Diagnostic Accuracy of Non-Invasive Thermal Evaluation of Ventriculoperitoneal Shunt Flow in Shunt Malfunction: A Prospective, Multi-Site, Operator-Blinded Study
| Autor: | Joseph R. Madsen, Paula Zakrzewski, Gregory G. Heuer, Robert F. Keating, Julie C. Leonard, Jonathan E. Bennett, Joseph H. Piatt, Tehnaz P. Boyle, Mark I. Neuman, Joseph J. Zorc, Robert W Hickey, Petra M. Klinge, Eun-Hyoung Park, Mandeep S. Tamber, David M. Frim, James M. Chamberlain, Jeffrey R. Leonard, Mustafa Q. Hameed, David I. Sandberg, Frederick A. Boop, Lisa H. Merck |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male AcademicSubjects/MED00930 Neuros/4 Diagnostic accuracy Thermometry Ventriculoperitoneal Shunt Cohort Studies 03 medical and health sciences Postoperative Complications 0302 clinical medicine 030225 pediatrics Medical imaging Humans Medicine Ventriculoperitoneal shunt malfunction Prospective Studies business.industry Non invasive Shunt malfunction Multi site medicine.disease Hydrocephalus Research—Human—Clinical Studies Cerebrospinal fluid Ventriculoperitoneal shunt flow Equipment Failure Female Surgery Neurology (clinical) Nuclear medicine business 030217 neurology & neurosurgery Shunt (electrical) Blinded study |
| Zdroj: | Neurosurgery |
| ISSN: | 1524-4040 0148-396X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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