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Background: The Fontan operation, a palliative procedure for single ventricle patients, has evolved to improve outcomes and reduce complications. While extracardiac conduit (ECC) is favored for its simplicity and potential hemodynamic benefits, concerns arise about conduit size adequacy over time. Undersized ECC conduits may cause hemodynamic inefficiencies and long-term complications, while oversizing can lead to flow disturbances, stagnation, and thrombosis, necessitating surgical revision or upsizing to optimize hemodynamics., Objectives: The study aimed to predict the impact of upsizing by developing a patient-specific workflow using cardiac magnetic resonance-based imaging and computational fluid dynamics to assess Fontan hemodynamic changes and determine the most optimal conduit size., Methods: We simulated upsizing in patient-specific models, computing reduction in power loss (PL), and analyzed pressure gradients, wall shear stress (WSS), and other local flow dynamic parameters such as vorticity and viscous dissipation that influence PL in a Fontan. Additionally, we quantified the impact of upsizing on hepatic flow distribution (HFD)., Results: Across the patient cohort, upsizing resulted in a PL reduction of 16 %-63 %, with the greatest reduction observed in patients with the smallest pre-existing conduit sizes (14 mm). The optimal conduit size for minimizing PL was highly patient-specific. For instance, a 20 mm conduit reduced PL by 63 % in one patient, while another patient showed 16 % reduction with upsizing. Pressure gradients decreased by 15 %-35 %, correlating with the reduction in PL, while WSS decreased consistently with upsizing. Vorticity and viscous dissipation exhibited more variability but followed the overall trend of reduced PL. HFD changes were modest with a maximum variation of 30 %., Conclusions: Our findings underscore the importance of individualized approaches in Fontan conduit upsizing. CFD-based quantitative evaluations of PL, pressure gradients, HFD, and WSS can guide optimal conduit sizing, improving long-term outcomes for patients., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:VG reports research funding from the AHA (19TPA34860013), the NHLBI/NIH (R01HL161507) and in-kind research support from NSF (high-performance computing resources from TACC). AS, EE, DH, PEH, and RR report research funding from the NHLBI/NIH (R01HL161507)., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Cardiac magnetic resonance (CMR) offers valuable hemodynamic insights post-Fontan, but is limited by the absence of normative single ventricle data. The Fontan Outcomes Registry using CMR Examinations (FORCE) is a large international Fontan-specific CMR registry. This study used FORCE registry data to evaluate expected CMR ventricular size/function and create Fontan-specific z-scores adjusting for ventricular morphology (VM) in healthier Fontan patients., Methods: "Healthier" Fontan patients were defined as patients free of adverse outcomes, who are New York Heart Association Class I, have mild or less valve disease, and <30% aortopulmonary collateral burden. General linear modeling was performed on 70% of the dataset to create z-scores for volumes and function. Models were tested using the remainder (30%) of the data. The z-scores were compared between children and adults. The z-scores were also compared between "healthier" Fontan and patients with adverse outcomes (death, listing for transplantation or multiorgan disease)., Results: The "healthier" Fontan population included 885 patients (15.0 ± 7.6 years) from 18 institutions with 1,156 CMR examinations. Patients with left ventricle morphology had lower volume, mass and higher ejection fraction (EF) compared to right or mixed (two-ventricles) morphology (p<0.001 for all pairwise comparisons). Gender, BSA and VM were used in z-scores. Of the "healthier" Fontan patients, 647 were children <18 years and 238 were adults. Adults had lower ascending aorta flow (2.9 ± 0.7 vs 3.3 ± 0.8L/min/m2, p<0.001) and ascending aorta flow z-scores (-0.16 ± 1.23 vs 0.05 ± 0.95, 0.02) compared to children. Additionally, there were 1595 patients with adverse outcomes who were older (16.1 ± 9.3 vs 15.0 ± 7.6, p<0.001) and less likely to have LV morphology (35 vs 47%, p<0.001). Patients with adverse outcomes had higher z-scores for ventricular volume and mass and lower z-scores for EF and ascending aorta flow compared to the "healthier" Fontan cohort., Conclusion: This is the first study to generate CMR z-scores post-Fontan. Importantly the z-scores were generated and tested in "healthier" Fontan patients and both pediatric and adult Fontan patients. These equations may improve CMR-based risk stratification after the Fontan operation., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Tarek Alsaied reports statistical analysis was provided by National Institutes of Health. Rahul Rathod reports a relationship with Additional Ventures LLC that includes: funding grants. Evan’s Heart Foundation also supported the FORCE registry If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Among patients with congenital heart disease, those with single ventricles have the highest risk of early mortality. Sudden cardiac death is an important cause of death in this population. Understanding the risk factors for sudden cardiac events (SCE) in Fontan patients could improve prediction and prevention., Objectives: The goal of this study was to determine the prevalence of SCE and risk factors for SCE in the Fontan population., Methods: The Fontan Outcomes Registry Using CMR Examinations (FORCE) is an international registry collecting clinical and imaging data on Fontan patients. SCE was defined as: 1) cardiac arrest from a shockable rhythm; 2) need for emergent cardioversion/defibrillation; or 3) documented sustained ventricular tachycardia. Univariate and multivariate Cox proportional hazards regression models estimated hazard ratios for predictors of SCE., Results: Our sample included 3,132 patients (41% female). The median age at first cardiac magnetic resonance was 14.6 years. SCE was experienced by 3.5% (n = 109) over a median follow-up time of 4.00 years. Of the 109 patients with SCE, 39 (36%) died. On multivariable analysis, NYHA functional class >II (HR: 4.91; P < 0.0001), history of protein-losing enteropathy/plastic bronchitis (HR: 2.37; P = 0.0082), single-ventricle end-diastolic volume index >104 mL/m 2 (HR: 3.15; P < 0.0001), and ejection fraction <50% (HR: 1.73; P = 0.0437) were associated with SCE. Kaplan-Meier analysis demonstrated that in patients with none of the above risk factors, the 4-year freedom from SCE was 99.5%., Conclusions: SCE occurred in 3.5% of the study population, and one-third of patients who experienced SCE died. Mild ventricular dysfunction and dilatation by cardiac magnetic resonance, NYHA functional class, and history of protein-losing enteropathy/plastic bronchitis were associated with SCE., Competing Interests: Funding Support and Author Disclosures The FORCE registry is funded through a grant from Additional Ventures and Evan’s Heart. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Fontan patients exhibit decreased exercise capacity. However, there is a subset of high-performing Fontan (HPF) patients with excellent exercise capacity., Objectives: This study aims to: 1) create a Fontan-specific percent predicted peak VO 2 tool using exercise data; 2) examine clinical factors associated with HPF patients; and 3) examine late outcomes in HPF patients., Methods: Patients in the multi-institutional Fontan Outcomes Registry Using CMR Examination above the age of 8 years who had a maximal exercise test were included. An HPF patient was defined as a patient in the upper Fontan-specific percent predicted peak VO 2 quartile. Multivariable logistic regression was employed to investigate factors associated with the HPF and Cox regression was used to examine the association between HPF patients and late outcomes (composite of death or listing for cardiac transplant)., Results: The study included 813 patients (mean age: 20.2 ± 8.7 years). An HPF patient was associated with left ventricular morphology (OR: 1.50, P  = 0.04), mixed morphology (OR: 2.23, P  < 0.001), and a higher ejection fraction (OR: 1.31 for 10% increase, P  = 0.01). Patients with at least moderate atrioventricular valve regurgitation, protein-losing enteropathy, or who were using psychiatric medications, were less likely to be an HPF patient. After a mean follow-up of 3.7 years, 46 (5.7%) patients developed a composite endpoint. HPF had a lower risk of death or listing for cardiac transplant (HR: 0.06 [95% CI: 0.01-0.25])., Conclusions: Patients with HPF have more favorable outcomes when compared to patients with lower exercise capacity. This large registry data highlights the role of exercise testing in providing personalized care and surveillance post-Fontan., Competing Interests: The FORCE registry is funded through a grant from 10.13039/100020415Additional Ventures and Evan’s Heart. The project described was supported by the 10.13039/100000002National Institutes of Health through Grant Number UL1 TR001857, KL2 TR001856, and/or TL1 TR001858. Dr Rathod received research grant support from Mezzion Pharmaceuticals as the Global PI for the FUEL-2 trial which is a drug RCT in Fontan patients. Dr Alsaied is a center PI for the same trial and also receives similar grant support. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Outpatient cardiologists provide longitudinal care for Fontan patients. As these patients age, they face mounting morbidities, necessitating challenging conversations about prognosis and goals of care. We created a novel survey to evaluate cardiologists' attitudes surrounding risk counseling for patients/caregivers. Cardiologists were recruited during concomitant outpatient enrollment of individuals with Fontan operation > age 10. Physician demographic data, expectations of timing in discussing adverse event risk, and perceived barriers were collected. Barriers were analyzed using a thematic approach. 40 cardiologists (9 institutions) responded regarding 155 patients (mean age 21.2 years, SD 7.7). Physicians were mostly male (58%) with mean practice of 21 years post-fellowship (SD 12). Most felt the time was right to have a conversation with patient (55%) and family (62%), and majority thought patient (53%) and family (75%) were ready for such a conversation. Most had previously discussed prognosis with patient (72%) and family (75%). Providers were inclined to discuss risk with caregivers earlier (mean patient age 9 years, SD 11) than patients (mean patient age 17 years, SD 6.4). Nevertheless, 42% of physicians perceived significant barriers and provided 58 narrative comments categorized into 4 major themes: (1) Patient-related (53.4%), including cognitive limitations and mental health; (2) Provider-related (16.4%), including lack of familiarity, preservation of happiness, and discomfort; (3) Family related (12.3%), including protection/denial and psychosocial stressors; (4) Other (26%), including social barriers. Experienced cardiologists are willing to have difficult conversations; nearly half reported largely patient-related barriers. Facilitating these conversations is critical for the adolescent/young adult with Fontan physiology., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Competing Interests: Declaration of competing interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Dr. Rathod receives research grant support from Mezzion Pharmaceuticals.

