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Comparison of hemolysis with different pulsed field ablation systems
Iwanari Kawamura1, Shinsuke Miyazaki1, Ryosuke Kato1
1Department of Cardiovascular Medicine, Institute of Science Tokyo, Tokyo, Japan.
Heart Rhythm
|June 5, 2025
Summary
Pulsed field ablation (PFA) systems show varying levels of hemolysis, a known complication. Farapulse demonstrated significantly higher hemolysis biomarkers compared to PulseSelect, indicating potential differences in safety profiles.
Area of Science:
- Cardiology
- Medical Devices
- Electrophysiology
Background:
- Hemolysis is a unique complication associated with pulsed field ablation (PFA).
- Understanding the differences in hemolysis between various PFA systems is crucial for patient safety.
- Current knowledge regarding comparative hemolysis across PFA technologies is limited.
Purpose of the Study:
- To investigate and compare the incidence and severity of hemolysis between two distinct PFA systems: PulseSelect and Farapulse.
- To evaluate hemolysis biomarkers and myocardial injury markers post-procedure.
- To compare PFA systems against cryoballoon ablation as a control.
Main Methods:
- A comparative study involving patients undergoing PFA for atrial fibrillation (PulseSelect: 38 patients, Farapulse: 38 patients) and cryoballoon ablation (14 patients).
- Measurement of free hemoglobin levels pre- and post-procedure.
- Assessment of hemolysis biomarkers (lactate dehydrogenase, total bilirubin, haptoglobin) and myocardial injury biomarkers (creatine kinase) within 24 hours post-ablation.
Main Results:
- No significant difference in the total number of PFA applications between PulseSelect and Farapulse.
- Farapulse group showed significantly higher levels of free hemoglobin, lactate dehydrogenase, and total bilirubin compared to PulseSelect.
- A higher incidence of low haptoglobin levels was observed in the Farapulse group, indicating more pronounced hemolysis.
- No significant difference in hemolysis biomarkers between PulseSelect and cryoballoon ablation.
- Both PFA systems showed higher creatine kinase levels than cryoballoon ablation, but no difference between PFA systems.
- No acute kidney injury was reported in any group.
Conclusions:
- The degree of hemolysis can differ significantly between PFA systems.
- Further research is warranted to establish system-specific safe application limits for PFA to mitigate hemolysis risks.
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