Abstract BACKGROUND 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. OBJECTIVE 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. METHODS 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%. RESULTS 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. CONCLUSION 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.

中文翻译：

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分流故障中脑室腹腔分流血流的非侵入性热评估的诊断准确性：前瞻性、多站点、操作员盲法研究

摘要 背景热流评估（TFE）是一种评估脑室腹腔分流功能的非侵入性方法。TFE 检测到的血流是需要进行翻修手术的负面预测因素。测试方案的进一步优化、多个中心的评估以及与临床和成像印象的整合促进了当前的研究。目的 比较两种 TFE 方案（使用微型泵 (TFE+MP) 或不使用（仅 TFE））与神经影像学对急诊出现分流故障相关症状的患者的诊断准确性。方法 我们对接受分流故障评估的连续系列患者进行了前瞻性多中心操作员盲法试验。进行了 TFE，并记录了成像前临床医生的印象和成像结果。主要结果是需要在 7 d 内进行神经外科修复的分流阻塞。使用前瞻性确定的 -2.5% 的先验裕度来测试 TFE 与神经成像在检测分流阻塞方面的敏感性的非劣效性。结果 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 评估有分流阻塞。仅 TFE 检测阻塞的灵敏度为 100%（95% CI：88%-100%），TFE+MP 为 90%（95% CI：80%-96%），76%（95% CI：65） %-86%）用于 TFE+MP 队列中的成像，77%（95% CI：58%-90%）用于仅 TFE 队列中的成像。TFE 方法和成像之间的灵敏度差异没有超过非劣效性界限。结论 TFE 在排除分流故障方面不劣于成像，可能有助于避免成像和其他步骤。