News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation

Abstract

Cryoballoon (CB)-guided pulmonary vein isolation (PVI) represents a cornerstone in the treatment of atrial fibrillation (AF). Recently, a novel balloon-guided single shot device (POLARx, Boston Scientific) was designed. Our study aimed to compare the efficacy, safety and characteristics of the novel CB system with the established one (Arctic Front Advance (Pro), AFA, Medtronic). A total number of 596 patients undergoing CB-guided ablation for AF were included. 65 patients (65.0 ± 11.6, 31% female) undergoing PVI with the POLARx were compared to a cohort of 531 consecutive patients (63.0 ± 27.9, 25% female) treated with AFA. Acute PVI was achieved in all patients (n = 596, 100%). Total procedure duration (POLARx 113.3 ± 23.2 min, AFA 100.9 ± 21.3 min; p < 0.001) and fluoroscopy time (POLARx 10.5 ± 5.9 min, AFA 4.8 ± 3.6 min; p < 0.001) were significantly longer in the POLARx group. The POLARx balloon achieved significantly lower nadir temperatures (POLARx −57.7 ± 0.9 °C, AFA −45.1 ± 2.6 °C; p < 0.001) and a significantly higher percentage of pulmonary veins successfully isolated with the first freeze (p = 0.027 *). One major complication occurred in the POLARx (2%) and three (1%) in the AFA group. Both ablation systems are comparably safe and effective. AF ablation utilizing the POLARx system is associated with longer procedure and fluoroscopy times as well as lower nadir temperatures.

Impact of pulmonary vein variant anatomy and cross-sectional orifice area on freedom from atrial fibrillation recurrence after cryothermal single-shot guided pulmonary vein isolation

“…Enlarged PVs and the related CSOA might impede complete electrical isolation of the PVs and inadequate isolation or lesion formation increases the risk for PV reconnection. In a prior study, we documented that the presence of an enlarged PV (LCV) is associated with more freeze cycles for complete PVI [ 22 ]. Larger PVs seem to require more freeze applications for complete PVI.…”

“…Beyond that, the handling of the POLARx system is comparably smart and straightforward due to improved material properties. The POLARSTEATH appears to be softer and more flexible [ 22 ].…”

Comparison of the acute outcome of two cryoballoon technologies for pulmonary vein isolation: An updated systematic review and meta-analysis

“…For the outcomes first freeze isolation RSPV, first freeze isolation RIPV, TTI recording RSPV and TTI RIPV, the between-study heterogeneity became < 50 % after the exclusion of a single study, however, the overall effect size did not change. Heterogeneity for the outcome of first freeze isolation LIPV was driven primarily by the study of Guckel et al [13] After the exclusion of this study, no difference between was detected in the likelihood of first freeze isolation LIPV (P = 0.16) (Supplemental figure S5 A). Heterogeneity for the outcomes of TTI recording LSPV, TTI LSPV and TTI RSPV was driven primarily by the study of Moser et al [16] After the exclusion of this study, TTI recording LSPV and TTI LSPV became in favour of POLARx (P = 0.004 and P = 0.02, respectively) (Supplemental figure S5 B and S5C).…”

“…1 ). [8] , [9] , [10] , [11] , [13] , [14] , [15] , [16] All included studies were observational in design and found to be of good quality based on the Newcastle Ottawa scale (Supplemental table S1 ).

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“… [12] After this publication, other centers has published their experience with POLARx. [13] , [14] , [15] , [16] Therefore, we performed an updated systematic review and meta -analysis to confirm the robustness of the results of our previous meta -analysis. In addition, new outcome variables were evaluated such as time-to-isolation (TTI), likelihood of TTI recordings, minimal esophageal temperature, and thrombo-embolic events.…”