Valvular & structural heart diseaseCohort study
1-Year Outcomes of Transcatheter Aortic Valve Replacement Using a Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve
- Retrospective cohort study
- propensity-score matched
- 3 centres
Authors' conclusion
Despite differing immediate results, the outcomes at 1 year, including the composite of all-cause mortality, stroke, or hospitalization, were similar for neo2 and Ultra transcatheter heart valves.
Study context
- Population
- Patients undergoing transfemoral TAVR
- Participants
- 2,106 patients · 702 matched pairs
- Exposure
- Self-expanding ACURATE neo2 vs balloon-expandable SAPIEN 3 Ultra
- neo2n = 1,166
- Ultran = 940reference
- Outcome
- Composite of:
- All-cause mortality
- Stroke
- Rehospitalization
- Follow-up
- 1 year
Main finding
As reported in the abstract
P = 0.819
Observational data: associations, not effects.
Secondary outcomes
Device success · irrespective of matching
P = 0.007
Mean pressure gradient after the procedure
P < 0.001
Individual components of the primary endpoint · 1 year
- No difference between the groups
Safety
In-hospital complications
- Paravalvular leakage, device embolization and multiple valve implantations more common with neo2
- Major cardiac structural and major vascular complications more frequent with Ultra
- All other in-hospital complication rates similar
Original publication
1-Year Outcomes of Transcatheter Aortic Valve Replacement Using a Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve. JACC Cardiovasc Interv. Published 20 November 2024. doi:10.1016/j.jcin.2024.09.042
Summarised from the published abstract; every number is checked against it