Association of Surgical Hematoma Evacuation vs Conservative Treatment With Functional Outcome in Patients With Cerebellar Intracerebral Hemorrhage,JAMA

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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

Department of Neurology, University of Erlangen-Nuremberg, Erlangen, Germany.
Department of Neurology, Massachusetts General Hospital, Boston.
Hemorrhagic Stroke Research Program, J. Philip Kistler Stroke Research Center, Boston, Massachusetts.
Department of Neurology, Yale University School of Medicine, New Haven, Connecticut.
Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
German Centre for Cardiovascular Research (DZHK), Berlin, Germany.
German Center for Neurodegenerative Diseases (DZNE), partner site Berlin, Berlin, Germany.
Department of Neurology, University of Würzburg, Würzburg, Germany.
Department of Neurosurgery, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany.
Department of Neurology, Alfried Krupp Krankenhaus Essen, Essen, Germany.
Department of Neurology, Community Hospital Nuremberg, Nuremberg, Germany.
Department of Neurology and Neurogeriatry, Johannes Wesling Medical Center Minden, UK RUB, Minden, Germany.
Department of Neurosurgery, Johannes Wesling Medical Center Minden, UK RUB, Minden, Germany.
Department of Neurology, University of Cologne, Cologne, Germany.
Department of Neurology, University of Münster, Münster, Germany.
Department of Neurology, Community Hospital Helios Klinikum Berlin-Buch, Berlin, Germany.
Department of Neurology, University of Dresden, Dresden, Germany.
Department of Neurology, Klinikum Augsburg, Augsburg, Germany.
Department of Neurology, University of Ulm, Ulm, Germany.
Department of Neurology, Community Hospital Asklepios Klinik Hamburg Altona, Hamburg, Germany.
Department of Neurology, Community Hospital Klinikum Dortmund, Dortmund, Germany.
Department of Neurology, Community Hospital Klinikum Stuttgart, Stuttgart, Germany.
Department of Neurology, University of Leipzig, Leipzig, Germany.
Department of Neurology, Community Hospital Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen, Germany.
Department of Neurology, Community Hospital Klinikum Koblenz, Koblenz, Germany.
Department of Neurology, Community Hospital Bad Hersfeld, Bad Hersfeld, Germany.
Department of Neurology, University of Jena, Jena, Germany.
Department of Neurology and Neurological Rehabilitation, Bezirkskrankenhaus Günzburg, Günzburg, Germany.
Department of Neuroradiology, University of Erlangen-Nuremberg, Erlangen, Germany.
Department of Neurology and Rehabilitation, University of Illinois College of Medicine, Chicago.
Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, Ohio.

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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