Valvular & structural heart diseaseDiagnostic or prognostic study
Initial Experience and Bench Validation of the CLEVE Prosthetic Leaflet Modification Procedure During Aortic and Mitral Valve-in-Valve Procedures
- Case series with bench validation
Authors' conclusion
Patients with a degenerated surgical valve who are unsuitable for a valve-in-valve replacement due to anatomic concerns regarding displacement of the index prosthetic leaflet can be successfully treated after using the CLEVE method of leaflet modification.
Study context
- Population
- Patients with failing surgical aortic or mitral valves unsuitable for typical valve-in-valve due to threatened coronary or LV outflow tract obstruction
- Participants
- 8 vs 6
- Comparison
- Aortic valve replacement (AVR) vs mitral valve replacement (MVR)
- AVRn = 8
- MVRn = 6
Performance
As reported in the abstract
Successful leaflet clearance
- Successful leaflet clearance in all, without ostial coronary obstruction (AVR) or LV outflow tract obstruction (MVR)
- Bench: complete clearance of the threatening leaflet (detachment from a surgical post in AVR model; splitting across leaflet edge in MVR model)
Safety
Complications · 30 days
- Left main trunk obstruction from suspected embolization, treated percutaneously (patient died of further complications)
- 1
- No other complications at 30 days
Original publication
Initial Experience and Bench Validation of the CLEVE Prosthetic Leaflet Modification Procedure During Aortic and Mitral Valve-in-Valve Procedures. JACC Cardiovasc Interv. Published 24 March 2025. doi:10.1016/j.jcin.2024.11.037
Summarised from the published abstract; every number is checked against it