Industry payments to academic neurosurgeons in 2021: an open payments cross-sectional analysis.

OBJECTIVE: The Open Payments Program (OPP) was a database started in 2013 by the US government to report payments made by the medical device and pharmaceutical industry to physicians. Neurosurgery is a technologically advanced field that relies heavily on the latest innovations for complex treatment of its patient population. This study sought to explore the financial relationship between academic neurosurgeons and the industry. METHODS: OPP data were reviewed for the year 2021 of all faculty neurosurgeons affiliated with a neurosurgery residency program. Trends related to general payments, research payments, associated research funding, ownership and investment interest, name of the companies making payments, monetary amount of payments per company, and number of payments per company were analyzed. RESULTS: Industry payments to 1151 US academic neurosurgeons were reviewed. These neurosurgeons received $121.4 million in payments. Three hundred thirty-two companies made 18,466 payments. The average payment per neurosurgeon was approximately six-fold higher than that of all other physicians. Vascular and spine subspecialties received the highest payments. A higher proportion of research money was allocated to the Pacific division, while all other categories (including total amount) were higher in the Eastern US. Most financial contributions were made by a small number of companies. CONCLUSIONS: Neurosurgery has been rated by many as a field fueled by research, innovation, and technology. In 2021, academic neurosurgeons had a strong relationship with the medical device and pharmaceutical industry as reflected in the OPP data. While the true impact on patient care cannot be directly measured, the advancement of the field relies heavily on these collaborations.

Endoscopic endonasal obliteration of the frontal recess and anterior skull base.

BACKGROUND: Although endoscopic techniques have become more widespread in repair of frontal sinus (FS) defects, certain pathologies still require open approach (extensive trauma or tumors). Under certain circumstances even multiple complex open reconstructive procedures might fail to resolve persistent pneumocephalus or CSF leak and subsequently surgeons tend to escalate the invasiveness and employ even more complex and aggressive approaches. We present our experience treating persistent pneumocephalus or CSF leak after previously failed transcranial reconstruction utilizing an endoscopic endonasal approach (EEA). METHODS: We retrospectively reviewed a prospectively maintained database of all patients undergoing an EEA for repair of persistent pneumocephalus or CSF leak following FS cranialization between 2016 and 2020. RESULTS: Six patients who underwent cranialization of the FS with subsequent persistent pneumocephalus or CSF leak were identified; two patients suffered a traumatic fracture of the FS, remaining four patients had undergone previous cranial surgery. Clear violation of the FS was not recognized in one patient. All patients underwent cranialization of the FS either directly following initial craniotomy or during open repair of a FS fracture. Two patients underwent multiple transcranial surgeries including using vascularized free tissue transfer. Complete cessation of pneumocephalus/CSF leak was achieved in 83.3% (5/6) after the first and 100% (6/6) after two endoscopic procedures. No morbidity or mortality resulted from the endoscopic procedure. CONCLUSIONS: Skull base defects following a failed cranialization of FS are usually located in or in close proximity to the frontal recess. These defects can be safely and effectively repaired via an EEA.

Middle meningeal artery embolization following surgical evacuation of symptomatic chronic subdural hematoma improves outcomes, interim results of a prospective randomized trial.

BACKGROUND: Outcomes after surgical treatment of chronic subdural hematoma (cSDH) remain undesirable in a significant proportion of patients. We aimed to show the role of middle meningeal artery (MMA) embolization and to demonstrate its benefits. METHODS: Thirty-five patients with symptomatic cSDH were enrolled in a prospective randomized trial following evacuation surgery. Participants were randomized to embolization or control group (expectant management following surgical evacuation without embolization). Patients were followed throughout their hospitalization and outpatient follow-ups. The main goals of this planned interim analysis were to assess neurological outcome and resource utilization. RESULTS: The groups were comparable in terms of sex, age and follow-up retention rates. Side(s) of intervention(s) and hematoma size were similar. There was no statistical difference in neurological examination improvement at discharge, but at follow-up, we observed a decline in neurologic exam in the control group (p = 0.03). Control group participants required more re-interventions (p = 0.02) and were followed in clinic and during related readmissions for longer (p = 0.02). The number of imaging studies obtained in relation to the disease management was higher in the control group (p = 0.01). CONCLUSIONS: Our results suggest a beneficial role for the addition of MMA embolization to surgical intervention in the treatment of symptomatic chronic subdural hematoma. Neurological outcomes were significantly better in the embolization group. This contributed to less need for follow-up, re-interventions, and imaging studies.

No change in network connectivity measurements between separate rsfMRI acquisition times.

