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1.
Clin Infect Dis ; 2024 Apr 24.
Article in English | MEDLINE | ID: mdl-38656065

ABSTRACT

Vascular graft infection (VGI) is one of the most serious complications following arterial reconstructive surgery. VGI has received increasing attention over the past decade, but many questions remain regarding its diagnosis and management. In this review, we describe our approach to VGI through multidisciplinary collaboration and discuss decision making for challenging presentations. This review will concentrate on VGI that impacts both aneurysms and pseudoaneurysms excluding the ascending thoracic aorta.

2.
Clin Infect Dis ; 2024 Apr 18.
Article in English | MEDLINE | ID: mdl-38635420

ABSTRACT

Vascular graft infection (VGI) is one of the most serious complications following arterial reconstructive surgery. VGI has received increasing attention over the past decade, but many questions remain regarding its diagnosis and management. In this review, we describe our approach to VGI through multidisciplinary collaboration and discuss decision-making for challenging presentations. This document will concentrate on VGI that impacts both aneurysms and pseudoaneurysms excluding the ascending thoracic aorta.

3.
J Neurosurg ; : 1-13, 2024 Mar 15.
Article in English | MEDLINE | ID: mdl-38489823

ABSTRACT

OBJECTIVE: The International Mission on Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury (IMPACT) and Corticosteroid Randomization After Significant Head Injury (CRASH) prognostic models for mortality and outcome after traumatic brain injury (TBI) were developed using data from 1984 to 2004. This study examined IMPACT and CRASH model performances in a contemporary cohort of US patients. METHODS: The prospective 18-center Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study (enrollment years 2014-2018) enrolled subjects aged ≥ 17 years who presented to level I trauma centers and received head CT within 24 hours of TBI. Data were extracted from the subjects who met the model criteria (for IMPACT, Glasgow Coma Scale [GCS] score 3-12 with 6-month Glasgow Outcome Scale-Extended [GOSE] data [n = 441]; for CRASH, GCS score 3-14 with 2-week mortality data and 6-month GOSE data [n = 831]). Analyses were conducted in the overall cohort and stratified on the basis of TBI severity (severe/moderate/mild TBI defined as GCS score 3-8/9-12/13-14), age (17-64 years or ≥ 65 years), and the 5 top enrolling sites. Unfavorable outcome was defined as GOSE score 1-4. Original IMPACT and CRASH model coefficients were applied, and model performances were assessed by calibration (intercept [< 0 indicated overprediction; > 0 indicated underprediction] and slope) and discrimination (c-statistic). RESULTS: Overall, the IMPACT models overpredicted mortality (intercept -0.79 [95% CI -1.05 to -0.53], slope 1.37 [1.05-1.69]) and acceptably predicted unfavorable outcome (intercept 0.07 [-0.14 to 0.29], slope 1.19 [0.96-1.42]), with good discrimination (c-statistics 0.84 and 0.83, respectively). The CRASH models overpredicted mortality (intercept -1.06 [-1.36 to -0.75], slope 0.96 [0.79-1.14]) and unfavorable outcome (intercept -0.60 [-0.78 to -0.41], slope 1.20 [1.03-1.37]), with good discrimination (c-statistics 0.92 and 0.88, respectively). IMPACT overpredicted mortality and acceptably predicted unfavorable outcome in the severe and moderate TBI subgroups, with good discrimination (c-statistic ≥ 0.81). CRASH overpredicted mortality in the severe and moderate TBI subgroups and acceptably predicted mortality in the mild TBI subgroup, with good discrimination (c-statistic ≥ 0.86); unfavorable outcome was overpredicted in the severe and mild TBI subgroups with adequate discrimination (c-statistic ≥ 0.78), whereas calibration was nonlinear in the moderate TBI subgroup. In subjects ≥ 65 years of age, the models performed variably (IMPACT-mortality, intercept 0.28, slope 0.68, and c-statistic 0.68; CRASH-unfavorable outcome, intercept -0.97, slope 1.32, and c-statistic 0.88; nonlinear calibration for IMPACT-unfavorable outcome and CRASH-mortality). Model performance differences were observed across the top enrolling sites for mortality and unfavorable outcome. CONCLUSIONS: The IMPACT and CRASH models adequately discriminated mortality and unfavorable outcome. Observed overestimations of mortality and unfavorable outcome underscore the need to update prognostic models to incorporate contemporary changes in TBI management and case-mix. Investigations to elucidate the relationships between increased survival, outcome, treatment intensity, and site-specific practices will be relevant to improve models in specific TBI subpopulations (e.g., older adults), which may benefit from the inclusion of blood-based biomarkers, neuroimaging features, and treatment data.

