Appropriate patient selection or health care rationing? Lessons from surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves I trial

J Thorac Cardiovasc Surg. 2015 Sep;150(3):557-68.e11. doi: 10.1016/j.jtcvs.2015.05.073. Epub 2015 Jun 30.

Abstract

Objectives: 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.

Trial registration: ClinicalTrials.gov NCT00530894.

Keywords: Society of Thoracic Surgeons; aortic stenosis; aortic valve replacement.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / surgery*
  • Benchmarking
  • Female
  • Health Care Rationing* / standards
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Heart Valve Prosthesis Implantation* / mortality
  • Heart Valve Prosthesis Implantation* / standards
  • Hospital Mortality
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Medical Futility
  • Patient Selection*
  • Postoperative Complications / mortality
  • Process Assessment, Health Care* / standards
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • United States

Associated data

  • ClinicalTrials.gov/NCT00530894