The role of resting state functional MRI (rsfMRI) is increasing in the field of epilepsy surgery because it is possible to interpolate network connectivity patterns across the brain with a high degree of spatial resolution. Prior studies have shown that by rsfMRI with scalp electroencephalography (EEG), an epileptogenic network can be modeled and visualized with characteristic patterns of connectivity that are relevant to both seizure-related and neuropsychological outcomes after surgery. The aim of this study is to show that a 5-min acquisition time provides reproducible results related to the relevant connectivity metrics when compared to a separately acquired 5-min scan. Fourteen separate rsfMRI sessions from ten different patients were used for comparison, comprised of patients with temporal lobe epilepsy both pre- and post-operation. Results showed that there was no significant difference in any of the connectivity metrics when comparing both 5-min scans to each other. These data support the continued use of a 5-min scan for epileptogenic network modeling in future studies because the inter-scan variability is sufficiently low as not to alter the output metrics characterizing the network connectivity.

Single episode of moderate to severe traumatic brain injury leads to chronic neurological deficits and Alzheimer's-like pathological dementia.

Traumatic brain injury (TBI) is one of the foremost causes of disability and mortality globally. While the scientific and medical emphasis is to save lives and avoid disability during acute period of injury, a severe health problem can manifest years after injury. For instance, TBI increases the risk of cognitive impairment in the elderly. Remote TBI history was reported to be a cause of the accelerated clinical trajectory of Alzheimer's disease-related dementia (ADRD) resulting in earlier onset of cognitive impairment and increased AD-associated pathological markers like greater amyloid deposition and cortical thinning. It is not well understood whether a single TBI event may increase the risk of dementia. Moreover, the cellular signaling pathways remain elusive for the chronic effects of TBI on cognition. We have hypothesized that a single TBI induces sustained neuroinflammation and disrupts cellular communication in a way that results later in ADRD pathology. To test this, we induced TBI in young adult CD1 mice and assessed the behavioral outcomes after 11 months followed by pathological, histological, transcriptomic, and MRI assessment. On MRI scans, these mice showed significant loss of tissue, reduced CBF, and higher white matter injury compared to sham mice. We found these brains showed progressive atrophy, markers of ADRD, sustained astrogliosis, loss of neuronal plasticity, and growth factors even after 1-year post-TBI. Because of progressive neurodegeneration, these mice had motor deficits, showed cognitive impairments, and wandered randomly in open field. We, therefore, conclude that progressive pathology after adulthood TBI leads to neurodegenerative conditions such as ADRD and impairs neuronal functions.

Clinical safety and feasibility of a novel implantable neuroimmune modulation device for the treatment of rheumatoid arthritis: initial results from the randomized, double-blind, sham-controlled RESET-RA study.

BACKGROUND: Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease that causes persistent synovitis, bone damage, and progressive joint destruction. Neuroimmune modulation through electrical stimulation of the vagus nerve activates the inflammatory reflex and has been shown to inhibit the production and release of inflammatory cytokines and decrease clinical signs and symptoms in RA. The RESET-RA study was designed to determine the safety and efficacy of an active implantable device for treating RA. METHODS: The RESET-RA study is a randomized, double-blind, sham-controlled, multi-center, two-stage pivotal trial that enrolled patients with moderate-to-severe RA who were incomplete responders or intolerant to at least one biologic or targeted synthetic disease-modifying anti-rheumatic drug. A neuroimmune modulation device (SetPoint Medical, Valencia, CA) was implanted on the left cervical vagus nerve within the carotid sheath in all patients. Following post-surgical clearance, patients were randomly assigned (1:1) to active stimulation or non-active (control) stimulation for 1 min once per day. A predefined blinded interim analysis was performed in patients enrolled in the study's initial stage (Stage 1) that included demographics, enrollment rates, device implantation rates, and safety of the surgical procedure, device, and stimulation over 12 weeks of treatment. RESULTS: Sixty patients were implanted during Stage 1 of the study. All device implant procedures were completed without intraoperative complications, infections, or surgical revisions. No unanticipated adverse events were reported during the perioperative period and at the end of 12 weeks of follow-up. No study discontinuations were due to adverse events, and no serious adverse events were related to the device or stimulation. Two serious adverse events were related to the implantation procedure: vocal cord paresis and prolonged hoarseness. These were reported in two patients and are known complications of surgical implantation procedures with vagus nerve stimulation devices. The adverse event of vocal cord paresis resolved after vocal cord augmentation injections with filler and speech therapy. The prolonged hoarseness had improved with speech therapy, but mild hoarseness persists. CONCLUSIONS: The surgical procedures for implantation of the novel neuroimmune modulation device for the treatment of RA were safe, and the device and its use were well tolerated. TRIAL REGISTRATION: NCT04539964; August 31, 2020.