Valvular & structural heart diseaseCohort study
Electrosurgical Leaflet Modification to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement in Failing Native and Bioprosthetic Valves
- Single-arm prospective trial
- multicentre
- 11 US centres
Authors' conclusion
Electrosurgical leaflet modification using the TELLTALE system is safe and effective in patients undergoing TAVR for native aortic stenosis or bioprosthetic valve failure at high risk of coronary obstruction.
Study context
- Population
- High or prohibitive surgical risk patients undergoing transcatheter aortic valve replacement (TAVR) for native AS or bioprosthetic valve failure with CT core-lab-confirmed high risk of coronary obstruction30 native AS, 60 bioprosthetic
- Participants
- 90 participants
- Outcome
- Efficacy: technical success in the catheterization lab; safety: inpatient safety
Main finding
As reported in the abstract
Technical success in the catheterization lab (primary efficacy endpoint)
Primary efficacy endpoint met
100% (95% CI: 95%-100%)
Observational data: associations, not effects.
Further findings
Traversal and laceration attempts per participant
- Median traversal and laceration attempts per participant; leaflet modification easy and reliable
- 1
Mortality and delayed coronary obstruction · 30 days
- Mortality
- 0
- Delayed coronary obstruction
- 0
Safety
Inpatient safety (primary safety endpoint)
- Primary safety endpoint met
- 96% (95% CI: 88%-99%)
- Mortality
- 0
- Strokes (1 disabling, 2 nondisabling)
- 3
- Coronary obstruction from THV commissural suture post-malalignment
- 1
Original publication
Electrosurgical Leaflet Modification to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement in Failing Native and Bioprosthetic Valves. JACC Cardiovasc Interv. Published 13 October 2025. doi:10.1016/j.jcin.2025.07.032
Summarised from the published abstract; every number is checked against it