Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy

Circulation. 2015 Jun 2;131(22):1989-2000. doi: 10.1161/CIRCULATIONAHA.114.012525. Epub 2015 Apr 1.

Abstract

Background: The higher risk of adverse outcomes after transapical (TA) versus transfemoral (TF) transcatheter aortic valve replacement (TAVR) could be attributable to TA-TAVR being an open surgical procedure or to clinical differences between TA- and TF-TAVR patients. We compared outcomes after neutralizing patient differences using propensity score matching.

Methods and results: From April 2007 to February 2012, 1100 Placement of Aortic Transcatheter Valves (PARTNER)-I patients underwent TA-TAVR and 1521 underwent TF-TAVR with Edwards SAPIEN balloon-expandable bioprostheses. Propensity matching based on 111 preprocedural variables, exclusive of femoral access morphology, identified 501 well-matched patient pairs (46% of possible matches), 95% of whom had peripheral arterial disease. Matched TA-TAVR patients experienced more adverse procedural events, longer length of stay (5 versus 8 days; P<0.0001), and slower recovery (New York Heart Association class I, 31% versus 38% at 30 days, equalizing by 6 months at 51% versus 47%); stroke risk was similar (3.4% versus 3.3% at 30 days and 6.0% versus 6.7% at 3 years); mortality was elevated for the first 6 postprocedural months (19% versus 12%; P=0.01); but aortic regurgitation was less (34% versus 52% mild and 8.9% versus 12% moderate to severe at discharge, P=0.001; 36% versus 50% mild and 10% versus 15% moderate to severe at 6 months, P<0.0001).

Conclusions: The likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors, although stroke risk is equivalent and aortic regurgitation is less. As smaller delivery systems permit TF-TAVR in many of these patients, we recommend a TF-first access strategy for TAVR when anatomically feasible.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Keywords: aortic valve insufficiency; mortality; propensity score; stroke; transcatheter aortic valve replacement.

Publication types

  • Clinical Trial, Phase I
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / mortality*
  • Aortic Valve Stenosis / surgery*
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / mortality*
  • Female
  • Femoral Artery*
  • Follow-Up Studies
  • Humans
  • Longitudinal Studies
  • Male
  • Mortality / trends
  • Propensity Score*
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / mortality*
  • Transcatheter Aortic Valve Replacement / trends
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00530894