Multicenter Prospective Observational Study Research Articles

Heterologous Versus Homologous COVID-19 Boosters: Immune Response Outcomes in Renal Transplant Recipients.

We aimed to investigate the immune responses to homologous and heterologous COVID-19 booster vaccinations in renal transplant recipients (RTRs) and to identify factors affecting these responses. In this prospective multicenter observational study, we measured the antibody kinetics of 90 RTRs using the chemiluminescent microparticle immunoassay method. The mean age of participants was 45.2 ± 11.4 years, with 35.6% being female. On the 42nd day after the first vaccine dose, the median antibody level was 16.7 (IQR 2.5-249.5) AU/mL, and the seropositivity rate was 60% (n = 36). Mycophenolic acid (MFA) (OR: 0.087, 95% CI: 0.024-0.311) and ACE inhibitor use (OR: 0.203, 95% CI: 0.052-0.794) were identified as independent factors affecting seropositivity. Patients who received the Pfizer/BioNTech booster had significantly higher antibody levels compared to those who received the CoronaVac/Sinovac booster (p = 0.021). Additionally, a significantly higher rate of COVID-19 positivity was observed among patients who received the CoronaVac/Sinovac booster (p = 0.031). Heterologous COVID-19 booster vaccination is significantly more effective than homologous inactivated booster vaccination in enhancing immune responses and preventing new infections in RTRs. MFA and ACE inhibitor usage were independent factors affecting seropositivity. Additional COVID-19 vaccine doses are needed in this patient group.

Revisits and frailty in older patients in the emergency department - a prospective observational multicenter study

BackgroundAn increased number of revisits may signal that the immediate medical needs of patients seeking care at Emergency Departments (EDs) are not being met. The prevalence and characteristics of revisits to the EDs in Sweden among older patients, and its association to frailty, are unknown. We aimed to investigate the prevalence of ED revisits among patients over 65 years of age, living with or without frailty, and its association with rate of admission, and mortality; in the Swedish ED setting.MethodsThis was a prospective, multicentre study of patients over 65 years of age with an index visit to one of three Swedish EDs during May-Nov 2021. Frailty was assessed in conjunction with standard triage, using the 9-level Clinical Frailty Scale (CFS) with a CFS score of 5 to 8 as cut-off for identifying frailty. For all patients who made a revisit within 90 days of their index visit, we collected information about the revisit, admission, and mortality.ResultsA total of 1835 patients made an index visit which were included, and out of those, 595 patients made a revisit within 90 days of the index visit. Patients living with frailty (CFS 5 to 8) were more likely to make a revisit to the ED at 8 to 30 days (17% vs. 11%, diff 6%, 95% CI 2–10%, p < 0.001) and at 31 to 90 days (19% vs. 12%, diff 7%, 95% CI 3–10%, p < 0.001) and be admitted to in-hospital care during their revisit (57% vs. 47%, diff 10%, 95% CI, 1–18%, p < 0.05), compared to patients living without frailty. Results also show that patients living with frailty had a higher overall mortality rate (17% vs. 5%, diff 12%, 95% CI 7–18%, p < 0.001). However, among patients living without frailty, making a revisit slightly increased the mortality rate compared to those who did not (5% vs. 2%, diff 3%, 95% CI 1–10%, p < 0.05).ConclusionsPatients living with frailty make more revisits, are more often admitted to in-hospital care, and have a higher overall mortality rate than patients not living with frailty. Frailty, assessed with the CFS may be a simple and useful indicator of increased risk of adverse events, including revisits, in the ED.

Comparison of characteristics and acute ablation outcome of atrial fibrillation drivers detected using octaray vs. pentaray catheter

