Neurological Events Research Articles

Outcome Through the Years of Left-Ventricular Assist Devices Therapy for End-Stage Heart Failure: A Review

Heart transplantation remains the gold standard surgical treatment for advanced heart failure. Over time, medical therapies have achieved remarkable outcomes in terms of survival and quality of life, yet their results may be insufficient, even when maximized. The limited availability of organ donors and the selective criteria for heart transplant eligibility have led to a significant rise in the utilization of long-term mechanical circulatory support, including left ventricular assist devices. Patients receiving LVADs often present with multiple comorbidities, constituting a highly vulnerable population. Individuals living with LVADs may experience various long-term complications, such as bleeding, driveline infections, neurological events, and right ventricular dysfunction. Fortunately, the development of increasingly biocompatible LVAD devices in recent years has resulted in a notable reduction in these complications. This review aims to summarize the principal complications encountered by patients with LVADs throughout their treatment and the associated daily management strategies.

Perioperative Management of Pediatric Combined Heart and Liver Transplantation: A 17 year single center experience.

An increasing number of centers are undertaking combined heart and liver transplantation in adult and pediatric patients with congenital heart disease. The primary aim of this study was to describe the perioperative management of a single center cohort, identifying challenges and potential solutions. We conducted a retrospective review of all patients undergoing combined heart and liver transplantation at Stanford Children's Hospital from 2006 to 2022. Preoperative information included cardiac diagnosis, hemodynamics, and severity of liver disease. Intraoperative data included length of surgery, cardiopulmonary bypass time, and blood products transfused. Postoperative data included blood products transfused in the intensive care unit, time to extubation, length of intensive care unit stay, survival outcomes and 30-day adverse events. Eighteen patients underwent en bloc combined heart and liver transplantation at Stanford Children's Hospital from 2006 to 2022, and the majority 15 (83%) were transplanted for failing Fontan circulation with Fontan Associated Liver Disease. Median surgical procedure time was 13.4 [11.5, 14.5] h with a cardiopulmonary bypass time of 4.3 [3.9, 5.8] h. Median total blood products transfused in the operating room post cardiopulmonary bypass was 89.4 [63.9, 127.0] mLs/kg. Nine patients (50%) had vasoplegia during cardiopulmonary bypass. Activated prothrombin complex concentrates were used post cardiopulmonary bypass in 15 (83%) patients with a 30-day thromboembolism rate of 22%. Median time to extubation was 4.0 [2.8, 6.5] days, median intensive care unit length of stay 20.0 [7.8, 48.3] days and median hospital length of stay 54.0 [30.5, 68.3] days. Incidence of renal replacement therapy was 11%; however, none required renal replacement therapy by the time of hospital discharge. Neurological events within 30 days were 17% and the 30 day and 1 year survival was 89%. Perioperative challenges include major perioperative bleeding, unstable hemodynamics, and end organ injury including acute kidney injury and neurological events. Successful outcomes for en bloc combined heart and liver transplantation are possible with careful multidisciplinary planning, communication, patient selection, and integrated peri-operative management.

Clinical Course of Neurologic Adverse Events Associated With Immune Checkpoint Inhibitors

Clinical Course of Neurologic Adverse Events Associated With Immune Checkpoint Inhibitors

Emerging Treatments for Subarachnoid Hemorrhage.

The current landscape of therapeutic strategies for subarachnoid hemorrhage (SAH), a significant adverse neurological event commonly resulting from the rupture of intracranial aneurysms, is rapidly evolving. Through an in-depth exploration of the natural history of SAH, historical treatment approaches, and emerging management modalities, the present work aims to provide a broad overview of the shifting paradigms in SAH care. By synthesizing the historical management protocols with contemporary therapeutic advancements, patient-specific treatment plans can be individualized and optimized to deliver outstanding care for the best possible SAH-related outcomes.

Risk of collagen-related disorders and neurological events among patients with uncomplicated urinary tract infection following short treatment with fluoroquinolones: a cohort study.