Background: Individuals with a Fontan circulation encompass a heterogeneous group with adverse outcomes linked to ventricular dilation, dysfunction, and dyssynchrony. The purpose of this study was to assess if unsupervised machine learning cluster analysis of cardiovascular magnetic resonance (CMR)-derived dyssynchrony metrics can separate ventricles in the Fontan circulation from normal control left ventricles and identify prognostically distinct subgroups within the Fontan cohort., Methods: This single-center, retrospective study used 503 CMR studies from Fontan patients (median age 15 y) and 42 from age-matched controls from January 2005 to May 2011. Feature tracking on short-axis cine stacks assessed radial and circumferential strain, strain rate, and displacement. Unsupervised K-means clustering was applied to 24 mechanical dyssynchrony metrics derived from these deformation measurements. Clusters were compared for demographic, anatomical, and composite outcomes of death, or heart transplantation., Results: Four distinct phenotypic clusters were identified. Over a median follow-up of 4.2 y (interquartile ranges 1.7-8.8 y), 58 (11.5%) patients met the composite outcome. The highest-risk cluster (largely comprised of right or mixed ventricular morphology and dilated, dyssynchronous ventricles) exhibited a higher hazard for the composite outcome compared to the lowest-risk cluster while controlling for ventricular morphology (hazard ratio [HR] 6.4; 95% confidence interval [CI] 2.1-19.3; P value 0.001) and higher indexed end-diastolic volume (HR 3.2; 95% CI 1.04-10.0; P value 0.043) per 10 mL/m 2 ., Conclusion: Unsupervised machine learning using CMR-derived dyssynchrony metrics identified four distinct clusters of patients with Fontan circulation and healthy controls with varying clinical characteristics and risk profiles. This technique can be used to guide future studies and identify more homogeneous subsets of patients from an overall heterogeneous population., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Inc.)

Background: Multiple clinical studies have described the benefits of probiotic Saccharomyces boulardii (S. boulardii) CNCM I-745 against diarrhoea, but the real-world evidence supporting its use is lacking., Objective: To evaluate effectiveness of the S. boulardii CNCM I-745 group in a real-world setting., Methods: This was an electronic medical record (EMR)-based, retrospective, multicentre, comparative study in Indian adult patients presenting with diarrhoea managed between January 2020 and January 2022. Data of patients at the baseline visit, with a follow-up visit within 15 days, and who were administered S. boulardii CNCM I-745 (for the test group) or any other treatment modality excluding probiotics (for the control group) were considered. Effectiveness was evaluated on the basis of number of patients who did not complain of diarrhoea at follow-up., Results: Of 30,385 adult patients with diarrhoea, 270 patients prescribed S. boulardii CNCM I-745 were included, while the control group comprised 1457 patients. The baseline median age of the test group was 47 years (range 19-86 years), while it was 44 years (range 19-100 years) for the control group. The majority of patients in both study groups were females (56.7% in the test and 51.5% in the control group). Median duration between visits was 5 days (range 1-15 days) in both study groups. In all, 77.8% patients (95% CI 72.34-82.59) in the test group did not complain of diarrhoea at follow-up, while the proportion was 15.8% (95% CI 13.95-17.76) in the control group (p < 0.05). Odds ratio (OR) for absence of diarrhoea in the S. boulardii CNCM I-745 group versus the control group was 18.7 (95% CI 13.6-25.7, p < 0.05). For subgroups on concomitant antibiotics, a significant advantage was noted again for the test versus the control group (76.8% versus 18.4%; p < 0.05; OR: 14.7 with 95% CI 8.8-24.4; p < 0.05)., Conclusion: The effect of S. boulardii CNCM I-745 probiotic in controlling diarrhoea was better than anti-diarrhoeal and/or oral rehydration therapy in real-world clinical practice. The effect was similar even with concomitant antibiotic usage., (© 2024. The Author(s).)

Cardiovascular magnetic resonance (CMR) has become the reference standard for quantitative and qualitative assessment of ventricular function, blood flow, and myocardial tissue characterization. There is a preponderance of large CMR studies and registries in adults; However, similarly powered studies are lacking for the pediatric and congenital heart disease (PCHD) population. To date, most CMR studies in children are limited to small single or multicenter studies, thereby limiting the conclusions that can be drawn. Within the PCHD CMR community, a collaborative effort has been successfully employed to recognize knowledge gaps with the aim to embolden the development and initiation of high-quality, large-scale multicenter research. In this publication, we highlight the underlying challenges and provide a practical guide toward the development of larger, multicenter initiatives focusing on PCHD populations, which can serve as a model for future multicenter efforts., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Michael DiLorenzo reports a relationship with GE Healthcare that includes: funding grants. Mark Fogel reports a relationship with Rocket Pharmaceuticals Inc that includes: consulting or advisory. Mark Fogel reports a relationship with CMP Pharma that includes: funding grants. Andrew Powell reports a relationship with Siemens Medical Solutions USA Inc that includes: consulting or advisory. Shaine Morris reports a relationship with Aytu BioPharma Inc that includes: non-financial support. Kanwal Farooqi reports a relationship with Bristol-Myers Squibb Foundation that includes: funding grants. Jonathan Soslow reports a relationship with Pfizer Inc that includes: consulting or advisory. Jonathan Soslow reports a relationship with Sarepta Therapeutics Inc that includes: consulting or advisory. Jonathan Soslow reports a relationship with Immunoforge that includes: consulting or advisory. Heynric Grotenhuis serves as an associate editor for JCMR. Mark Fogel and Andrew Powell serve as members of the editorial board for JCMR. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Congenital heart disease (CHD) comprises a range of structural anomalies, each with a unique natural history, evolving treatment strategies, and distinct long-term consequences. Current prediction models are challenged by generalizability, limited validation, and questionable application to extended follow-up periods. In this JACC Scientific Statement, we tackle the difficulty of risk measurement across the lifespan. We appraise current and future risk measurement frameworks and describe domains of risk specific to CHD. Risk of adverse outcomes varies with age, sex, genetics, era, socioeconomic status, behavior, and comorbidities as they evolve through the lifespan and across care settings. Emerging technologies and approaches promise to improve risk assessment, but there is also need for large, longitudinal, representative, prospective CHD cohorts with multidimensional data and consensus-driven methodologies to provide insight into time-varying risk. Communication of risk, particularly with patients and their families, poses a separate and equally important challenge, and best practices are reviewed., Competing Interests: Funding Support and Author Disclosures Dr Opotowsky is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number R01HL151604. Dr Marelli is supported by a Canadian Institutes of Health Research Foundation grant (no. 148462). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Protein-energy wasting (PEW) affects about 50-75% of patients with chronic kidney disease (CKD), particularly those who are on maintenance hemodialysis (MHD). This study evaluated the efficacy and tolerability of an oral nutritional supplement in Indian patients receiving MHD., Materials and Methods: This was a 3-month, prospective, open-label, and single-centered study. Eligible participants supplemented their regular diet with one sachet (40 gm) of oral nutritional supplement powder twice daily for 90 days. The study efficacy endpoints were mean change in acute phase proteins (albumin and prealbumin), anthropometric measurements [weight, body mass index (BMI), and triceps skin fold thickness], handgrip strength, hemoglobin, total iron binding capacity (TIBC), potassium, and phosphorus levels, malnutrition score (MS)-modified subjective global assessment (modified SGA), malnutrition inflammation score (MIS), and nutritional status., Results: The study population comprised 36 (42.9%) men and 48 (57.1%) women with a mean age of 54.85 ± 15.50 years. A paired sample t -test was used to compare the baseline with end-of-study values for continuous variables. Serum albumin, prealbumin, hemoglobin, and phosphorus levels remained stable throughout the study period. The mean change in weight, BMI, triceps skin fold thickness, handgrip strength, and TIBC for the overall study population was 1.11 kg (1.82%, p < 0.0001), 0.46 kg/m 2 (1.98%, p < 0.0001), 3.47 mm (30.78%, p < 0.0001), 6.05 kg (44.98%, p < 0.0001) and 11.80 µg/dL (6.06%, p < 0.0001), respectively. At the end of the study period, there was a significant ( p < 0.0001) improvement in the SGA and MIS scores. Further, there was a significant improvement in nutritional status as demonstrated by the overall intake of calories ( p < 0.001), proteins ( p < 0.0001), carbohydrates ( p = 0.003, and fats ( p < 0.0001)., Conclusion: Protein-energy malnutrition is a strong predictor of morbidity, mortality, and poor outcomes in CKD patients. A scientifically designed formula in accordance with KDOQI standards was able to improve the nutritional status, overall body composition, sarcopenia, and quality of life in CKD patients on MHD., (© Journal of the Association of Physicians of India 2024.)

