University Heart Center Lübeck, Department of Rhythmology, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, D-23538 Lübeck, Germany.
German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.
Europace. 2023 Aug 2;25(9). doi: 10.1093/europace/euad248.
Catheter ablation with a cryoballoon (CB) provides effective and durable pulmonary vein (PV) isolation (PVI) associated with encouraging clinical outcome data. The novel POLARx CB incorporates unique features, which may translate into improved safety, efficacy, and outcomes. The ICE-AGE-1 study aimed to assess the efficacy, safety, and 1-year clinical follow-up of the POLARx CB in comparison to the Arctic Front Advance Pro CB (AF-CB4).
A total of 103 consecutive patients with paroxysmal or persistent atrial fibrillation (AF) who underwent POLARx-based PVI (POLARx group) were prospectively enrolled and were compared to 102 consecutive patients previously treated with the AF-CB4 (AF-CB4 group). The mean age was 68.7 ± 10.2 (POLARx) and 65.7 ± 12 (AF-CB4, P = 0.0551) years. A total of 412 (POLARx) and 404 (AF-CB4) PVs were identified. All PVs, except for one PV in the POLARx group, were successfully isolated. A significant difference regarding the mean minimal CB temperature reached using the POLARx CB (-56.1 ± 8.3°C) and AF-CB4 (-46.9 ± 10.1°C) was observed (P < 0.0001). Real-time PVI was visualized in 71% of PVs in the POLARx group and 46% of them in the AF-CB4 group (P < 0.001). The mean procedure time was comparable: 54.5 ± 17.1 min for POLARx and 59.4 ± 18.6 min for AF-CB4 (P = 0.0509). No differences were observed in terms of periprocedural complications. There were comparable rates in freedom of AF or atrial tachycardia recurrence after 12 months, beyond a 90-day long blanking period: 78.9% in the POLARx group vs. 77.2% in the AF-CB4 group (P = 0.804).
The novel POLARx CB showed similar safety, efficacy, and 1-year recurrence-free survival rates 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.
使用冷冻球囊导管（CB）进行导管消融可实现有效的、持久的肺静脉（PV）隔离（PVI），并带来令人鼓舞的临床结果数据。新型 POLARx CB 具有独特的特点，这可能转化为提高安全性、有效性和结果。ICE-AGE-1 研究旨在评估与北极前进步进 CB（AF-CB4）相比，基于 POLARx 的 PVI 中 POLARx CB 的疗效、安全性和 1 年临床随访结果。
共纳入 103 例阵发性或持续性心房颤动（AF）患者，前瞻性地接受基于 POLARx 的 PVI（POLARx 组），并与 102 例先前接受 AF-CB4 治疗的患者（AF-CB4 组）进行比较。平均年龄为 68.7±10.2 岁（POLARx 组）和 65.7±12 岁（AF-CB4 组，P=0.0551）。共识别出 412 个（POLARx 组）和 404 个（AF-CB4 组）PV。除了 POLARx 组中的一个 PV 外，所有的 PV 均成功隔离。使用 POLARx CB（-56.1±8.3°C）和 AF-CB4（-46.9±10.1°C）达到的平均最小 CB 温度有显著差异（P<0.0001）。在 POLARx 组中，71%的 PV 实时可视化，而在 AF-CB4 组中，46%的 PV 实时可视化（P<0.001）。平均手术时间相当：POLARx 组为 54.5±17.1 分钟，AF-CB4 组为 59.4±18.6 分钟（P=0.0509）。围手术期并发症无差异。在 90 天空白期后 12 个月，无 AF 或房性心动过速复发的自由率相当：POLARx 组为 78.9%，AF-CB4 组为 77.2%（P=0.804）。
与 AF-CB4 相比，新型 POLARx CB 具有相似的安全性、疗效和 1 年无复发生存率。与 AF-CB4 相比，使用 POLARx 时观察到实时电 PV 记录的比例更高，球囊温度显著更低。
