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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.

Background - Pulsed-field ablation (PFA) is a rapid and nonthermal energy with higher selectivity to myocardial tissue in comparison to radiofrequency ablation (RFA). However, its effects on ventricular myocardium, and titration of lesion dimensions have not been well studied. This study examined the effect of PFA on ventricular myocardium, and the influence of application repetition on lesion dimensions. Methods - An 8Fr lattice catheter with a compressible 9 mm nitinol tip was used with a PFA generator (Affera Inc) applying a bipolar and biphasic waveform (±1.3-2.0 kV, 4 sec per application). We examined the impact of single applications (1x) vs four repetitive applications (4x) interspaced by 10 seconds. The latter was performed to determine whether repetitions of a similar electrical field can increase lesion dimensions. Experiments were performed in an in-vivo porcine model and a survival period of 24 hours (n=6) or 23±5.4 days (n=6) for evaluation of early and late histopathological effects. Results - PFA in ventricular myocardium showed repetition dependency. Acute lesion depth and volume increased from 5.6±1.43mm and 860±362mm 3 to 8.8±0.74mm and 2383±548mm 3 for 1x and 4x applications, respectively (P<0.001 for both comparisons). This effect was maintained in the chronic lesion phase with lesion depth and volume of 3.9±0.92mm and 655±286mm 3 compared with 7.3±0.83mm and 2170±488mm 3 , respectively (P<0.001 for both comparisons). Acute lesions showed well demarcated necrotic core without coagulation necrosis while chronic lesions showed tissue thinning with fibro-fatty replacement. Conclusions - PFA in ventricular myocardium exhibits repetition dependency as lesion dimension increases with consecutive applications of a similar electrical field.

Background: Pulsed field ablation (PFA) is a nonthermal energy that may provide safety advantages over radiofrequency ablation (RFA). One-shot PFA catheters have been developed for pulmonary vein isolation, but they do not permit flexible lesion sets. This study investigated a novel lattice-tip catheter designed for focal RFA or PFA ablation. Methods: The effects of PFA (biphasic, 24 amperes) were investigated in 25 swine using a lattice-tip catheter and system (Affera Inc). Step 1 (n=14) examined the feasibility to create atrial line of block and described its acute effects on the phrenic nerve and esophagus. Step 2 (n=7) examined the subacute effects of PFA on block durability, phrenic nerve, and esophagus ≥2 weeks. Step 3 compared the effects of PFA and RFA on the esophagus using a mechanical deviation model approximating the esophagus to the right atrium (n=4) and by direct ablation within its lumen (n=4). The effects of endocardial PFA and RFA on the phrenic nerve were also compared (n=10). Histological analysis was performed. Results: PFA produced acute block in 100% of lines, achieved with 2.1 (1.3–3.2) applications/cm line. Histological analysis following (35 [18–37]) days showed 100% transmurality (thickness range 0.4–3.4 mm) with a lesion width of 19.4 (10.9–27.4 mm). PFA selectively affected cardiomyocytes but spared blood vessels and nervous tissue. PFA applied from the posterior atria (23 [21–25] applications) to the approximated esophagus (6 [4.5–14] mm) produced transmural lesions without esophageal injury. PFA (16.5 [15–18] applications) applied inside the esophageal lumen produced mild edema compared with RFA (13 [12–14] applications) which produced epithelial ulcerations. PFA resulted in no or transient stunning of the phrenic nerve (<5 minutes) without histological changes while RFA produced paralysis. Conclusions: PFA using a lattice-tip ablation catheter for focal ablation produced durable atrial lesions and showed lower vulnerability to esophageal or phrenic nerve damage compared with RFA.

Background: Ventricular tachycardia ablation is often limited by insufficient lesion creation. A novel radiofrequency catheter with an expandable lattice electrode has a larger surface area capable of delivering higher currents at a lower density to potentially increase lesion dimensions without overheating. Methods: This 8F bidirectional irrigated catheter (Sphere-9, Affera Inc) has a 9 mm spherical lattice tip (“lattice”) with an effective surface area 10-fold larger than standard linear catheters. Nine surface thermocouples provide temperature feedback to a proprietary high-current generator operating in a temperature-controlled mode. Ex vivo phase: in 11 bovine hearts, unipolar ablation at 30, 60, and 120 seconds was compared between the lattice (Tmax60°C) and a standard linear irrigated-tip catheter (40 W) at contact force of 10 g. In 5 porcine hearts, bipolar ablation was compared between the catheters (Tmax60°C versus 40 W; 60 seconds). In vivo phase: in 9 swine, ventricular ablation at Tmax60°C versus 40 W was performed for 60 seconds. In addition, direct tissue temperature at 3- and 7-mm tissue depth was measured in a thigh muscle preparation. Results: Ex vivo: lattice produced deeper lesions at 30, 60, and 120 seconds application duration (6.7±1.3 versus 4.8±1.2 mm; 8.3±1.4 versus 5.4±0.8 mm; 10.0±1.6 versus 6.1±1.6 mm, respectively, P ≤0.001 for all). Bipolar lesions were deeper (15.8±4.1 versus 10.5±1.4 mm, P <0.001) and more likely to be transmural (80% versus 0%, P =0.002). In vivo: lattice produced deeper lesions (10.5±1.4 versus 6.5±0.8 mm, P ≤0.001). Tissue temperature at 7 mm was higher with the lattice (+15.1±2.4°C; P <0.001). The steam-pop occurrence was lower with the lattice (total: 4% versus 18%, P =0.02; in vivo 0% versus 14.2%, P =0.13). Conclusions: This novel radiofrequency system produces larger ventricular lesions compared with standard irrigated catheters and at a lower risk of tissue overheating. This may improve the efficacy of ventricular tachycardia ablation procedures while reducing the number of applications and procedural duration.