Preliminary Results from the eShunt® System Pilot Study in idiopathic Normal Pressure Hydrocephalus

Sunday, May 5, 2024

4:13 PM – 4:17 PM CT

Location: S405a

Presenting Author(s)

Adel M. Malek, MD, PhD, MBA (he/him/his)

Chief, Neurovascular Surgery
Neurosurgery, Tufts Medical center. Tufts University School of Medicine
Boston, MA, US

Co-Author(s)

Joseph P. Antonios, MD, PhD

Resident
Yale Neurosurgery
New Haven, CT, US
BB

Brandon Beneduce, n/a

Product Manager
CereVasc, Inc., United States
CB

Carlos Bleise, MD

Interventional Neuroradiologist
Interventional Neuroradiology ENERI, Clinica La Sagrada Familia, Argentina
CH

Carl Heilman, MD

Neurosurgeon-in-Chief and Chair, Department of Neurosurgery; Chair and Professor
Department of Neurosurgery, Tufts Medical Center
Boston, Massachusetts, United States
Elad I. Levy, MD, MBA (he/him/his)

Neurosurgeon
University at Buffalo Neurosurgery
Williamsville, NY, US
IL

Ivan Lylyk, MD

Interventional Neuroradiologist
ENERI, Clinica La Sagrada Familia, Argentina
PL

Pedro Lylyk, MD

Professor, Chair, CEO
Clinica La Sagrada Familia
Buenos Aires, Argentina
CM

Charles Matouk, MD

Department Vice-Chair
Yale Neurosurgery
New Haven, Connecticut, United States
Howard A. Riina, MD

Neurosurgeon
NYU Langone Health
New York, NY, US
ES

Esteban Scrivano, MD

Interventional Neuroradiologist
Interventional Neuroradiology ENERI, Clinica La Sagrada Familia, Argentina
Adnan Siddiqui, MD PhD

Vice-Chairman and Professor of Neurosurgery
Department of Neurosurgery, University of Buffalo, SUNY
Buffalo, New York, United States

Disclosure(s):

Adel M. Malek, MD, PhD, MBA: CereVasc Inc.: Consultant (Ongoing), Stock Shareholder (excluding mutual funds) (Ongoing)

Joseph P. Antonios, MD, PhD: No financial relationships to disclose

Elad I. Levy, MD, MBA: ABNS: Board Member/Officer/Trustee (Ongoing); Claret Medical: Stock Shareholder (excluding mutual funds) (Ongoing); Clarion: Consultant (Ongoing); CNS: Board Member/Officer/Trustee (Ongoing); Cognition Medical: Advisor (Ongoing), Stock Shareholder (excluding mutual funds) (Ongoing); Endostream Medical : Advisor (Ongoing); GLG Consulting: Consultant (Ongoing); Guidepoint Global: Consultant (Ongoing); Haniva Technology: Board Member/Officer/Trustee (Ongoing); Imperative Care: Consultant (Ongoing), Stock Shareholder (excluding mutual funds) (Ongoing); Integra: Speaker/Honoraria (Ongoing); IRRAS AB: Advisor (Ongoing); MEDICAL LEGAL REVIEW: Consultant (Ongoing), Ownership or Partnership (Ongoing); Medtronic: Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (Ongoing); Medtronic (STRATIS STUDY-SUB I): Grant/Research Support (Ongoing); MEDX: Advisor (Ongoing); Microvention: Grant/Research Support (Ongoing), Speaker/Honoraria (Ongoing); Microvention (CONFIDENCE STUDY): Grant/Research Support (Ongoing); MISIONIX: Consultant (Ongoing); Mosaic: Consultant (Ongoing); NextGen Biologics: Advisor (Ongoing), Stock Shareholder (excluding mutual funds) (Ongoing); Penumbra: Speaker/Honoraria (Ongoing); Q'Apel: Stock Shareholder (excluding mutual funds) (Ongoing); Rapid Medical: Stock Shareholder (excluding mutual funds) (Ongoing); Rebound Therapeutics: Stock Shareholder (excluding mutual funds) (Ongoing); StimMed: Consultant (Ongoing), Stock Shareholder (excluding mutual funds) (Ongoing); STRYKER AIS CLINICAL ADVISORY BOARD: Advisor (Ongoing); Three Rivers Medical: Stock Shareholder (excluding mutual funds) (Ongoing); UBNS: Board Member/Officer/Trustee (Ongoing)

Introduction: idiopathic Normal Pressure Hydrocephalus (iNPH) is a potentially reversible form of dementia and one of the most common forms of adult hydrocephalus. Conventional treatment involves implantation of a ventriculo-peritoneal shunt which is invasive and plagued by significant complications, frequent hospital readmissions, and revision surgeries. Prospective, multicenter, pilot investigation of the first percutaneous endovascular cerebrospinal fluid shunt (eShunt System; CereVasc, Inc., Boston, MA, USA) was initiated in iNPH patients and here we present our clinical experience.

Methods: Patients were included after demonstrating sufficient gait improvement following lumbar drainage trial concomitant with favorable inferior petrosal sinus anatomy and absence of petrous bone overhang to enable successful Implant deployment. Assessed outcomes included gait using Timed Up & Go (TUG), cognitive function using Montreal cognitive assessment (MoCA), and urinary incontinence using Neurogenic Bladder Symptom Score (NBSS). Clinical examination occurred at post-operative 30-, 90-, and 180-days for comparison to baseline.

Results: Twenty-one patients (7 female; mean age 75.6+/-8.6 years) underwent successful percutaneous transdural Implant placement without technical complications. Confirmation of Implant deployment in the cerebello-pontine angle cistern and absence of subarachnoid/intraparenchymal hemorrhage was obtained using cone-beam CT. Improvement in at least one of the iNPH triad at 90 days compared to baseline was achieved in 88.2% (15/17) of patients. Significant gait improvement was observed at all time points using matched-pair analysis, by 32.1% at 30-days (n=17, P< 0.003), 31.3% at 90-days (n=17, p< 0.03), and 34.3% at 180-days (n=11, p< 0.01). 90.9% of eleven patients exhibited TUG improvement at 180-day follow-up evaluations.

Conclusion : In elderly patients affected by iNPH our results show that the endovascular transdural device can be safely implanted with significant sustained improvement in functional outcome scores. These positive early results suggest a potential future role for the less invasive percutaneous endovascular approach and warrant further device evaluation in a large pivotal trial.