Effect of Baseline Aortic Regurgitation on Mortality in Patients Treated With Transcatheter or Surgical Aortic Valve Replacement (from the CoreValve US Pivotal Trial)

Am J Cardiol. 2018 Nov 1;122(9):1527-1535. doi: 10.1016/j.amjcard.2018.07.018. Epub 2018 Aug 3.

Abstract

This study was performed to determine if baseline aortic regurgitation (AR) affects the deleterious effects of postprocedure paravalvular leak following transcatheter aortic valve implantation (TAVI). We evaluated the effect of baseline AR on mortality in a large cohort of patients randomized to transcatheter or surgical aortic valve replacement (SAVR). The analysis cohort comprised 739 patients who underwent attempted TAVI (n = 386) or SAVR (n = 353) in the CoreValve US Pivotal High Risk Trial and had baseline AR measurements. Patients were stratified by the severity of baseline AR into those with none and/or trace and those with ≥mild AR. Echocardiographic measurements were assessed by an independent core laboratory. Of the 386 TAVI patients, 204 (52.9%) had none and/or trace at baseline AR; 182 (47.2%) had ≥mild AR. Of the 353 SAVR patients, 169 (47.9%) had none and/or trace and 184 (52.1%) ≥mild AR. The presence of ≥mild baseline AR was associated with lower all-cause mortality at 1 year following TAVI (9.4% vs 18.6%, p = 0.008) or SAVR (13.3% vs 24.4%, p = 0.009). Mortality remained lower in the ≥mild baseline AR patients at 3 years after SAVR (p = 0.011), but not TAVI. In conclusion, baseline AR appears to provide a protective effect on survival and quality of life in both TAVI and SAVR patients at 1 year; this effect persists out to 3 years in SAVR patients.

Trial registration: ClinicalTrials.gov NCT01240902.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aortic Valve Insufficiency / mortality*
  • Aortic Valve Stenosis / surgery
  • Echocardiography
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Humans
  • Prosthesis Failure
  • Quality of Life
  • Severity of Illness Index
  • Transcatheter Aortic Valve Replacement* / adverse effects

Associated data

  • ClinicalTrials.gov/NCT01240902