Multicenter Prospective Observational Study Research Articles

Association of low muscle strength with incident pneumonia in older patients with heart failure.

Patients with heart failure (HF) are at an increased risk of developing pneumonia, leading to a high mortality. A decrease in muscle strength due to aging or concomitant disease may contribute to the development of pneumonia in older adults. We sought to investigate the relationship between low muscle strength and pneumonia incidence in older patients hospitalized for worsening HF. We carried out a sub-analysis of the FRAGILE-HF, a prospective multicenter observational study, including 1266 consecutive older (≥65 years) patients hospitalized with HF (mean age 80.2±7.8 years; 57.4% male; left ventricular ejection fraction 46±17%) and information of incident pneumonia observed after discharge. Patients were followed up for two years post-discharge. A total of 88 patients (7.0%) developed pneumonia after discharge, with an incidence of 42.7 per 1,000 person-years. A total of 893 patients with low muscle strength, defined as handgrip strength <28kg for men and <18kg for women according to international criteria, were more likely to develop pneumonia than those with normal muscle strength (p <0.001; log-rank test). Low muscle strength was a significant predictor of incident pneumonia (adjusted hazard ratio with 95% confidence interval: 2.65 [1.31-5.35], p=0.007). Furthermore, the mortality rates were 43.2% in patients who developed pneumonia and 19.3% in those who did not, indicating a heightened risk of death following the onset of pneumonia (adjusted hazard ratio: 4.25 [2.91-6.19], p<0.001). In older patients hospitalized for HF, low muscle strength was associated with incident pneumonia after discharge.

The Clinical Significance of Interstitial Pneumonia with Autoimmune Features in Cryptogenic Organizing Pneumonia: A Prospective Multicenter Observational Study

Background: There are cases of idiopathic interstitial pneumonias (IIPs) that do not meet the diagnostic criteria for connective tissue disease but have clinical features suggestive of autoimmune process. Interstitial pneumonia with autoimmune features (IPAF) was recently proposed as a research concept for these patients. Although several prospective studies on IPAF have been conducted, its clinical significance in cryptogenic organizing pneumonia (COP) remains unclear. Methods: Patients aged ≥20 years with suspected COP were prospectively enrolled between June 2018 and December 2022. Among the enrolled patients, those diagnosed with COP based on computed tomography (CT) and bronchoalveolar lavage (BAL) findings were compared between the IPAF and non-IPAF groups. Results: A total of 56 patients were enrolled in this study. Of these, 30 were diagnosed with COP and included in the analysis. Clinical and serological features were positive in two and six patients, respectively. Each feature was exclusive, and eight patients (26.7%) were diagnosed with IPAF. There were no differences between the IPAF and non-IPAF groups in terms of clinical features, including BAL findings, laboratory data, CT findings, and clinical course. During the one-year follow-up period, the frequency of COP exacerbation did not differ between the IPAF and non-IPAF groups, and no cases of systemic autoimmune disease or death occurred in either group. Conclusions: The COP characteristics of the IPAF and non-IPAF groups are similar in all aspects, and distinguishing between the two groups may be of little significance.

Equimolar oxygen-nitrous oxide (EMONO) in dental pediatric care: which patients achieve therapeutic effects? A French national exploratory prospective observational multicenter study.

Equimolar oxygen-nitrous oxide mixture (EMONO) is considered as a reference for dental care in children. Completion of dental treatment has usually been used as a criterion to assess EMONO treatment. However, other patient-reported outcomes are needed. We sought to assess the prevalence of complete therapeutic effects (analgesia and anxiolysis) experienced by children during dental care under EMONO and identifying associated factors. A national prospective observational multicentric study was conducted between September 2018 and June 2020 in 13 French university hospitals. Participants were children between 3 and 15years of age requiring dental care under EMONO. 677 children were analyzed. Anxiolysis and analgesia were experienced by a large majority of patients (86.5% and 79.0%, respectively, and 73% experienced both effects). Several factors were associated with both analgesia and anxiolysis effects: the presence of expected effects (no loss of judgment and slight decrease in level of consciousness), the absence of agitation and distress, a positive perception of EMONO and ethnicity. Most patients benefit from the therapeutic effects (anxiolysis and analgesia) expected by EMONO during dental treatment. It is reassuring to observe that most sociodemographic characteristics and medical history do not seem to influence the effectiveness of care. The study was registered at www. gov under the reference number NCT03453411.

The Association Between Perioperative Red Blood Cell Transfusions and 1-Year Mortality After Major Cancer Surgery: An International Multicenter Observational Study.

