Guidewire during TAVR procedures appears to be efficacious and safe: Study
In a recent study, the SavvyWire, a 0.035-inch pre-shaped guidewire with unique pacing properties and a distal pressure sensor, has demonstrated remarkable efficacy and safety during transcatheter aortic valve replacement (TAVR) procedures. The study, conducted across eight European centers, aimed to assess the device's performance and safety in patients with severe aortic stenosis undergoing TAVR. This study was published in the journal JACC: Cardiovascular Interventions by Ander R. and colleagues.
Continuous hemodynamic pressure monitoring is crucial during TAVR procedures, and the SavvyWire takes innovation to the next level by combining this feature with dedicated pacing properties. This prospective multicenter study delves into the device's ability to achieve effective left ventricular rapid pacing runs and maintain safety throughout the procedure.
This prospective, multicenter clinical study enrolled 121 patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) across eight European centers. The participants, with a mean age of 82.2 ± 5.9 years and 50% women, were included in the study, with 119 ultimately treated with the SavvyWire. The primary efficacy endpoint focused on the device's ability to induce effective left ventricular rapid pacing runs resulting in a significant systemic pressure drop below 60 mm Hg.
Key Findings:
• High Efficacy: The primary efficacy endpoint was achieved in 98.3% of patients, showcasing the SavvyWire's effectiveness in left ventricular rapid pacing runs.
• Mean aortic systolic arterial pressure during rapid pacing: 46.6 ± 11.3 mm Hg.
• Hemodynamic assessment with OptoMonitor 3 achieved in 99.2% of patients.
• Safety First: The safety endpoint was achieved in 99.2% of patients, with no reported procedural mortality, stroke, or ventricular perforation.
• Procedural Insights: The SavvyWire's use could minimize interventions during TAVR procedures, offering significant systemic pressure drops and aiding in clinical decision-making post-transcatheter heart valve deployment.
The SavvyWire has emerged as a reliable and safe tool for TAVR procedures, demonstrating high efficacy in achieving effective left ventricular rapid pacing runs. This pioneering device not only enhances patient safety but also optimizes procedural outcomes, positioning itself as a valuable asset in the realm of transcatheter aortic valve replacement.
Reference:
Regueiro, A., Alperi, A., Vilalta, V., Asmarats, L., Baz, J. A., Nombela-Franco, L., Calabuig, A., Muñoz-GarcÃa, A., Sabaté, M., Moris, C., Picard-Deland, M., Pelletier-Beaumont, E., & Rodés-Cabau, J. Safety and efficacy of TAVR with a pressure sensor and pacing guidewire. JACC. Cardiovascular Interventions,2023;16(24):3016–3023. https://doi.org/10.1016/j.jcin.2023.10.035