Studies of fluoroquinolone (FQ) safety across indications show increased collagen/neurological adverse event (AE) risk, yet patients still receive FQs for uncomplicated urinary tract infections (uUTIs). This retrospective, cohort study investigated the risk of collagen/neurological AEs of special interest (AESIs) with short-term FQ use versus standard-of-care antibiotics (trimethoprim-sulfamethoxazole [SXT], nitrofurantoin [NTF]) among female outpatients with uUTIs. This study was conducted between December 2009 and 2019 using Optum's de-identified Clinformatics Data Mart Database. Adjusted absolute risks were calculated for composite/collagen/neurological AESIs (Kaplan-Meier cumulative hazards, after applying stabilized inverse probability of treatment weighting [sIPTW]). Adjusted hazard ratios were generated (sIPTW Cox proportional hazard modeling). Overall, 954,777 patients were included: FQ (n = 386,537 [40.5%]); SXT (n = 237,120 [24.8%]); NTF (n = 314,585 [32.9%]). Adjusted absolute risk range for collagen/neurological AESIs was <1%-4.5%. The hazard (95% CI) of tendon rupture was 25% higher with FQ versus SXT (1.25 [1.00-1.57]; P = 0.0497). Patients receiving FQ had lower hazard of neurological (0.95 [0.93-0.97]; P < 0.0001), central nervous system (0.85 [0.80-0.89]; P < 0.0001), and peripheral nervous system (0.96 [0.93-0.98]; P = 0.0016) AESIs versus NTF. Following a short treatment duration, FQs were associated with increased risk of tendon rupture versus SXT and reduced risk (adjusted hazard ratios) of neurological AESI versus NTF. Individual patient risk and consequences for known uncommon, yet serious, AEs need to inform appropriate antibiotic choice in treating uUTIs. Patient profile, efficacy, microbiome impact, safety, and surveillance should inform antibiotic selection for uUTI management, in accordance with guidelines.

Neurologic recurrence after transcatheter PFO closure in patients with cryptogenic stroke

Abstract Background Patent foramen ovale (PFO) is associated with an increased risk of cryptogenic stroke, and interventional closure is recommended for secondary prevention. However, there is limited real-world data on long-term results. Our objective was to evaluate outcomes following successful transcatheter PFO occlusion. Methods Data from patients undergoing PFO closure for cryptogenic stroke between 2010 and 2015 were analysed to determine short- and long-term outcomes and to identify potential predictors of neurological recurrence. Results 330 patients underwent successful PFO closure. The mean age of patients was 49 (standard deviation (SD) ±12) years, and 55.5% were male. Any in-hospital adverse event was observed in eight patients (2.4%). During a median follow-up of 9.85 (SD ±2.5) years, the combined outcome of transient ischemic attack (TIA), stroke, or death from stroke was observed in 3.6% of patients (0.38 events per 100 person-years). After 5, 10, and 12 years the percentage of patients free of the composite outcome was 97.5%, 96.2%, and 96.2% respectively (Figure 1). New onset atrial fibrillation was detected in 10 patients (3.0%). A thorough analysis of the neurologic recurrences revealed a total number of six cryptogenic strokes (1.8%). Our results revealed that the Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.70, 95% confidence interval [CI]: 0.52 to 0.95; p=0.022) and the number of prior neurologic events (adjHR: 9.78, 95% CI: 2.66 to 35.99; p&amp;lt;0.001) were strong independent predictors of future recurrent neurologic events. Kaplan Meier survival analysis stratified by number of previous neurologic events proved to be statistically significant (p&amp;lt;0.001; Figure 2). Conclusion In this real-world cohort of patients with cryptogenic stroke we observed excellent safety and good efficacy of percutaneous PFO closure, similar to randomized controlled trials or other long-term cohort studies. The rate of recurrent neurological events was low, especially cryptogenic strokes. The RoPE score confirmed good predictive power; in particular, the number of previous neurological events should be taken more into account when determining the indication for closure.

Safety Profile of Statins for Post-Marketing Adverse Cardiovascular Events: A Real-World Pharmacovigilance Analysis.

