Introduction Aneurysmal subarachnoid hemorrhage (aSAH) often necessitates the surgical placement of a ventriculo-peritoneal (VP) shunt surgery in the subset of patients with intractable elevated intracranial pressure not amenable to weaning of cerebrospinal fluid (CSF) external ventricular drainage (EVD). This is often performed on the contralateral frontal lobe with attendant risk of intraparenchymal hemorrhage and infection. Following our recent first use of the endovascular CSF shunt (eShunt® System; CereVasc, Inc., Auburndale, MA, USA) for aSAH-induced hydrocephalus, we hereby present initial single-center clinical experience with the eShunt implant in the post-aneurysmal hydrocephalus population.

Methods Patients were included in the study after demonstrating elevated sustained ICP upon clamping of EVD along with having favorable inferior petrosal sinus venous anatomy and lack of bony overgrowth to enable successful transdural eShunt deployment. ICP was measured continuously before and after deployment of the eShunt implant via the present EVD which was kept in place for 36-48 hours to evaluate for resolution of elevated ICP. Primary endpoint was reached when the ICP remained below 20 cmH₂O consistently at which point the EVD was removed. CT imaging of the brain was obtained immediately post-eShunt placement to evaluate eShunt placement and assess for any presence of new procedural hemorrhage.

Results Seven out of eight patients (5 female; mean age 64+/-12 years) underwent successful transfemoral transvenous eShunt™ placement at a mean of 25.3 days (Range 14-38) following initial aSAH. All seven patients achieved the primary endpoint enabling removal of all EVD catheters by 36-48 hours following eShunt placement. There were no cases of delayed hemorrhage in the follow-up period. Mean ICP (figure 1) rapidly decreased from pre-procedural clamping pressure of 33.4 to 13 cmH₂O within 1 hour (p<0.0001) and progressively decreased to 9 cmH₂O (p<0.0001) at 36 hours post eShunt transdural placement.

Conclusion The preliminary results of the first-in-human cohort study of the eShunt implant for treatment of intractable hydrocephalus confirm the concept of biomimetic shunting from the cerebello-pontine angle cistern to the jugular vein with all patients achieving the primary endpoint and normalized intracranial pressure. These encouraging results suggest a role for the eShunt system in the management of subarachnoid hemorrhage possibly eschewing the need for VP shunt surgery and enabling minimally invasive CSF diversion in patients requiring dual anti-platelet or anticoagulant therapy.

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Abstract O-038 Figure 1

Mean Intracranial Pressure (ICP) measurements of (n=7 patients) with aneurysmal subarachnoid hemorrhage-induced intractable communicating hydrocephalus following endovascular eShunt@ implant procedure

Disclosures P. Lylyk: 2; C; CereVasc. 3; C; CereVasc. I. Lylyk: None. C. Bleise: None. E. Scrivano: None. N. Lylyk: None. B. Beneduce: 5; C; CereVasc Inc. C. Heilman: 2; C; CereVasc Inc. 4; C; CereVasc Inc. A. Malek: 2; C; CereVasc Inc. 4; C; CereVasc Inc.