Hagai Yavin1, Erez Brem2, Israel Zilberman3, Ayelet Shapira-Daniels4, Keshava Datta2, Assaf Govari3, Andres Altmann3,5, Ante Anic, Oussama Wazni1, Elad Anter1. 1. Cardiac Electrophysiology Section, Department of Cardiovascular Medicine, Cleveland Clinic, OH (H.Y., O.W., E.A.). 2. Research and Development Division, Biosense Webster, Johnson and Johnson, Irwindale, CA (E.B., K.D.). 3. Advanced Research and Development Biosense Webster, Johnson and Johnson, Yokneam, Israel (I.Z., A.G., A.A.). 4. Harvard-Thorndike Electrophysiology Institute, Cardiovascular Division, Department of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (A.S.-D.). 5. University Clinical Hospital Split, Croatia (A.A.).
Abstract
BACKGROUND: Pulsed field ablation (PFA) is a nonthermal energy with potential safety advantages over radiofrequency ablation. 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 used 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 to the inferior vena cava. 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 radiofrequency ablation (1-2 applications). Histopathologic 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 seconds (interquartile range [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 14.2 mm. High-intensity PFA (9 [IQR, 8-14] application) had no effect on the esophagus while standard intensity radiofrequency ablation (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 radiofrequency ablation (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.
BACKGROUND: Pulsed field ablation (PFA) is a nonthermal energy with potential safety advantages over radiofrequency ablation. 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 used 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 to the inferior vena cava. 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 radiofrequency ablation (1-2 applications). Histopathologic 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 seconds (interquartile range [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 14.2 mm. High-intensity PFA (9 [IQR, 8-14] application) had no effect on the esophagus while standard intensity radiofrequency ablation (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 radiofrequency ablation (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.
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