机器人辅助经颅多普勒与经胸超声心动图用于检测右向左分流。
Robot-Assisted Transcranial Doppler Versus Transthoracic Echocardiography for Right to Left Shunt Detection.
机构信息
Edward Hines, Jr. Veterans Affairs Medical Center, IL (M.N.R.).
CHI Memorial Hospital, Chattanooga, TN (R.S., T.D.).
出版信息
Stroke. 2023 Nov;54(11):2842-2850. doi: 10.1161/STROKEAHA.123.043380. Epub 2023 Oct 5.
BACKGROUND
Right to left shunt (RLS), including patent foramen ovale, is a recognized risk factor for stroke. RLS/patent foramen ovale diagnosis is made by transthoracic echocardiography (TTE), which is insensitive, transesophageal echocardiography, which is invasive, and transcranial Doppler (TCD), which is noninvasive and accurate but scarce.
METHODS
We conducted a prospective, single-arm device clinical trial of robot-assisted TCD (raTCD) versus TTE for RLS diagnosis at 6 clinical sites in patients who presented with an event suspicious for embolic cerebrovascular ischemia from October 6, 2020 to October 20, 2021. raTCD was performed with standard TCD bubble study technique. TTE bubble study was performed per local standards. The primary outcome was rate of RLS detection by raTCD versus TTE.
RESULTS
A total of 154 patients were enrolled, 129 evaluable (intent to scan) and 121 subjects had complete data per protocol. In the intent to scan cohort, mean age was 60±15 years, 47% were women, and all qualifying events were diagnosed as ischemic stroke or transient ischemic attack. raTCD was positive for RLS in 82 subjects (64%) and TTE was positive in 26 (20%; absolute difference 43.4% [95% CI, 35.2%-52.0%]; <0.001). On prespecified secondary analysis, large RLS was detected by raTCD in 35 subjects (27%) versus 13 (10%) by TTE (absolute difference 17.0% [95% CI, 11.5%-24.5%]; <0.001). There were no serious adverse events.
CONCLUSIONS
raTCD was safe and ≈3 times more likely to diagnose RLS than TTE. TTE completely missed or underdiagnosed two thirds of large shunts diagnosed by raTCD. The raTCD device, used by health professionals with no prior TCD training, may allow providers to achieve the known sensitivity of TCD for RLS and patent foramen ovale detection without the need for an experienced operator to perform the test. Pending confirmatory studies, TCD appears to be the superior screen for RLS compared with TTE (funded by NeuraSignal).
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT04604015.
背景
右向左分流（RLS），包括卵圆孔未闭，是中风的公认危险因素。RLS/卵圆孔未闭的诊断通过经胸超声心动图（TTE）进行，但其敏感性差；经食管超声心动图（TEE）具有侵入性；经颅多普勒超声（TCD）是非侵入性的，且准确，但稀缺。
方法
我们在 2020 年 10 月 6 日至 2021 年 10 月 20 日期间，在 6 个临床地点进行了一项前瞻性、单臂设备临床试验，以评估机器人辅助 TCD（raTCD）与 TTE 在怀疑为栓塞性脑血管缺血事件的患者中的 RLS 诊断价值。raTCD 使用标准 TCD 气泡研究技术进行。TTE 气泡研究按照当地标准进行。主要结局是 raTCD 与 TTE 检测 RLS 的检出率。
结果
共纳入 154 例患者，129 例（意向扫描）可评估，121 例符合方案要求。在意向扫描队列中，患者平均年龄为 60±15 岁，47%为女性，所有符合条件的事件均被诊断为缺血性卒中和短暂性脑缺血发作。raTCD 检测出 82 例（64%）RLS 阳性，TTE 检测出 26 例（20%）（绝对差异 43.4%[95%CI，35.2%-52.0%]；<0.001）。在预先指定的次要分析中，raTCD 检测到 35 例（27%）较大 RLS，而 TTE 检测到 13 例（10%）（绝对差异 17.0%[95%CI，11.5%-24.5%]；<0.001）。无严重不良事件。
结论
raTCD 安全，诊断 RLS 的可能性比 TTE 高约 3 倍。TTE 完全漏诊或低估了 raTCD 诊断的三分之二的大分流。raTCD 设备由未经 TCD 培训的医疗保健专业人员使用，可能使提供者能够实现 TCD 对 RLS 和卵圆孔未闭检测的已知敏感性，而无需经验丰富的操作者进行检测。在等待确认性研究的结果期间，与 TTE 相比，TCD 似乎是 RLS 的更优筛查方法（由 NeuraSignal 资助）。
注册
临床试验
gov；唯一标识符：NCT04604015。
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