Department of Cardiac Electrophysiology and Arrhythmology, San Raffaele University Hospital, Milan, Italy (P.D.B., F.B., P.V., G.P., A.R.).
Cardiology Department, Ospedale di Desio, Italy (P.B., S.A.R.).
Circulation. 2022 Jun 21;145(25):1829-1838. doi: 10.1161/CIRCULATIONAHA.122.059598. Epub 2022 Apr 3.
Optimal timing for catheter ablation of ventricular tachycardia is an important unresolved issue. There are no randomized trials evaluating the benefit of ablation after the first implantable cardioverter defibrillator (ICD) shock.
We conducted a 2-phase, prospective, multicenter, randomized clinical trial. Patients with ischemic or nonischemic dilated cardiomyopathy and primary or secondary prevention indication for ICD were enrolled in an initial observational phase until first appropriate shock (phase A). After reconsenting, patients were randomly assigned 1:1 in phase B to immediate ablation (within 2 months from shock delivery) or continuation of standard therapy. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure. Amiodarone intake was not allowed except for documented atrial tachyarrhythmias. On July 23, 2021, phase B of the trial was interrupted as a result of the first interim analysis on the basis of the Bayesian adaptive design.
Of the 517 patients enrolled in phase A, 154 (30%) had ventricular tachycardia, 56 (11%) received an appropriate shock over a median follow-up of 2.4 years (interquartile range, 1.4-4.4), and 47 of 56 (84%) agreed to participate in phase B. After 24.2 (8.5-24.4) months, the primary end point occurred in 1 of 23 (4%) patients in the ablation group and 10 of 24 (42%) patients in the control group (hazard ratio, 0.11 [95% CI, 0.01-0.85]; =0.034). The results met the prespecified termination criterion of >99% Bayesian posterior probability of superiority of treatment over standard therapy. No deaths were observed in the ablation group versus 8 deaths (33%) in the control group (=0.004); there was 1 worsening heart failure hospitalization in the ablation group (4%) versus 4 in the control group (17%; =0.159). ICD shocks were less frequent in the ablation group (9%) than in the control group (42%; =0.039).
Ventricular tachycardia ablation after first appropriate shock was associated with a reduced risk of the combined death or worsening heart failure hospitalization end point, lower mortality, and fewer ICD shocks. These findings provide support for considering ventricular tachycardia ablation after the first ICD shock.
URL: https://www.
gov; Unique identifier: NCT01547208.
室性心动过速导管消融的最佳时机是一个未解决的重要问题。目前尚无随机试验评估首次植入式心脏复律除颤器（ICD）电击后消融的益处。
我们进行了两阶段、前瞻性、多中心、随机临床试验。患有缺血性或非缺血性扩张型心肌病以及原发性或继发性 ICD 适应证的患者纳入初始观察阶段，直到首次出现适当的电击（阶段 A）。重新同意后，患者在阶段 B 中按 1:1 随机分配至即刻消融（电击后 2 个月内）或继续标准治疗。主要终点是任何原因死亡或因心力衰竭恶化而住院的复合终点。除了记录的房性心动过速外，不允许使用胺碘酮。2021 年 7 月 23 日，由于基于贝叶斯自适应设计的首次中期分析，试验的阶段 B 被中断。
在阶段 A 中纳入的 517 例患者中，154 例（30%）患有室性心动过速，56 例（11%）在中位随访 2.4 年（四分位距，1.4-4.4）期间接受了适当的电击，其中 56 例的 47 例（84%）同意参加阶段 B。24.2（8.5-24.4）个月后，消融组的 1 例（4%）患者和对照组的 10 例（42%）患者发生了主要终点事件（风险比，0.11[95%CI，0.01-0.85]；=0.034）。结果满足治疗优于标准治疗的 99%贝叶斯后验概率 >99%的预设终止标准。消融组无死亡（0%），对照组有 8 例死亡（33%）（=0.004）；消融组有 1 例因心力衰竭恶化住院（4%），对照组有 4 例（17%）（=0.159）。消融组 ICD 电击频率较低（9%），对照组（42%）较高（=0.039）。
首次适当电击后行室性心动过速消融与降低死亡或心力衰竭恶化住院终点的风险、降低死亡率和减少 ICD 电击相关。这些发现为考虑在首次 ICD 电击后行室性心动过速消融提供了支持。
网址：https://www.
gov；唯一标识符：NCT01547208。
