PFA Linked to Increased Risk of Heart Damage – Real-World Data (April 30, 2025)
PFA Linked to Increased Risk of Heart Damage – Real-World Data (April 30, 2025)
Source: JACC
1. Study Overview:
• Real-world data presented at Heart Rhythm 2025 and published in JACC: Clinical Electrophysiology show that pulsed field ablation (PFA), while increasingly popular, may carry higher risks of myocardial injury compared to traditional radiofrequency (RF) ablation.
• Study included 871 patients (mean age 68.9, 70% male) treated with either PFA or RF for atrial fibrillation.
2. PFA Devices Used:
• Majority underwent PFA using FDA-approved systems from:
• Boston Scientific (Farapulse – 70.9%)
• Medtronic (PulseSelect – 14.1%, Affera – 12.4%)
• Johnson & Johnson (Varipulse – 2.3%)
3. Key Findings – Myocardial Injury:
• PFA was linked to significantly greater elevations in cardiac biomarkers:
• High-sensitivity troponin (cTn)
• Lactate dehydrogenase (LDH)
• Haptoglobin
• Changes were dose-dependent, suggesting that limiting energy delivery may reduce myocardial damage.
• Greater reductions in left atrial ejection fraction were also observed, indicating possible atrial stunning or dysfunction.
4. Device-Specific Differences:
• The Farapulse pentaspline catheter showed the highest biomarker elevations (cTn, LDH, and plasma free hemoglobin – PFH).
• The Affera spherical catheter was also linked to elevated PFH levels.
5. Clinical Outcomes:
• Despite these findings, major adverse outcomes were rare.
• Real-world adverse event rate was ~3%, slightly higher than previous trials (1–2%), possibly due to operator learning curve.
6. Implications & Future Directions:
• Authors stress the need for standardized monitoring protocols across PFA systems.
• Results highlight opportunities to optimize catheter designs and dosing strategies.
• More research is needed to understand both short- and long-term effects of PFA on the heart.