Valvular & structural heart disease
Transcatheter Aortic Valve Replacement in Pure Aortic Regurgitation: The Randomized SEASON-AR Clinical Trial
Primary result · Composite of all-cause death, disabling stroke, or heart failure rehospitalization (Kaplan-Meier estimate)Result — go to the resultHazard ratio 0.31 95% CI 0.14–0.66Authors' conclusion
Among patients with severe pure AR, TAVR plus GDMT significantly reduced the rate of all-cause death, disabling stroke, or heart failure rehospitalization at 1 year compared with GDMT alone despite higher 30-day rates of major or life-threatening bleeding and new permanent pacemaker implantation.
Study context
- Population
- Patients with severe pure aortic regurgitation (AR) for whom surgery was considered difficult or unacceptable by the local heart team or who persistently declined surgeryrandomized
- Participants
- 210 patients
- Comparison
- Transfemoral transcatheter aortic valve replacement (TAVR) with the VitaFlow system plus guideline-directed medical therapy (GDMT) or GDMT alone
- TAVR groupn = 109
- GDMT groupn = 101reference
- Primary endpoint
- Composite of:
- All-cause death
- Disabling stroke
- Heart failure rehospitalization (Kaplan-Meier estimate)
- Follow-up
- 1 year
Methodological detailsChina, 18 centers, 1:1 randomization
- China
- 18 centers
- 1:1 randomization
Primary result
As reported in the abstract
Hazard ratio
0.31
95% CI 0.14–0.66
P = 0.001
By group
TAVR group vs GDMT group
HR 0.31 (95% CI 0.14–0.66); P = 0.001
Further findings
| Outcome | TAVR group | GDMT group | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Heart failure rehospitalization · 1 year | 3.7% | 21.3% | 0.16 (0.06–0.47) | P < 0.001 | |
| 0.050.21520Hazard ratio (log scale) |
Safety
Major or life-threatening bleeding and new permanent pacemaker implantation
- Higher rates with TAVR, most within 30 days after the procedure
Original publication
Transcatheter Aortic Valve Replacement in Pure Aortic Regurgitation: The Randomized SEASON-AR Clinical Trial. Circulation. Published 31 October 2026. doi:10.
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