Abstract Background Atrial fibrillation (AF) driver ablation is proposed as treatment strategy beyond pulmonary vein (PV) isolation in persistent AF patients. The CARTOFINDER mapping system (Biosense Webster Inc.) can depict two types of activation patterns, focal and rotational activation, using unipolar potentials during AF. Recently, an 8-spline 48-electrodes mapping catheter (OctaRay) was developed. Purpose To evaluate the characteristics of AF drivers detected by CARTOFINDER using the OctaRay catheter and the acute termination compared to previous mapping catheter (PentaRay). Methods This is a multicenter prospective observational study from 6 hospitals where 47 persistent AF patients underwent initial catheter ablation from April to December 2023. We assessed the frequency and distribution of AF drivers in both atrium identified by CARTOFINDER using the OctaRay catheter before procedure. After PV isolation, additional ablation was performed on high-repetitive activations (focal activation&amp;gt;22 repetitions, rotational activation&amp;gt;17 repetitions) and the rate of acute AF termination was evaluated. Acute AF termination was defined as transition to sinus rhythm or atrial tachycardia (AT). The results were compared to 29 patients in whom the PentaRay catheter was used from September 2022 to March 2023. Results The mean age of OctaRay group was 72.0±8.6 years. The median AF duration was 0.7 years, and the prevalence of long-standing AF was 26%. All clinical characteristics was not significantly different between OctaRay and PentaRay group. Focal activation was more frequently identified in OctaRay group than in PentaRay group (94.1points/patient vs. 36.3points/patient, P&amp;lt;0.01), especially in anterior (P&amp;lt;0.01) and posterior (P&amp;lt;0.01) of right atrium (RA), posterior (P&amp;lt;0.01), roof (P&amp;lt;0.01) and lateral (P&amp;lt;0.01) of left atrium (LA), and PV antrum (P&amp;lt;0.01), respectively. Rotational activation was also more frequently identified in OctaRay group (54.7points/patient vs. 2.6points/patient, P&amp;lt;0.01), especially in anterior (P=0.02) and posterior (P=0.03) of RA, and anterior of LA (P=0.02), respectively. Furthermore, high-repetitive focal activation was more frequently identified in OctaRay group than in PentaRay group (P&amp;lt;0.01). On the other hand, the frequency of high-repetitive rotational activation was not significantly different between the two groups (P=0.63) (Figure A). In OctaRay group, high-repetitive focal activation was frequent in anterior of RA (72.3%) and LA appendage (48.9%) (Figure B), and had significantly shorter AF cycle length compared to the entire atrium (156ms vs. 162ms, P&amp;lt;0.01). Ablation for high-repetitive activations after PV isolation resulted in 12.8% acute AF termination in OctaRay group, significantly higher than in PentaRay group (vs. 0%, P=0.04). Conclusion The OctaRay catheter have the potential to detect more frequent and accurate AF drivers than the PentaRay catheter, leading to the improvement of acute AF termination.

Different right ventricular mechanics in atrial and ventricular secondary tricuspid regurgitation and their prognostic role. A multicentric three-dimensional echocardiography study

Abstract Background/Introduction Secondary tricuspid regurgitation (STR) can develop from markedly different etiologies. Both progressive dilation and dysfunction of the right atrium (atrial phenotype, ASTR), and adverse right ventricular (RV) remodeling (ventricular phenotype, VSTR) may result in STR. RV function is a major determinant of outcome in patients with STR. However, data about how RV function adapts to ASTR and VSTR are scarce, and the prognostic implications of RV mechanics in ASTR and VSTR remain to be clarified. Purpose Accordingly, we aimed to investigate the RV mechanical patterns in ASTR and VSTR and to examine their prognostic role using three-dimensional (3D) echocardiography. Methods We enrolled 192 patients with STR (60% women) who underwent clinically indicated transthoracic echocardiography in a multicentric prospective observational study. The primary outcome was defined as a composite of heart failure hospitalization or cardiac death. STR etiology was assessed based on the TVARC criteria (ventricular STR n=134, atrial STR n=58). STR severity was categorized using STR effective regurgitant orifice area according to current guidelines. We assessed RV function by measuring the tricuspid annular plane systolic excursion (TAPSE) by M-mode echocardiography and RV ejection fraction (EF) by 3D echocardiography. In addition, we imported the 3D RV meshes into the ReVISION software package (Argus Cognitive, Inc, Lebanon, USA) to quantify the relative contribution of the longitudinal (LEFi), radial (REFi), and anteroposterior motion components (AEFi) to total RV EF. Results ASTR and VSTR patients had comparable TAPSE (17±5 mm vs. 18±5 mm, p=0.10), while RV EF was significantly higher in ASTR (54±7% vs. 47±10% p&amp;lt;0.001). Although LEFi (0.37±0.08 vs. 0.38±0.10, p=0.95) and AEFi (0.45±0.08 vs. 0.44±0.11, p=0.53) were comparable between ASTR and VSTR, REFi was significantly lower in VSTR (0.52±0.09 vs. 0.47±0.12, p&amp;lt;0.01). RF EF was comparable among STR severity grades (mild vs. moderate vs. severe: 50±11 vs. 49±9 vs. 50±10%, respectively, p=0.85). Conversely, LEFi was significantly higher in mild and moderate STR vs severe STR (0.39±0.08 vs. 0.39±0.09 vs. 0.35±0.10, respectively, p=0.04). Using multivariable Cox regression based on variables significant in the univariate analysis, REFi was a significant independent predictor of outcome in the entire cohort (hazard ratio: 0.978 [CI, 0.959-0.999], p= 0.037). Conclusions Using 3D echocardiographic assessment, ASTR and VSTR patients demonstrated significant differences in the RV mechanical pattern, with a lower contribution of the radial contraction in the case of ventricular STR etiology. While RV EF was comparable between STR severity grades, the relative importance of the longitudinal motion significantly differed. Notably, the relative contribution of radial motion to RV function demonstrated independent prognostic value in patients with STR.RV mechanics in STR severity stages

Acute kidney injury as a risk factor for heart failure hospitalisation after major non-cardiac surgery

