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直接导管取栓治疗急性缺血性脑卒中的可行性和安全性。心脏病专家、神经科医生和放射科医生之间的合作。前瞻性登记研究 PRAGUE-16。

Feasibility and safety of direct catheter-based thrombectomy in the treatment of acute ischaemic stroke. Cooperation among cardiologists, neurologists and radiologists. Prospective registry PRAGUE-16.

机构信息

Charles University, Third Faculty of Medicine, University Hospital Kralovske Vinohrady, Prague, Czech Republic.

出版信息

EuroIntervention. 2017 May 15;13(1):131-136. doi: 10.4244/EIJ-D-16-00979.

DOI:10.4244/EIJ-D-16-00979
PMID:28242586
Abstract

AIMS

The aim of this study was to evaluate the role of direct catheter-based thrombectomy (d-CBT, without thrombolysis) and the feasibility and safety of d-CBT performed in an interventional cardiology centre.

METHODS AND RESULTS

This single-centre, prospective observational registry based on the pre-specified protocol included three months of follow-up. The decision to perform acute stroke intervention was made by a neurologist based on the clinical and imaging findings. Inclusion criteria were moderate-to-severe acute ischaemic stroke (NIHSS ≥6), <6 hours from symptom onset, no large ischaemia on the admission CT scan and CT evidence for an occluded large artery. The primary outcome was functional neurologic recovery (mRS 0-2) at three months. Key secondary outcomes were the angiographic recanalisation rate and symptomatic intracranial bleeding. A total of 115 consecutive patients (mean age 66 years) were enrolled during a period of four years: 84 patients underwent d-CBT and 31 patients bridging thrombolysis with immediate catheter intervention (TL-CBT). The annual number of procedures increased from 13 (initial 12 months) to 41 (last 12 months). Angiographic success (TICI flow 2b-3) was 69% after d-CBT and 81% after TL-CBT. It was higher in isolated occlusions of the middle cerebral artery (MCA, 74% and 100%) or of the proximal internal carotid artery (ICA, 80% and 100%), while it was lower in combined ICA+MCA occlusions (63% and 70%) and in basilar or vertebral occlusions (57% and 50%). Neurologic recovery (mRS ≤2 after 90 days) was achieved in 40% of patients. It was higher (43%) in anterior circulation strokes than in posterior circulation strokes (25%). Direct CBT led to neurologic recovery in 36%, while in TL-CBT this was 52%. Best clinical outcomes (51% and 71% neurologic recovery rates) were achieved among patients with isolated MCA occlusion. Any symptomatic intracranial bleeding was present in 3.6% (d-CBT) and 6.5% (TL-CBT). Vessel perforation or major dissection occurred in 5.2% overall, and distal embolisation to other territory in 3.5% of patients.

CONCLUSIONS

Direct catheter-based thrombectomy may be considered in patients with contraindications for thrombolysis or in patients with very short CT-groin puncture times. A randomised trial is needed to evaluate better the role of direct catheter-based thrombectomy. Acute stroke interventions performed in close cooperation among cardiologists, neurologists and radiologists are feasible and safe.

摘要

目的

本研究旨在评估直接导管血栓切除术(不溶栓)的作用,以及在心血管介入治疗中心进行直接导管血栓切除术的可行性和安全性。

方法和结果

本单中心前瞻性观察性注册研究基于预设方案,随访 3 个月。急性脑卒中干预的决策由神经病学家根据临床和影像学发现做出。纳入标准为中度至重度急性缺血性脑卒中(NIHSS≥6),症状发作<6 小时,入院 CT 扫描未见大的缺血灶,CT 显示大血管闭塞。主要结局为 3 个月时的功能神经恢复(mRS 0-2)。关键次要结局为血管造影再通率和症状性颅内出血。在 4 年期间,共纳入 115 例连续患者(平均年龄 66 岁):84 例行直接导管血栓切除术,31 例行溶栓后立即导管介入(TL-CBT)。每年手术例数从 13 例(最初 12 个月)增加到 41 例(最后 12 个月)。直接导管血栓切除术的血管造影成功率(TICI 血流 2b-3)为 69%,TL-CBT 为 81%。MCA 或颈内动脉近端闭塞的成功率更高(74%和 100%),而颈内动脉+MCA 联合闭塞的成功率较低(63%和 70%),基底动脉或椎动脉闭塞的成功率更低(57%和 50%)。90 天后 mRS≤2 的神经功能恢复患者占 40%。前循环卒中患者(43%)的神经功能恢复高于后循环卒中患者(25%)。直接 CBT 导致神经功能恢复的比例为 36%,而 TL-CBT 为 52%。在单纯 MCA 闭塞患者中,最佳临床结局(51%和 71%的神经恢复率)的比例最高。直接导管血栓切除术(3.6%)和溶栓后立即导管介入(TL-CBT)(6.5%)均出现任何症状性颅内出血。总的血管穿孔或大夹层发生率为 5.2%,患者有 3.5%发生其他部位的远端栓塞。

结论

对于溶栓禁忌或 CT-股动脉穿刺时间极短的患者,可考虑直接导管血栓切除术。需要随机试验来更好地评估直接导管血栓切除术的作用。心血管介入医师、神经科医师和放射科医师密切合作进行急性脑卒中干预是可行和安全的。

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