Valvular & structural heart disease
Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States
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
Methodological detailspropensity-matched, registry-based
- Propensity-matched
- Registry-based
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.
Summarised from the published abstract; every number is checked against it