4.
Am J Pharm Educ ; 88(2): 100646, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38211883

ABSTRACT

OBJECTIVE: This study aimed to describe the purpose, implementation, and perceived utility of course evaluations in pharmacy programs. METHODS: After a literature review, a 34-item survey was developed, pretested, and sent to assessment administrators at accredited pharmacy programs (N = 139) with at least 3 follow-ups. Descriptive and inferential statistics were performed in IBM SPSS Statistics software. RESULTS: A total of 90 programs responded (64.7% response rate). Most students (94%) were offered the opportunity to complete course evaluations. Some students completed evaluations during the course (47%), while others did so within 1 week of completion of the course (49%). Whether or not class time was given for students to complete the survey was often dependent on faculty choice (52.2%). Results were typically released after final grades were posted (92%), in time to use for the next semester of teaching (77%). Faculty were chosen to be evaluated by the number of teaching hours (50%) followed by all instructors (45.6%). Programs used the results for performance reviews by chairs (91%), course coordinator reviews (84%), and committee continuous quality improvement efforts (72%). Most programs did not provide faculty guidance on using evaluations (78%) nor development/mentoring (57%); only 22% of programs offered student development in completing evaluations. CONCLUSION: While most programs invite feedback from all students via evaluations, most did not provide guidance to faculty on how to use this feedback for faculty or course development purposes. A more robust process to optimize the use of course evaluations should be developed.


Subject(s)
Education, Pharmacy , Students, Pharmacy , Humans , Schools, Pharmacy , Education, Pharmacy/methods , Faculty , Surveys and Questionnaires
5.
BMJ Open ; 13(12): e072144, 2023 12 10.
Article in English | MEDLINE | ID: mdl-38072491

ABSTRACT

OBJECTIVES: The study aim was to evaluate vaccine effectiveness (VE) of COVID-19 vaccines in preventing symptomatic COVID-19 among healthcare workers (HCWs) in Zambia. We sought to answer the question, 'What is the vaccine effectiveness of a complete schedule of the SARS-CoV-2 vaccine in preventing symptomatic COVID-19 among HCWs in Zambia?' DESIGN/SETTING: We conducted a test-negative case-control study among HCWs across different levels of health facilities in Zambia offering point of care testing for COVID-19 from May 2021 to March 2022. PARTICIPANTS: 1767 participants entered the study and completed it. Cases were HCWs with laboratory-confirmed SARS-CoV-2 and controls were HCWs who tested SARS-CoV-2 negative. Consented HCWs with documented history of vaccination for COVID-19 (vaccinated HCWs only) were included in the study. HCWs with unknown test results and unknown vaccination status, were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was VE among symptomatic HCWs. Secondary outcomes were VE by: SARS-CoV-2 variant strains based on the predominant variant circulating in Zambia (Delta during May 2021 to November 2021 and Omicron during December 2021 to March 2022), duration since vaccination and vaccine product. RESULTS: We recruited 1145 symptomatic HCWs. The median age was 30 years (IQR: 26-38) and 789 (68.9%) were women. Two hundred and eighty-two (24.6%) were fully vaccinated. The median time to full vaccination was 102 days (IQR: 56-144). VE against symptomatic SARS-CoV-2 infection was 72.7% (95% CI: 61.9% to 80.7%) for fully vaccinated participants. VE was 79.4% (95% CI: 58.2% to 90.7%) during the Delta period and 37.5% (95% CI: -7.0% to 63.3%) during the Omicron period. CONCLUSIONS: COVID-19 vaccines were effective in reducing symptomatic SARS-CoV-2 among Zambian HCWs when the Delta variant was circulating but not when Omicron was circulating. This could be related to immune evasive characteristics and/or waning immunity. These findings support accelerating COVID-19 booster dosing with bivalent vaccines as part of the vaccination programme to reduce COVID-19 in Zambia.


Subject(s)
COVID-19 Vaccines , COVID-19 , Female , Humans , Adult , Male , COVID-19 Vaccines/therapeutic use , COVID-19/epidemiology , COVID-19/prevention & control , SARS-CoV-2 , Zambia/epidemiology , COVID-19 Testing , Case-Control Studies , Vaccine Efficacy , Health Personnel
6.
J Neurosurg ; : 1-12, 2023 Nov 24.
Article in English | MEDLINE | ID: mdl-38000069

