Johnson & Johnson has announced that Biosense Webster’s QDOT Micro catheter facilitates high power-short duration radiofrequency (RF) ablation demonstrated safety and efficacy in achieving pulmonary vein isolation in patients with symptomatic drug-refractory paroxysmal atrial fibrillation (AF) in QDOT-Fast, the first in-human multicentre study of the device.
Procedure and fluoroscopy times were also reported to be shorter than ablation with conventional catheters.
The findings were published in JACC: Clinical Electrophysiology and presented at Heart Rhythm 2019 by Vivek Y. Reddy, director of cardiac arrhythmia services for The Mount Sinai Hospital and the Mount Sinai Health System and the Helmsley Trust professor of medicine in cardiac electrophysiology at Icahn School of Medicine at Mount Sinai in New York. The study was funded by Biosense Webster.
Dr Reddy, co-author of the study said: “The results are very promising and may lead to better patient outcomes and improved procedural efficiencies, including short overall procedure and fluoroscopy times. Additional prospective studies are needed to assess for the durability of the lesion set and long-term freedom from recurrent atrial arrhythmias.”
QDOT Micro delivers up to 90 watts of RF power in up to four seconds in a temperature-controlled ablation mode. The current practice of RF ablation with irrigated catheters involves the delivery of moderate power (20 to 40 watts) for a relatively long duration (20 to 40 seconds).
In the three-month multicentre prospective study, researchers reported pulmonary vein isolation (PVI) was successful in all 52 paroxysmal AF patients treated with a total average procedure time of 105.2 minutes. PVI was achieved in 44.3 minutes and most fluoroscopy times were between 2.5 and 5.7 minutes. Primary adverse events occurred in 3.8% of patients (one pseudoaneurysm, one asymptomatic thromboembolism) and one non-serious adverse event (oesophageal ulcer) was device/procedure related.
Uri Yaron, worldwide president of Biosense Webster: “We continue to study QDOT Micro and generate the evidence necessary to offer a next generation device that we expect to be groundbreaking for catheter ablation procedures. This study is one of many that we hope elevates the standard of care for atrial fibrillation patients throughout the world.”
