Source:

Osorio J, et al. Late-Breaking Clinical Trials, First-Report Clinical Investigations and Best Abstract Award. Presented at: AF Symposium; Jan. 13-15, 2022; New York.

Disclosures: The study was funded by Biosense Webster. Osorio reports receiving grants from Abbott and Biosense Webster; consultant fees from Biosense Webster, Boston Scientific and Medtronic; and payments or honoraria for lectures/presentations/speakers bureaus from Biosense Webster and Boston Scientific.
January 31, 2022
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Next-generation catheter cuts AF ablation time

Source:

Osorio J, et al. Late-Breaking Clinical Trials, First-Report Clinical Investigations and Best Abstract Award. Presented at: AF Symposium; Jan. 13-15, 2022; New York.

Disclosures: The study was funded by Biosense Webster. Osorio reports receiving grants from Abbott and Biosense Webster; consultant fees from Biosense Webster, Boston Scientific and Medtronic; and payments or honoraria for lectures/presentations/speakers bureaus from Biosense Webster and Boston Scientific.
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A next-generation radiofrequency ablation catheter to treat atrial fibrillation shortened procedure times without compromising safety or efficacy, researchers reported at the AF Symposium.

Jose Osorio

“The current practice of radiofrequency ablation with power-controlled irrigated catheters involves the delivery of moderate power (20 W to 40 W) for a relatively long duration (up to approximately 30 seconds). Open irrigation decreases the risk of thrombus and char formation on the catheter’s tip but prevents accurate temperature feedback,” Jose Osorio, MD, director of the Atrial Fibrillation Clinic and Cardiac Electrophysiology Program at Grandview Medical Center Alabama Cardiovascular Group in Birmingham, told Healio. “Biosense Webster’s Qdot Micro catheter used in the Q-FFICIENCY study is the only contact force-sensing radiofrequency ablation catheter with temperature-controlled ablation and 3D electroanatomical mapping integration. It incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation and higher signal resolution, providing physicians with a simplified workflow that helps shorten procedure time.”

For the nonrandomized investigational Q-FFICIENCY study, Osorio and colleagues enrolled 191 patients from 22 sites (mean age, 64 years; 61% men; mean CHA2DS2-VASC score, 2.4), of whom 166 underwent ablation with the novel catheter.

Pulmonary vein isolation using only the mode of very high power and short duration (90 W in 4 seconds) was achieved in 89 patients.

The median procedure time, including 20-minute wait time, was 132 minutes, and the median radiofrequency application time was 9.8 minutes, according to the researchers.

The mean number of radiofrequency applications was 121.2, and a median of 93.3% applications were with the mode of very high power and short duration, Osorio and colleagues found.

The mean maximum temperature, impedance drop and contact force per radiofrequency application were similar between the mode of very high power and short duration and normal power mode, according to the researchers.

The rate of primary adverse events at 7 days was 3.6%, and there were no cases of device- or procedure-related death, atrioesophageal fistula, stroke, transient ischemic attack or severe pulmonary vein stenosis, Osorio and colleagues found.

“This is similar to the rate reported in previous atrial fibrillation studies,” Osorio told Healio.

The 12-month Kaplan-Meier estimate of the primary effectiveness outcome of freedom from documented atrial tachyarrhythmia recurrence and additional predefined failure modes — acute failure, repeat ablation or new/higher dose antiarrhythmic drugs — was 76.7%, and the 12-month Kaplan-Meier estimate of freedom from repeat ablation was 92.1%.

“The clinically meaningful 12-month effectiveness result of freedom from symptomatic recurrence was 86%, presenting an up to 23% improvement compared to predecessor catheters,” Osorio said in an interview.

Osorio told Healio, “The Q-FFICIENCY study was an important advancement to bring back temperature-controlled ablation, which improves efficiency and effectiveness without affecting the safety profile. We are currently assessing different ablation combinations to simplify and optimize workflows to further enhance procedural efficiencies. We are also assessing the safety and long-term clinical benefits of using the Qdot Micro catheter to treat other cardiac arrythmias, including ventricular tachycardia, as well as understanding the full potential of the catheter-embedded microelectrodes to guide more effective mapping and ablations.”