ABSTRACT

OBJECTIVE: The object of this study was to describe the use of patient-reported outcome measures (PROMs) in cerebrovascular neurosurgery and to outline a framework for incorporating them into future cerebrovascular research. METHODS: Following the standardized PRISMA guidelines, the authors performed a search of the PubMed and Embase databases in February 2023 using filters to investigate six specific cerebrovascular pathologies/procedures: subarachnoid hemorrhage (SAH), intracranial hemorrhage, ischemic stroke, arteriovenous malformation, chronic subdural hematoma, and carotid artery stenosis. PROMs in the identified articles were distinguished and classified as generic, symptom specific, or disease specific. RESULTS: A total of 259 studies including 51 PROMs were eligible for inclusion in the review. Most of the PROMs were generic or symptom specific. Only 5 PROMs were disease specific, and all of these pertained to stroke or SAH. CONCLUSIONS: There are only a limited number of disease-specific PROMs available for cerebrovascular pathologies and outcomes. Further validation of existing measures in independent cohorts, expanded incorporation of disease-specific PROMs in prospective trials, and the development of new PROMs specific to cerebrovascular conditions are critical to a better understanding of the impact of cerebrovascular diseases and novel therapies on patient lives.

7.
Open Forum Infect Dis ; 10(8): ofad431, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37663086

ABSTRACT

Background: The PROTECT study is a longitudinal cohort study initiated in July 2021 with weekly testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 4 states: Arizona, Florida, exas, and Utah. This study aims to examine vaccine-elicited antibody response against postvaccination SARS-CoV-2 infections. Methods: Children aged 5-11 years had serum collected 14-59 days after their second dose of monovalent Pfizer-BioNTech coronavirus disease 2019 messenger RNA vaccine. Vaccine-elicited antibodies were measured using the area under the curve (AUC) and end-point titer using enzyme-linked immunosorbent assay (receptor-binding domain [RBD] and S2) and surrogate neutralization assays against ancestral (WA1) and Omicron (BA.2). Results: 79 vaccinated participants (33 [41.7%] female; median age, 8.8 years [standard deviation, 1.9 years]), 48 (60.8%) were from Tucson, Arizona; 64 (81.0%) were non-Hispanic white; 63 (80.8%) attended school in person; 68 (86.1%) did not have any chronic conditions; and 47 (59.5%) were infected after vaccination. Uninfected children had higher AUCs against WA1 (P = .009) and Omicron (P = .02). The geometric mean and surrogate neutralization titer above the limit of detection was 346.0 for WA1 and 39.7 for Omicron, an 8.7-fold decrease (P < .001). After adjustment of covariates in the WA1-specific model, we observed a 47% reduction in the odds of postvaccination infection for every standard deviation increase in RBD AUC (aOR, 0.53 [95% confidence interval, .29-.97) and a 69% reduction in the odds of infection for every 3-fold increase in RBD end titer (0.31 [.06-1.57]). Conclusions: Children with higher antibody levels experienced a lower incidence of postvaccination SARS-CoV-2 infection.

8.
Influenza Other Respir Viruses ; 17(9): e13189, 2023 09.
Article in English | MEDLINE | ID: mdl-37693773

ABSTRACT

Background: Uncertainty about risk of illness and the value of influenza vaccines negatively affects vaccine uptake among persons targeted for influenza vaccination. Methods: During 2016-2019, we followed a cohort of healthcare personnel (HCP) targeted for free-of-charge influenza vaccination in five Lima hospitals to quantify risk of influenza, workplace presenteeism (coming to work despite illness), and absenteeism (taking time off from work because of illness). The HCP who developed acute respiratory illnesses (ARI) (≥1 of acute cough, runny nose, body aches, or feverishness) were tested for influenza using reverse-transcription polymerase chain reaction (rt-PCR). Findings: The cohort (2968 HCP) contributed 950,888 person-days. Only 36 (6%) of 605 HCP who participated every year were vaccinated. The HCP had 5750 ARI and 147 rt-PCR-confirmed influenza illnesses. The weighted incidence of laboratory-confirmed influenza was 10.0/100 person-years; 37% used antibiotics, and 0.7% used antivirals to treat these illnesses. The HCP with laboratory-confirmed influenza were present at work while ill for a cumulative 1187 hours. Interpretation: HCP were frequently ill and often worked rather than stayed at home while ill. Our findings suggest the need for continuing medical education about the risk of influenza and benefits of vaccination and stay-at-home-while-ill policies.


