Borzov Egor, Efraim Roi, Suleiman Mahmoud, Bar-Deroma Raquel, Billan Salem, Xie Jingyang, Hohmann Stephan, Blanck Oliver, Charas Tomer
Department of Radiotherapy, Rambam Health Care Campus, Haifa, Israel.
Department of Radiation Oncology, University Medical Center Schleswig-Holstein, Kiel, Germany.
Strahlenther Onkol. 2025 Feb;201(2):126-134. doi: 10.1007/s00066-024-02300-z. Epub 2024 Sep 16.
Ventricular tachycardia (VT) is a life-threatening arrhythmia originating from the heart's ventricles. Traditional treatments include antiarrhythmic medications, implantable cardioverter-defibrillators (ICDs), and catheter ablation. Stereotactic body radiation therapy (SBRT) targeting the arrhythmogenic focus in the left ventricle-stereotactic arrhythmia radioablation (STAR)-is an emerging treatment and may offer a potential solution for patients with refractory VT.
We designed an interventional prospective clinical trial in Israel aligned with the STOPSTORM.eu consortium's benchmarks, recommendations, and directives to assess the safety and efficacy of STAR in patients with refractory VT.
Our phase I/II single-institutional trial was approved by the Ministry of Health of Israel for 10 patients, initially assessing safety in the first 3 patients. We included patients with ICDs experiencing symptomatic monomorphic VT after an inadequate response to previous therapies. The primary endpoints were treatment-related serious adverse events and a reduction in VT burden as assessed by ICD interrogation. Secondary outcomes included a reduction in antiarrhythmic medications and changes in quality of life.
From August 2023 to August 2024, 3 patients underwent STAR treatment. The prescription dose was a single fraction of 25 Gy. Planning target volumes were 47.8, 49.7, and 91.8 cc, and treatment was successfully delivered with no grade 3 or higher adverse events reported. Over a follow-up period of 12 months for the first patient and 8 months for the second one, no VT events were recorded after treatment. The third patient died from progressive heart failure 3 months after treatment. Left ventricular ejection fraction remained stable, and no significant radiation-induced inflammatory changes were noted.
The initial results of this trial suggest that STAR can reduce VT episodes in patients with refractory VT without severe adverse effects. The study highlights the importance of international collaboration and standardization in pioneering new treatments. Further follow-up and additional patient data will be necessary to confirm these findings and evaluate long-term outcomes, including potential adjustments to antiarrhythmic medication regimens.
室性心动过速（VT）是一种起源于心室的危及生命的心律失常。传统治疗方法包括抗心律失常药物、植入式心脏复律除颤器（ICD）和导管消融。针对左心室致心律失常灶的立体定向体部放射治疗（SBRT）——立体定向心律失常射频消融（STAR）——是一种新兴的治疗方法，可能为难治性VT患者提供潜在的解决方案。
我们在以色列设计了一项介入性前瞻性临床试验，符合STOPSTORM.eu联盟的基准、建议和指令，以评估STAR对难治性VT患者的安全性和有效性。
我们的I/II期单机构试验获得了以色列卫生部的批准，纳入10名患者，最初评估前3名患者的安全性。我们纳入了植入ICD且在先前治疗反应不佳后出现症状性单形性VT的患者。主要终点是与治疗相关的严重不良事件以及通过ICD问询评估的VT负荷降低。次要结局包括抗心律失常药物的减少和生活质量的变化。
2023年8月至2024年8月，3名患者接受了STAR治疗。处方剂量为单次25 Gy。计划靶体积分别为47.8、49.7和91.8 cc，治疗成功实施，未报告3级或更高等级的不良事件。第一名患者随访12个月，第二名患者随访8个月，治疗后未记录到VT事件。第三名患者在治疗后3个月死于进行性心力衰竭。左心室射血分数保持稳定，未观察到明显的辐射诱导炎症变化。
该试验的初步结果表明，STAR可减少难治性VT患者的VT发作，且无严重不良反应。该研究强调了国际合作和标准化在开拓新治疗方法中的重要性。需要进一步随访和更多患者数据来证实这些发现并评估长期结局，包括对抗心律失常药物治疗方案的潜在调整。
