Primary Outcome In Patients Research Articles

Comparison of Hernia Sac Transection and Full Sac Reduction for the Treatment of Inguinal Hernias: A Systematic Review and Meta-Analysis of Clinical Trials.

The history of inguinal hernia repair has been marked by the description of several therapies over ages, each with its own approach to managing the hernial sac. An analysis of hernia sac transection (with or without high ligation) versus reduction (invagination) in adults who underwent Lichtenstein open tension-free inguinal hernia repair and in adult and pediatric patients who underwent suture repair has been the primary aim of this systematic review and meta-analysis. The authors conducted a comprehensive review and meta-analysis. A comprehensive literature search yielded 15 publications, consisting of 12 randomized controlled trials (RCTs) including 1598 patients and 3 controlled clinical trials (CCTs) including 243 patients. In total, the included patients amounted to 1.841. Analysis of the data revealed a lower rate of recurrence in patients who had sac reduction (0.35% in randomized controlled trials and 0 in clinical trials) compared to patients who had sac excision and ligation (0.86% in randomized controlled trials and 0.93% in clinical trials). However, this difference was not statistically significant (RCTs: relative risk 2.94 [0.30, 29.24]-CCTs: relative risk 4.46 [0.18, 111.36]). The reduction of sacs does not result in a statistically significant decrease in recurrence compared to patients who underwent sac excision and subsequent ligation. This study has demonstrated that the various courses of treatment for the inguinal hernia sac have similar primary and secondary outcomes in both adult and pediatric patients.

Initial Decline in Glomerular Filtration Rate With Finerenone in HFmrEF/HFpEF: A Prespecified Analysis of FINEARTS-HF.

An initial decline in estimated glomerular filtration rate (eGFR) often leads to reluctance to continue life-saving therapies in patients with heart failure (HF). The goal of this study was to describe the association between initial decline in eGFR and subsequent clinical outcomes in patients randomized to placebo or finerenone. In this prespecified analysis of FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with HeartFailure), we examined the association between initial decline in eGFR (≥15%) from randomization to 1month and subsequent outcomes in patients assigned to finerenone or placebo. The primary outcome was the composite of total HF events and cardiovascular death. Among 5,587 patients with an eGFR measurement at both baseline and 1month, 1,018 (18.2%) experienced a≥15% decline in eGFR. The proportion of patients experiencing a≥15% decline in eGFR was 23.0% with finerenone and 13.4% with placebo (OR: 1.95; 95%CI: 1.69-2.24; P< 0.001). After adjustment, an eGFR decline was associated with a higher risk of the primary outcome in patients assigned to placebo (adjusted rate ratio: 1.50; 95%CI: 1.20-1.89) but not in those assigned to finerenone (adjusted rate ratio: 1.07; 95%CI: 0.84-1.35; Pinteraction=0.04). By contrast, the efficacy of finerenone was consistent across the range of change in eGFR from baseline to 1month (Pinteraction=0.50 for percent change in eGFR), and safety, including hyperkalemia, was similar regardless of an early eGFR decline. Although an initial decline in eGFR was associated with worse outcomes in patients assigned to placebo, this relationship was not as strong in those treated with finerenone. An early decline in eGFR can be anticipated with finerenone and should not automatically lead to the discontinuation of this disease-modifying therapy (FINEARTS-HF Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with HeartFailure [NCT04435626]; A Multicenter, Randomized, Double-Bline, Parallel-Group, Placebo-Controlled Study to Evaluate the efficacy and safety of finerenone on morbidity and mortality in participants With HeartFailure [NYHA II-IV] and left ventricular ejection fraction≥40% [EudraCT 2020-000306-29]).

PTSD Coach as an early mobile intervention to improve cancer-related anxiety and psychosocial oncology uptake in patients newly diagnosed with head and neck cancer: pilot randomized controlled trial

BackgroundThis pilot study aimed to provide supportive evidence for the feasibility of conducting a full-scale intervention trial with patients newly diagnosed with head and neck cancer (HNC). This included assessing the acceptability and potential usefulness of the PTSD Coach mobile app as an early self-management intervention that gives information about anxiety symptoms, offers self-assessment of symptoms with feedback, tools to self-manage anxiety, and connects to support.MethodsA three-arm randomized controlled trial was conducted. The primary pilot study questions related to feasibility were: (1) can we recruit enough (i.e., n = 60 over 8 months or 8/month) and retain a sufficient proportion (i.e., ≥ 85% at three months post-randomization, having completed the primary outcome) of patients with HNC in all trial arms? (2) Will there be at least a 90% completion rate of PTSD Coach within 3 weeks from randomization? (3) Will at least 85% of the content for each module of PTSD Coach be completed? (4) Will there be at least a 90% completion rate of the attention-control tasks (i.e., 45 min/week over 3 weeks)? (5) What would be the anticipated sample size for a full study? (6) We also explored a signal for intervention effects on 1-, 3-, and 6-month levels of cancer-related anxiety, quality of life, anxiety and depression, self-stigma of seeking help, and professional psycho-oncology service uptake.ResultsParticipants comprised 39 patients (11 experimental group (EG), 13 attention-control (AC), 15 usual care (UC)), primarily male (82%). Enrolment was lower than expected, with strategies implemented to increase the study’s participation rate (i.e., shortening the questionnaire, more relevant AC games, pacing study components, and enlarging eligibility to 4 weeks post-diagnosis instead of 2). Retention rates, intervention completion rates, and completion time were adequate. The intervention was acceptable with all patients (100%) who received PTSD Coach reporting it a positive experience and that they would recommend it to others. When compared to UC, there was a signal for the PTSD Coach group to report lower 3-month cancer-related anxiety (PCL-S; eta squared = 0.013), lower anxiety and depression (HADS; eta squared = 0.015), anxiety (HADS-A; eta squared = 0.028), and higher functional wellbeing (FACT-FW; eta squared = 0.09), based on effect sizes calculated across all three groups. The sample size for a full study was estimated to be 118 to 154 per group.ConclusionA repeat pilot study with an expanded oncology population is warranted to further investigate feasibility prior to a full Phase III study. PTSD Coach could be a valuable self-management tool as an initial stepped-care approach intervention in patients newly diagnosed with HNC.Trial registrationClinicalTrials.gov, NCT03651570. Registered June 26, 2018.

