Objectives:There is a critical need for effective focal therapies for patients with inoperable or anatomically complex tumors where conventional ablation techniques pose high risk or are ineffective. Integrated Nanosecond Pulsed Irreversible Electroporation (INSPIRE) is a novel non-thermal ablation modality which uses real time temperature feedback during pulse delivery to safely treat tumors near critical structures. This study evaluated the impact of exposed electrode length on ablation zone size, reproducibility, and cardiac safety in a large animal model.Methods:INSPIRE treatments were performed in an in vivo healthy porcine liver model. All treatments administered 6000 V 1000 ns pulses with a 45 °C temperature set point. Treatments were administered percutaneously via an electrode and grounding pad approach using an internally cooled electrode applicator. The exposed electrode region at the distal end of the applicator was set to either 0.5, 1.0, 1.5, or 2.0 cm. Ablation zones were assessed via ultrasound, contrast-enhanced CT, and gross pathology one week post-treatment. Cardiac safety was evaluated by measuring pre- and post-treatment serum Troponin levels.Results:All treatments were completed without adverse events. Troponin levels remained stable (pre: 0.249 ng/mL; post: 0.224 ng/mL), indicating no measurable cardiac injury. The 1.5 cm exposure length produced the largest and most consistent ablation volumes, with a mean volume of 12.8 ± 2.6 cm3and average dimensions of 3.7 × 2.7 cm in under 6 min. Increasing exposure length beyond 1.5 cm introduced greater variability and reduced treatment volumes.Conclusions:INSPIRE enables safe, large-volume, single-applicator ablation without a need for electrical pulse synchronization with R wave in cardiac rhythm. The 1.5 cm exposure length offers optimal balance between energy delivery and treatment consistency. These findings support further clinical investigation of INSPIRE for non-thermal ablation of inoperable tumors.
目的：对于无法手术或解剖结构复杂的肿瘤患者，当传统消融技术风险较高或效果不佳时，亟需有效的局部治疗方法。集成纳秒脉冲不可逆电穿孔（INSPIRE）是一种新型非热消融技术，通过在脉冲输送过程中实时监测温度反馈，可安全处理邻近关键结构的肿瘤。本研究通过大型动物模型评估了电极暴露长度对消融区域大小、可重复性及心脏安全性的影响。 方法：在健康猪肝脏活体模型中实施INSPIRE治疗。所有治疗均采用6000V、1000ns脉冲参数，温度设定点为45℃。通过经皮电极与接地垫方式，使用内部冷却电极施术器进行治疗。施术器远端电极暴露区域分别设定为0.5、1.0、1.5或2.0厘米。治疗后一周通过超声、增强CT及大体病理学评估消融区域。通过检测治疗前后血清肌钙蛋白水平评估心脏安全性。 结果：所有治疗均顺利完成，无不良事件发生。肌钙蛋白水平保持稳定（治疗前：0.249 ng/mL；治疗后：0.224 ng/mL），表明未出现可检测的心脏损伤。1.5厘米暴露长度产生的消融体积最大且最稳定，平均体积为12.8±2.6 cm³，平均尺寸为3.7×2.7厘米，治疗时间不足6分钟。暴露长度超过1.5厘米会导致更大变异性并降低治疗体积。 结论：INSPIRE技术无需与心电R波进行电脉冲同步，即可实现安全、大体积的单施术器消融。1.5厘米暴露长度在能量输送与治疗稳定性之间达到最佳平衡。这些发现为INSPIRE技术应用于不可手术肿瘤的非热消融临床研究提供了支持依据。
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