Subject(s)
Influenza Vaccines , Influenza, Human , Virus Diseases , Humans , Influenza, Human/drug therapy , Influenza, Human/epidemiology , Influenza, Human/prevention & control , Antiviral Agents/therapeutic use , Prospective Studies , Anti-Bacterial Agents , Delivery of Health Care
9.
J Stroke Cerebrovasc Dis ; 32(9): 107287, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37531723

ABSTRACT

OBJECTIVES: Carotid stenosis may cause silent cerebrovascular disease (CVD) through atheroembolism and hypoperfusion. If so, revascularization may slow progression of silent CVD. We aimed to compare the presence and severity of silent CVD to the degree of carotid bifurcation stenosis by cerebral hemisphere. MATERIALS AND METHODS: Patients age ≥40 years with carotid stenosis >50% by carotid ultrasound who underwent MRI brain from 2011-2015 at Mayo Clinic were included. Severity of carotid stenosis was classified by carotid duplex ultrasound as 50-69% (moderate), 70-99% (severe), or occluded. White matter lesion (WML) volume was quantified using an automated deep-learning algorithm applied to axial T2 FLAIR images. Differences in WML volume and prevalent silent infarcts were compared across hemispheres and severity of carotid stenosis. RESULTS: Of the 183 patients, mean age was 71±10 years, and 39.3% were female. Moderate stenosis was present in 35.5%, severe stenosis in 46.5% and occlusion in 18.0%. Patients with carotid stenosis had greater WML volume ipsilateral to the side of carotid stenosis than the contralateral side (mean difference, 0.42±0.21cc, p=0.046). Higher degrees of stenosis were associated with greater hemispheric difference in WML volume (moderate vs. severe; 0.16±0.27cc vs 0.74±0.31cc, p=0.009). Prevalence of silent infarct was 23.5% and was greater on the side of carotid stenosis than the contralateral side (hemispheric difference 8.8%±3.2%, p=0.006). Higher degrees of stenosis were associated with higher burden of silent infarcts (moderate vs severe, 10.8% vs 31.8%; p=0.002). CONCLUSIONS: WML and silent infarcts were greater on the side of severe carotid stenosis.


Subject(s)
Carotid Stenosis , Cerebrovascular Disorders , White Matter , Humans , Female , Middle Aged , Aged , Aged, 80 and over , Adult , Male , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/epidemiology , White Matter/diagnostic imaging , White Matter/pathology , Constriction, Pathologic/complications , Cerebrovascular Disorders/complications , Magnetic Resonance Imaging , Infarction/pathology
10.
Heliyon ; 9(6): e16951, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37484281

ABSTRACT

The renin-angiotensin system (RAS) is a hormonal cascade that contributes to several disorders: systemic hypertension, heart failure, kidney disease, and neurodegenerative disease. Activation of the RAS can promote inflammation and fibrosis. Drugs that target the RAS can be classified into 3 categories, AT1 angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, and renin inhibitors. The therapeutic efficacy of current RAS-inhibiting drugs is limited by poor penetration across the blood-brain barrier, low bioavailability, and to some extent, short half-lives. Nanoparticle-mediated drug delivery systems (DDSs) are possible emerging alternatives to overcome such limitations. Nanoparticles are ideally 1-100 nm in size and are considered efficient DDSs mainly due to their unique characteristics, including water dispersity, prolonged half-life in blood circulation, smaller size, and biocompatibility. Nano-scale DDSs can reduce the drug dosage frequency and acute toxicity of drugs while enhancing therapeutic success. Different types of nanoparticles, such as chitosan, polymeric, and nanofibers, have been examined in RAS-related studies, especially in hypertension, cardiovascular disease, and COVID-19. In this review article, we summarize the physical and chemical characteristics of each nanoparticle to elaborate on their potential use in RAS-related nano-drug delivery research and clinical application.

11.
AJNR Am J Neuroradiol ; 44(9): 1032-1038, 2023 09.
Article in English | MEDLINE | ID: mdl-37500290

ABSTRACT

BACKGROUND AND PURPOSE: Most multinodular and vacuolating neuronal tumors (MVNTs) are diagnosed and followed radiologically without any change across time. There are no surveillance guidelines or quantitative volumetric assessments of these tumors. We evaluated MVNT volumes during long follow-up periods using segmentation tools with the aim of quantitative assessment. MATERIALS AND METHODS: All patients with MVNTs in a brain MR imaging report in our system were reviewed. Patients with only 1 brain MR imaging or in whom MVNT was not clearly the most likely diagnosis were excluded. All MVNTs were manually segmented. For all follow-up examinations, absolute and percentage volume change from immediately prior and initial examinations were calculated. RESULTS: Forty-eight patients (32 women; median age, 50.5 years at first scanning) underwent 158 brain MRIs. The median duration between the first and last scan was 15.6 months (interquartile range, 5.7-29.6 months; maximum, 6.4 years) and between consecutive scans, it was 6.7 months (interquartile range, 3.3-12.4 months; maximum, 4.9 years). Pearson correlation coefficients between days since immediately prior scan versus absolute and percentage volume change from immediately prior scan were r = 0.05 (P = .60) and r = 0.07 (P = .45), respectively. For the relationship between days since the first scan versus absolute and percentage volume change from the first scan, values were r = -0.06 (P = .53) and r = -0.04 (P = .67), respectively. CONCLUSIONS: MVNT segmentation across follow-up brain MR imaging examinations did not demonstrate significant volume differences, suggesting that these tumors do not enlarge with time. Hence, frequent surveillance imaging of newly diagnosed MVNTs may not be necessary.