Packed red blood cell (pRBC) transfusions in patients undergoing surgery for cancer are given to treat anemia or acute hemorrhage. Evidence indicates that pRBC transfusions are associated with poor perioperative and oncological outcomes. The ARCA-1 (Perioperative Care in the Cancer Patient-1) study was designed to test the association between perioperative pRBC transfusions and postoperative morbidity and mortality in patients undergoing cancer surgery. The primary hypothesis of our study was that perioperative pRBC transfusions have a negative impact on postoperative morbidity and 1-year mortality. ARCA-1 was an international multicenter prospective observational cohort study. Participating centers enrolled a minimum of 30 consecutive adult patients with cancer who underwent surgery with curative intent. The primary end point was all-cause mortality 1 year after major cancer surgery. Secondary end points were rates of perioperative blood product use, 1-year cancer-specific mortality, overall survival, and 30-day morbidity and mortality. We performed a propensity score matching analysis to adjust for selection bias. A multivariable logistic regression model was fitted to estimate the effects of significant covariates on 1-year mortality, cancer-related mortality, and overall survival. A total of 1079 patients were included in the study. The rate of perioperative pRBC transfusions was 21.1%. Preoperative comorbidities, including anemia, American Society of Anesthesiologists (ASA) score of III to IV, a history of coronavirus disease 2019 (COVID-19), myocardial infarction, stroke, need for dialysis, history of blood transfusions, and metastatic disease were statistically significantly more frequent in transfused patients compared to nontransfused patients. The 1-year mortality rate was higher in transfused patients before (19.7% vs 6.5%; P < .0001) and after (17.4% vs 13.2%; P = .29) propensity score matching. 1-year mortality was 1.97 times higher in transfused than in no-transfused patients (odd ratio [OR], 1.97; 95% confidence interval [CI], 1.13-3.41). The odds of 1-year cancer mortality for patients who had perioperative pRBCs was 1.82 times higher (OR, 1.82; 95% CI, 0.97-3.43) compared to those who did not receive perioperative pRBC transfusion. The effect of perioperative pRBC transfusion on overall survival was also significant (hazard ratio [HR], 1.85; 95% CI, 1.15-2.99). Transfused patients also had a higher rate of 30-day postoperative mortality before (3.5% vs 0.7%; P = .0009) and after propensity score matching (4.2% vs 1.8%; P = .34). This international, multicenter observational study showed that perioperative pRBC transfusion was associated with an increased mortality risk.

Long-term maternal outcomes 5 years after cesarean section in Sierra Leone: A prospective cohort study.

Cesarean section (CS) is a life-saving procedure when performed for the right indication but carries substantial risks, specifically during subsequent pregnancies. The aim of this study was to evaluate obstetric outcomes for women 5 years after a CS performed by medical doctors and associate clinicians. This was a prospective multi-center observational study of women who had a CS at any of nine hospitals in Sierra Leone. Women and their offspring were followed up with three home visits for 5 years after surgery. Outcomes of interest included long-term complications, mode and place of delivery, and maternal and pediatric outcomes of subsequent pregnancies. Of the 1274 women included in the study, 140 (11.0%) were lost to follow-up. Within 5 years after the index CS, 27.0% of the women became pregnant and 2.5% had a second pregnancy. Women with perinatal death at the index CS had 5.25 higher odds of becoming pregnant within 1 year. Of the 259 women who delivered, 31 (12.0%) had a planned CS and 228 (88.0%) attempted a trial of labor after CS, resulting in either a successful vaginal birth (n = 138; 60.5%) or an emergency CS (n = 90; 39.5%). Peripartum and long-term complications did not significantly differ between those that were operated on by medical doctors and associate clinicians. Within 5 years after CS, one in four women became pregnant again and more than half had a vaginal delivery. Significant differences in place and mode of birth between wealth quintiles illustrate inequities.

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.