The purpose of this study was to comprehensively evaluate the association of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) with neurological adverse events using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, with the aim of guiding the rational use of statins. The number and clinical characteristics of adverse events (AEs) to statins in the FAERS database between 2012 and March, 2023, were extracted. Neurological AEs were defined by the system organ classes (SOCs) of "Nervous System Disorders (10029205)" and the corresponding PT. Disproportionality was calculated using the reporting dominance ratio (ROR), proportional reporting ratio (PRR), and information component (IC025). Between January, 2012 and March, 2023, a total of 90,357 AEs were reported for the three statins (atorvastatin, resuvastatin, and simvastatin). The majority of reports on AEs came from the United States (n = 7284). A total of 8409 reports described neurological AEs following the use of the three statins, with atorvastatin accounting for more than half of the reports (n = 4430). The mean age of patients who developed neurological AEs was 55 years and older. The prevalence was similar in female patients (2230/4480) and male patients (1999/4480). Disproportionate analyses showed that at the SOC level, only the correlation between atorvastatin and neurological AEs suggested a positive signal (ROR: 9.77 (9.56-9.99); IC025: 3.28; PRR (χ2): 9.76 (16.07)) and in total, there were 32 PTs with a positive signal. The median time for neurological AEs was 71 days (IQR: 14-559 days), and the most common AEs were other serious effects (important medical event) (OT) (n = 2283) and hospitalization (HO) (n = 715). This study suggests that atorvastatin may be associated with an increased risk of neurological AEs. This study provides realistic evidence of the potential risk of statin-related adverse events.

Clinical, echocardiographic, and pathologic characteristics of patients with pathology-proven nonbacterial thrombotic endocarditis

Abstract Background Non-bacterial thrombotic endocarditis (NBTE) is a non-infectious condition characterized by thrombotic and/or inflammatory depositions involving the cardiac valves. It is a challenging diagnosis of exclusion. Purpose This study aimed to better characterize patients with pathologically proven NBTE and assess its clinical, echocardiographic characteristics and prognostic implications. Methods We retrospectively identified patients with pathology-proven NBTE at a single center. Patients with positive preoperative blood cultures, a history of active or treated infective endocarditis, or identification of valvular organisms by special stains were excluded from the study. Patients with pathology reports of valve perforation or chordal rupture were also excluded because of the high likelihood of an infectious etiology for these lesions. Results A total of 53 patients with NBTE (median age 57 years; 61% females) were identified. In this cohort, 22% had a history of malignancy, 30% had connective tissue disease, 32% had coronary artery disease, and 11% prior history of NBTE. Neurological events accounted for 18 (34%) of the presenting symptoms (TIA n=17, CVA n=9), while new valvular dysfunction in 7 (13%) and fever in 8 (15%) of patients. Five patients (9%) had NBTE involving more than one valve. NBTE involved the mitral valve in 64%, aortic valve in 38% prosthetic/mechanical valve in 11%, and tricuspid valve in 5%. NBTE was identified at the time of autopsy in 34% of patients. NBTE recurred in 3 patients during follow-up. Excluding patients diagnosed at the time of autopsy, 9% of patients died within 1 year of NBTE diagnosis. Conclusion NBTE was diagnosed pathologically in the presence of hyper-inflammatory states due to critical illness or immunological diseases. It was predominantly on the left side of the heart and was associated with embolic phenomena, either clinically or on imaging. Patients diagnosed with antemortem with NBTE have a high mortality in the first year (9%).

Imaging signs of carotid plaque vulnerability predict subclinical neurological events in asymptomatic patients: the carotid artery multi-modality imaging prognostic study

Abstract Background Carotid artery plaques should be considered for invasive treatment if diameter stenoses is ≥60%, in the presence of clinical and/or imaging characteristics associated with an increased risk of ipsilateral stroke, such as intraplaque haemorrhage (IPH) or lipid-rich necrotic core (LRNC). However, little is known about plaque’s characteristics in patients with &amp;lt;60% stenoses. Purpose To evaluate the prevalence and significance of imaging signs of plaque vulnerability in patients with asymptomatic &amp;lt;60% carotid artery stenoses. Methods In the Carotid Artery Multi-modality imaging Prognostic (CAMP) study (granted by Bando Ricerca Salute 2018 - Regione Toscana) we prospectively enrolled 200 patients with asymptomatic, mild/moderate (40-60%) carotid artery stenoses, as assessed at Doppler ultrasound (DUS). All patients were evaluated with multimodality imaging, including computed tomography angiography (CTA), magnetic resonance angiography (MRA) and brain magnetic resonance imaging (MRI), whenever not contraindicated. A subgroup of 75 patients underwent also a 18[F]-fluorodeoxyglucose (FDG) positron emission tomography (PET). A thorough clinical, biochemical, cardiological and neurological evaluation was performed in all patients. Results Imaging signs of plaque vulnerability were frequent (IPH and/or LRNC at MRA were found in 26.3% patients, plaque ulceration at CTA was found in 36.7% of patients). No difference in the prevalence of cardiovascular risk factors was noted in those with and without signs of vulnerability. Subclinical embolic brain infarctions at brain MRI were found in 8.8% of patients at enrollment. These patients had more frequently a LRNC at MRA than patients without subclinical embolic brain infarctions (50% vs 17%, p&amp;lt;0.05), lower estimated glomerular filtration rate (55±8 vs 73±23 mL/min/1.73mq, p&amp;lt;0.001), higher troponin HS values (16±4 vs 12±8 ng/ml, p&amp;lt;0.05). Presence of LRNC at MRA was the only predictor of embolic lesions at MRI (odds ratio 4.86, 95% confidence interval 1.08-21.8, p&amp;lt;0.05). Conclusions Imaging signs of vulnerability are highly prevalent in patients with asymptomatic intermediate carotid artery stenosis. Presence of a LRNC at MRA is associated with subclinical embolic brain infarcts. The use of non-invasive multi-imaging can better characterize carotid plaques, independent of the degree of stenosis, and help identifying a subgroup of patients at higher risk of events.

Stroke recurrence after transcatheter PFO closure in patients with cryptogenic stroke.

Patent foramen ovale (PFO) closure is recommended for secondary prevention of cryptogenic stroke. However, data on long-term results are limited. We aimed to evaluate safety and efficacy of transcatheter PFO closure and predict neurologic recurrence. Data from patients undergoing PFO closure between 2010 and 2015 was collected to assess the combined endpoint of transient ischemic attack (TIA), stroke, or death from stroke at short- and long-term follow-up. 330 patients were included, mean age was 49 (±12) years and 55.5% were male. Before PFO closure, 86% experienced a stroke and 19% multiple neurological events. Procedure-related complications occurred in 2.4% of patients. Over a median follow-up of 10 years, the combined endpoint occurred in 3.6%, with a recurrence rate of 0.38 per 100 patient-years. Freedom from the combined endpoint at 5 and 10 years was 97.5% and 96.2%, respectively. New-onset atrial fibrillation was detected in 3%. The Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.68; p=0.032), the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system (adjHR: 0.37; p=0.042), and a history of prior neurological events (adjHR: 9.94; p<0.001) were independent predictors of future recurrent neurologic events. Age, sex, and cardiovascular risk factors did not influence outcomes. In this real-world cohort, transcatheter PFO closure was associated with low long-term recurrence of neurologic events, especially cryptogenic strokes. The RoPE score, the PASCAL score and history of previous neurological events were predictive of recurrent events. This study supports the safety and efficacy of PFO closure for secondary prevention of cryptogenic strokes, and underscores the importance of patient selection.

Understanding perioperative risk determinants in carotid endarterectomy: the impact of compromised circle of Willis morphology on inter-hemispheric blood flow indices based on intraoperative internal carotid artery stump pulse pressure and backflow patterns.

Carotid artery stenosis (CAS) often requires surgical intervention through carotid endarterectomy (CEA) to prevent stroke. Accurate cerebrovascular risk assessments are crucial in CEA, as poor collateral circulation can lead to insufficient interhemispheric blood flow compensation, resulting in ischemic complications. Therefore, understanding perioperative risk determinants is vital. This study aims to determine the impact of compromised circle of Willis (CoW) morphology on inter-hemispheric blood flow, focusing on indices based on intraoperative internal carotid artery stump pulse pressure and backflow patterns. In 80 CAS patients who underwent CEA, preoperative CT angiography for CoW was conducted. Patients were categorized into five subgroups based on their CoW anatomy and three additional groups based on intraoperative internal carotid artery (ICA) stump backflow patterns evaluated by the surgeon. Continuous blood pressure signals, including systolic, diastolic, mean, and pulse pressure values, were recorded during the procedure. The relationship between CoW anatomical variants and the systolic and diastolic segments of the averaged pressure waveforms, particularly diastolic pressure decay, was analyzed. The correlation between CoW anatomy and stump backflow intensity was also examined. Significant variability in ICA stump backflow and pressure values was evident across CoW variants. Patients with compromised CoW morphology exhibited weaker backflow patterns and lower ICA stump pulse pressure values, consistent with impaired interhemispheric blood flow. Notably, ICA stump diastolic pressure decay was consistent across most CoW variant groups, indicating developed collateral circulation in cases with CoW anomalies. Thus, impaired CoW integrity is associated with compromised interhemispheric blood flow indices based on intraoperative ICA stump pulse pressure and backflow patterns during CEA. Integrating intraoperative pulse waveform analysis with preoperative CT angiography provides a more detailed assessment of cerebrovascular risk, guiding the selective use of shunts. This combined approach may improve surgical outcomes and patient safety by identifying patients at increased risk of perioperative neurological events due to CoW anomalies.

Determinants of immune checkpoint inhibitor use and factors linked to neurological adverse events in Korean lung cancer.

Aim: Studies on immune checkpoint inhibitor (ICI)-related potential neurological adverse events (pNAEs) in Korean lung cancer (LC) patients are scarce. We aimed to examine ICI prescription trends from 2018 to 2022, patient characteristics and factors associated with ICI prescription or concurrent pNAEs in LC.Research design & methods: This observational, cross-sectional study of Korean LC patients investigated four ICIs (pembrolizumab, nivolumab, atezolizumab and durvalumab). The annual ICI prescription rate was calculated by dividing the number of LC patients prescribed ICIs with the total annual number of LC patients. Factors associated with ICI prescriptions or concurrent pNAEs were assessed.Results: The annual ICI prescription rate increased from 3.29% to 9.74% (average: 6.20%). Higher Charlson Comorbidity Index (CCI) scores were associated with more ICI prescriptions (odds ratio [OR], 1.08; 95% confidence interval [CI], 1.07-1.08). Targeted therapy was associated with fewer prescriptions (OR: 0.45; 95% CI: 0.41-0.49). The anti-programmed cell death protein 1 (anti-PD-1) prescription rate was higher in patients with concurrent pNAEs than those without pNAEs (53.09% vs. 50.84%), and this was associated with higher pNAEs prevalence (OR: 1.10; 95% CI: 1.03-1.18).Conclusion: ICI prescription for LC has increased in Korea, CCI and anti-PD-1 increased pNAEs prevalence.

Evaluation of neurological events following minimally invasive mitral valve surgery

Objective: To determine the rate of neurological events in patients undergoing minimally invasive mitral valve surgery and evaluate factors associated with the groups with and without postoperative neurological events. Subjects and Methods: Inclusion Criteria: Patients undergoing minimally invasive mitral valve surgery at the Cardiac Surgery Department, University Medical Center. Exclusion Criteria: Patients with infective endocarditis, patients requiring ECMO support. Study Design: Retrospective case series study. Results: A total of 358 patients underwent minimally invasive mitral valve surgery between 2017 and 2022, with an average age of 50.7 years. Male patients accounted for 53.2%, and the surgical risk according to EuroScore II was 1.6%. Neurological complications occurred in 46 patients, representing 12.8%. Among these, delirium was the most common complication, occurring in 42 patients (91.3%), while stroke with sequelae occurred at a lower rate of 2.2%. The average age of the group with neurological complications was higher than that of the group without complications (53.9 ± 10.8 years vs. 50.2 ± 12.6 years). Additionally, the male proportion in the complication group (63.0%) was higher than in the group without complications (50.6%). The history of stroke in the complication group was 4.3%. The duration of mechanical ventilation and ICU stay was longer in the group with neurological complications, with an average mechanical ventilation time of 36.1 ± 71.3 hours compared to 18.4 ± 24.5 hours in the group without complications. The rate of new-onset atrial fibrillation after surgery was also higher in the complication group (19.6% vs. 10.6%). Conclusion: Neurological complications after surgery are a significant issue, occurring in 12.8% of patients undergoing minimally invasive mitral valve surgery, with delirium and stroke being the most common. Key risk factors include age, hypertension, and atrial fibrillation.

