O14 One-year safety of treating communicating hydrocephalus with the eShunt® implant
<h3>Introduction</h3> The eShunt Implant is a novel, endovascular cerebrospinal fluid (CSF) shunt developed to treat communicating hydrocephalus. The transdural Implant’s self-expanding anchor resides within the cerebellopontine angle subarachnoid cistern and tubular body resides within the inferior petrosal dural venous sinus, draining CSF into the internal jugular vein. A differential pressure valve allows 10 cc/hr CSF outflow at physiologic pressures and prevents backflow during transient retrograde pressure spikes. <h3>Aim of Study</h3> We present safety results through one-year in the first series of treated patients. <h3>Methods</h3> Patients across three different hydrocephalus etiologies were implanted: normal pressure hydrocephalus (NPH), intractable hydrocephalus post-aneurysmal subarachnoid hemorrhage (paSAH), and idiopathic intracranial hypertension (IIH). Radiologic evaluation by MR or CT and modified Rankin Scale (mRS) scoring occurred at one-year and was compared to baseline. <h3>Results</h3> Fourteen treated patients completed one-year follow-up: nine NPH (4 female; mean 75.7+/-7.3 years), four paSAH (3 female; mean 57.5+/-16.5 years), and one IIH (1 male, 50 years). No observations of radiologic or symptomatic overdrainage occurred. No instances of procedural or delayed subarachnoid, intraparenchymal or subdural hemorrhage occurred. Cross-sectional imaging immediately post-operatively compared to one-year confirmed Implant stability without antegrade or retrograde migration. mRS scores were either stable or improved compared to baseline. <h3>Conclusion</h3> The eShunt Implant was designed as a permanent implant to drain CSF into the venous system. These preliminary results indicate a potentially acceptable long-term safety profile for treating communicating hydrocephalus. A planned clinical trial will provide a comprehensive safety assessment in a large population of patients. <h3>Disclosure of Interest</h3> yes BB, CH, AM- CereVasc shareholders.
Authors
- Esteban Scrivano (ORCID: https://orcid.org/0000-0001-8824-9545)
- Pedro Nicolas Lylyk (ORCID: https://orcid.org/0000-0001-7044-4369)
- Adnan H. Siddiqui (ORCID: https://orcid.org/0000-0002-9519-0059)
- Carlos Bleise (ORCID: https://orcid.org/0000-0003-2292-3263)
- Brandon Beneduce
- Iván Lylyk (ORCID: https://orcid.org/0000-0002-6048-4225)
- Carl B. Heilman (ORCID: https://orcid.org/0000-0001-9744-1010)
- Adel M. Malek (ORCID: https://orcid.org/0000-0002-0642-7609)
- Howard A. Riina (ORCID: https://orcid.org/0000-0002-9303-8176)
- Joseph Antonios (ORCID: https://orcid.org/0000-0002-5147-1377)
- Charles Matouk (ORCID: https://orcid.org/0000-0003-3234-9541)
- Elad Levy
Institutions
- Tufts Medical Center (US)
- Yale New Haven Hospital (US)
- Medical University of the Americas (KN)
- Clínica Sagrada Esperança (AO)
- New York University (US)
- University at Buffalo, State University of New York (US)
Publication Details
- Journal
- Abstracts
- Published
- 2024-09-01
- DOI
- https://doi.org/10.1136/jnis-2024-esmint.14
- Primary Topic
- Cerebrospinal fluid and hydrocephalus
- Type
- article
- Field-Weighted Citation Impact
- 0.00