Characterizing the safety profile of vagus nerve stimulation devices for epilepsy from 21,448 manufacturer and user reports.

OBJECTIVE: This study summarizes medical device reports (MDRs) associated with adverse events for vagus nerve stimulation (VNS) devices indicated for epilepsy as reported by the Manufacturer and User Facility Device Experience (MAUDE) database of the US Food and Drug Administration. METHODS: The MAUDE database was surveyed for MDRs from November 2013 to September 2022 regarding VNS devices for epilepsy. Event descriptions, device problems, correlated patient consequences, and device models were grouped and analyzed in Python. Based on event description, revision surgeries and other unique events were identified. Revenue from VNS device sales was used to approximate growth in their use over time. RESULTS: A total of 21,448 MDRs met the inclusion criteria. High VNS impedance, the most prevalent device malfunction overall (17.0% of MDRs), was the most common factor for 18 of the 102 encountered patient problems and led to 1001 revision surgeries (3371 total revisions). Included in those 18 device malfunctions were 3 of the top 6 occurring patient problems: seizure recurrence (9.9% associated with high impedance; encompassed focal, absence, and grand mal subtypes), death (1.3%), and generalized pain (7.9%). The next 4 top cited device malfunctions-lead fracture (13.7% of MDRs), operational issue (6.6%), battery problem holding charge (4.2%), and premature end-of-life indicator (2.9%)-differed widely in their percentage of cases that did not impact patients (77.4%, 57.3%, 48.9%, and 92.2%, respectively), highlighting differing malfunction severities. Seizure recurrence, the most prevalent patient impact, was the outcome most associated with 32 of the 68 encountered device problems, including high impedance (12.8%), lead fracture (12.2%), operational issue (18.4%), battery problem holding charge (31.2%), and premature end-of-life indicator (8.9%), which comprised the top 5 occurring device problems. In general, MDRs spanned a diverse range including device age, hardware, software, and surgeon or manufacturer error. Trends were seen over time with declining annual MDRs coupled with a rise in the use of VNS devices as gauged by revenue growth. Shifting device and patient problem profiles were also seen in successive models, reflecting engineering updates. CONCLUSIONS: This study characterizes the most common and consequential side effects of VNS devices for epilepsy while clarifying likely causes. In addition, the outcomes of 68 distinct device malfunctions were identified, including many not ubiquitously present in literature, lending critical perspective to clinical practice.

Atraumatic Polycompartment Syndrome Secondary to Cardiogenic Shock: A Case Report.

We report the case of a 53-year-old male who developed polycompartment syndrome (PCS) secondary to cardiogenic shock. After suffering a cardiac arrest, a self-perpetuating cycle of intra-abdominal hypertension (IAH) and vital organ damage led to abdominal compartment syndrome (AbCS), which then contributed to the precipitation of extremity compartment syndrome (CS) in bilateral thighs, legs, forearms, and hands. This report is followed by a review of the literature regarding the pathophysiology of this rare sequela of cardiogenic shock. While the progression from cardiogenic shock to AbCS and ultimately to PCS has been hypothesized, no prior case reports demonstrate this. Furthermore, this case suggests more generally that IAH may be a risk factor for extremity CS. Future studies should examine the potential interplay between IAH and extremity CS in patients at risk, such as polytrauma patients with tibial fractures.

What Factors Are Associated With Arterial Line-Related Limb Ischemia in Patients on Extracorporeal Membrane Oxygenation? A Single-Center Retrospective Cohort Study.

OBJECTIVES: The primary purpose of this study was to identify factors associated with the development of arterial line-related limb ischemia in patients on extracorporeal membrane oxygenation (ECMO). The authors also sought to characterize and report the outcomes of patients who developed arterial line-related limb ischemia. DESIGN: Retrospective cohort study. SETTING: A single academic tertiary referral ECMO center. PARTICIPANTS: Consecutive patients who were treated with ECMO over 6 years. INTERVENTIONS: Use of arterial line. MEASUREMENTS AND MAIN RESULTS: A total of 278 consecutive ECMO patients were included, with 19 (7%) patients developing arterial line-related limb ischemia during the ECMO run. Postcannulation Sequential Organ Failure Assessment (SOFA) (adjusted odds ratio [aOR] 1.20, 95% CI 1.08-1.32), Acute Physiology and Chronic Health Evaluation-II (aOR 0.84, 95% CI 0.74-0.95), and adjusted Vasopressor Dose Equivalence (aOR 1.03, 95% CI 1.01-1.05) scores were independently associated with the development of arterial line-associated limb ischemia. A SOFA score of ≥17 at the time of ECMO cannulation had an 80% sensitivity and 87% specificity for predicting arterial line-related limb ischemia. CONCLUSIONS: Arterial line-related limb ischemia is much more common in ECMO patients than in the typical intensive care unit setting. The SOFA score may be useful in identifying which patients may be at risk for arterial line-related limb ischemia. As this was a single-center retrospective study, these results are inherently exploratory, and prospective multicenter studies are necessary to validate these results.

Pearls and pitfalls of ChatGPT in medical oncology.

Recently, ChatGPT has drawn attention to the potential uses of artificial intelligence (AI) in academia. Here, we discuss how ChatGPT can be of value to medicine and medical oncology and the potential pitfalls that may be encountered.

What Factors Are Associated With Delayed Wound Closure in Open Reduction and Internal Fixation of Adult Both-bone Forearm Fractures?