CO2 delivery techniques in mini-sternotomy surgery and neurological events: a multicentric study

BackgroundThe impact of air bubbles into the cerebral circulation after open heart surgery has been a topic of discussion since the introduction of the heart-lung machine. The aim of the study was to evaluate whether the use of a dedicated commercial sponge diffuser is better than a custom-made narrow section cannula or the absence of CO2 in preventing neurological events after aortic valve replacement via J mini-sternotomy.MethodsThree cohorts of J-shaped mini-sternotomy performed at three different centers were prospectively compared: CO2 supplied via sponge diffuser, CO2 supplied via cannula, and no CO2 supply. Propensity matching was used to obtain comparable groups. The primary endpoints were postoperative stroke, transitory ischemic attack, convulsions, and dizziness. Secondary endpoints were 30-day mortality, duration of mechanical ventilation, and intensive care unit length of stay.Results275 patients were enrolled in the study. After propensity matching, the sponge diffuser cohort had a significantly lower duration of mechanical ventilation (P < 0.001) and 30-day mortality (P = 0.05) when compared to the cannula cohort and the no-CO2 cohort, a lower incidence of all neurological events (P = 0.03) and dizziness (P = 0.05) when compare to the no-CO2 cohort, and a lower intensive care unit length of stay when compared to the cannula cohort (P = 0.001).ConclusionsThe sponge diffuser used to deliver the CO2 into the surgical field during aortic valve replacement via J mini-sternotomy has been demonstrated to guarantee better neurological outcomes compared to a custom-made narrow section cannula or the absence of CO2.

Neurotoxicity associated with chimeric antigen receptor T-cell therapy: a real-world study leveraging the FDA Adverse Event Reporting System

ABSTRACT Background CAR-T-associated neurotoxicity is extremely frequent with highly variable clinical presentation. Research design and methods Disproportionality analysis was conducted leveraging the FDA Adverse Event Reporting System (FAERS), covering the period from 1 January 2017, through 31 March 2023. The reporting odds ratio (ROR) and the information component (IC) were utilized to assess the adverse signals in total/individual CAR-T product. The lower limit of the ROR and IC 95% confidence interval (ROR025 and IC025) both exceeding threshold value (1 and 0, respectively) was considered a significant signal. Results Of the 60, 730 records associated with CAR-T, 11, 037 (18.17%) pertained to neurological events. Tisagenlecleucel exhibited the highest percentage of death (38.02%) and life‐threatening (12.90%) outcomes. Notably, it also displayed the broadest distribution of neurotoxicity. Additionally, distinct adverse signals unique to individual CAR-T products were identified. For instance, paraparesis, cerebral hemorrhage, impaired pupillary reflex, Guillain-Barre syndrome, brain death following tisagenlecleucel; dysarthria, orthostatic hypotension, and spinal cord edema after axicabtagene; parkinsonism, Bell’s palsy, and cranial nerve paralysis post ciltacabtagene. Conclusions Axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, idecabtagene vicleucel, and ciltacabtagene autoleucel exhibited increased odds of neurotoxicity, with some discrepancies in their characteristics, profiles, and severity.

Extracranial internal carotid artery aneurysm: Surgical approach to a rare entity.

