Valvular & structural heart disease
Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial
Authors' conclusion
In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups.
Study context
- Population
- Severe AS and small aortic annulus (mean diameter <23 mm)140 (93%) women
- Participants
- 151 participants
- Comparison
- Transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR)
- TAVRn = 77
- SAVRn = 74reference
- Primary endpoint
- Impaired valve hemodynamics (severe prosthesis patient mismatch or moderate-severe aortic regurgitation) by Doppler echocardiography, central core laboratory
- Follow-up
- 60 days
Methodological detailsmulticentre, international, 15 university hospitals
- Multicentre
- International
- 15 university hospitals
Primary result
As reported in the abstract
| Group | Value | Moderate-severe aortic regurgitation |
|---|---|---|
| TAVR | 5.6% | 0 |
| SAVR | 10.3% | 0 |
Value
TAVR5.6%
SAVR10.3%
Moderate-severe aortic regurgitation
TAVR0
SAVR0
- TAVR vs SAVR: P = 0.30 — severe prosthesis patient mismatch
Secondary outcomes
Mortality · 30 days
P = 1.00
Mortality · median follow-up 2 (IQR 1-4) years
P = 0.89
Stroke · median follow-up 2 (IQR 1-4) years
P = 0.95
Cardiac hospitalization · median follow-up 2 (IQR 1-4) years
P = 0.80
| Outcome | TAVR | SAVR | P value |
|---|---|---|---|
| Stroke · 30 days | 0 events | 2.7% | P = 0.24 |
Original publication
Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial. Circulation. Published 26 October 2023. doi:10.
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