Initial clinical experience with the novel POLARx FIT cryoballoon system for pulmonary vein isolation in patients with atrial fibrillation.

ABSTRACT

Background: The POLARx FIT system (Boston Scientific, MA, USA) is a novel cryoballoon (CB) ablation technology in which the balloon diameter can be expanded from 28 to 31 mm. The aim of this study was to compare the benefits and safety of the new POLARx FIT system to those of the existing POLARx system currently in use for pulmonary vein (PV) isolation (PVI) in patients with atrial fibrillation. Methods: The first 70 consecutive patients who underwent CB-based PVI with the POLARx FIT system were retrospectively compared with 200 consecutive patients treated with the POLARx system at Sakakibara Heart Institute from October 2021 to May 2023. Results: The POLARx FIT system yielded a higher mean ± standard deviation nadir temperature in the right inferior PV (-59.2 ± 5.29 °C vs. - 62.0 ± 5.08 °C, p = 0.006), but this required a balloon size reduction to 28 mm in 30 % of cases. No significant differences were detected in the time to isolation and thaw time of any PV between the two groups. After the CB-based PVI procedure, no residual PV carina potentials were observed with the POLARx FIT system, whereas 4/20 were with the POLARx system (p = 0.04). Conclusions: The POLARx FIT system had comparable effectiveness and safety to the basic POLARx system. This technology may improve the ablation area, including the PV carina. However, the 31-mm balloon alone was not sufficient to isolate certain PVs.