Extracranial internal carotid artery aneurysms are rare entities that arise within the carotid triangle. Although rare, they are clinically significant due to the risk of neurologic thromboembolic events, compression of cranial nerves and vasculature, rupture, and ischemia. Surgery is the gold-standard treatment for symptomatic patients of all ages with extracranial internal carotid artery aneurysm. A 26-year-old female patient was admitted to our institution with complaints of left auricular pain, hoarseness, and uncontrollable hypertension. She had a pulsatile mass located at the left cervical region. After diagnosing the extracranial internal carotid artery aneurysm, it was decided that surgery was necessary to relieve the patient's discomfort and prevent possible complications from the aneurysm in the left carotid artery. In the operation, the aneurysmatic segment was resected and sent for histopathological evaluation. Saphenous vein graft was interposed as end to end anastomosis to the proximal and distal healthy segments of the internal carotid artery. This case report highlights the surgical management of a 26-year-old female patient who presented to our institution with complaints of left auricular pain, hoarseness, uncontrolled hypertension, and a pulsatile mass localized at the left cervical region and diagnosed extracranial internal carotid artery aneurysm.

Comparable Overall Risk of Neurologic Adverse Events Following Cervicothoracic Interlaminar and Transforaminal Epidural Injections: An Analysis of 1.29 Million Patients.

Retrospective cohort study. To characterize the incidence and odds of neurologic adverse events following interlaminar (IL) and transforaminal (TF) cervicothoracic epidural spinal injections (CESI). CESI may be considered in the management of various cervical pathology. Adverse events, although rare, can be devastating and have been reported following both IL and TF injections. The literature is mixed with regard to the risk-profile of these two types of CESI, but is largely limited to case reports, single centered studies, and literature reviews, which may incompletely characterize the relative risk of these injections at a national level. All adult patients undergoing IL and TF-CESI were identified from a large, national, multi-insurance database. The incidence of any post-injection neurologic complication was reported per 1,000 patients. The odds of specific neurologic adverse events occurring within 48-hours following TF-CESI, relative to IL-CESI, were compared by multivariable logistic regression controlling for age, sex, and Elixhauser comorbidity index (ECI). A total of 1,073,215 IL-CESI patients and 220,597 TF-CESI patients were identified. The overall incidence of any neurologic complication following IL and TF-CESI occurred at a rate of 4.15 and 4.56 per 1,000 patients, respectively (P=0.889). TF-CESI was associated with higher odds ratio (OR) of nerve root injury (OR 1.69, P<0.001), but lower odds of epidural hematoma (OR 0.60, P=0.040), relative to IL-CESI. Conversely, no other neurologic adverse events were statistically different between approaches (P>0.05 for all). Following IL and TF-CESI, adverse events are relatively rare but not absent. Although the odds of the majority of individual neurologic adverse events were found to be similar, both approaches were independently associated with specific complications. Providers should therefore recognize that, at the national level, one CESI approach may not be universally associated with a lower risk of complications.

Neurological and Psychiatric Adverse Events Associated with Cyclin-Dependent Kinase 4/6 Inhibitors in Breast Cancer Patients: Insights from a Pharmacovigilance Study via the FDA Adverse Event Reporting System.

Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have revolutionised cancer therapy, particularly breast cancer therapy. However, concerns about their potential to cause neurological and psychiatric adverse events (AEs) have emerged, and these concerns remain underexplored. This study aimed to investigate the signals related to neurological and psychiatric AEs associated with CDK4/6 inhibitor use. A retrospective study was performed to analyse reports of AEs associated with the use of CDK4/6 inhibitors (abemaciclib, ribociclib and palbociclib) from the first quarter of 2015 to the fourth quarter of 2023 on the basis of the FDA Adverse Event Reporting System (FAERS). Both the reporting odds ratio (ROR) and the multi-item gamma Poisson shrinker (MGPS) were used for signal detection. The timing of events was assessed with the Weibull shape parameter (WSP). The management, analysis and presentation of the data were performed via Python (version 3.8) and R software (version 4.3.2). A total of 19,001 AE reports in which CDK4/6 inhibitors were identified as the 'primary suspect drug' were included in this study. These events were predominantly observed in patients aged 65 to 85 years. Through an ROR analysis, 85 positive signals for neurological and psychiatric AEs associated with CDK4/6 inhibitors were identified. The MGPS method revealed 61 positive AE signals for neurological and psychiatric AEs associated with CDK4/6 inhibitors. A total of 34 positive AE signals were identified by both the ROR and MGPS analyses. The WSP indicated that the onset times for AEs associated with all three CDK4/6 inhibitors tended to be early in drug therapy, suggesting a propensity for early failuretype. The present study revealed neurological and psychiatric AEs associated with CDK4/6 inhibitors that often occur early in treatment. Significant signals include spinal cord herniation and cerebral microangiopathy. Close monitoring of these AEs is crucial. Further studies are necessary to verify the connection between CDK4/6 inhibitors and neurological and psychiatric AEs.

