Johnson & Johnson MedTech’s Biosense Webster today announced data from a study of its QDOT Micro catheter for treating AFib.
JACC: Clinical Electrophysiology published data from the Q-FFICIENCY study evaluating QDOT Micro’s safety and 12-month effectiveness. The study observed use of the catheter in paroxysmal AFib ablation using a combination of high-power and conventional modes. QDOT features a very high-power, short-duration QMODE+ mode and a conventional-power, temperature-controlled QMODE setting.
Irvine, California-based Biosense Webster conducted its prospective, multicenter study across 22 U.S. centers. It evaluated 166 patients with drug-refractory, symptomatic paroxysmal AFib. The study demonstrated that the use of QDOT’s QMODE+ setting, alone or inc combination with QMODE, improved procedural efficiency. It also showed enhanced 12-month effectiveness without compromising safety.
Authors reported a 76.7% Kaplan-Meier estimated 12-month rate for primary effectiveness success. The clinical success rate (defined as freedom from symptomatic recurrence) totaled 86%. Biosense Webster said the data demonstrated increased efficiency and efficacy when compared to legacy catheters. The primary safety event rate fell in line with previous studies.
“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 Dr. Jose Osorio, medical director of electrophysiology, Grandview Medical Center, Birmingham AL. Osorio served as the publication’s lead author.
About the Biosense Webster QDOT catheter
The QDOT Micro catheter, a next-generation radiofrequency (RF) ablation catheter, utilizes advanced, high-energy baltion. It offers improved temperature monitoring, optimized irrigation and higher signal resolution. In QMODE+, it enables the delivery of ablation at 90 watts for up to four seconds. Standard QMODE delivers RF ablation using up to 50 watts for up to 60 seconds. The QDOT Micro catheter received CE Mark in 2020 and FDA approval in 2022.
Biosense Webster said it designed the catheter to provide temperature control through intelligent adjustment of power and/or irrigation fluid output based on real-time temperature management. This temperature control safely enables the use of higher average RF power.
Osorio called the catheter versatile with a unique design, making it a “great tool” for personalized treatment. He added that it provides flexibility to physicians while optimizing their preferred workflows.
The system also integrates with the CARTO 3 system. Biosense Webster said this enables efficient and consistent lesion creation with a simplified workflow and lower procedure time. Real-world evidence demonstrated 48% shorter procedures using QMODE+ and 36% shorter procedures with QMODE. Those procedures lasted 60 minutes or less.
“Biosense Webster has been dedicated to advancing innovation and driving better patient outcomes in AFib treatment for the past three decades, and QDOT Micro is our latest innovation in focal RF ablation,” said Celine Martin, company group chair, Cardiovascular & Specialty Solutions Group, Johnson & Johnson MedTech. “As the Q-FFICIENCY trial demonstrated, use of temperature-controlled ablation for the treatment of AFib can be safe, effective and highly efficient, benefitting physicians and patients.”