European Stroke Guidelines on Mechanical Thrombectomy in Acute Ischemic Stroke 2019 PDF

Guidelines European Stroke Organisation (ESO) – European Society for Minimally Invasive Neurological Therapy (ESMINT) Guidelines on Mechanical Thrombectomy in Acute Ischaemic Stroke European Stroke Journal 2019, Vol. 4(1) 6–12 ! European Stroke Organisation 2019 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/2396987319832140 journals.sagepub.com/home/eso Endorsed by Stroke Alliance for Europe (SAFE) Guillaume Turc1,2,3,4, Pervinder Bhogal5, Urs Fischer6, Pooja Khatri7, Kyriakos Lobotesis8, Mika€ el Mazighi3,9,10,11, Peter D. Schellinger12, Danilo Toni13, Joost de Vries14, Philip White15 and Jens Fiehler16 Abstract Background: Mechanical thrombectomy (MT) has become the cornerstone of acute ischaemic stroke management in patients with large vessel occlusion (LVO). The aim of this guideline document is to assist physicians in their clinical decisions with regard to MT. Methods: These Guidelines were developed based on the standard operating procedure of the European Stroke Organisation and followed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. An interdisciplinary working group identified 15 relevant questions, performed systematic reviews and meta-analyses of the literature, assessed the quality of the available evidence, and wrote evidence based recommendations. Expert opinion was provided if not enough evidence was available to provide recommendations based on the GRADE approach. Results: We found high quality evidence to recommend MT plus best medical management (BMM, including intravenous thrombolysis whenever indicated) to improve functional outcome in patients with LVO-related acute ischaemic stroke within 6 hours after symptom onset. We found moderate quality of evidence to recommend MT plus BMM in the 6-24h time window in patients meeting the eligibility criteria of published randomized trials. These guidelines further detail 1 Neurology Department, Sainte-Anne Hospital, Paris, France 2 Université Paris Descartes, Paris, France 3 DHU NeuroVasc, Paris, France 4 INSERM U1266, Paris, France 5 The Royal London Hospital, London, UK 6 Department of Neurology, Inselspital, University Hospital Bern and University of Bern, Switzerland 7 Department of Neurology, University of Cincinnati, Cincinnati, Ohio, USA 8 Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK 9 INSERM U1148, Sorbonne Paris Cité Université Paris Diderot, Paris, France 10 Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France 11 Stroke Unit Lariboisière Hospital, Paris, France 12 Department of Neurology and Neurogeriatry, Johannes Wesling Medical Center Minden, University hospitals of the Ruhr-University of Bochum, Germany 13 Hospital Policlinico Umberto I, Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy 14 Department of Neurosurgery, Radboudumc, Nijmegen, The Netherlands 15 Institute of Neuroscience (Stroke Research Group), Newcastle, University, Newcastle Upon Tyne, UK 16 Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universit€atsklinikum Hamburg-Eppendorf, Hamburg, Germany Corresponding author: Guillaume Turc, Neurology Department, GHU Psychiatrie et Neurosciences, Sainte-Anne Hospital, 1 rue Cabanis, 75014 Paris, France. Email: [email protected] This contribution, is being co-published in the following journals: European Stroke Journal and Journal of NeuroInterventional Surgery in February 2019. To request permission to re-use any part of this contribution, please view the Article reuse guidelines: sagepub.com/journals-permissions Turc et al. 7 aspects of prehospital management, patient selection based on clinical and imaging characteristics, and treatment modalities. Conclusions: MT is the standard of care in patients with LVO-related acute stroke. Appropriate patient selection and timely reperfusion are crucial. Further randomized trials are needed to inform clinical decision making with regard to the mothership and drip-and-ship approaches, anesthaesia modalities during MT, and to determine whether MT is beneficial in patients with low stroke severity or large infarct volume. Date received: 14 November 2018; accepted: 1 January 2019 Due to space constraints, the print version of this guideline only incorporate the abstract and the synoptic table summarizing the evidence-based recommendations and the expert opinions (table 1). The full guideline document