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Background: A novel ablation and mapping system can toggle between delivering biphasic pulsed field (PF) and radiofrequency energy from a 9-mm lattice-tip catheter. We assessed the preclinical feasibility and safety of (1) focal PF-based thoracic vein isolation and linear ablation, (2) combined PF and radiofrequency focal ablation, and (3) PF delivered directly atop the esophagus. Methods: Two cohorts of 6 swine were treated with pulsed fields at low dose (PF LD ) and high dose (PF HD ) and followed for 4 and 2 weeks, respectively, to isolate 25 thoracic veins and create 5 right atrial (PF LD ), 6 mitral (PF HD ), and 6 roof lines (radiofrequency+PF HD ). Baseline and follow-up voltage mapping, venous potentials, ostial diameters, and phrenic nerve viability were assessed. PF HD and radiofrequency lesions were delivered in 4 and 1 swine from the inferior vena cava onto a forcefully deviated esophagus. All tissues were submitted for histopathology. Results: Hundred percent of thoracic veins (25 of 25) were successfully isolated with 12.4±3.6 applications/vein with mean PF times of <90 seconds/vein. Durable isolation improved from 61.5% PF LD to 100% with PF HD ( P =0.04), and all linear lesions were successfully completed without incurring venous stenoses or phrenic injury. PF HD sections had higher transmurality rates than PF LD (98.3% versus 88.1%; P =0.03) despite greater mean thickness (2.5 versus 1.3 mm; P <0.001). PF lesions demonstrated homogenous fibrosis without epicardial fat, nerve, or vessel involvement. In comparison, radiofrequency+PF HD sections revealed similar transmurality but expectedly more necrosis, inflammation, and epicardial fat, nerve, and vessel involvement. Significant ablation-related esophageal necrosis, inflammation, and fibrosis were seen in all radiofrequency sections, as compared with no PF sections. Conclusions: The lattice-tip catheter can deliver focal PF to durably isolate veins and create linear lesions with excellent transmurality and without complications. The PF lesions did not damage the phrenic nerve, vessels, and the esophagus.
Background: A novel ablation and mapping system can toggle between delivering biphasic pulsed field (PF) and radiofrequency energy from a 9-mm lattice-tip catheter. We assessed the preclinical feasibility and safety of (1) focal PF-based thoracic vein isolation and linear ablation, (2) combined PF and radiofrequency focal ablation, and (3) PF delivered directly atop the esophagus. Methods: Two cohorts of 6 swine were treated with pulsed fields at low dose (PF LD ) and high dose (PF HD ) and followed for 4 and 2 weeks, respectively, to isolate 25 thoracic veins and create 5 right atrial (PF LD ), 6 mitral (PF HD ), and 6 roof lines (radiofrequency+PF HD ). Baseline and follow-up voltage mapping, venous potentials, ostial diameters, and phrenic nerve viability were assessed. PF HD and radiofrequency lesions were delivered in 4 and 1 swine from the inferior vena cava onto a forcefully deviated esophagus. All tissues were submitted for histopathology. Results: Hundred percent of thoracic veins (25 of 25) were successfully isolated with 12.4±3.6 applications/vein with mean PF times of <90 seconds/vein. Durable isolation improved from 61.5% PF LD to 100% with PF HD ( P =0.04), and all linear lesions were successfully completed without incurring venous stenoses or phrenic injury. PF HD sections had higher transmurality rates than PF LD (98.3% versus 88.1%; P =0.03) despite greater mean thickness (2.5 versus 1.3 mm; P <0.001). PF lesions demonstrated homogenous fibrosis without epicardial fat, nerve, or vessel involvement. In comparison, radiofrequency+PF HD sections revealed similar transmurality but expectedly more necrosis, inflammation, and epicardial fat, nerve, and vessel involvement. Significant ablation-related esophageal necrosis, inflammation, and fibrosis were seen in all radiofrequency sections, as compared with no PF sections. Conclusions: The lattice-tip catheter can deliver focal PF to durably isolate veins and create linear lesions with excellent transmurality and without complications. The PF lesions did not damage the phrenic nerve, vessels, and the esophagus.
Background: The tissue selectivity of pulsed field ablation (PFA) provides safety advantages over radiofrequency ablation in treating atrial fibrillation. One-shot PFA catheters have been shown capable of performing pulmonary vein isolation, but not flexible lesion sets such as linear lesions. A novel lattice-tip ablation catheter with a compressible 9-mm nitinol tip is able to deliver either focal radiofrequency ablation or PFA lesions, each in 2 to 5 s. Methods: In a 3-center, single-arm, first-in-human trial, the 7.5F lattice catheter was used with a custom mapping system to treat paroxysmal or persistent atrial fibrillation. Toggling between energy sources, point-by-point pulmonary vein encirclement was performed using biphasic PFA posteriorly and either temperature-controlled irrigated radiofrequency ablation or PFA anteriorly (RF/PF or PF/PF, respectively). Linear lesions were created using either PFA or radiofrequency ablation. Results: The 76-patient cohort included 55 paroxysmal and 21 persistent atrial fibrillation patients undergoing either RF/PF (40 patients) or PF/PF (36 patients) ablation. The pulmonary vein isolation therapy duration time (transpiring from first to last lesion) was 22.6±8.3 min/patient, with a mean of 50.1 RF/PF lesions/patient. Linear lesions included 14 mitral (4 RF/2 RF+PF/8 PF), 34 left atrium roof (12 RF/22 PF), and 44 cavotricuspid isthmus (36 RF/8 PF) lines, with therapy duration times of 5.1±3.5, 1.8±2.3, and 2.4±2.1 min/patient, respectively. All lesion sets were acutely successful, using 4.7±3.5 minutes of fluoroscopy. There were no device-related complications, including no strokes. Postprocedure esophagogastroduodenoscopy revealed minor mucosal thermal injury in 2 of 36 RF/PF and 0 of 24 PF/PF patients. Postprocedure brain magnetic resonance imaging revealed diffusion-weighted imaging+/fluid-attenuated inversion recovery- and diffusion-weighted imaging+/fluid-attenuated inversion recovery+ asymptomatic lesions in 5 and 3 of 51 patients, respectively. Conclusions: A novel lattice-tip catheter could safely and rapidly ablate atrial fibrillation using either a combined RF/PF approach (capitalizing on the safety of PFA and the years of experience with radiofrequency energy) or an entirely PF approach. Registration: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT04141007 and NCT04194307.
Pulsed-field ablation (PFA), specifically irreversible electroporation, induces cell membrane damage through the formation of irreversible pores, leading to apoptosis and necrosis, with applications in tumor treatment and myocardium ablation since 2007. This review is on PFA in the treatment of cardiac arrhythmias, including the basic principles, clinical applications, and hot issues of PFA. Presently, the pulsed electric field has demonstrated its effectiveness and safety in the treatment of atrial fibrillation, which is not inferior to that of traditional thermal energy. Research and application on pulsed electric ablation is rapidly advancing due to its advantages of rapidity and specificity in lesion creation. Moreover, pulsed electric ablation has reduced the difficulty of catheter manipulation in pulmonary vein isolation, making it an available treatment to benefit more patients.
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