Abstract Aim The importance of acute kidney injury (AKI) after major non-cardiac surgery is incompletely understood. The aim of this study was to evaluate the association of AKI with short-term complications (e.g. perioperative myocardial injury (PMI); acute heart failure (AHF)), and long-term adverse outcomes (e.g. readmission for AHF, all-cause mortality). Methods The prospective observational international multi-center BASEL PMI study screened inpatients aged 40-85 at high cardiovascular risk undergoing non-cardiac surgery at tertiary hospitals to detect asymptomatic PMI. This secondary analysis focused on AKI, with prospective adjudication of AKI, PMI and AHF by blinded experts. Results In 11'133 patient cases, the incidence of AKI within 7 days was 11.1%, classified as KDIGO stage one (68.3%), two (15.4%) and three (16.3%). Pre- and perioperative determinants for AKI were perioperative myocardial infarction / injury (PMI, OR 3.63), the need for intra-operative blood transfusion (OR 1.48), chronic heart failure (CHF, OR 1.42), surgery duration (OR 1.37), male sex (OR 1.27), preoperative GFR (OR 0.80) and preoperative hemoglobin concentration (OD 0.84). Median time to occurrence of AKI was 2 days (IQR 1-4), similar to PMI (median 1, IQR 1-2) and in contrast to AHF (median 4, IQR 2-9). 41% of all AKI patients experienced additionally a PMI. In multivariable Cox regression analysis, AKI (aHR 1.76, 95% CI 1.51-2.06, p &amp;lt; 0.001) and PMI (aHR 1.21, 95% CI 1.02-1.45, p = 0.025) were both independently associated with prediction of one-year all-cause mortality after adjustment for each other and confounding factors, whereas AHF was marginally not (aHR 1.28, 95% CI 0.98-1.68, p = 0.070). However, testing the assumed proportional hazards assumption, the impact of AKI, PMI and AHF on mortality depended significantly on time. AKI had significantly increased short- and long-term mortality, in contrast to PMI and AHF with just elevated short-term mortality. The coincidence of AKI and PMI resulted in an additive effect on overall mortality. Importantly, patients with AKI showed more in-hospital AHF (aHR 2.08, 95% CI 1.49-2.91) within 30 days and higher hospitalization rates for HF within one year (aHR 1.40, 95% CI 1.01-1.98, p = 0.046) than patients without AKI, particularly patients without known heart failure (aHR 1.65, 95% CI 1.05-2.60, p = 0.029). Conclusion AKI is a common complication, occurring in 11% after non-cardiac surgery. The occurrence of AKI was associated with increased risks for in-hospital AHF, hospitalizations for heart failure and all-cause mortality. Notably, AKI patients without known history of heart failure faced hospitalizations for de novo heart failure. The occurrence of AKI unveiling de novo heart failure highlights the importance of systematic monitoring for AKI after surgery and gives clinicians a window of opportunity to take action at an early stage.

Plaque phenotyping using deep learning in optical coherence tomography imaging

Abstract Background Artificial intelligence (AI) techniques have emerged as powerful tools in various computer vision tasks, particularly in classification, detection, and segmentation. Purpose This study aimed to develop a deep learning model for categorizing optical coherence tomography (OCT) frames into different plaque phenotypes, including thin-cap fibroatheroma (TCFA) and fibroatheroma. Methods A prospective multicenter observational study enrolled 168 patients who underwent percutaneous coronary intervention (PCI) and received OCT imaging for non-target lesions with angiographically estimated diameter stenosis greater than 30% (177 vessels). Among them, 129 patients (135 vessels) underwent follow-up OCT imaging at 1 year. A total of 45,072 OCT frames were randomly divided into training and validation sets in a 4:1 ratio. An EfficientNet-B3 convolutional neural network model was developed to classify OCT frames into TCFA, thick-cap fibroatheroma, non-fibroatheroma, adaptive intimal thickening, and normal vessel categories. Results A confusion matrix comparing manually assessed plaque phenotypes with AI-predicted phenotypes was presented in Table. In the validation datasets (9,015 frames), the overall accuracy of the model was 85.1%. For predicting the presence of TCFA, sensitivity was 81.1%, specificity was 98.8%, positive predictive value was 63.9%, and negative predictive value was 99.5%. Regarding the presence of fibroatheroma, sensitivity was 90.3%, specificity was 89.4%, positive predictive value was 93.1%, and negative predictive value was 85.4%. Conclusions The deep learning algorithm demonstrated high accuracy in detecting TCFA and fibroatheroma with excellent reproducibility. This automated process enables operators to promptly identify high-risk lesions during PCI, potentially leading to improved clinical outcomes.

Prognostic impact of systemic immune-inflammation index in patients with acute decompensated heart failure with preserved ejection fraction -PURSUIT-HFpEF Registry-