BACKGROUND: Delayed wound closure is often used after open reduction and internal fixation (ORIF) of both-bone forearm fractures to reduce the risk of skin necrosis and subsequent infection caused by excessive swelling. However, no studies we are aware of have evaluated factors associated with the use of delayed wound closure after ORIF. QUESTIONS/PURPOSES: (1) What proportion of patients undergo delayed wound closure after ORIF of adult both-bone forearm fractures? (2) What factors are associated with delayed wound closure? METHODS: The medical records of all patients who underwent ORIF with plate fixation for both-bone fractures by the adult orthopaedic trauma service at our institution were considered potentially eligible for analysis. Between January 2010 and April 2022, we treated 74 patients with ORIF for both-bone forearm fractures. Patients were excluded if they had fractures that were fixed more than 2 weeks from injury (six patients), if their fracture was treated with an intramedullary nail (one patient), or if the patient experienced compartment syndrome preoperatively (one patient). No patients with Gustilo-Anderson Type IIIB and C open fractures were included. Based on these criteria, 89% (66 of 74) of the patients were eligible. No further patients were excluded for loss of follow-up because the primary endpoint was the use of delayed wound closure, which was performed at the time of ORIF. However, one further patient was excluded for having bilateral forearm fractures to ensure that each patient had a single fracture for statistical analysis. Thus, 88% (65 of 74) of patients were included in the analysis. These patients were captured by an electronic medical record search of CPT code 25575. The mean ± SD age was 34 ± 15 years and mean BMI was 28 ± 7 kg/m 2 . The mean follow-up duration was 4 ± 5 months. The primary endpoint was the use of delayed wound closure, which was determined at the time of definitive fixation if tension-free closure could not be achieved. All surgeons used a volar Henry or modified Henry approach and a dorsal subcutaneous approach to the ulna for ORIF. Univariate logistic regression was used to identify which factors might be associated with delayed wound closure. A multivariable logistic regression analysis was then performed for male gender, open fractures, age, and BMI. RESULTS: Twenty percent (13 of 65) of patients underwent delayed wound closure, 18% (12 of 65) of which occurred in patients who had high-energy injuries and 14% (nine of 65) in patients who had open fractures. Being a man (adjusted odds ratio 9.9 [95% confidence interval 1 to 87]; p = 0.04) was independently associated with delayed wound closure, after adjusting for open fractures, age, and BMI. CONCLUSION: One of five patients had delayed wound closure after ORIF of both-bone forearm fractures. Being a man was independently associated with greater odds of delayed wound closure. Surgeons should counsel all patients with these fractures about the possibility of delayed wound closure, with particular attention to men with high-energy and open fractures. Future larger-scale studies are necessary to confirm which factors are associated with the use of delayed wound closure in ORIF of both-bone fractures and its effects on fracture healing. LEVEL OF EVIDENCE: Level III, therapeutic study.

Greater Disability Is Associated with Worse Vestibular and Compensatory Oculomotor Functions in People Living with Multiple Sclerosis.

Globally, there are nearly three million people living with multiple sclerosis (PLW-MS). Many PLW-MS experience vertigo and have signs of vestibular dysfunction, e.g., low vestibulo-ocular reflex (VOR) gains or the presence of compensatory saccades (CSs), on video head impulse testing (vHIT). We examined whether the vestibular function and compensatory oculomotor behaviors in PLW-MS differed based on the level of MS-related disability. The VOR gain, CS frequency and latency, and gaze position error (GPE) were calculated from the individual traces obtained during six-canal vHIT for 37 PLW-MS (mean age 53.4 ± 12.4 years-old, 28 females) with vertigo and/or an imbalance. The subjects were grouped by their Expanded Disability Status Scale (EDSS) scores: PLW-min-MS (EDSS = 1.0-2.5, n = 8), PLW-mild-MS (EDSS = 3.0-4.5, n = 23), and PLW-moderate-MS (EDSS = 5.0-6.0, n = 6). The between-group differences were assessed with Kruskal-Wallis tests. The VOR gains for most of the canals were higher for PLW-min-MS compared to PLW-mild- and mod-MS, respectively. CS occurred less often in PLW-min-MS versus PLW-mild- and mod-MS, respectively. No clear trend in CS latency was found. The GPE was often lower for PLW-min-MS compared to PLW-mild- and mod-MS, respectively. Thus, our data demonstrate that worse VOR and compensatory oculomotor functions are associated with a greater MS-related disability. PLW-MS may benefit from personalized vestibular physical therapy.

Extensions of Granger Causality Calculations on Brain Networks for Efficient and Accurate Seizure Focus Identification via iEEGs.

Current epilepsy surgery planning protocol determines the seizure onset zone (SOZ) through resource-intensive, invasive monitoring of ictal events. Recently, we have reported that Granger Causality (GC) maps produced from analysis of interictal iEEG recordings have potential in revealing SOZ. In this study, we investigate GC maps' network connectivity patterns to determine possible clinical correlation with patients' SOZ and resection zone (RZ). While building understanding of interictal network topography and its relationship to the RZ/SOZ, we identify algorithmic tools with potential applications in epilepsy surgery planning. These graph algorithms are retrospectively tested on data from 25 patients and compared to the neurologist-determined SOZ and surgical RZ, viewed as sources of truth. Centrality algorithms yielded statistically significant RZ rank order sums for 16 of 24 patients with RZ data, representing an improvement from prior algorithms. While SOZ results remained largely the same, this study validates the applicability of graph algorithms to RZ/SOZ detection, opening the door to further exploration of iEEG datasets. Furthermore, this study offers previously inaccessible insights into the relationship between interictal brain connectivity patterns and epileptic brain networks, utilizing the overall topology of the graphs as well as data on edge weights and quantity of edges contained in GC maps.