title: Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy.
abstract: BACKGROUND
  The long-term outcomes of transcatheter aortic valve replacement (TAVR) in inoperable patients with severe aortic stenosis remain unknown.
  
  
  RESULTS
  In the Placement of Aortic Transcatheter Valves (PARTNER) study, 358 patients were randomly assigned to TAVR or standard therapy. We report the 3-year outcomes on these patients, and the pooled outcomes for all randomly assigned inoperable patients (n=449) in PARTNER, as well, including the randomized portion of the continued access study (n=91). The 3-year mortality rate in the TAVR and standard therapy groups was 54.1% and 80.9%, respectively (P<0.001; hazard ratio, 0.53; 95% confidence interval, 0.41-0.68; P<0.001). In survivors, there was significant improvement in New York Heart Association functional class sustained at 3 years. The cumulative incidence of strokes at 3-year follow-up was 15.7% in TAVR patients versus 5.5% in patients undergoing standard therapy (hazard ratio, 2.81; 95% confidence interval, 1.26-6.26; P=0.012); however, the composite of death or strokes was significantly lower after TAVR versus standard therapy (57.4% versus 80.9%, P<0.001; hazard ratio, 0.60; 95% confidence interval, 0.46-0.77; P<0.001). Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR. Analysis of the 449 pooled randomly assigned patients (TAVR, n=220; standard therapy, n=229) demonstrated significant improvement in all-cause mortality and functional status during early and 3-year follow-up. The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial.
  
  
  CONCLUSIONS
  TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up. However, high residual mortality, even in successfully treated TAVR patients, highlights the need for more strategic patient selection.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.). kapadis@ccf.org.
authors.forename: Samir R
authors.initials: SR
authors.lastname: Kapadia
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Shikhar
authors.initials: S
authors.lastname: Agarwal
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Fontana
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Vasilis C
authors.initials: VC
authors.lastname: Babaliaros
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Wilson
authors.initials: W
authors.lastname: Szeto
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Mathew R
authors.initials: MR
authors.lastname: Williams
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: William N
authors.initials: WN
authors.lastname: Anderson
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Jodi J
authors.initials: JJ
authors.lastname: Akin
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: D Craig
authors.initials: DC
authors.lastname: Miller
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: From the Cleveland Clinic Foundation, Cleveland, OH (S.R.K., E.M.T., L.G.S., S.A.); Cedars Sinai Medical Center, Los Angeles, CA (R.R.M.); Columbia University Medical Center/New York Presbyterian Hospital, New York, NY (S.K., M.R.W., C.R.S., M.B.L.); Lenox Hill Hospital, New York, NY (G.P.F.); St. Paul's Hospital, Vancouver, BC, Canada (J.G.W.); Baylor Healthcare System, Plano, TX (M.M.); Emory University School of Medicine, Atlanta, GA (V.H.T., V.C.B.); Hospital of the University of Pennsylvania, Philadelphia, PA (H.C.H., W.S.); Medstar Washington Hospital Center, Washington, DC (A.D.P.); Edwards Lifesciences, Irvine, CA (W.N.A., J.J.A.); and Stanford University, Stanford, CA (D.C.M.).
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000401:mortality / Q000628:therapy; D001024:Aortic Valve Stenosis / Q000401:mortality* / Q000628:therapy*; D006328:Cardiac Catheterization; D005260:Female; D005500:Follow-Up Studies; D006439:Hemodynamics; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D017063:Outcome Assessment, Health Care; D010359:Patient Readmission / Q000706:statistics & numerical data; D016016:Proportional Hazards Models; D020521:Stroke / Q000209:etiology / Q000401:mortality; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000379:methods* / Q000401:mortality*; D016896:Treatment Outcome
keywords: aortic valve; aortic valve stenosis; outcome assessment (health care)