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Abstract
Introduction Idiopathic Normal Pressure Hydrocephalus (NPH) is a potentially reversible form of dementia and one of the most common forms of adult hydrocephalus. Treatment has involved ventriculo-peritoneal shunt surgery (VPS) with associated risk of infection, revision, and over-drainage. We recently described the first percutaneous transfemoral deployment of an endovascular CSF shunt (eShunt® System; CereVasc, Inc., Auburndale, MA, USA), via transvenous approach to treat communicating hydrocephalus following subarachnoid hemorrhage. Here we present our initial multi-center clinical experience with use of the eShunt implant for treatment of NPH.
Methods Patients were included after demonstrating sufficient gait improvement following a lumbar drainage trial concomitant with favorable inferior petrosal sinus anatomy and absence of bony overhang to enable successful eShunt deployment. Outcomes were assessed for gait using the Timed Up & Go (TUG) test, cognitive function using the Montreal cognitive assessment (MoCA), and urinary incontinence using the Neurogenic Bladder Symptom Score (NBSS). Results were normalized on a per-patient basis to pre-treatment scores. A composite outcome score (COS) was computed with equally weighted changes in TUG/MOCA/NBSS. Clinical examination was performed pre- and post-treatment and at 30-, 90-, and 180-days. CT imaging of the brain was obtained immediately post-eShunt placement to rule out procedural hemorrhage.
Results Eleven patients (4 female; mean age 74.8+/-4.2 years) underwent successful percutaneous transdural eShunt™ placement without technical complications. Confirmation of eShunt malecot inflow zone in the cerebello-pontine angle cistern and absence of procedural subarachnoid/intraparenchymal hemorrhage was obtained using cone-beam computed tomographic imaging. Preliminary ongoing follow-up data has revealed significant improvement in gait with TUG test improving 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 (figure 1). 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). There have been no unexpected readmissions or revisions in patients who underwent eShunt procedure during this early follow-up phase.
Conclusion In elderly patients affected by NPH and its insidious effect on mobility, cognition and urinary continence, our results show that the endovascular transdural eShunt device can be safely implanted with an acceptable risk profile and with rapid significant improvement in functional outcome scores. These early follow-up results suggest a potential future role for the less invasive percutaneous endovascular approach provided by the eShunt system in the NPH patient population.
Timed Up & Go (TUG) gait assessment in patients following CereVasc eShunt@ implant placement at follow-up compared to pre-procedure baseline (100%)
Disclosures P. Lylyk: 2; C; CereVasc Inc. 3; C; CereVasc Inc. C. Matouk: None. A. Siddiqui: None. I. Lylyk: None. C. Bleise: None. E. Scrivano: None. N. Lylyk: None. J. Antonios: None. B. Beneduce: 5; C; CereVasc Inc. E. Levy: None. C. Heilman: 2; C; CereVasc Inc. 4; C; CereVasc Inc. A. Malek: 2; C; CereVasc Inc. 4; C; CereVasc Inc.