A Circular Multielectrode Pulsed-Field Ablation Catheter "Lasso PFA": Lesion Characteristics, Durability and Effect on Neighboring Structures
Background - Pulsed field ablation (PFA) is a nonthermal energy with potential safety advantages over radiofrequency ablation (RFA). This study investigated a novel PFA system- a circular multielectrode catheter ("PFA lasso") and a multichannel generator designed to work with Carto 3® mapping system. Methods - A 7.5F bidirectional circular catheter with 10 electrodes and variable expansion was designed for PFA (biphasic, 1800 Volts). This study included a total of 16 swine utilized to investigate the following 3 experimental aims: Aim 1 examined the feasibility to create a right atrial ablation line of block from the superior vena cava (SVC) to the inferior vena cava (IVC). Aim 2 examined the effect of PFA on lesion maturation including durability after a 30-day survival period. Aim 3 examined the effect of high intensity PFA (10 applications) on esophageal and phrenic nerve tissue in comparison to normal intensity RFA (1-2 applications). Histopathological analysis of all cardiac, esophageal and phrenic nerve tissue was performed. Results - Acute line of block was achieved in 12/12 swine (100%) and required a total PFA time of 14 sec (IQR:9-24.5) per line. Ablation line durability after 28&3 days was maintained in 11/12 (91.7%) swine. PFA resulted in transmural lesions in 179/183 (97.8%) sections and a median lesion width of 14.2mm. High intensity PFA (9 [IQR:8-14] application) had no effect on the esophagus while standard intensity RFA (1.5 [IQR:1-2] applications) resulted in deep esophageal tissue injury involving the muscularis propria and adventitia layers. High intensity PFA (16 [IQR:10-28] applications) has no effect on phrenic nerve function and structure while standard dose RFA (1.5 [IQR:1-2] applications) resulted in acute phrenic nerve paralysis. Conclusions - In this preclinical model, a multielectrode circular catheter and multichannel generator produced durable atrial lesions with lower vulnerability to esophageal or phrenic nerve damage.