Background: Catheter ablation for ventricular tachycardia (VT) reduces the recurrence of VT in patients with implanted cardioverter-defibrillators (ICDs). The appropriate timing of VT ablation and its effects on mortality and heart failure progression remain a matter of debate. In patients with life-threatening arrhythmias necessitating ICD implantation, we compared outcomes of preventive VT ablation (undertaken before ICD implantation in order to prevent ICD shocks for VT) and deferred ablation after three ICD shocks for VT. Methods: The Preventive Ablation of Ventricular Tachycardia in Patients with Myocardial Infarction (BERLIN VT) study was a prospective, open, parallel, randomized trial performed at 26 centers. Patients with stable ischemic cardiomyopathy, a left ventricular ejection fraction between 30% and 50%, and documented VT were randomly assigned 1:1 to a preventive or deferred ablation strategy. The primary outcome was a composite of all-cause death and unplanned hospitalization for either symptomatic ventricular arrhythmia or worsening heart failure. Secondary outcomes included sustained ventricular tachyarrhythmia and appropriate ICD therapy. We hypothesized that preventive ablation strategy would be superior to deferred ablation strategy in the intention-to-treat population. Results: During a mean follow-up of 396{plus minus}284 days, the primary endpoint occurred in 25 (32.9%) of 76 patients in the preventive ablation group and 23 (27.7%) of 83 patients in the deferred ablation group (hazard ratio, 1.09; 95% CI, 0.62-1.92; P=0.77). Using prespecified criteria for interim analyses, the study was terminated early for futility. In the preventive versus deferred ablation group, six versus two patients died (7.9% vs. 2.4%; P=0.18), eight versus two patients were admitted for worsening heart failure (10.4% vs. 2.3%; P=0.062), and 15 versus 21 patients were hospitalized for symptomatic ventricular arrhythmia (19.5% vs. 25.3%; P=0.27). Among secondary outcomes, the proportions of patients with sustained ventricular tachyarrhythmia (39.7% vs. 48.2%; P=0.050) and appropriate ICD therapy (34.2% vs. 47.0%; P=0.030) were numerically reduced in the preventive ablation group. Conclusions: Preventive VT ablation before ICD implantation did not reduce mortality or hospitalization for arrhythmia or worsening heart failure during 1 year of follow-up when compared to the deferred ablation strategy. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02501005.

中文翻译：

---

缺血性心肌病和植入式除颤器 (BERLIN VT) 患者室性心动过速的预防性或延迟消融：一项多中心随机试验。

背景：室性心动过速 (VT) 的导管消融减少了植入式心律转复除颤器 (ICD) 患者的 VT 复发。VT 消融的适当时机及其对死亡率和心力衰竭进展的影响仍然存在争议。在需要植入 ICD 的危及生命的心律失常患者中，我们比较了预防性 VT 消融（在 ICD 植入前进行以防止 VT 引起 ICD 电击）和在 3 次 ICD 电击后延迟消融治疗 VT 的结果。方法：心肌梗死患者室性心动过速的预防性消融 (BERLIN VT) 研究是一项在 26 个中心进行的前瞻性、开放、平行、随机试验。稳定型缺血性心肌病患者，左心室射血分数在 30% 至 50% 之间，和记录的 VT 以 1:1 的比例随机分配到预防性或延迟消融策略。主要结局是全因死亡和因症状性室性心律失常或心力衰竭恶化而意外住院的复合结局。次要结果包括持续的室性快速性心律失常和适当的 ICD 治疗。我们假设在意向治疗人群中预防性消融策略优于延迟消融策略。结果：在平均 396{加减}284 天的随访期间，主要终点发生在预防性消融组 76 名患者中的 25 名（32.9%）和延迟消融组 83 名患者中的 23 名（27.7%）（风险比，1.09；95% CI，0.62-1.92；P=0.77）。使用预先指定的中期分析标准，该研究因无效而提前终止。在预防性消融组与延迟消融组中，6 对 2 名患者死亡（7.9% 对 2.4%；P=0.18），8 对 2 名患者因心力衰竭恶化而入院（10.4% 对 2.3%；P=0.062），以及15 名与 21 名患者因症状性室性心律失常住院（19.5% 与 25.3%；P=0.27）。在次要结果中，预防性消融组持续性室性心律失常（39.7% 对 48.2%；P=0.050）和适当 ICD 治疗（34.2% 对 47.0%；P=0.030）的患者比例在数值上有所降低。结论：与延迟消融策略相比，ICD 植入前预防性 VT 消融在 1 年随访期间并未降低死亡率或因心律失常或心力衰竭恶化而住院。临床试验注册：网址：https://www.clinicaltrials.gov。唯一标识符：