A novel contact force sensing pulsed field ablation catheter in a porcine model

BackgroundPulsed field ablation (PFA) has emerged as a novel non-thermal modality with highly myocardium-specific. However, the PFA catheter based on contact force (CF)-sensing has not been reported. The study aimed to evaluate the efficacy and safety of a novel CF-sensing PFA catheter.MethodsFirst, different CF (5, 15, 25, and 35 g) of the novel PFA catheter were evaluated on lesion dimensions during ablation on right and left ventricle in two pigs. Next, this catheter was further evaluated on four typical sites of superior vena cava (SVC), cavotricuspid isthmus (CTI), right superior pulmonary vein (RSPV), and right inferior pulmonary vein (RIPV) for atrial ablation in another six pigs. Electrical isolation was evaluated immediately after ablation and 30-day survival. Chronic lesions were assessed via histopathology after euthanasia. Acute and chronic safety outcomes were observed peri- and post-procedurally.ResultsIn ventricular ablation, increased CF from 5 to 15 g produced significantly greater lesion depth but nonsignificant increases from 15 to 35 g. In atrial ablation, the novel CF-sensing PFA deliveries produced an acute attenuation of local electrograms and formation of a continuous line of block in all 6 pigs. The ablation line remained sustained blockage at the 30-day survival period. The CF of SVC, CTI, RSPV, and RIPV was 9.4 +/- 1.5, 14.5 +/- 3.2, 17.2 +/- 2.6, and 13.4 +/- 2.8 g, respectively. Moreover, no evidence of damage to esophagus or phrenic nerve was observed.ConclusionThe novel CF-sensing PFA catheter potentiated efficient, safe, and durable ablation, without causing damage to the esophagus or phrenic nerve. Broadly, there were two parts in this preclinical experiment. In the first stage, we used different doses of contact force (5, 15 , 25, and 35 g) for endocardial ventricular ablation in two pigs to assess the relationship between the CF and lesions. In the second stage, we examined the feasibility and safety of this novel to create an exit block from the superior vena cava or pulmonary vein and assessed its durability after 30 days, along with observation of the potential vulnerability of the esophagus and phrenic nerve. PFA, pulsed field ablation; CF, contact force; SVC, superior vena cava; CTI, cavotricuspid isthmus; RSPV, right superior pulmonary vein; RIPV, right inferior pulmonary vein. RIPV, right inferior pulmonary vein. image