A novel polarity configuration for enhancing ablation depth of pulsed field ablation: Design, modeling, and in vivo validation.

Abstract

Pulsed field ablation (PFA) has been increasingly used to cut off the delivery of abnormal electrical signals in the treatment of cardiac arrhythmias. A successful cut off requires forming a layer of transmural damage on the heart wall, and this layer depends on the depth of ablation by PFA. This study aims to propose a novel polarity configuration of PFA to increase the ablation depth in the treatment of cardiac arrhythmias. A novel polarity configuration was designed for a multi-electrode system, where the number of electrodes is greater than two. The polarity configuration in such multi-electrode system is called the paired-electrode interlaced configuration (PIC). The existing configuration called the single-electrode interlaced configuration (SIC) was used to compare with the PIC. To both the SIC and PIC, a full-SIC or a full-PIC is called when all electrodes (anode, cathode) in a catheter is used otherwise partial-SIC or partial-PIC is called. By the comparison between the full-SIC and full-PIC, the benefit of the PIC was exhibited as opposed to the SIC, but an extra ablation step was added in the PIC in order to form a continuous ablation zone. The other comparative study was taken between a partial-PIC and a partial-SIC with the same number of ablation step. In this study, a rabbit model was built by infusing 0.4% saline solution (at 37°C) into the rabbit's abdominal cavity which surrounds the liver. This model was considered as a biometric environment of the heart, namely cardiac-mimetic model (CMM). The experimental results have shown that the full-PIC is superior to the full-SIC in the ablation depth, specifically in both the maximum (4.14±0.55mm vs. 3.35±0.26mm, p<0.01) and the minimum (3.18±0.29mm vs. 2.76±0.28mm, p<0.05), and in the ablation width, specifically only in the maximum (8.27±0.76mm vs. 7.09 ± 0.51mm, p=0.019) under an identical ablation time (i.e., 5s). It is noted that the minimum ablation width did not show a significant difference between the full-PIC and full-SIC (specifically, 5.61±0.86mm vs. 4.67±0.73mm, p=0.069). Considering the lethal electric field threshold (LEFT) to be 600V/cm for liver tissues, the maximum and minimum ablation depth generated by the full-PIC was found larger than that by the full-SIC (3.90vs. 3.52mm, and 3.03vs. 2.48mm, respectively) in the simulation. Meanwhile, similar experiment results by comparing the partial-PIC and partial-SIC have been obtained, which shows a significant increase in both the maximum ablation depth (4.81±0.87mm vs. 3.30±0.73mm, p<0.001) and the maximum ablation width (8.19±0.85mm vs. 6.47±1.13mm, p=0.001). (1) The electric field in the PIC is concentrated around the pair of electrodes, and the pattern of the field is a significant factor in the energy delivery along the direction of the depth. (2) The increase of the ablation depth can significantly expand the range of the tissue on the heart, where the PFA can apply, and can therefore readily form a layer of transmural damage on the heart wall at positions at which the wall is thicker.