Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial
Por:
Regueiro, A, Alperi, A, Vilalta, V, Asmarats, L, Baz, JA, Nombela-Franco, L, Calabuig, A, Muñoz-García, A, Sabaté, M, Moris, C, Picard-Deland, M, Pelletier-Beaumont, E, Rodés-Cabau, J
Publicada:
25 dic 2023
Ahead of Print:
1 dic 2023
Resumen:
BACKGROUND The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring.OBJECTIVES This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures.METHODS This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire.RESULTS A total of 121 patients (mean age: 82.2 +/- 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary effi-cacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 +/- 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported.CONCLUSIONS The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment.
Filiaciones:
Regueiro, A:
Univ Barcelona, Hosp Clin Barcelona, Clin Cardiovasc Inst, Inst Invest Biomed August Pi I Sunyer, Barcelona, Spain
Univ Barcelona, Hosp Clin Barcelona, Clin Cardiovasc Inst, Inst Invest Biomed August Pi i Sunyer, Villarroel 170, Barcelona 08036, Spain
Alperi, A:
Hosp Univ Cent Asturias, Dept Cardiol, Inst Invest Sanitaria Principado Asturias, Heart Area, Oviedo, Spain
Vilalta, V:
Hosp Badalona Germans Trias & Pujol, Heart Inst, Badalona, Spain
Asmarats, L:
Hosp Santa Creu & Sant Pau, Intervent Cardiol Dept, Cardiol Unit, Barcelona, Spain
Baz, JA:
Hosp Alvaro Cunqueiro, Intervent Cardiol Unit, Vigo, Spain
Nombela-Franco, L:
Hosp Clin San Carlos, Inst Invest Sanitaria, Cardiovasc Inst, Madrid, Spain
Calabuig, A:
Hosp Univ Vall dHebron, Vall dHebron Res Inst, Barcelona, Spain
Muñoz-García, A:
Hosp Reg Univ Virgen Victoria, Ctr Invest Biomed Red Enfermedades Cardiovaculares, Malaga, Spain
Sabaté, M:
Univ Barcelona, Hosp Clin Barcelona, Clin Cardiovasc Inst, Inst Invest Biomed August Pi I Sunyer, Barcelona, Spain
Moris, C:
Hosp Univ Cent Asturias, Dept Cardiol, Inst Invest Sanitaria Principado Asturias, Heart Area, Oviedo, Spain
Picard-Deland, M:
OpSens Inc, Quebec City, PQ, Canada
Pelletier-Beaumont, E:
Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
Rodés-Cabau, J:
Laval Univ, Quebec Heart & Lung Inst, Quebec City, PQ, Canada
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