立体定向心律失常放射消融治疗难治性室性心动过速:STOPSTORM.eu研究
STOPSTORM是一项欧洲前瞻性多中心注册研究,纳入28个中心193例接受立体定向心律失常放射消融(STAR)的难治性室性心动过速(VT)患者,平均年龄68±9岁,88%男性,53%非缺血性心肌病,中位随访19个月。在107例可评估患者中,STAR后VT发作负荷中位数降低80%;生存≥6个月的患者中72%未发生ICD电击;12例严重不良事件被判定为可能或很可能与治疗相关;12个月总生存概率77%。结论认为STAR与VT负荷和ICD电击显著减少相关,治疗相关严重不良事件频率低。
要点
- STAR后VT发作负荷中位数降低80%。
- 生存≥6个月者72%未发生ICD电击。
- 12个月总生存概率77%,治疗相关严重不良事件12例。
核心结论
- 在迄今最大的前瞻性多中心队列中,STAR与VT负荷和ICD电击的大幅减少相关,可能或很可能与治疗相关的严重不良事件频率低。
研究设计与样本
- STOPSTORM为欧洲前瞻性、国际、多中心注册研究,纳入28个中心193例接受STAR的难治性VT患者,平均年龄68±9岁,88%男性,53%非缺血性心肌病,中位随访19个月。
主要发现
- 在107例随访≥6个月的可评估患者中,STAR后VT发作负荷中位数降低80%。
- 生存≥6个月的患者中72%未发生ICD电击。
- 全队列中12例严重不良事件被判定为可能或很可能与治疗相关,包括心包积液、冠状动脉事件和治疗后早期室性心律失常。
- 12个月总生存概率为77%。
以上解读依据论文摘要(全文未开放获取或许可不允许翻译转载)。
原文
BACKGROUND AND AIMS: Stereotactic arrhythmia radioablation (STAR) is increasingly used for refractory ventricular tachycardia (VT), yet prospective multicentre outcome data remain limited. Here, the planned interim analysis of the prospective Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary (STOPSTORM) registry is reported. METHODS: STOPSTORM is a European prospective, international, multicentre registry of patients treated with STAR. The primary efficacy endpoint was the change in sustained VT episode burden comparing the 6 months before versus the 6 months after STAR. The primary safety endpoint was the occurrence of serious adverse events (SAEs) adjudicated as possibly or probably treatment-related. Overall survival was assessed using time-to-event methods. RESULTS: Across 28 centres, 193 patients were included (mean age 68±9 years; 88% male; 53% non-ischaemic cardiomyopathy). Median follow-up was 19 months. Among 107 evaluable patients with ≥6-month follow-up, the median VT episode burden was reduced by 80% after STAR. Among patients surviving ≥6 months, 72% were free from implantable cardioverter-defibrillator (ICD) shock. In the full cohort, 12 SAEs were adjudicated as possibly or probably treatment-related, including pericardial effusion, coronary events, and early post-treatment ventricular arrhythmia. Overall survival probability was 77% at 12 months. CONCLUSIONS: In the largest prospective multicentre cohort reported to date, STAR was associated with a substantial reduction in VT burden and ICD shocks, with a low frequency of possibly or probably treatment-related SAEs.
引用
- van der Pol LHG, Tomasik B, Hoeksema WF, et al. Stereotactic arrhythmia radioablation for refractory ventricular tachycardia: the STOPSTORM.eu study. Eur Heart J. 2026. PMID: 42008523. doi:10.1093/eurheartj/ehag338
供执业医师工作参考,不替代临床判断;数值与分级以指南原文为准。