Article Text
Abstract
Introduction 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.
Aim of Study We present safety results through one-year in the first series of treated patients.
Methods 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.
Results 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.
Conclusion 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.
Disclosure of Interest yes BB, CH, AM- CereVasc shareholders.