Pulse Field Ablation for Atrial Fibrillation: Insights Based on Published Studies and MAUDE Database

Introduction Pulse Field Ablation (PFA) has proven its efficacy and safety profile through multiple studies for atrial fibrillation. However, there is limited insight into the post-market outcomes given the recency of the approvals. Methods Our objective is to characterize the major device and patient complications of PFA in the United States outside the controlled setting of clinical trials using the Manufacturer and User Facility Device Experience (MAUDE) database and review complications shown in published major clinical studies. We used the Food and Drug Administration (FDA) MAUDE Database to assess device and patient complications from PFA technologies. We also discussed all the trials in which PFA was performed and searched through multiple databases. Results From the MAUDE database, there were 649 events reported involving entrapment of the device. Reported structural cardiac events included 295 pericardial effusion events and 150 cardiac tamponade events. After FDA approval, the number of FARAPULSE events was 88 death events and 1,180 injury events. After FDA approval, the number of PulseSelect events was 9 deaths and 220 injury events. There were 50 published studies that described the outcomes of PFA for atrial fibrillation that met our selection criteria. The most common complications were pericardial tamponade (0.00-5.00%), coronary spasm (0.00-5.00%) and stroke (0.00-4.35%). Conclusion The risk of serious adverse events that we reported necessitates continued refinements of device design and operator technique to improve patient outcomes. Establishing a rigorous registry in the early stage of adoption of PFA technology is strongly warranted to identify complications accurately.