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

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.

Feasibility and safety of left atrial posterior wall isolation with a new Cryoballoon technology in patients with persistent atrial fibrillation

Introduction: Left atrial posterior wall isolation (LAPWI) is often performed in addition to pulmonary vein isolation (PVI) to improve outcome in patients with persistent atrial fibrillation (AF). In this setting, LAPWI + PVI using cryoballoon ablation had comparable results with radiofrequency ablation (RFA). The aim of the study is to evaluate the feasibility and safety of a new cryoballoon ablation system in PVI + LAPWI isolation, comparing it with the historical platform. Methods: The study was a prospective, non-randomized, single center study. Forty consecutive patients, undergoing PVI + LAPWI with the novel POLARx™, were compared to 40 consecutive patients who underwent the same procedure with the established Arctic Front Advance PRO™. Results: Acute isolation was achieved in all PVs in both groups and LAPWI was achieved in 38 patients (95%) in the POLARx group and in 36 patients (90%) in Arctic Front group. Procedural outcomes were similar between the two groups, except for lower temperatures during cryoapplications in the POLARx group, for both PVI and LAPWI. The complication rate was low and similar between groups. Conclusion: LAPWI+PVI with the novel POLARx™ Cryoballoon is feasible and safe; the results are comparable with the Arctic Front Advance PRO™ system.

Initial experience and follow up on the PolarX cryoablation system compared to the established Arctic Front cryoablation system in PVI ablations

Introduction Pulmonary vein isolation (PVI) with cryoablation was shown to be comparable to radiofrequency ablation (RF) in terms of safety and outcome for patients with atrial fibrillation (AF), so that both techniques are recommended equally by the current guidelines. A new cryoablation system PolarX® was introduced in 2020. We analysed the first patients, who underwent ablation with the new system with respect to procedural and safety outcome and evaluated the freedom from arrhythmia occurrence in the first 6 months compared to patients treated with the established Arctic Front Advance® cryoablation system. Methods We included the consecutive 44 patients who underwent cryoablation with the new PolarX® cryoablation system (28mm) and 24 patients who underwent cryoablation with the established Arctic Front Advance® cryoablation system (28mm) for paroxysmal AF. We retrospectively analysed baseline characteristics, procedural- and safety data. In 5 patients of each group an additional high-density 3D-mapping was performed, evaluating the scar-area after cryoablation in both groups (figure 1A+B). After 6 months the freedom of AF (by 7d-Holter-ECG) was evaluated in both groups. Results Baseline, procedural characteristics and results are listed in table 1. Mean total procedure duration (“door-to-door-time”) was significantly shorter in the PolarX group compared to the Arctic-Front group (136±34min vs. 163±43min; p&lt;0.05). Number of freezes required to achieve isolation of all pulmonary veins (PVs) and cumulative freezing time was comparable in both groups. Minimal achieved temperatures were significantly lower in the PolarX group vs. ArcticFront group. The scar-area analyzed by 3D-mapping post ablation did not differ in the two groups. Complication rates as well as clinical outcome (freedom from AF) were low and did not differ in the Kaplan-Meier analysis (table 1; figure 1C). Conclusion Based on these initial results, cryoablation with the PolarX cryoballoon seems to be comparably effective and safe, with a significantly shorter procedure time and significantly lower achieved temperatures. Nevertheless, future controlled trials with a longer follow-up period will be necessary to evaluate long-term effectiveness. FUNDunding Acknowledgement Type of funding sources: None.

Novel cryoballoon ablation system for single shot pulmonary vein isolation: The prospective ICE-AGE-X Study

Funding Acknowledgements Type of funding sources: None. Background The arctic front cryoballon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome data. The POLARx cryoballoon incorporates unique features which may translate into improved efficacy and safety. Purpose To assess efficacy and safety of the novel POLARx cryoballoon in comparison to the fourth generation arctic front cryoballon (AF-CB4). Methods Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation (AF) were prospectively enrolled, underwent POLARx based PVI (POLARx group) and were compared to 25 consecutive patients treated with the fourth generation AF-CB (AF-CB4 group). Results A total of 100 (POLARx) and 97 (AF-CB4) pulmonary veins (PV) were identified and all PVs were successfully isolated utilizing the POLARx and AF-CB4, respectively. A significant difference regarding the mean minimal cryoballoon temperatures reached using the AF-CB4 and POLARx (-50 ± 6°C vs. -57 ± 7°C, p = 0.004) was observed. Real-time PVI was visualized in 81% of POLARx patients and 42% of AF-CB4 patients (p &lt; 0.001). Despite a certain learning curve utilizing the POLARx a trend towards shorter median procedure time (POLARx: 45 (39, 53) minutes vs. AF-CB4: 55 (50, 60) minutes (p = 0.062) was found. No differences were observed for periprocedural complications. Conclusions The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time electrical PV recordings and significantly lower balloon temperatures were observed using the POLARx as compared to AF-CB4.

A Second Cryoballoon System- new and improved?

Generations of cryoballoon transformed the atrial fibrillation ablation landscape. New advancements continue to make cryoballoon more successful and safer treatment. A new cryoballoon PolaRx from Boston Scientific has unique features compared to that of the Medtronic Arctic Front Advance system. Comparison of the two available cryoballoons will require ongoing larger trial and clinical experience.

Ablation of atrial fibrillation using the fourth-generation cryoballoon Arctic Front Advance PRO

The cryoballoon (CB) is a popular ablation technology used for pulmonary vein isolation. The fourth-generation CB, Arctic Front Advance PRO features a 40% shorter distal tip but retains the internal design from its second-generation predecessor. The Arctic Front Advance PRO and the second-generation CB demonstrated similar thermodynamic characteristics in a computational model. Several observational and retrospective studies established the acute safety and efficacy of the Arctic Front Advance PRO. Real-time electrical isolation was observed in 75–85% of pulmonary veins targeted with the Arctic Front Advance PRO resulting in shorter fluoroscopy and procedure times.