First-in-human study demonstrates safety and efficacy of QDOT MICRO ablation catheter

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QDOT MICRO

Data presented at Heart Rhythm 2019 (8–11 May, San Francisco, USA) and published in JACC: Clinical Electrophysiology indicates that the QDOT MICRO (Biosense Webster), designed to facilitate high power-short duration radiofrequency ablation, demonstrated safety and efficacy in achieving pulmonary vein isolation in patients with symptomatic drug-refractory paroxysmal atrial fibrillation in QDOT-FAST.

Furthermore, according to a press release, procedure and fluoroscopy times were also reported to be shorter than ablation with conventional catheters. In the three-month multicentre prospective study, researchers reported pulmonary vein isolation was successful in all 52 paroxysmal atrial fibrillation patients treated with a total average procedure time of 105.2 minutes. Pulmonary vein isolation 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 and one asymptomatic thromboembolism) and one non-serious adverse event (oesophageal ulcer) was device/procedure related.

Vivek Y Reddy (The Mount Sinai Hospital, Mount Sinai Health System, and the Helmsley Trust; Icahn School of Medicine, New York, USA), who presented the study at Heart Rhythm, comments: “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, which is only available for investigational use in the USA and Europe, is the first irrigated contact force catheter to deliver up to 90 watts of radiofrequency power in up to four seconds in a temperature-controlled ablation mode. The current practice of radiofrequency ablation with irrigated catheters involves the delivery of moderate power (20 to 40 watts) for a relatively long duration (20 to 40 seconds).

Uri Yaron, worldwide president of Biosense Webster, says: “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.”

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