Downloaded from http://journals.lww.com/jcraniofacialsurgery by BhDMf5ePHKbH4TTImqenVL1JTkTFNsTAh+5kQd4LJE+knWeg37lcbdzHp9npOk97 on 10/11/2020 Investigation of a Valve-Agnostic Cranial Implant for Adult Hydrocephalus Patients Requiring Ventriculoperitoneal Shunting Kerry-Ann S. Mitchell, MD, PhD,  Tamir Shay, MD,  Charity Huggins, BS,  Christina R. Maxwell, PhD, y Hirad Hedayat, MD, z Judy Huang, MD, § Kenneth Liebman, MD, zjj Mark Luciano, MD, PhD, § Erol Veznedaroglu, MD, zjj and Chad Gordon, DO  Introduction: Currently, the most effective treatment strategy for adults with hydrocephalus involves cerebrospinal fluid diversion by means of a shunt system, most commonly ventriculoperitoneal shunts (VPS). Ventriculoperitoneal shunting is associated with high complication and/or revision rates, in part due to the high-profile programmable valve designs. Thus, the valve-agnostic cranial implant (VACI) was designed and investigated as a safe and effective method of reducing the valve’s high profile and is currently undergoing clinical trials. As such, the objective of this study was to collate preliminary, multi-institutional data of early outcomes using a VACI approach for patients requiring VPS by way of an Institutional Review Board approved registry. Methods: A total of 25 adult patients across 4 institutions and 6 surgeons underwent VACI placement for VPS based on preoperative evaluation and perceived benefit. Patient demographics, operative details, and preliminary outcomes are presented here. Results: Valve-agnostic cranial implant placement via a limited size craniectomy at time of shunt revision was performed with no adverse events. Over an average follow-up period of 1 year (394  178 days), 92% of patients experienced no major shunt- related or scalp-related complications. There were 2 cases with a major complication requiring reoperation: 1 shunt tubing extrusion and 1 case of meningitis. The most frequent postsurgical intervention seen in this study was related to adjustment of drainage: a non- invasively performed valve reprogramming after initial shunt placement when proper flow rate is being established. Of the 8 cases of drainage adjustment, all but 1 (88%) were receiving a VPS for the first time, with the exception undergoing a fourth shunt revision. All instances of improper flow were treated non-surgically and remediated effectively via shunt reprogramming in clinic. Removal of the VACI was not indicated in any treatment course. In this way, all complications as they relate to the shunt valve were minor and required nonsurgical intervention, and no complications reported were directly or indirectly caused by using the VACI. Conclusion: Preliminary findings from this multicenter trial suggest promising outcomes with a low complication rate for patients with hydrocephalus undergoing VACI placement during VPS. Ongoing research will continue to provide a more robust clinical picture of VACI in hydrocephalus management as more data becomes available. Key Words: Cranial, cranioplasty, deformity, hydrocephalus, implant, shunt, shunt, valve (J Craniofac Surg 2020;31: 1998–2002) C linically defined as the abnormal dilation of the cerebral ventricles with pathologic accumulation of cerebrospinal fluid (CSF), hydrocephalus affects over one million Americans, with an estimated global prevalence of 85/100,000. 1 The etiologies include congenital, acquired, and idiopathic forms, and disease severity encompass a wide range of symptoms. Left untreated, hydrocepha- lus can result in progressive neurological damage and death, making it a major contributor to worldwide morbidity and mortality. 2,3 Despite its severity and prevalence, relatively small advances and improvement in clinical practice or treatment have been made in the past fifty years, and there remains no known cure. 4 Presently, the mainstay of hydrocephalus management in adults remains CSF diversion with shunting, most commonly ventriculoperitoneal shunts (VPS) with high-profile valve designs and programmable From the  Section of Neuroplastic and Reconstructive Surgery, Depart- ments of Plastic Surgery and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD; y Global Neuroscience Institute, Poughkeepsie, NY; z Department of Neurosurgery, Global Neuroscience Institute, Philadelphia, PA; § Department of Neurosurgery, Johns Hop- kins University School of Medicine, Baltimore, MD; and jj Department of Neurosurgery, Drexel University College of Medicine, Philadelphia, PA. Received February 18, 2020. Accepted for publication April 29, 2020. Address correspondence and reprint requests to Chad Gordon, DO, Section Chief, Neuroplastic and Reconstructive Surgery, Associate Professor of Plastic Surgery and Neurosurgery, Johns Hopkins University School of Medicine, JHOC, 8th Floor, 601 N. Caroline Street, Baltimore, MD 21287; E-mail: cgordon@jhmi.edu KASM and TS are co-first authors. Dr. Huang is a stockholder in Longeviti Neuro Solutions. Dr. Veznedaroglu is a paid consultant for Longeviti Neuro Solutions. Under a licensing agreement between Longeviti Neuro Solutions, LLC and the Johns Hopkins University, both the University and Dr Gordon are entitled to royalty distributions on technologies described in this publication. Dr Gordon is a co-founder of Longeviti Neuro Solutions, owns equity in the company, and is a paid consultant to the company. This arrangement has been reviewed and approved by the Johns Hopkins University in accor- dance with its conflict of interest policies. None of the other authors have any relevant disclosures. Supplemental digital contents are available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.jcraniofa- cialsurgery.com). This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Copyright # 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Mutaz B. Habal, MD ISSN: 1049-2275 DOI: 10.1097/SCS.0000000000006730 CLINICAL STUDY 1998 The Journal of Craniofacial Surgery  Volume 31, Number 7, October 2020