Use of the SONAS Ultrasound Device for the Assessment of Cerebral Perfusion in Acute Ischemic Stroke

Amir M Molaie, Sibylle Wilfling, Mustafa Kilic, C. Wendl, Ralf A. Linker, F. Schlachetzki, David S. Liebeskind
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Abstract

Early recognition of large‐vessel occlusion in acute ischemic stroke is pivotal to ensuring timely and effective treatment. However, current prehospital evaluation strategies largely rely on stroke scales that lack sensitivity and specificity. Recently, a novel, portable, noninvasive brain perfusion ultrasound device (SONAS) was developed as a diagnostic aid and demonstrated robust correlation with magnetic resonance imaging–based brain perfusion imaging. The present study aimed to investigate the feasibility and diagnostic performance of the SONAS device in identifying alterations in cerebral blood flow in patients with acute ischemic stroke with suspected or known perfusion deficits. We performed a phase II, single‐arm, prospective study using SONAS in a close timely relation to computed tomography perfusion imaging in subjects diagnosed with acute ischemic stroke and suspected or known large‐vessel pathology, presenting within 24 hours of symptom onset between April 2019 through December 2019. Performance end points included successful measurement of time‐to‐peak in each hemisphere and comparison of perfusion deficits measured by SONAS to the reference standard computed tomography perfusion imaging. Safety end points included frequency, severity, and outcome of adverse events. A total of 20 subjects were enrolled. Eighteen subjects (90%) had microbubble signals successfully detected on initial assessment by SONAS. The diagnostic accuracy of the SONAS device in identifying a perfusion deficit was 88.9%. The sensitivity was 14 of 15 (93.3%), and the specificity was 2 of 3 (66.7%). No adverse events were reported secondary to SONAS or the contrast agent used. In this clinical study, we demonstrated that the SONAS system is a safe tool that can aid in identifying cerebral perfusion deficits in this selected population of patients with acute ischemic stroke with suspected or known perfusion deficits. Future studies should assess the efficacy and impact on clinical outcomes of using SONAS in a real‐world “in the field” setting on a large subset of patients with suspected stroke and in addition to prehospital stroke scales.
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使用 SONAS 超声设备评估急性缺血性脑卒中的脑灌注情况
早期识别急性缺血性卒中的大血管闭塞是确保及时有效治疗的关键。然而,目前的院前评估策略主要依赖于缺乏敏感性和特异性的卒中量表。最近,一种新型、便携式、无创脑灌注超声设备(SONAS)作为诊断辅助工具被开发出来,并与基于磁共振成像的脑灌注成像显示出很强的相关性。本研究旨在探讨 SONAS 设备在识别疑似或已知灌注障碍的急性缺血性脑卒中患者脑血流改变方面的可行性和诊断性能。 我们进行了一项 II 期、单臂、前瞻性研究,在 2019 年 4 月至 2019 年 12 月期间,对诊断为急性缺血性卒中、疑似或已知大血管病变、在症状出现 24 小时内就诊的受试者使用 SONAS,并与计算机断层扫描灌注成像密切及时联系。性能终点包括成功测量每个半球的达峰时间,以及 SONAS 测量的灌注缺损与参考标准计算机断层扫描灌注成像的比较。安全性终点包括不良事件的频率、严重程度和结果。 共有 20 名受试者入选。18名受试者(90%)在SONAS的初步评估中成功检测到了微气泡信号。SONAS 设备在确定灌注不足方面的诊断准确率为 88.9%。灵敏度为 15 分之 14(93.3%),特异性为 3 分之 2(66.7%)。没有关于 SONAS 或所用造影剂继发不良事件的报告。 在这项临床研究中,我们证明了 SONAS 系统是一种安全的工具,可以帮助确定疑似或已知有灌注缺损的急性缺血性卒中患者的脑灌注缺损情况。未来的研究应评估在真实世界的 "现场 "环境中对大量疑似卒中患者使用 SONAS 系统以及院前卒中量表的疗效和对临床结果的影响。
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