Analysis of reported adverse events of pipeline stents for intracranial aneurysms using the FDA MAUDE database.

OBJECTIVE: Flow diverting stents (FDS) are a validated device in the treatment of intracranial aneurysms, allowing for minimally invasive intervention. However, after its approval for use in the United States in 2011, post-market surveillance of adverse events is limited. This study aims to address this critical knowledge gap by analyzing the FDA Manufacturer and User Facility Device Experience (MAUDE) database for patient and device related (PR and DR) reports of adverse events and malfunctions. METHODS: Using post-market surveillance data from the MAUDE database, PR and DR reports from January 2012-December 2021 were extracted, compiled, and analyzed with R-Studio version 2021.09.2. PR and DR reports with insufficient information were excluded. Raw information was organized, and further author generated classifications were created for both PR and DR reports. RESULTS: A total of 2203 PR and 4017 DR events were recorded. The most frequently reported PR adverse event categories were cerebrovascular (60%), death (11%), and neurological (8%). The most frequent PR adverse event reports were death (11%), thrombosis/thrombus (9%) cerebral infarction (8%), decreased therapeutic response (7%), stroke/cerebrovascular accident (6%), intracranial hemorrhage (5%), aneurysm (4%), occlusion (4%), headache (4%), neurological deficit/dysfunction (3%). The most frequent DR reports were activation/positioning/separation problems (52%), break (9%), device operates differently than expected (4%), difficult to open or close (4%), material deformation (3%), migration or expulsion of device (3%), detachment of device or device component (2%). CONCLUSIONS: Post-market surveillance is important to guide patient counselling and identify adverse events and device problems that were not identified in initial trials. We present frequent reports of several types of cerebrovascular and neurological adverse events as well as the most common device shortcomings that should be explored by manufacturers and future studies. Although inherent limitations to the MAUDE database are present, our results highlight important PR and DR complications that can help optimize patient counseling and device development.

MedCDI: A technology-based documentation and quality improvement initiative in neurosurgery.

Background: Clinical documentation of patient care alters coding accuracy of Medicare Severity Diagnosis-Related Groups (MS-DRGs), expected mortality, and expected length of stay (LOS) which impact quality metrics. We aimed to determine if neurosurgical quality metrics could be improved by facilitating accurate documentation and subsequently developed a mobile application and educational video to target areas of opportunity. Methods: Vizient software was used to analyze MS-DRGs and expected LOS for sample of patients requiring surgery for spinal pathology, brain tumors, and subarachnoid hemorrhage (SAH) between January 2019 and August 2021. Chart reviews were conducted to discover variables missed by documenting provider and/or coder. Results: Review of 114 spinal surgeries, 20 brain tumors, and 53 SAH patients revealed at least one additional variable impacting LOS in 43% of spine, 75% of brain tumor, and 92% of SAH patients, with an average of 1 (1.25), 2 (1.75), and 3 (2.89) new variables, respectively. Recalculated expected LOS increased by an average of 0.86 days for spine, 3.08 for brain tumor, and 6.46 for SAH cases. Conclusion: Efforts to accurately document patient care can improve quality metrics such as expected LOS, mortality, and cost estimates. We determined several missing variables which impact quality metrics, showing opportunity exists in neurosurgical documentation improvement. Subsequently, we developed an educational video and mobile-supported application to specifically target these variables. To the best of our knowledge, this represents the first initiative to utilize the proven powers of mobile phones in health care toward the novel application of specifically improving neurosurgical quality metrics.

Endovascular treatment of a sacral dural arteriovenous fistula.

