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立体定向心动过速射频消融术(STAR)——代表STOPSTORM.eu联盟对前瞻性试验进行的系统评价和荟萃分析。

Stereotactic arrhythmia radioablation (STAR)-A systematic review and meta-analysis of prospective trials on behalf of the STOPSTORM.eu consortium.

作者信息

Miszczyk Marcin, Hoeksema Wiert F, Kuna Kasper, Blamek Sławomir, Cuculich Phillip S, Grehn Melanie, Molon Giulio, Nowicka Zuzanna, van der Ree Martijn H, Robinson Clifford G, Sajdok Mateusz, Verhoeff Joost J C, Postema Pieter G, Blanck Oliver

机构信息

Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Collegium Medicum - Faculty of Medicine, WSB University, Dąbrowa Górnicza, Poland.

Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam UMC Location University of Amsterdam, Amsterdam Cardiovascular Sciences, Heart Failure & Arrhythmias, Amsterdam, The Netherlands.

出版信息

Heart Rhythm. 2025 Jan;22(1):80-89. doi: 10.1016/j.hrthm.2024.07.029. Epub 2024 Jul 18.

Abstract

Stereotactic arrhythmia radioablation (STAR) is a noninvasive treatment of refractory ventricular tachycardia (VT). In this study, we aimed to systematically review prospective trials on STAR and pool harmonized outcome measures in a meta-analysis. After registration in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42023439666), we searched OVID Medline, OVID Embase, Web of Science Core Collection, the Cochrane Central Register of Controlled Trials, and Google Scholar on November 9, 2023, to identify reports describing results of prospective trials evaluating STAR for VT. Risk of bias was assessed using the Risk Of Bias In Non-randomized Studies of Interventions tool. Meta-analysis was performed using generalized linear mixed models. We identified 10 prospective trials in which 82 patients were treated with STAR between 2016 and 2022. The 90-day rate of treatment-related grade ≥3 adverse events was 0.10 (95% confidence interval [CI] 0.04-0.2). The proportions of patients achieving given VT burden reductions were 0.61 (95% CI 0.45-0.74) for ≥95%, 0.80 (95% CI 0.62-0.91) for ≥75%, and 0.9 (95% CI 0.77-0.96) for ≥50% in 63 evaluable patients. The 1-year overall survival rate was 0.73 (95% CI 0.61-0.83) in 81 patients, 1-year freedom from recurrence was 0.30 (95% CI 0.16-0.49) in 61 patients, and 1-year recurrence-free survival was 0.21 in 60 patients (95% CI 0.08-0.46). Limitations include methodological heterogeneity across studies and moderate to significant risk of bias. In conclusion, STAR is a promising treatment method, characterized by moderate toxicity. We observed 1-year mortality of ≈27% in this population of critically ill patients suffering from refractory VT. Most patients experience a significant reduction in VT burden; however, 1-year recurrence rates are high. STAR should still be considered an investigational approach and recommended to patients primarily within the context of prospective trials.

摘要

立体定向心律失常射频消融术(STAR)是一种用于治疗难治性室性心动过速(VT)的非侵入性治疗方法。在本研究中,我们旨在系统回顾关于STAR的前瞻性试验,并在荟萃分析中汇总统一的结局指标。在国际前瞻性系统评价注册库(PROSPERO:CRD42023439666)注册后,我们于2023年11月9日检索了OVID Medline、OVID Embase、Web of Science核心合集、Cochrane对照试验中央注册库和谷歌学术,以识别描述评估STAR治疗VT的前瞻性试验结果的报告。使用干预性非随机研究中的偏倚风险工具评估偏倚风险。采用广义线性混合模型进行荟萃分析。我们确定了10项前瞻性试验,在2016年至2022年期间,有82例患者接受了STAR治疗。治疗相关≥3级不良事件的90天发生率为0.10(95%置信区间[CI]0.04 - 0.2)。在63例可评估患者中,实现特定室性心动过速负荷降低的患者比例分别为:≥95%降低的比例为0.61(95%CI 0.45 - 0.74),≥75%降低的比例为0.80(95%CI 0.62 - 0.91),≥50%降低的比例为0.9(95%CI 0.77 - 0.96)。81例患者的1年总生存率为0.73(95%CI 0.61 - 0.83),61例患者的1年无复发率为0.30(95%CI 0.16 - 0.49),60例患者的1年无复发生存率为0.21(95%CI 0.08 - 0.46)。局限性包括各研究间的方法学异质性以及中度至显著的偏倚风险。总之,STAR是一种有前景的治疗方法,具有中度毒性。在这群患有难治性室性心动过速的重症患者中,我们观察到1年死亡率约为27%。大多数患者的室性心动过速负荷显著降低;然而,1年复发率很高。STAR仍应被视为一种研究性方法,主要在临床试验的背景下推荐给患者。

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