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

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

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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Episoder(173)

The Lead Episode 169: A Discussion of Radiofrequency Ablation Produces Stiffer Atrial Lesions Than Pulse Field Ablation: In vivo and ex vivo magnetic resonance elastography in pigs

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In this episode of The Lead, host Deep Chandh Raja, MBBS, MD, PhD, FHRS, is joined by Kars Neven, MD, PhD, and David Chieng, MBBS, CCDS, to discuss the journal article, Radiofrequency Ablation Produce...

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The Lead Episode 168: A Discussion of Weight Loss in Older Patients With Persistent Atrial Fibrillation, The LOSE-AF Randomized Clinical Trial

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The Lead Episode 167: A Discussion of The Long-Term Outcomes of Left Bundle-Branch Pacing vs Biventricular Pacing in Heart Failure (The HeartSync-LBBP Randomized Clinical Trial)

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The Lead Episode 166: A Discussion of Relationship Between Time-to-First Atrial Tachyarrhythmia Recurrence and Atrial Fibrillation Burden: Implications for Trial Design

The Lead Episode 166: A Discussion of Relationship Between Time-to-First Atrial Tachyarrhythmia Recurrence and Atrial Fibrillation Burden: Implications for Trial Design

In this episode of The Lead recorded at EHRA, host Christopher Kowalewski, MD, is joined by Tina Baykaner, MD, MPH, and Sanjiv M. Narayan, MD, PhD, FHRS, to discuss the journal article, Relationship B...

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The Lead Episode 165: A Discussion of Left Atrial Appendage Closure or Medical Therapy in Atrial Fibrillation (The CLOSURE-AF Trial)

The Lead Episode 165: A Discussion of Left Atrial Appendage Closure or Medical Therapy in Atrial Fibrillation (The CLOSURE-AF Trial)

In this episode of The Lead recorded at HRS2026, host Danesh Kella, MBBS, FHRS is joined by Jeffrey S. Healey, MD, FHRS and Fred M. Kusumoto, MD, FHRS to discuss the journal article, Left Atrial Appen...

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The Lead Episode 164: A Discussion of Digital Twin–Guided Ablation for Ventricular Tachycardia

The Lead Episode 164: A Discussion of Digital Twin–Guided Ablation for Ventricular Tachycardia

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The Lead Episode 163: A Discussion of Conduction System vs Biventricular Pacing in Heart Failure, The PhysioSync-HF Randomized Clinical Trial

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Recorded at EHRA 2026, this episode of The Lead features host Melissa Middeldorp, MPH, PhD, FHRS, in conversation with Sana Al-Khatib, MD, MHS, FHRS, and Wei Hua, MD, FHRS, about the journal article, ...

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The Lead Episode 162: A Discussion of Atrial Fibrillation Screening According to Genetic Risk: A Secondary Analysis of the Randomized LOOP Study

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