Subject(s)
Brain Neoplasms , Magnetic Resonance Imaging , Humans , Female , Middle Aged , Follow-Up Studies , Brain Neoplasms/diagnostic imaging , Brain Neoplasms/pathology , Brain/diagnostic imaging , Brain/pathology , Neuroimaging
12.
Interv Neuroradiol ; : 15910199231188862, 2023 Jul 17.
Article in English | MEDLINE | ID: mdl-37461320

ABSTRACT

This is a case report of an adult with chronic subdural hematoma (cSDH) who underwent endovascular treatment for middle meningeal artery (MMA) embolization. There was a prominent meningo-ophthalmic branch with an absence of an ophthalmic artery from the internal carotid artery. MMA embolization was performed utilizing particles with no complications and the resolution of the cSDH was within 4 months. This case report demonstrates that despite extreme variant anatomy, MMA embolization with particles is feasible, effective, and safe when appropriate techniques are used.

13.
NPJ Microgravity ; 9(1): 35, 2023 May 05.
Article in English | MEDLINE | ID: mdl-37147378

ABSTRACT

Pharmaceuticals selected for exploration space missions must remain stable and effective throughout mission timeframes. Although there have been six spaceflight drug stability studies, there has not been a comprehensive analytical analysis of these data. We sought to use these studies to quantify the rate of spaceflight drug degradation and the time-dependent probability of drug failure resulting from the loss of active pharmaceutical ingredient (API). Additionally, existing spaceflight drug stability studies were reviewed to identify research gaps to be addressed prior to exploration missions. Data were extracted from the six spaceflight studies to quantify API loss for 36 drug products with long-duration exposure to spaceflight. Medications stored for up to 2.4 years in low Earth orbit (LEO) exhibit a small increase in the rate of API loss with a corresponding increase in risk of product failure. Overall, the potency for all spaceflight-exposed medications remains within 10% of terrestrial lot-matched control with a ~1.5 increase in degradation rate. All existing studies of spaceflight drug stability have focused primarily on repackaged solid oral medications, which is important because non-protective repackaging is a well-established factor contributing to loss of drug potency. The factor most detrimental to drug stability appears to be nonprotective drug repackaging, based on premature failure of drug products in the terrestrial control group. The result of this study supports a critical need to evaluate the effects of current repackaging processes on drug shelf life, and to develop and validate suitable protective repackaging strategies that help assure the stability of medications throughout the full duration of exploration space missions.

14.
Nature ; 617(7960): 277-281, 2023 May.
Article in English | MEDLINE | ID: mdl-37100910

ABSTRACT

Correlations of partitioned particles carry essential information about their quantumness1. Partitioning full beams of charged particles leads to current fluctuations, with their autocorrelation (namely, shot noise) revealing the particles' charge2,3. This is not the case when a highly diluted beam is partitioned. Bosons or fermions will exhibit particle antibunching (owing to their sparsity and discreteness)4-6. However, when diluted anyons, such as quasiparticles in fractional quantum Hall states, are partitioned in a narrow constriction, their autocorrelation reveals an essential aspect of their quantum exchange statistics: their braiding phase7. Here we describe detailed measurements of weakly partitioned, highly diluted, one-dimension-like edge modes of the one-third filling fractional quantum Hall state. The measured autocorrelation agrees with our theory of braiding anyons in the time domain (instead of braiding in space); with a braiding phase of 2θ = 2π/3, without any fitting parameters. Our work offers a relatively straightforward and simple method to observe the braiding statistics of exotic anyonic states, such as non-abelian states8, without resorting to complex interference experiments9.

