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Treatment and Outcome of Hemorrhagic AHA/ASA Scientific Statement Treatment and Outcome of Hemorrhagic Transformation After Intravenous Alteplase in Acute Ischemic Stroke A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. The American Association of Neurological Surgeons/Congress of Neurological Surgeons Joint Cerebrovascular Section affirms the educational benefit of this document. Shadi Yaghi, MD, Chair; Joshua Z. Willey, MD, MS, FAHA, Vice Chair; Brett Cucchiara, MD, FAHA; Joshua N. Goldstein, MD, PhD, FAHA; Nicole R. Gonzales, MD; Pooja Khatri, MD, MSc, FAHA; Downloaded from Louis J. Kim, MD; Stephan A. Mayer, MD, FAHA; Kevin N. Sheth, MD, FAHA; Lee H. Schwamm, MD, FAHA; on behalf of the American Heart Association Stroke Council; Council 48 on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Quality of Care and Outcomes Research 12 http://stroke.ahajournals.org/ Purpose—Symptomatic intracranial hemorrhage (sICH) is the most feared complication of intravenous thrombolytic therapy in acute ischemic stroke. Treatment of sICH is based on expert opinion and small case series, with the efficacy of such treatments not well established. This document aims to provide an overview of sICH with a focus on pathophysiology and treatment. Methods—A literature review was performed for randomized trials, prospective and retrospective studies, opinion papers, case series, and case reports on the definitions, epidemiology, risk factors, pathophysiology, treatment, and outcome of sICH. The document sections were divided among writing group members who performed the literature review, summarized the literature, and provided suggestions on the diagnosis and treatment of patients with sICH caused by systemic thrombolysis with alteplase. Several drafts were circulated among writing group members until a consensus was achieved. by guest on March 9, 2018 Results—sICH is an uncommon but severe complication of systemic thrombolysis in acute ischemic stroke. Prompt diagnosis and early correction of the coagulopathy after alteplase have remained the mainstay of treatment. Further research is required to establish treatments aimed at maintaining integrity of the blood-brain barrier in acute ischemic stroke based on inhibition of the underlying biochemical processes. (Stroke. 2017;48:e343–e361. DOI: 10.1161/STR.0000000000000152.) Key Words: AHA Scientific Statements◼ stroke ◼ therapeutics ◼ thrombolytic therapy ◼ tissue plasminogen activator ◼ treatment outcome ntravenous alteplase improves outcome in selected patients symptomatic intracranial hemorrhage (sICH). The risk of Iwith acute ischemic stroke when given within 4.5 hours sICH varies on the basis of patient population and the defi- from onset.1,2 Despite its efficacy, the use of alteplase is lim- nition of sICH used but generally ranges from 2% to 7%.3 ited by the risk of hemorrhagic complications, particularly Treatment of alteplase-associated sICH is based on expert The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest. This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on May 12, 2017, and the American Heart Association Executive Committee on August 21, 2017. A copy of the document is available at http://professional.heart.org/statements by using either “Search for Guidelines & Statements” or the “Browse by Topic” area. To purchase additional reprints, call 843-216-2533 or e-mail [email protected]. The American Heart Association requests that this document be cited as follows: Yaghi S, Willey JZ, Cucchiara B, Goldstein JN, Gonzales NR, Khatri P, Kim LJ, Mayer SA, Sheth KN, Schwamm LH; on behalf of the American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Quality of Care and Outcomes Research. Treatment and outcome of hemorrhagic transformation after intravenous alteplase in acute ischemic stroke: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2017;48:e343–e361. DOI: 10.1161/STR.0000000000000152. Expert peer review of AHA Scientific Statements is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines development, visit http://professional.heart.org/statements. Select the “Guidelines & Statements” drop-down menu, then click “Publication Development.” Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association. Instructions for obtaining permission are located at http://www.heart.org/HEARTORG/General/Copyright- Permission-Guidelines_UCM_300404_Article.jsp. A link to the “Copyright Permissions Request Form” appears on the right side of the page. © 2017 American Heart Association, Inc. Stroke is available at http://stroke.ahajournals.org DOI: 10.1161/STR.0000000000000152 e343 e344 Stroke December 2017 opinion and small case series, and the efficacy of such treat- definition used. In addition, the interrater agreement for dif- ments is not well established. In this scientific statement, we ferent definitions of sICH varies significantly, as does the cor- aim to provide an overview of sICH with a focus on patho- relation with clinical outcomes such as mortality.11 Although physiology and treatment. the ECASS (European Cooperative Acute Stroke Study) II definition appears to have the highest interrater agreement,3,11 Definitions of sICH the SITS-MOST (Safe Implementation of Thrombolysis in Classification of sICH after thrombolytic therapy is typically Stroke: Monitoring Study) definition correlates most strongly 3,11,12 based on 2 main factors: the radiographic appearance of the with mortality. hemorrhage and the presence of associated neurological dete- In summary, the definitions of sICH used are widely vari- rioration. Radiographic classification of postthrombolytic able, depending on the radiological classification of hem- intracranial hemorrhage (ICH) has traditionally distinguished orrhage and degree of neurological deterioration, and this between hemorrhagic infarction, which represents petechial should be taken into account in the reporting and interpreta- hemorrhage into the area of infarction, and parenchymal tion of sICH rates. To allow proper comparisons with clinical hematoma, representing a sharply defined area of hemor- trial benchmarks, stroke centers should classify the appear- rhage with or without mass effect (Figure 1).4 Limitations of ance of hemorrhagic transformation according to radiographic this radiological categorization scheme include the lack of criteria (hemorrhagic infarction [HI] type 1, HI-2, parenchy- explicit distinction between parenchymal hematomas within mal hematoma [PH] type 1, PH-2, or remote ICH), assess the degree of neurological worsening by National Institutes of Downloaded from as opposed to remote from the area of infarction and the lack of clear criteria to categorize subarachnoid, subdural, or intra- Health Stroke Scale (NIHSS) point change, and provide an ventricular hemorrhage. To address these issues, an expanded attribution of causality for the worsening. radiographic classification system, the Heidelberg Bleeding Classification, has recently been proposed (Table 1).5 The Epidemiology of sICH http://stroke.ahajournals.org/ integration of ICH and clinical neurological deterioration in Incidence the setting of alteplase is challenging given that variable defi- Early-phase randomized trials of fibrinolytic therapy in acute nitions of neurological deterioration may be used and dete- myocardial infarction required dose reduction of concurrent rioration may occur for reasons other than ICH. A number intravenous heparin because of excessive risk of sICH (pooled of definitions of sICH have been used or proposed for use in rate, 1.56%; range, 0.92%–2.80%). Rates of sICH in the 7 clinical trials of thrombolytic therapy (Table 2). The choice major published randomized trials of patients with acute myo- of sICH definition has a dramatic impact on the reported cardial infarction treated with alteplase and low-dose heparin sICH rate (see Incidence)2; therefore, comparison of sICH ranged from 0.64% to 0.94%.13 Because of this feared compli- by guest on March 9, 2018 rates across studies must carefully consider the specific sICH cation, acute stroke clinical trials were designed to minimize Figure 1. Radiographic classifica- tion of hemorrhagic transformation with the blue arrow in each figure showing the hemorrhage. Top left, Hemorrhagic infarction type 1. Top right, Hemorrhagic infarction type 2. Bottom left, Parenchymal hematoma type 1. Bottom mid- dle, Parenchymal hematoma type 2. Bottom right, Extraischemic hematoma. Yaghi et al Hemorrhage After Alteplase in Acute Ischemic Stroke e345 Table 1. Radiographic Classification of ostthrombolysisP Intracerebral Hemorrhage NINDS Trial Criteria ECASS* Proposed Heidelberg
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