title: Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial.
abstract: OBJECTIVE
  The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement.
  
  
  METHODS
  From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 ± 6.3 years, were randomized in PARTNER-IA; 313 patients underwent surgical aortic valve replacement. Median follow-up was 2.8 years. Survival for therapy without aortic valve replacement used 181 PARTNER-IB patients.
  
  
  RESULTS
  Operative mortality was 10.5% (expected 9.3%), stroke 2.6% (expected 3.5%), renal failure 5.8% (expected 12%), sternal wound infection 0.64% (expected 0.33%), and prolonged length of stay 26% (expected 18%). However, calibration of observed events in this relatively small sample was poor. Survival at 1, 2, 3, and 4 years was 75%, 68%, 57%, and 44%, respectively, lower than 90%, 81%, 73%, and 65%, respectively, in the US population, but higher than 53%, 32%, 21%, and 14%, respectively, in patients without aortic valve replacement. Risk factors for death included smaller body mass index, lower albumin, history of cancer, and prosthesis-patient mismatch. Within this high-risk aortic valve replacement group, only the 8% of patients with the poorest risk profiles had estimated 1-year survival less than that of similar patients treated without aortic valve replacement.
  
  
  CONCLUSIONS
  PARTNER selection criteria for surgical aortic valve replacement, with a few caveats, may be more appropriate, realistic indications for surgery than those of the past, reflecting contemporary surgical management of severe aortic stenosis in high-risk patients at experienced sites.
authors.affiliation: Division of Cardiovascular Surgery, University of Pennsylvania Health System, Philadelphia, Pa.
authors.forename: Wilson Y
authors.initials: WY
authors.lastname: Szeto
authors.affiliation: Placement of Aortic Transcatheter Valves Publications Office, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: Placement of Aortic Transcatheter Valves Publications Office, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Jeevanantham
authors.initials: J
authors.lastname: Rajeswaran
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
authors.forename: John
authors.initials: J
authors.lastname: Ehrlinger
authors.affiliation: Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Rakesh M
authors.initials: RM
authors.lastname: Suri
authors.affiliation: Department of Surgery, Columbia University Medical Center/New York Presbyterian Hospital, New York, NY.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: Cardiovascular Surgery, Baylor Scott & White Health, Plano, Tex.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Department of Cardiovascular Surgery, Falk Cardiovascular Research Center, Stanford University School of Medicine, Stanford, Calif.
authors.forename: D Craig
authors.initials: DC
authors.lastname: Miller
authors.affiliation: Cardiac Surgery, Northwestern Memorial Hospital, Chicago, Ill.
authors.forename: Patrick M
authors.initials: PM
authors.lastname: McCarthy
authors.affiliation: Division of Thoracic Surgery, University of Pennsylvania Health System, Philadelphia, Pa.
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bavaria
authors.affiliation: Department of Surgery, Brigham and Women's Hospital, Boston, Mass.
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Cohn
authors.affiliation: Department of Cardiac Surgery, Medstar Washington Hospital Center, Washington, DC.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Corso
authors.affiliation: Department of Surgery, Division of Cardiothoracic Surgery, Emory University Hospital, Atlanta, Ga.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Guyton
authors.affiliation: Department of Surgery, Division of Cardiothoracic Surgery, Emory University Hospital, Atlanta, Ga.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Lytle
authors.affiliation: Department of Cardiothoracic Surgery & Department of Medicine, New York University, Langone Medical Center, New York, NY.
authors.forename: Mathew R
authors.initials: MR
authors.lastname: Williams
authors.affiliation: Division of Cardiology, Department of Medicine, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: Division of Cardiology, St. Luke's Mid-America Heart Institute, Kansas City, Mo.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Cardiac Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Hartzell V
authors.initials: HV
authors.lastname: Schaff
authors.affiliation: Placement of Aortic Transcatheter Valves Publications Office, Cleveland, Ohio; Center for Interventional Vascular Therapy, Division of Cardiology, Department of Medicine, Columbia University Medical Center/New York Presbyterian Hospital, New York, NY.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Placement of Aortic Transcatheter Valves Publications Office, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address: blackse@ccf.org.
authors.forename: Eugene H
authors.initials: EH
authors.lastname: Blackstone
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D019985:Benchmarking; D005260:Female; D015276:Health Care Rationing / Q000592:standards; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000401:mortality / Q000592:standards; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D018447:Medical Futility; D018579:Patient Selection; D011183:Postoperative Complications / Q000401:mortality; D017064:Process Assessment, Health Care / Q000592:standards; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
keywords: Society of Thoracic Surgeons; aortic stenosis; aortic valve replacement