Atrial fibrillation (AF) is an irregular heartbeat or heart rhythm disorder affecting millions across the world in some form. AF patients can undergo a catheter ablation procedure, which involves making scars in small areas of the heart that contribute to the abnormal rhythm, thereby preventing abnormal electrical signals from circulating within the heart. The two prevalent ablation techniques are radiofrequency ablation, utilizing heat energy, and cryoablation, employing cold energy. Both methods carry risks, including possible damage to the esophagus, pulmonary vein stenosis, and injury to the phrenic nerve, which is crucial for breathing. Now, a new study has found that pulsed field ablation (PFA), an emerging technology for the treatment of AF, is safe for treating patients with common types of irregular heart rhythm disorder.

The findings of the study led by the Icahn School of Medicine at Mount Sinai (New York, NY, USA, published July 8 in Nature Medicine, presents compelling evidence for the adoption of PFA over traditional methods for managing AF. Unlike conventional therapies, PFA utilizes brief, high-energy electrical pulses without generating extreme temperatures, allowing for more targeted ablation that spares the esophagus, pulmonary veins, and phrenic nerve from damage. The MANIFEST-17K international study, the most extensive of its type to examine this new technology, included 17,642 patients with paroxysmal and persistent AF who underwent PFA at 106 centers in 2021 using the pentaspline PFA catheter, the most widely used PFA catheter globally.

The study's findings revealed no energy-specific complications such as esophageal damage, pulmonary vein stenosis, or lasting phrenic nerve injury. The overall major complication rate stood at 1%, with specific incidences of 0.36% for pericardial tamponade, 0.30% for vascular complications, 0.12% for stroke, and 0.03% for death. Additionally, unexpected complications included coronary arterial spasm (0.14%) and hemolysis-related acute renal failure requiring hemodialysis (0.03%). While there is a need to continue being vigilant to detect any potential rare complications of PFA, these favorable safety outcomes from over 17,000 patients bolster confidence in the efficacy and safety of this innovative PFA catheter technology.

“MANIFEST-17K provides confidence that, unlike conventional thermal ablation, PFA 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,” said senior author Vivek Reddy, MD, The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn Mount Sinai. “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.” 

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