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Association of Surgical Hematoma Evacuation vs Conservative Treatment With Functional Outcome in Patients With Cerebellar Intracerebral Hemorrhage
JAMA ( IF 63.1 ) Pub Date : 2019-10-08 , DOI: 10.1001/jama.2019.13014
Joji B Kuramatsu 1 , Alessandro Biffi 2, 3 , Stefan T Gerner 1 , Jochen A Sembill 1 , Maximilian I Sprügel 1 , Audrey Leasure 4 , Lauren Sansing 4 , Charles Matouk 4 , Guido J Falcone 4 , Matthias Endres 5, 6, 7, 8 , Karl Georg Haeusler 5, 6, 9 , Jan Sobesky 5, 6 , Johannes Schurig 6 , Sarah Zweynert 5 , Miriam Bauer 6 , Peter Vajkoczy 10 , Peter A Ringleb 11 , Jan Purrucker 11 , Timolaos Rizos 11, 12 , Jens Volkmann 9 , Wolfgang Müllges 9 , Peter Kraft 9 , Anna-Lena Schubert 9 , Frank Erbguth 13 , Martin Nueckel 13 , Peter D Schellinger 14 , Jörg Glahn 14 , Ulrich J Knappe 15 , Gereon R Fink 16 , Christian Dohmen 16 , Henning Stetefeld 16 , Anna Lena Fisse 17 , Jens Minnerup 17 , Georg Hagemann 18 , Florian Rakers 18 , Heinz Reichmann 19 , Hauke Schneider 19, 20 , Jan Rahmig 19 , Albert Christian Ludolph 21 , Sebastian Stösser 21 , Hermann Neugebauer 9, 21 , Joachim Röther 22 , Peter Michels 22 , Michael Schwarz 23 , Gernot Reimann 23 , Hansjörg Bäzner 24 , Henning Schwert 24 , Joseph Claßen 25 , Dominik Michalski 25 , Armin Grau 26 , Frederick Palm 26 , Christian Urbanek 26 , Johannes C Wöhrle 27 , Fahid Alshammari 27 , Markus Horn 28 , Dirk Bahner 28 , Otto W Witte 29 , Albrecht Günther 29 , Gerhard F Hamann 30 , Manuel Hagen 1 , Sebastian S Roeder 1 , Hannes Lücking 31 , Arnd Dörfler 31 , Fernando D Testai 32 , Daniel Woo 33 , Stefan Schwab 1 , Kevin N Sheth 4 , Hagen B Huttner 1
Affiliation  

Importance The association of surgical hematoma evacuation with clinical outcomes in patients with cerebellar intracerebral hemorrhage (ICH) has not been established. Objective To determine the association of surgical hematoma evacuation with clinical outcomes in cerebellar ICH. Design, Setting, and Participants Individual participant data (IPD) meta-analysis of 4 observational ICH studies incorporating 6580 patients treated at 64 hospitals across the United States and Germany (2006-2015). Exposure Surgical hematoma evacuation vs conservative treatment. Main Outcomes and Measures The primary outcome was functional disability evaluated by the modified Rankin Scale ([mRS] score range: 0, no functional deficit to 6, death) at 3 months; favorable (mRS, 0-3) vs unfavorable (mRS, 4-6). Secondary outcomes included survival at 3 months and at 12 months. Analyses included propensity score matching and covariate adjustment, and predicted probabilities were used to identify treatment-related cutoff values for cerebellar ICH. Results Among 578 patients with cerebellar ICH, propensity score-matched groups included 152 patients with surgical hematoma evacuation vs 152 patients with conservative treatment (age, 68.9 vs 69.2 years; men, 55.9% vs 51.3%; prior anticoagulation, 60.5% vs 63.8%; and median ICH volume, 20.5 cm3 vs 18.8 cm3). After adjustment, surgical hematoma evacuation vs conservative treatment was not significantly associated with likelihood of better functional disability at 3 months (30.9% vs 35.5%; adjusted odds ratio [AOR], 0.94 [95% CI, 0.81 to 1.09], P = .43; adjusted risk difference [ARD], -3.7% [95% CI, -8.7% to 1.2%]) but was significantly associated with greater probability of survival at 3 months (78.3% vs 61.2%; AOR, 1.25 [95% CI, 1.07 to 1.45], P = .005; ARD, 18.5% [95% CI, 13.8% to 23.2%]) and at 12 months (71.7% vs 57.2%; AOR, 1.21 [95% CI, 1.03 to 1.42], P = .02; ARD, 17.0% [95% CI, 11.5% to 22.6%]). A volume range of 12 to 15 cm3 was identified; below this level, surgical hematoma evacuation was associated with lower likelihood of favorable functional outcome (volume ≤12 cm3, 30.6% vs 62.3% [P = .003]; ARD, -34.7% [-38.8% to -30.6%]; P value for interaction, .01), and above, it was associated with greater likelihood of survival (volume ≥15 cm3, 74.5% vs 45.1% [P < .001]; ARD, 28.2% [95% CI, 24.6% to 31.8%]; P value for interaction, .02). Conclusions and Relevance Among patients with cerebellar ICH, surgical hematoma evacuation, compared with conservative treatment, was not associated with improved functional outcome. Given the null primary outcome, investigation is necessary to establish whether there are differing associations based on hematoma volume.

