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

Abstract

BACKGROUND Decompressive craniectomy is a lifesaving treatment for intractable intracranial hypertension. For patients who survive, a second surgery for cranial reconstruction (cranioplasty) is required. The effect of cranioplasty on intracranial pressure (ICP) is unknown. OBJECTIVE To integrate the recently Food and Drug Administration-approved, fully implantable, noninvasive ICP sensor within a customized cranial implant (CCI) for postoperative monitoring in patients at high risk for intracranial hypertension. METHODS A 16-yr-old female presented for cranioplasty 4-mo after decompressive hemicraniectomy for craniocerebral gunshot wound. Given the persistent transcranial herniation with concomitant subdural hygroma, there was concern for intracranial hypertension following cranioplasty. Thus, cranial reconstruction was performed utilizing a CCI with an integrated wireless ICP sensor, and noninvasive postoperative monitoring was performed. RESULTS Intermittent ICP measurements were obtained twice daily using a wireless, handheld monitor. The ICP ranged from 2 to 10 mmHg in the supine position and from −5 to 4 mmHg in the sitting position. Interestingly, an average of 7 mmHg difference was consistently noted between the sitting and supine measurements. CONCLUSION This first-in-human experience demonstrates several notable findings, including (1) newfound safety and efficacy of integrating a wireless ICP sensor within a CCI for perioperative neuromonitoring; (2) proven restoration of normal ICP postcranioplasty despite severe preoperative transcranial herniation; and (3) proven restoration of postural ICP adaptations following cranioplasty. To the best of our knowledge, this is the first case demonstrating these intriguing findings with the potential to fundamentally alter the paradigm of cranial reconstruction.

Reflections of six neuroscientists: The influences of training at minority serving institutions

“…Undoubtedly, by working in these systematic care teams, we can improve patient outcomes. One tangible example of this is the ability to embed various neuromodulatory devices within cranial implants, as we have shown with a wireless intracranial pressure monitor (Mitchell, Anderson, et al, 2020) and hydrocephalus shunts (Mitchell, Shay, Huggins, et al, 2020). My current research interests reflect my dual training as a physician and a neuroscientist, where my dissertation work focused on developing and characterizing one of the first described animal models of infection-induced epilepsy (Stewart et al, 2010a(Stewart et al, , 2010b.…”

Exploring the experiences and challenges for patients undergoing cranioplasty: a mixed-methods study protocol

“…However, a growing trend for an earlier cranioplasty results in timings within 3 months becoming increasingly common in some institutions. Apart from the apparent benefit of restoring a degree of mechanical protection to the brain, several studies suggest cranioplasty helps restore intracranial physiology, with a case study showing the integration of a wireless intracranial pressure monitor to aid in postoperative monitoring of these patients 5. These known pathophysiological manifestations and developing technologies help us better understand why there is often an improved neurological function6 following cranioplasty, with a growing body of evidence showing that an early cranioplasty can enhance this effect further.…”

The Safety of Micro-Implants for the Brain

“…Several discrete brain implants are currently in development, with functions varying from neuronal sensing and stimulating to pressure measurement ( Guenther et al, 2009 ; McCall et al, 2013 ; Benabid et al, 2019 ; Mitchell et al, 2020 ). Confidence in their safety has specific challenges and their long-term clinical use comes with novel risks.…”