Abstract Background Systemic inflammation has been implicated in the pathophysiology of heart failure with preserved ejection fraction. Several studies have shown that systemic immune-inflammation index (SII), a novel index based on platelets, neutrophils, and lymphocytes, predicts poor prognosis in patients with cardiovascular disease. However, it remains to be elucidated whether SII could have predictive value in patients with acute decompensated heart failure with preserved ejection fraction (ADHF-HFpEF). Purpose This study is designed to investigate the association of SII at admission or discharge with poor clinical outcome in patients with ADHF-HFpEF. Methods Patients’ data were extracted from The Prospective mUlticenteR obServational stUdy of patIenTs with Heart Failure with Preserved Ejection Fraction (PURSUIT HFpEF) study, which is a prospective multicenter observational registry for ADHF-HFpEF in a city. Laboratory data and body weight measurements were performed just before discharge. We analyzed 966 patients (mean age: 81 years old, male: 45%) after exclusion of patients on dialysis, missing follow-up data, or missing data to calculate SII. SII was calculated as follows: SII = platelet count × neutrophil count / lymphocyte count on admission and at discharge. The primary endpoint was the composite of all-cause death and rehospitalization for worsening heart failure. Results During a mean follow-up period of 1.8±1.3 years, the primary endpoint was observed in 435 patients (259 patients died and 176 patients underwent rehospitalization for worsening heart failure). In multivariate Cox analysis, high SII at discharge (&amp;gt; 536×109 determined by receiver operating characteristic curve analysis (AUC: 0.564 [0.526-0.602]) was significantly independently associated with not only the primary endpoint (hazard ratio 1.28 [1.04-1.57], p=0.020) but also all-cause death ((hazard ratio 1.39 [1.06-1.81], p=0.018) after adjustment for major confounders such as age, gender, body mass index, NYHA class, systolic blood pressure, heart rate and laboratory data including NT-proBNP and CRP. However, high SII on admission was not significantly associated with primary endpoint after multivariate adjustment. Kaplan-Meier analysis revealed that patients with high SII at discharge had significantly greater risk of both the primary endpoint (56% vs 43%, p&amp;lt;0.001) and all-cause mortality than those with low SII (36% vs 24%, p&amp;lt;0.001). Conclusion Systemic immune-inflammation index at discharge, but not on admission, would be associated with post-discharge poor outcome in patients with acute decompensated heart failure with preserved ejection fraction.

Patient-reported outcomes, postoperative pain and pain relief after day case surgery (POPPY): methodology for a prospective, multicentre observational study.

In the UK, approximately 70% of surgical procedures are undertaken as day-cases. Little information exists about recovery from day-case surgery, yet international data highlights patients are at risk of developing significant longer-term health problems including chronic post-surgical pain and persistent postoperative opioid use. The Patient-reported Outcomes, Postoperative Pain and pain relief after daY case surgery (POPPY) study was a national prospective multicentre observational study, measuring short- and longer-term patient-reported outcomes, postoperative pain and pain relief after day-case surgery. This was a collaborative project led by resident anaesthetists under the Research and Audit Federation of Trainees umbrella. Adult day-case surgical patients were recruited on the day of surgery. Baseline data including patient characteristics; procedure details; pre-operative analgesic use; pre-existing pain; and quality of life scores were recorded. Patients were followed up through automated short message service messages. Short-term (postoperative days 1, 3 and 7) outcomes included: quality of recovery; pain severity; impact of pain on function; and analgesic use. Longer-term outcomes (postoperative day 97) included: quality of life; analgesic use; incidence of chronic post-surgical pain; and incidence persistent postoperative opioid use. Additional outcomes were completed by those patients with chronic post-surgical pain and persistent postoperative opioid use, with 30 patients recruited to a qualitative semi-structured interview study exploring postoperative expectations, recovery, postoperative pain and opioid use. An embedded pilot study at four sites recruited 129 patients. Responses to the automated short message service were gained from 129 patients (100%) at day 1; 116 (89.9%) at day 3; 108 (83.7%) at day 7; and 77 (59.7%) at day 97 postoperatively. The pilot enabled refinement of the methods and processes before the national roll out. This paper outlines the methods for the POPPY study, the largest UK multicentre prospective observational study considering short- and longer-term outcomes following day-case surgery.

Beyond secondary prevention drugs: added benefit in survival and events of a healthy lifestyle in patients after an acute coronary syndrome

Abstract Background Despite advances in drug treatment and secondary prevention programs, cardiovascular disease remains the leading cause of death. The full extent and independent benefit of a healthy lifestyle, particularly after optimal medical therapy in secondary prevention, has not been widely reported. Purpose To quantify the added benefit on survival and events of a healthy lifestyle following an acute coronary syndrome (ACS). Our study seeks to answer the question: Is adherence to medical therapy sufficient or a healthy lifestyle provides additional improvement?. Methods This a prospective observational multi-center study of 685 patients included during admission for ACS. At 6 months patients were asked about their post-ACS lifestyle and were given a score (range: 0-7) with the following items: Intake of ≥3 fruits and vegetables/day, ≥2 fish servings/week, ≤7 alcohol beverages/week, feeling stress RESULTS: After adjusting for demographic variables, cardiovascular risk factors, characteristics of the index event, high-sensitivity C-reactive protein (hs-CRP), and drug therapy, multivariate Cox regression showed that the lifestyle SCORE was independently and inversely associated with both the incidence of the primary outcome (ischemic events [any ACS, stroke, or Transient Ischemic Attack] or death) (HR 0.65 (CI95% 0.44-0.96); p=0.029) and death (HR 0.41 [95%CI 0.18-0.91]; p=0.029). Statin therapy was also independently and inversely associated with both the incidence of the primary outcome. Kaplan-Meier curves showed a higher event-free survival for both outcomes in patients with SCORE≥4 than in those with SCORE&amp;lt;4 (p=0.03 and p&amp;lt;0.001, respectively). Additionally, patients with a SCORE≥4 had a significantly greater decrease of total cholesterol (-52 [-16.5, -79] vs -38 [-7.5, -68] mg/dl; p=0.040) and hs-CRP (-1.1 [-0.1, 2.5] vs -0.5 [0.7, -1.9] mg/L; p=0.001) at six months. Conclusions Among patients with ACS and similar medical therapy, a healthy lifestyle is an independent and added marker of a lower incidence of ischemic events and death. It is also associated with a better lipid profile and lower inflammation.