中文翻译:

手术血肿清除与保守治疗与小脑脑出血患者功能结果的关系

重要性 手术血肿清除与小脑脑出血 (ICH) 患者临床结果的关系尚未确定。目的 确定手术血肿清除术与小脑脑出血临床结果的关系。设计、设置和参与者 对 4 项观察性 ICH 研究进行的个体参与者数据 (IPD) 荟萃分析,纳入了美国和德国 64 家医院治疗的 6580 名患者(2006-2015 年)。暴露手术血肿清除与保守治疗。主要结果和措施 主要结果是 3 个月时采用改良 Rankin 量表评估的功能障碍([mRS] 评分范围:0,无功能缺陷至 6,死亡);有利(mRS,0-3)与不利(mRS,4-6)。次要结局包括 3 个月和 12 个月的生存率。分析包括倾向评分匹配和协变量调整,并使用预测概率来确定小脑脑出血的治疗相关截止值。结果 在 578 名小脑 ICH 患者中,倾向评分匹配组包括 152 名接受手术血肿清除的患者和 152 名接受保守治疗的患者(年龄,68.9 岁 vs 69.2 岁;男性,55.9% vs 51.3%;既往抗凝治疗,60.5% vs 63.8%) ;以及中位 ICH 体积,20.5 cm3 vs 18.8 cm3)。调整后,手术血肿清除与保守治疗与 3 个月时更好的功能障碍的可能性没有显着相关(30.9% vs 35.5%;调整后的比值比 [AOR],0.94 [95% CI,0.81 至 1.09],P = . 43;调整后的风险差异 [ARD],-3.7% [95% CI,-8.7% 至 1.2%]),但与 3 个月时较高的生存概率显着相关(78.3% vs 61.2%;AOR,1.25 [95%] CI,1.07 至 1.45],P = 0.005;ARD,18.5% [95% CI,13.8% 至 23.2%]),12 个月时(71.7% vs 57.2%;AOR,1.21 [95% CI,1.03 至 1.42] ],P = .02;ARD,17.0% [95% CI,11.5% 至 22.6%])。确定体积范围为 12 至 15 cm3;低于此水平,手术血肿清除与良好功能结果的可能性较低相关(体积≤12 cm3,30.6% vs 62.3% [P = .003];ARD,-34.7% [-38.8% 至 -30.6%];P交互作用值,0.01)及以上,与更大的生存可能性相关(体积≥15 cm3,74.5% vs 45.1% [P < .001];ARD,28.2% [95% CI,24.6% 至 31.8] %];交互作用的 P 值,0.02)。结论和相关性 在小脑 ICH 患者中,与保守治疗相比,手术血肿清除与功能结果的改善无关。鉴于主要结果无效,有必要进行调查以确定是否存在基于血肿体积的不同关联。
更新日期:2019-10-08
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