Background Minimally invasive surgery (MIS) for spontaneous supratentorial intracerebral haemorrhage (ICH) is controversial but may be beneficial if end-of-treatment (EOT) haematoma volume is reduced to ≤15 mL. We explored whether MRI findings of cerebral small vessel disease (CSVD) modify the effect of MIS on long-term outcomes. Methods Prespecified blinded subgroup analysis of 288 subjects with qualified imaging sequences from the phase 3 Minimally Invasive Surgery Plus Alteplase for Intracerebral Haemorrhage Evacuation (MISTIE) trial. We tested for heterogeneity in the effects of MIS and MIS+EOT volume ≤15 mL on the trial’s primary outcome of good versus poor function at 1 year by the presence of single CSVD features and CSVD scores using multivariable models. Results Of 499 patients enrolled in MISTIE III, 288 patients had MRI, 149 (51.7%) randomised to MIS and 139 (48.3%) to standard medical care (SMC). Median (IQR) ICH volume was 42 (30–53) mL. In the full MRI cohort, there was no statistically significant heterogeneity in the effects of MIS versus SMC on 1-year outcomes by any specific CSVD feature or by CSVD scores (all Pinteraction >0.05). In 94 MIS patients with EOT ICH volume ≤15 mL, significant reduction in odds of poor outcome was found with cerebral amyloid angiopathy score <2 (OR, 0.14 (0.05–0.42); Pinteraction=0.006), absence of lacunes (OR, 0.37 (0.18–0.80); Pinteraction=0.02) and absence of severe white matter hyperintensities (WMHs) (OR, 0.22 (0.08–0.58); Pinteraction=0.03). Conclusions Following successful haematoma reduction by MIS, we found significantly lower odds of poor functional outcome with lower total burden of CSVD in addition to absence of lacunes and severe WMHs. CSVD features may have utility for prognostication and patient selection in clinical trials of MIS. Data are available upon reasonable request.

中文翻译：

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脑小血管疾病改变脑出血微创手术后的结果

背景 自发性幕上脑出血 (ICH) 的微创手术 (MIS) 存在争议，但如果治疗结束 (EOT) 血肿量减少至 ≤15 mL，则可能是有益的。我们探讨了脑小血管疾病 (CSVD) 的 MRI 结果是否会改变 MIS 对长期结果的影响。方法 对来自 3 期微创手术加阿替普酶脑内出血清除 (MISTIE) 试验的合格成像序列的 288 名受试者进行预先指定的盲法亚组分析。我们通过使用多变量模型，通过单一 CSVD 特征和 CSVD 评分的存在，测试了 MIS 和 MIS+EOT 体积≤15 mL 对一年时功能良好与不良功能的试验主要结果影响的异质性。结果 在参加 MISTIE III 的 499 名患者中，288 名患者进行了 MRI，149 名患者 (51.7%) 随机接受 MIS，139 名患者 (48.3%) 接受标准医疗护理 (SMC)。中位 (IQR) ICH 体积为 42 (30–53) mL。在完整的 MRI 队列中，通过任何特定的 CSVD 特征或 CSVD 评分，MIS 与 SMC 对 1 年结果的影响不存在统计学上显着的异质性（所有 Pinteraction > 0.05）。在 94 名 EOT ICH 体积≤15 mL 的 MIS 患者中，脑淀粉样血管病评分 <2（OR，0.14（0.05–0.42）；Pinteraction=0.006）、无腔隙（OR，0.37）时，不良结果的几率显着降低。 （0.18–0.80）；Pinteraction=0.02）并且不存在严重的白质高信号（WMH）（OR，0.22（0.08–0.58）；Pinteraction=0.03）。结论 在通过 MIS 成功减少血肿后，我们发现除了没有腔隙和严重的 WMH 之外，功能结果不佳的几率也显着降低，脑小血管病的总负担也较低。CSVD 特征可能对 MIS 临床试验中的预测和患者选择有用。数据可根据合理要求提供。