Pulsed field ablation linked to low complication rates in large real-world cohort
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Key takeaways:
- Pulsed field ablation was safe in a cohort of more than 17,000 real-world patients with atrial fibrillation.
- There were no cases of esophageal damage, a traditional risk of AF ablation.
In the largest study to date of pulsed field ablation for patients with atrial fibrillation, the technology was associated with low rates of major complications, especially esophageal damage.
For the MANIFEST-17K study, published in Nature Medicine, researchers analyzed data from 17,642 patients with AF requiring ablation who underwent treatment with a pentaspline catheter (Farawave/Farapulse, Boston Scientific) at 106 centers after the device was approved for commercial use.
“MANIFEST-17K provides confidence that, unlike conventional thermal ablation, [pulsed field ablation] with the pentaspline catheter does not cause the most feared complication of AF ablation — esophageal damage — nor does it cause pulmonary vein stenosis or persistent injury to the diaphragm,” Vivek Reddy, MD, The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn School of Medicine at Mount Sinai, said in a press release. “This study found that other general complications were also rare, including pericardial tamponade occurring in approximately one in 200 patients, stroke in one in 1,000, and death in even less than one in 1,000 patients. Given the relative novelty of pulsed field ablation, these are important safety outcomes.”
As Healio previously reported, the FDA in January approved the pentaspline catheter for the treatment of adults with drug-refractory, recurrent, symptomatic, paroxysmal AF, and the decision was based in part on data from MANIFEST-17K.
The MANIFEST-17K cohort had a mean age of 64 years and consisted of 35% women and 58% patients with paroxysmal AF.
There were no cases reported of esophageal complications, pulmonary vein stenosis or persistent phrenic palsy, though 11 patients (0.06%) had transient palsy, the researchers wrote.
Major complications occurred for slightly less than 1% of patients, and included pericardial tamponade for 63 patients (0.36%) and vascular complications for 53 patients (0.3%), according to the researchers.
Rates of stroke (22 patients, or 0.12%) and death (five patients, or 0.03%) were very low, Reddy and colleagues wrote.
Unexpected complications included coronary arterial spasm for 25 patients (0.14%) and hemolysis-related acute renal failure necessitating hemodialysis for five patients (0.03%), they wrote.
“While we should continue to remain vigilant to identify any other rare complications of [pulsed field ablation] that may be identified in the future, these favorable safety outcomes in over 17,000 patients increase our confidence in the use of this [pulsed field ablation] catheter technology,” Reddy said in the release.
Reference:
- Pulsed field ablation procedures found safe and effective for atrial fibrillation patients. https://www.mountsinai.org/about/newsroom/2024/pulsed-field-ablation-procedures-found-safe-and-effective-for-atrial-fibrillation-patients. Published July 8, 2024. Accessed July 8, 2024.
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