Spinal dural arteriovenous fistula (SDAVF) is a rare pathological communication between arterial and venous vessels within the spinal dural sheath. Clinical presentation includes progressive spinal cord symptoms including gait difficulty, sensory disturbances, changes in bowel or bladder function, and sexual dysfunction. These fistulas are most often present in the thoracolumbar region. Diagnoses of SDVAFs are commonly missed, possibly due to the low index of suspicion, non-specific symptoms and challenging imaging. In this case report, we describe a rare presentation of a sacral SDAVF which was detected by collective efforts between endovascular neurosurgery and interventional radiology. We outline the diagnostic and imaging challenges we faced to discover the fistula. In particular, mechanical pump injection instead of hand injection during angiography was required to reveal the fistula. Following identification, the fistula was successfully treated endovascularly by using onyx (ethylene vinyl alcohol glue), a less invasive alternative to surgical intervention.

Prevalence of Potentially Clinically Significant Magnetic Resonance Imaging Findings in Athletes with and without Sport-Related Concussion.

Previous studies have shown that mild traumatic brain injury (mTBI) can cause abnormalities in clinically relevant magnetic resonance imaging (MRI) sequences. No large-scale study, however, has prospectively assessed this in athletes with sport-related concussion (SRC). The aim of the current study was to characterize and compare the prevalence of acute, trauma-related MRI findings and clinically significant, non-specific MRI findings in athletes with and without SRC. College and high-school athletes were prospectively enrolled and participated in scanning sessions between January 2015 through August 2017. Concussed contact sport athletes (n = 138; 14 female [F]; 19.5 ± 1.6 years) completed up to four scanning sessions after SRC. Non-concussed contact (n = 135; 15 F; 19.7 ± 1.6) and non-contact athletes (n = 96; 15 F; 20.0 ± 1.7) completed similar scanning sessions and served as controls. Board-certified neuroradiologists, blinded to SRC status, reviewed T1-weighted and T2-weighted fluid-attenuated inversion recovery and T2*-weighted and T2-weighted images for acute (i.e., injury-related) or non-acute findings that prompted recommendation for clinical follow-up. Concussed athletes were more likely to have MRI findings relative to contact (30.4% vs. 15.6%; odds ratio [OR] = 2.32; p = 0.01) and non-contact control athletes (19.8%; OR = 2.11; p = 0.04). Female athletes were more likely to have MRI findings than males (43.2% vs. 19.4%; OR = 2.62; p = 0.01). One athlete with SRC had an acute, injury-related finding; group differences were largely driven by increased rate of non-specific white matter hyperintensities in concussed athletes. This prospective, large-scale study demonstrates that <1% of SRCs are associated with acute injury findings on qualitative structural MRI, providing empirical support for clinical guidelines that do not recommend use of MRI after SRC.

Primary Intracranial Synovial Sarcoma.

Background. Synovial sarcoma is an aggressive soft tissue sarcoma with uncertain histological origin. The pathology frequently presents as a localized disease, especially near large joints around the knee and thigh. Intracranial disease, which is rare, has been reported as metastasis from synovial sarcoma. We report a case with no obvious primary extracranial pathology, suggesting primary intracranial disease; this has not been reported in the literature. Case Description. A 21-year-old male, with a prior right skull lesion resection for atypical spindle cell neoplasm, presented with headaches, gait instability, left arm weakness, and left homonymous hemianopsia. CT of head demonstrated a right parietal hemorrhagic lesion with mass effect, requiring surgical decompression. Histopathology revealed synovial sarcoma. FISH analysis noted the existence of the t(X;18)(p11.2;q11.2) chromosomal translocation. PET scan did not show other metastatic disease. He underwent stereotactic radiotherapy and adjuvant chemotherapy. At 2-year follow-up, he remained nonfocal without recurrence. Conclusion. We report the first known case of primary intracranial synovial sarcoma. Moreover, we stress that intracranial lesions may have a tendency for hemorrhage, requiring urgent lifesaving decompression.

Effect of treatment modality on the hypothalamic-pituitary function of patients treated with radiation therapy for pituitary adenomas: hypothalamic dose and endocrine outcomes.

