Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.
Medical University of Lodz, Łódź, Poland.
J Interv Card Electrophysiol. 2024 Apr;67(3):493-501. doi: 10.1007/s10840-023-01582-0. Epub 2023 Jul 28.
Cryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized.
Patients with AF were enrolled in the Cryo Global Registry (NCT02752737) from May 2016 to Sept 2021 at 128 sites in 37 countries and treated with cryoballoon ablation according to local clinical practice. Baseline patient and procedural characteristics were summarized for 8 regions (Central Asia & Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Serious procedure-related adverse events (SAEs) were evaluated in a subset of patients with ≥ 7 days of follow-up.
A total of 3,680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was commonly performed in patients with paroxysmal AF. Mean age ranged from 47 ± 12 years in the Middle East to 64 ± 11 years in East Asia. Mean procedure time was ≤ 95 min in all regions. Average freeze duration ranged from 153 ± 41 s in Southeast Asia to 230 ± 29 s in Central Asia & Russia. Acute procedural success was ≥ 94.7% in all geographies. In 3,126 subjects with ≥ 7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%) and remained low in all regions. One procedure-related death was reported during data collection.
Despite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation was performed with high acute success and short procedural times around the world.
冷冻球囊消融术是一种成熟的解剖学方法，用于治疗心房颤动（AF）患者的肺静脉隔离（PVI）。尽管该技术已被广泛采用，但在护理标准方面的区域差异尚未得到充分描述。
从 2016 年 5 月至 2021 年 9 月，在 37 个国家的 128 个地点，根据当地临床实践，对符合条件的 AF 患者进行 Cryo Global Registry（NCT02752737）登记，并使用冷冻球囊消融术进行治疗。总结了 8 个地区（中亚和俄罗斯、东亚、欧洲、中东、北美、南非、南美和东南亚）的患者基线特征和手术特征。对≥7 天随访的部分患者进行严重手术相关不良事件（SAE）评估。
共纳入 3680 例接受初始 PVI 的 AF 患者。冷冻球囊消融术常用于治疗阵发性 AF 患者。中东地区患者的平均年龄为 47±12 岁，东亚地区患者的平均年龄为 64±11 岁。所有地区的平均手术时间均≤95 分钟。平均冷冻时间在东南亚为 153±41 秒，在中亚和俄罗斯为 230±29 秒。所有地区的即刻手术成功率均≥94.7%。在 3126 例随访≥7 天的患者中，111 例（3.6%）报告了 122 例与手术相关的 SAE，所有地区的 SAE 发生率均较低。在数据收集期间报告了 1 例与手术相关的死亡。
尽管在患者选择和手术特征方面存在区域性差异，但全球范围内使用冷冻球囊消融术进行 PVI 操作具有较高的即刻成功率和较短的手术时间。
