O-037 One-year follow-up of the eShunt® System for the treatment of normal pressure hydrocephalus
Bibliographic record
Abstract
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.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".