Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire : SAFE-TAVI Trial
Regueiro, Ander (Hospital Clínic i Provincial de Barcelona)
Alperi, Alberto (Hospital Universitario Central de Asturias)
Vilalta, Victoria (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Asmarats, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Baz, Jose Antonio (Hospital Alvaro Cunqueiro)
Nombela-Franco, Luís (Hospital Clínico San Carlos)
Calabuig Goena, Alvaro (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Muñoz-García, Antonio (Hospital Regional Universitario Virgen de la Victoria)
Sabaté Tenas, Manel (Hospital Clínic i Provincial de Barcelona)
Moris, Cesar (Hospital Universitario Central de Asturias)
Picard-Deland, Maxime (OpSens Inc)
Pelletier-Beaumont, Emilie (Quebec Heart and Lung Institute)
Rodés-Cabau, Josep (Laval University)
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	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. This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. 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. 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 efficacy 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. 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. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383).
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Aortic stenosis ; Hemodynamic assessment ; Left ventricular pacing ; Transcatheter aortic valve replacement
Published in:	JACC: Cardiovascular Interventions, Vol. 16 Núm. 24 (25 2023) , p. 3016-3023, ISSN 1876-7605

DOI: 10.1016/j.jcin.2023.10.035
PMID: 37902144

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles