Incidence and predictors of new-onset atrial fibrillation in ST-elevation myocardial infarction: A single-center study.

Background and Aims: Atrial fibrillation (AF) is a common arrhythmia that occurs following ST-elevation myocardial infarction (STEMI) and can significantly impact clinical outcomes. We investigated the incidence and predictors of AF following STEMI in patients, as well as its association with major adverse cardiac and cerebrovascular events (MACCE). Methods: We conducted a retrospective cohort study, including all STEMI patients who presented under code 247 to Tehran Heart Center between 2016 and 2020 and completed a 1-year follow-up. Patients were divided into two groups based on the development of AF during follow-up, and their baseline and clinical characteristics were compared. We used multivariable regression models to identify predictors of MACCE. Results: Out of 3647 STEMI patients, 84 (2.3%) developed new-onset AF (NOAF). Patients with AF were significantly older and had lower levels of total and low-density lipoprotein cholesterol, triglyceride, and hemoglobin, but higher levels of fasting blood sugar and creatinine. AF patients were also more likely to have a history of hypertension, chronic kidney disease (CKD), congestive heart failure, and cerebrovascular accidents. The multivariable logistic regression model identified the CHA2DS2-VASc score and CKD as independent predictors of NOAF following primary percutaneous coronary intervention. Furthermore, the incidence of MACCE was higher in the AF group, and AF independently predicted MACCE with a hazard ratio of 2.766. Conclusion: The CHA2DS2-VASc score and the presence of CKD can serve as useful predictors of NOAF among patients with STEMI. Early detection and appropriate management are crucial to improve outcomes.

Comparison of Surgical Burden, Radiographic and Clinical Outcomes According to the Severity of Baseline Sagittal Imbalance in Adult Spinal Deformity Patients.

OBJECTIVE: To determine the clinical impact of the baseline sagittal imbalance severity in patients with adult spinal deformity (ASD). METHODS: We retrospectively reviewed patients who underwent ≥ 5-level fusion including the pelvis, for ASD with a ≥ 2-year follow-up. Using the Scoliosis Research Society-Schwab classification system, patients were classified into 3 groups according to the severity of the preoperative sagittal imbalance: mild, moderate, and severe. Postoperative clinical and radiographic results were compared among the 3 groups. RESULTS: A total of 259 patients were finally included. There were 42, 62, and 155 patients in the mild, moderate, and severe groups, respectively. The perioperative surgical burden was greatest in the severe group. Postoperatively, this group also showed the largest pelvic incidence minus lumbar lordosis mismatch, suggesting a tendency towards undercorrection. No statistically significant differences were observed in proximal junctional kyphosis, proximal junctional failure, or rod fractures among the groups. Visual analogue scale for back pain and Scoliosis Research Society-22 scores were similar across groups. However, severe group's last follow-up Oswestry Disability Index (ODI) scores significantly lower than those of the severe group. CONCLUSION: Patients with severe sagittal imbalance were treated with more invasive surgical methods along with increased the perioperative surgical burden. All patients exhibited significant radiological and clinical improvements after surgery. However, regarding ODI, the severe group demonstrated slightly worse clinical outcomes than the other groups, probably due to relatively higher proportion of undercorrection. Therefore, more rigorous correction is necessary to achieve optimal sagittal alignment specifically in patients with severe baseline sagittal imbalance.

The predictive value of GLIM criteria on clinical outcomes and responses to nutritional support in patients with neurocritical illnesses.

Neurocritically ill patients frequently exhibit coma, gastroparesis, and intense catabolism, leading to an increased risk of malnutrition. The Global Leadership Initiative on Malnutrition (GLIM) criteria for the diagnosis of malnutrition was created to achieve a consistent malnutrition diagnosis across diverse populations. This study aimed to validate the concurrent and predictive validity of GLIM criteria in patients with neurocritical illnesses. A total of 135 participants were followed from admission to the neurocritical unit (NCU) until discharge. Comparing GLIM criteria to the Subjective Global Assessment (SGA), sensitivity was 0.95 and specificity was 0.69. Predictive validity of GLIM criteria was assessed using a composite adverse clinical outcome, comprising mortality and various major complications. Adjusted hazard ratios for moderate and severe malnutrition were 2.86 (95% CI 1.45-5.67) and 3.88 (95% CI 1.51-9.94), respectively. Changes in indicators of nutritional status, including skeletal muscle mass and abdominal fat mass, within 7 days of admission were obtained for 61 participants to validate the predictive capability of the GLIM criteria for the patients' response of standardized nutritional support. The GLIM criteria have a statistically significant predictive validity on changes in rectus femoris muscle thickness and midarm muscle circumference. In conclusion, the GLIM criteria demonstrate high sensitivity for diagnosing malnutrition in neurocritically ill patients and exhibit good predictive validity.

Plasma neurofilament light chain as a biomarker for poor outcome after aneurysmal subarachnoid hemorrhage.