Background: The Fontan operation is a palliative technique for patients born with single ventricle heart disease. The superior vena cava (SVC), inferior vena cava (IVC), and hepatic veins are connected to the pulmonary arteries in a total cavopulmonary connection by an extracardiac conduit or a lateral tunnel connection. A balanced hepatic flow distribution (HFD) to both lungs is essential to prevent pulmonary arteriovenous malformations and cyanosis. HFD is highly dependent on the local hemodynamics. The effect of age-related changes in caval inflows on HFD was evaluated using cardiac magnetic resonance data and patient-specific computational fluid dynamics modeling., Methods: SVC and IVC flow from 414 patients with Fontan were collected to establish a relationship between SVC:IVC flow ratio and age. Computational fluid dynamics modeling was performed in 60 (30 extracardiac and 30 lateral tunnel) patient models to quantify the HFD that corresponded to patient ages of 3, 8, and 15 years, respectively., Results: SVC:IVC flow ratio inverted at ≈8 years of age, indicating a clear shift to lower body flow predominance. Our data showed that variation of HFD in response to age-related changes in caval inflows (SVC:IVC, 2, 1, and 0.5 corresponded to ages, 3, 8, and 15+, respectively) was not significant for extracardiac but statistically significant for lateral tunnel cohorts. For all 3 caval inflow ratios, a positive correlation existed between the IVC flow distribution to both the lungs and the HFD. However, as the SVC:IVC ratio changed from 2 to 0.5 (age, 3-15+) years, the correlation's strength decreased from 0.87 to 0.64, due to potential flow perturbation as IVC flow momentum increased., Conclusions: Our analysis provided quantitative insights into the impact of the changing caval inflows on Fontan's long-term HFD, highlighting the importance of SVC:IVC variations over time on Fontan's long-term hemodynamics. These findings broaden our understanding of Fontan hemodynamics and patient outcomes., Competing Interests: Disclosures Dr Govindarajan reports research funding from the American Heart Association (19TPA34860013), the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH; R01HL161507) and in-kind research support from National Science Foundation (high-performance computing resources from Texas Advanced Computing Center). A. Sahni, E. Eickhoff, and Drs Hoganson, Hammer, and Rathod report research funding from the NHLBI/NIH (R01HL161507). In addition, Dr Govindarajan reports collaborative research funding from Polyvascular Corp, Houston, TX.

Background Dental pain among adults is a prevalent concern impacting oral health and quality of life. Dental pain management presents a significant challenge for dental practitioners in effectively alleviating patient discomfort. Among the medications available, non-steroidal anti-inflammatory drugs (NSAIDs) are considered the most effective analgesics in dental care. While numerous studies have been conducted to assess the role of antibiotics in dental practice, there is a scarcity of studies specifically examining the prescription patterns of analgesics. The primary aim of this study was to evaluate the knowledge, attitudes, and practices of dental practitioners (DPs) in India concerning the management of adult dental pain. Method This survey utilized a computer-aided questionnaire-based approach. A total of 110 dentists, including 16 from metropolitan areas and 84 from non-metropolitan cities practicing at dental healthcare setups, clinics, and hospitals, were interviewed as part of the survey. The participants comprised dental professionals specializing in prosthodontics, endodontics, orthodontics, periodontics, oral surgery, pedodontics, and oral medicine. The study was conducted between September 2022 and January 2023. Results The primary reason patients seek dental consultation, as reported by 95% of dentists, is tooth cavities, followed by tooth sensitivity, post-root canal treatment, and pulpitis. All surveyed dentists prescribed NSAIDs to their patients for managing dental pain. Local anesthesia (LA) was the second choice for 75% of dentists, prescribed to 23% of their patients. The primary use of NSAIDs was for patients experiencing severe pain and to manage post-procedure pain. Eighty percent of DPs recognized ketorolac as a fast-acting molecule, providing immediate relief within 10-15 minutes. Overall, analysis indicated that 98% of DPs are satisfied and 67% are extremely satisfied with ketorolac among monotherapies for dental pain management due to its quick onset of action, fast pain relief, and usefulness in post-surgical pain management. Conclusion NSAIDs like ketorolac, diclofenac, and aceclofenac were the preferred prescriptions for overall dental pain management. Dental practitioners associated ketorolac with fast pain relief, quick onset of action, and effectiveness in post-surgical pain management, emphasizing its lasting effects. The insights from the study contribute to enhancing dental pain management strategies., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Shukla et al.)

Background: Coexisting hypertension, type 2 diabetes mellitus (T2DM), and dyslipidemia (triple disease) can lead to greater risk of cardiovascular morbidity and mortality. The present study sought to comprehend the prevalence, demographic traits, clinical traits, and treatment patterns in Indian patients with these coexisting conditions., Methods: An electronic medical record (EMR)-based, retrospective, multicenter, cross-sectional study was conducted, and data were collected for patients who were diagnosed with coexistent hypertension, T2DM, and dyslipidemia. Baseline patient variables evaluated were the percentage of patients with triple comorbidity, demographic characteristics, diagnostic laboratory parameters, and treatment pattern details., Results: Data from 4793 centers (clinics) were included, with a total of 6,722,173 patients. Of these, 427,835 (6.36%) patients were found to have coexistent hypertension, T2DM, and dyslipidemia. Most of the patients belonged to the 40-64 year age group (62.10%) and were males (57.00%), while 27.40% patients had a body mass index (BMI) within normal limits, 43.30% patients were pre-obese, and 20.90% patients were class 1 obese. Further, 3402 patients (0.80%) had a recorded history of smoking. Mean glycated hemoglobin (HbA1c) for the patients included in the study was 8.35 ± 1.96 g%. Mean systolic blood pressure (SBP) was 138.81 ± 19.59 mm Hg, while mean diastolic blood pressure (DBP) was 82.17 ± 10.35 mm Hg; 27.60% cases had SBP < 130 mm Hg, while 28.37% cases had DBP < 80 mm Hg. The mean low-density lipoprotein (LDL), total cholesterol, and high-density lipoprotein (HDL) in mg/dl were 98.38 ± 40.39, 174.75 ± 46.73, and 44.5 ± 10.05, respectively. Of the enrolled cases, 55.64% had serum LDL below 100 mg/dl, 72.03% cases had serum cholesterol below 200 mg/dl, and 44.15% males and 71.77% females had serum HDL below the normal prescribed range. The most common monotherapy used for managing hypertension was angiotensin receptor blockers (ARB) (24.80%), followed by beta-blockers (24.30%). The most common combinations administered for management of hypertension were antihypertensives with diuretics (14.30%), followed by ARB plus calcium channel blockers (CCB) (13.30%). For dyslipidemia, the majority of patients (56.60%) received lipid-lowering medication in combination with drugs for other comorbidities. The most common antidiabetic agents prescribed were biguanides (74.60%)., Conclusions: Coexistence of triple disease is not uncommon in the Indian population, with middle-aged patients diagnosed as pre-obese and obese being affected more commonly and receiving treatment for the same. The present study highlights that, though there are medications against the three chronic conditions, the rate of uncontrolled cases of hypertension, T2DM, and dyslipidemia remains high. Coexistence of triple disease increases the risk of cardiovascular and renal complications, which need to be closely monitored and effectively treated., (© 2023. The Author(s).)

