Diagnostic yield of endoscopic ultrasound in dilated common bile duct with non-diagnostic cross-sectional imaging.

BACKGROUND: Biliary dilatation without obvious etiology on cross sectional imaging warrants further investigation. This study aimed to assess yield of endoscopic ultrasound in providing etiologic diagnosis in such situation. METHODS: Prospective cohort of consecutive patients with biliary dilatation & non diagnostic computed tomography (CT) and /or magnetic resonance imaging (MRI) underwent endoscopic ultrasound (EUS) with/without fine needle aspiration cytology (FNAC) and were followed clinically, biochemically with/without radiology for up to six months. The findings of EUS were corroborated with histopathology of surgical specimens and endoscopic retrograde cholangiography (ERCP) findings in relevant cases. RESULTS: Median age of 121 patients completing follow up was 55 years. 98.2% patients were symptomatic and median common bile duct (CBD) diameter was 13 mm. EUS was able to identify lesions attributable for biliary dilatation in (67 out of 121) 55.4% cases with ampullary neoplasm being the commonest (29 out of 67 i.e. 43%). Multivariate logistic regression analysis identified jaundice as the predictor of positive diagnosis on EUS, of finding ampullary lesion and pancreatic lesion on EUS. EUS had sensitivity, specificity, positive predictive value and diagnostic accuracy of 95.65%, 94.23%, 95.65% and 95.04% respectively in providing etiologic diagnosis. Threshold value for baseline bilirubin of 10 mg%, for baseline CA 19.9 of 225 u/L and for largest CBD diameter of 16 mm were determined to have specificity of 98%, 95%, 92.5% respectively of finding a positive diagnosis on EUS. CONCLUSION: EUS provides considerable diagnostic yield with high accuracy in biliary dilatation when cross sectional imaging fails to provide etiologic diagnosis.

PIONEER REAL Japan: Primary results from a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in Japanese clinical practice.

AIMS/INTRODUCTION: PIONEER REAL Japan was a non-interventional prospective study of oral semaglutide in adults with type 2 diabetes in Japanese clinical practice. MATERIALS AND METHODS: Adults naïve to injectable glucose-lowering therapies initiated oral semaglutide in routine clinical practice and were followed for 34-44 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c) from baseline to end of study; the co-primary endpoint was number of adverse events (AEs). Secondary endpoints included change in bodyweight from baseline to end of study. Analyses were also carried out for subgroups aged <75 and ≥75 years. RESULTS: A total of 624 participants initiated oral semaglutide; 578 completed the study. Mean baseline HbA1c and bodyweight were 7.7% and 72.4 kg, respectively. At end of study, estimated change (95% confidence interval [CI]) in HbA1c from baseline was -0.7 percentage points (-0.77, -0.61) overall, -0.8 percentage points (-0.86, -0.67) in the <75 years subgroup and -0.5 percentage points (-0.68, -0.41) in the ≥75 years subgroup (all P < 0.0001). Estimated change (95% CI) in bodyweight was -2.8 (-3.19, -2.50) kg overall, -2.9 (-3.38, -2.49) kg in the <75 years subgroup and - 2.7 (-3.18, -2.14) kg in the ≥75 years subgroup (all P < 0.0001). AEs occurred in 161 (25.8%) participants: 99 of 423 (23.4%) and 62 of 201 (30.8%) participants in the <75 and ≥75 years subgroups, respectively. Gastrointestinal AEs were the AEs most frequently leading to oral semaglutide discontinuation. CONCLUSIONS: In routine clinical practice, HbA1c and bodyweight were significantly reduced from baseline in adults initiating oral semaglutide, including those aged ≥75 years, with no new safety concerns.

Elastic Scattering Spectroscopy on Patient-Selected Lesions Concerning for Skin Cancer.

BACKGROUND: Access to dermatologists is limited in parts of the US, making primary care clinicians (PCCs) integral for early detection of skin cancers. A handheld device using elastic scattering spectroscopy (ESS) was developed to aid PCCs in their clinical assessment of skin lesions. METHODS: In this prospective study, 3 PCCs evaluated skin lesions reported by patients as concerning and scanned each lesion with the handheld ESS device. The comparison was pathology results or a 3-dermatologist panel examining high resolution dermatoscopic and clinical images. PCCs reported their diagnosis, management decision, and confidence level for each lesion. Evaluation of results included sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and Area Under the Curve (AUC). RESULTS: A total of 155 patients and 178 lesions were included in the final analysis. The most commonly patient-reported concerning feature was "new or changing lesion" (91.6%). Device diagnostic sensitivity and specificity were 90.0% and 60.7%, respectively, based on biopsy result or dermatologist panel reference standard; comparatively, PCC sensitivity was 40.0% and 84.8% specificity without the use of the device. Device NPV was 98.9%, and device PPV was 13.6%. The device recommended patient referral to dermatology with 88.2% concordance with the dermatologist panel. AUC for the device and PCCs were 0.815 and 0.643, respectively. CONCLUSIONS: The use of the ESS device by PCCs can improve diagnostic and management sensitivity for select malignant skin lesions by correctly classifying most benign lesions of patient concern. This may increase skin cancer detection while improving access to specialist care.

Impact of preoperative anxiety on postoperative outcomes in patients undergoing minimally invasive thoracoscopic surgery: A prospective cohort study.

BACKGROUND: Preoperative anxiety is a common preoperative psychological state in patients with cancer and associated with worsening perioperative outcomes. However, high-quality prospective studies on preoperative anxiety in patients undergoing lung surgery are scarce. METHODS: We conducted a prospective cohort study, enrolling a total of 540 patients. Preoperative anxiety in patients undergoing thoracic surgery was measured using the Hospitalization Anxiety Scale. Patients were grouped according to the Hospitalization Anxiety Scale scores as follows: no anxiety (score <8) and anxiety (score ≥8). The association of preoperative anxiety with postoperative complications and non-complicated adverse events was determined by univariate regression and polynomial regression analyses. RESULTS: A total of 121 patients (22.4 %) experienced preoperative anxiety. The anxiety group had a longer average hospital stay (4.33 vs. 3.85 days). Postoperative complications were similar between groups, but the anxiety group reported worse sleep quality (measured by the Athens Insomnia Scale). Regarding postoperative pain, both groups had comparable rates of mild and severe pain on postoperative day 1. However, the anxiety group experienced significantly higher rates of severe pain on postoperative day 2 and mild pain on postoperative day 3. Additionally, the incidence of postoperative nausea and vomiting was significantly higher in the anxiety group on postoperative day 1. CONCLUSIONS: Preoperative anxiety may not increase the rates of postoperative complications in patients undergoing lung surgery. However, it may be associated with postoperative sleep disturbances, pain, nausea, and vomiting, as well as prolong the length of postoperative hospitalization.

Practice-based research in dentistry: Exploring methodologies, benefits, and challenges.

BACKGROUND: Practice-Based Research Network (PBRN) studies typically assess the effectiveness of clinical interventions in settings that match real-world conditions. Dental PBRNs have the capacity to amass, identify, and analyze vast amounts of data from patient populations that include diverse racial, ethnic, socio-economic, and geographic backgrounds. These dental studies encompass a broad spectrum of healthcare aspects, including prevention, diagnosis, symptom and disease treatment, quality enhancement, and care coordination. METHODS: An extensive range of research methodologies can be employed within dental PBRNs to investigate these topics, including randomized controlled trials. Dental PBRNs have evolved from primarily focusing on case observations to leveraging advanced network infrastructure and collaborating across multiple regional and national sites. In addition to producing numerous high-impact peer-reviewed publications, study results have led to improved clinical care. However, PBRNs encounter challenges, such as the sustainability of research capacity (relying heavily on ongoing support from funding agencies), diverse research cultures, and an imperative to design studies that are both feasible and relevant to everyday clinical practice. Recognizing the pivotal role of real-world evidence, it is important to have sustained investment in dental PBRN infrastructure and feasible opportunities for practitioners to participate in network activities nationwide. CONCLUSION: Practice-Based Research Network studies capitalize on an important research context within which to investigate a range of clinical topics that can employ multiple research methodologies. However, sustaining productive networks requires strategic effort, ongoing financial support, and customized organizational skills.

Longitudinal assessment of female carriers of choroideremia using multimodal retinal imaging.

BACKGROUND/AIMS: Female choroideremia carriers present with a spectrum of disease severity. Unlike in men, the rate of disease progression has not been well characterised in carriers. This longitudinal study aimed to determine the rate of retinal degeneration in choroideremia carriers, using multimodal imaging and microperimetry. METHODS: Choroideremia carriers previously seen at Oxford Eye Hospital (United Kingdom) between 2012 and 2017 returned for testing between 2015 and 2023, providing up to 11 years' follow-up data. Participants had optical coherence tomography, fundus-tracked microperimetry and fundus autofluorescence (FAF) imaging performed. RESULTS: Thirty-four eyes of 17 choroideremia carriers were examined using multimodal imaging. Median age was 44 (range: 15-73) years at baseline and median follow-up duration was 7 (range: 1-11) years. At baseline, phenotype was classified as fine (n=5 eyes), coarse (n=13 eyes), geographic (n=12 eyes) or male pattern (n=4 eyes). Thirteen patients showed no change in phenotype classification, four showed slight changes associated with choroideremia-related retinal degeneration. Despite this, carriers with severe retinal phenotypes had a statistically significant decline in average retinal sensitivity (-0.7 dB and -0.8 dB per year, respectively, p<0.001), area of geographic loss defined by FAF (+2.5 mm2 and +3.7 mm2 per year, respectively, p<0.001) and thinning of the photoreceptor complex (up to -2.8 microns and -10.3 microns per year, p<0.001). CONCLUSION: Choroideremia carriers, particularly those with severe retinal phenotypes, exhibit progressive retinal degeneration, as evident by multimodal imaging biomarkers and functional testing. Clinicians should not rely on retinal severity classification alone to assess disease progression.

Ankle-GO score is associated with the probability of becoming coper after lateral ankle sprain: a 1-year prospective cohort study.

OBJECTIVE: To analyse the association between Ankle-GO score during the return to sport process and the probability of becoming a coper 1 year after lateral ankle sprain (LAS). Copers were defined as patients returning to their preinjury sport without loss of function and reporting no episodes of reinjury or giving-way. METHODS: Two months after a LAS, patients performed the Ankle-GO assessment which includes a cluster of four functional tests and two self-reported questionnaires for a maximum score of 25 points. One year after injury, participants were classified as copers or non-copers. Eight potential predictive variables associated with coper status were compared between the groups. Receiver operating characteristic curves (area under the curve (AUC)) and multivariable logistic regression models with OR and 95% CIs were used to determine the association of potential factors, including the Ankle-GO score, with copers. RESULTS: 64 patients (56% females; age 33.7±13.2 years) completed the Ankle-GO-GO at 2 months postinjury. At 1 year postinjury, 10 patients (15%) were lost to follow-up, and only 17 of 54 patients (31%) became copers. Two-month Ankle-GO score was higher among copers (9.9±4.9 points vs 6.9±3.7, p=0.015) and was associated with future coper status at 1 year (AUC=0.70). Patients with an Ankle-GO score above 11 points and male patients were more likely to become copers (OR=12.1; 95% CI 2.5 to 59, p=0.002 and OR=5.2; 95% CI 1.2 to 22.4, p=0.026, respectively). CONCLUSION: The Ankle-GO may help identify patients more likely to become copers within a year of injury. Those with low Ankle-GO scores and female patients should receive additional rehabilitation to increase the odds of becoming a coper.

Acquired antithrombin deficiency in adult patients with postcardiotomy extracorporeal membrane oxygenation.

