Safety and efficacy aspects of pulsed field ablation catheters as a function of electrode proximity to blood and energy delivery method

脉冲场消融导管的安全性和有效性与电极与血液的距离以及能量输送方式的关系

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Abstract

BACKGROUND: Pulsed field ablation (PFA) is a promising technology based on electroporation. It is unclear if different catheter designs imply efficacy and safety differences. OBJECTIVE: To vary geometry, blood exposure, and energy delivery methods among 3 representative catheter designs, and then compare lesion transmurality, extra-atrial safety, and embolic risk. METHODS: A computed tomography-derived computer model was used. Balloon, flexible-circuit splined, and circular catheters were placed near the left pulmonary veins. Four energy delivery methods were tested: multi-unipolar, sequential unipolar, interlaced, and wide interlaced. A posterior wall target was defined. Efficacy was defined as percent target with >600 V/cm. Safety aspects included aortic/esophageal electroporation damage and a bubble-generation surrogate (electrode current density), with 90% transmurality requirement. RESULTS: Balloon catheters had highest efficacy, followed by flexible polymer splined and circular catheters. On energy delivery methods, the multi-unipolar one was most efficacious, followed by interlaced bipolar and sequential-unipolar ones. Electroporation risks to aorta and esophagus were highest with multi-unipolar energy delivery. Bubble risk was lowest with balloon catheters. CONCLUSION: Computer models show that catheters with electrodes on a balloon surface or on flexible circuit splines are about 4 times more efficacious than circular catheters with electrodes exposed to atrial blood. Multi-unipolar energy delivery methods have a higher risk of electroporating aortic and esophageal tissue, when compared to bipolar interlaced methods. Considering embolic risks, circular catheters had the highest bubble-generating potential. A balloon or flexible circuit splined system with a wide interlaced delivery method showed the best balance in efficacy and safety.

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