July 19, 2024
Pulsed Field Ablation

Pulsed Field Ablation Proven to be Safe and Effective for Women with Atrial Fibrillation

A new study led by the Icahn School of Medicine at Mount Sinai has found that women with atrial fibrillation (AF) who undergo pulsed field ablation (PFA) have outcomes that are just as successful as men who undergo the same procedure. PFA is a cutting-edge technology and the latest form of ablation therapy used to restore a regular heartbeat.

This groundbreaking study, published in JAMA Cardiology, is the first to compare outcomes based on gender for AF patients undergoing PFA. The results indicate that PFA is equally safe and effective for both men and women. AF is a heart rhythm disorder that affects approximately 2.7 million Americans. Catheter ablation is a common procedure used to treat this condition. During this procedure, scars are created in small regions of the heart that are responsible for the abnormal rhythm. These scars prevent abnormal electrical signals from moving through the heart.

Currently, there are two types of ablation therapies in use: radiofrequency ablation, which uses heat energy, and cryoablation, which uses cold energy. These therapies carry an increased risk of potential complications, such as damage to the esophagus, pulmonary vein stenosis, and phrenic nerve injury. PFA, on the other hand, uses short, high-energy electrical pulses that specifically target cardiac cells, making it a more precise procedure. Unlike radiofrequency and cryoablation, PFA does not cause damage to the esophagus, pulmonary veins, or phrenic nerve.

The research team conducted a retrospective analysis of 1,568 patients from the Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation (MANIFEST-PF). This large multinational registry includes patients who underwent their first-ever PFA for AF between March 2021 and May 2022. The study categorized patients by gender and evaluated their outcomes after PFA. The researchers examined the elimination of AF and potential adverse events, such as esophageal complications, pulmonary vein stenosis, phrenic nerve injury, pericardial tamponade, and vascular injury.

The results demonstrated no significant difference in recurring atrial arrhythmia between men and women. Specifically, 79 percent of men and 76 percent of women did not experience recurring atrial arrhythmia after PFA, revealing no statistically significant difference. The rate of patients requiring a second ablation was similar between genders, with 8.3 percent for men and 10 percent for women, also not reaching statistical significance. Among those who needed a second AF ablation, women exhibited significantly higher pulmonary vein isolation durability compared to men (63 percent versus 37.8 percent), indicating that women were less likely to require additional ablation in their pulmonary veins. The overall complication rates for the procedure were low, and there was no significant difference in complications between genders (2.5 percent for women and 1.5 percent for men).

This study adds to the growing body of evidence supporting the effectiveness of pulsed field energy in treating atrial fibrillation. The analysis of the MANIFEST-PF registry demonstrates that women experience the same level of success as men, achieving a success rate of 76.3 percent after one year with a low complication rate of 2.5 percent. Therefore, women should not be denied the life-enhancing benefits of catheter ablation for atrial fibrillation, according to senior author Vivek Reddy, MD, The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn Mount Sinai.

It is important to note that this study was sponsored by Boston Scientific Corporation, the manufacturer of the PFA device. However, the company had no involvement in data collection, analysis, or manuscript preparation.


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