Published in the Journal of Cardiovascular Electrophysiology, the results demonstrate improved AFib control. They also showed relief of symptoms and overall quality of life improvements with QDOT Micro ablation treatment.
The QDOT Micro catheter, a next-generation radiofrequency (RF) ablation catheter, utilizes advanced, high-energy ablation. 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.
Q-FFICIENCY evaluated the catheter’s safety and 12-month efficacy in patients with paroxysmal AFib. The study found a 99% and 93.1% improvement in control of AFib and relief of AFib symptoms, respectively. Meanwhile, 87.9% of patients experienced a meaningful clinical improvement in quality of life.
“AFib places a substantial burden on patients’ daily lives and healthcare resources, including physician visits, drug costs and side effects, and hospitalizations. At Biosense Webster, we are focused on improving patient outcomes, while offering innovative solutions for physicians treating the growing number of AFib patients today,” said Jasmina Brooks, president, Biosense Webster. “As the Q-FFICIENCY study findings demonstrate, use of the temperature-controlled QDOT Micro catheter allows physicians to customize treatment for each patient, reduce procedural times and offer significant benefits to patients through improving their quality of life.”
More about the Biosense Webster study
The latest data builds upon positive Q-FFICIENCY results for QDOT Micro published in May of this year. In that study, 86% of patients experienced freedom from symptomatic recurrence. Catheter-related primary adverse events remained low at 1.8%.
Q-FFICIENCY, a prospective, multicenter, nonrandomized study, looked at patients with drug-refractory, symptomatic paroxysmal AFib. They underwent PV isolation with QDOT Micro, with very high-power, short duration as the primary ablation mode.
Biosense Webster had a primary safety endpoint of incidence of primary adverse events within seven days of ablation. It set the primary effectiveness endpoint as freedom from documented atrial tachyarrhythmia recurrence and acute procedural, repeat ablation, and antiarrhythmic drug (AAD) failure. The study met both the primary safety and efficacy endpoints.
Q-FFICIENCY evaluated quality of life using the Atrial Fibrillation Effect on Quality-of-Life Tool (AFEQT). The questionnaire measures symptoms, daily activities, treatment concerns and satisfaction at baseline and throughout 12 months.
Biosense Webster reported a 79.9% reduction in Class I/III AAD. More than half of the participants discontinued use of all AADs post-ablation. Compared with the 12-month pre-ablation period, the cardioversion rate decreased by 93.9% during the evaluation period. Hospitalizations also decreased following ablation. The study saw 80.9% and 88.8% Kaplan-Meier estimated 12-month freedom from all-cause and cardiovascular hospitalizations, respectively.
Dr. Ayman A. Hussein said the findings “highlight the advantage” of using QDOT Micro to treat AFib. Hussein serves as director of cardiac electrophysiological outcomes research and director of the center for AFib at Cleveland Clinic. He also authored the publication of the study results.
“Paired with previously published Q-FFICIENCY study data showing that the unique design of the QDOT Micro catheter enhanced efficiency and efficacy without compromising safety, the benefit of treatment with this state-of-the-art tool is clear for both patients and physicians,” Hussein said.