First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt

Abstract

Surgical ventriculoperitoneal shunting remains standard treatment for communicating hydrocephalus, despite persistently elevated infection and revision rates. A novel minimally invasive endovascular cerebrospinal fluid (CSF) shunt was developed to mimic the function of the arachnoid granulation which passively filters CSF from the central nervous system back into the intracranial venous sinus network. The endovascular shunt is deployed via a femoral transvenous approach across the dura mater into the cerebellopontine angle cistern. An octogenarian with intractable hydrocephalus following subarachnoid hemorrhage underwent successful endovascular shunting, resulting in swift intracranial pressure reduction from 38 to <20 cmH2O (<90 min) and resolution of ventriculomegaly. This first successful development of a percutaneous transluminal venous access to the central nervous system offers a new pathway for non-invasive treatment of hydrocephalus and the potential for intervention against neurological disorders.

Keywords: catheter; hydrocephalus; intervention; intracranial pressure; technology.

Conflict of interest statement

Competing interests: AMM and CBH are shareholders, investors, and co-founders of CereVasc Inc.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

(A) An endovascular shunt in its deployed position with its tip malecot in the cerebellopontine angle cistern, draining into the internal jugular vein. (B) Endovascular technique for transdural controlled penetration using conventional venous catheterization. (C) eShunt biomimetic design with a one-way slit valve. (D) eShunt implant in close view. CSF, cerebrospinal fluid.

Figure 2

(A) T1-Weighted axial gadolinium-enhanced MRI scan highlights the inferior petrosal sinus (IPS) and adjacent cerebellopontine angle (CPA) cistern (arrow showing intended transdural device placement). (B) Three-dimensional rendering of computed tomographic angiography with arrow highlighting intended transdural trajectory for deployment. (C) Segmentation from T1-gadolinium- enhanced MRI scan highlights the IPS (purple), vertebral and posterior inferior cerebellar artery (red) and their >6 mm distance away from the intended trajectory (arrow) for transdural egress of eShunt. (D) Intraprocedural IPS roadmap showing successful dural penetration with delivery catheter needle into the CPA cistern. (E) Successful deployment of the eShunt with its tip in the CPA cistern, its body in the IPS, and its valved tip draining into the internal jugular vein. (F) Postprocedural reconstruction of computed tomographic acquisition confirming stable position of eShunt malecot tip at intended target site.

Figure 3

(A) Intracranial pressure measured through external ventricular drain following eShunt placement shows a rapid and sustained normalization; insets show transient intracranial pressure spikes coinciding with activity/postural change with return to baseline. (B) Computed tomographic scan before (left), 3 hours after eShunt procedure (contrast enhancing, centre), and at 2 days (right) show resolution of third ventricular enlargement following procedure (top panel). Corresponding cuts at the level of the eShunt insertion in to the cerebellopontine angle (CPA) cistern show no evidence of blood or extravasation at/near the malecot tip of the eShunt (arrow, bottom panel). (C) Follow-up heme-sensitive gradient echo at the level of the eShunt insertion (left) in the CPA cistern show artefactual metal blooming from the malecot (arrow) but no adjacent blood. MRI-T1-dadolinium-enhanced in axial and oblique views reveal the malecot metallic signal void adjacent to the enhancing inferior petrosal sinus (IPS; arrow, middle) as well as the body of the eShunt within the IPS and internal jugular vein (arrows, right).