Acute myocarditis presentation and intra-hospital prognosis: results of the multicenter prospective MYOCARDITIRM study

Abstract Background Acute myocarditis (AM) usually presents as chest pain with rising troponin and normal coronary arteries. Despite frequent favorable evolution at the acute phase, it is associated with heart failure and ventricular rhythm disorders and is considered the leading cause of sudden cardiac death in young apparently healthy adults. There is no recommendation for AM, only expert consensus, given the lack of important databases for a strong level of confidence. Methods We performed a multicenter prospective observational study of patients admitted for AM acknowledged by cardiac MRI to describe baseline characteristics, management, in-hospital and long-term outcomes of AM patients in France. Secondary objectives were to investigate determinants of prognosis, modalities of treatment and follow-up, and to identify gaps between expert consensus and real-life management. Results We enrolled 805 consecutive patients hospitalized for AM in 49 participating centers between May 2016 and February 2019. Median age was 31 (IQR 23-41) with 19% of female. Chest pain was the most frequent symptom (93%) and 112 (14%) had severity criteria upon admission (LVEF&amp;lt;50% or severe ventricular arrythmia or high-grade AV block or cardiogenic shock). ST elevation was observed in 49% of patients. One 26-years old patient died during initial hospital stay. Overall, 62 patients (8%) experienced intra-hospital complication of their AM, defined as a combined endpoint of death, LVEF&amp;lt;40% (MRI), sustained ventricular or supraventricular arrythmia, acute renal failure, cardiogenic shock, need for ventricular assistance device, need for inotropic drugs, temporary cardiac pacing, pace-maker or cardiac defibrillator implantation. Patients with initial severity criteria were 10 times more likely to present intra-hospital complication (33% vs 3.6%, p&amp;lt;0.001). Conclusion This prospective cohort represents the largest database on AM worldwide. Here we report baseline characteristics and in hospital events. Most patients had typical presentation with favorable outcomes but as much as 8% of patients did exhibit intra-hospital complication. The prospective follow up will provide valuable data to better identify subset of patients with poor prognosis that may be of interest to develop new therapeutic strategies.Acute myocarditis on cardiac MRI

Machine learning model for predicting the cold–heat pattern in Kampo medicine: a multicenter prospective observational study

ObjectiveThe purpose of this study was to predict the four cold–heat patterns in patients who have the subjective symptoms of the cold–heat pattern described in the International Classification of Diseases Traditional Medicine Conditions – Module 1 by applying a machine learning algorithm.MethodsSubjects were first-visit Kampo outpatients at six institutions who agreed to participate in this multicenter prospective observational study. The cold pattern model and the heat pattern model were created separately with 148 symptoms, body mass index, blood pressure (systolic and diastolic), age, and sex. Along with a single cold or heat pattern, the tangled heat/cold pattern is defined as being predicted by both cold and heat patterns, while the moderate (heat/cold) pattern is defined as being predicted by neither the cold pattern nor the heat pattern.ResultsWe included 622 participants (mean age ±standard deviation, 54.4 ± 16.9; with female 501). The accuracy, macro-recall, precision, and F1-score of a combination of the two prediction models were 96.7%, 93.2%, 85.6%, and 88.5% respectively. The important items were compatible with the definitions of the cold–heat pattern.ConclusionWe developed a prediction model on cold–heat patterns with data from patients whose subjective cold/heat-related symptoms matched the cold–heat pattern diagnosis by the physician.

Inflammatory Neuropathy Consortium base (INCbase): a protocol of a global prospective observational cohort study for the development of a prediction model for treatment response in chronic inflammatory demyelinating polyneuropathy

