Real‐World Safety of Two Pulsed Field Ablation Catheters for Atrial Fibrillation: A MAUDE Analysis
Sami J. Shoura, Shreyas Singireddy, Kyle Coombes, Ragavendar Saravanabavanandan, Skylar Murphy, Abdul‐Rahim Shilbayeh, Chetan Bhardwaj, Siddharth ShahABSTRACT
Background
Two pulsed field ablation (PFA) catheter systems for atrial fibrillation (AF) are widely adopted: the Affera Sphere‐9 (Medtronic) and the Varipulse (Biosense Webster). Their comparative real‐world safety is unknown.
Methods
We searched the FDA MAUDE database (June 27, 2026) for all reports naming either catheter since U.S. release. After excluding duplicates and non‐catheter components, 743 Affera and 361 Varipulse reports remained. Reports were classified by FDA Event Type (device‐ vs. patient‐related) and complication status, with complications grouped by organ system. Proportions were compared with chi‐square or Fisher exact tests in R 4.3.3.
Results
Neurologic events were far more frequent among Varipulse reports (44.3 % vs. 14.8%; P < 0.001), driven by stroke (38.0% vs. 9.7%; P < 0.001). Cardiovascular events predominated among Affera reports (43.2% vs. 29.1%; P < 0.001), including ventricular fibrillation (52 vs. 1), heart block (8.7% vs. 1.4%; P < 0.001), and hypotension (5.5% vs. 0.8%; P <0.001); effusion/tamponade was more frequent with Varipulse (15.2% vs. 9.0%; P = 0.003). Complication‐free reports were more frequent with Affera (35.3% vs. 21.1%; P < 0.001). Deaths did not differ (2.6% vs 1.4%; P = 0.30).
Conclusions
These PFA systems show distinct reported safety signatures: neurologic/stroke‐predominant for Varipulse and cardiovascular/arrhythmic (ventricular fibrillation, heart block) for Affera. Because MAUDE lacks procedural denominators, these proportions describe reported events, not incidence. Prospective, patient‐level studies are needed to establish causation.