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.

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Published
2024-09-01
DOI
https://doi.org/10.1136/jnis-2024-esmint.14
Primary Topic
Cerebrospinal fluid and hydrocephalus
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article
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article

O14 One-year safety of treating communicating hydrocephalus with the eShunt® implant

Esteban Scrivano, Pedro Nicolas Lylyk, Adnan H. Siddiqui, Carlos Bleise et al.
Abstracts
Cerebrospinal fluid and hydrocephalus
article

O14 One-year safety of treating communicating hydrocephalus with the eShunt® implant

Esteban Scrivano, Pedro Nicolas Lylyk, Adnan H. Siddiqui, Carlos Bleise, Brandon Beneduce, Iván Lylyk, Carl B. Heilman, Adel M. Malek, Howard A. Riina, Joseph Antonios, Charles Matouk, Elad Levy
article en

Abstract

<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.

Abstracts
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)
Openalex Percentile: Top 86%
Cerebrospinal fluid and hydrocephalus
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