BackgroundINCbase is an international, multicenter prospective observational study using a customizable web-based modular registry to study the clinical, biological and electrophysiological variation and boundaries of chronic inflammatory demyelinating polyneuropathy (CIDP). The primary objective of INCbase is to develop and validate a clinical prediction model for treatment response.MethodsAll patients meeting clinical criteria for CIDP can be included in INCbase. Collected data include demographics, clinical history, diagnostics and various domains of clinical outcomes. Data is collected at a minimum of every 6 months for two years, and more frequently at the discretion of the investigational site to allow for assessment of unexpected changes in treatment response or clinical status. Participants can be enrolled in various sub-studies designed to capture data relevant to specific groups of interest. Data is entered directly into the web-based data entry system by local investigators and/or participants. Collection and local storage of biomaterial is optional. To develop a clinical prediction model for treatment response, newly diagnosed patients with active disease warranting start of first-line treatment will be included. The study population will be split into a development and validation cohort. Univariate and multivariate logistic regression analysis will be used to identify and combine predictors at start of treatment for treatment response at six months. Model performance will be assessed through discrimination and calibration in an external validation cohort. The externally validated prediction model will be made available to researchers and clinicians on the INCbase website.DiscussionWith this study, we aim to create a clinically relevant and implementable prediction model for treatment response to first line treatments in CIDP. INCbase enrollment started in April 2021, with 29 centers across 8 countries and 303 patients participating to date. This collaborative effort between academia, patient advocacy organizations and pharmaceutical industry will deepen our understanding of how to diagnose and treat CIDP.

Respiratory rate-oxygenation index on the 3rd day is the best predictor of treatment failure in COVID-19 patients.

Predictors of outcomes are essential to identifying severe COVID-19 cases and optimizing treatment and care settings. The respiratory rate-oxygenation (ROX) index, originally introduced for predicting the failure of non-invasive support in acute hypoxemic respiratory failure (AHRF), has not been extensively studied over time during hospitalization. This multicenter prospective observational study analyzed COVID-19-related AHRF patients admitted to eight Italian hospitals during the second pandemic wave. The study assessed the ROX index using receiver operator characteristic curves and areas under the curve with 95% confidence intervals to predict treatment failure, defined as endotracheal intubation (ETI) or death. A total of 227 patients (69.2% males) were enrolled, with a median arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio at admission of 248 (interquartile range: 170-295). Nearly one-third (29.5%) required ETI or died during hospitalization. Those who experienced treatment failure were older (median age 70 versus 61 years, p<0.001), more likely to be current or former smokers (8.5% versus 6.4% and 42.4% versus 25.5%, p=0.039), had a higher prevalence of cardiovascular diseases (74.6% versus 46.3%, p<0.001), and had a lower PaO2/FiO2 ratio at presentation (median 229 versus 254, p=0.014). Gender, body mass index, and other comorbidities showed no significant differences. In patients who failed treatment, the ROX index was higher at presentation and worsened sharply by days 3 and 4. Conversely, in patients who survived without requiring ETI, the ROX index remained stable and reduced after 5-6 days. The ROX index's predictive ability improved notably by the third day of hospitalization, with the best cut-off value identified at 8.53 (sensitivity 75%, specificity 68%). Kaplan-Meier curves indicated that a ROX index of 8.53 or lower on days 1, 2, or 3 was associated with a higher risk of treatment failure. Thus, a single ROX index assessment on day 3 is more informative than its variability over time, with values of 8.53 or lower predicting non-invasive respiratory support failure in hospitalized COVID-19 patients.

Polymer Everolimus-Eluting Stent as Bailout Stenting for Below-the-Knee Artery Repair in Patients with Critical Limb-Threatening Ischemia: A Real-World National Registry.

Percutaneous old balloon angioplasty is still the preferred treatment for the treatment of below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). In the case of a suboptimal angioplasty result, a bailout stenting is required. So far, few data are available to assess the outcomes of bailout stenting after BTK angioplasty. This study aims to investigate the 1-year efficacy and safety after implantation of a polymer everolimus-eluting stent (PEES) as bailout stenting for BTK repair in patients with CLTI in a real-world setting. This was a national multicenter prospective observational study. Patients with CLTI (Rutherford 4 to 6) BTK lesions (including P3) and requiring a bailout PEES due to dissection, thrombosis, or residual stenosis ≥30% after angioplasty were included. The freedom of a major adverse limb event at 12 months of the target limb was the primary endpoint. XIENCE assessed 106 limbs (CLTI, 96.2%; chronic total occlusion, 2.8%) in 106 patients (mean age 77.1 years; males, 71.7%; diabetes mellitus, 66.9%; chronic kidney failure, 36.8%) with CLTI undergoing PEES stenting as a bailout for BTK lesions. Bailout stenting was required after 75.5% and 26.4% of residual stenosis and dissection, respectively. The mean diameter and length of the PEES were 3 mm and 3.4 ± 0.5 cm, respectively. At 1 year, the freedom of a major adverse limb event was 79.6% (95% CI, 71.5%-88.7%), the major amputation rate was 6.2% (95% CI, 1.3%-11%), and the target revascularization rate was 14.9% (95% CI, 6.5%-22.5%). In CLTI patients with BTK lesions, PEES stenting showed safety and efficacy as bailout stenting for BTK arterial lesions. This confirms the need for PEES stenting in a real-world practice. The XIENCE study introduces the PEES as an effective bailout stenting option for patients with CLTI undergoing BTK revascularization, particularly for lesions under 4 cm. The study focuses on real-world cases where POBA alone is insufficient, demonstrating that PEES significantly improves outcomes by enhancing limb salvage and reducing the need for major amputations. For clinicians, this innovation offers a precise, size-adaptable solution, especially in cases where bailout stenting is required for short, focal lesions, improving both clinical and procedural results.