INTRODUCTION: This study aimed to investigate the relationship between acquired antithrombin deficiency in patients undergoing postcardiotomy extracorporeal membrane oxygenation (PC-ECMO) and thromboembolic or haemorrhagic events such as bleeding, peripheral arterial thromboembolism, and ischemic cerebrovascular events. METHODS: The study was designed as a single-center, prospective study and conducted at our hospital between November 2019 and June 2021. 50 patients who underwent ECMO due to postcardiotomy cardiogenic shock were included in the study. Antithrombin (AT) activity testing was performed immediately after ECMO placement and continued for 5 days. The total of haemorrhagic or thromboembolic events was defined as morbidity. The entire patient population was assessed daily for AT measurements according to morbidity status, and ROC analysis was applied to determine the cut-off point. The correlation between clinical outcomes and morbidities with antithrombin levels was analysed. RESULTS: In our study, we identified a cut-off for AT levels on the first postoperative day. The risk of both bleeding (p = .006) and thromboembolism (p = .012) was significantly higher in patients below the 48.9% cut-off value. AT levels were compared with data on separation from PC-ECMO. The rate of separation from ECMO was 7.969 times higher in cases with AT levels above 51.8 on the third postoperative day and 5.6 times higher in cases with AT levels above 47.5 on the fourth postoperative day. CONCLUSION: Acquired antithrombin deficiency may develop in adults undergoing PC-ECMO. In our study, we demonstrated that in patients with low antithrombin levels, the risk of bleeding and thromboembolism increased. Additionally, since AT levels were higher in survivors, this can be considered an indicator of severity. This study is the first prospective study related to determining target antithrombin levels in adult patients undergoing PC-ECMO.

Early Improvement in Interstitial Fluid Flow in Patients With Severe Carotid Stenosis After Angioplasty and Stenting.

Background and Purpose: This study aimed to investigate early changes in interstitial fluid (ISF) flow in patients with severe carotid stenosis after carotid angioplasty and stenting (CAS). Methods: We prospectively recruited participants with carotid stenosis ≥80% undergoing CAS at our institute between October 2019 and March 2023. Magnetic resonance imaging (MRI), including diffusion tensor imaging (DTI), and the Mini-Mental State Examination (MMSE) were performed 3 days before CAS. MRI with DTI and MMSE were conducted within 24 hours and 2 months after CAS, respectively. The diffusion tensor image analysis along the perivascular space (DTI-ALPS) index was calculated from the DTI data to determine the ISF status. Increments were defined as the ratio of the difference between post- and preprocedural values to preprocedural values. Results: In total, 102 participants (age: 67.1±8.9 years; stenosis: 89.5%±5.7%) with longitudinal data were evaluated. The DTI-ALPS index increased after CAS (0.85±0.15; 0.85 [0.22] vs. 0.86±0.14; 0.86 [0.21]; P=0.022), as did the MMSE score (25.9±3.7; 24.0 [4.0] vs. 26.9±3.4; 26.0 [3.0]; P<0.001). Positive correlations between increments in the DTI-ALPS index and MMSE score were found in all patients (rs=0.468; P<0.001). Conclusion An increased 24-hour post-CAS DTI-ALPS index suggests early improvement in ISF flow efficiency. The positive correlation between the 24-hour DTI-ALPS index and 2-month MMSE score increments suggests that early ISF flow improvement may contribute to long-term cognitive improvement after CAS.

Trajectories of choriocapillaris perfusion in healthy individuals and patients with diabetes mellitus: a prospective cohort study.

PURPOSE: To evaluate the longitudinal rate of choriocapillaris flow deficits (CFD) in healthy participants and patients with diabetes mellitus. METHODS: This prospective cohort study included healthy individuals and diabetic patients without diabetic retinopathy (non-DR) or with mild-to-moderate non-proliferative DR (NPDR). The swept-source optical coherence tomography angiography (OCTA) was adopted for quantifying CFD annually, and linear mixed models were used to analyse the CFD change and its 95% CI overtime. RESULTS: A total of 1025 individuals were included, including 465 healthy controls, 454 in the non-DR group and 106 in the NPDR group. Significant increase in CFDs was observed in NPDR group (0.423%, 95% CI 0.230% to 0.616%) and non-DR group (0.319%, 95% CI 0.225% to 0.412%), which were higher than the CFD in healthy controls (0.173%, 95% CI 0.079% to 0.266%). After adjusting for other factors, the non-DR and NPDR group had a greater annual elevation of CFD by 0.171% (95% CI 0.060% to 0.283%; p=0.003) and 0.258% (95% CI 0.068% to 0.449%; p=0.008) in comparisons with controls. Furthermore, higher serum creatinine and glycated haemoglobin levels, poorer best-corrected visual acuity, lower OCTA image quality scores and smaller CFD at baseline were independently related to accelerated CFD worsening (all p<0.05). CONCLUSIONS: The CFD among healthy individuals and patients with diabetes increased consistently overtime, regardless of the presence or absence of DR, suggesting that CFD alterations could be an early indicator of microvascular complications, potentially aiding in the earlier DR detection.