15.
Mayo Clin Proc Innov Qual Outcomes ; 7(3): 143-152, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37020901

ABSTRACT

Objective: To investigate the performance of a commercially available artificial intelligence (AI) algorithm for the detection of pulmonary embolism (PE) on contrast-enhanced computed tomography (CT) scans in patients hospitalized for coronavirus disease 2019 (COVID-19). Patients and Methods: Retrospective analysis was performed of all contrast-enhanced chest CT scans of patients admitted for COVID-19 between March 1, 2020 and December 31, 2021. Based on the original radiology reports, all PE-positive examinations were included (n=527). Using a reversed-flow single-gate diagnostic accuracy case-control model, a randomly selected cohort of PE-negative examinations (n=977) was included. Pulmonary parenchymal disease severity was assessed for all the included studies using a semiquantitative system, the total severity score. All included CT scans were sent for interpretation by the commercially available AI algorithm, Aidoc. Discrepancies between AI and original radiology reports were resolved by 3 blinded radiologists, who rendered a final determination of indeterminate, positive, or negative. Results: A total of 78 studies were found to be discrepant, of which 13 (16.6%) were deemed indeterminate by readers and were excluded. The sensitivity and specificity of AI were 93.2% (95% CI, 90.6%-95.2%) and 99.6% (95% CI, 98.9%-99.9%), respectively. The accuracy of AI for all total severity score groups (mild, moderate, and severe) was high (98.4%, 96.7%, and 97.2%, respectively). Artificial intelligence was more accurate in PE detection on CT pulmonary angiography scans than on contrast-enhanced CT scans (P<.001), with an optimal Hounsfield unit of 362 (P=.048). Conclusion: The AI algorithm demonstrated high sensitivity, specificity, and accuracy for PE on contrast-enhanced CT scans in patients with COVID-19 regardless of parenchymal disease. Accuracy was significantly affected by the mean attenuation of the pulmonary vasculature. How this affects the legitimacy of the binary outcomes reported by AI is not yet known.

16.
J Endovasc Ther ; : 15266028231156089, 2023 Mar 01.
Article in English | MEDLINE | ID: mdl-36859812

ABSTRACT

BACKGROUND: Overall inferior vena cava filter (IVCF) utilization has decreased in the United States since the 2010 US Food and Drug Administration (FDA) safety communication. The FDA renewed this safety warning in 2014 with additional mandates on reporting IVCF-related adverse events. We evaluated the impact of the FDA recommendations on IVCF placements for different indications from 2010 to 2019 and further assessed utilization trends by region and hospital teaching status. METHODS: Inferior vena cava filter placements between 2010 and 2019 were identified in the Nationwide Inpatient Sample database using the associated International Classification of Diseases, Ninth Revision, Clinical Modification, and Tenth Revision codes. Inferior vena cava filter placements were categorized by indication for venous thromboembolism (VTE) "treatment" in patients with VTE diagnosis and contraindication to anticoagulation and "prophylaxis" in patients without VTE. Generalized linear regression was used to analyze utilization trends. RESULTS: A total of 823 717 IVCFs were placed over the study period, of which 644 663 (78.3%) were for VTE treatment and 179 054 (21.7%) were for prophylaxis indications. The median age for both categories of patients was 68 years. The total number of IVCFs placed for all indications decreased from 129 616 in 2010 to 58 465 in 2019, with an aggregate decline rate of -8.4%. The decline rate was higher between 2014 and 2019 than between 2010 and 2014 (-11.6% vs -7.2%). From 2010 to 2019, IVCF placement for VTE treatment and prophylaxis trended downward at rates of -7.9% and -10.2%, respectively. Urban nonteaching hospitals saw the highest decline for both VTE treatment (-17.2%) and prophylactic indications (-18.0%). Hospitals located in the Northeast region had the highest decline rates for VTE treatment (-10.3%) and prophylactic indications (-12.5%). CONCLUSION: The higher decline rate in IVCF placements between 2014 and 2019 compared with 2010 and 2014 suggests an additional impact of the renewed 2014 FDA safety indications on national IVCF utilization. Variations in IVCF use for VTE treatment and prophylactic indications existed across hospital teaching types, locations, and regions. CLINICAL IMPACT: Inferior vena cava filters (IVCF) are associated with medical complications. The 2010 and 2014 FDA safety warnings appeared to have synergistically contributed to a significant decline in IVCF utilization rates from 2010 - 2019 in the US. IVC filter placements in patients without venous thromboembolism (VTE) declined at a higher rate than VTE. However, IVCF utilization varied across hospitals and geographical locations, likely due to the absence of universally accepted clinical guidelines on IVCF indications and use. Harmonization of IVCF placement guidelines is needed to standardize clinical practice, thereby reducing the observed regional and hospital variations and potential IVC filter overutilization.

