To study the safety and reproducibility of high-voltage integrated nanosecond pulse irreversible electroporation (INSPIRE) administered through a single applicator and grounding pad approach in a healthy liver model.
Methods:
A percutaneous approach to the liver was made under ultrasound guidance in female pigs weighing between 25 and 35 kg. INSPIRE treatments at 3000 V, 4500 V, and 6000 V using 1000 ns or 2000 ns waveforms, with a 0.02 s dose and a 45°C temperature set point were delivered using an actively cooled single applicator and distal grounding pad. Ablation size, muscle stimulation, and cardiac safety were evaluated.
Results:
All INSPIRE treatments were completed successfully without cardiac synchronization or break-through muscle stimulation. Ablations were visible on ultrasound shortly after treatments were complete. Treatments were completed within approximately 2–8 minutes. The largest ablations, achieved with the 2000 ns waveform at 6000 V, measured 4.4 ± 0.7 cm by 2.9 ± 0.1 cm.
Conclusion:
INSPIRE can be safely used to achieve significantly larger ablations significantly faster than current irreversible electroporation (IRE) technologies using a simplified single-applicator and grounding pad approach.
Significance:
INSPIRE overcomes technical and procedural challenges facing IRE including ablation size limitations, muscle stimulation, the need for cardiac synchronization, long procedure times, and the lack of visualization during procedures.
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