Real-world comparison of dual versus single antiplatelet treatment in patients with non-cardioembolic mild-to-moderate ischemic stroke: A propensity matched analysis.

Short-term dual antiplatelet treatment (DAPT) is superior to single antiplatelet treatment (SAPT) for secondary prevention in non-cardioembolic minor ischemic stroke and high-risk transient ischemic attack (TIA). As the real-world use of DAPT is broader than in trials, it is important to clarify its benefit/risk profile in a diverse population. Post hoc analysis of prospectively collected data from the READAPT cohort and three prospective stroke registries including patients with mild-to-moderate (National Institute of Health Stroke Scale (NIHSS) score 0-10) ischemic stroke receiving early DAPT or SAPT. The primary effectiveness outcome was 90-day return to pre-stroke neurological functioning using modified Rankin Scale (mRS) score. Secondary effectiveness outcomes were 90-day mRS shift, new ischemic stroke/TIA, vascular and all-cause death, 24 h early neurological improvement or deterioration. The safety outcome was 90-day intracranial hemorrhage. We matched 1008 patients treated with DAPT and 1008 treated with SAPT. Compared to SAPT, patients treated with DAPT showed higher likelihood of 90-day primary effectiveness outcome (87.5% vs. 84.4%, risk difference 3.1% (95% confidence interval (CI): 0.1%-6.1%); p = 0.047, risk ratio 1.03 (95% CI: 1.01-1.07); p = 0.043) and higher rate of 24-h early neurological improvement (25.3% vs. 15.4%, risk difference 9.9% (95% CI: 6.4%-13.4%); p < 0.001, risk ratio 1.65 (95% CI: 1.37-1.97); p < 0.001). No differences were observed for other study outcomes. Subgroup analysis confirmed benefit of DAPT over SAPT for primary effectiveness outcome in patients with moderate stroke, those treated with intravenous thrombolysis, and those who received antiplatelet loading dose. Our findings suggest that DAPT use might be safe and more effective than SAPT even in the real world and in patients who do not strictly fulfill the criteria of landmark large clinical trials.

Impact of Dual Antithrombotic Therapy with Aspirin and Rivaroxaban on Secondary Cardiovascular Outcomes.

BACKGROUND Dual antiplatelet therapy is the main treatment for cardiovascular diseases (CADs). In this study, we evaluated the efficacy and safety of aspirin combined with low-dose rivaroxaban in the secondary prevention of high-risk ischemic cardiovascular diseases. MATERIAL AND METHODS In total, 168 patients who were diagnosed with acute myocardial infarction or multiple vessel disease 1 year after percutaneous coronary intervention were divided into 2 groups: the aspirin group (aspirin as acetylsalicylic acid: 100 mg once daily) and the aspirin + rivaroxaban group (aspirin: 100 mg once daily, rivaroxaban: 2.5 mg twice daily). The patients were followed up for 2 years to assess the clinical efficacy and safety of a new dual-channel antithrombotic treatment strategy. RESULTS The occurrence of MACE (recurrent myocardial infarction, in-stent restenosis, coronary target vessel revascularization, stent thrombosis, heart failure, rehospitalization, and all-cause mortality) in the rivaroxaban + aspirin group was lower than that in the aspirin group (3.57% of patients received aspirin + rivaroxaban treatment vs 13.10% of patients received aspirin treatment). There were not more adverse events in the rivaroxaban + aspirin group than in the aspirin group. Compared with patients administered aspirin, the coagulation function of patients taking aspirin + rivaroxaban was significantly changed. No heart failure occurred in either group of patients with CADs. CONCLUSIONS Aspirin + rivaroxaban had better primary outcome and secondary outcomes in patients with a high risk of ischemia. Our results provide a basis for evaluating the efficacy and safety of drugs used in secondary prevention among patients with high risk of ischemia.