Background: Real-world Indian studies evaluating effectiveness of dapagliflozin as an add-on to other oral antidiabetic drugs (OAD) in patients with type 2 diabetes mellitus (DM) are scarce., Methods: An electronic medical record (EMR)-based, retrospective, multicentre study was conducted to evaluate the effectiveness of dapagliflozin as add-on therapy in adult patients with inadequately controlled DM on metformin with or without other OAD. Baseline characteristics (visit 1: metformin or metformin plus OAD treatment for at least 30 days) and treatment-related outcomes (visit 2: follow-up) considered between 60 and 140 days after adding/switching dapagliflozin [glycated haemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were analysed., Results: A total of 3616 patients were screened from 478 centres. Most patients had received dapagliflozin (D) + metformin (M) + at least one other OAD [D + M + OAD, n = 2907 (80.4%), 408 followed-up with HbA1c reported], while 709 patients (19.6%, 138 followed-up with HbA1c reported) received dapagliflozin + metformin (D + M). Treatment with dapagliflozin as an add-on therapy resulted in significant change in HbA1c (-1.1 ± 1.44%; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.6 ± 1.41%; p < 0.05 for HbA1c subgroup ≥ 8%) at visit 2 compared with visit 1. Significant change in body weight (-1.4 ± 3.31 kg; p < 0.05 for HbA1c subgroup ≥ 7.5%; - 1.5 ± 3.22 kg; p < 0.05 for HbA1c subgroup ≥ 8%) was observed at visit 2. Similarly, a significant change in BMI was noted for the HbA1c subgroup ≥ 7.5% (-1.0 ± 8.38 kg/m 2 ). However, the change in BMI in the HbA1c subgroup ≥ 8% was noted to be -1.4 ± 10.4 kg/m 2 , which was not statistically significant (p = 0.08). In the overall study population, significant change in the SBP (-4.5 ± 14.9 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -4.5 ± 15.1 mmHg; p < 0.0001 for HbA1c subgroup ≥ 8%) was observed at visit 2 compared with visit 1. On identical lines, significant change in DBP (-1.5 ± 8.94 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.4 ± 8.91 mmHg; p < 0.05 for HbA1c subgroup ≥ 8%) was noted., Conclusions: Dapagliflozin showed significant improvement in glycemic parameter, BMI and BP when added to metformin, with or without other OADs in a real-world scenario., (© 2023. The Author(s).)

Purpose To develop an end-to-end deep learning (DL) pipeline for automated ventricular segmentation of cardiac MRI data from a multicenter registry of patients with Fontan circulation (Fontan Outcomes Registry Using CMR Examinations [FORCE]). Materials and Methods This retrospective study used 250 cardiac MRI examinations (November 2007-December 2022) from 13 institutions for training, validation, and testing. The pipeline contained three DL models: a classifier to identify short-axis cine stacks and two U-Net 3+ models for image cropping and segmentation. The automated segmentations were evaluated on the test set ( n = 50) by using the Dice score. Volumetric and functional metrics derived from DL and ground truth manual segmentations were compared using Bland-Altman and intraclass correlation analysis. The pipeline was further qualitatively evaluated on 475 unseen examinations. Results There were acceptable limits of agreement (LOA) and minimal biases between the ground truth and DL end-diastolic volume (EDV) (bias: -0.6 mL/m 2 , LOA: -20.6 to 19.5 mL/m 2 ) and end-systolic volume (ESV) (bias: -1.1 mL/m 2 , LOA: -18.1 to 15.9 mL/m 2 ), with high intraclass correlation coefficients (ICCs > 0.97) and Dice scores (EDV, 0.91 and ESV, 0.86). There was moderate agreement for ventricular mass (bias: -1.9 g/m 2 , LOA: -17.3 to 13.5 g/m 2 ) and an ICC of 0.94. There was also acceptable agreement for stroke volume (bias: 0.6 mL/m 2 , LOA: -17.2 to 18.3 mL/m 2 ) and ejection fraction (bias: 0.6%, LOA: -12.2% to 13.4%), with high ICCs (>0.81). The pipeline achieved satisfactory segmentation in 68% of the 475 unseen examinations, while 26% needed minor adjustments, 5% needed major adjustments, and in 0.4%, the cropping model failed. Conclusion The DL pipeline can provide fast standardized segmentation for patients with single ventricle physiology across multiple centers. This pipeline can be applied to all cardiac MRI examinations in the FORCE registry. Keywords: Cardiac, Adults and Pediatrics, MR Imaging, Congenital, Volume Analysis, Segmentation, Quantification Supplemental material is available for this article. © RSNA, 2023.

The Pediatric Heart Network's Fontan Udenafil Exercise Longitudinal (FUEL) Trial (Mezzion Pharma Co. Ltd., NCT02741115) demonstrated improvements in some measures of exercise capacity and in the myocardial performance index following 6 months of treatment with udenafil (87.5 mg twice daily). In this post hoc analysis, we evaluate whether subgroups within the population experienced a differential effect on exercise performance in response to treatment. The effect of udenafil on exercise was evaluated within subgroups defined by baseline characteristics, including peak oxygen consumption (VO 2 ), serum brain-type natriuretic peptide level, weight, race, gender, and ventricular morphology. Differences among subgroups were evaluated using ANCOVA modeling with fixed factors for treatment arm and subgroup and the interaction between treatment arm and subgroup. Within-subgroup analyses demonstrated trends toward quantitative improvements in peak VO 2 , work rate at the ventilatory anaerobic threshold (VAT), VO 2 at VAT, and ventilatory efficiency (VE/VCO 2 ) for those randomized to udenafil compared to placebo in nearly all subgroups. There was no identified differential response to udenafil based on baseline peak VO 2 , baseline BNP level, weight, race and ethnicity, gender, or ventricular morphology, although participants in the lowest tertile of baseline peak VO 2 trended toward larger improvements. The absence of a differential response across subgroups in response to treatment with udenafil suggests that the treatment benefit may not be restricted to specific sub-populations. Further work is warranted to confirm the potential benefit of udenafil and to evaluate the long-term tolerability and safety of treatment and to determine the impact of udenafil on the development of other morbidities related to the Fontan circulation.Trial Registration NCT0274115., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: It is unknown how well cardiologists predict which Fontan patients are at risk for major adverse events (MAEs)., Objectives: The purpose of this study was to examine the accuracy of cardiologists' ability to identify the "good Fontan" patient, free from MAE within the following year, and compare that predicted risk cohort to patients who experienced MAE., Methods: This prospective, multicenter study included patients ≥10 years with lateral tunnel or extracardiac Fontan. The cardiologist was asked the yes/no "surprise" question: would you be surprised if your patient has a MAE in the next year? After 12 months, the cardiologist was surveyed to assess MAE. Agreement between cardiologist predictions of MAE and observed MAE was determined using the simple kappa coefficient. Multivariable generalized linear mixed effects models were performed to identify factors associated with MAE., Results: Overall, 146 patients were enrolled, and 99/146 (68%) patients w`ere predicted to be a "good Fontan." After 12 months, 17 (12%) experienced a MAE. The simple kappa coefficient of cardiologists' prediction was 0.17 (95% CI: 0.02-0.32), suggesting prediction of MAE was 17% better than random chance. In the multivariable cardiologist-predicted MAE (N = 47) model, diuretic/beta-blocker use ( P  ≤ 0.001) and systolic dysfunction ( P  = 0.005) were associated with MAE. In the observed multivariable MAE (N = 17) model, prior unplanned cardiac admission ( P  = 0.006), diuretic/beta-blocker use ( P  = 0.028), and ≥moderate atrioventricular valve regurgitation ( P  = 0.049) were associated with MAE., Conclusions: Cardiologists are marginally able to predict which Fontan patients are at risk for MAE over a year. There was overlap between factors associated with a cardiologist's prediction of risk and observed MAE, namely the use of diuretic/beta-blocker., Competing Interests: This project was supported by a grant from the New England Congenital Cardiology Research Foundation, Boston, Massachusetts, USA. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Background: Ventricular dyssynchrony and its relationship to clinical outcomes is not well characterized in patients following Fontan palliation., Methods: Single-center retrospective analysis of cardiac magnetic resonance (CMR) imaging of patients with a Fontan circulation and an age-matched healthy comparison cohort as controls. Feature tracking was performed on all slices of a ventricular short-axis cine stack. Circumferential and radial strain, strain rate, and displacement were measured; and multiple dyssynchrony metrics were calculated based on timing of these measurements (including standard deviation of time-to-peak, maximum opposing wall delay, and maximum base-to-apex delay). Primary endpoint was a composite measure including time to death, heart transplant or heart transplant listing (D/HTx)., Results: A total of 503 cases (15 y; IQR 10, 21) and 42 controls (16 y; IQR 11, 20) were analyzed. Compared to controls, Fontan patients had increased dyssynchrony metrics, longer QRS duration, larger ventricular volumes, and worse systolic function. Dyssynchrony metrics were higher in patients with right ventricular (RV) or mixed morphology compared to those with LV morphology. At median follow-up of 4.3 years, 11% had D/HTx. Multiple risk factors for D/HTx were identified, including RV morphology, ventricular dilation, dysfunction, QRS prolongation, and dyssynchrony. Ventricular dilation and RV morphology were independently associated with D/HTx., Conclusions: Compared to control LVs, single right and mixed morphology ventricles in the Fontan circulation exhibit a higher degree of mechanical dyssynchrony as evaluated by CMR-FT. Dyssynchrony indices correlate with ventricular size and function and are associated with death or need for heart transplantation. These data add to the growing understanding regarding factors that can be used to risk-stratify patients with the Fontan circulation., (© 2023. The Author(s).)

