith has received travel reimbursements from Edwards Lifesciences Corporation related to work as an unpaid member of the PARTNER Trial Executive Committee. Dr. Rodés-Cabau has received grant support from Boston Scientific Corporation and Edwards Lifesciences Corporation; and has received consulting fees/honoraria from AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo/Eli Lilly, GlaxoSmithKline, Janssen, Merck/Schering-Plough, and Regeneron. Dr. Webb is a member of the PARTNER Trial Executive Committee; and has received consulting fees from Edwards Lifesciences Corporation. Dr. Lim has received consulting fees/honoraria from Boston Scientific Corporation, Guerbet, and St. Jude Medical Inc. Dr. Leon has received travel reimbursements from Edwards Lifesciences Corporation related to work as an unpaid member of the PARTNER Trial Executive Committee. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 6, 2014.
- Revision received June 3, 2014.
- Accepted June 8, 2014.
- American College of Cardiology Foundation