BACKGROUND: Neurofilament light chain (NfL), a biomarker reflecting neuro-axonal damage, may be useful in improving clinical outcome prediction after aSAH. We explore the robust and additional value of NfL to neurological and radiological grading scales in predicting poor outcome after aSAH. METHODS: In this prospective cohort study conducted in a single tertiary center, blood samples were collected of aSAH patients within 24 hours after ictus and before endovascular/surgical intervention. The primary endpoint was poor outcome at six months' follow-up. Receiver operating curves (ROC), area under the curve (AUC, 95% CI) and model-fit (Nagelkerke R2) were calculated for NfL, neurological grading scale (WFNS), modified Fisher, age and sex. A combined ROC and AUC were calculated for variables with an AUC≥0.70. RESULTS: A total of 66 (42%) had poor outcome. The AUC of NfL for poor outcome was 0.70 (0.62-0.78). Combining NfL and WFNS resulted in a slightly higher model-fit and not-significantly higher AUC for predicting poor outcome (R2 0.51; AUC 0.86, 0.80-0.92) compared to WFNS alone. When patients were stratified according to hemorrhage severity, median NfL [IQR] levels were significantly higher in poor grade (14 [7-32] pg/ml) than good grade patients (7 [5-14] pg/ml). Within poor grade patients, median NfL [IQR] levels were significantly higher in non-survivors (19 [11-36] pg/ml) than survivors (7 [6-13] pg/ml). CONCLUSION: In the entire aSAH cohort, plasma NfL has an acceptable predictive performance but does not improve clinical outcome prediction. However, NfL may have potential value in subgroups based on hemorrhage severity.

Predicting Role of GFAP and UCH-L1 biomarkers in Spontaneous Subarachnoid Hemorrhage: a preliminary study to evaluate in the short-term their correlation with severity of bleeding and prognosis.

BACKGROUND: Spontaneous non-traumatic subarachnoid hemorrhage (sSAH) is a severe brain vascular accident. Glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) can be theoretically assayed to predict a patient's progression, picturing different aspects of clinical failure after sSAH. The study aims to: a) explore the correlation between sSAH blood volume and biomarkers variation; b) evaluate if these can be predictive of the neurogenic response after sSAH and be prognostic of patient outcome; c) establish eventual threshold levels of biomarkers to define patients' clinical outcome. METHODS: Blood volumetry at CT scan upon admission, GFAP and UCH-L1 were collected at 24 h, at 72 h, and after 7 days from hemorrhage. Trends and cut-off serum sampling were determined. Clinical outcome was assessed with mRS scale at 14 days. RESULTS: A strong correlation between GFAP and UCH-L1 and blood diffusion volume in all explored serum intervals related to unfavorable outcome. GFAP and UCH-L1 were very early predictors of unfavorable outcomes at 24 h from sSAH (p = 0.002 and 0.011 respectively). Threshold levels of UCH-L1 apparently revealed a very early, early and late predictor of unfavorable outcomes. CONCLUSION: GFAP and UCH-L1 represent a potential tool for prompt monitoring and customization of therapies in neurosurgical patients.

Individual participant data analysis comparing acute stroke patients with anterior versus posterior circulation dissections.

BACKGROUND: Cervical artery dissection (CAD) is a relevant etiology of transient ischemic attacks and strokes. Several trials explored the significance of specific antithrombotic treatments, i.e. oral anticoagulation (OAC) versus antiplatelet treatment (APT), on recurrent ischemic complications and clinical outcomes. As overall incidence rates of complications were low there is still controversy which antithrombotic treatment should be used. However, up to now there has been no systematic investigation among CAD-patients with ischemic stroke specifically comparing clinical course and outcome of patients with anterior versus posterior CAD. METHODS: We performed an individual participant data analysis of patients with CAD and ischemic stroke. Over a five-year period we pooled data from three sites (i.e. West China Hospital, Chengdu, China as well as Erlangen and Giessen University Hospitals, Germany) and enrolled patients with CAD-associated ischemic stroke. Patient demographics, clinical and in-hospital measures as well as radiological data were retrieved from institutional databases. Clinical follow-up was over 6 months and included data on recurrent ischemic strokes and hemorrhages as well as clinical functional outcome assessed by the modified Rankin Scale dichotomized into favourable (mRS=0-2) and unfavourable. RESULTS: A total of 203 patients with CAD were included of which n=112 had anterior and n=91 had posterior CAD. Patients with posterior CAD were younger (46.0 vs. 41.0 y; p<0.001) than patients with anterior CAD and showed less often arterial hypertension. (42.0 % vs. 28.6 %; p<0.048). Antithrombotic treatment with APT and OAC was similarily distributed among patients with anterior and posterior CAD and not significantly differently related to ischemic or hemorrhagic complications during follow-up (all p=n.s.). Main difference between Chinese and German patients were mode of antithrombotic treatment consisting predominantly of APT in China compared to OAC in Germany. Functional outcome overall was good, yet worse in patients with anterior CAD compared to posterior CAD (80.2 % favorable in anterior CAD vs. 92.2 % in posterior CAD (p=0.014). CONCLUSION: This study provides evidence that anterior and posterior CAD show baseline imbalances regarding age and comorbidity which may affect clinical outcome. There are no signals of superiority or harm of any specific mode of antithrombotic treatment nor relevant discrepancies in clinical outcome among Chinese and German CAD-associated stroke patients.

Clinical outcome assessments of disease burden and progression in late-onset GM2 gangliosidoses.

The late-onset GM2 gangliosidoses, comprising late-onset Tay-Sachs and Sandhoff diseases, are rare, slowly progressive, neurogenetic disorders primarily characterized by neurogenic weakness, ataxia, and dysarthria. The aim of this longitudinal study was to characterize the natural history of late-onset GM2 gangliosidoses using a number of clinical outcome assessments to measure different aspects of disease burden and progression over time, including neurological, functional, and quality of life, to inform the design of future clinical interventional trials. Patients attending the United States National Tay-Sachs & Allied Diseases Family Conference between 2015 and 2019 underwent annual clinical outcome assessments. Currently, there are no clinical outcome assessments validated to assess late-onset GM2 gangliosidoses; therefore, instruments used or designed for diseases with similar features, or to address various aspects of the clinical presentations, were used. Clinical outcome assessments included the Friedreich's Ataxia Rating Scale, the 9-Hole Peg Test, and the Assessment of Intelligibility of Dysarthric Speech. Twenty-three patients participated in at least one meeting visit (late-onset Tay-Sachs, n = 19; late-onset Sandhoff, n = 4). Patients had high disease burden at baseline, and scores for the different clinical outcome assessments were generally lower than would be expected for the general population. Longitudinal analyses showed slow, but statistically significant, neurological progression as evidenced by worsening scores on the 9-Hole Peg Test (2.68%/year, 95% CI: 0.13-5.29; p = 0.04) and the Friedreich's Ataxia Rating Scale neurological examination (1.31 points/year, 95% CI: 0.26-2.35; p = 0.02). Time since diagnosis to study entry correlated with worsening scores on the 9-Hole Peg Test (r = 0.728; p < 0.001), Friedreich's Ataxia Rating Scale neurological examination (r = 0.727; p < 0.001), and Assessment of Intelligibility of Dysarthric Speech intelligibility (r = -0.654; p = 0.001). In summary, patients with late-onset GM2 gangliosidoses had high disease burden and slow disease progression. Several clinical outcome assessments suitable for clinical trials showed only small changes and standardized effect sizes (change/standard deviation of change) over 4 years. These longitudinal natural history study results illustrate the challenge of identifying responsive endpoints for clinical trials in rare, slowly progressive, neurogenerative disorders where arguably the treatment goal is to halt or decrease the rate of decline rather than improve clinical status. Furthermore, powering such a study would require a large sample size and/or a long study duration, neither of which is an attractive option for an ultra-rare disease with no available treatment. These findings support the development of potentially more sensitive late-onset GM2 gangliosidoses-specific rating instruments and/or surrogate endpoints for use in future clinical trials.

Effect of intraoperative cell salvage on coagulation function outcomes in patients with massive post-Cesarean section hemorrhage.

OBJECTIVE: To examine the impact of using intraoperative cell salvage (ICS) for the restoration of coagulation function in cases of massive Post-Cesarean Section Hemorrhage (PCSH). METHODS: A retrospective analysis was conducted on 60 cases of massive PCSH meeting inclusion criteria at Suqian Maternity and Children's Hospital from January 2020 to July 2022. Patients were divided into two groups: allogeneic blood transfusion group (Group A, n = 30) and ICS group (Group B, n = 30), based on transfusion methods. Blood parameters, coagulation function, and adverse reactions were assessed before (T0) and after (T1) transfusion. Patients were categorized into good prognosis (GP) and poor prognosis (PP) groups based on adverse reaction occurrence. Clinical profiles were compared between groups, and multivariate binary logistic regression analysis was employed to evaluate the factors that may affect the prognosis in women with PCSH. RESULTS: No significant differences in routine blood parameters were observed between groups at T0 and T1 (P>0.05). At T0, no significant differences in PT, APTT, TT, or FIB were found between groups (P>0.05). Both groups showed a reduction in PT, APTT, and TT values at T1 compared to T0, with Group B experiencing a more significant decrease than Group A (P<0.05). FIB increased in both groups at T1 compared to T0, with Group B demonstrating a higher increase than Group A (P<0.05). Both groups showed increased blood pressure at T1 compared to T0, with Group B showing a more pronounced elevation than Group A (P<0.05). The occurrence of adverse reactions was significantly lower in Group B (1/30, 3.33%) compared to Group A (7/30, 23.33%) (P<0.05). Logistic regression analysis identified FIB<1.52 g/L and HR<45.35 times/min as factors associated with increased risk of unfavorable outcome in women with PCSH. CONCLUSION: In patients experiencing significant PCSH, ICS may lead to better postoperative recovery of blood parameters, faster restoration of coagulation function, and reduced risk of adverse events compared to ABT. Moreover, early detection of coagulation function and blood gas indexes is crucial for clinicians to implement timely prevention and treatment measures.

Assessing the prognostic value of KRAS mutation combined with tumor size in stage I-II non-small cell lung cancer: a retrospective analysis.

Background: KRAS mutation status is a well-established independent prognostic factor in advanced non-small cell lung cancer (NSCLC), yet its role in early-stage disease is unclear. Here, we investigate the prognostic value of combining survival data on KRAS mutation status and tumor size in stage I-II NSCLC. Methods: We studied the combined impact of KRAS mutational status and tumor size on overall survival (OS) in patients with stage I-II NSCLC. We performed a retrospective study including 310 diagnosed patients with early (stage I-II) NSCLCs. All molecularly assessed patients diagnosed with stage I-II NSCLC between 2016-2018 in the Västra Götaland Region of western Sweden were screened in this multi-center retrospective study. The primary study outcome was overall survival. Results: Out of 310 patients with stage I-II NSCLC, 37% harbored an activating mutation in the KRAS gene. Our study confirmed staging and tumor size as prognostic factors. However, KRAS mutational status was not found to impact OS and there was no difference in the risk of death when combining KRAS mutational status and primary tumor size. Conclusions: In our patient cohort, KRAS mutations in combination with primary tumor size did not impact prognosis in stage I-II NSCLC.

Leveraging sensor-based functional outcomes to enhance understanding of the patient experience: challenges and opportunities.

INTRODUCTION: Sensor-based digital health technology (DHT) has emerged as a promising means to assess patient functioning within and outside clinical trials. Sensor-based functional outcomes (SBFOs) provide valuable insights that complement other measures of how a patient feels or functions to enhance understanding of the patient experience to inform medical product development. AREAS COVERED: This perspective paper provides recommendations for defining SBFOs, discusses the core evidence required to support SBFOs to inform decision-making, and considers future directions for the field. EXPERT COMMENTARY: The clinical outcome assessment (COA) development process provides an important starting point for developing patient-centered SBFOs; however, given the infancy of the field, SBFO development may benefit from a hybrid approach to evidence generation by merging exploratory data analysis with patient engagement in measure development. Effective SBFO development requires combining unique expertise in patient engagement, measurement and regulatory science, and digital health and analytics. Challenges specific to SBFO development include identifying concepts of interest, ensuring measurement of meaningful aspects of health, and identifying thresholds for meaningful change. SBFOs are complementary to other COAs and, as part of an integrated evidence strategy, offer great promise in fostering a holistic understanding of patient experience and treatment benefits, particularly in real-world settings.

Predicting CD27 expression and clinical prognosis in serous ovarian cancer using CT-based radiomics.

BACKGROUND: This study aimed to develop and evaluate radiomics models to predict CD27 expression and clinical prognosis before surgery in patients with serous ovarian cancer (SOC). METHODS: We used transcriptome sequencing data and contrast-enhanced computed tomography images of patients with SOC from The Cancer Genome Atlas (n = 339) and The Cancer Imaging Archive (n = 57) and evaluated the clinical significance and prognostic value of CD27 expression. Radiomics features were selected to create a recursive feature elimination-logistic regression (RFE-LR) model and a least absolute shrinkage and selection operator logistic regression (LASSO-LR) model for CD27 expression prediction. RESULTS: CD27 expression was upregulated in tumor samples, and a high expression level was determined to be an independent protective factor for survival. A set of three and six radiomics features were extracted to develop RFE-LR and LASSO-LR radiomics models, respectively. Both models demonstrated good calibration and clinical benefits, as determined by the receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis. The LASSO-LR model performed better than the RFE-LR model, owing to the area under the curve (AUC) values of the ROC curves (0.829 vs. 0.736). Furthermore, the AUC value of the radiomics score that predicted the overall survival of patients with SOC diagnosed after 60 months was 0.788 using the LASSO-LR model. CONCLUSION: The radiomics models we developed are promising noninvasive tools for predicting CD27 expression status and SOC prognosis. The LASSO-LR model is highly recommended for evaluating the preoperative risk stratification for SOCs in clinical applications.

Patient-advocate-led global coalition adapting fit-for-purpose outcomes measures to assure meaningful inclusion of DEEs in clinical trials.

Existing clinical tools that measure non-seizure outcomes lack the range and granularity needed to capture skills in developmental and epileptic encephalopathy (DEE)-affected individuals who also fall in the severe to profound range of intellectual disability. This effectively excludes those with severe impairments from clinical trials, impeding the ability of sponsors to evaluate disease-modifying therapies (DMTs). The Inchstone Project, an international, patient advocate-led collaboration, brings together leading researchers, clinicians, pharmaceutical companies, and advocates to develop an adapted, validated assessment battery within 5 years. The goal is to support trials of DMTs for the DEEs by providing sufficiently sensitive measurement tools to demonstrate therapeutic efficacy. An initial pilot study administered 7 established assessments to 10 individuals affected by SCN2A-DEE, identifying specific limitations of existing measures and areas for improvement. It was clear that most tools do not account for challenges throughout the DEE population, including vision impairments, significant motor impairments and profound intellectual disability, which need to be accounted for in creating a 'fit-for-purpose' battery for the DEE population. Several novel assessments, including two measures of responsivity developed for use in monitoring recovery after acquired brain injury as well as individualized Goal Attainment Scaling, showed promise in this group. The team also completed a DEE-wide survey with over 270 caregivers documenting their children's abilities and priorities for their improvement from new treatments. The Inchstone team is using this information to evaluate how existing tools might be updated to better capture what is most important to families and measure their child's small but important improvements over time. These efforts are building a coherent picture across multiple DEEs of what domains, or concepts of interest, have the greatest impact on most patients and families. The Inchstone team is on course to adapt non-seizure outcome measures that are (1) sufficiently sensitive to measure small increments of meaningful change ('Inchstones') and (2) applicable to multiple DEE conditions.

DEE-P Connection's Inchstone project is adapting assessment tools to measure the smallest developmental changes in those affected by developmental and epileptic encephalopathies (DEEs) - severe epilepsy and related developmental disorders. More sensitive measures will allow profoundly impacted individuals to be effectively included in clinical trials and result in better DEE treatments. Caregivers of children with DEEs understand firsthand that clinical tools intended to measure non-seizure outcomes, like communication and motor skills, were not designed for and don't work for their children. More sensitive tools are needed to measure the small changes that occur in DEEs. The limitations of existing measurement tools for DEEs have significant consequences: - Non-seizure responses to new therapies cannot be measured without tools designed specifically for individuals with severe to profound intellectual disability.- If a response cannot be measured in a trial, a potentially beneficial impact will be missed and a therapy, having failed to demonstrate an effect, may not gain regulatory approval.- DEE-affected individuals are less likely to benefit from the wave of new disease-modifying therapies providing hope for many other rare genetic diseases. DEE-P Connections, a patient advocacy organization supporting families caring for those severely affected by DEEs, launched The Inchstone Project to address this problem. This team science research collaborative unites researchers, pharmaceutical companies, advocates and others around a shared vision of adapting existing tools to reliably capture the small but important changes in skills in those severely affected by DEEs. To better understand these gaps, the Inchstone team conducted a pilot study with 10 children with SCN2A DEE. The team administered multiple assessments to explore how to adapt the tools to better capture the abilities and growth of this population. The team also completed a comprehensive DEE-wide survey with over 270 caregivers documenting their children's abilities and priorities for their improvement from new treatments, helping to document how existing tools may be updated to better capture what's most important to families and measure their children's small but important improvements over time. The Inchstone Project is on course to assure those profoundly impacted by DEEs are meaningfully included in clinical trials by establishing trusted and reliable non-seizure measurement tools.

Smartwatch-based functional assessment for upper extremity impairment after musculoskeletal injuries: A pilot study.

Introduction: Wearable sensors are increasingly applied to rehabilitation for arm movement analysis. However, simple and clinically relevant applications are scarce. Objectives: To investigate the feasibility of single smart watch-based parameters for functional assessment in upper limb rehabilitation for musculoskeletal injuries using a commercial smart watch. Method: Ten patients with unilateral shoulder pain and range-of-motion limitations were enrolled. They wore Galaxy Watch® and performed three sets of upper extremity tasks consisting of gross activities-of-daily-living tasks, Wolf Motor Function Test (WMFT), and Upper Extremity Functional Index (UEFI), and the acceleration and angular velocities were acquired. The motion segment size (MSS), representing motion smoothness from a clinical perspective, and various sensor-based parameters were extracted. The correlation between the parameters and clinical outcome measures were analyzed. The percent relative range (PRR) of the significant parameters was also calculated. Results: For overhead and behind body activity task set, mean MSS for elbow flexion/extension axis significantly correlated with WMFT score (R = 0.784, p = .012). For planar tasks, mean MSS for the forearm supination/pronation (R = 0.815, p = .007) and shoulder rotation (R = 0.870, p = .002) axes significantly correlated with WMFT score. For forearm and fine movement task set, mean MSS of the elbow flexion/extension angle showed significant correlation with WMFT (R = 0.880, p < .001) and UEFI (R = 0.718, p = .019). The total performance time (R = -0.741, p = .014) also showed significant correlation with WMFT score. The PRR for mean MSS in forearm supination (71.5%, planar tasks) and mean MSS in x-direction (49.8%, forearm and fine motor movements) were similar to the PRR of WMFT (58.5%), suggesting sufficient variation range across different degree of impairments. Conclusion: The commercial smart watch-based parameters showed consistent potential for use in clinical functional assessments.

Long-term prognostic implications of brachial-ankle pulse wave velocity in patients undergoing percutaneous coronary intervention.

Objective: The long-term clinical effect of arterial stiffness in high-risk disease entities remains unclear. The prognostic implications of brachial-ankle pulse wave velocity (baPWV) were assessed using a real-world registry that included patients who underwent percutaneous coronary intervention (PCI). Methods: Arterial stiffness was measured using baPWV before discharge. The primary outcome was net adverse clinical events (NACE), defined as a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or major bleeding. Secondary outcomes included major adverse cardiac and cerebrovascular events (MACCE: a composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke), and major bleeding. The outcomes were assessed over a 4-year period. Results: Patients (n = 3,930) were stratified into high- and low-baPWV groups based on a baPWV cut-off of 1891 cm/s determined through time-dependent receiver operating characteristic curve analysis. baPWV was linearly correlated with 4-year post-PCI clinical events. The high baPWV group had a greater cumulative incidence of NACE, MACCE, and major bleeding. According to multivariable analysis, the high baPWV groups had a significantly greater risk of 4-year NACE (adjusted hazard ratio [HRadj]: 1.44; 95% confidence interval [CI]: 1.12-1.85; p = 0.004), MACCE (HRadj: 1.40; 95% CI: 1.07-1.83; p = 0.015), and major bleeding (HRadj: 1.94; 95% CI: 1.15-3.25; p = 0.012). Conclusion: In PCI-treated patients, baPWV was significantly associated with long-term clinical outcomes, including ischemic and bleeding events, indicating its value for identifying high-risk phenotypes.

Association between procedural time and outcome in unsuccessful mechanical thrombectomy for acute ischemic stroke: analysis from the Italian Registry of Endovascular Treatment in Acute Stroke.

BACKGROUND: We aim to assess the association between procedural time and outcomes in patients in unsuccessful mechanical thrombectomy (MT) for anterior circulation acute stroke. METHODS: We conducted a cohort study on prospectively collected data from patients with M1 and/or M2 segment of middle cerebral artery occlusion with a thrombolysis in cerebral infarction 0-1 at the end of procedure. Primary outcome was 90-day poor outcome. Secondary outcomes were early neurological deterioration (END), symptomatic intracranial hemorrhage (sICH) according to ECASS II and sICH according to SITS-MOST. RESULTS: Among 852 patients, after comparing characteristics of favourable and poor outcome groups, logistic regression analysis showed age (OR: 1.04; 95%CI: 1.02-1.05; p < 0.001), previous TIA/stroke (OR: 0.23; 95%CI: 0.12-0.74; p = 0.009), M1 occlusion (OR: 1.69; 95%CI: 1.13-2.50; p = 0.01), baseline NIHSS (OR: 1.01; 95%CI: 1.06-1.13; p < 0.001) and procedural time (OR:1.00; 95% CI: 1.00-1.01; p = 0.003) as independent predictors poor outcome at 90 days. Concerning secondary outcomes, logistic regression analysis showed NIHSS (OR:0.96; 95%CI: 0.93-0.99; p = 0.008), general anaesthesia (OR:2.59; 95%CI: 1.52-4.40; p < 0.001), procedural time (OR: 1.00; 95% CI: 1.00-1.01; p = 0.002) and intraprocedural complications (OR: 1.89; 95%CI: 1.02-3.52; p = 0.04) as independent predictors of END. Bridging therapy (OR:2.93; 95%CI: 1.21-7.09; p = 0.017) was associated with sICH per SITS-MOST criteria whereas M1 occlusion (OR: 0.35; 95%CI: 0.18-0.69; p = 0.002), bridging therapy (OR: 2.02; 95%CI: 1.07-3.82; p = 0.03) and intraprocedural complications (OR: 5.55; 95%CI: 2.72-11.31; p < 0.001) were independently associated with sICH per ECASS II criteria. No significant association was found between the number of MT attempts and analyzed outcomes. CONCLUSIONS: Regardless of the number of MT attempts and intraprocedural complications, procedural time was associated with poor outcome and END. We suggest a deeper consideration of procedural time when treating anterior circulation occlusions refractory to MT.

The Relationship between Patient Self-Reported, Pre-Morbid Physical Activity and Clinical Outcomes of Inpatient Treatment in Youth with Anorexia Nervosa: A Pilot Study.

Links between premorbid physical activity (PA) and disease onset/course in patients with anorexia nervosa (AN) remain unclear. The aim was to assess self-reported PA as a predictor of change in percent median BMI (%mBMI) and length of hospital stay (LOS). Five PA domains were assessed via semi-structured interview in adolescents with AN at hospitalization: premorbid PA in school grades 1-6 (PA1-6); PA before AN onset (PA-pre) and after AN onset (PA-post); new, pathological motivation for PA (PA-new); and high intensity PA (PA-high). Eating disorder psychopathology was measured via the Eating Disorder Examination Questionnaire (EDE-Q), and current PA (steps/day) with accelerometry. PA1-6 was also assessed in healthy controls (HCs). Using stepwise backward regression models, predictors of %mBMI change and LOS were examined. Compared with 22 HCs (age = 14.7 ± 1.3 years, %mBMI = 102.4 ± 12.1), 25 patients with AN (age = 15.1 ± 1.7 years, %mBMI = 74.8 ± 6.0) reported significantly higher PA1-6 (median, AN = 115 [interquartile range IQR = 75;200] min vs. HC = 68 [IQR = 29;105] min; p = 0.017). PA-post was 244 ± 323% higher than PA-pre. PA1-6 was directly associated with PA-pre (p = 0.001) but not with PA-post (p = 0.179) or change in PA-pre to PA-post (p = 0.735). Lower %mBMI gain was predicted by lower baseline %mBMI (p = 0.001) and more PA-high (p = 0.004; r2 = 0.604). Longer LOS was predicted by higher PA-pre (p = 0.003, r2 = 0.368). Self-reported PA may identify a subgroup of youth with AN at risk of less weight gain and prolonged LOS during inpatient treatment for AN.

A Decade-Long Cohort Analysis of Human Cytomegalovirus (HCMV)-Induced Early and Late Renal Rejection in Post-Transplant Patients in the Eastern Indian Population.

Background: HCMV causes severe clinical complications in transplant recipients and may lead to graft rejection. Successful renal transplantation heavily relies on the early prevention and diagnosis of CMV infections, followed by prompt prophylactic treatment before transplantation. Despite the majority of renal rejection cases with acute HCMV infections being asymptomatic and occurring one to two years later, the objective of this research was to comprehend the effect of late HCMV infection on renal rejection by examining specific clinical parameters in the Eastern Indian cohort. Method: In this study, 240 patients were studied for five years following transplantation, and their data were collected from the local metropolitan hospital in Eastern India. Both HCMV-positive and -negative post-transplant patients were investigated using the clinical parameters and viral loads for latent infection. Results: Within the studied population, 79 post-transplant patients were found to be HCMV positive. Among them, 13 (16.45%) patients suffered from renal rejection within less than 2 yrs. of transplantation (early rejection) and 22 (27.84%) patients suffered from renal rejection after 2 yrs. from the operation date (late rejection). Assessment of clinical parameters with respect to HCMV infection revealed that in early rejection cases, fever (p-0.035) and urinary tract infection (p-0.017) were prominent, but in late rejection, hematuria (p-0.032), diabetes (p-0.005), and creatinine level changes (p < 0.001) were significant along with urinary tract infection (p-0.047). Conclusions: This study provides valuable insights into monitoring latent CMV infections and highlights the understanding of reducing renal rejection rates and the need for further research in this field.

Assessing the predictive capability of machine learning models in determining clinical outcomes for patients with cervical spondylotic myelopathy treated with laminectomy and posterior spinal fusion.

BACKGROUND: Cervical spondylotic myelopathy (CSM) is a prevalent degenerative condition resulting from spinal cord compression and injury. Laminectomy with posterior spinal fusion (LPSF) is a commonly employed treatment approach for CSM patients. This study aimed to assess the effectiveness of machine learning models (MLMs) in predicting clinical outcomes in CSM patients undergoing LPSF. METHODS: A retrospective analysis was conducted on 329 CSM patients who underwent LPSF at our institution from Jul 2017 to Jul 2023. Neurological outcomes were evaluated using the modified Japanese Orthopaedic Association (mJOA) scale preoperatively and at the final follow-up. Patients were categorized into two groups based on clinical outcomes: the favorable group (recovery rates ≥ 52.8%) and the unfavorable group (recovery rates < 52.8%). Potential predictors for poor clinical outcomes were compared between the groups. Four MLMs-random forest (RF), logistic regression (LR), support vector machine (SVM), and k-nearest neighborhood (k-NN)-were utilized to predict clinical outcome. RF model was also employed to identify factors associated with poor clinical outcome. RESULTS: Out of the 329 patients, 185 were male (56.2%) and 144 were female (43.4%), with an average follow-up period of 17.86 ± 1.74 months. Among them, 267 patients (81.2%) had favorable clinical outcomes, while 62 patients (18.8%) did not achieve favorable results. Analysis using binary logistic regression indicated that age, preoperative mJOA scale, and symptom duration (p < 0.05) were independent predictors of unfavorable clinical outcomes. All models performed satisfactorily, with RF achieving the highest accuracy of 0.922. RF also displayed superior sensitivity and specificity (sensitivity = 0.851, specificity = 0.944). The Area under the Curve (AUC) values for RF, Logistic LR, SVM, and k-NN were 0.905, 0.827, 0.851, and 0.883, respectively. The RF model identified preoperative mJOA scale, age, symptom duration, and MRI signal changes as the most significant variables associated with poor clinical outcomes in descending order. CONCLUSIONS: This study highlighted the effectiveness of machine learning models in predicting the clinical outcomes of CSM patients undergoing LPSF. These models have the potential to forecast clinical outcomes in this patient population, providing valuable prognostic insights for preoperative counseling and postoperative management.