BACKGROUND: Both fractionated external beam radiotherapy and single fraction radiosurgery for pituitary adenomas are associated with the risk of hypothalamic-pituitary (HP) axis dysfunction. OBJECTIVE: To analyze the effect of treatment modality (Linac, TomoTherapy, or gamma knife) on hypothalamic dose and correlate these with HP-axis deficits after radiotherapy. METHODS: Radiation plans of patients treated post-operatively for pituitary adenomas using Linac-based 3D-conformal radiotherapy (CRT) (n = 11), TomoTherapy-based intensity modulated radiation therapy (IMRT) (n = 10), or gamma knife stereotactic radiosurgery (n = 12) were retrospectively reviewed. Dose to the hypothalamus was analyzed and post-radiotherapy hormone function including growth hormone, thyroid stimulating hormone, adrenocorticotropic hormone, prolactin, and gonadotropins (follicle stimulating hormone/luteinizing hormone) were assessed. RESULTS: Post-radiation, 13 of 27 (48%) patients eligible for analysis developed at least one new hormone deficit, of which 8 of 11 (72%) occurred in the Linac group, 4 of 8 (50%) occurred in the TomoTherapy group, and 1 of 8 (12.5%) occurred in the gamma knife group. Compared with fractionated techniques, gamma knife showed improved hypothalamic sparing for DMax Hypo and V12Gy. For fractionated modalities, TomoTherapy showed improved dosimetric characteristics over Linac-based treatment with hypothalamic DMean (44.8 vs. 26.8 Gy p = 0.02), DMax (49.8 vs. 39.1 Gy p = 0.04), and V12Gy (100 vs. 76% p = 0.004). CONCLUSION: Maximal dosimetric avoidance of the hypothalamus was achieved using gamma knife-based radiosurgery followed by TomoTherapy-based IMRT, and Linac-based 3D conformal radiation therapy, respectively.

Multimodal endovascular therapy of traumatic and spontaneous carotid cavernous fistula using coils, n-BCA, Onyx and stent graft.

BACKGROUND AND PURPOSE: Carotid cavernous fistula (CCF) can be classified as either direct or indirect according to the arterial feeder source. The current standard treatment for CCF is endovascular embolization. In this case series, 21 CCF (direct and indirect) embolization procedures were treated with multimodal endovascular therapy to explore safety, technique and clinical efficacy. METHOD AND PATIENTS: The neurointerventional database was reviewed for all cases of CCF. Demographic information, indications for the procedure, presenting symptoms, endovascular therapy types, complications and procedure angiographic and clinical efficacy were collected. RESULTS: 21 CCF embolization procedures were performed using multimodal therapy on 15 patients (eight females and seven males) with a mean age of 56.4±22.4 years (15-90 years), with 60% traumatic CCF and 40% spontaneous CCF presenting mainly with typical visual symptoms. 10 patients were treated in one session, four patients underwent two sessions and one required three sessions of endovascular therapy. Complete fistula occlusion was achieved in 10/15 patients (73.3%) in one session and in 14/15 (93.3%) patients after two or more sessions. One patient's symptoms (case No 15) improved dramatically after the second session despite incomplete obliteration of the CCF. No periprocedural complications were reported. Long term follow-up showed one recurrence of the CCF with a mean follow-up time of 201±17.2 months (range 1-56 months). Patient No 6 was lost to follow-up. CONCLUSION: Multimodal endovascular embolization of CCF appears to be safe with a high success rate of complete obliteration. This case series demonstrates complete occlusion in 73.3% of the patients after one session and in 93.3% after the second session.

Vasopressors and propofol infusion syndrome in severe head trauma.

