Introduction Idiopathic Normal Pressure Hydrocephalus (NPH) is a reversible form of dementia typically treated with ventriculo-peritoneal shunt surgery. Recently we have described the first percutaneous transfemoral transvenous deployment of an endovascular CSF shunt (eShunt® System; CereVasc, Inc., Auburndale, MA, USA) to treat communicating hydrocephalus.
Aim of Study We sought to evaluate the response of NPH to endovascular eShunt implant deployment in an initial multi-center clinical pilot trial using gait, bladder and cognitive outcome measures.
Methods Patients were included after demonstrating >20% gait improvement in lumbar drainage trial. Gait was assessed using Timed Up & Go (TUG) test, cognition using Montreal cognitive assessment (MoCA), and urinary incontinence using Neurogenic Bladder Symptom Score (NBSS). Results were normalized per-patient to pre-treatment scores. A composite outcome score (COS) incorporating TUG/MOCA/NBSS was computed.
Results Eleven patients (4 female; mean age 74.8+/-4.2 years) underwent successful eShunt placement. Follow-up data showed significant improvement in gait by 35.4% at 30-days (n=6, P<0.003), 24.8% at 90-days (n=6, p<0.03) and by 32.8% at 180-days (n=4, p<0.01) compared to baseline. MOCA and NBSS showed significant improvements at 30-days and the COS was significantly improved at all time points (p<0.005 at 30-, 90- and 180-days). No procedural/delayed hemorrhage or unexpected readmissions were encountered during this early follow-up phase.
Conclusion In elderly patients affected by NPH and its insidious effect on mobility, cognition and urinary continence, these results show that the endovascular eShunt implant can be safely deployed with a favorable risk profile and with rapid and sustained improvements in functional outcome scores.
Disclosure of Interest A. Malek and C. Heilman are co-founders, shareholders, investors and consultants
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