Identification of risk factors associated with post-ERCP pancreatitis in patients with easy cannulation: A prospective multicenter observational study

Identification of risk factors associated with post-ERCP pancreatitis in patients with easy cannulation: A prospective multicenter observational study

Analysis of risk factors in angiographically proven coronary artery disease in rural and urban Indian population. Prospective observational multicentre study: Kashmir Heart Survey

ABSTRACT Background: The global burden of cardiovascular diseases is increasing rapidly, and changing trends in epidemiological risk factors are identified among diverse Indian population. There has been a significant increase in heart attack deaths over the past 3 years after the COVID-19 pandemic. Are we missing a link? There is an urgent need for studies to confirm any epidemiological shift in coronary artery disease (CAD) risk factors. Aims and Objectives: To analyse the risk factors in patients with established CAD in rural and urban Indian Kashmiri populations in the post-COVID period. Material and Methods: A prospective observational study of all patients with angiographically proven CAD who have undergone revascularisation or have a clinical suspicion of CAD on the basis of symptoms or positive stress test and later proven to have CAD on coronary angiograms, coming from rural and urban areas of Jammu and Kashmir were enrolled for the study and screened for various modifiable and non-modifiable CAD risk factors. Data was compiled and analysed to know the pattern of various CAD risk factors in our population. Results: The study included total 600 patients (rural and urban 300 each), mean age was 59.13 ± 11.62 years. Male patients were 65.50% with a mean age of 57.53 ± 14.17 years and female patients were 34.50% with a mean age of 62.16 ± 10.02 years. In rural subgroup of 300 patients mean age was 60.99 ± 16.86 years and in the urban population we found a mean age of 57.26 ± 16.21 years. The most common risk factor was smoking in 76% rural and 67% urban. Diabetes (39% rural, 43% urban), dyslipidaemia (47.33%, 48.66% urban), hypertension (61% rural, 66% urban), obesity (23% rural, 29.33% urban) and physical inactivity (33.66% rural, 37.33% urban. Conclusion: CAD manifests earlier in males and urban populations. Smoking is the most common risk factor for CAD in the Kashmiri Indian population and is more common in the rural population. Coronary artery disease risk factors, such as physical inactivity, diabetes, smoking, hypertension, obesity and dyslipidaemia, are more common in the urban population. Preventive strategies should focus on modifying the risk factors to decrease the prevalence of CAD in communities.

Comparing the Efficacy of Empirical Anti-Infective Therapy and Follow-Up Observation for Newly Diagnosed Pulmonary Ground-Glass Nodules With Suspected Inflammatory Etiology: A Multicenter Prospective Observational Study Protocol.

The optimal management strategy for newly diagnosed pulmonary ground-glass nodules (GGNs) with suspected inflammatory etiology remains controversial in clinical practice. Empirical anti-inflammatory therapy is commonly used, but its efficacy compared with that of follow-up observation lacks high-quality evidence. Therefore, this study aims to compare the effectiveness of empirical anti-infective therapy and follow-up observation for pulmonary GGNs in real-world settings. This study intends to include 254 participants with newly discovered pulmonary ground-glass opacities (GGOs) suspected to be related to inflammation but without current radiographic features suggestive of malignancy. Antibiotics will be recommended when the doctor considers the GGOs may be infection-related. Upon enrollment, all participants will be assessed with the Self-Rating Anxiety Scale (SAS) and divided into either the intervention or observation group. A repeat CT scan and SAS assessment will be conducted with all participants after 1 month ( ± 2 weeks) following the initial discovery of the GGOs. The primary outcome is the participants' response rate at the first follow-up CT. The secondary outcome is the GGO response rate and total scores of SAS at 1 month after enrollment. A non-inferiority test will be conducted to compare the outcomes between the two groups. To date, the efficacy and necessity of using antibiotics for GGOs suspected to be inflammatory upon primary CT screening remain controversial. This protocol describes the rationale and methodology to address this unmet clinical need using real-world data, aiming to bridge the gap between clinical guidelines and real-world practice. Trial Registration: ChiCTR2200056975.

Prospective study of the real impact of fusion centered genomic assays in patient management in a national collaborative group: the GETHI-XX-16 study.

Precision medicine represents a paradigm shift in oncology. Access to genetic testing and targeted therapies is frequently limited. Assays based on DNA sequencing can miss druggable alterations. We aimed to determine the impact of a free access program to RNA tests in patient management. We designed a multicenter prospective observational study within the Spanish National Group for Translational Oncology and Rare and Orphan Tumors (GETTHI). Eligible patients were adults with solid cancers that had progressed on standard therapies. Tumor samples were analyzed using two RNA sequencing assays (Trailblaze PharosTM and Archer FusionPlex Solid TumorTM). A central committee evaluated the actionability of genetic alterations and reported the findings to attending physicians, who made the final clinical management decisions. Between November 2016 and April 2019, 395 patients with 41 different tumors across 30 hospitals were included. Molecular analysis revealed actionable genetic alterations in 57 individuals (14.4%). Targeted therapies were advised for 23 and seven received a matched targeted therapy: two lung cancers (EML4-ALK and CD74-ROS1 fusion), three glioblastomas (EGFR point mutations), one oligodendroglioma (FGFR3-TACC3 fusion) and a prostate cancer (SND1-BRAF fusion). The outcomes included two tumor responses, one disease stabilization, one early withdrawal due to toxicity, one progression, and one unknown. Despite the growing knowledge of cancer biology and its translation to drug development, the overall impact of personalized treatments remains low. Access to comprehensive molecular tests covering properly all known actionable alterations and programs for a wide access to targeted therapies seem to be critical steps.