J-shaped association between serum glucose potassium ratio and prognosis in heart failure with preserved ejection fraction with stronger predictive value in non-diabetic patients

Background: The relationship between serum glucose/potassium ratio (GPR) and the adverse outcomes in patients with heart failure with preserved ejection fraction (HFpEF) has not been completely clarified. Methods: Patients were included from the American cohort of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial. The primary endpoint was the composite of cardiovascular mortality, aborted cardiac arrest, and hospitalization for HF. The Cox regression models were applied to calculate the hazard ratio (HR) and 95% confidence interval (CI) to examine the relationship between GPR and prognosis. Restricted cubic spline (RCS) curves were performed to explore the nonlinear relationship between GPR and the primary endpoint. Receiver Operating Characteristic (ROC) curves were constructed, and the areas under the curves (AUCs) for GPR and its components were compared using the DeLong test. Subgroup analysis and interaction effect were also explored. Results: A total of 1749 HFpEF patients were included. During the follow-up, 514 (29.4%) patients reached the primary outcome. An increase in GPR was independently associated with a higher risk in the primary endpoint [Tertile 3 vs. Tertile 1: HR (95% CI), 1.35 (1.07–1.70), P = 0.012] and HF hospitalization [Tertile 3 vs. Tertile 1: HR (95% CI), 1.57 (1.20–2.05), P = 0.001]. RCS curve showed a J-shape trend between GPR and primary endpoint (non-linear P = 0.002). The AUC for GPR was superior to that of the glucose and potassium (De long test P < 0.05). Additionally, the prognostic value of GPR was stronger in patients without diabetes and with less severe heart failure symptoms (P interaction < 0.05). Conclusion: A J-shaped relationship was existed between GPR levels and the primary outcome in HFpEF patients. An increased GPR was an independent predictor of poor prognosis in HFpEF patients, especially in non-diabetic patients and those with less severe heart failure symptoms.

Finerenone, Obesity, and HeartFailureWith Mildly Reduced/Preserved Ejection Fraction: Prespecified Analysis of FINEARTS-HF.

Obesity is associated with excessive adipocyte-derived aldosterone secretion, independent of the classical renin-angiotensin-aldosterone cascade, and mineralocorticoid receptor antagonists may be more effective in patients with heart failure (HF) and obesity. This study sought to examine the effects of the nonsteroidal mineralocorticoid receptor antagonist finerenone compared with placebo, according to body mass index (BMI) in FINEARTS-HF (FINerenone trial to investigate Efficacy and sAfety superioR to placebo in paTientS with HeartFailure). A total of 6,001 patients with HF with NYHA functional class II, III, and IV, a left ventricular ejection fraction of≥40%, evidence of structural heart disease, and elevated natriuretic peptide levels were randomized to finerenone or placebo. BMI (kg/m2) was examined using World Health Organization categories, namely, underweight/normal weight (<25.0 kg/m2; n=1,306); overweight (25.0-29.9 kg/m2; n=1,990); obesity class I (30.0-34.9 kg/m2; n=1,546); obesity class II (35.0-39.9kg/m2; n=751); and obesity class III (≥40 kg/m2; n=395). The primary outcome was cardiovascular death and total worsening HF events. Data on baseline BMI were available for 5,988 patients (median: 29.2 kg/m2; Q1-Q3: 25.5-33.6 kg/m2). Compared with patients who were underweight/normal weight, those with obesity class II or III had a higher risk of the primary outcome (underweight/normal weight, reference; overweight, unadjusted rate ratio: 0.96 [95%CI: 0.81-1.15]; obesity class I: 1.04 [95%CI: 0.86-1.26]; obesity class II-III: 1.26 [95%CI: 1.03-1.54]). The effect of finerenone on the primary outcome did not vary by baseline BMI (underweight/normal weight, rate ratio: 0.80 [95%CI: 0.62-1.04]; overweight: 0.91 [95%CI: 0.72-1.15]; obesity class I: 0.92 [95%CI: 0.72-1.19]; obesity class II-III: 0.67 [95%CI: 0.50-0.89]; Pinteraction=0.32). However, when BMI was examined as a continuous variable, the beneficial effect of finerenone seemed to be greater in those with a higher BMI (Pinteraction=0.005). A similar pattern was observed for total worsening HF events. Consistent effects across baseline BMI were observed for cardiovascular and all-cause death and improvement in the Kansas City Cardiomyopathy Questionnaire scores. In patients with HF with mildly reduced/preserved ejection fraction, the beneficial effects of finerenone on clinical events and symptoms were consistent, irrespective of BMI at baseline, possibly with a greater effect on the primary outcome in patients with higher BMI. (FINEARTS-HF [FINerenone trial to investigate Efficacy and sAfety superioR to placebo in paTientS with Heart Failure]; NCT04435626).

Effectiveness of smartphone-based virtual reality relaxation (SVR) for enhancing comfort in cancer patients undergoing chemotherapy: a randomized controlled trial.