17.
J Clin Med ; 12(5)2023 03 03.
Article in English | MEDLINE | ID: mdl-36902811

ABSTRACT

INTRODUCTION: Neuroworsening may be a sign of progressive brain injury and is a factor for treatment of traumatic brain injury (TBI) in intensive care settings. The implications of neuroworsening for clinical management and long-term sequelae of TBI in the emergency department (ED) require characterization. METHODS: Adult TBI subjects from the prospective Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot Study with ED admission and disposition Glasgow Coma Scale (GCS) scores were extracted. All patients received head computed tomography (CT) scan <24 h post-injury. Neuroworsening was defined as a decline in motor GCS at ED disposition (vs. ED admission). Clinical and CT characteristics, neurosurgical intervention, in-hospital mortality, and 3- and 6-month Glasgow Outcome Scale-Extended (GOS-E) scores were compared by neuroworsening status. Multivariable regressions were performed for neurosurgical intervention and unfavorable outcome (GOS-E ≤ 3). Multivariable odds ratios (mOR) with [95% confidence intervals] were reported. RESULTS: In 481 subjects, 91.1% had ED admission GCS 13-15 and 3.3% had neuroworsening. All neuroworsening subjects were admitted to intensive care unit (vs. non-neuroworsening: 26.2%) and were CT-positive for structural injury (vs. 45.4%). Neuroworsening was associated with subdural (75.0%/22.2%), subarachnoid (81.3%/31.2%), and intraventricular hemorrhage (18.8%/2.2%), contusion (68.8%/20.4%), midline shift (50.0%/2.6%), cisternal compression (56.3%/5.6%), and cerebral edema (68.8%/12.3%; all p < 0.001). Neuroworsening subjects had higher likelihoods of cranial surgery (56.3%/3.5%), intracranial pressure (ICP) monitoring (62.5%/2.6%), in-hospital mortality (37.5%/0.6%), and unfavorable 3- and 6-month outcome (58.3%/4.9%; 53.8%/6.2%; all p < 0.001). On multivariable analysis, neuroworsening predicted surgery (mOR = 4.65 [1.02-21.19]), ICP monitoring (mOR = 15.48 [2.92-81.85], and unfavorable 3- and 6-month outcome (mOR = 5.36 [1.13-25.36]; mOR = 5.68 [1.18-27.35]). CONCLUSIONS: Neuroworsening in the ED is an early indicator of TBI severity, and a predictor of neurosurgical intervention and unfavorable outcome. Clinicians must be vigilant in detecting neuroworsening, as affected patients are at increased risk for poor outcomes and may benefit from immediate therapeutic interventions.

18.
Otolaryngol Head Neck Surg ; 169(3): 548-555, 2023 09.
Article in English | MEDLINE | ID: mdl-36939577

ABSTRACT

OBJECTIVE: Da Vinci single port (SP) has been recently approved for transoral robotic surgery (TORS). Its characteristics make it particularly feasible for laryngeal and hypopharyngeal surgery. We report our experience comparing intra- and postoperative outcomes, technical advantages, and shortcomings of transoral laryngeal and hypopharyngeal resections performed with the da Vinci SP and the da Vinci Si/Xi systems. STUDY DESIGN: Retrospective database review. SETTING: Single academic tertiary care hospital. METHODS: Subjects included adult patients with laryngeal and hypopharyngeal carcinoma who underwent TORS between 2008 and 2022. The SP and multiport (MP) systems were compared in terms of intraoperative times, short-term postoperative outcomes, and TORS-related complications after a propensity score matching. RESULTS: A total of 185 patients were enrolled (56 SP vs 129 MP patients), and a cohort of 112 patients was analyzed after matching. The docking time was reduced in the SP group (8.84 ± 4.67 vs 6.45 ± 3.11 minutes; p = .003), as well as console time (53.91 ± 29.38 vs 42.70 ± 13.72 minutes; p = .035). Positive margins were more frequent in the MP group (52% vs 43%; p = .34). The mean decannulation time was 1.86 days longer in the SP group (p = .046). No significant differences emerged from the analysis of the duration of hospitalization, enteral feeding, and TORS-related complications. CONCLUSION: SP safety profile is comparable to that of previous models, while it showed advantages in terms of reduced docking times. Console times were also shortened due to improved maneuverability and field visualization.


Subject(s)
Carcinoma , Laryngeal Neoplasms , Robotic Surgical Procedures , Adult , Humans , Retrospective Studies , Laryngeal Neoplasms/surgery , Hypopharynx/surgery
19.
Stem Cell Res Ther ; 14(1): 49, 2023 03 22.
Article in English | MEDLINE | ID: mdl-36949528

