非侵入性立体定向心律失常放射治疗室性心动过速：前瞻性 STARNL-1 试验结果。
Non-invasive stereotactic arrhythmia radiotherapy for ventricular tachycardia: results of the prospective STARNL-1 trial.
机构信息
Amsterdam UMC location University of Amsterdam, Department of Cardiology, Meibergdreef 9, Amsterdam, the Netherlands.
Amsterdam Cardiovascular Sciences, Heart Failure and arrhythmias, Amsterdam, the Netherlands.
出版信息
Europace. 2023 Mar 30;25(3):1015-1024. doi: 10.1093/europace/euad020.
AIMS
Stereotactic arrhythmia radiotherapy (STAR) is suggested as potentially effective and safe treatment for patients with therapy-refractory ventricular tachycardia (VT). However, the current prospective knowledge base and experience with STAR is limited. In this study we aimed to prospectively evaluate the efficacy and safety of STAR.
METHODS AND RESULTS
The StereoTactic Arrhythmia Radiotherapy in the Netherlands no.1 was a pre-post intervention study to prospectively evaluate efficacy and safety of STAR. In patients with therapy-refractory VT, the pro-arrhythmic region was treated with a 25 Gy single radiotherapy fraction. The main efficacy measure was a reduction in the number of treated VT-episodes by ≥50%, comparing the 12 months before and after treatment (or end of follow-up, excluding a 6-week blanking period). The study was deemed positive when ≥50% of patients would meet this criterion. Safety evaluation included left ventricular ejection fraction, pulmonary function, and adverse events. Six male patients with an ischaemic cardiomyopathy were enrolled, and median age was 73 years (range 54-83). Median left ventricular ejection fraction was 38% (range 24-52). The median planning target volume was 187 mL (range 93-372). Four (67%) patients completed the 12-month follow-up, and two patients died (not STAR related) during follow-up. The main efficacy measure of ≥50% reduction in treated VT-episodes at the end of follow-up was achieved in four patients (67%). The median number of treated VT-episodes was reduced by 87%. No reduction in left ventricular ejection fraction or pulmonary function was observed. No treatment related serious adverse events occurred.
CONCLUSIONS
STAR resulted in a ≥ 50% reduction in treated VT-episodes in 4/6 (67%) patients. No reduction in cardiac and pulmonary function nor treatment-related serious adverse events were observed during follow-up.
CLINICAL TRIAL REGISTRATION
Netherlands Trial Register-NL7510.
目的
立体定向心律失常放疗（STAR）被认为是一种对治疗抵抗性室性心动过速（VT）患者有效且安全的治疗方法。然而，目前 STAR 的前瞻性知识基础和经验有限。本研究旨在前瞻性评估 STAR 的疗效和安全性。
方法和结果
荷兰 1 号立体定向心律失常放射治疗研究是一项干预前后的前瞻性研究，旨在评估 STAR 的疗效和安全性。在治疗抵抗性 VT 患者中，采用 25Gy 单次放疗剂量治疗促心律失常区域。主要疗效指标是治疗后 12 个月与治疗前（或排除 6 周空白期后的随访结束时）相比，VT 发作次数减少≥50%。当≥50%的患者符合这一标准时，研究被认为是阳性。安全性评估包括左心室射血分数、肺功能和不良事件。共纳入 6 名男性缺血性心肌病患者，中位年龄为 73 岁（范围 54-83 岁）。中位左心室射血分数为 38%（范围 24-52）。中位计划靶区体积为 187mL（范围 93-372）。4 名（67%）患者完成了 12 个月的随访，2 名患者在随访期间死亡（与 STAR 无关）。在随访结束时，≥50%的患者达到了治疗性 VT 发作次数减少≥50%的主要疗效指标。治疗性 VT 发作次数中位数减少了 87%。未观察到左心室射血分数或肺功能下降。未观察到与治疗相关的严重不良事件。
结论
STAR 使 6 名患者中的 4 名（67%）达到了治疗性 VT 发作次数减少≥50%。在随访期间，未观察到心脏和肺功能下降或与治疗相关的严重不良事件。
临床试验注册
荷兰临床试验注册中心-NL7510。
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