Diagnostic Accuracy of Non-Invasive Thermal Evaluation of Ventriculoperitoneal Shunt Flow in Shunt Malfunction: A Prospective, Multi-Site, Operator-Blinded Study.
Diagnostic Accuracy of Non-Invasive Thermal Evaluation of Ventriculoperitoneal Shunt Flow in Shunt Malfunction: A Prospective, Multi-Site, Operator-Blinded Study.
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DOI：
10.1093/neuros/nyaa128
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发表时间：
2020-10-15
期刊：
影响因子：
4.8
通讯作者：
Hameed MQ
中科院分区：
文献类型：
--
作者：
Madsen JR;Boyle TP;Neuman MI;Park EH;Tamber MS;Hickey RW;Heuer GG;Zorc JJ;Leonard JR;Leonard JC;Keating R;Chamberlain JM;Frim DM;Zakrzewski P;Klinge P;Merck LH;Piatt J;Bennett JE;Sandberg DI;Boop FA;Hameed MQ
热流评估（TFE）是一种评估脑室腹腔分流功能的非侵入性方法。 TFE 检测到的流量是是否需要进行修复手术的负面预测指标。测试方案的进一步优化、多中心评估以及与临床和影像印象的整合促使了当前的研究。比较两种 TFE 方案（使用微泵（TFE+MP）或不使用（仅 TFE））与神经影像学对紧急出现分流故障症状的患者的诊断准确性。我们对一系列连续接受分流故障评估的患者进行了前瞻性多中心操作者盲法试验。进行了 TFE，并记录了成像前临床医生的印象和成像结果。主要结果是分流阻塞，需要在 7 天内进行神经外科修复。使用前瞻性确定的 -2.5% 的先验裕度测试了 TFE 与神经影像学检测分流阻塞的敏感性的非劣性。我们在 10 个中心招募了 406 名患者。其中，68/348 (20%) 接受 TFE+MP 评估，30/215 (14%) 仅接受 TFE 评估存在分流阻塞。仅 TFE 检测梗阻的灵敏度为 100%（95% CI：88%-100%），TFE+MP 为 90%（95% CI：80%-96%），TFE+MP 队列中成像为 76%（95% CI：65%-86%），仅 TFE 队列中成像为 77%（95% CI：58%-90%）。 TFE 方法和成像之间的敏感性差异没有超过非劣效性界限。 TFE 在排除分流故障方面并不逊色于成像，并且可能有助于避免成像和其他步骤。为此，仅 TFE 优于 TFE+MP。
Thermal flow evaluation (TFE) is a non-invasive method to assess ventriculoperitoneal shunt function. Flow detected by TFE is a negative predictor of the need for revision surgery. Further optimization of testing protocols, evaluation in multiple centers, and integration with clinical and imaging impressions prompted the current study. To compare the diagnostic accuracy of 2 TFE protocols, with micropumper (TFE+MP) or without (TFE-only), to neuro-imaging in patients emergently presenting with symptoms concerning for shunt malfunction. We performed a prospective multicenter operator-blinded trial of a consecutive series of patients who underwent evaluation for shunt malfunction. TFE was performed, and preimaging clinician impressions and imaging results were recorded. The primary outcome was shunt obstruction requiring neurosurgical revision within 7 d. Non-inferiority of the sensitivity of TFE vs neuro-imaging for detecting shunt obstruction was tested using a prospectively determined a priori margin of −2.5%. We enrolled 406 patients at 10 centers. Of these, 68/348 (20%) evaluated with TFE+MP and 30/215 (14%) with TFE-only had shunt obstruction. The sensitivity for detecting obstruction was 100% (95% CI: 88%-100%) for TFE-only, 90% (95% CI: 80%-96%) for TFE+MP, 76% (95% CI: 65%-86%) for imaging in TFE+MP cohort, and 77% (95% CI: 58%-90%) for imaging in the TFE-only cohort. Difference in sensitivities between TFE methods and imaging did not exceed the non-inferiority margin. TFE is non-inferior to imaging in ruling out shunt malfunction and may help avoid imaging and other steps. For this purpose, TFE only is favored over TFE+MP.
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