Purpose : To evaluate the effectiveness of rabeprazole and other proton pump inhibitors (PPIs) in providing symptomatic relief in patients with varying severity of gastroesophageal reflux disease (GERD). Methods : In this multicenter retrospective study, electronic medical records (EMRs) of GERD patients prescribed with PPIs at two Indian clinics/hospitals were reviewed (2016-2020). Rabeprazole's effectiveness was assessed at different follow-up visits and compared with other PPIs. Results : Overall, 269 patients (moderate and severe GERD: 84.39%) were included in three groups, viz rabeprazole, pantoprazole, and esomeprazole groups. A significant proportion of patients experienced quick and complete symptomatic relief at visit 1 with rabeprazole compared to the baseline visit, which gradually increased till visit 4 for both daytime [ viz heartburn (38.78-93.88%; p < 0.001)] and nocturnal symptoms [ viz sleep disturbances (62.92-97.75%; p < 0.001)]. Rabeprazole provided quick relief at visit 1 when compared with pantoprazole for daytime heartburn (38.78 vs 5.56%; p = 0.01), daytime epigastric pain (66.04 vs 12.12%; p = 0.049), and nocturnal water brash (60.71 vs 16.13%; p = 0.015), and when compared with esomeprazole for nocturnal nausea (82.61 vs 20.00%; p = 0.013). Further, the proportion of patients exhibiting complete treatment response was relatively higher in the rabeprazole group (83.33%) than in the pantoprazole (62.07%) and esomeprazole (65.67%) groups at visit 4. Conclusion : Rabeprazole was effective in providing quick and sustained relief for both daytime and nocturnal GERD symptoms in patients with moderate and severe GERD. Rabeprazole also demonstrated greater effectiveness when compared with pantoprazole and esomeprazole in reducing the severity of multiple GERD symptoms. How to cite this article : Lawate P, Jilawar N, Vyas K, et al. Effectiveness of Rabeprazole and Other Proton Pump Inhibitors in Managing GERD with Varying Severity: A Retrospective, Real-world EMR-based Study (POWER GERD Study). J Assoc Physicians India 2023;71(10):37-44., (© Journal of the Association of Physicians of India 2023.)

The Single Ventricle Reconstruction (SVR) Trial was a randomized prospective trial designed to determine survival advantage of the modified Blalock-Taussig-Thomas shunt (BTTS) vs the right ventricle to pulmonary artery conduit (RVPAS) for patients with hypoplastic left heart syndrome. The primary aim of the long-term follow-up (SVRIII) was to determine the impact of shunt type on RV function. In this work, we describe the use of CMR in a large cohort follow up from the SVR Trial as a focused study of single ventricle function. The SVRIII protocol included short axis steady-state free precession imaging to assess single ventricle systolic function and flow quantification. There were 313 eligible SVRIII participants and 237 enrolled, ages ranging from 10 to 12.5 years. 177/237 (75%) participants underwent CMR. The most common reasons for not undergoing CMR exam were requirement for anesthesia (n = 14) or ICD/pacemaker (n = 11). A total of 168/177 (94%) CMR studies were diagnostic for RVEF. Median exam time was 54 [IQR 40-74] minutes, cine function exam time 20 [IQR 14-27] minutes, and flow quantification time 18 [IQR 12-25] minutes. There were 69/177 (39%) studies noted to have intra-thoracic artifacts, most common being susceptibility artifact from intra-thoracic metal. Not all artifacts resulted in non-diagnostic exams. These data describe the use and limitations of CMR for the assessment of cardiac function in a prospective trial setting in a grade-school-aged pediatric population with congenital heart disease. Many of the limitations are expected to decrease with the continued advancement of CMR technology., (© 2023. The Author(s).)

Probiotics, both bacterial and yeast, have long been associated with a beneficial health history and human well-being. Among yeasts, Saccharomyces is a genus that is efficacious in rendering better human health, with Saccharomyces boulardii ( S. boulardii ) CNCM I-745 being classified as a probiotic agent. The present review highlights the unique properties of S. boulardii and its rolein the prevention of antibiotic-associated diarrhea (AAD) and pediatric acute gastroenteritis (PAGE) in comparison to bacterial probiotics. Its unique properties,such as viability over a wide pH range, inability to acquire antibiotic resistance genes, and property to achieve a steady state rapidly, have given S. boulardii an edge over bacterial probiotics. In AAD patients, prophylactic use of S. boulardii has shown a significantly lower risk of AAD (in comparison to controls) and restored the diversity of gut microbiota. Among Indian children with PAGE, S. boulardii CNCM I-745 was found superior to Lactobacillus rhamnosus GG and four strains of Bacillus clausii in shortening the duration of diarrhea and reducing the length of hospital stay. S. boulardii CNCM I-745 being considered a safe probiotic for use in children and adults also finds recommendations in several international guidelines for the management of acute diarrhea. The current review discusses evidence for the proven efficacy and safety of S. boulardii CNCM I-745 as a probiotic for preventing gastrointestinal disorders., Competing Interests: The authors have declared financial relationships, which are detailed in the next section., (Copyright © 2023, Gopalan et al.)

Introduction Skin hydration is important for maintaining adequate skin barrier function. After delivery, the baby's skin faces the most difficult challenge as they are exposed to the exterior world's environmental changes, friction, and microorganisms. The management is further complicated by the availability of a large range of infant skin-care products with varying claims. The first-ever Indian study on babies was done to analyze the test product (Venusia baby moisturizer; Dr. Reddy's Laboratories Ltd., Hyderabad, India) in order to bring scientific clarity to consumers. This product is devoid of parabens, alcohol, and animal origin (Dr. Reddy's Laboratories Ltd., Hyderabad, India) and is designed for skin hydration and in-use tolerance in babies with dry and/or normal skin. The endpoints were hydration and clinical evaluation of the skin, evaluated using a moisture meter scale (MMSC; Delfin Technologies Ltd., Kuopio, Finland) and parent self-assessment questionnaire, respectively. Material and methods A total of 136 healthy babies aged between six months to two years were enrolled in a four-group, monocentric, non-randomized, evaluator-blinded study: Group 1 (Venusia baby cream for dry skin), Group 2 (Venusia baby lotion for Dry Skin), Group 3 (Venusia baby cream for normal skin), and Group 4 (Venusia baby lotion for normal skin). The endpoints were hydration and clinical evaluation of the skin, evaluated using an MMSC and parent self-assessment questionnaire, respectively. Results In babies with dry skin, skin hydration was improved with Venusia baby cream (37.50%) and Venusia baby lotion (66.40%). Additionally, 66.66% of participants strongly agreed that the baby's skin became softer and smoother after the application of Venusia baby cream; 76.47% of participants strongly agreed that the baby's skin became softer and smoother after the application of Venusia baby lotion. In babies with normal skin, skin hydration was improved with Venusia baby cream (12.20%) and Venusia baby lotion (7.20%); 59.37% of participants strongly agreed that the baby's skin became softer and smoother after the application of Venusia baby cream; and 84.84% of participants strongly agreed that the baby's skin became softer and smoother after the application of Venusia baby lotion. Conclusion Significant improvement was seen in skin hydration using Venusia baby cream and Venusia baby lotion in babies with dry skin and normal skin. No skin intolerances and product-related adverse or serious adverse events were clinically observed or reported during the study duration. Venusia baby lotion had the highest effect (66.4%) on skin hydration in babies with dry skin, where there was a significant shift from dry skin to normal skin range., Competing Interests: The authors have declared financial relationships, which are detailed in the next section., (Copyright © 2023, . et al.)

