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Characterization of Phrenic Nerve Response to Pulsed Field Ablation
Brian Howard1, David E Haines2, Atul Verma3
1Medtronic, Minneapolis, MN (B.H., N.K., N.B., B.O., M.T.S., D.C.S.).
Pulsed field ablation (PFA) shows a dose-dependent effect on phrenic nerve function in animal models, with no chronic injury observed. Careful catheter proximity and PFA energy levels are key to preventing nerve damage during cardiac procedures.
Area of Science:
- Cardiac electrophysiology
- Medical device technology
- Nerve injury research
Background:
- Phrenic nerve palsy is a known complication of traditional thermal cardiac ablation.
- Pulsed field ablation (PFA) is an emerging technology with potential to reduce phrenic nerve injury.
- The impact of PFA on phrenic nerve function requires further characterization.
Purpose of the Study:
- To investigate the acute and chronic effects of pulsed field ablation (PFA) on phrenic nerve function in a porcine model.
- To establish a dose-response relationship between PFA energy delivery and phrenic nerve response.
- To evaluate the safety of PFA for cardiac procedures concerning phrenic nerve integrity.
Main Methods:
- Utilized accelerometers and continuous pacing during PFA in a porcine model.
- Established acute dose-response by escalating PFA intensity to the phrenic nerve (n=12).
- Assessed acute effects of repetitive ablations (n=4) and chronic histopathology (n=6).
Main Results:
- Observed a dose-dependent, reversible stunning of phrenic nerve function acutely (R²=0.965, P<0.001).
- PFA effects varied with energy levels and catheter proximity, ranging from no effect to stunning.
- Successful superior vena cava isolation with appropriate PFA dosing showed normal phrenic nerve function and histopathology at 4 weeks.
Conclusions:
- Catheter proximity and PFA dose are critical factors influencing phrenic nerve response.
- No gross or histopathologic injury to phrenic nerves was found at chronic time points.
- Results support understanding PFA's impact on nerves and necessitate caution when translating to human studies.
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