Anterolateral Dual Plate Fixation for Distal Metaphyseal-Diaphyseal Junction Fractures of the Humerus: Biomechanical Finite Element Analysis with Clinical Results.

Background: Distal metaphyseal-diaphyseal junction fractures of the humerus are a subset of injuries between humeral shaft fractures and distal intra-articular humerus fractures. A lack of space for distal fixation and the unique anatomy of concave curvature create difficulties during operative treatment. The closely lying radial nerve is another major concern. The aim of this study was to determine whether anterolateral dual plate fixation could be effective for a distal junctional fracture of the humerus both biomechanically and clinically. Methods: A right humerus 3-dimensional (3D) model was obtained based on plain radiographs and computed tomography data of patients. Two fractures, a spiral type and a spiral wedge type, were constructed. Three-dimensional models of locking compression plates and screws were constructed using materials provided by the manufacturer. The experiment was conducted by using COMSOL Multiphysics, a finite element analysis, solver, and simulation software package. For the clinical study, from July 2008 to March 2021, a total of 72 patients were included. Their medical records were retrospectively reviewed to obtain patient demographics, elbow range of motion, Disabilities of the Arm, Shoulder and Hand (DASH) scores, Mayo Elbow Performance Scores (MEPS), and hand grip strength. Results: No fracture fixation construct completely restored stiffness comparable to the intact model in torsion or compression. Combinations of the 7-hole and 5-hole plates and the 8-hole and 6-hole plates showed superior structural stiffness and stress than those with single lateral plates. At least 3 screws (6 cortices) should be inserted into the lateral plate to reduce the load effectively. For the anterior plate, it was sufficient to purchase only the near cortex. Regarding clinical results of the surgery, the range of motion showed satisfactory results in elbow flexion, elbow extension, and forearm rotation. The average DASH score was 4.3 and the average MEPS was 88.2. Conclusions: Anterolateral dual plate fixation was biomechanically superior to the single-plate method in the finite element analysis of a distal junctional fracture of the humerus model. Anterolateral dual plate fixation was also clinically effective in a large cohort of patients with distal junctional fractures of the humerus.

Development of a Novel Statistical Model for Predicting Clinical Outcomes in Stroke Patients With Tandem Occlusions After Endovascular Therapy.

BACKGROUND: Tandem occlusions are intracranial large vessel occlusions (LVOs) with a concomitant ipsilateral extracranial internal carotid artery occlusion and can cause more severe stroke symptoms. AIM: To develop a simple, rigorously cross-validated novel tool to predict clinical outcomes following tandem occlusion in patients with acute LVO stroke, based on data that are easily available to clinicians. To have used machine learning approaches to utilize the available information from clinical and angiographic data to make predictive models able to distinguish between mortality versus survival and good (modified Rankin Scale (mRS) ≤ 2) versus unfavorable neurological outcomes (mRs ≥ 3) Materials and methods: Retrospective data from 87 consecutive patients with anterior circulation stroke and tandem occlusions who underwent mechanical thrombectomy and stenting between December 2009 and January 2020 were analyzed. Patients were stratified into three groups based on the location of their LVO, and these groups were compared using statistical tests. Predictive models were built and cross-validated 1000 times to estimate their predictive power, measured by accuracy and area under the receiver operating curve (AUROC). RESULTS: For distinguishing good outcome (mRS ≤ 2) versus poor outcome (mRS ≥ 3), the model comprised age, initial National Institute of Health Stroke Scale (NIHSS) score, Alberta Stroke Program Early CT Score (ASPECTS), NIHSS at 24 hours, NIHSS at discharge and intracranial haemorrhage and yielded an accuracy of 83% and the AUROC of 0.91. For mortality prediction, the model comprised age, initial NIHSS, intravenous thrombolysis, NIHSS at 24 hours and NIHSS at discharge and yielded an accuracy of 91% and an AUROC of 0.94. CONCLUSIONS: Models developed exhibit strong predictive performance and can distinguish between both the instances of survival versus mortality and good versus poor outcome with an aim to support clinicians in deciding on optimal management for these complex patients. The developed model will help identify those at risk of poorer outcomes and the prospective better selection of patients with acute ischaemic large vessel stroke secondary to tandem occlusions.