The study evaluated the use of the dual-energy ThermoCool SmartTouch SF catheter. ThermoCool SmartTouch SF is the first dual-energy pulsed field ablation (PFA)/radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index. Biosense Webster’s system in this study featured the catheter alongside the TruPulse generator. Both offer full integration with the Carto 3 mapping system.
Results demonstrated 100% acute procedural success during standard electrophysiology mapping and ablation procedures in drug refractory symptomatic paroxysmal AFib patients. Additionally, investigators said 96.8% of patients showed no acute reconnections in the veins.
Dr. Mattias Duytschaever of the AZ Sint-Jan Hospital, Brugge, Belgium, served as an investigator. Duytschaever said early results showed both procedural success and the seamless transition of ablation workflow with dual-energy.
“Having the ability to easily switch between RF and PF energy provides the flexibility to customize treatment depending on the patient anatomy and clinical need, enabling electrophysiologists to perform more targeted ablation procedures which could lead to improved outcomes for patients,” Duytschaever said in a news release.
More about the Biosense Webster SmartfIRE study
SmartfIRE enrolled 149 adult patients in Europe with drug refractory paroxysmal AFib. The company aims to complete the trial by the end of this calendar year.
When used for the isolation of the atrial pulmonary veins (PVs) in the treatment of patients with paroxysmal AFib (137 in total), catheter ablation using PF and RF enabled a total energy application time of median 12.8 min and fluoroscopy exposure of 4.2 minutes.
Biosense Webster reported primary adverse events in 4.4% of patients. Prespecified remapping performed at 75 days post-procedure in a subset of patients demonstrated 87% of targeted veins as durable isolated.
“The initial results from the SmartfIRE trial suggest that the dual-energy ThermoCool SmartTouch SF catheter, together with the TruPulse generator and the Carto 3 system, is a promising advancement in cardiac ablation,” said VP, Scientific Affairs, Cardiovascular & Specialty Solutions Group at Johnson & Johnson MedTech, Jennifer Currin. “As Biosense Webster works to develop a versatile portfolio of PFA solutions, we believe that the Dual Energy ThermoCool SmartTouch SF catheter will be a valuable addition to the set of tools electrophysiologists use to address diverse ablation strategies in the treatment of atrial arrhythmias.”
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