Pulsed field ablation (PFA) is safe for treating patients with common types of atrial fibrillation (AF), according to the largest study of its kind on this new technology, led by the Icahn School of Medicine at Mount Sinai. The "MANIFEST-17K" international study is the first to show important safety outcomes in a large patient population, including no significant risk of esophageal damage, with PFA. PFA is the latest ablation modality approved by the Food and Drug Administration that can be used to restore a regular heartbeat.
The findings, published July 8 in Nature Medicine, could lead to more frequent use of PFA instead of conventional therapies to manage AF patients. MANIEFST-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. 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." Vivek Reddy, MD, Senior Author, The Leona M. and Harry B.
Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn Mount Sinai AF is an irregular heartbeat or heart rhythm disorder; 2.7 million Americans live.