Comfort, anxiety, and pain significantly impact the quality of life and treatment adherence in cancer patients undergoing chemotherapy. Virtual reality (VR) technology offers a novel non-pharmacological intervention to address these primary concerns. While vital signs provide objective physiological data, they are considered secondary outcomes that may reflect changes in patients' subjective experiences. This study aims to evaluate the effectiveness of smartphone-based virtual reality relaxation (SVR) interventions on improving comfort and reducing anxiety and pain (primary outcomes) in patients with cancer undergoing chemotherapy. Additionally, it assesses the impact on blood pressure and pulse rate (secondary outcomes). This prospective, two-arm, randomized controlled trial involved 99 cancer patients undergoing chemotherapy who were randomized into the SVR group (n = 50) and control group (n = 49) from March to May 2023. The SVR group received a 10-min immersive VR experience featuring 360-degree natural scenery videos with relaxing sounds, while participants in the control group received standard care and guided imagery leaflets. The primary outcomes-comfort, anxiety, and pain-were evaluated at various time points: comfort was assessed at baseline and post-chemotherapy, while anxiety and pain were assessed at four stages (pre-chemotherapy, pre-VR, immediate post-intervention, and post-chemotherapy). Secondary outcomes included vital signs (blood pressure and pulse rate), which were assessed at the same four stages. Cybersickness symptoms were examined post-chemotherapy. Data analysis involved independent t tests, linear regression, and Generalized Estimating Equations (GEE). Among 99 randomized patients, the SVR group reported significantly higher comfort levels (p = 0.01; Cohen's d = 0.4), reduced anxiety (p = 0.01; Cohen's d = 0.50), and pain (p = 0.015; Cohen's d = 0.35) compared to the control group. No significant differences were found in heart rate (p = 0.92), systolic blood pressure (p = 0.36), or diastolic blood pressure (p = 0.95). The majority of participants (66-96%) in the SVR group did not report cybersickness symptoms. SVR shows promise as an intervention for improving comfort and reducing anxiety and pain in cancer patients undergoing chemotherapy. Healthcare providers at chemotherapy centers should consider incorporating VR devices and curated content into patient care routines. ClinicalTrials.gov: NCT05756465, registered on January 22, 2023.

Oral Glucocorticoids for Skin Fibrosis in Early Diffuse Systemic Sclerosis: A Target Trial Emulation Study From the European Scleroderma Trials and Research Group Database.

The objective of this study is to evaluate whether adding oral glucocorticoids to immunosuppressive therapy improves skin scores and ensures safety in patients with early diffuse cutaneous systemic sclerosis (dcSSc). We performed an emulated randomized trial comparing the changes from baseline to 12 ± 3 months of the modified Rodnan skin score (mRSS: primary outcome) in patients with early dcSSc receiving either oral glucocorticoids (≤20 mg/day prednisone equivalent) combined with immunosuppression (treated) or immunosuppression alone (controls), using data from the European Scleroderma Trials and Research Group. Secondary end points were the difference occurrence of progressive skin or lung fibrosis and scleroderma renal crisis. Matching propensity score was used to adjust for baseline imbalance between groups. We matched 208 patients (mean age 49 years; 33% male; 59% anti-Scl70), 104 in each treatment group, obtaining comparable characteristics at baseline. In the treated group, patients received a median prednisone dose of 5 mg/day. Mean mRSS change at 12 ± 3 months was similar in the two groups (decrease of 2.7 [95% confidence interval {95% CI} 1.4-4.0] in treated vs 3.1 [95% CI 1.9-4.4] in control, P = 0.64). Similar results were observed in patients with shorter disease duration (≤ 24 months) or with mRSS ≤22. There was no between-group difference for all prespecified secondary outcomes. A case of scleroderma renal crisis occurred in both groups. We did not find any significant benefit of adding low-dose oral glucocorticoids to immunosuppression for skin fibrosis, and at this dosage, glucocorticoid did not increase the risk of scleroderma renal crisis.

Abstract 4138721: Outcomes of Coronary Revascularization in Patients with Contemporaneous Abdominal Organ Transplant

Background: Clinical evaluation surrounding liver and kidney transplantation may reveal obstructive coronary artery disease (CAD). However, little is known about outcomes after revascularization in this population. Our aim was to examine coronary artery bypass grafting (CABG) and percutaneous intervention (PCI) in peri-transplant patients compared to the general CABG/PCI populations. Methods: We conducted a matched retrospective cohort study between 2014-2022 at a single academic center. Matching was done by optimal full matching of a logistic regression-based propensity score adjusting for age, chronic kidney disease, diabetes, tobacco use, chronic lung disease, hypertension, prior myocardial infarction, and valvular disease. Covariate balance was assessed as standardized mean difference &lt;0.2. The primary outcome was a composite of in-hospital death, stroke, and myocardial infarction, and a key secondary outcome was incident arrhythmia. Results: The study population comprised 2655 patients: 24 CABG/transplant (median age, 64 [IQR, 59-66]; 4 female [17%]), 1037 CABG/non-transplant (age, 66 [59-73]; 190 female [18%]), 27 PCI/transplant (age, 62 [IQR, 55-67]; 6 female [22%]), and 1567 PCI/non-transplant (age, 70 [IQR, 60-78]; 399 female [25%]). CABG/PCI preceded transplant by a median 321/324 days, respectively, and followed transplant by a median 461/36 days, respectively. For the primary outcome in CABG patients, there were no events in the transplant group and an estimated potential outcome in 6.5% of the matched non-transplant group (marginal RR, &lt;0.001; p&lt;0.001). For the primary outcome in PCI patients, there were no events in the transplant group and an estimated potential outcome in 2.4% of the matched non-transplant group (marginal RR, &lt;0.001; p&lt;0.001). For incident arrhythmia in CABG patients, the estimated potential outcome was 12% and 17.5% in the transplant and matched non-transplant groups, respectively (marginal RR, 0.98; 95% CI, 0.37-2.6; p=0.97). For incident arrhythmia in PCI patients, the estimated potential outcome was &lt;0.001% and 3.6% in the transplant and matched non-transplant groups, respectively (marginal RR, 0.89; 95% CI, 0.12-6.5; p=0.91). Conclusions: Patients with contemporaneous abdominal organ transplant undergoing coronary revascularization suffered no in-hospital mortality, stroke, or myocardial infarction, and were not at greater risk of incident arrhythmia than similar non-transplant patients.

Abstract 045: First‐Line Mechanical Thrombectomy Device in Intracranial Atherosclerotic Large Vessel Occlusion

Introduction First‐line mechanical thrombectomy devices are associated with heterogeneous functional and safety outcomes in large vessel ischemic stroke. Successful recanalization rates are influenced by associated technical difficulties of navigating torturous vessels and interactions with recalcitrant thrombi of atherosclerotic lesions. As such, studies are required to evaluate these devices to determine the optimal initial thrombectomy approach in patients with these lesions. Method This is an analysis of the RESCUE‐ICAS international prospective observational registry which included patients with residual stenosis (50‐99% reperfusion) following successful mechanical thrombectomy. Patients were dichotomized into those receiving first‐line aspiration catheter or stentriever devices. Primary and secondary efficacy outcomes were defined as excellent functional outcomes (modified Rankin Scale 0‐2) and procedure times, respectively. Primary safety outcomes were defined symptomatic intracranial hemorrhage (sICH) rates. Multivariate analysis was performed on the primary outcome. Results There were four‐hundred‐twenty‐six patients included in this analysis with 218 and 208 patients receiving first‐line aspiration catheter and stentriever devices, respectively. Patients were generally older (median 68 years old) Caucasian (59%) males (61%). Patients in the aspiration catheter cohort were more likely to have dyslipidemia (55% vs 45% p = 0.04) and prior stroke (28% vs 19% p = 0.03) compared to the stentriever cohort; no other significant differences were noted. At 90‐days, there were equivalent rates of excellent functional outcomes in the aspiration and stentriever cohorts (35.4% vs 31.4% p = 0.48) and redemonstrated following multivariate analysis (OR 0.90 95% CI 0.59 ‐ 1.37; p = 0.62). Yet, aspiration catheters were noted to have shorter procedure times (45 mins vs 62 mins p &lt; 0.001). Additionally, there was a trend towards lower sICH rates in the aspiration cohort (5% vs 9.6% p =0.07) compared to the stentriever cohort. Conclusion There were equivalent primary functional outcomes in patients with atherosclerotic large vessel occlusions treated with either aspiration catheter or stentriever devices yet, procedure times favored aspiration catheters. There was a trend towards lower symptomatic ICH rates with first‐line aspiration catheters. Further randomized studies are required to further evaluate procedural benefits and risks.

Adherence to the Atrial Fibrillation Better Care (ABC) pathway and outcomes in patients with chronic kidney disease: A report from the APHRS-AF registry

Abstract Background The Atrial Fibrillation Better Care (ABC) pathway is based on three pillars: "A" avoid stroke with oral anticoagulation, "B" better symptoms control, and "C" optimization of cardiovascular risk factors and lifestyles. This integrated approach has been associated with improved outcomes in atrial fibrillation (AF) patients, but few data are available in patients with chronic kidney disease (CKD). Purpose To investigate the correlation between chronic kidney disease, adherence to the ABC pathway, and the occurrence of adverse events in patients with AF enrolled in the Asian-Pacific Heart Rhythm Society-AF Registry. Methods Logistic regression was used to investigate factors associated with CKD, warfarin use and rhythm control strategies. Cox regression analysis adjusted for age≥75 years, paroxysmal AF, CHA2DS2VASc≥2, chronic obstructive pulmonary disease, cancer, and ABC adherence was used to calculate Hazard Ratios (HRs) and 95% Confidence Interval (CI) for the risk of primary outcomes in patients with CKD (eGFR &amp;lt;60 ml/min/1.73m2). Sensitivity analyses were performed in moderate (eGFR 59-30) and severe CKD (eGFR&amp;lt;30). Interaction analysis investigated the effect of ABC pathway based on presence or absence of CKD. Primary outcomes were the risks of all-cause death, major cardiovascular events (MACE: Cardiovascular death, acute coronary syndromes, thromboembolic events, and acute heart failure) and major bleeding. Results We included 2 578 AF patients without CKD (age 66.5±11.3 years, 32.5% females) and 1 047 AF patients with CKD (75.3±10.3 years, 40.8% females). Lower ABC pathway full adherence was observed in CKD patients (42.1% vs 29.5%, p&amp;lt;0.001), primarily due to low adherence to "A" and "C" criteria. Logistic regressions confirmed the lower likelihood of anticoagulation (Odds Ratio (OR) 0.61, 95%CI 0.44-0.83), a higher use of warfarin (OR 1.50, 95%CI 1.23-1.83) and lower use of rhythm control strategies (OR 0.79, 95%CI 0.66-0.94) in CKD patients. After one-year follow up, patients with CKD had a higher incidence of all-cause death (1.6% vs 7.2%, p&amp;lt;0.001) and MACE (3.4% vs 8.1%, p,0.001) compared to those without CKD. On Cox multivariable analysis (Figure 1, Panel A-D), CKD and ABC adherence were independently associated with the risk of all-cause death (HR 2.54, 95%CI 1.69-3.80 and HR 0.57, 95%CI 0.35-0.93, respectively) and MACE (HR 1.58, 95%CI 1.14-2.20 and HR 0.66, 95%CI 0.46-0.95, respectively). The risk of primary outcomes was the highest in those with severe CKD. No association was found with the risk of major bleeding. The interaction analysis confirmed that the beneficial effect of ABC pathway adherence on death (p int= 658) and MACE (p int= 0.568) was irrespective of CKD. Conclusion AF patients with CKD have low ABC pathway adherence and high risk of all-cause death and MACE. Efforts to improve the ABC pathway adherence in AF patients with CKD are needed to improve their long-term clinical outcomes.Figure 1.Cox regression analyses

