Objective:

Describe interim safety and efficacy results from a prospective, multicenter, pilot investigation of a novel, minimally invasive, endovascular cerebrospinal fluid (CSF) shunting system for treatment of idiopathic Normal Pressure Hydrocephalus (iNPH).

Background:

iNPH is a potentially reversible form of dementia and one of the most common forms of adult hydrocephalus. Conventional treatment involves ventriculo-peritoneal shunt surgery which is invasive and plagued by significant complications, frequent hospital readmissions, and need for revisions. We describe our initial clinical experience with a minimally invasive, percutaneous, transvenous endovascular biomimetic CSF shunt system.

Design/Methods:

Patients were included after demonstrating a clinical presentation consistent with iNPH, including ventriculomegaly, and gait improvement following a lumbar drainage trial. Outcomes were assessed for gait using Timed Up & Go (TUG) test, cognitive function using Montreal cognitive assessment (MoCA), and urinary incontinence using Neurogenic Bladder Symptom Score (NBSS). Clinical examination occurred at post-operative 30-, 90-, and 180-days for comparison to baseline.

Results:

Nineteen patients (7 female; mean age 75.2+/-8.8 years) underwent successful percutaneous transdural Implant placement without technical complications. Confirmation of Implant location in the cerebello-pontine angle cistern and absence of subarachnoid/intraparenchymal hemorrhage was obtained using cone-beam CT. Improvement in at least one of the iNPH triad at 90 days compared to baseline was achieved in 93.8% (15/16) of patients completing 90-day follow-up evaluations. Significant gait improvement was observed at all time points using matched-pair analysis, by 32.1% at 30-days (n=17, P<0.003), 33.3% at 90-days (n=16, p<0.03), and 39.0% at 180-days (n=9, p<0.01).

Conclusions:

In elderly patients affected by iNPH, our results show that this minimally invasive endovascular device can be safely implanted resulting in rapid and significant improvement in functional outcome scores. These positive pilot results suggest a potential future role for this less invasive percutaneous endovascular approach and warrant further evaluation in a larger pivotal trial.