title: Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of Aortic Transcatheter Valve) trial.
abstract: BACKGROUND
  Transcatheter aortic valve replacement (TAVR) is a less invasive option for treatment of high-risk patients with severe aortic stenosis. We sought to identify patients at high risk for poor outcome after TAVR using a novel definition of outcome that integrates quality of life with mortality.
  
  
  RESULTS
  Among 2137 patients who underwent TAVR in the PARTNER (Placement of Aortic Transcatheter Valve) trial or its associated continued access registry, quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Scale (KCCQ-OS; range 0-100, where a higher score equates to a better quality of life) at baseline and at 1, 6, and 12 months after TAVR. A poor 6-month outcome (defined as death, KCCQ-OS score <45, or ≥10-point decrease in KCCQ-OS score compared with baseline) occurred in 704 patients (33%). Using a split-sample design, we developed a multivariable model to identify a parsimonious set of covariates to identify patients at high risk for poor outcome. The model demonstrated moderate discrimination (c-index=0.66) and good calibration with the observed data, performed similarly in the separate validation cohort (c-index=0.64), and identified 211 patients (10% of the population) with a ≥50% likelihood of a poor outcome after TAVR. A second model that explored predictors of poor outcome at 1 year identified 1102 patients (52%) with ≥50% likelihood and 178 (8%) with ≥70% likelihood of a poor 1-year outcome after TAVR.
  
  
  CONCLUSIONS
  Using a large, multicenter cohort, we have developed and validated predictive models that can identify patients at high risk for a poor outcome after TAVR. Although model discrimination was moderate, these models may help guide treatment choices and offer patients realistic expectations of outcomes based on their presenting characteristics.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.). suz.v.arnold@gmail.com.
authors: Suzanne V
authors: SV
authors: Arnold
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Matthew R
authors: MR
authors: Reynolds
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Yang
authors: Y
authors: Lei
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Elizabeth A
authors: EA
authors: Magnuson
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Ajay J
authors: AJ
authors: Kirtane
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Susheel K
authors: SK
authors: Kodali
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Alan
authors: A
authors: Zajarias
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Vinod H
authors: VH
authors: Thourani
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Philip
authors: P
authors: Green
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Josep
authors: J
authors: Rodés-Cabau
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Nirat
authors: N
authors: Beohar
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Michael J
authors: MJ
authors: Mack
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: Martin B
authors: MB
authors: Leon
authors: From Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A., Y.L., E.A.M., D.J.C.); University of Missouri-Kansas City, Kansas City, MO (S.V.A., E.A.M., D.J.C.); Harvard Clinical Research Institute, Boston, MA (M.R.R.); Columbia-Presbyterian Hospital, New York, NY (A.J.K., S.K.K., P.G., M.B.L.); Washington University, St. Louis, MO (A.Z.); Emory University School of Medicine, Atlanta, GA (V.H.T.); Laval University, Quebec, Canada (J.R.-C.); Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (N.B.); and Baylor Healthcare System, Plano, TX (M.J.M.).
authors: David J
authors: DJ
authors: Cohen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis* / Q000601:surgery*; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D008297:Male; D015233:Models, Statistical; D015999:Multivariate Analysis; D011379:Prognosis; D011788:Quality of Life; D012189:Retrospective Studies; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: aortic valve stenosis; heart valves; outcomes assessment; quality of life