Department of Cardiology, Thorax Institute, Hospital Clínic de Barcelona, C/ Villarroel 170, 6° - Escala 3, 08036, University of Barcelona, Barcelona, Spain
Department of Cardiology, Thorax Institute, Hospital Clínic de Barcelona, C/ Villarroel 170, 6° - Escala 3, 08036, University of Barcelona, Barcelona, Spain.
Eur Heart J. 2014 Jun 7;35(22):1466-78. doi: 10.1093/eurheartj/ehu001. Epub 2014 Jan 31.
The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse how centres assess in routine clinical practice the success of the procedure and to evaluate the success rate and long-term safety/complications.
Seventy-two centres in 10 European countries were asked to enrol 20 consecutive patients undergoing a first AFib ablation procedure. A web-based case report form captured information on pre-procedural, procedural, and 1-year follow-up data. Between October 2010 and May 2011, 1410 patients were included and 1391 underwent an AFib ablation (98.7%). A total of 1300 patients (93.5%) completed a follow-up control 367 ± 42 days after the procedure. Arrhythmia documentation was done by an electrocardiogram in 76%, Holter-monitoring in 52%, transtelephonic monitoring in 8%, and/or implanted systems in 4.5%. Over 50% became asymptomatic. Twenty-one per cent were re-admitted due to post-ablation arrhythmias. Success without antiarrhythmic drugs was achieved in 40.7% of patients (43.7% in paroxysmal AF; 30.2% in persistent AF; 36.7% in long-lasting persistent AF). A second ablation was required in 18% of the cases and 43.4% were under antiarrhythmic treatment. Thirty-three patients (2.5%) suffered an adverse event, 272 (21%) experienced a left atrial tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause).
The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib in a real-world setting. The methods used to assess the success of the procedure appeared at least suboptimal. Even in this context, the 12-month success rate appears to be somewhat lower to the one reported clinical trials.
心房颤动消融先导研究是一项前瞻性登记研究，旨在描述在欧洲进行的心房颤动（AFib）消融患者的临床流行病学，并描述应用于欧洲的诊断/治疗过程。一年随访的目的是分析中心在常规临床实践中如何评估手术的成功率，并评估成功率和长期安全性/并发症。
10 个欧洲国家的 72 个中心被要求招募 20 例连续进行首次 AFib 消融术的患者。一个基于网络的病例报告表收集了术前、术中及 1 年随访的数据。2010 年 10 月至 2011 年 5 月，共纳入 1410 例患者，其中 1391 例行 AFib 消融术（98.7%）。共 1300 例患者（93.5%）在术后 367 ± 42 天完成了随访控制。心律失常记录通过心电图完成 76%，动态心电图监测完成 52%，远程监测完成 8%，植入系统完成 4.5%。超过 50%的患者无症状。21%的患者因消融后心律失常再次入院。无抗心律失常药物治疗的成功率为 40.7%（阵发性 AF 为 43.7%；持续性 AF 为 30.2%；持续性持久性 AF 为 36.7%）。18%的患者需要再次消融，43.4%的患者接受抗心律失常治疗。33 例（2.5%）发生不良事件，272 例（21%）发生左房性心动过速，4 例死亡（1 例出血性卒中，1 例缺血性心脏病伴心室颤动，1 例癌症，1 例原因不明）。
心房颤动消融先导研究提供了关于导管消融治疗心房颤动的流行病学、管理和结果的重要信息，在真实环境中。用于评估手术成功率的方法似乎至少不太理想。即使在这种情况下，12 个月的成功率似乎也略低于临床试验报告的成功率。
