Objective:

Describe interim safety and efficacy results from a pilot investigation of a novel, endovascular cerebrospinal fluid (CSF) shunt system for treating communicating hydrocephalus following aneurysmal subarachnoid hemorrhage (aSAH).

Background:

aSAH often necessitates surgical placement of a ventriculo-peritoneal shunt in patients with intractable elevated intracranial pressure (ICP) not amenable to cerebrospinal fluid (CSF) external ventricular drain (EVD) weaning. We previously reported first use of an endovascular CSF shunt to treat aSAH-induced hydrocephalus and here we present additional patients treated with the novel device.

Design/Methods:

Patients were included after demonstrating elevated sustained ICP upon EVD clamping, with favorable venous and osseous anatomy allowing for successful transdural Implant deployment. ICP was measured continuously before and after Implant deployment via the pre-existing, clamped  EVD, which remained in place for 36-48 hours to evaluate for resolution of elevated ICP. The primary endpoint was consistent ICP maintenance below 20 cmH2O, at which point the EVD was removed. CT imaging immediately post-operatively confirmed Implant placement and observations of any new procedural hemorrhage.

Results:

Nine patients (6 female; mean 62.6+/-21.4 years) underwent successful transfemoral transvenous Implant placement at a mean 28.7 days following initial aSAH. All patients achieved the primary endpoint, enabling EVD removal 36-48 hours following Implant placement. No cases of delayed hemorrhage occurred in the follow-up period. Mean ICP rapidly decreased from pre-procedural clamping pressure of 34.4 to 10.8 cmH2O within 1 hour (p<0.0001) and remained within the normal range at 10.9 cmH2O (p<0.0001) 36 hours post-Implant placement.  

Conclusions:

These preliminary pilot results demonstrate that this novel, endovascular CSF shunt system can be safely implanted resulting in rapid, sustained ICP reduction in the setting of intractable hydrocephalus. This suggests a potential future role for the device in the management of aSAH and a safe CSF shunting option for patients requiring dual anti-platelet or anticoagulant therapy.