A new study led by the Icahn School of Medicine at Mount Sinai indicates that pulsed field ablation (PFA) is a safe treatment option for common types of atrial fibrillation (AF).
The “MANIFEST-17K” international study, published in Nature Medicine, highlights the safety of PFA in treating AF. This study, the largest of its kind, shows promising results, including no significant risk of esophageal damage with PFA. PFA is a recently FDA-approved ablation technique that aims to restore normal heart rhythm, potentially offering an alternative to traditional therapies for managing AF.
Dr. Vivek Reddy, the senior author of the study, emphasized the favorable safety outcomes of PFA, noting that it does not pose serious risks like esophageal damage, pulmonary vein stenosis, or diaphragm injury, commonly associated with other ablation methods.
Atrial fibrillation is a heart rhythm disorder affecting millions of Americans. Patients with AF may undergo catheter ablation procedures to address the irregular heart rhythm by creating scars in specific areas of the heart to block abnormal electrical signals.
Currently, radiofrequency ablation and cryoablation are commonly used ablation techniques that involve heat or cold energy, respectively. However, these methods carry risks of complications such as esophageal damage or nerve injury. Unlike these approaches, PFA employs short high-energy electrical pulses without temperature changes, offering a more precise and safer alternative.
The retrospective study analyzed data from 17,642 patients who underwent PFA procedures at multiple centers using the pentaspline PFA catheter. The findings revealed no energy-specific complications, with only a 1% major complication rate. Specific complication rates included 0.36% for pericardial tamponade, 0.30% for vascular issues, 0.12% for stroke, and 0.03% for death. Rare unexpected complications like coronary arterial spasm and hemolysis-related renal failure were also observed.
Dr. Reddy, who has ties to Boston Scientific, the manufacturer of the PFA catheter, acknowledges the need for continued monitoring of PFA outcomes but expresses confidence in the technology’s safety based on the study’s results.