Introduction/Purpose The eShunt System (CereVasc, Inc., Boston, MA, USA) is a novel endovascular cerebrospinal fluid shunt currently under pilot investigation for the treatment of normal pressure hydrocephalus (NPH). The System comprises a transdural implant to drain cerebrospinal fluid (CSF) from the cerebellopontine angle subarachnoid cistern into the venous system. The implant is deployed through a dedicated percutaneous transvenous delivery system under fluoroscopic guidance in the angiography suite. Two NPH clinical trials have been initiated, one in Argentina and one in the United States. We previously described follow-up data in the acute post-operative period and hereby present data on patients who have reached the one-year timepoint.

Materials and Methods Nine patients treated eShunt have been followed for at least one year post-operatively. Symptoms of the NPH triad of gait disturbance, cognitive impairment, and urinary incontinence were assessed and compared to baseline performance. The Timed Up & Go (TUG) test evaluated the duration for a patient to rise from a chair, walk 3 meters around a marker, and return to sit in the chair. The Montreal Cognitive Assessment (MoCA), a validated test administered by a certified assessor, scored cognitive function from 0 - 30 with a higher score representing improved performance. The Neurogenic Bladder Symptom Score (NBSS), a validated patient-reported scale, scored urinary symptoms from 0 - 28 with a lower score representing fewer symptoms. Patients were treated if they exhibited at least 20% TUG improvement following screening lumbar CSF withdrawal and candidate anatomy on brain MRI and CT.

Results All patients (4 female, 5 male; mean age 75.7±7.3 years) improved in at least one of the NPH triad components at one-year follow-up compared to baseline. Using matched-pair analysis, statistically significant improvement was observed in TUG time of 35.7% (p=0.003) and MoCA score of +1.6 points (p=0.043). NBSS score similarly improved by -3.6 points (p=0.118). Eight of nine (88.9%) patients exhibited gait improvement exceeding the established minimal clinically important difference (MCID) of 16.5% following conventional surgical CSF shunting for NPH.

Conclusions NPH patients treated with the eShunt System exhibit durable clinical improvement that was sustained at one-year follow-up. These preliminary long-term results suggest that minimally invasive, endovascular shunting for NPH may offer a promising alternative to conventional surgical shunting in this frail older patient population. Further clinical evaluation with additional patients is warranted to establish a more comprehensive device safety and efficacy profile.

Disclosures P. Lylyk: None. C. Matouk: None. A. Siddiqui: None. H. Riina: None. I. Lylyk: None. C. Bleise: None. E. Scrivano: None. P. Lylyk: None. J. Antonios: None. B. Beneduce: 4; C; CereVasc. 5; C; CereVasc. E. Levy: None. C. Heilman: 2; C; CereVasc. 4; C; CereVasc. A. Malek: 2; C; CereVasc. 4; C; CereVasc.