Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced that data from the Q-FFICIENCY study was published in JACC: Clinical Electrophysiology. The study evaluated the safety and 12-month effectiveness of the QDOT MICRO Catheter in paroxysmal atrial fibrillation (AFib) ablation using the very high-power short-duration mode combined with conventional-power temperature-controlled mode.
The prospective, multicenter study, conducted across 22 centers in the United States, included 166 evaluable patients with drug-refractory symptomatic paroxysmal AFib. The study found that the use of the QDOT MICRO™ Catheter with the QMODE+™ setting, alone or in combination with the QMODE™ setting, improved procedural efficiency and enhanced 12-month effectiveness without compromising safety. The authors reported the Kaplan-Meier estimated 12-month rate for primary effectiveness success was 76.7%, and clinical success rate – defined as freedom from symptomatic recurrence – was 86.0%. The data showed increased efficiency and efficacy when compared with legacy catheters, while the primary safety event rate was in line with previous studies.
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“The Q-FFICIENCY study demonstrated that the use of very high-power, short-duration ablation delivered by the temperature-controlled QDOT MICRO Catheter allowed very efficient ablation procedures – with ablation times, fluoroscopy times and radiofrequency (RF) times for ablating pulmonary veins (PV) that were lower compared to similarly-designed studies. We achieved better success rates at one year, with improved efficiency without compromising safety,” said Jose Osorio, MD, FHRS, Medical Director of Electrophysiology, Grandview Medical Center, Birmingham AL and the Publication’s Lead Author.
AFib is the most common type of cardiac arrhythmia affecting an estimated 37.5 million people globally. By 2030, the number of people with AFib is projected to increase by up to 70 percent. Given those projections, physicians are looking for innovative ways to improve the safety, efficacy and efficiency of procedures and deliver better outcomes for their patients.
The current practice of RF ablation with irrigated catheters involves the delivery of moderate power (20–50 watts) for a relatively long duration – 20 seconds or longer. The QDOT MICRO Catheter is a next-generation RF ablation catheter that incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation, and higher signal resolution. In QMODE+, the catheter allows the delivery of very high-power, short-duration ablation – 90 watts for up to four seconds, significantly improving ablation efficiency. QMODE is comparative to conventional RF ablation while using up to 50 watts for up to 60 seconds.
SOURCE: PR Newswire