Safety of endovascular shunting for normal pressure hydrocephalus from a prospective, multicenter, single-arm study.

OBJECTIVE

Normal pressure hydrocephalus (NPH) is a neurological condition characterized by impaired gait, cognitive decline, and urinary incontinence. Endovascular shunting using the eShunt Implant diverts cerebrospinal fluid (CSF) from basal cisterns to the internal jugular vein via a transvenous, transfemoral procedure. We report initial eShunt safety data for treatment of NPH through 90 days in a prospective, multicenter, single-arm trial.

METHODS

NPH participants indicated for endovascular shunt placement were included after exhibiting positive gait response to lumbar CSF withdrawal and candidate anatomy. NPH symptoms at baseline and following eShunt Implant placement were assessed using the Timed Up & Go (TUG) test for gait, Montreal Cognitive Assessment (MoCA) for cognition, and Neurogenic Bladder Symptom Score-Short Form (NBSS-SF) for urinary symptoms. The primary endpoint was the rate of device and/or procedure-related serious adverse events (SAE) at 90-day follow-up.

RESULTS

Sixty-six participants were treated with the eShunt Implant without immediate or delayed cerebral hemorrhage, over-drainage, infection or device-related SAEs. Two procedure-related SAEs (3.0%) occurred, one sigmoid sinus thrombosis and one femoral artery pseudoaneurysm, both resolved without surgical intervention. Matched-pair analysis showed statistically significant improvements in TUG time (37.2%; P<0.0001), MoCA score (+2.3; P<0.0001), and NBSS-SF score (-2.1; P<0.002).

CONCLUSIONS

Endovascular shunting for NPH was feasible with a low rate of SAEs typically associated with conventional shunt surgery. An acceptable clinical response through 90 days was observed. These findings suggest further investigation of this minimally invasive, endovascular approach to NPH in a randomized controlled trial comparing to standard of care.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifiers: NCT05250505 and NCT05232838.