Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• Pulsed field ablation (PFA) is gaining traction for atrial fibrillation (AF) treatment due to its perceived safety advantages over traditional methods.
• Potential rare complications of PFA may only become apparent with widespread adoption and large patient volumes.

Purpose of the Study:

• To evaluate the real-world utilization and safety of the pentaspline PFA catheter in the United States.
• To identify the incidence of major and minor adverse events associated with pentaspline PFA in a broad patient population.

Main Methods:

• Retrospective analysis of data from U.S. centers using the pentaspline PFA catheter.
• Data collection included patient demographics, procedural details, and adverse events (AEs).
• Analysis focused on the incidence of procedure-related major and minor AEs.

Main Results:

• Over 41,000 patients treated across 102 U.S. centers demonstrated a major AE rate of 0.63%.
• No cases of esophageal fistula, pulmonary vein stenosis, or persistent phrenic nerve paralysis were reported.
• Rare complications included stroke (0.10%) and cardiac tamponade (0.16%); mortality was 0.04% at 30 days.

Conclusions:

• Real-world use of pentaspline PFA in the U.S. confirms a favorable safety profile for atrial fibrillation ablation.
• The safety data align with PFA's targeted ablation of myocardial tissue, avoiding critical structure injury.
• Initial implementation of pentaspline PFA is deemed safe, with low rates of major complications like stroke and death.