Imperial College London, London, UK.
Imperial Clinical Trials Unit, Imperial College London, London, UK.
Am Heart J. 2019 Aug;214:36-45. doi: 10.1016/j.ahj.2019.04.015. Epub 2019 May 3.
Atrial Fibrillation (AF) ablation using the cryoballoon is effective at reducing symptomatic AF episodes. The prevalence of AF is increasing with the aging population and access to such treatment would be enhanced by reducing the resource requirements. Relinquishing electrical mapping of the pulmonary veins (PV) removes the need for PV catheters, electrical recording equipment and staff trained in using this equipment. Moreover, the majority of complications are peri-procedural so overnight hospitalization maybe unnecessary. We tested this streamlined approach to AF ablation against medical therapy using the endpoint of time to all hospital episodes. METHODS: The AVATAR-AF study is a prospective, multicenter, randomized controlled trial testing the primary hypothesis that AF ablation done without PV mapping or overnight hospitalization is more effective than anti-arrhythmic drugs at reducing all hospital episodes related to recurrent atrial arrhythmias. We included a third arm to test a secondary hypothesis that confirming PV entrance block as per consensus guidelines can improve outcomes. Three hundred twenty-one patients with documented paroxysmal AF will be randomized in a 1:1:1 manner to one of three investigation arms: (1) AVATAR protocol cryoballoon ablation without assessment of acute PV isolation or overnight hospitalization; (2) medical therapy with anti-arrhythmic drugs; or (3) conventional cryoballoon ablation with assessment of acute PV isolation. The primary endpoint is defined as the time to all hospital episodes (including outpatient consultation) related to treatment for atrial arrhythmia. CONCLUSION: The AVATAR-AF study will determine whether the resource utilization for AF ablation can be reduced whilst maintaining superiority over medical therapy.
心房颤动（AF）消融使用冷冻球囊可有效减少有症状的 AF 发作。随着人口老龄化和这种治疗方法的普及，减少资源需求将提高其可及性。放弃肺静脉（PV）的电描记法可以消除对 PV 导管、电记录设备和接受过使用这种设备培训的人员的需求。此外，大多数并发症是围手术期的，因此可能不需要过夜住院。我们测试了这种简化的 AF 消融方法，将其与使用与复发性心房心律失常相关的所有住院发作的终点的药物治疗进行比较。方法：AVATAR-AF 研究是一项前瞻性、多中心、随机对照试验，旨在检验主要假设，即不进行 PV 描记或不进行过夜住院的 AF 消融在减少与复发性心房心律失常相关的所有住院发作方面比抗心律失常药物更有效。我们还设置了第三个试验组，以检验次要假设，即按照共识指南确认 PV 入口阻滞可以改善结果。将 321 例有记录的阵发性 AF 患者以 1:1:1 的比例随机分配到三个试验组之一：（1）AVATAR 方案冷冻球囊消融，不评估急性 PV 隔离或过夜住院；（2）抗心律失常药物治疗；或（3）常规冷冻球囊消融，评估急性 PV 隔离。主要终点定义为与心房心律失常治疗相关的所有住院发作（包括门诊咨询）的时间。结论：AVATAR-AF 研究将确定是否可以在保持优于药物治疗的情况下减少 AF 消融的资源利用。
