First-in-Human Experience With Integration of a Hydrocephalus Shunt Device Within a Customized Cranial Implant

Abstract

BACKGROUNDImplantable shunt devices are critical and life saving for hydrocephalus patients. However, these devices are fraught with high complication rates including scalp dehiscence, exposure, and extrusion. In fact, high shunt valve profiles are correlated with increased complications compared to those with lower profiles. As such, we sought a new method for integrating shunt valves for those challenging patients presenting with scalp-related complications.OBJECTIVETo safely implant and integrate a hydrocephalus shunt valve device within a customized cranial implant, in an effort to limit its high-profile nature as a main contributor to shunt failure and scalp breakdown, and at the same time, improve patient satisfaction by preventing contour deformity.METHODSA 64-yr-old male presented with an extruding hydrocephalus shunt valve and chronic, open scalp wound. The shunt valve was removed and temporary shunt externalization was performed. He received 2 wk of culture-directed antibiotics. Next, a contralateral craniectomy was performed allowing a new shunt valve system to be implanted within a low-profile, customized cranial implant. All efforts were made, at the patient's request, to decrease the high-profile nature of the shunt valve contributing to his most recent complication.RESULTSFirst-in-human implantation was performed without complication. Postoperative shunt identification and programming was uncomplicated. The high-profile nature of the shunt valve was decreased by 87%. At 10 mo, the patient has experienced no complications and is extremely satisfied with his appearance.CONCLUSIONThis first-in-human experience suggests that a high-profile hydrocephalus shunt device may be safely integrated within a customized cranial implant.

First-In-Human Experience With Integration of Wireless Intracranial Pressure Monitoring Device Within a Customized Cranial Implant

“…For instance, we described first-in-human experiences integrating neuromodulation devices and hydrocephalus shunts within CCIs. 13 , 14 Together with the current study, these reports demonstrate an obvious role for also integrating functional devices within cranial implants for improved neuromonitoring and biosensing. Indeed, technological advances in cardiac surgery have enabled real-time recording of heart rhythm signals via smart phone-compatible implanted sensors and signal transmission to a remote secure server for physician interpretation.…”

“…Besides the visual deformity, which can contribute to negative social stigma, this type of suboptimal design leads to supraphysiologic pressures on the overlying scalp, which, in turn, leads to localized ischemia and increased risk for device extrusion. 13 , 14 However, in a case such as the one presented here – severe brain herniation, encephalomalacia, subdural hygroma, and large cranial defect following hemicraniectomy decompression – the benefits of providing a cranial implant with an embedded wireless, ICP-monitoring device, far outweighed the risks. Furthermore, given the successful outcomes from this case, our team will remain dedicated to investigating different approaches for ICP sensor integration for improved outcomes and safety.…”

“… 11 , 12 Recently, as part of a new paradigm shift led by the burgeoning field of neuroplastic surgery, we have demonstrated newfound functionalities of CCIs by incorporating neurotechnology devices such as high-profile hydrocephalus shunts or neuromodulatory devices for refractory epilepsy. 13 , 14 These advances are based on strategic utilization of the skull space, with the accompanying benefits of reducing scalp-related complications and preventing visible contour deformity, extrusion, infection, and explantation. With this in mind, our objective was to integrate the first ever FDA-approved wireless ICP monitoring device within a CCI (acronym “LID-ICP,” for “low-profile intracranial device for ICP monitoring”) for utilization in patients at risk for intracranial hypertension after cranioplasty.…”

How Should Risk Managers Respond to Cases for Which No Risk Profile Exists?

“…Similar technology has already been utilized by neurosurgeons for other types of implanted devices, such as deep brain stimulators. 6 These potential benefits appear significant in the case, in large part because the patient has already experienced dehiscence and a need for revision, which, as noted above, could increase this patient's morbidity and mortality risk. Identifying specific subpopulations of patients who could benefit most from implantation of a novel device is a key next step in MM and Dr N's risk-assessment process.…”

“…5 Mortality for revision surgery is much higher than for first implantations (11.9 % vs 6.1%, respectively), and need for revision alone increases the incidence of subsequent shunt revision 9-fold. 5,6 A new device, which could possibly decrease the risk of complications and shunt revision, could offer significant potential benefits for this patient.…”