Introduction: Implantable 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. To 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.
Methods: Beginning in December 2017, seven preliminary cases were performed within the U.S. The sentinel case included a 64-year old male who 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 two weeks 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.
Results: First-in-human implantation was performed without complication in the first seven cases. Post-operative shunt identification and programming was uncomplicated. The high-profile nature of the shunt valve was decreased, on average, by 87%. At 15 months, none of the preliminary patients have experienced any complications to date and are all extremely satisfied with their appearance.
Conclusion: This first-in-human experience suggests that a high-profile, hydrocephalus shunt device may be safely integrated within a customized cranial implant.