Abstract 531: A Prospective, Multicenter Study of the eShunt System for the Treatment of Normal Pressure Hydrocephalus
Bibliographic record
Abstract
Introduction Normal pressure hydrocephalus (NPH) is a condition of excess cerebrospinal fluid (CSF) in the brain, associated with a symptom triad of impaired gait, cognition, and urinary incontinence. Standard of care treatment for NPH is surgical placement of a ventriculoperitoneal (VP) shunt, performed through a burr hole in the skull, catheter passage through brain parenchyma, and subcutaneous catheter tunneling for placement in the peritoneum. The eShunt System is a novel, endovascular cerebrospinal fluid (CSF) shunting approach for the treatment of normal pressure hydrocephalus (NPH), performed using transvenous, transfemoral catheter access. We conducted a prospective, multicenter, single‐arm trial to study the safety and effectiveness of the eShunt System to treat patients with NPH. The trial has completed enrollment and follow‐up through the primary endpoint, assessed at 90‐day follow‐up. Methods NPH triad symptoms of gait, cognition, and urinary dysfunction were assessed at baseline and 90‐days to evaluate the degree of improvement after eShunt Implant placement. The Timed Up & Go (TUG) test assessed patient gait, measuring duration to rise from a chair, walk 3 meters around a marker, and return to sitting; the Montreal Cognitive Assessment (MoCA) assessed patient cognition; and the Neurogenic Bladder Symptom Score (NBSS)[1] assessed patient urinary dysfunction. Study inclusion criteria were > 20% TUG improvement after screening lumbar CSF withdrawal, an opening pressure > 8 cmH 2 O, and candidate anatomy on brain MRI and CT. Results Sixty‐six subjects (21 female; mean 75.4 +/‐ 5.0 years) were treated with sixty‐four completing 90‐day follow‐up. Sixty‐one out of sixty‐four (95.3%) patients met the efficacy endpoint of improvement in any one of the three NPH symptoms relative to baseline. Matched pair analysis demonstrated statistically significant mean improvements for each symptom assessment with decreased TUG time (37.2%; p<0.0001; n=63), improved MoCA score (+2.3 points; p<0.0001; n=61) and improved NBSS score (‐2.1 points; p=0.0017; n=61). Mean TUG improvement surpassed the established minimal clinically important difference of >16.5%. There were no instances of hemorrhage, over‐drainage, infection or device‐related serious adverse events (SAE). Two procedure‐related SAEs occurred (3.0%), one sigmoid sinus thrombosis and one femoral artery pseudoaneurysm, resolving without surgical intervention. Conclusion In this cohort of sixty‐six (66) patients, treatment of NPH using the eShunt System was safe and effective resulting in clinically meaningful improvements in gait, cognition, and urinary symptoms through 90 days. A low incidence of SAEs, without any observations of cerebral hemorrhage, overdrainage or infection support minimally‐invasive endovascular shunting as a promising alternative to conventional VP shunt surgery for the treatment of NPH. A randomized controlled trial comparing the eShunt System to a VP shunt control arm is ongoing and will provide further longer term safety and efficacy data. [1] Welk, B., et al. (2014). The validity and reliability of the neurogenic bladder symptom score. The Journal of Urology, 192(2), 452‐457. NBSS ©2013 Dr. Blayne Welk, All rights reserved. NBSS contact information and permission to use: https://www.nbrg.org/research/nbss/”
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".