Increase in Intraoperative Intraocular Pressure in the Prone Position.

Introduction: This study aimed to measure the intraocular pressure (IOP) of patients undergoing open surgery in the supine position (control group) and spine surgery in the prone position (spine group) to clarify IOP range and change by posture, determine the risk factors for increased IOP in the prone position, and reduce visual complications after surgery in the prone position. Methods: A prospective cohort study was conducted in healthy adults (34-83 years of age) with an American Society of Anesthesiologists classification I/II. The spine group was examined for IOP, anterior chamber angle (ACA), and fundus findings the day prior to surgery. On the day of surgery, IOP measurements were taken at fixed time points: immediately after intubation; at 0.5, 1, and 2 h after intubation; at suture closure; and at the end of surgery in the control group. In the spine group, they were taken immediately after intubation; at 0.5, 1, and 2 h after prone position; at suture closure; and immediately and 5 min after returning to the supine position. The risk factors for increased IOP in the prone position were examined. Results: The control group showed no significant changes in IOP within the normal range (<20 mmHg) during surgery. In the spine group, IOP was higher at each time point than immediately after intubation. IOP increased sharply above the normal range within 1 h after changing from the supine to the prone position and continued to gradually increase until suture closure. IOP decreased 5 min after the patient returned to the supine position. ACA, body mass index, blood loss, time in the prone position, and operative time were not risk factors for increased IOP in the prone position. Conclusions: Patients were constantly exposed to above-normal IOP during prone spinal surgery. However, neither group reported visual impairment. No risk factors were identified for increased IOP in the prone position.

One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis.

Background: Mechanical thrombectomy is a promising treatment option for deep vein thrombosis; however, long-term data are lacking. Here, we report for the first time the 1-year clinical outcomes from the completely enrolled ClotTriever Outcomes (CLOUT) registry evaluating mechanical thrombectomy with the ClotTriever System (Inari Medical). Methods: The CLOUT registry (NCT03575364) is a prospective, multicenter, single-arm study that enrolled 500 patients with proximal lower extremity deep vein thrombosis. Prespecified 1-year outcomes include Villalta score and corresponding postthrombotic syndrome (PTS) severity, duplex ultrasound findings of patency (defined as the presence of flow with normal or partial compressibility), Revised Venous Clinical Severity Score, and quality of life (QoL). Results: In CLOUT, the median age was 61.9 years and 50.5% of patients were women. A total of 310 patients completed the 1-year visit. The 1-year PTS rate (Villalta score ≥ 5) was 19.3% and the moderate-to-severe PTS rate (Villalta score ≥ 10) was 8.8%. Median Villalta score decreased from 9.0 (IQR, 5.0-14.0) at baseline to 1.0 (IQR, 0.0-4.0) at 1 year (P < .0001). Similar rates of PTS and moderate-to-severe PTS were observed among limbs assessed at all study time points. Patency was observed in 94.2% of limbs. Median Revised Venous Clinical Severity Score was 6.0 (IQR, 3.0-9.0) at baseline and 3.0 (IQR, 1.0-4.0) at 1 year (P < .0001). Additionally, 90.4% of patients experienced improvements in QoL. Conclusions: One-year outcomes from the CLOUT registry demonstrate low PTS rates and preserved patency accompanied by improved symptom relief and QoL. Study follow-up through 2 years is ongoing.

The effects of potentially traumatic events on the recovery from pre-existing anxiety and depression symptomatology and the risk of PTSD.