INTRODUCTION: Propofol infusion syndrome (PRIS) is a rare, but lethal complication of high-dose propofol infusions. We undertook this study to evaluate the incidence of PRIS in a cohort of patients with severe head trauma and its relation to the use of vasopressors. METHODS: We reviewed all patients with severe head trauma admitted to our Neuro-Intensive Care Unit over a 4-year period for use of propofol and vasopressors. Those patients who developed unexplained acidosis, creatine kinase elevation unrelated to trauma, and electrocardiographic changes were considered having PRIS. We investigated the concomitant use of vasopressors while propofol was used and calculated odds ratios for developing PRIS. RESULTS: We report three adult patients who developed PRIS out of 50 (6%) admitted patients with severe head trauma on propofol infusions. Two of these patients survived and one expired after withdrawal of life support. Concomitant use of vasopressors was associated with development of PRIS in this cohort (odds ratio 29, 95% CI 1.5-581, P < 0.05). CONCLUSIONS: Awareness and early recognition of PRIS in critically ill neurosurgical patients on vasopressors and daily screening for creatine kinase elevation, unexplained acidosis, or electrocardiographic changes may reduce the incidence and case-fatality.

Subdural hematomas in chronic dialysis patients: significant and increasing.

BACKGROUND AND OBJECTIVES: Subdural hematoma is a known complication of long-term hemodialysis. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: The US Renal Data System was used to determine the occurrence rate of nontraumatic subdural hematoma in long-term dialysis patients and to evaluate time trends. RESULTS: The occurrence rate of subdural hematoma in long-term dialysis patients is 10 times higher than that of the general population. From 1991 to 2002, the occurrence rate of subdural hematoma in hemodialysis patients doubled, whereas it did not change in peritoneal dialysis patients. CONCLUSIONS: This high occurrence rate of subdural hematoma and its recent increase may be related to increased use of anticoagulants in long-term hemodialysis patients.

Biomechanical characterization of internal layer subfailure in blunt arterial injury.

Blunt carotid artery injuries occur in 0.3% of blunt injured patients and may lead to devastating neurological consequences. However, arterial mechanics leading to internal layer subfailure have not been quantified. Twenty-two human carotid artery segments and 18 porcine thoracic aorta segments were opened to expose the intimal side and longitudinally distracted to failure. Porcine aortas were a geometrically accurate model of human carotid arteries. Internal layer subfailures were identified using videography and correlated with mechanical data. Ninety-three percent (93%) of vessels demonstrated subfailure prior to catastrophic failure. All subfailures occurred on the intimal surface. Initial subfailure occurred at 79% of the stress and 85% of the strain to catastrophic failure in younger porcine specimens, compared to 44% and 60%, respectively, in older human specimens. In most cases, multiple subfailures occurred prior to catastrophic failure. Due to limitations in human specimen quality (age, prior storage), young and fresh porcine aorta specimens are likely a more accurate model of clinical blunt carotid artery injuries. Present results indicate that vessels are acutely capable of maintaining physiologic function following initial subfailure. Delayed symptomatology commonly associated with blunt arterial injuries is explained by this mechanics-based and experimentally quantified onset of subcatastrophic failure.

Clipping or coiling of ruptured cerebral aneurysms and shunt-dependent hydrocephalus.

BACKGROUND: Hydrocephalus may develop either early in the course of aneurysmal subarachnoid hemorrhage (SAH) or after the first 2 weeks. Because the amount of SAH is a predictor of hydrocephalus, the two available aneurysmal treatments, clipping or coiling, may lead to differences in the need for cerebrospinal fluid (CSF) diversion, as only surgery permits clot removal. METHODS: Hospital and University Hospitals Consortium (UHC) databases were used to retrieve data on all patients admitted to our hospital with aneurysmal SAH during the last 4 years. The incidence of permanent ventricular shunt (VS) according to treatment modality used was evaluated. RESULTS: One hundred eighty-eight patients were admitted with aneurysmal SAH. Coiling was performed on 48 (26%) and clipping on 135 (73.8%) patients. Fifty-six (31%) patients required CSF diversion. External ventricular drain was placed in 30 (22.2%) clipped and 13 (27.1%) coiled patients ( p = 0.5 ), and VS in 6 patients of the two treatment groups (4.4 versus 12.5%, respectively; p = 0.08). Patients requiring VS had longer UHC-expected hospital length of stay (LOS), as well as observed ICU and hospital LOS, compared to patients with temporary or no CSF diversion (24 +/- 14 versus 15 +/- 8, 20.5 +/- 9 versus 11 +/- 7, and 30 +/- 13 versus 16 +/- 11 days, respectively; p

Intraventricular hemorrhage after aneurysmal subarachnoid hemorrhage: pilot study of treatment with intraventricular tissue plasminogen activator.