Clinical phenotyping and treatment response in patients with chronic heart failure: a latent class analysis from a Japanese multicentre registry

Abstract Background There are diversities of pathophysiology and co-morbidities in patients with chronic heart failure (HF), irrespective of left ventricular ejection fraction (LVEF). Therefore, the identification of subgroups with different outcomes and treatment response patterns may help to tailor strategies to each individual HF patient. Purpose We sought to identify phenogroups of patients with different prognosis and response to medical therapies in patients with chronic HF. Methods A total of 1565 patients with a broad spectrum of LVEF in a prospective multicentre registry of patients with chronic HF were enrolled between January 2020 and December 2023. Latent class analysis was performed in each subgroup using 80 features including patients’ demographics, laboratory, and echocardiographic data. The optimal number of phenogroups was determined using the first minimum of the Bayesian information criterion. The primary outcome was a composite of all-cause death and hospitalisation due to worsening HF. Results The analysis subclassified patients into six phenogroups. Patients in phenogroup A (young non-ischaemic cardiomyopathy, n = 242, 15.5%) were the youngest and had lower LVEF and lowest prevalence of coronary artery disease (CAD) and other comorbidities. Phenogroup B (atrial fibrillation [AF] and small left atrium, n = 282, 18.0%) had higher proportion of AF but smaller left atrium volume. Phenogroup C (ischaemic cardiomyopathy, n = 204, 13.0%) had the highest proportion of CAD and lower LVEF. Phenogroup D (classical HF with preserved ejection fraction [HFpEF], n =308, 19.7%) had the highest age, proportion of female, LVEF and thickness of LV wall. Phenogroup E (elderly and AF , n = 235, 15.0%) had higher age, the highest proportion of AF and largest left atrium volume. Phenogroup F (biventricular failure and multiple comorbidities, n = 294, 18.8%) had the highest proportion of co-morbidities and the lowest LVEF, right ventricular systolic function and renal function. During a median follow-up period of 538 (interquartile range 286-701) days, the incidence of the primary outcome significantly differed among the phenogroups (P &amp;lt; 0.001, Figure 1). Regarding treatment response for renin-angiotensin system blockers and beta blockers, there were no significant associations between the use of renin-angiotensin system blockers and the risk of the primary outcome among the phenogroups whereas the use of beta-blockers was significantly associated with increased risk of the primary outcome in patients classified to phenogroup D (classical HFpEF) (hazard ratio 1.83 95% confidence interval 1.05-3.19) among the phenogroups (Figure 2). Conclusion We identified six phenogroups with distinct clinical outcomes in patients with chronic HF, and the use of beta-blockers might have unfavorable effect in the classical HFpEF phenogroup. This phenotyping provides novel risk stratification and may aid in clinical decision making.Clinical outcomes among the phenogroupsTreatment effect among the phenogroups

Granulocyte colony-stimulating factor for stem cell mobilisation in acute myocardial infarction: a randomised controlled trial

BackgroundTo determine whether granulocyte colony-stimulating factor (G-CSF) improves clinical outcomes after large ST-elevation myocardial infarction (STEMI) when administered early in patients with left ventricular (LV) dysfunction after successful percutaneous coronary...

Effects of synbiotic supplementation on the components of metabolic syndrome in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial

BackgroundAntipsychotic drugs may have adverse effects on the components of metabolic syndrome. Previous studies have shown that changes in the intestinal microbiome are associated with metabolic disturbances in patients with schizophrenia. The objective of this study was to determine the effects of synbiotics on the components of metabolic syndrome as primary outcomes in patients with schizophrenia. Secondary outcomes were HbA1c, insulin resistance, LDL-c, and anthropometric measurements.MethodsIn this double-blind, placebo-controlled trial, seventy patients with schizophrenia receiving antipsychotic drugs who had at least two criteria of metabolic syndrome were randomly divided into two groups to receive either two capsules of a synbiotic supplement or a placebo daily for 8 weeks. Anthropometric indices and biochemical parameters were measured at baseline and after the intervention.ResultsFifty-five patients completed the study. The synbiotic supplement significantly decreased waist circumference and HbA1C compared to placebo (-2.66 ± 4.20 vs. 3.03 ± 4.50 and − 0.26 ± 0.54 vs. 0.20 ± 0.75, respectively). Although BMI did not change significantly in the synbiotic + antipsychotic group, it increased in the placebo + antipsychotic group (-0.37 ± 1.00 vs. 0.61 ± 1.09 P < 0.5). LDL-c and triglyceride (TG) levels decreased significantly in the synbiotic + antipsychotic group, but the change was not significantly different from that of the placebo + antipsychotic group. FBS, HDL-c, systolic and diastolic blood pressure, insulin resistance, and total cholesterol were not significantly different between the two groups after intervention.ConclusionSynbiotic supplement may decrease waist circumference, HbA1c, LDL and TG and prevent BMI increase in patients receiving antipsychotic drugs.Trial registrationIranian Registry of Clinical Trials (IRCT Number: IRCT20090901002394N45), Date: 26-12-2019.

