Valvular & structural heart disease
Safety and Efficacy of Transcatheter Aortic Valve Replacement (TAVR) With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial
Authors' conclusion
The use of the guidewire during TAVR procedures appeared to be efficacious and safe.
Study context
- Population
- Patients with severe AS undergoing TAVR119 treated with device
- Participants
- 121 patients
- Outcome
- Effective LV rapid pacing runs with the guidewire producing significant systemic pressure drop (<60 mm Hg)
Methodological detailsmulticentre, 8 European centres
- Multicentre
- 8 European centres
Main finding
As reported in the abstract
Effective LV rapid pacing with the guidewire causing systemic pressure drop <60 mm Hg
Primary efficacy endpoint achieved, n (%)
116
98.3%
Mean aortic systolic arterial pressure during rapid pacing
46.6 ± 11.3 mm Hg
Observational data: associations, not effects.
Further findings
Hemodynamic assessment with OptoMonitor 3 without additional catheter exchange
- Achieved, n (%)
- 117 (99.2%)
Safety
Safety endpoint (no major procedural complications related to the guidewire)
- Safety endpoint achieved, n (%)
- 117 (99.2%)
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial. JACC Cardiovasc Interv. Published 23 October 2023. doi:10.
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