Valvular & structural heart diseaseCohort study
Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement
- Registry-based cohort study
- nationwide registry
- propensity-score matched
- median follow-up 20 months (IQR 14 to 30)
Authors' conclusion
The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV.
Study context
- Population
- Patients undergoing TAVR for native AS, FRANCE-TAVI registry, 2013–2015matched 3910 per group
- Participants
- 12,141 patients
- Exposure
- SE-THV vs BE-THV for TAVR
- SE-THVn = 4,103
- BE-THVn = 8,038reference
- Outcome
- Coprimary: ≥ moderate paravalvular regurgitation or in-hospital mortality, or both; 2-year all-cause mortality
Main finding
As reported in the abstract
SE-THV
19.8%
≥ moderate PVR or in-hospital mortality · 2-year mortality 29.8%
BE-THV
11.9%
≥ moderate PVR or in-hospital mortality · 2-year mortality 26.6%
SE-THV vs BE-THVEstimate (95% CI)P value
first coprimary outcome
RR 1.68(1.46–1.91)
P < 0.00012-year all-cause mortality; deaths 899 vs 801
HR 1.17(1.06–1.29)
P = 0.003Observational data: associations, not effects.
Further findings
| Outcome | BE-THV | SE-THV | RR (95% CI) | P value | |
|---|---|---|---|---|---|
| ≥ moderate paravalvular regurgitation | 8.3% | 15.5% | 1.90 (1.63–2.22) | P < 0.0001 | |
| In-hospital mortality | 4.2% | 5.6% | 1.34 (1.07–1.66) | P = 0.01 | |
| 0.512Relative risk (log scale) |
Original publication
Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement. Circulation. Published 16 November 2019. doi:10.1161/circulationaha.119.043785
Summarised from the published abstract; every number is checked against it