VISIT STROKE: non-inferiority of telemedicine-based neurological consultation for post-acute stroke patients – protocol of a prospective observational controlled multi-center study

BackgroundTelemedicine provides specialized medical expertise in underserved areas where neurological expertise is frequently not available on a daily basis for hospitalized stroke patients. While tele-consultations are well established in acute stroke assessment, the value of telemedicine-based ward-rounds in the subsequent in-patient stroke management is unknown.MethodsFour telemedicine stroke networks in Germany, implemented in eight out of 16 federal states, participate in this prospective observational multi-center study. We plan to enroll 523 patients hospitalized due to acute (suspected or confirmed) stroke or transient ischemic attack. Each recruited patient will receive both a tele-consultation and an on-site consultation at the same day within the first three days after hospital admission. We will test non-inferiority of telemedicine-based assessments in ward-rounds in terms of quality of medical assessment and recommendations for hospitalized stroke patients. The correctness of the medical assessment and recommendation is defined as positive evaluation (binary, correct vs. in-correct) of six out of six predefined quality indicators by at least two out of three blinded independent raters. The non-inferiority margin for the difference in proportions of correct assessments is set to 5%-points.DiscussionIf non-inferiority of telemedicine-based ward-rounds compared to on-site ward-rounds by a neurologist were demonstrated, telemedicine-based neurological consultation for post-acute stroke patients may contribute to deliver evidence-based high-quality stroke care more easily in underserved regions.Trial registrationDRKS - DRKS00028671 (https://drks.de/search/de/trial/DRKS00028671; registration date 09-27-2022).

Lung Ultrasound Score, Severity of Acute Lung Disease and Prolonged Mechanical Ventilation in Children.

Lung ultrasound may be useful for prognostication of acute lung disease. To assess whether the lung ultrasound score is associated with the severity of lung disease and may predict prolonged invasive mechanical ventilation in critically ill children. Prospective observational multicenter study in children aged 1 month to 18 years who required respiratory support in the intensive care unit. Children with chronic parenchymal lung disease were excluded. The lung ultrasound score was obtained at 12 hours and 48-72 hours from admission. Prolonged invasive mechanical ventilation was defined as >7 consecutive days. Correlation of the lung ultrasound score with oxygenation as well as its prognostic accuracy for prolonged invasive mechanical ventilation were investigated. 538 children were included and 62 (11.5%) required prolonged mechanical ventilation. In these subjects, the lung ultrasound score was higher at 12 [24 (19-26) vs. 8 (3-14); p<0.001] and 48-72 hours [16 (10.5-22.5) vs. 6 (3-11) vs; p<0.001]. At 12 hours the lung ultrasound score correlated with oxygenation index [R2= 0.435 (95% CI: 0.293-0.566), rho coefficient -0.705, p<0.001] and oxygen saturation index [R2 0.499 (95% CI: 0.370-0.613), rho coefficient 0.651, p<0.001p<0.001]. To predict prolonged invasive mechanical ventilation, the lung ultrasound score at 12 hours had a good accuracy [AUROC=0.87 (95% CI: 0.81-0.93)] while its use in a multivariable model had an excellent accuracy both in derivation [AUROC=0.92 (95% CI: 0.89-0.95)] and internal validation [AUROC=0.91 (95% CI: 0.90-0.92)]. In critically ill children, the lung ultrasound score early after admission may predict prolonged invasive mechanical ventilation.

Prediction of poor prognosis using the peak systolic velocity and early diastolic velocity of the central retinal artery in patients with post‐cardiac arrest syndrome

AbstractIntroductionMonitoring intracranial pressure (ICP) in patients with post‐cardiac arrest syndrome (PCAS) is crucial for effective management and prognosis assessment. However, continuous ICP monitoring is rarely practiced. Increased ICP is often associated with the impairment of brain autoregulation. This study investigated whether central retinal artery (CRA) flow velocity, autoregulation status according to mean arterial pressure (MAP), and the optic nerve sheath diameter (ONSD)/eyeball transverse diameter (ETD) ratio could predict poor prognosis related to increased ICP in PCAS patients.MethodsIn this multicenter prospective observational study, transocular ultrasonography of the optic nerve sheath was performed on 38 PCAS patients treated with targeted temperature management from December 2021 to November 2022. CRA peak systolic velocity (PSV), early diastolic velocity (eDV), MAP, CRA‐PSV changes following MAP changes (autoregulation), and ONSD/ETD ratio were measured repeatedly from days 0 to 4 post‐admission.ResultsUnivariable analysis indicated that CRA‐PSV, nonpositive or flat CRA‐eDV, and disrupted autoregulation correlated with a poor prognosis (Cerebral Performance Category 4 or 5). In multivariable analysis, nonpositive CRA‐eDV or disrupted autoregulation was the most significant predictor of poor prognosis (odds ratio, 40.576; p = 0.002), with an area under the curve of 0.774. The ONSD/ETD ratio did not show a significant correlation.ConclusionsNonpositive CRA‐eDV, CRA‐PSV and disrupted autoregulation can predict poor prognosis in PCAS patients. Transocular Doppler ultrasonography of the CRA and autoregulation assessment may aid in ICP monitoring and management in PCAS patients.