Objectives This prospective study assessed the effectiveness and patient satisfaction of four-week omeprazole therapy in acid peptic disease (APD). Methods This was an observational, post-marketing, real-world evidence, patient-reported outcome (PRO) measures study. Patients visiting the five study sites across India with symptoms of APD, and who were prescribed oral omeprazole (20/40 mg per day) for at least four weeks were enrolled after obtaining informed consent. Study assessments included frequency and severity of symptoms and overall satisfaction reported by the patients using the Patient Assessment of Gastrointestinal Disorder Symptom Severity Index (PAGI-SYM) questionnaire. The satisfaction with therapy was reported by the patients using the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire. Both PAGI-SYM and TSQM were reported by patients on days 14 and 28. Omeprazole safety was assessed based on the adverse events reported by the patients. Results A total of 96 (62 males and 34 females) patients were included in the study, of which 38.54% had significant findings related to APD at baseline. The proportion of patients with symptoms reduced to 16.67% on day 14 and 8.33% on day 28 with omeprazole therapy. The PAGI-SYM total scores at baseline were 41.32 (15.487), which reduced to 20.86 (11.620) on day 14 (p < 0.0001), and to 8.93 (8.361) on day 28 (p < 0.0001). Significant reductions were also seen in individual symptom scores. The TSQM total scores increased to 36.67 (range: 13 to 63) on day 28 from 34.69 (range: 12 to 58) on day 14. Improvement in scores for all domains of TSQM (effectiveness, convenience, and global satisfaction) was seen on day 28. Improvement in reflux symptoms was reported by 46.74% and 68.48% of patients on day 14 and day 28, respectively. Four (4.17%) patients reported adverse events, which were of mild severity and were unrelated to omeprazole. Conclusions Omeprazole provides significant improvement in PAGI-SYM and TSQM questionnaires on day 14 and day 28. Patients reported the omeprazole-based therapy as effective, convenient, and satisfactory. Omeprazole therapy is safe and effective for the treatment of APD and shows good improvement in APD in patients suffering from duodenal ulcers, gastric ulcers, and reflux oesophagitis., Competing Interests: Suresh Jain, Sandeep Kulkarni, Jyoti Mahapatra, and Dilip Todi were the investigators of the study. Anup Petare, Ritwik Banerjee, Rahul Rathod, Syed Mujtaba Hussain Naqvi, Amey Mane, Gauri Dhanaki, and Bhavesh Kotak are employees of Dr. Reddy’s Laboratory India., (Copyright © 2023, Jain et al.)

Background: Lymphatic complications are common in patients with Fontan circulation. Three-dimensional balanced steady-state free precession (3D bSSFP) angiography by cardiovascular magnetic resonance (CMR) is widely used for cardiovascular anatomical assessment. We sought to determine the frequency of thoracic duct (TD) visualization using 3D bSSFP images and assess whether TD characteristics are associated with clinical outcomes., Methods: This was a retrospective, single-center study of patients with Fontan circulation who underwent CMR. Frequency matching of age at CMR was used to construct a comparison group of patients with repaired tetralogy of Fallot (rTOF). TD characteristics included maximum diameter and a qualitative assessment of tortuosity. Clinical outcomes included protein-losing enteropathy (PLE), plastic bronchitis, listing for heart transplantation, and death. A composite outcome was defined as presence of any of these events., Results: The study included 189 Fontan patients (median age 16.1 years, IQR 11.0-23.2 years) and 36 rTOF patients (median age 15.7 years, IQR 11.1-23.7 years). The TD diameter was larger (median 2.50 vs. 1.95 mm, p = 0.002) and more often well visualized (65% vs. 22%, p < 0.001) in Fontan patients vs. rTOF patients. TD dimension increased mildly with age in Fontan patients, R = 0.19, p = 0.01. In Fontan patients, the TD diameter was larger in those with PLE vs. without PLE (age-adjusted mean 4.11 vs. 2.72, p = 0.005), and was more tortuous in those with NYHA class ≥ II vs. class I (moderate or greater tortuosity 75% vs. 28.5%, p = 0.02). Larger TD diameter was associated with a lower ventricular ejection fraction that was independent of age (partial correlation = - 0.22, p = 0.02). More tortuous TDs had a higher end-systolic volume (mean 70.0 mL/m 2 vs. 57.3 mL/m 2 , p = 0.03), lower creatinine (mean 0.61 mg/dL vs. 0.70 mg/dL, p = 0.04), and a higher absolute lymphocyte count (mean 1.80 K cells/µL vs. 0.76 K cells/µL, p = 0.003). The composite outcome was present in 6% of Fontan patients and was not associated with TD diameter (p = 0.50) or tortuosity (p = 0.09)., Conclusions: The TD is well visualized in two-thirds of patients with Fontan circulation on 3D-bSSFP images. Larger TD diameter is associated with PLE and increased TD tortuosity is associated with an NYHA class ≥ II., (© 2023. The Author(s).)

Background: Abnormal left ventricular (LV) rotational mechanics in biventricular hearts are associated with adverse outcomes; however, these are less well characterized for hearts with functionally single ventricles., Objectives: The purpose of this study was to characterize ventricular rotational mechanics in the Fontan circulation and their relationship to outcomes., Methods: Single-center, retrospective analysis of magnetic resonance examinations for 329 Fontan patients (15 [IQR: 10-21] years) and 42 controls. The ventricular cine short-axis stack was analyzed to derive torsion metrics. Torsion calculated as the difference between apical and basal rotation normalized to ventricular length., Results: Fontan patients had higher indexed ventricular end-diastolic volume (97 mL/body surface area 1.3 vs 72 mL/body surface area 1.3 ), lower ejection fraction (53% vs 60%), and lower proportion of basal clockwise rotation (62% vs 93%), apical counterclockwise rotation (77% vs 95%), and positive torsion (82% vs 100%); P < 0.001 for all. A composite outcome of death or heart transplant-listing occurred in 31 (9%) patients at a median follow-up of 3.9 years. Torsion metrics were associated with the outcome; although, on multivariate analysis only right ventricular (RV) morphology and indexed ventricular end-diastolic volume were independently associated. LVs with negative torsion, and RVs regardless of torsional pattern, had worse outcomes compared to LVs with positive torsion ( P = 0.020)., Conclusions: Single ventricles in a Fontan circulation exhibit abnormal torsional mechanics, which are more pronounced for RV morphology. Abnormal torsion is associated with death or need for heart transplantation. Fontan patients with LV morphology and preserved torsion exhibit the highest transplant-free survival and torsion may offer incremental prognostic data in this group of patients., Competing Interests: This study was in part supported by the Fred Lovejoy Housestaff Research and Education Fund and 10.13039/100000002NIH T32 Research Methods in Pediatric Cardiovascular Disease Award Number: 5T32HL007572-38. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background Calcium-channel blockers (CCB) are a mainstay in the management of hypertension (HTN), and amlodipine is the preferred CCB due to its longer half-life and better safety. Patients and methods This practice-based, observational, real-world evidence study assessed the 24-hour ambulatory blood pressure (ABP) control in mild-to-moderate essential hypertensive patients (treatment naïve receiving amlodipine monotherapy, or as add-on therapy) in inadequately controlled blood pressure (BP goal not met after one month of existing therapy). One hundred four (62M/42F) patients between 18 and 65 years of age who received amlodipine 5/10 mg/day for >8 weeks were included after obtaining informed written consent. The primary outcome was a change from baseline in the mean 24-h SBP and DBP on ABP monitoring at eight (±1) weeks. Secondary outcomes were different from baseline in the mean morning, day-time, night-time, and last six-hour dosing interval period. Other outcomes assessed BP variability (dippers and non-dippers), and responder rates based on ABP monitoring and in-clinic trough cuff measurements. Safety outcomes included adverse effects reported, electrocardiogram, and laboratory abnormalities (hepatic and renal function). Changes in BP parameters in different sub-groups (age, gender, BMI, physical activity, occupation, duration of hypertension, the total daily dose of amlodipine, type of amlodipine therapy, and hypertension severity at baseline) were estimated. Results Of the 104 patients, 49 patients (completed eight weeks) were included in the per-protocol (PP) data for efficacy analysis. Safety analysis was done on the intent-to-treat (ITT) dataset. Significant reductions (p<0.0001) from baseline in all BP measurements on ABPM were observed at the end of eight weeks. Similar improvements were observed in office BP recordings. There was a marginal but non-significant (p>0.05) increase in the proportion of dippers and extreme dippers with amlodipine at the end of the eight-week treatment period. Conclusions Amlodipine 5/10 mg/day therapy used as monotherapy or adjuvant therapy provided significant reductions in both office BP and ambulatory BP over eight weeks., Competing Interests: Prabhakar D and Santanu Guha were the Investigators of the study. Rahul Rathod and Kumar Gaurav are employees of the Dr. Reddy’s Laboratory India. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors., (Copyright © 2023, D et al.)