AIM: The extent to which recent potentially traumatic events (PTEs) hinder the recovery from pre-existing mental health problems is largely unknown. The same applies to the extent to which non-recovery from pre-existing mental health problems increases the risk of posttraumatic stress disorder (PTSD). The aim of the present study is to gain insight in these effects. METHODS: Data were extracted from six annual surveys of the Dutch population-based Victims in Modern Society (VICTIMS) study. Of the adult respondents who participated in two subsequent surveys (labeled T1 and T2, n = 6942), those with severe anxiety and depression symptoms (ADS) at T1 (n = 487) were selected. We distinguished respondents exposed to PTEs (PTE-group, n = 162) and not exposed to PTEs (comparison group, n = 325) between T1 and T2. We applied five indicators of recovery [based on the Reliable Change Index (RCI), degrees of symptom reduction, and the cut-off score at T2]. Differences in the recovery from ADS and probable PTSD at T2 were examined using multivariate logistic regression. RESULTS: The PTE group less often recovered from severe ADS between T1 and T2 than the comparison group according to all five indicators of recovery, while controlling for 11 different variables (0.40 ≤ adjusted OR's ≤ 0.66). Those in the PTE group who did not recover, considerably more often suffered from probable PTSD at T2 (63%-82%) than those who did recover (0%-29%; 8.96 ≤ adjusted OR ≤ 26.33). CONCLUSION: Recent potentially traumatic events hinder the recovery from pre-existing anxiety and depression symptomatology and thereby increase the risk of probable PTSD.

Impact of sleeve gastrectomy on the periodontal status of patients with and without type 2 diabetes: a 1-year prospective real-world study.

Background: Periodontitis is a chronic inflammatory disease potentially associated with obesity and type 2 diabetes (T2D). Sleeve gastrectomy (SG) has shown substantial effect on weight loss and treatment of T2D. However, there is no direct evidence comparing the impact of SG on the periodontal status of patients with and without T2D. Objectives: To determine the impact of SG on the periodontal status of patients with and without T2D in a real-world setting. Methods: In a prospective and two-armed cohort design, participants who were scheduled for SG at an affiliated hospital between April 2022 and December 2022 were approached for eligibility. After a clinical evaluation and oral examination, those with periodontitis were included and further divided into the DM group (diabetic) and the Control group (non-diabetic) with a 1-year follow-up after surgery. The primary outcome was the periodontal status of patients at 12 months after SG. The secondary outcomes included weight loss, diabetes remission, and alterations in inflammatory markers for up to 1 year after SG. Results: Fifty-seven and 49 patients were included in the DM and the Control group, respectively. Before surgery, patients in the DM group had further worsened periodontal condition compared with those in the Control group. Accompanied by weight loss and glucose reduction, patients in both groups demonstrated significant decreases in plaque index (PLI) and bleeding index (BI) with no alterations in probing depth or clinical attachment loss for up to 1 year after SG. Even patients in the DM group achieved less TWL% (32.79 ± 6.20% vs. 37.95 ± 8.34, P<0.01), their periodontal condition had more substantial improvement with no significant difference in PLI and BI between groups at 1 year after SG. We also observed a significant reduction in the levels of high sensitive C-reactive protein and interleukin-6 in both groups at 1 year after SG. Conclusion: Both patients with and without T2D demonstrated improved periodontal status for up to 1 year after SG. Patients with T2D achieved less weight loss but a more substantial improvement in periodontal condition. The significant reduction in inflammatory biomarkers contributed to the improvement of periodontal status after SG.

Social disparity is associated with an increased risk of acute and chronic pancreatitis.

