Valvular & structural heart disease
Balloon-Expandable vs Self-Expanding Valves for Transcatheter Treatment of Sievers Type 1 Bicuspid Aortic Stenosis
Main finding · Major adverse eventsResult — go to the resultHazard ratio 0.75 95% CI 0.49–1.16Authors' conclusion
Current-generation BEVs and SEVs proved similar technical success and midterm clinical efficacy in Sievers type 1 BAV stenosis. Compared to SEVs, BEVs were associated with less permanent pacemaker implantation and moderate or greater paravalvular regurgitation but with more severe patient-prosthesis mismatch.
Study context
- Population
- Patients with Sievers type 1 bicuspid aortic valve stenosis undergoing TAVR (AD-HOC registry)
- Participants
- 955 patients301 matched pairs
- Exposure
- BEV vs SEV for TAVR in Sievers type 1 bicuspid aortic valve (BAV) stenosis
- BEVn = 301
- SEVn = 301reference
- Outcome
- Midterm major adverse events:
- All-cause death
- Neurologic events
- Hospitalization for HF
- Follow-up
- Median 1.3 years
Methodological detailspropensity-score matched (1:1), multicentre (24 international centres)
- Propensity-score matched (1:1)
- Multicentre (24 international centres)
Main finding
Major adverse events
Hazard ratio
0.75
95% CI 0.49–1.16
P = 0.200
BEVvs SEV
HR 0.75 (95% CI 0.49–1.16); P = 0.200
As reported in the abstract
Observational data: associations, not effects.
Further findings
| Outcome | OR (95% CI) | P value | |
|---|---|---|---|
| New permanent pacemaker implantation · 30 daysLower risk with BEV · matched cohort | 0.42 (0.24–0.72) | P = 0.002 | |
| Moderate or greater paravalvular regurgitation · 30 daysLower risk with BEV · matched cohort | 0.16 (0.05–0.48) | P = 0.001 | |
| Severe patient-prosthesis mismatch · 30 daysHigher risk with BEV · matched cohort | 3.03 (1.02–8.95) | P = 0.045 | |
| 0.050.21520Odds ratio (log scale) |
Technical success
- Technical success similar with BEV and SEV (OR 1.38; 95% CI 0.63-3.04)
- P = 0.421
Safety
| Outcome | OR (95% CI) | P value | |
|---|---|---|---|
| New permanent pacemaker implantation · 30 days | 0.42 (0.24–0.72) | P = 0.002 | |
| Moderate or greater paravalvular regurgitation · 30 days | 0.16 (0.05–0.48) | P = 0.001 | |
| Severe patient-prosthesis mismatch · 30 days | 3.03 (1.02–8.95) | P = 0.045 | |
| 0.050.21520Odds ratio (log scale) |
Original publication
Balloon-Expandable vs Self-Expanding Valves for Transcatheter Treatment of Sievers Type 1 Bicuspid Aortic Stenosis. JACC Cardiovasc Interv. Published 3 September 2024. doi:10.
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