Biosense Webster—a stem 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 (AF) ablation using the very high-power short-duration (QMode+) mode combined with conventional-power temperature-controlled (QMode) mode.
The prospective, multicentre study, conducted across 22 centres in the USA, included 166 evaluable patients with drug-refractory symptomatic paroxysmal AF. 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.
“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 (Grandview Medical Center, Birmingham, USA), the publication’s lead author.
AF is the most common type of cardiac arrhythmia affecting an estimated 37.5 million people globally. By 2030, the number of people with AF is projected to increase by up to 70%. 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, optimised 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. The catheter has been designed to provide temperature control through intelligent adjustment of power and/or irrigation fluid output based on real-time temperature measurement; use of higher average RF power with QDot Micro catheter is safely enabled by this precise temperature control.
“The versatility of the QDot Micro catheter, with its unique design features and two ablation modes, make it a great tool for personalising treatment for each patient,” explained Osorio. “Very high-power, short-duration ablation mode may be more suitable on the thin atrial tissue and for the posterior wall, while ablation at thicker tissues may require the conventional-power temperature-controlled mode. This gives physicians the flexibility to adjust the RF application at various cardiac anatomies to improve outcomes while optimising their preferred workflows.”
In addition to demonstrating safety and efficacy, the QDot Micro catheter is fully integrated with the CARTO 3 system, enabling efficient and consistent lesion creation with a simplified workflow and lower total procedure time. Real world evidence studies with the QDot Micro catheter demonstrated that procedures with QDot Micro were 48% shorter on average with QMode+ and 36% shorter with QMode, lasting approximately 60 minutes or less. These time savings may also enable more procedures per day, facilitating patient access.
“Biosense Webster has been dedicated to advancing innovation and driving better patient outcomes in AF treatment for the past three decades, and QDot Micro is our latest innovation in focal RF ablation,” said Celine Martin, company group chairman, Cardiovascular & Specialty Solutions Group, Johnson & Johnson MedTech. “As the Q-FFICIENCY trial demonstrated, use of temperature-controlled ablation for the treatment of AF can be safe, effective and highly efficient, benefitting physicians and patients.”
The QDot Micro catheter received CE mark in 2020 and US Food and Drug Administration (FDA) approval in 2022.