AIM: To study social disparity in acute pancreatitis (AP) and chronic pancreatitis (CP).We also aimed at exploring whether an interaction exists between alcohol intake and socioeconomic factors. METHODS: Prospective cohort study based on data from 271 696 men and women participating in the Danish National Health Surveys 2010, and 2013. Information on alcohol and smoking parameters, body mass index (BMI), diet, and education, were self-reported and information on family income was obtained from administrative registers. Outcome variables (acute and chronic pancreatitis) were obtained from national health registers. RESULTS: The incidence rate ratio (IRR) of developing AP and CP increased with decreasing family income. Compared to participants in the highest income quintile, participants in the lowest income quintile had 43 (95% CI: 14-80%), 99 (95% CI: 26-214%), and 56% (95% CI: 26-94%) higher incidence rates of AP, CP, and all pancreatitis, respectively. The associations persisted after adjustment for alcohol intake, smoking, BMI, and diet.Likewise, participants with only primary school education had an IRR for an AP of 1.30 (95% CI: 1.06-1.59) compared to those with higher education after adjustment for baseline year, age, and sex. We found no interactions between alcohol intake and income or between alcohol intake and education in relation to neither AP, CP, nor all pancreatitis. CONCLUSION: This large prospective population study showed a significant social disparity in incidence rates of pancreatitis by family income, with higher rates among those with the lowest income and education independent of risk factors such as alcohol intake, smoking, BMI, and diet.

Intensive Versus Moderate Statin-Based Therapies in Patients With Mild Ischemic Stroke: A Prospective Multicenter Cohort Study.

BACKGROUND: Statins are widely used for treating patients with ischemic stroke at risk of secondary cerebrovascular events. It is unknown whether Asian populations benefit from more intensive statin-based therapy for stroke recurrence. Therefore, in the present study we evaluated the effectiveness and safety of high-dose and moderate-dose statins for patients who had experienced mild ischemic stroke during the acute period. METHODS AND RESULTS: This multicenter prospective study included patients with mild ischemic stroke who presented within 72 hours of symptom onset. The outcomes of patients in the high-intensity and moderate-intensity statin treatment groups were compared, with the main efficacy outcome being stroke recurrence and the primary safety end point being intracranial hemorrhage. The propensity score matching method was employed to control for imbalances in baseline variables. Subgroup analyses were conducted to evaluate group differences. In total, the data of 2950 patients were analyzed at 3 months, and the data of 2764 patients were analyzed at 12 months due to loss to follow-up. According to the multivariable Cox analyses adjusted for potential confounders, stroke recurrence occurred similarly in the high-intensity statin and moderate-intensity statin groups (3 months: adjusted hazard ratio [HR], 1.12 [95% CI, 0.85-1.49]; P=0.424; 12 months: adjusted HR, 1.08 [95% CI, 0.86-1.34]; P=0.519). High-intensity statin therapy was associated with an increased risk of intracranial hemorrhage (3 months: adjusted HR, 1.81 [95% CI, 1.00-3.25]; P=0.048; 12 months: adjusted HR, 1.86 [95% CI, 1.10-3.16]; P=0.021). The results from the propensity score-matched analyses were consistent with those from the Cox proportional hazards analysis. CONCLUSIONS: Compared with moderate-intensity statin therapy, high-dose statin therapy may not decrease the risk of mild, noncardiogenic ischemic stroke recurrence but may increase the risk of intracranial hemorrhage. REGISTRATION: URL: www.chictr.org.cn/. Unique Identifier: ChiCTR1900025214.

Stroke Severity, Caregiver Feedback, and Cognition in the REGARDS-CARES Study.

BACKGROUND: Cognitive impairment after stroke is common and is present in up to 60% of survivors. Stroke severity, indicated by both volume and location, is the most consequential predictor of cognitive impairment, with severe strokes predicting higher chances of cognitive impairment. The current investigation examines the associations of 2 stroke severity ratings and a caregiver-report of poststroke functioning with longitudinal cognitive outcomes. METHODS AND RESULTS: One hundred fifty-seven caregivers and stroke survivor dyads participated in the CARES (Caring for Adults Recovering From the Effects of Stroke) project, an ancillary study of the REGARDS (Reasons for Geographic and Racial Differences in Stroke) national cohort study. The Glasgow Outcome Scale and modified Rankin Scale scores collected at hospitalization discharge were included as 2 primary predictors of cognitive impairment. The number of caregiver-reported problems and impairments at 9 months following stroke were included as a third predictor. Cognition was measured using a biennial telephone battery and included the domains of learning, memory, and executive functioning. Multiple cognitive assessments were analyzed up to 5 years poststroke, controlling for prestroke cognition and demographic variables of the stroke survivor. Separate mixed models showed significant main effects of the Glasgow Outcome Scale (b=0.3380 [95% CI, 0.14-0.5]; P=0.0009), modified Rankin Scale (b=-0.2119 [95% CI, -0.32 to -0.10]; P=0.0002), and caregiver-reported problems (b=-0.0671 [95% CI, -0.09 to -0.04]; P<0.0001) on longitudinal cognitive scores. In a combined model including all 3 predictors, only caregiver-reported problems significantly predicted cognition (b=-0.0480 [95% CI, -0.08 to -0.03]; P<0.0001). CONCLUSIONS: These findings emphasize the importance of caregiver feedback in predicting cognitive consequences of stroke.

