Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons

J Am Coll Cardiol. 2014 Mar 11;63(9):901-11. doi: 10.1016/j.jacc.2013.08.1641. Epub 2013 Oct 23.

Abstract

Objectives: The goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR).

Background: Patients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear.

Methods: Patients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial and the nonrandomized continued access registry. Patients were classified according to whether they were classified as technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity, and potential for injury to previous bypass graft on sternal re-entry. Reasons for CLI were systemic factors that were deemed to make survival unlikely.

Results: Of the 369 patients, 23.0% were considered inoperable for technical reasons alone; the remaining were judged to be CLI. For TI, the most common cause was a porcelain aorta (42%); for CLI, it was multiple comorbidities (48%) and frailty (31%). Quality of life and 2-year mortality were significantly better among TI patients compared with CLI patients (mortality 23.3% vs. 43.8%; p < 0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts.

Conclusions: Patients undergoing TAVR based solely on TI have better survival and quality of life improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

Keywords: TAVI; TAVR; inoperable; risk; transcatheter aortic valve.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aorta / surgery
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / surgery*
  • Aortic Valve Stenosis / therapy*
  • Cohort Studies
  • Female
  • Heart Valve Prosthesis / adverse effects*
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / mortality
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Registries
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00530894