OBJECTIVE: Intraventricular (IVen) hemorrhage is considered a predictor of poor outcome after subarachnoid hemorrhage (SAH). This prospective study examines the feasibility and outcome of administration of IVen tissue plasminogen activator (tPA) after aneurysmal SAH. METHODS: Ten patients with SAH who received IVen tPA after the aneurysm had been secured were compared with 10 age-, sex-, and Glasgow Coma Scale score-matched control patients. The primary end point was third and fourth ventricle clot resolution. IVen blood was quantified by use of the Graeb and Le Roux scales on admission and at an additional time (equal or longer for the control group) after the injection was terminated. RESULTS: Six men and four women with a mean age of 52 years in each group were evaluated. On average, 3.5 mg tPA was injected 68 +/- 51 hours after admission without ensuing complications. Although the treated group had significantly more IVen blood on admission than control subjects (mean Le Roux scale +/- standard deviation, 11 +/- 3 versus 7.6 +/- 4.2, P = 0.055, and mean Graeb scale +/- standard deviation, 8.5 +/- 2.3 in tPA versus 5.3 +/- 3, P < 0.02), it also had a significant decrease in the amount of IVen blood (mean Le Roux and Graeb scale decrease +/- standard deviation, 6.7 +/- 3.3 and 4.8 +/- 2 in tPA patients versus 0.9 +/- 3.2 and 0.5 +/- 2.6 in control subjects, P = 0.002). The tPA group had a non-statistically significantly shorter length of stay, decreased mortality, and better Glasgow Outcome Scale and modified Rankin Scale scores at discharge. Treated survivors showed a decreased need for shunt placement (2 [22%] of 9 patients versus 5 [83%] of 6 control subjects, P = 0.04). CONCLUSION: This pilot study shows that IVen tPA administration is feasible without complications after SAH and may be associated with better outcomes. These results warrant a randomized clinical trial.

Traumatic brain injury elevates glycogen and induces tolerance to ischemia in rat brain.

Previous studies have demonstrated that traumatic brain injury (TBI) increases the vulnerability of the brain to an acute episode of hypoxia-ischemia. The objective of the present study was to determine whether TBI alters the vulnerability of the brain to a delayed episode of ischemia and, if so, to identify contributing mechanisms. Sprague-Dawley rats were subjected to lateral fluid-percussion (FP) brain injury (n = 14) of moderate severity (2.3-2.5 atm), or sham-injury (n = 12). After recovery for 24 h, all animals underwent an 8-min episode of forebrain ischemia, followed by survival for 6 days. Ischemic damage in the hippocampus and cerebral cortex of the FP-injured hemisphere was compared to that in the contralateral hemisphere and to that in sham-injured animals. Remarkably, the number of surviving CA(1) neurons in the middle and lateral segments of the hippocampus in the FP-injured hemisphere was significantly greater than that in the contralateral hemisphere and sham-injured animals (p < 0.05). Likewise, in the cerebral cortex the number of damaged neurons tended to be lower in the FP-injured hemisphere than in the contralateral hemisphere. These results suggest that TBI decreased the vulnerability of the brain to a delayed episode of ischemia. To determine whether TBI triggers protective metabolic alterations, glycogen levels were measured in cerebral cortex and hippocampus in additional animals 24 h after FP-injury (n = 13) or sham-injury (n = 7). Cortical glycogen levels in the ipsilateral hemisphere increased to 12.9 +/- 6.4 mmol/kg (mean +/- SD), compared to 6.4 +/- 1.8 mmol/kg in the opposite hemisphere and 5.7 +/- 1.3 mmol/kg in sham-injured animals (p < 0.001). Similarly, in the hippocampus glycogen levels in the FP-injured hemisphere increased to 13.4 +/- 4.9 mmol/kg, compared to 8.1 +/- 2.4 mmol/kg in the contralateral hemisphere (p < 0.004) and 6.2 +/- 1.5 mmol/kg in sham-injured animals (p < 0.001). These results demonstrate that TBI triggers a marked accumulation of glycogen that may protect the brain during ischemia by serving as an endogenous source of metabolic energy.