Main versus segmental hepatic artery angioembolization in patients with traumatic liver injuries: A Western Trauma Association multicenter study

IntroductionHepatic angioembolization is highly effective for hemorrhage control in hemodynamically stable patients with traumatic liver injuries and contrast extravasation. However, there is a paucity of data regarding the specific location of angioembolization within the hepatic arterial vasculature and its implications on patient outcomes. MethodsA post-hoc analysis of a multicenter prospective observational study across 23 centers was performed. Adult patients undergoing main hepatic artery angioembolization or segmental hepatic artery angioembolization within 8 hours of arrival were included. The primary outcome was liver-related complications, defined as perihepatic fluid collection, bile leak/biloma, pseudoaneurysm, hepatic necrosis, and/or hepatic abscess. Secondary outcomes were liver-related complication interventions, length of stay, and mortality. ResultsA total of 55 patients underwent hepatic angioembolization, with 23 (41.8%) undergoing main hepatic artery angioembolization and 32 (58.2%) receiving segmental hepatic artery angioembolization. Both groups were comparable in age, vitals, mechanism of injury, liver injury grade distribution, and injury severity score (all P > .05). The main hepatic artery angioembolization group had greater rates of overall liver-related complications (65.2% vs 31.2%, P = .039), specifically perihepatic fluid collection (26.1% vs 6.3%, P = .040) and bile-leak/biloma (34.8% vs 12.5%, P = .048). Main hepatic artery angioembolization had greater rates of 2 or more liver-related complications (47.8% vs 9.4%, P = .001) and readmission within 30 days (30.4% vs 9.4%, P = .046). No significant differences were observed in hospital length of stay and mortality (all P > .05). ConclusionsMain hepatic artery angioembolization is associated with increased rates of liver-related complications, multiple liver-related complications, and readmission within 30 days compared with segmental hepatic artery angioembolization. Thus, main hepatic artery angioembolization should be reserved for use only when segmental hepatic artery angioembolization is not feasible, albeit with significantly increased morbidity.

Factors affecting outcome of acquired comitant esotropia with restricted use of digital devices: ACEDD Study 3.

The objective of this study is to investigate factors associated with outcomes after 3 months of instructed usage of hand-held digital devices (DD) in patients with acquired comitant esotropia (ACE). This prospective multicentre observational study included patients with ACE, aged 5-35 years, who used DD within 1 year of onset and were followed up for clinical findings and instructed use of DD. The outcomes were classified into four groups: cured, improved, unchanged and worsened. After the analysis of group differences in the clinical and DD use-related factors by univariate analysis, we used ordinal logistic regression models to identify factors associated with favourable outcomes. Of 156 patients (mean age (SD): 16.4 (7.4) years), 10 (6%), 58 (37%), 67 (43%) and 21 (14%) were classified into the cured, improved, unchanged, and worsened, respectively. In the univariate analysis, consultation within 3 months of onset, small-angle strabismus at distance and good stereoacuity were associated with good outcomes. Ordinal logistic regression analysis on adjusting for age with stereoacuity or successful DD-use time halving showed that small-angle strabismus at distance (OR: 1.02, 95% CI 1.00 to 1.03, p=0.023), good stereoacuity (OR: 1.31; 95% CI 1.10 to 1.56; p=0.003) and successful halving of DD-use time (OR: 0.63; 95% CI 0.43 to 0.92; p=0.016) influenced favourable outcomes. Patients with small-angle esotropia, good stereoacuity on consultation and success in halving DD-use time had a higher chance of recovery through instructional DD usage. Further studies using objectively measurable systems are needed to ensure the accuracy of DD-use time.

Salt Based or BaLanced SolUtion–Trends Existing in Indian Intensive Care Units: A Multicenter Prospective Observational Cohort Study (SOLUTE Study)

Salt Based or BaLanced SolUtion–Trends Existing in Indian Intensive Care Units: A Multicenter Prospective Observational Cohort Study (SOLUTE Study)

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.