Dural Venous Sinus Stent in Idiopathic Intracranial Hypertension

Official title

Predictors of Dural Venous Sinus Stenting in Idiopathic Intracranial Hypertension Patients and Outcomes

Overview

This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.

Detailed description

Idiopathic intracranial hypertension (IIH) has long been associated with the hallmark clinical triad of headaches, papilledema, and visual loss in the absence of neurologic signs (except possible CN VI palsy), Hydrocephalus or intracranial masses on CT or MRI. findings without evidence of thrombosis; lumbar puncture opening pressure of \>25 cmH2O; normal biochemical and cytological composition of the CSF. The overall age-adjusted and gender-adjusted annual incidence is increasing and was reported to be 2.4 per 100 000 within the last decade (2002-2014).A variety of aetiologies have been suggested to explain the pathophysiology behind IIH, including meningeal inflammation, metabolic disturbances (e.g., hyper- or hypoadrenalism and hypoparathyroidism), medication effects (e.g., excess vitamin A, corticosteroids, and tetracycline), and cerebral venous hypertension.Imaging of patients with IIH is traditionally performed to exclude lesions that produce intracranial hypertension. MR imaging features of IIH include posterior globe flattening, a protrusion of the subarachnoid space in the cavum sellae (Empty Sella), distension of the preoptic subarachnoid space, enhancement of the prelaminar optic nerve, vertical tortuosity of the orbital optic nerve, and intraocular protrusion of the prelaminar optic nerve. Although these findings support the presence of elevated ICP and, thus, the diagnosis of IIH, they are not predictive of the severity of visual loss, and their absence does not exclude the diagnosis. It should not guide a specific management of patients with IIH .

The first line of treatment for IIH consists of weight loss and/or medical therapy including diuretics such as acetazolamide. When medical treatment fails, surgical options include cerebrospinal fluid (CSF) diversion via ventriculoperitoneal (VP) or lumboperitoneal (LP) shunting or optic nerve sheath fenestration. Recently, another etiology of cerebral venous hypertension has garnered increasing attention as a putative cause of IIH, cerebral venous Dural sinus stenosis. In medically refractory IIH patients with a physiologic pressure gradient across venous stenosis, cerebral venous stenting has emerged as an alternative treatment to traditional surgical approaches.

Transverse sinus stenosis can be seen in 2 morphologic forms: an extrinsic smooth gradually narrowing tapered stenosis and intrinsic discrete obstructions, presumably due to arachnoid granulations or fibrous septae. While intrinsic transverse sinus stenosis might cause IIH by completely occluding the transverse sinus, the extrinsic compression resolves with CSF drainage. might be secondary to intracranial hypertension. Venous sinus stenting (VSS) reduces intracranial venous pressures and improves idiopathic intracranial hypertension (IIH) symptoms.

Interventions

• Procedure Dural venous sinus stenting
  40 patients with idiopathic intracranial hypertension according to Modified Dandy Criteria will subjected to Dural venous stenting

Primary outcome measures

• change in headache impact scale(HIT-6) [Time frame: 3, 6 months]
• Papilledema Friesen grading scale [Time frame: 3 months and 6 months]
• Visual filed Assessment Perimetry [Time frame: 3,6 months]
• Changes in other symptoms tinnitus, abducent nerve palsy and Transient visual Obsecuration [Time frame: 3,6 months]

Secondary outcome measures (4)

• Stent Patency and pressure change [Time frame: 6 months]
• stent Patency [Time frame: 6 months]
• Safety outcome measures [Time frame: 10 days]
• Quality of life improvement [Time frame: 3,6 months]

Eligibility criteria

Inclusion criteria

• 40 Patients of idiopathic intracranial hypertension subjected to Dural venous sinus stenting met the modified Dandy criteria for (IIH).

• Signs and symptoms of increased intracranial pressure: Headaches, nausea, vomiting, visual changes, and papilledema.
• No localizing or focal neurologic signs: Except for possible unilateral or bilateral VI nerve paresis.
• Elevated cerebrospinal fluid (CSF) pressure: Without cytologic or chemical abnormalities.
• No etiology for increased intracranial pressure: On neuroimaging findings.

• Age: 18-60 years
• Gender: Male or Female Inclusion Criteria.

Exclusion criteria

• Age less than or equal to 18 years.
• severe allergic reaction to iodine contrast or chronic Kidney disease.
• contraindication to general anesthesia or antiplatelet anticoagulants, Hemorrhagic Diathesis
• patients with secondary causes of intracranial hypertension: Dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.
• pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Medicine — Asyut

Publications

• Hilvert AM, Gauhar F, Longo M, Grimaudo H, Dugan J, Mummareddy N, Chitale R, Froehler MT, Fusco MR. Venous sinus stenting versus ventriculoperitoneal shunting: comparing clinical outcomes for idiopathic intracranial hypertension. J Neurointerv Surg. 2024 Nov 22;16(12):1264-1267. doi: 10.1136/jnis-2024-022174. PMID 39209429
• McGonigal A, Bone I, Teasdale E. Resolution of transverse sinus stenosis in idiopathic intracranial hypertension after L-P shunt. Neurology. 2004 Feb 10;62(3):514-5. doi: 10.1212/wnl.62.3.514. No abstract available. PMID 14872049
• Subramaniam RM, Tress BM, King JO, Eizenberg N, Mitchell PJ. Transverse sinus septum: a new aetiology of idiopathic intracranial hypertension? Australas Radiol. 2004 Jun;48(2):114-6. doi: 10.1111/j.1440-1673.2004.01269.x. PMID 15230741
• Aguilar-Perez M, Martinez-Moreno R, Kurre W, Wendl C, Bazner H, Ganslandt O, Unsold R, Henkes H. Endovascular treatment of idiopathic intracranial hypertension: retrospective analysis of immediate and long-term results in 51 patients. Neuroradiology. 2017 Mar;59(3):277-287. doi: 10.1007/s00234-017-1783-5. Epub 2017 Mar 2. PMID 28255904
• Saindane AM, Bruce BB, Riggeal BD, Newman NJ, Biousse V. Association of MRI findings and visual outcome in idiopathic intracranial hypertension. AJR Am J Roentgenol. 2013 Aug;201(2):412-8. doi: 10.2214/AJR.12.9638. PMID 23883223
• Degnan AJ, Levy LM. Pseudotumor cerebri: brief review of clinical syndrome and imaging findings. AJNR Am J Neuroradiol. 2011 Dec;32(11):1986-93. doi: 10.3174/ajnr.A2404. Epub 2011 Jun 16. PMID 21680652
• Brodsky MC, Vaphiades M. Magnetic resonance imaging in pseudotumor cerebri. Ophthalmology. 1998 Sep;105(9):1686-93. doi: 10.1016/S0161-6420(98)99039-X. PMID 9754178
• Kilgore KP, Lee MS, Leavitt JA, Mokri B, Hodge DO, Frank RD, Chen JJ. Re-evaluating the Incidence of Idiopathic Intracranial Hypertension in an Era of Increasing Obesity. Ophthalmology. 2017 May;124(5):697-700. doi: 10.1016/j.ophtha.2017.01.006. Epub 2017 Feb 7. PMID 28187976

Identifiers

NCT: NCT06833424 · intracranial hypertension

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