P-031 One-year safety of the eShunt® implant used in the treatment of communicating hydrocephalus
Year: 2024
Type: conference-abstract
Abstract: Introduction/Purpose The eShunt Implant (CereVasc, Inc., Boston, MA, USA) is a novel endovascular cerebrospinal fluid (CSF) shunt developed for the treatment of communicating hydrocephalus. The transdural Implant is comprised of a self-expanding nitinol anchor intended to deploy within the cerebellopontine angle subarachnoid cistern and a smooth, tubular polymer shunt body residing within the inferior petrosal dural venous sinus with CSF drainage in the internal jugular vein. A differential pressure slit valve at the end of the shunt allows 10 cc/hr cerebrospinal fluid outflow at physiologic pressure conditions preventing venous blood backflow during transient retrograde pressure spikes. Acute safety and efficacy data has been previously reported. We hereby present safety results through one-year follow-up in the first series of communicating hydrocephalus patients treated with the implant. Materials and Methods The eShunt has been implanted in patients of three different hydrocephalus etiologies: normal pressure hydrocephalus (NPH), intractable hydrocephalus post-aneurysmal subarachnoid hemorrhage (aSAH), and idiopathic intracranial hypertension (IIH). Fourteen total patients have been treated and followed for a period of one year; nine (9) in ongoing NPH clinical trials (4 female and 5 male; mean age 75.7±7.3 years), four in an ongoing aSAH clinical trial (3 female, 1 male; mean age 57.5±16.5 years), and one IIH compassionate use case (1 male, age 50 years). All patients underwent radiologic evaluation by either MR or CT at the one-year follow-up visit. Modified Rankin Scale (mRS) scoring was recorded and compared to baseline. Results Through one-year follow-up in fourteen patients no observations of radiographic or symptomatic overdrainage or subdural hygromas were detected. There were no instances of procedural or delayed subarachnoid, intraparenchymal or subdural hemorrhage. Cross-sectional imaging immediately post-operatively compared to one-year confirmed stability of the Implant without antegrade or retrograde migration. mRS scores were either stable or improved at one-year relative to baseline. Conclusions The eShunt Implant has been designed for permanent implantation to drain cerebrospinal fluid into the venous system. These preliminary results indicate a potentially acceptable safety profile for long-term use in the treatment of communicating hydrocephalus. A planned clinical trial will provide a more comprehensive safety assessment in a large population of patients. Disclosures P. Lylyk: None. C. Matouk: None. A. Siddiqui: None. H. Riina: None. I. Lylyk: None. C. Bleise: None. E. Scrivano: None. P. Lylyk: None. J. Antonios: None. B. Beneduce: 4; C; CereVasc. 5; C; CereVasc. E. Levy: None. C. Heilman: 2; C; CereVasc. 4; C; CereVasc. A. Malek: 2; C; CereVasc. 4; C; CereVasc.
Authors: P Lylyk, C Matouk, A Siddiqui, H Riina, I Lylyk, C Bleise, E Scrivano, P Lylyk, J Antonios, B Beneduce, E Levy, C Heilman, A Malek
Language: English
Subfield: Cellular and Molecular Neuroscience
Field: Neuroscience
Domain: Life Sciences
Open Access status: bronze
OpenAlex ID: W4400892946