In This Article:
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter.
Dive Brief:
-
Boston Scientific’s pulsed field ablation catheter, Farapulse, was noninferior to Medtronic’s Arctic Front cryoballoon in a randomized trial, researchers found in a study published in The New England Journal of Medicine.
-
The study, which was published Monday and funded by a Swiss hospital, randomized 210 patients with symptomatic paroxysmal atrial fibrillation to undergo PFA or cryoablation. Atrial tachyarrhythmia, a heart rhythm disorder where the atria beat too fast, recurred in 39 patients in the PFA cohort and 53 people in the cryoablation group.
-
Medtronic reported declines in its cryoablation business last year but said the losses were offset by growth of its PulseSelect single-shot catheter, which competes with Farapulse for the growing PFA market.
Dive Insight:
Boston Scientific compared PFA with Farapulse to conventional radiofrequency or cryoballoon ablation in its Advent clinical trial from 2021 to 2023. The study found PFA was noninferior to conventional therapy on a composite endpoint that looked at one-year outcomes including atrial tachyarrhythmia after a three-month period.
However, the authors of the new NEJM paper said Advent and other PFA studies “lacked continuous rhythm monitoring, which limited the sensitivity to detect the recurrence of atrial tachyarrhythmia and the burden of atrial fibrillation.” All patients in the Swiss hospital study received Medtronic’s Reveal Linq, an implantable cardiac monitor, for continuous rhythm monitoring.
The researchers began checking for the recurrence of atrial tachyarrhythmia 91 days after ablation with either Farapulse or Arctic Front. Through day 365, the researchers saw recurrences in 37.1% of the PFA patients and 50.7% of the cryoablation patients, achieving the study’s primary noninferiority endpoint.
Once the noninferiority endpoint was met, the researchers checked whether the result showed PFA was statistically superior to cryoablation. The superiority test was “formally positive,” they said. However, because the result “reached only borderline statistical significance,” the researchers concluded larger outcome trials are needed to show whether PFA is superior to cryoablation.
No PFA patients in the Swiss trial had energy-related complications such as pulmonary vein stenosis, persistent phrenic nerve palsy or atrioesophageal fistula. The finding is in line with the results of Boston Scientific’s Advent trial.