Valvular & structural heart diseaseCohort study
Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study
- Prospective single-arm pivotal study
- 22 clinical sites
- independent core laboratories
- adjudicated by clinical events committee
Images assessed by independent angiographic, echocardiographic and CT core laboratories; safety events adjudicated by a clinical events committee and data safety monitoring board
Authors' conclusion
Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.
Study context
- Population
- Patients with failed bioprosthetic aortic valves scheduled for transcatheter aortic valve implantation (TAVI) at risk for coronary artery obstruction
- Participants
- 60 patients
- Outcome
- Safety: procedure-related mortality or stroke; efficacy: per-patient leaflet splitting success
- Follow-up
- Discharge or 7 days (safety)
Main finding
As reported in the abstract
Successful leaflet splitting in all patients
100%
Observational data: associations, not effects.
Further findings
Procedure time, incl. imaging confirmation of leaflet splitting
- Procedure time (min)
- 30.6 ± 17.9
Freedom from coronary obstruction · 30 days
- Freedom from coronary obstruction
- 95%
- 95% CI 86.1%-99.0%
Freedom from mortality · 90 days
- Freedom from mortality
- 95%
- No CV deaths
- 95% CI 86.1%-99.0%
Original publication
Summarised from the published abstract; every number is checked against it