Comprehensive Airway Quality Improvement Program: Reducing Life-Threatening Airway Complications.

There is often unfamiliarity with the care of artificial airway devices (ie, endotracheal tubes, tracheostomies, and laryngectomies). The objective of this study was to design an Airway Quality Improvement Program (AQIP) to improve airway care. This was a retrospective chart review of a prospectively-initiated AQIP. The AQIP has 3 parts: 1) Mandatory "airway signs" 2) In-service teaching with a corresponding order set and 3) an overhead "Surgical Airway Emergency" page involving automatic pages to Anesthesia, Otolaryngology, and Respiratory Therapy. Pre- and post-intervention survey data was collected. The incidence of airway emergency was the primary patient outcome and was hypothesized to decrease after AQIP intervention. Airway emergencies decreased 8.4% after AQIP (P = .45). Length of stay decreased after AQIP, 47.0 ± 76.5 days compared to 23.5 ± 23.6 (P = .004). Two hundred eight-one nurses and 76 respiratory therapists were educated. Pre-AQIP comfortability scores improved for the routine care of endotracheal tubes, tracheostomies, and laryngectomies, 4.3 ± 0.9, 4.3 ± 0.8, and 3.5 ± 1.2, compared to 4.7 ± 0.6, 4.5 ± 0.7, and 4.4 ± 0.7 post-AQIP (P = .0006, P = .02, P = .0001). The same improvement was noted for emergency airway care. Tracheostomy vs. laryngectomy recognition increased from 66.5 to 97.0% (P = .0001). Quiz questions regarding emergency airway management for laryngectomies improved from 76.2 to 93.8% (P = .0001). The AQIP was associated with decreased length of hospital stay and improved competency in airway care among hospital staff. Further application of AQIP is needed for replication in other institutions and long-term application.

A subset of image-defined risk factors predict completeness of resection in children with high-risk neuroblastoma: An international multicenter study.

Image-defined risk factors (IDRFs) were promulgated for predicting the feasibility and safety of complete primary tumor resection in children with neuroblastoma (NB). There is limited understanding of the impact of individual IDRFs on resectability of the primary tumor or patient outcomes. A multicenter database of patients with high-risk NB was interrogated to answer this question. Patients with high-risk NB (age <20years) were eligible if cross-sectional imaging was performed at least twice prior to resection. IDRFs and primary tumor measurements were recorded for each imaging study. Extent of resection was determined from operative reports. There were 211 of 229 patients with IDRFs at diagnosis, and 171 patients with IDRFs present pre-surgery. A ≥90% resection was significantly more likely in the absence of tumor invading or encasing the porta hepatis, hepatoduodenal ligament, superior mesenteric artery (SMA), renal pedicles, abdominal aorta/inferior vena cava (IVC), iliac vessels, and/or diaphragm at diagnosis or an overlapping subset of IDRFs (except diaphragm) at pre-surgery. There were no significant differences in event-free survival (EFS) and overall survival (OS) when patients were stratified by the presence versus absence of any IDRF either at diagnosis or pre-surgery. Two distinct but overlapping subsets of IDRFs present either at diagnosis or after induction chemotherapy significantly influence the probability of a complete resection in children with high-risk NB. The presence of IDRFs was not associated with significant differences in OS or EFS in this cohort.

Impact of glucagon-like peptide-1 receptor agonists on diabetic retinopathy: A meta-analysis of clinical studies emphasising retinal changes as a primary outcome.

To determine if glucagon-like peptide-1 receptor agonists (GLP-1RA) are associated with the development and progression of diabetic retinopathy (DR). A systematic search was conducted on PubMed, Cochrane Library, and Embase from inception to February 2024 to identify clinical studies reporting the development of and changes in DR as the primary outcome in patients with type 2 diabetes taking GLP-1RA, insulin, or oral antidiabetic medication (OAD). Two researchers independently completed the search and referred to a third as necessary. Data for meta-analysis was pooled using a random-effects model. Analysis of seven studies representing 242 537 patients showed a significantly decreased risk of incidence of DR between GLP-1RA and insulin use (RR = 0.66, 95% CI (0.48, 0.91), p = 0.01). There was no difference in the risk of DR complications (e.g., vitreous haemorrhage, retinal detachment, or requiring treatment with intravitreal injections, lasers, vitrectomy). Between GLP-1RA and OAD use, there was no difference in the risk of incidence of DR, while there was a significantly increased risk of DR complications (RR = 1.39, 95% CI (1.07, 1.80), p = 0.01). Our findings indicate no elevated risk of incidence of DR linked to GLP-1RA compared to insulin. In fact, GLP-1RA may offer potential advantages over insulin regarding the overall incidence of DR. The increased risk of DR requiring treatment and associated complications in the GLP-1RA group compared to OAD may be due to the transient progression of DR associated with a rapid decrease in HbA1c - a phenomenon not specific to GLP-1RA and warrants further investigation.

