Pulsed field ablation for AF safe, effective at 1 year
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NEW ORLEANS — In the PULSED AF pivotal trial, pulsed field ablation of symptomatic atrial fibrillation yielded a low rate of adverse events and demonstrated effectiveness consistent with established ablation strategies at 1 year.
Pulsed field ablation is a novel ablation technology that utilizes electrical pulses to treat AF.
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“The PULSED AF trial is one of the first global pivotal trials using this technology. There have been a number of smaller studies, but no one has really been sure what this technology would deliver,” Atul Verma, MD, head of cardiology at McGill University Health Centre in Montreal, told Healio.
Pulsed field ablation is different from traditional thermal modes of ablation, such as radiofrequency or cryoablation, which are limited by the potential for collateral tissue damage, Verma told Healio. Pulsed field ablation leverages a nonthermal mechanism of cell death, allowing procedures to be performed in less time and with lower risk for damage to surrounding tissues, he said.
Patients with recurrent symptomatic paroxysmal (n = 150) or persistent (n = 150) AF and prior antiarrhythmic drug failure underwent pulmonary vein isolation using the PulseSelect pulsed field ablation system (Medtronic).
At 1-year follow-up, pulsed field ablation was effective, which was defined as freedom from acute procedure failure, arrhythmia recurrence, repeat ablation, direct current cardioversion, left atrial surgery or drug escalation, in 66.2% of patients with paroxysmal AF and 55.1% with persistent AF, Verma told Healio. Looking at only arrhythmia recurrence for more than 30 seconds, the success rate in the paroxysmal group was about 70% and in the persistent group was 62%, he said.
Results showed “incredible safety” of this technology, Verma told Healio. There was only one serious procedure- or device-related adverse event in each of the cohorts, for a rate of 0.7%. There were no incidences of pulmonary vein stenosis and phrenic nerve or esophageal injury, according to the results. The researchers also performed cerebral MRI to look at asymptomatic cerebral lesions and the rate was 9%, which Verma said is in line with other ablation technologies.
Pulsed field ablation procedures were generally performed in about 60 minutes with a mandated 20-minute wait time. Verma said if you subtract the wait time, then total procedure time was about 40 minutes. In comparison, thermal ablation procedures take about 1.5 to 2 hours, he said, noting that there is “a huge efficiency benefit” with pulsed field ablation.
The trial was conducted at 41 centers in nine countries. Procedures were performed by 67 different operators, 61 of whom did not use the system in the PULSED AF pilot trial, according to the researchers.
Operators first treated one patient each to gain experience with the technique, in a total of 60 patients. Then, they continued to enroll patients and perform pulsed field ablations up to an additional 300 procedures at all sites, according to an ACC press release.
The results were simultaneously published in Circulation.
The data from this study are on par with outcomes from thermal ablation procedures, according to the researchers.
“The efficacy rate is likely consistent with thermal ablation, either radiofrequency or cryoablation,” Verma told Healio. “This study didn’t have a comparator arm, so we can’t say pulsed field ablation is better than thermal ablation. But it certainly was safer.”
The PulseSelect system is not yet approved for use in the United States.
Editor’s Note: The article was updated on March 7, 2023 to correct that the serious procedure- or device-related adverse event rate was 0.7%. The Editors regret the error.
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Perspective
Back to TopThe PULSED AF trial shows that pulsed field ablation, at least in this subset of patients with both paroxysmal and persistent AF is safe and effective. The efficacy seems quite in line with early clinical studies of other pulsed field ablation technologies. I think that it is a welcome addition to the evidence base and may potentially usher in a new era, which remains to be seen.
This study was conducted at a broad range of centers and with a range of operators. I think the learning curve will probably not be that high. This is one of several pulsed field ablation systems; it will be interesting to see how the uptake occurs as this technology is refined. There are always going to be improvements in the technology, but I think that the fact that you can do the procedure safely, which is No. 1 priority, and to do so in a very efficient manner will probably lower a lot of the barriers that we typically see with newer technologies.
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Verma A, et al. Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 4-6, 2023; New Orleans (hybrid meeting).
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