ABSTRACT

BACKGROUND: Therapeutic interventions that optimize angiogenic activities may reduce rates of end-stage kidney disease, critical limb ischemia, and lower extremity amputations in individuals with diabetic kidney disease (DKD). Infusion of autologous mesenchymal stromal cells (MSC) is a promising novel therapy to rejuvenate vascular integrity. However, DKD-related factors, including hyperglycemia and uremia, might alter MSC angiogenic repair capacity in an autologous treatment approach. METHODS: To explore the angiogenic activity of MSC in DKD, the transcriptome of adipose tissue-derived MSC obtained from DKD subjects was compared to age-matched controls without diabetes or kidney impairment. Next-generation RNA sequencing (RNA-seq) was performed on MSC (DKD n = 29; Controls n = 9) to identify differentially expressed (DE; adjusted p < 0.05, |log2fold change|> 1) messenger RNA (mRNA) and microRNA (miRNA) involved in angiogenesis (GeneCards). Paracrine-mediated angiogenic repair capacity of MSC conditioned medium (MSCcm) was assessed in vitro using human umbilical vein endothelial cells incubated in high glucose and indoxyl sulfate for a hyperglycemic, uremic state. RESULTS: RNA-seq analyses revealed 133 DE mRNAs (77 upregulated and 56 down-regulated) and 208 DE miRNAs (119 up- and 89 down-regulated) in DKD-MSC versus Control-MSC. Interestingly, miRNA let-7a-5p, which regulates angiogenesis and participates in DKD pathogenesis, interacted with 5 angiogenesis-associated mRNAs (transgelin/TAGLN, thrombospondin 1/THBS1, lysyl oxidase-like 4/LOXL4, collagen 4A1/COL4A1 and collagen 8A1/COL8A1). DKD-MSCcm incubation with injured endothelial cells improved tube formation capacity, enhanced migration, reduced adhesion molecules E-selectin, vascular cell adhesion molecule 1 and intercellular adhesion molecule 1 mRNA expression in endothelial cells. Moreover, angiogenic repair effects did not differ between treatment groups (DKD-MSCcm vs. Control-MSCcm). CONCLUSIONS: MSC from individuals with DKD show angiogenic transcriptome alterations compared to age-matched controls. However, angiogenic repair potential may be preserved, supporting autologous MSC interventions to treat conditions requiring enhanced angiogenic activities such as DKD, diabetic foot ulcers, and critical limb ischemia.


Subject(s)
Diabetes Mellitus , Diabetic Nephropathies , Mesenchymal Stem Cells , MicroRNAs , Humans , Diabetic Nephropathies/genetics , Diabetic Nephropathies/therapy , Diabetic Nephropathies/metabolism , Chronic Limb-Threatening Ischemia , Transcriptome , Neovascularization, Physiologic/genetics , Mesenchymal Stem Cells/metabolism , MicroRNAs/genetics , MicroRNAs/metabolism , Human Umbilical Vein Endothelial Cells/metabolism , RNA, Messenger/metabolism , Diabetes Mellitus/metabolism , Protein-Lysine 6-Oxidase/genetics , Protein-Lysine 6-Oxidase/metabolism
20.
Histopathology ; 83(2): 168-177, 2023 Aug.
Article in English | MEDLINE | ID: mdl-36849852

ABSTRACT

AIMS: The prognostic role of EGFR mutations remains controversial. We aimed to evaluate the prognostic role of EGFR mutation in consideration of the IASLC histological grade in patients with resected early-stage lung adenocarcinoma. METHODS AND RESULTS: A total of 3297 patients with stages I-IIA resected lung adenocarcinoma who had had EGFR mutation tests between January 2014 and December 2019 at the Samsung Medical Center, Seoul, Korea were included. Recurrence-free survival (RFS) was compared by EGFR mutation status (EGFR-M+ versus EGFR-WT) and IASLC histological grade (G1, G2 and G3). Cox proportional hazards models were used to estimate the adjusted HRs (aHRs) and 95% confidence intervals (CIs). RESULTS: Compared to the EGFR-WT group, the EGFR-M+ group had a significantly lower proportion of G3 tumour (16 versus 33%, P < 0.001). During a median follow-up of 41.4 months, 376 patients experienced recurrence. After adjusting for histological grade, the aHR for recurrence comparing the EGFR-M+ to the EGFR-WT was 1.30 (95% CI = 1.04-1.62, P = 0.022). The EGFR-M+ group had a significantly lower 5-year RFS than the EGFR-WT group among G3 patients (58.4 versus 71.5%, P < 0.001), but not among G1 and G2 patients. CONCLUSIONS: EGFR mutation status was associated with a risk of recurrence after consideration of the IASLC histological grading, especially in G3 tumours. The results of this study would be useful for developing a new staging system and identifying a subset of patients who may benefit from adjuvant targeted therapy.


Subject(s)
Adenocarcinoma of Lung , Adenocarcinoma , Lung Neoplasms , Humans , Prognosis , Lung Neoplasms/pathology , Neoplasm Staging , ErbB Receptors/genetics , Adenocarcinoma of Lung/genetics , Adenocarcinoma of Lung/pathology , Adenocarcinoma/genetics , Adenocarcinoma/surgery , Mutation , Retrospective Studies
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