TAVR in Low-Risk Patients: 1-Year Results From the LRT Trial

JACC Cardiovasc Interv. 2019 May 27;12(10):901-907. doi: 10.1016/j.jcin.2019.03.002. Epub 2019 Mar 12.

Abstract

Objectives: This study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients.

Background: Early results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement.

Methods: The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year.

Results: The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53).

Conclusions: TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.

Keywords: aortic stenosis; hypoattenuated leaflet thickening; low risk; subclinical leaflet thrombosis; transcatheter aortic valve replacement.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery*
  • Feasibility Studies
  • Female
  • Hemodynamics
  • Humans
  • Male
  • Postoperative Complications / etiology
  • Prospective Studies
  • Recovery of Function
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / mortality
  • Trauma Severity Indices
  • Treatment Outcome
  • United States