Valvular & structural heart diseaseCohort study
3-Year Outcomes From the Evolut Low Risk Transcatheter Aortic Valve Replacement (TAVR) Bicuspid Study
- Prospective single-arm study
- multicentre
- 25 US centres
Independent clinical events committee adjudicated all deaths and endpoint-related adverse events · Central echocardiographic core laboratory assessed hemodynamic endpoints
Authors' conclusion
The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance.
Study context
- Population
- Severe AS at low surgical risk with bicuspid aortic valve anatomy (all subtypes)attempted implant
- Participants
- 150 participants
- Outcome
- All-cause mortality or disabling stroke (Kaplan-Meier rate)
- Follow-up
- 3 years
Main finding
As reported in the abstract
Kaplan-Meier rate of all-cause mortality or disabling stroke at 3 years
4.1% (95% CI: 1.6%-10.7%)
Observational data: associations, not effects.
Further findings
All-cause mortality or disabling stroke (Kaplan-Meier rate) · 1 year
- Kaplan-Meier rate at 1 year
- 1.3% (95% CI: 0.3%-5.3%)
All-cause mortality or disabling stroke (Kaplan-Meier rate) · 2 years
- Kaplan-Meier rate at 2 years
- 3.4% (95% CI: 1.4%-8.1%)
Moderate or severe paravalvular aortic regurgitation · 2 and 3 years
- No instances of moderate or severe paravalvular aortic regurgitation
Safety
New permanent pacemaker implantation · 3 years
- Incidence of new permanent pacemaker implantation at 3 years
- 19.4% (95% CI: 12.4%-29.6%)
Original publication
Summarised from the published abstract; every number is checked against it