Safety and Efficacy of Transcatheter Aortic Valve Replacement With a Pressure Sensor and Pacing Guidewire: SAFE-TAVI Trial.
aortic stenosis
hemodynamic assessment
left ventricular pacing
transcatheter aortic valve replacement
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
23 Oct 2023
23 Oct 2023
Historique:
received:
03
09
2023
revised:
16
10
2023
accepted:
16
10
2023
pubmed:
30
10
2023
medline:
30
10
2023
entrez:
30
10
2023
Statut:
aheadofprint
Résumé
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. The objective of the study was 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).
Sections du résumé
BACKGROUND
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
OBJECTIVE
The objective of the study was to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures.
METHODS
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
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 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.
CONCLUSIONS
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. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383).
Identifiants
pubmed: 37902144
pii: S1936-8798(23)01401-2
doi: 10.1016/j.jcin.2023.10.035
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT05492383']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Funding Support and Author Disclosures This study was sponsored by Opsens Medical. Dr Regueiro is a consultant from Abbott, Meril Life, and Opsens Medical. Dr Picard-Deland is an employee of Opsens Medical. Dr Rodés-Cabau is a consultant for and has received institutional research grants and consulting fees from Opsens Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.