Background:The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4).

Methods and Results:Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. A significant difference regarding the mean minimal cryoballoon temperatures reached using the AF-CB4 and POLARx (−50±6℃ vs. −57±7℃, P=0.004) was observed. Real-time PVI was visualized in 81% of POLARx patients and 42% of AF-CB4 patients (P<0.001). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications.

Conclusions:The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.

背景：北极前冷冻球囊 (AF-CB) 提供了有效且持久的肺静脉隔离 (PVI)，与令人鼓舞的临床结果相关。POLARx cryoballoon 结合了独特的功能和设计变化，可以转化为更高的功效、安全性和进一步简化的基于球囊的程序。将新型 POLARx cryoballoon 的功效和安全性与第四代 AF-CB (AF-CB4) 进行了比较。

方法和结果：25 名连续性阵发性或持续性心房颤动患者被前瞻性纳入，接受基于 POLARx 的 PVI（POLARx 组），并与连续 25 名接受 AF-CB4 治疗的患者（AF-CB4 组）进行比较。使用 POLARx 和 AF-CB4 成功隔离了所有 PV。观察到使用 AF-CB4 和 POLARx 达到的平均最低低温球温度存在显着差异（-50±6℃ vs. -57±7℃，P=0.004）。81% 的 POLARx 患者和 42% 的 AF-CB4 患者可以看到实时 PVI（P<0.001）。利用 POLARx，发现了中位手术时间缩短的趋势（POLARx：45 [39, 53] 分钟对比 AF-CB4：55 [50, 60] 分钟；P=0.062）。AF-CB4 和 POLARx 在导管可操作性、导管稳定性和围手术期并发症方面没有观察到差异。

结论：与 AF-CB4 相比，新型 POLARx 显示出相似的安全性和有效性。使用 POLARx 观察到更高的实时 PV 记录率和显着降低的最低球囊温度。