is available online at https://journals.sagepub.com/doi/full/10.1177/2396987319832140 Table 1. Summary of PICO questions, evidence-based recommendations, and expert opinion PICO Question Recommendations Expert opinion There is a consensus among the guideline group (11/11 votes) that patients with M2 occlusion fulfilled the inclusion criteria in most randomized trials and therefore mechanical thrombectomy is reasonable in this situation. There is a consensus among the panel (11/11 votes) that in analogy to anterior circulation LVO and with regard to the grim natural course of basilar artery occlusions, the therapeutic approach with IVT plus MT should strongly be considered. Patients should be treated with MT plus BMM In adults with anterior circulation LVO-related PICO 2: For adults with LVOup to approximately 7 hours 18 min after acute ischaemic stroke presenting between 6 related acute ischaemic stroke stroke onset, without the need of perfusion and 24 hours from time last known well and 6 to 24 hours from time last imaging-based selection. fulfilling the selection criteria of DEFUSE-3* or known well, does MT plus DAWN**, we recommend MT plus BMM over 10/11 experts agree that patients can be BMM compared with BMM treated in the 6-12 hour time window if BMM alone to improve functional outcome. alone improve functional they fulfill the ESCAPE criteria, notably Quality of evidence: Moderate 丣丣丣 outcome ? ASPECTS 6 and moderate-to-good colStrength of recommendation: Strong "" lateral circulation. However, such patients should preferably be treated in the context of clinical studies. Also, concurrent software applications utilizing similar perfusion algorithms and rendering equivalent volumetry results as those used in the DAWN and DEFUSE-3 trials may be options, as well as simple volumetry on a high quality DWI scan for core volume when applying DAWN criteria. Therefore we advocate further research, inclusion of patients into late window trials, and implementation of institutional imaging standard operating procedures. In adults with anterior circulation LVO-related PICO 1: For adults with LVOacute ischaemic stroke presenting within 6 related acute ischaemic stroke hours after symptom onset, we recommend within 6 hours of symptom MT plus BMM, including IVT whenever indionset, does MT plus BMM cated, over BMM alone to improve functional compared with BMM alone outcome. improve functional outcome ? Quality of evidence: High 丣丣丣丣 Strength of recommendation: Strong "" (continued) 8 European Stroke Journal 4(1) Table 1. Continued. PICO Question PICO 3: For adults with LVOrelated acute ischaemic stroke, does IVT plus MT compared with MT alone improve functional outcome ? Recommendations • In LVO-related ischaemic stroke patients eligible for both treatments, we recommend IVT plus MT over MT alone. Both treatments should be performed as early as possible after hospital arrival. MT should not prevent the initiation of IVT, and IVT should not delay MT. Quality of evidence: Very low 丣, Strength of recommendation: Strong "" • In LVO-related ischaemic stroke patients not eligible for IVT, we recommend MT as standalone treatment. Quality of evidence: Low 丣丣, Strength of recommendation: Strong "" In patients with suspected stroke, we cannot make a recommendation on the use of a prehospital scale for improving identification of patients eligible for MT. We suggest enrolling patients in a dedicated randomized controlled trial, whenever possible. Quality of evidence: Very low 丣, Strength of recommendation: - Expert opinion In LVO-related ischaemic stroke patients eligible for IVT before MT, 7/11 experts suggest the use of tenecteplase (0.25 mg/kg) over alteplase (0.9 mg/kg) if the decision on IVT is made after vessel occlusion status is known. • 11/11 experts concluded that there is PICO 4: For adults with suspected acute stroke does the currently not enough evidence to use a use of a prehospital scale clinical scale in routine care to help compared with no prehospitriage potential thrombectomy candital scale: dates in the prehospital field. • improve identification of • All patients suspected of having an acute patients eligible for MT? stroke, irrespective of the time of onset, • reduce time to reperfushould undergo emergency imaging of the brain, including vascular imaging. sion ? PICO 5: For adults identified as We cannot make recommendations on whether – As