BACKGROUND:The effect of contact force (CF) on lesion formation is not clear during pulsed field ablation (PFA). The aim of this study was to evaluate the impact of CF, PFA, and their interplay through the PFA index (PF index) formula on the ventricular lesion size in swine.METHODS:PFA was delivered through the CF-sensing OMNYPULSE catheter. Predefined PFA applications (×3, ×6, ×9, and ×12) were delivered maintaining low (5–25 g), high (26–50 g), and very high (51–80 g) CFs. First, PFA lesions were evaluated on necropsy in 11 swine to investigate the impact of CF/PFA—and their integration in the PF index equation—on lesion size (study characterization). Then, 3 different PF index thresholds—300, 450, and 600—were tested in 6 swine to appraise the PF index accuracy to predict the ventricular lesion depth (study validation).RESULTS:In the study characterization data set, 111 PFA lesions were analyzed. CF was 32±17 g. The average lesion depth and width were 3.5±1.2 and 12.0±3.5 mm, respectively. More than CF and PFA dose alone, it was their combined effect to impact lesion depth through an asymptotically increasing relationship. Likewise, not only was the PF index related to lesion depth in the study validation data set (r²=0.66; P<0.001) but it also provided a prediction accuracy of the observed depth of ±2 mm in 69/73 lesions (95%).CONCLUSIONS:CF and PFA applications play a key role in lesion formation during PFA. Further studies are required to evaluate the best PFA ablation settings to achieve transmural lesions.

中文翻译：

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脉冲场消融指数——针对病变形成的引导消融：接触力的影响和心室模型中的应用次数

背景：脉冲场消融（PFA）过程中接触力（CF）对病变形成的影响尚不清楚。本研究的目的是通过 PFA 指数（PF 指数）公式评估 CF、PFA 及其相互作用对猪心室病变大小的影响。方法：通过 CF 传感 OMNYPULSE 导管输送 PFA。交付预定义的 PFA 应用（×3、×6、×9 和 ×12），保持低 CF（5-25 g）、高 CF（26-50 g）和极高 CF（51-80 g）。首先，对 11 头猪进行尸检评估 PFA 病变，以研究 CF/PFA 及其在 PF 指数方程中的整合对病变大小的影响（研究特征）。然后，在 6 头猪中测试了 3 个不同的 PF 指数阈值（300、450 和 600），以评估 PF 指数预测心室病变深度的准确性（研究验证）。 结果：在研究特征数据集中，对 111 个 PFA 病变进行了测试。分析了。 CF为32±17克。平均病变深度和宽度分别为3.5±1.2和12.0±3.5mm。与单独使用 CF 和 PFA 剂量相比，它们的综合效应通过渐近递增关系影响病变深度。同样，PF 指数不仅与研究验证数据集中的病变深度相关（r ² =0.66；P <0.001），而且还提供了 69/73 个病变中观察深度 ±2 mm 的预测精度（95 %). 结论：CF 和 PFA 应用在 PFA 期间病变形成中发挥着关键作用。需要进一步的研究来评估实现透壁损伤的最佳 PFA 消融设置。