PULSED AF Pivotal Trial: New Ablation Technology Found Safe, Effective as AFib Treatment
Pulsed field ablation was found to be successful at treating atrial fibrillation (AFib) for 12 months in up to two-thirds of patients, according to findings from the PULSED AF Pivotal trial presented at ACC.23/WCC and simultaneously published in Circulation.
In a prospective, international, multicenter, nonrandomized study, Atul Verma, MD, FACC, et al., included patients with paroxysmal (n=150) or persistent (n=150) symptomatic AFib resistant to class I and III antiarrhythmic drugs, treating them with pulsed field ablation. Participants were monitored for one year following treatment with weekly and symptomatic transtelephonic monitoring; ECGs at three, six and 12 months; and 24-hour Holter monitoring at the six- and 12-month marks.
Researchers set the primary effectiveness endpoint as freedom from a composite of acute procedural failure, arrhythmia recurrence or antiarrhythmic escalation over 12 months, apart from the first three months postprocedure to allow for recovery. They found that 66.2% of patients with paroxysmal AFib (95% CI, 57.9-73.2) and 55.1% of patients with persistent AFib (95% CI, 46.7-62.7) met the primary endpoint.
The primary safety endpoint, freedom from a composite of serious procedure- and device-related adverse events, occurred in one patient from each cohort (0.7%; 95% CI, 0.1-4.6). Study limitations included lack of a control group and the need for larger studies to provide more definitive evidence of the procedure's safety.
Researchers also noted that most pulsed field ablation procedures were completed in less than one hour, making them substantially faster than thermal ablation procedures.
"The efficacy of the procedure is similar to what we see in thermal ablation, but we're getting it much faster and with much more safety," said Verma. "That is a major development for the field of electrophysiology."
Keywords: ACC Annual Scientific Session, ACC23, Atrial Fibrillation, Arrhythmias, Cardiac
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