Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients

Circ Cardiovasc Interv. 2024 Nov;17(11):e014018. doi: 10.1161/CIRCINTERVENTIONS.124.014018. Epub 2024 Oct 18.

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery.

Methods: The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years.

Results: In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (P=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P<0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe prosthesis-patient mismatch (P<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation.

Conclusions: Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR.

Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.

Keywords: aortic valve stenosis; humans; incidence; stroke; transcatheter aortic valve replacement.

Publication types

  • Randomized Controlled Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Age Factors
  • Aged
  • Aortic Valve Stenosis* / diagnostic imaging
  • Aortic Valve Stenosis* / mortality
  • Aortic Valve Stenosis* / physiopathology
  • Aortic Valve Stenosis* / surgery
  • Aortic Valve* / diagnostic imaging
  • Aortic Valve* / physiopathology
  • Aortic Valve* / surgery
  • Bioprosthesis
  • Female
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Middle Aged
  • Prosthesis Design
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index*
  • Stroke* / etiology
  • Stroke* / mortality
  • Time Factors
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / instrumentation
  • Transcatheter Aortic Valve Replacement* / mortality
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02701283