The University of Chicago, Center for Arrhythmia Care, Pritzker School of Medicine, IL (R.T., D.Y.S., S.A.B.).
Guangdong Provincial People's Hospital, China (R.T., Y.X., H.L.).
Circulation. 2022 Jun 21;145(25):1839-1849. doi: 10.1161/CIRCULATIONAHA.122.060039. Epub 2022 May 4.
Catheter ablation as first-line therapy for ventricular tachycardia (VT) at the time of implantable cardioverter defibrillator (ICD) implantation has not been adopted into clinical guidelines. Also, there is an unmet clinical need to prospectively examine the role of VT ablation in patients with nonischemic cardiomyopathy, an increasingly prevalent population that is referred for advanced therapies globally.
We conducted an international, multicenter, randomized controlled trial enrolling 180 patients with cardiomyopathy and monomorphic VT with an indication for ICD implantation to assess the role of early, first-line ablation therapy. A total of 121 patients were randomly assigned (1:1) to ablation plus an ICD versus conventional medical therapy plus an ICD. Patients who refused ICD (n=47) were followed in a prospective registry after stand-alone ablation treatment. The primary outcome was a composite end point of VT recurrence, cardiovascular hospitalization, or death.
Randomly assigned patients had a mean age of 55 years (interquartile range, 46-64) and left ventricular ejection fraction of 40% (interquartile range, 30%-49%); 81% were male. The underlying heart disease was ischemic cardiomyopathy in 35%, nonischemic cardiomyopathy in 30%, and arrhythmogenic cardiomyopathy in 35%. Ablation was performed a median of 2 days before ICD implantation (interquartile range, 5 days before to 14 days after). At 31 months, the primary outcome occurred in 49.3% of the ablation group and 65.5% in the control group (hazard ratio, 0.58 [95% CI, 0.35-0.96]; =0.04). The observed difference was driven by a reduction in VT recurrence in the ablation arm (hazard ratio, 0.51 [95%CI, 0.29-0.90]; =0.02). A statistically significant reduction in both ICD shocks (10.0% versus 24.6%; =0.03) and antitachycardia pacing (16.2% versus 32.8%; =0.04) was observed in patients who underwent ablation compared with control. No differences in cardiovascular hospitalization (32.0% versus. 33.7%; hazard ratio, 0.82 [95% CI, 0.43-1.56]; =0.55) or mortality (8.9% versus 8.8%; hazard ratio, 1.40 [95% CI, 0.38-5.22]; =0.62]) were observed. Ablation-related complications occurred in 8.3% of patients.
Among patients with cardiomyopathy of varied causes, early catheter ablation performed at the time of ICD implantation significantly reduced the composite primary outcome of VT recurrence, cardiovascular hospitalization, or death. These findings were driven by a reduction in ICD therapies.
URL: https://www.
gov; Unique identifier: NCT02848781.
在植入式心脏复律除颤器（ICD）植入时，导管消融作为室性心动过速（VT）的一线治疗方法尚未被纳入临床指南。此外，对于非缺血性心肌病患者，前瞻性检查 VT 消融的作用存在未满足的临床需求，此类患者在全球范围内被转诊接受高级治疗，其人群数量不断增加。
我们开展了一项国际性、多中心、随机对照试验，纳入了 180 例有 ICD 植入适应证的心肌病和单形性 VT 患者，以评估早期一线消融治疗的作用。共有 121 例患者被随机（1:1）分配至消融加 ICD 组或常规药物治疗加 ICD 组。47 例拒绝 ICD 的患者在接受单独消融治疗后，前瞻性注册随访。主要终点是 VT 复发、心血管住院或死亡的复合终点。
随机分配的患者平均年龄为 55 岁（四分位距 46-64 岁），左心室射血分数为 40%（四分位距 30%-49%）；81%为男性。基础心脏病为缺血性心肌病占 35%，非缺血性心肌病占 30%，心律失常性心肌病占 35%。消融在 ICD 植入前中位数 2 天（四分位距 5 天前至 14 天后）进行。31 个月时，消融组的主要终点发生率为 49.3%，对照组为 65.5%（风险比，0.58[95%CI，0.35-0.96]；=0.04）。观察到的差异主要是由于消融组 VT 复发减少（风险比，0.51[95%CI，0.29-0.90]；=0.02）。与对照组相比，接受消融治疗的患者 ICD 电击（10.0%比 24.6%；=0.03）和抗心动过速起搏（16.2%比 32.8%；=0.04）均显著减少。心血管住院（32.0%比 33.7%；风险比，0.82[95%CI，0.43-1.56]；=0.55）或死亡率（8.9%比 8.8%；风险比，1.40[95%CI，0.38-5.22]；=0.62）无差异。8.3%的患者发生与消融相关的并发症。
在不同病因的心肌病患者中，在 ICD 植入时进行早期导管消融显著降低了 VT 复发、心血管住院或死亡的复合主要终点。这些发现是由 ICD 治疗的减少所驱动的。
网址：https://www.
gov；唯一标识符：NCT02848781。
