Evaluation of Ablation Parameters to Predict Irreversible Lesion Size During Pulsed Field Ablation.

BACKGROUND: During pulsed field ablation (PFA), relationships between ablation parameters (contact force [CF], number of burst pulses, impedance decrease, and electrode temperature) and lesion size in beating hearts have not been well validated. METHODS: A 7F-catheter with a 3.5-mm ablation electrode and CF sensor (ThermoCool SmartTouch SF-Dual-Energy, Biosense Webster, Inc, Irwindale, CA) was connected to a PFA system (TRUPULSE2, Biosense Webster, Inc). In 11 closed-chest swine, biphasic PFA current was delivered between the ablation electrode and the skin patch at 219 sites in left ventricle and right ventricle using 12, 18, and 24 burst pulses with 4 different levels of CF: (1) low (n=57; CF, 4-15g; median, 10g); (2) moderate (n=60; CF, 16-30g; median, 22.5g); (3) high (n=68; CF, 32-65g; median, 40g); and (4) no electrode contact (n=34), 2 mm away from the endocardium. Swine were euthanized 2 hours after ablation, and lesion size was measured using triphenyl tetrazolium chloride staining. RESULTS: All PFA lesions with electrode-myocardium contact were well demarcated with triphenyl tetrazolium chloride staining, demonstrating (1) pale central zone (contraction band necrosis with minimal coagulation necrosis), (2) dark brown zone (contraction band necrosis with hemorrhage), and (3) hyperstained red zone by triphenyl tetrazolium chloride (unaffected normal myocardium with preserved mitochondrial activity, consistent with reversible zone). Lesion depth increased significantly with increasing CF and the number of PFA burst pulses. An exponential/logarithmic formula combined with CF and the number of PFA burst pulses correlated lesion depth with high accuracy: R=0.809, P<0.0001, ±1.0-mm accuracy in 128 of 163 (79%) lesions, and ±1.5-mm accuracy in 153 of 163 (94%) lesions. Impedance decrease and electrode temperature were poor predictors of lesion size. There were no detectable lesions resulting from ablation without electrode contact. CONCLUSIONS: Acute PFA ventricular lesions demonstrate irreversible and reversible lesion boundaries. Electrode-tissue contact is required for effective lesion formation. Lesion depth increases significantly with increasing CF and PFA burst pulses. A new exponential/logarithmic formula combined with CF and the number of PFA burst pulses correlates lesion depth with high accuracy.

Point-by-Point Pulsed Field Ablation Using a Multimodality Generator and a Contact Force-Sensing Ablation Catheter: Comparison With Radiofrequency Ablation in a Remapped Chronic Swine Heart.

BACKGROUND: Pulsed field ablation (PFA) has emerged as an alternative to radiofrequency ablation. However, data on focal point-by-point PFA are scarce. The aim of this study was to compare lesion durability and collateral damage between focally delivered unipolar/biphasic PFA versus radiofrequency in swine. METHODS: Eighteen swine were randomized to low-dose PFA, high-dose PFA, and radiofrequency using a multimodality generator. Radiofrequency delivered by market-available generator served as control group. A contact force-sensing catheter was used to focally deliver PFA/radiofrequency at the pulmonary veins and other predefined sites in the atria. Animals were remapped postprocedurally and 28 days postablation to test lesion durability followed by gross necroscopy and histology. RESULTS: All targeted sites were successfully ablated (contact force value, 13.9±4.1 g). Follow-up remapping showed persistent pulmonary vein isolation in all animals (100%) with lesion durability at nonpulmonary vein sites proven in most (98%). Regardless of the energy source used, the lesion size was similar across the study groups. Transmurality was achieved in 95% of targeted sites and 100% at pulmonary veins. On histology, PFA animals showed more mature scar formation than their radiofrequency counterpart without myocardial necrosis or inflammation. Finally, no sign of collateral damage was observed in any of the groups. CONCLUSIONS: In a randomized preclinical study, focally delivered unipolar/biphasic PFA guided by contact force values was associated with durable lesions on chronic remapping and with mature scar formation on histology without signs of collateral injury on necroscopy. Further studies are needed to investigate the long-term feasibility of this new approach to atrial fibrillation treatment.

Comparison of In Vivo Tissue Temperature Profile and Lesion Geometry for Radiofrequency Ablation With High Power-Short Duration and Moderate Power-Moderate Duration: Effects of Thermal Latency and Contact Force on Lesion Formation.

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A 10-Fr ultrasound catheter with integrated micromotor for 4-D intracardiac echocardiography.

We developed prototype real-time 3-D intracardiac echocardiography catheters with integrated micromotors, allowing internal oscillation of a low-profile 64-element, 6.2-MHz phased-array transducer in the elevation direction. Components were designed to facilitate rotation of the array, including a low-torque flexible transducer interconnect and miniature fixtures for the transducer and micromotor. The catheter tip prototypes were integrated with two-way deflectable 10-Fr catheters and used in in vivo animal testing at multiple facilities. The 4-D ICE catheters were capable of imaging a 90° azimuth by up to 180° elevation field of view. Volume rates ranged from 1 vol/sec (180° elevation) to approximately 10 vol/sec (60° elevation). We successfully imaged electrophysiology catheters, atrial septal puncture procedures, and detailed cardiac anatomy. The elevation oscillation enabled 3-D visualization of devices and anatomy, providing new clinical information and perspective not possible with current 2-D imaging catheters.