Prothrombin complex concentrate for emergency surgery in patients on oral Xa-inhibitors.

BACKGROUND: It is uncertain whether prothrombin complex concentrate (PCC) improves hemostasis in patients on treatment with oral factor Xa-inhibitors (XaI) who require emergency surgery. OBJECTIVES: To evaluate whether, in patients with therapeutic levels of oral XaI, preoperative PCC prevents excessive bleeding during and after emergency surgery and is not associated with thrombotic complications. METHODS: We conducted a prospective cohort study wherein a fixed 2000 IU dose of 4-factor PCC was given to patients taking oral XaI with plasma XaI levels of at least 75 ng/mL before the emergency surgery with an expected blood loss of at least 50 mL. Patients were followed for 30 days. The primary efficacy outcome was the incidence of normal or mildly abnormal surgical hemostasis, as assessed by the surgeon; primary safety outcome was the incidence of thromboembolic events within 7 days. RESULTS: We included 20 patients, of which 50% were female, on apixaban (75%) or rivaroxaban (25%) with median XaI level of 128 ng/mL (range, 77-497 ng/mL). The median duration of surgery was 2 hours 42 minutes (range, 15 minutes to 8 hours 17 minutes). Normal or mildly abnormal hemostasis was observed in 16 patients (80%); 2 patients had moderately abnormal and 2 had severely abnormal hemostasis, 1 each of those was considered due to local or technical factors. There were 4 deaths (20%) secondary to underlying disease and 1 incidental pulmonary embolism in a patient with cancer. CONCLUSION: A fixed dose of PCC appears to control hemostasis in patients with therapeutic plasma levels of apixaban or rivaroxaban requiring emergency surgery.

Laparoscopic vs open approach for acute cholecystitis in octogenarians. A prospective multicenter observational nationwide study.

BACKGROUND: The world population is aging, with octogenarians expected to reach over 400 million by 2050. Acute cholecystitis is a serious complication in the elderly. Age is not a contraindication for emergency cholecystectomy, an option that can both save lives and preserve quality of life. METHODS: The present study aimed to compare open and laparoscopic surgical approaches. Over six months, 38 emergency surgery units enrolled all consecutive octogenarians with acute cholecystitis undergoing cholecystectomy. Postoperative outcomes were compared after propensity score matching analysis. RESULTS: The study included 212 patients (84 years [81-86], 47.2% women). The open approach was used in 32.1% of patients, and the laparoscopic approach in 67.9%. After propensity score matching, a decrease in hospital stays (open, 8 days [6-13]; laparoscopic, 5 days [4-8]; P < .001), 30-day morbidity (open, 48.5%; laparoscopic, 26.5%; P = .01), and 30-day mortality (open, 13.2%, laparoscopic, 1.5%; P = .02) was found. Among the specific postoperative complications, a decrease in septicemia (open, 14.7%; laparoscopic, 0%; P = .001) was observed. CONCLUSIONS: Laparoscopic approach was used in two out of three octogenarians. After propensity score matching, octogenarians undergoing laparoscopic approach had shorter length of hospital stay, fewer 30-day postoperative complications, fewer episodes of septicemia, and less 30-day mortality than octogenarians undergoing open approach. These findings suggest that the laparoscopic approach may be the preferred choice for octogenarians with acute cholecystitis undergoing cholecystectomy.