Preoperative collateralization depending on posterior components in the prediction of transient neurological events in moyamoya disease.

Changes in local cerebral blood flow (CBF) are a major cause of transient neurological events (TNEs) after revascularization for moyamoya disease (MMD); however, the influence of preoperative collateral pathway development on TNEs has not yet been investigated. This study included 28 hemispheres from 28 consecutive patients with MMD who underwent surgical revascularization, including a superficial temporal artery (STA) to middle cerebral artery (MCA) bypass, between January 2014 and March 2022. The collateralization pathways included the anterior communicating artery (AcomA) collaterals, posterior communicating artery (PcomA) collaterals, transdural collaterals, posterior pericallosal anastomosis, lenticulostriate anastomosis, thalamic anastomosis, and choroidal anastomosis. These collateral pathways were analyzed to identify predictive factors significantly associated with TNEs. TNEs were observed in 11 (39.3%) hemispheres. The development of posterior pericallosal anastomosis and choroidal anastomosis was a significant independent predictor of the occurrence of TNEs after bypass surgery for MMD (P = 0.01, OR 26.9, 95% CI 1.50-480.0; P = 0.002, OR 47.6, 95% CI 2.65-856.6). The development of choroidal and posterior pericallosal anastomosis could be reliable preoperative predictors of TNEs after bypass surgery for MMD. Our results provide useful information for future studies aimed at clarifying the mechanisms underlying TNEs.

A Nationwide Analysis in France on Sex Difference and Outcomes Following Carotid Intervention in Asymptomatic Patients.

Objective: The impact of sex on outcomes following carotid endarterectomy (CEA) and carotid artery stenting (CAS) is not fully elucidated. The aim of this study was to analyze the association between sex and outcomes of asymptomatic patients who underwent primary carotid interventions in France. Methods: This nationwide retrospective study was performed using the French National Health Insurance Information System and included asymptomatic patients who underwent primary carotid intervention over a 10-year period (1 January 2013 to 31 August 2023). Symptomatic patients and patients who had peri-operative neurologic events were excluded. The primary endpoints were the occurrence of death and stroke/transient ischaemic attack (TIA) at 30 days, 1 and 5 years after patients' discharge. Results: In total, 115,879 patients were admitted for an index CEA (29.4% women) and 6500 for CAS (29.8% women). In the CEA group, no significant sex-related difference was observed for 30-day mortality; however, women had significantly lower 1-year and 5-year mortality rates compared to men (1.9% vs. 2.6%, p < 0.001 and 7.9% vs. 11.1%, p < 0.001). In the CAS group, women had lower 30-day, 1-year and 5-year mortality (0.6% vs. 1.0%, p = 0.040, 3.8% vs. 4.9%, p = 0.048, and 10.4% vs. 15.0%, p < 0.001). A multivariate analysis showed that sex was not associated with the risk of stroke/TIA and mortality at 30 days (OR 0.84 (95% CI 0.67-1.04) and 1.27 (95% CI 0.98-1.64)). Male sex was associated with a higher risk of 1-year and 5-year mortality (OR 1.24 (95% CI 1.13-1.36) and 1.25 (95% CI 1.18-1.31)), but a lower risk of stroke/TIA than female sex. Conclusions: No significant sex-related difference was observed at 30 days in patients being discharged alive and without peri-operative neurologic events. Male sex was associated with a higher risk of mortality but a lower risk of stroke/TIA at 1 and 5 years.