Cost-effectiveness of bioimpedance-guided fluid management in patients undergoing haemodialysis: the BISTRO RCT.

The BioImpedance Spectroscopy to maintain Renal Output randomised controlled trial investigated the effect of bioimpedance spectroscopy added to a standardised fluid management protocol on the risk of anuria and preservation of residual kidney function (primary trial outcomes) in incident haemodialysis patients. Despite the economic burden of kidney disease, the cost-effectiveness of using bioimpedance measurements to guide fluid management in haemodialysis is not known. To assess the cost-effectiveness of bioimpedance-guided fluid management against current fluid management without bioimpedance. Within-trial economic evaluation (cost-utility analysis) carried out alongside the open-label, multicentre BioImpedance Spectroscopy to maintain Renal Output randomised controlled trial. Thirty-four United Kingdom outpatient haemodialysis centres, both main and satellite units, and their associated inpatient hospitals. Four hundred and thirty-nine adult haemodialysis patients with > 500 ml urine/day or residual glomerular filtration rate > 3 ml/minute/1.73 m2. The study intervention was the incorporation of bioimpedance technology-derived information about body composition into the clinical assessment of fluid status in patients with residual kidney function undergoing haemodialysis. Bioimpedance measurements were used in conjunction with usual clinical judgement to set a target weight that would avoid excessive fluid depletion at the end of a dialysis session. The primary outcome measure of the BioImpedance Spectroscopy to maintain Renal Output economic evaluation was incremental cost per additional quality-adjusted life-year gained over 24 months following randomisation. In the main (base-case) analysis, this was calculated from the perspective of the National Health Service and Personal Social Services. Sensitivity analyses explored the impact of different scenarios, sources of resource use data and value sets. The bioimpedance-guided fluid management group was associated with £382 lower average cost per patient (95% CI -£3319 to £2556) and 0.043 more quality-adjusted life-years (95% CI -0.019 to 0.105) compared with the current fluid management group, with neither values being statistically significant. The probability of bioimpedance-guided fluid management being cost-effective was 76% and 83% at commonly cited willingness-to-pay threshold of £20,000 and £30,000 per quality-adjusted life-year gained, respectively. The results remained robust to a series of sensitivity analyses. The missing data level was high for some resource use categories collected through case report forms, due to COVID-19 disruptions and a significant dropout rate in the informing BioImpedance Spectroscopy to maintain Renal Output trial. Compared with current fluid management, bioimpedance-guided fluid management produced a marginal reduction in costs and a small improvement in quality-adjusted life-years. Results from both the base-case and sensitivity analyses suggested that use of bioimpedance is likely to be cost-effective. Future work exploring the association between primary outcomes and longer-term survival would be useful. Should an important link be established, and relevant evidence becomes available, it would be informative to determine whether and how this might affect longer-term costs and benefits associated with bioimpedance-guided fluid management. This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number HTA 14/216/01 (NIHR136142).

Alteration of cardiac structure and function and its prognostic value in patients with Takayasu arteritis: a cardiac magnetic resonance study.

To investigate the prevalence and characteristics of late gadolinium enhancement (LGE) by cardiac magnetic resonance (CMR) and its prognostic value in patients with Takayasu arteritis (TA). Sixty TA patients with a CMR examination were retrospectively included. All TA patients were divided into with LGE-positive and LGE-negative groups. Bi-ventricular function and location, distribution, and pattern of left ventricular (LV) LGE were evaluated in both LGE-positive and LGE-negative groups. Primary outcome was defined as a composite of cardiovascular death, hospitalization for heart failure, coronary artery revascularization, and stroke. Univariate and multivariate Cox proportional hazard regression analyses were used to evaluate the association between variables and primary outcomes. Sixty consecutive TA patients were enrolled in this study. The mean age was 38.2 ± 13.8 years and 54 patients (54/60, 90.0%) were female. LGE-positive was observed in twenty-one (21/60, 35%) patients in the total patients with TA. LGE was predominantly distributed in the middle wall and subendocardial. The patchy and infarcted LGE patterns were the most common. Compared with the LGE-negative group, the LGE-positive group had reduced LV ejection fraction (P = 0.033), elevated LV end-diastolic volume index (P = 0.008), LV end-systolic volume index (P = 0.012), and LV mass (P = 0.008). During a median follow-up period of 1,892 days (interquartile range: 1,764-1,988 days), the primary outcomes occurred in thirteen patients. In the univariate analysis, LGE-positive (hazard ratio [HR] = 4.478, 95% confidence interval [CI]: 1.376-14.570; P = 0.013) were independently associated with the primary outcomes. However, LGE-positive did not retain its value as an independent predictor of primary outcomes in the multivariate analysis. Instead, LVMI (HR = 1.030, 95%CI: 1.013-1.048; P = 0.001) was the strongest independent predictor of primary outcomes in patients with TA. The Kaplan-Meier plot revealed that patients with LVMI ≥ 57.5 g/m2 have a worse prognosis. LGE-positive detected by CMR was observed in 35% of total TA patients with different distributions and patterns. LGE is associated with adverse LV remodeling and worsen cardiac function. However, LVMI rather than LGE can provide independent prognostic information in patients with TA.