Valvular & structural heart disease
Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study
Authors' conclusion
The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR.
Study context
- Population
- Inoperable patients with severe pure native-valve aortic regurgitation (AR) (bicuspid valve excluded)
- Participants
- 256 patients
- Exposure
- Purpose-built Jena Valve Trilogy (JVT) vs off-label transcatheter heart valves (THVs)
- JVTn = 88
- Off-label THVsn = 168reference
- Outcome
- Technical and device success, 1-year all-cause mortality, and composite of 1-year mortality and HF rehospitalization
Methodological detailsmulticentre, 18 centres worldwide
- Multicentre
- 18 centres worldwide
Main finding
As reported in the abstract
Technical and device success; 1-year all-cause mortality; 1-year composite of mortality and HF rehospitalization
Technical success
P < 0.001
Device success
P < 0.001
- No significant difference in 1-year mortality, HR 0.99
- P = 0.980
- No significant difference in 1-year composite endpoint, HR 1.5
- P = 0.355
Observational data: associations, not effects.
Further findings
THV embolization, need for second valve, moderate residual AR
THV embolization
Second valve
Moderate residual AR
- THV embolization, need for second valve, moderate residual AR: embolization P < 0.001
- THV embolization, need for second valve, moderate residual AR: second valve P = 0.004
- THV embolization, need for second valve, moderate residual AR: residual AR P = 0.007
Safety
Permanent pacemaker implantation · comparable
P = 0.70
Original publication
Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study. JACC Cardiovasc Interv. Published 8 July 2024. doi:10.
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