Pseudo-subarachnoid hemorrhage: report of three cases and review of the literature.

Subarachnoid hemorrhage (SAH) appears on CT as hyperdensity in the subarachnoid space. In rare circumstances a similar appearance may occur in the absence of subarachnoid blood, a finding that has been termed "pseudo-subarachnoid hemorrhage." We describe three patients who presented with abrupt alterations in mental status in whom CT falsely suggested SAH, and we review the literature regarding this imaging finding. In contrast to prior reports, all three of our patients had a favorable outcome.

Sensitivity of scalp EEG, cortical EGG, and somatosensory evoked responses during surgery for intracranial aneurysms.

BACKGROUND: We estimated the relative sensitivity and reliability of scalp EEG, cortical EEG and somatosensory evoked potentials (SSEPs) to detect significant changes during aneurysm surgery. METHODS: Two observers independently reviewed data from 18 patients who were monitored with scalp EEG, cortical EEG, and SSEPs to determine which if any modality demonstrated significant changes during 25 different episodes of temporary intracranial vascular occlusion. RESULTS: Kappa scores indicating the degree of agreement between the two observers were highest for the cortical strip EEG (kappa = 0.92) and the SSEPs (kappa = 0.82) and much greater than for the scalp EEG data (kappa = -0.07). The cortical strip recordings showed changes more often than either the scalp EEG or SSEP during temporary vascular occlusion. In no case did the scalp EEG change when neither the strip nor SSEP changed. In only 4% of events did the observers feel that the SSEP changed when the strip did not, but in 16% of cases, the strip changed without changes in any of the other modalities. CONCLUSIONS: Recording of EEG from strip electrodes placed on the cortical surface detects changes more frequently than either scalp EEG or SSEPs during vascular occlusion. Different observers were more likely to agree on whether the cortical strip EEG changed during vascular occlusion than the other modalities. This argues for the possible advantages of recording from strip electrodes during aneurysm surgery.

Complete regression of intracranial arteriovenous malformations.

BACKGROUND: Spontaneous and complete regression of intracranial arteriovenous malformations (AVMs) is a rare occurrence, with only 59 angiographically proven cases reported in the English literature. We present three new cases and perform a literature review to determine possible mechanisms underlying this unusual phenomenon. METHODS: Three patients with angiographically proven AVMs demonstrated complete obliteration of the AVM on follow-up angiography. Two patients had MRIs performed at the time of follow-up angiography. RESULTS: A literature review of all reported cases shows that the vast majority (88%) of spontaneously closing AVMs had a single draining vein as did our three cases. In addition, hemodynamic alterations of intracranial (IC) blood flow, including intracranial hemorrhage, were seen in a majority (79%) of patients, including two of our three cases. MRI was performed in two of our three cases and showed a thrombosed-draining vein in both. CONCLUSIONS: Complete spontaneous regression of intracranial AVMs is a rare occurrence. The phenomenon seems to require the interaction of hemodynamic changes in compromising or closing the limited, usually single, venous drainage pathway from the AVM. Hemorrhage may contribute to the effect by further compromising flow though the lesion, or it may merely be a phenomenon associated with the effects of venous hypertension on the AVM nidus.