Background: Dyspepsia includes a spectrum of symptoms ranging from epigastric pain and early satiety to postprandial fullness. The worldwide prevalence of dyspepsia is 20-30%. It is slightly higher in the Western population and occurs more frequently among women. While the precise prevalence of dyspepsia in India is not available, different studies estimate that it affects 7.6-49% of the Indian population. Through our current study, we wanted to understand the demographics, clinical profile, patient presentation, and management in India. We also wanted to document the pattern of use of proton pump inhibitors (PPI) and patient satisfaction with PPIs in Indian patients with dyspepsia., Materials and Methods: This pan-India, multi-centric, cross-sectional, questionnaire-based, noninterventional, observational study was conducted between February and October 2021 in patients &gt;18 years of age with a clinical diagnosis of any form of dyspepsia. Descriptive statistics were used for categorical variables, and between-group comparisons were made using Fischer's exact test, with p &lt; 0.05 denoting statistical significance., Results: A total of 3,739 patients from across 29 states of India participated in the study. Most of the patients were male (70.8%) and were from urban areas (56.8%). The highest percentage of patients were aged 31-40 (33.8%), and most patients (60.2%) had dyspepsia for a duration of 6-12 months. Patients with functional dyspepsia (FD) (78.5%) were significantly higher compared to organic dyspepsia (OD) (21.5%) (p &lt; 0.001). The most frequent presenting symptoms were epigastric pain, nausea, vomiting, and heartburn. A quarter (25.6%) of the dyspepsia patients were associated with various comorbid conditions, of which diabetes mellitus, hypertension, and irritable bowel syndrome are the most common ones. A total of 619 patients in the study were on concomitant medications, of which the most common were antidiabetic drugs (271/619, 43.8%). Rabeprazole was the most frequently used PPI (2467/3739, 66.0%) among the study participants. The patient satisfaction analysis showed that, overall, patients were satisfied with PPIs, as most patients (~80%) agreed to almost all questions. The analysis for individual PPIs showed the highest "agree" responses in the rabeprazole group for almost all questions (12 of 13). Around 86.4% of patients on rabeprazole agreed with "immediate relief from acidity," 84.9% for "gives me complete relief," and 85.9% for "relief from nighttime acidity symptoms.", Conclusion: Our study involving over 3,700 Indian patients with Dyspepsia adds to the growing knowledge of dyspepsia in India. Dyspepsia is more prevalent in males and in the 31-50 age group. FD is the most common form. Overall, patients were satisfied with PPIs in dyspepsia management in India. Patients on rabeprazole showed higher levels of medication adherence, satisfaction with symptom relief, convenience of therapy, and safety compared to patients on other PPIs. Against the backdrop of a paucity of reliable data about dyspepsia in India, our study results provide valuable insights into Dyspepsia and its management in an Indian setting., (© Journal of the Association of Physicians of India 2011.)

Background: Probiotics are co-prescribed with co-amoxiclav to prevent antibiotic-associated diarrhea (AAD). The study assesses the co-prescription pattern of probiotics with co-amoxiclav in pediatric patients with respiratory tract infections (RTIs)., Methods: This was a mixed methods research study with a retrospective study and a prospective survey. The retrospective part included a multicenter, observational, real-world study utilizing patients' electronic medical records for three years (2018-2020) from seven outpatient pediatric clinics and hospitals. The qualitative evaluation was performed with a predefined questionnaire., Results: The patients having RTIs (N=984) were prescribed Clamp ® (46.7%), CAA (23.8%), and CAM (29.5%). The mean age of the patients was 4.05 years, with 59.25% males and most patients having upper RTIs. Co-amoxiclav was prescribed twice daily for one to 15 days. A significantly lesser number of probiotic co-prescriptions were observed with Clamp ® (19.57%) than with CAA (38.46%) and CAM (29.31%) at baseline ( p <0.001). Similar findings were observed for follow-up visits one and two. Saccharomyces boulardii , Bacillus clausii ,and lactic acid bacillus were the most commonly co-prescribed probiotics. The qualitative evaluation indicated that most clinicians were aware of the co-amoxiclav-related gastrointestinal side effects and the benefits of probiotics in preventing them., Conclusion: The frequency of co-prescriptions of probiotics with Clamp ® among pediatric patients with RTIs was significantly less, potentially indicating better gastrointestinal tolerability., Competing Interests: The authors have declared financial relationships, which are detailed in the next section., (Copyright © 2023, Choudhury et al.)

Background: Proton-pump inhibitors, along with a prokinetic agent, are widely used to provide symptomatic relief amongst patients with acid peptic disease (APD). This article evaluates the effectiveness and safety of the omeprazole-domperidone combination amongst patients with type 2 diabetes mellitus for the management of APD., Methods: PRIDE-2 (PRoton-pump Inhibitor in patients with type 2 DiabEtes mellitus) is a retrospective study reviewing electronic medical records of patients with type 2 diabetes mellitus and APD who were receiving the omeprazole-domperidone combination and visiting multiple Indian healthcare settings between March 2018 and April 2021. The effectiveness outcome of the therapy was evaluated in terms of resolution of APD symptoms at visit 5 (120 days after baseline visit) compared with visit 1 (baseline visit). Safety was determined in terms of reported adverse events (AEs) during the treatment period (120 days)., Results: A total of 174 patients were included in the study. The mean age of the patients was 51.5±9.6 years, with the majority (59.8%) being men. A significant proportion of patients reported relief from APD symptoms, including abdominal pain (91.6%), epigastric burning (68.7%), nausea (89.5%), flatulence (100.0%), loss of appetite (93.6%), and altered bowel movements (94.7%) ( p <0.001 for each) at visit 5 compared with visit 1. No serious AEs were reported., Conclusion: Omeprazole-domperidone combination was beneficial in providing symptomatic relief to patients with diabetes and APD. The combination therapy was well tolerated, with few reports of minor AEs., Competing Interests: Disclosure and potential conflicts of interest: AUP, KCV and CSP are the Medical Advisor, Team Lead and Clinical Research Specialist, respectively, at Medical Affairs Department, Dr. Reddy’s Laboratories Ltd, Hyderabad. AM, RR and BK are Medical Cluster Head, Head Ideation & Clinical Research and Head Medical Affairs, respectively, at the Medi-cal Affairs Department, Dr. Reddy’s Laboratories Ltd, Hyderabad. BS and NM have no conflicts of interest to disclose. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2023/01/dic.2022-10-3-COI.pdf, (Copyright © 2023 Saboo B, Mulwani N, Petare AU, Veligandla KC, Pinto CS, Mane A, Rathod R, Kotak B.)

Background: The optimal strategy for thromboprophylaxis in patients with a Fontan circulation is unknown., Objectives: The aim of this study was to compare the efficacy and safety of aspirin, warfarin, and nonvitamin K oral anticoagulants (NOACs) in a network meta-analysis., Methods: Relevant studies published by February 2022 were included. The primary efficacy outcome was thromboembolic events; major bleeding was a secondary safety outcome. Frequentist network meta-analyses were conducted to estimate the incidence rate ratios (IRRs) of both outcomes. Ranking of treatments was performed based on probability (P) score., Results: A total of 21 studies were included (26,546 patient-years). When compared with no thromboprophylaxis, NOAC (IRR: 0.11; 95% CI: 0.03-0.40), warfarin (IRR: 0.23; 95% CI: 0.14-0.37), and aspirin (IRR: 0.24; 95% CI: 0.15-0.39) were all associated with significantly lower rates of thromboembolic events. However, the network meta-analysis revealed no significant differences in the rates of major bleeding (NOAC: IRR: 1.45 [95% CI: 0.28-7.43]; warfarin: IRR: 1.38 [95% CI: 0.41-4.69]; and aspirin: IRR: 0.72 [95% CI: 0.20-2.58]). Rankings, which simultaneously analyze competing interventions, suggested that NOACs have the highest P score to prevent thromboembolic events (P score 0.921), followed by warfarin (P score 0.582), aspirin (P score 0.498), and no thromboprophylaxis (P score 0.001). Aspirin tended to have the most favorable overall profile., Conclusions: Aspirin, warfarin, and NOAC are associated with lower risk of thromboembolic events. Recognizing the limited number of patients and heterogeneity of studies using NOACs, the results support the safety and efficacy of NOACs in patients with a Fontan circulation., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background In this study, we aimed to assess the effectiveness of omeprazole therapy in the management of acid peptic disease (APD) among type 2 diabetes mellitus (T2DM) patients. Methodology In this multicenter retrospective study, electronic medical records (EMRs) of T2DM patients with APD who were prescribed omeprazole between March 2018 and April 2021 at multiple Indian healthcare settings were reviewed. The resolution of APD symptoms was assessed at visit five (120 days after the index visit) and compared to visit one (index visit). Safety was established in terms of reported adverse events during the study period. Results Overall, 174 patients were included. The majority of patients (63.8%) were males with a mean age of 48.6 ± 11.03 years. After receiving omeprazole therapy, a significant number of patients reported improvement in symptoms such as abdominal pain (98.2%), epigastric burning (74.2%), altered bowel movements (62.1%), and nausea (80.5%) (p < 0.001 for each). Complete resolution was observed in all patients who complained about flatulence (100.0%) and loss of appetite (100.0%) (p < 0.001 for each). The drug was found to be well tolerated. Conclusions Omeprazole therapy was well tolerated and highly effective in resolving APD symptoms among T2DM patients receiving fixed oral hypoglycemic agents., Competing Interests: The authors have declared financial relationships, which are detailed in the next section., (Copyright © 2022, Saboo et al.)

