title: Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement: A Placement of AoRTic TraNscathetER Valve (PARTNER) Trial Substudy.
abstract: BACKGROUND
  In the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved.
  
  
  RESULTS
  We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales.
  
  
  CONCLUSIONS
  Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Hemal
authors.initials: H
authors.lastname: Gada
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Kaijun
authors.initials: K
authors.lastname: Wang
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Yang
authors.initials: Y
authors.lastname: Lei
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Magnuson
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Reynolds
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Mathew R
authors.initials: MR
authors.lastname: Williams
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Torsten P
authors.initials: TP
authors.lastname: Vahl
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Suzanne V
authors.initials: SV
authors.lastname: Arnold
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Vinod
authors.initials: V
authors.lastname: Thourani
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
authors.forename: Wilson Y
authors.initials: WY
authors.lastname: Szeto
authors.affiliation: From the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.). dcohen@saint-lukes.org.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000523:psychology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D011788:Quality of Life; D012042:Registries; D011795:Surveys and Questionnaires; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome
keywords: aortic valve; follow-up studies; quality of life; transapical; transcatheter aortic valve replacement