Valvular & structural heart disease
1-Year Real-World Outcomes of Transcatheter Aortic Valve Replacement (TAVR) With the Fifth-Generation Balloon-Expandable Valve in the United States
Authors' conclusion
TAVR with the S3UR is associated with superior 1-year clinical outcomes and lower gradients than its predecessors, with less PVL and low valve reintervention.
Study context
- Population
- Patients undergoing native TAVR, STS/ACC TVT Registry, September 2022 to March 2023matched from 32,536 S3 and S3U
- Participants
- 4,598 vs 4,598
- Exposure
- TAVR with S3UR vs S3 and S3U valves
- S3URn = 4,598
- S3 and S3Un = 4,598reference
- Outcome
- Clinical and echocardiographic outcomes
- Follow-up
- 1 year
Methodological detailspropensity-score matched, national registry (STS/ACC TVT Registry), Median follow-up 358 days (Q1-Q3: 47-365) S3UR vs 364 days (Q1-Q3: 80-365) S3 and S3U
- Propensity-score matched
- National registry (STS/ACC TVT Registry)
- Median follow-up 358 days (Q1-Q3: 47-365) S3UR vs 364 days (Q1-Q3: 80-365) S3 and S3U
Main finding
As reported in the abstract
Clinical and echocardiographic outcomes
S3UR
- All-cause mortality
- 7.6%
- Mild or greater paravalvular leak (PVL)
- 15.6%
S3 and S3U
- All-cause mortality
- 9.7%
- Mild or greater PVL
- 18.5%
All-cause mortality
S3UR7.6%
S3 and S3U9.7%
Mild or greater paravalvular leak (PVL)
S3UR15.6%
S3 and S3U18.5%
S3UR vs S3 and S3UHazard ratio (95% CI)P value
All-cause mortality
0.8(0.67–0.93)
P = 0.004Mild or greater PVL
0.82(0.69–0.97)
P = 0.02- Larger effective orifice areas with S3UR at discharge
- P < 0.0001
- Lower mean gradient with S3UR at discharge, maintained at 30 days and 1 year
- P < 0.0001
Observational data: associations, not effects.
Further findings
Predictors of 1-year mortality
- S3UR and mild or greater PVL predictive of 1-year mortality in the overall cohort and in low-risk patients
Safety
| Outcome | S3UR | S3 and S3U | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Life-threatening bleeding · 1 year · propensity-matched | 2.0% | 2.7% | 0.7 (0.54–0.94) | P = 0.03 | |
| Valve reintervention · 1 year · propensity-matched | 0.6% | 0.4% | 1.46 (0.77–2.78) | P = 0.25 | |
| 0.20.5125Hazard ratio (log scale) |
Valve reintervention · 1 year
- Valve reintervention remained rare at 1 year
Original publication
1-Year Real-World Outcomes of TAVR With the Fifth-Generation Balloon-Expandable Valve in the United States. JACC Cardiovasc Interv. Published 24 November 2024. doi:10.
Summarised from the published abstract; every number is checked against it