there is lack of strong evidence for superiority of one organizational model, the for adults identified as potential candidates for potential candidates for MT in choice of model should depend on local and MT in the prehospital field, the mothership or the prehospital field, does the regional service organization and patient the drip-and-ship model should be applied to mothership model, compared characteristics (vote: 11/11 experts agree). improve functional outcome. with the drip-and-ship model, • The mothership model might be favored Quality of evidence: Very Low 丣, Strength of improve functional recommendation: outcome? in metropolitan areas, with transportation time to a comprehensive stroke center of less than 30-45 minutes and the use of the drip-and-ship model when transportation times are longer (vote: 11/11 experts agree). • As there is limited experience with the other two models (drip-and-drive and mobile stroke unit) no expert opinion can be provided when to use these models (vote: 11/11 experts agree). • We recommend that patients aged 80 years PICO 6: For patients aged 80 years or more with LVOor more with LVO-related acute ischaemic related acute ischaemic stroke within 6 hours of symptom onset stroke, does MT plus BMM should be treated with MT plus BMM, compared with BMM alone including IVT whenever indicated. improve functional outcome? Application of an upper age limit for MT is not justified. Quality of evidence: Moderate 丣丣丣, Strength of recommendation: Strong "" • We suggest that patients aged 80 years or more with LVO-related acute ischaemic stroke between 6 and 24 hours from time last known well should be treated with MT (continued) Turc et al. 9 Table 1. Continued. PICO Question PICO 7: For adults with LVOrelated acute ischaemic stroke, does selection of MT candidates based on a particular NIHSS score threshold compared with no specific threshold improve functional outcome ? PICO 8: For adults with LVOrelated acute ischaemic stroke, does selection of MT candidates based on a particular ASPECTS or infarct core volume threshold compared with no specific threshold: – improve identification of patients with a therapy effect of MT on functional outcome ? – decrease the risk of symptomatic intracerebral hemorrhage ? Recommendations Expert opinion plus BMM if they meet the eligibility criteria of the DEFUSE-3* or DAWN** trials. Quality of evidence: Low 丣丣, Strength of recommendation: Weak"? • We do not recommend an upper NIHSS In patients with a low NIHSS score (0-5) who are not eligible for a dedicated randomized score limit for decision-making on MT. We controlled trial, we suggest that treatment recommend that patients with high stroke with mechanical thrombectomy in addition severity and LVO-related acute ischaemic to intravenous thrombolysis (or alone in stroke be treated with MT plus BMM, case of contraindication to intravenous including IVT whenever indicated. These thrombolysis) may be reasonable: recommendations also apply for patients in • in patients with deficits that appear disthe 6-24h time window, provided that they meet the inclusion criteria for the DAWN* abling (e.g. significant motor deficit or or DEFUSE-3** studies. aphasia or hemianopia) at presentation Quality of evidence: High 丣丣丣丣, Strength of (vote: 9/11 experts) • in the case of clinical worsening despite recommendation: Strong "". • We recommend that patients with low intravenous thrombolysis (vote: 9/ 11 experts) stroke severity (NIHSS 0-5) and LVO• we did not reach a majority vote to related acute ischaemic stroke within 24 hours from time last known well be suggest mechanical thrombectomy in included in randomized controlled trials patients with deficits that appear noncomparing MT plus BMM versus BMM disabling (e.g. mild hypoesthesia) at alone. presentation (vote: 5/11 experts) Quality of evidence: Very Low 丣, Strength of recommendation: • In the 0-6 hour time window, we recom- If inclusion of the patient in a dedicated randomized controlled trial is not possible, we mend MT plus BMM (including IVT whensuggest that treatment with MT may be ever indicated) over BMM alone in LVOreasonable on an individual basis in selected related anterior circulation stroke patients cases with ASPECTS <6 or core volume without evidence of extensive infarct core >70 ml (11/11 experts agree). Patient (e.g. ASPECTS 6 on non-contrast CT scan selection criteria might include