Valvular & structural heart diseaseCohort study

Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States

JACC Cardiovasc IntervPublished

  • Retrospective cohort study
  • propensity-matched
  • registry-based

Authors' conclusion

S3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.

Study context

Population
Patients undergoing transcatheter aortic valve replacement (TAVR) with balloon expandable valves in the STS/ACC TVT Registry, January 2021–June 2023matched from 150,539 S3U/S3
Participants
10,314 vs 10,314
Exposure
S3UR vs S3/S3U
  • S3URn = 10,314
  • S3/S3Un = 10,314reference

Main finding

As reported in the abstract

30-day death, stroke, bleeding and hospital readmission · 30 days
  • No statistically significant differences in death, stroke or bleeding
  • S3UR vs S3/S3U: P = 0.04
  • propensity-matched

Observational data: associations, not effects.

Further findings

Mean gradient · discharge

P < 0.0001

Aortic valve area · discharge

P < 0.0001

Mild paravalvular leak (PVL), 29-mm valve size

29-mm valve: significant reduction in mild PVL, 5.3% vs 9.4%
P < 0.0001

Original publication

Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States. JACC Cardiovasc Interv. Published 8 March 2024. doi:10.1016/j.jcin.2024.02.015

Summarised from the published abstract; every number is checked against it