Concept, study design, and baseline nighttime blood pressure control status of the WISDOM-Night Study using a wrist-type oscillometric home blood pressure monitoring device.

There is growing evidence that nocturnal hypertension is an independent risk factor for cardiovascular diseases, including heart failure. However, brachial blood pressure (BP) measurements during sleep might themselves disturb sleep quality. We initiated a nationwide, multicenter observational prospective study using a wrist-type oscillometric nighttime BP monitoring device with new algorithms to measure supine BP accurately without sleep disturbance. This study, named the Wrist ICT-based Sleep and Circadian Blood Pressure Monitoring Program-Night BP Study (WISDOM-Night Study), was designed to clarify the impact of wrist-measured daily nighttime BPs on cardiovascular prognosis (stroke, coronary artery disease, heart failure, etc.) using 7 days of BP measurements at 2:00 a.m., 3:00 a.m., 4:00 a.m., and 4 h after bedtime. A total of 2751 patients with one or more cardiovascular risk factors were recruited between March 2021 and March 2024 and are currently being followed up for 7 years. Additionally, 1416 of the WISDOM-Night Study-enrolled patients who also agreed to participate in the WISDOM-Hypertension-Mediated Organ Damage (HMOD) Study underwent echocardiography to evaluate the association between wrist-measured BP and left ventricular structure. Data from this WISDOM-Night Study should provide the prospective association between nighttime BP and cardiovascular disease and reveal the indexes of nighttime BP with clinical pathological relevance. This first report of the WISDOM-Night Study describes the study design, baseline characteristics, and BP control status.

Update to: Study Pre-protocol for "BronchStart - The Impact of the COVID-19 Pandemic on the Timing, Age and Severity of Respiratory Syncytial Virus (RSV) Emergency Presentations; a Multi-Centre Prospective Observational Cohort Study".

In 2021 we launched the BronchStart study, which collected information on 17,899 presentations in children with serious respiratory tract infections following the release of lockdown restrictions. Our study informed the Joint Committee on Vaccination and Immunisation's decision to recommend the introduction maternal respiratory syncytial virus (RSV) vaccination, which was introduced in the United Kingdom in August/September 2024. We modified our original protocol to conduct a United Kingdom-wide assessment of maternal vaccination against RSV. We will conduct a multi-centre study, utilising the PERUKI network used in the original BronchStart study, to assess the effectiveness of maternal vaccination using a test-negative study design. We will gather detailed clinical information on children admitted with bronchiolitis in the post-RSV vaccination era, and understand possible reasons for incomplete vaccine uptake.

Analysis of nailfold capillaroscopy images with artificial intelligence: Data from literature and performance of machine learning and deep learning from images acquired in the SCLEROCAP study

ObjectiveTo evaluate the performance of machine learning and then deep learning to detect a systemic scleroderma (SSc) landscape from the same set of nailfold capillaroscopy (NC) images from the French prospective multicenter observational study SCLEROCAP. MethodsNC images from the first 100 SCLEROCAP patients were analyzed to assess the performance of machine learning and then deep learning in identifying the SSc landscape, the NC images having previously been independently and consensually labeled by expert clinicians. Images were divided into a training set (70 %) and a validation set (30 %). After features extraction from the NC images, we tested six classifiers (random forests (RF), support vector machine (SVM), logistic regression (LR), light gradient boosting (LGB), extreme gradient boosting (XGB), K-nearest neighbors (KNN)) on the training set with five different combinations of the images. The performance of each classifier was evaluated by the F1 score. In the deep learning section, we tested three pre-trained models from the TIMM library (ResNet-18, DenseNet-121 and VGG-16) on raw NC images after applying image augmentation methods. ResultsWith machine learning, performance ranged from 0.60 to 0.73 for each variable, with Hu and Haralick moments being the most discriminating. Performance was highest with the RF, LGB and XGB models (F1 scores: 0.75–0.79). The highest score was obtained by combining all variables and using the LGB model (F1 score: 0.79 ± 0.05, p < 0.01). With deep learning, performance reached a minimum accuracy of 0.87. The best results were obtained with the DenseNet-121 model (accuracy 0.94 ± 0.02, F1 score 0.94 ± 0.02, AUC 0.95 ± 0.03) as compared to ResNet-18 (accuracy 0.87 ± 0.04, F1 score 0.85 ± 0.03, AUC 0.87 ± 0.04) and VGG-16 (accuracy 0.90 ± 0.03, F1 score 0.91 ± 0.02, AUC 0.91 ± 0.04). ConclusionBy using machine learning and then deep learning on the same set of labeled NC images from the SCLEROCAP study, the highest performances to detect SSc landscape were obtained with deep learning and in particular DenseNet-121. This pre-trained model could therefore be used to automatically interpret NC images in case of suspected SSc. This result nevertheless needs to be confirmed on a larger number of NC images.