age, severity or infarct core volume 70 ml). and type of neurological impairment, time Quality of evidence: High 丣丣丣丣, Strength of since symptom onset, location of the recommendation: Strong "". • In the 6-24 hour time window, we recomischaemic lesion on plain CT scanner or MRI, and results of advanced imaging, mend MT plus BMM (including IVT whennotably perfusion-core mismatch. ever indicated) over BMM alone in LVOrelated anterior circulation stroke patients fulfilling the selection criteria of DEFUSE-3* or DAWN**, including estimated volume of infarct core. Quality of evidence: Moderate 丣丣丣, Strength of recommendation: Strong "". • We recommend that anterior circulation stroke patients with extensive infarct core (e.g. ASPECTS <6 on non-contrast CT scan or core volume >70 ml or >100 ml) be included in RCTs comparing mechanical thrombectomy plus best medical management versus best medical management alone. Quality of evidence: Very Low 丣, Strength of recommendation: (continued) 10 European Stroke Journal 4(1) Table 1. Continued. PICO Question Recommendations Expert opinion • In adult patients with anterior circulation PICO 9: For adults with LVOLVO-related acute ischaemic stroke prerelated acute ischaemic senting from 0-6 hours from time last stroke, does selection of MT known well, advanced imaging is not neccandidates based on advanced essary for patient selection. perfusion, core, or collateral Quality of evidence: Moderate 丣丣丣, imaging compared with no Strength of recommendation: Weak #? advanced imaging: • improve identification of • In adult patients with anterior circulation patients with a therapy LVO-related acute ischaemic stroke preeffect of mechanical senting beyond 6 hours from time last thrombectomy on funcknown well, advanced imaging selection is tional outcome ? necessary. • decrease the risk of sympQuality of evidence: Moderate 丣丣丣, Strength of recommendation: Strong "" tomatic intracerebral hemorrhage ? • In adult patients with LVO-related acute PICO 10: For adults with LVOrelated acute ischaemic ischaemic stroke, we recommend treatstroke, does MT performed in ment in a comprehensive stroke center. a comprehensive stroke Quality of evidence: Very low 丣, Strength of center compared with MT recommendation: Strong "" performed outside of a comprehensive stroke center: • improve functional outcome? • reduce time to reperfusion? • reduce the rate of symptomatic intracerebral haemorrhage? PICO 11: For adults with LVO- For adults with LVO-related acute ischaemic stroke, we recommend that interventionalists related acute ischaemic should attempt a TICI Grade 3 reperfusion, if stroke, does reperfusion TICI achievable with reasonable safety. Grade 3 compared with Quality of evidence: Low 丣丣, Strength of recreperfusion TICI Grade 2b ommendation: Strong "" improve functional outcome? • There is currently no evidence that contact 9/11 experts believe that ADAPT may be used PICO 12: For adults with LVOrelated acute ischaemic as standard first-line treatment, followed by aspiration alone improves functional outstroke, does MT using direct come compared with BMM in patients stent retriever thrombectomy as rescue aspiration compared with a undergoing MT. therapy if needed. • There is currently no evidence that contact Besides, stent retriever: • We did not reach a majority vote on – improve functional outaspiration alone increases the rate of come? reperfusion over thrombectomy using a that distal aspiration should be used only – increase the rate of comstent retriever. in combination with a stent-retriever • Therefore, we suggest the use of a stent plete reperfusion? (3/11 experts) • 8/11 experts believe that any MT proretriever over contact aspiration alone for MT in patients with acute ischaemic stroke. cedure should be performed preferably Quality of evidence: Very low 丣; Strength of in conjunction with a proximal balloon Recommendation: Weak"? guide catheter. We suggest that further randomized multiPICO 13: For adults with LVO- We cannot provide recommendations to use centric data with less bias should be genergeneral anesthesia or conscious sedation in related acute ischaemic stroke ated. However, if inclusion of the patient in patients undergoing MT, due to a low quality of undergoing MT, does cona randomized controlled trial is not possievidence and conflicting results between 3 scious sedation compared ble, 11/11 experts suggest that