The Lead Episode 150: Heart Rhythm 2026 Late-Breaker Coverage: A Discussion of Total Fatal Adverse Events Following Atrial Fibrillation Ablation Reported in an FDA Mandatory Reporting System: A Matter of Concern? The TiFFANY Study episode artwork

EPISODE · May 14, 2026 · 18 MIN

The Lead Episode 150: Heart Rhythm 2026 Late-Breaker Coverage: A Discussion of Total Fatal Adverse Events Following Atrial Fibrillation Ablation Reported in an FDA Mandatory Reporting System: A Matter of Concern? The TiFFANY Study

from The Lead Podcast presented by Heart Rhythm Society · host Heart Rhythm Society

This discussion reviews the late-breaking HRS 2026 study Total Fatal Adverse Events Following Atrial Fibrillation Ablation Reported in an FDA Mandatory Reporting System: A Matter of Concern? The TiFFANY Study, which examined fatal adverse event reports associated with atrial fibrillation ablation using data from the FDA MAUDE database. Faculty discuss the incidence and mechanisms of rare but serious complications across ablation technologies, including pulsed field ablation and thermal energy sources, and explore the implications for procedural safety, post-market surveillance, and clinical decision-making in AF ablation. Join host Melissa E. Middeldorp, MPH, PhD and her esteemed guests Christopher F. Liu, MD, FHRS and James Freeman, MD, MPH, Msci for this late-breaking coverage from Heart Rhythm 2026 in Chicago! Learning Objectives Describe the methodology and key findings of the TiFFANY study evaluating fatal adverse events following atrial fibrillation ablation. Compare reported safety signals and complication profiles among pulsed field ablation and traditional thermal ablation technologies. Assess the role and limitations of post-market adverse event databases in evaluating procedural safety and informing electrophysiology practice.  Podcast Contributors Melissa E. Middeldorp, MPH, PhD, FHRS Christopher F. Liu, MD, FHRS James Freeman, MD, MPH, Msci  Host and Contributor Disclosure(s): D.C. Raja Nothing to disclose. A. Deshmukh Honoraria/Speaking/Teaching/Consulting: GE Healthcare, Biotronik, Medtronic, Biosense Webster Research: AltaThera Pharmaceuticals P. Lim Nothing to disclose.  

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The Lead Episode 150: Heart Rhythm 2026 Late-Breaker Coverage: A Discussion of Total Fatal Adverse Events Following Atrial Fibrillation Ablation Reported in an FDA Mandatory Reporting System: A Matter of Concern? The TiFFANY Study

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