Currently, we observe an increase in the number of transcatheter aortic valve replacement (TAVR) procedures due to its expansion toward a younger population with lower risk. For this reason, it is crucial to maintain continuous technological innovation to minimize post-procedural complications.
The FDA has approved the SavyWire, a preformed 0.035-caliber guidewire that offers three essential functions: 1) it facilitates prosthesis transport and positioning; 2) it allows for continuous hemodynamic monitoring through a distal optical fiber sensor; 3) it enables pacing through the left ventricle.
The main objective of this prospective multicenter study, named SAFE-TAVI (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures), was to assess the safety and efficacy of the SavyWire in TAVR, using both balloon-expandable and self-expandable valves.
The primary endpoint (PEP) was defined as rapid and effective pacing with a significant decrease in pressure (reduction of systolic pressure below 60 mmHg). The secondary safety endpoint (SSE) included the absence of major guidewire-related complications.
Researchers analyzed a total of 119 patients with a mean age of 82.2 ± 5.9 years, 49.6% of whom were women. The average STS Score was 3.85. All patients were treated via transfemoral access. Balloon-expandable valves were used in 37.8% of cases. Predilation was performed in 74.8% of subjects and postdilation in 11.8% of patients.
Read also: Heterotopic Tricuspid Intervention: TricValve One-Year Outcomes.
Regarding the PEP, a drop in systolic pressure below 60 mmHg was achieved in 98.3% of patients, and the mean arterial systolic pressure during rapid pacing was 46.6 ± 11.3 mm Hg. The SSE was reached in 99.2% of patients, with no mortality, stroke, guidewire kinking, or ventricular perforation events.
Conclusion
The results of this study demonstrate the safety and efficacy of the SavyWire during TAVR. This device can contribute to minimizing intervention during the procedure and improving clinical outcomes after transcatheter aortic valve implantation.
Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.
Original Title: Safety and Efficacy of Transcatheter Aortic Valve Replacement With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial.
Reference: Ander Regueiro, MD, PHD et al J Am Coll Cardiol Intv 2023.
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