local anessmall single-center randomized clinical trials with general anaesthesia thesia or conscious sedation may be favored and the best available observational evidence. improve functional outcome? over general anesthesia, if the patient is able Therefore, we recommend the enrollment of (continued) Turc et al. 11 Table 1. Continued. PICO Question Recommendations Expert opinion to undergo MT without general anesthesia. On the other hand, general anesthesia does not need to be avoided if indicated. The decision for or against general anesthesia should be made rapidly and delays to induction of general anesthesia should be minimized. We suggest that, according to the three randomized controlled trials, a specialized neuro-anesthesiological or neurocritical care team should perform the general anesthesia procedure, whenever possible. Excessive blood pressure drops should be avoided (see PICO question 14). Adequate monitoring of vital parameters of patients under conscious sedation or local anesthesia is also advised. • We suggest to keep blood pressure below 11/11 experts think that the degree of reperfusion should be taken into account in the 180/105 mmHg during and 24 hours after choice of a blood pressure target after MT, MT. No specific blood pressure-lowering with a lower blood pressure target in case drug can be recommended. of complete reperfusion. Quality of evidence: Very low 丣, Strength of recommendation: Weak "? • During MT, systolic blood pressure drops should be avoided. Quality of evidence: Very low 丣, Strength of recommendation: Strong ## • No recommendation can be provided 9/11 experts suggest that if inclusion in a dedicated randomized controlled trial is not regarding which treatment modality should possible, patients with high-grade stenosis be favored in patients with LVO-related or occlusion may be treated with intraacute ischaemic stroke and associated procedural stenting if unavoidably needed. extracranial carotid artery stenosis or occlusion. We recommend the inclusion of such patients in dedicated randomized controlled trials. Quality of evidence: Very low 丣, Strength of recommendation: - patients in multicenter randomized controlled trials addressing this question. Quality of evidence: Very low 丣, Strength of recommendation: - PICO 14: For adults with LVOrelated acute ischaemic stroke undergoing MT, does maintaining blood pressure to a particular target compared with an alternative target improve functional outcome? PICO 15: For adults with LVOrelated acute ischaemic stroke and high-grade ipsilateral extracranial carotid stenosis, does cervical stenting in addition to MT compared with MT alone improve functional outcome? Abbreviations: IVT: intravenous thrombolysis; LVO: large vessel occlusion; MT: mechanical thrombectomy. DEFUSE-3: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke. DAWN: DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo. PICO: Population, Intervention, Comparator, Outcome. *DEFUSE-3: 6 to 16 hours since time last known well: – Age 90 years and NIHSS 6: infarct core volume <70 ml and penumbra volume >15 ml and penumbra volume/core volume >1.8. **DAWN: 6 to 24 hours since time last known well: – Age <80 years: infarct core 30 ml if NIHSS 10; infarct core 51 ml if NIHSS 20. – Age 80 years: infarct core 20 ml and NIHSS 10 Declaration of Conflicting Interests Ethical approval The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: See Supplemental Table 1. Not applicable. Guarantor GT. Funding The author(s) received no financial support for the research, authorship, and/or publication of this article. Informed consent Not applicable. 12 Contributorship GT and JF drafted the PICO questions, which were refined by all authors (GT, PB, UF, PK, KL, MM, PDS, DT, JdV, PW, JF). GT and JF conducted the literature search. GT conducted data extraction and performed meta-analyses. All authors (GT, PB, UF, PK, KL, MM, PDS, DT, JdV, PW and JF) participated in the writing of the first draft of European Stroke Journal 4(1) the manuscript. All authors reviewed and edited the manuscript for important intellectual content and approved the final version of the manuscript. Acknowledgements The authors acknowledge Avtar Lal for his assistance with the literature search strategy.

European Stroke Guidelines on Mechanical Thrombectomy in Acute Ischemic Stroke 2019 PDF

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