Background: Cross-sectional studies have reported that ventricular dilation and dysfunction are associated with adverse clinical outcome in Fontan patients; however, longitudinal changes and their relationship with outcome are not known., Methods: This was a single-center retrospective analysis of Fontan patients with at least 2 cardiovascular magnetic resonance (CMR) scans without intervening interventions. Serial measures of end-diastolic volume index (EDVI), end-systolic volume index (ESVI), ejection fraction (EF), indexed mass (mass i ), mass-to-volume ratio, and end-systolic wall stress (ESWS) were used to estimate within-patient change over time. Changes were compared for those with and without a composite outcome (death, heart transplant, or transplant listing) as well as between patients with left (LV) and right ventricular (RV) dominance., Results: Data from 156 patients were analyzed with a mean age at 1st CMR of 17.8 ± 9.6 years. 490 CMRs were included with median of 3 CMRs/patient (range 2-9). On regression analysis with mixed effects models, volumes and ESWS increased, while mass, mass-to-volume ratio, and EF decreased over time. With a median follow-up of 10.2 years, 14% met the composite outcome. Those with the composite outcome had a greater increase in EDVI compared to those without (4.7 vs. 0.8 ml/BSA 1.3 /year). Compared with LV dominance, RV dominance was associated with a greater increase in ESVI (1.4 vs. 0.5 ml/BSA 1.3 /year), a greater decrease in EF (- 0.61%/year vs. - 0.24%/year), and a higher rate of the composite outcome (21% vs. 8%)., Conclusions: Ventricles in the Fontan circulation exhibit a steady decline in performance with an increase in EDVI, ESVI, and ESWS, and decrease in EF, mass index, and mass-to-volume ratio. Those with death or need for heart transplantation have a faster increase in EDVI. Patients with rapid increase in EDVI (> 5 ml/BSA 1.3 /year) may be at a higher risk of adverse outcomes and may benefit from closer surveillance. RV dominance is associated with worse clinical outcomes and remodeling compared to LV dominance., (© 2022. The Author(s).)

Background: Infantile colic is characterized by prolonged periods of inconsolable, incessant crying and persistent fussing in an otherwise healthy infant. It is a self-limiting condition, but causes significant stress to mothers., Aim: To observe the role of Lactobacillus reuteri DSM 17938 in reducing crying time in colicky infants in routine clinical practice., Methods: This was a prospective observational multicentric clinic-based study. Each practitioner included approximately 30 infants < 5 months of age with infantile colic who were prescribed L. reuteri &nbsp; DSM 17938 for a period of 21 days. There were four physical consultations and two telephonic consultations. The parents were given a daily diary to record the duration of crying and fussing episodes and a questionnaire was administered during the consultations., Results: A total of 120 infants with a mean age of 56.9 ± 34.2 days were included in this 28-day study. The mean crying time as reported by the parents in the subject diary reduced from 248.2 ± 101.2 min, 95% CI: 229.45, 266.94 at baseline to 45.6 ± 79.1 min 95% CI: 31.02, 60.31 at study end ( P < 0.01). The clinical response (defined as reduction of 50% in crying time) was observed in 85% of subjects at study end. The fussiness and parental perception of colic recorded during the consultations were reduced by 66% and 72%, respectively, at study end. The maternal depression scores were reduced to 63% at study end., Conclusion: L. reuteri DSM 17938 was associated with a significant reduction in crying time in colicky infants, and showed improvement in maternal depression.

Pruritus is a common dermatological condition observed in patients with diabetes, making it a dermatometabolic condition. Being multiaethiological, pruritis is caused by autoimmune, genetic, infectious and various systemic diseases. The present survey aimed to understand the knowledge, attitude and practice toward pruritus among Indian physicians and patients with diabetes presenting with pruritus. A telephonic, cross-sectional, qualitative survey was conducted among physicians and patients across five cities in India from July-August 2020. An open-ended discussion guide was used for the interview; the data were analyzed to check for common themes and trends. A majority of the consulting physicians (CPs) believed that uncontrolled diabetes is the main causal factor for pruritus in patients with diabetes and reported that currently there are no standard tests or treatment guidelines for its management. CPs emphasized proper monitoring and counseling to overcome current challenges. Patients reported a negative impact of pruritus on their daily activities and quality of life. The survey concluded that poor management of diabetes is one of the main causal factors for patients with diabetes presenting with pruritus in India. CPs emphasized controlling diabetes along with symptomatic treatment. For patients, pruritus has multifaceted effects on their health, overall well-being, and quality of life.

Several circulating biomarkers have been found to play a role in the surveillance and risk stratification of heart failure without congenital heart disease, but these have not been widely studied in patients with single ventricles palliated with a Fontan operation. Imaging predictors of worse outcomes in this population include ventricular dilation and dysfunction. Patients who weighed >30 kg with a Fontan circulation referred for cardiac magnetic resonance imaging were invited to participate in the study. Blood and urine samples were obtained at the time of imaging and multiple conventional and novel biomarkers were measured. A total of 82 patients with a median age of 18 years were enrolled. Among the novel biomarkers, N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity troponin T had the strongest correlation with ventricular dilation and dysfunction. NT-ProBNP >100 pg/ml has a sensitivity of 91% for the detection of significant ventricular dilation (end-diastolic volume >120 ml/body surface area 1.3 ) and 82% for detection of ejection fraction <50%. The urinary neutrophil gelatinase-associated lipocalin-2 to creatinine ratio correlated with ejection fraction and estimated glomerular filteration rate. In conclusion, abnormalities in biomarkers of heart failure are common in ambulatory, largely asymptomatic patients with Fontan circulation. NT-ProBNP may serve as a sensitive marker for the identification of patients with significant ventricular dilation or dysfunction. Further work is needed to understand how these easily measured circulating biomarkers may be integrated into clinical care., Competing Interests: Disclosures Dr. Opotowsky has received grant funding from Roche Diagnostics. The authors have no other conflicts of interest to declare., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Transvenous permanent pacemaker (PPM) implantation is an available option for Fontan patients with sinus node dysfunction. However, the thrombogenic potential of leads within the Fontan baffle is unknown., Objective: The purpose of this study was to compare the clot burden in Fontan patients with a transvenous atrial PPM to those without a PPM and those with an epicardial PPM., Methods: This was a retrospective cohort study of all transvenous PPM implantations in Fontan patients followed at our institution (2000-2018). We performed frequency matching on Fontan type and age group. Primary outcome was identification of intracardiac clot, pulmonary embolus, or embolic stroke., Results: Of 1920 Fontan patients, 58 patients (median age 23 years; interquartile range [25th-75th percentiles] 14-33) at the time of transvenous PPM implantation and 174 matched subjects formed our cohort. The type of Fontan performed in case subjects was right atrium-pulmonary artery or right atrium-right ventricle conduit (54%), lateral tunnel (43%), and extracardiac (3%). The cumulative incidence of clot was highest in patients with transvenous PPM, followed by patients with epicardial PPM and no PPM (1.2 vs 0.87 vs 0.67 per 100 person-years of follow-up, respectively). In multivariable analysis, anticoagulation and/or antiplatelet therapy were protective against clot and resulted in reduction of clot risk by 3-fold (incidence rate ratio 0.33; 95% confidence interval 0.21-0.53; P <.001)., Conclusion: In a large cohort of Fontan patients matched for age and Fontan type, patients with transvenous PPM had a higher but not statistically significant incidence of clot compared to those with no PPM and epicardial PPM. Patients treated with warfarin/aspirin had lower clot risk., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: The Fontan operation has resulted in improved survival in patients with single-ventricle congenital heart disease. As a result, there is a growing population of teenagers and adults with a Fontan circulation. Many co-morbidities have been increasingly recognized in this population due to the unique features of the Fontan circulation. Standardization of how Fontan co-morbid conditions are defined will help facilitate understanding, consistency and interpretability of research and clinical experience. Unifying common language usage in Fontan is a critical precursor step for data comparison of research findings and clinical outcomes and ultimately accelerating improvements in management for this growing group of patients. This manuscript aimed to create unified definitions for morbidities seen after the Fontan palliation., Methods: In association of many congenital heart disease organizations, this work used Delphi methodology to reach a broad consensus among recognized experts regarding commonly used terms in Fontan care and research. Each definition underwent at least three rounds of revisions to reach a final definition through surveys sent to experts in the field of single-ventricle care., Results: The process of reaching a consensus on multiple morbidities associated with the Fontan procedure is summarized in this manuscript. The different versions that preceded reaching the consensus are also presented in the Supporting Information. Table 1 represents the final definitions according to the consensus., Conclusions: We propose the use of these definitions for clinical care, future research studies, registry development and clinical trials., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

India has a disproportionately high burden of acute and chronic pulmonary diseases. In India, 65 million suffer from non-communicable respiratory diseases. The outbreak of the novel coronavirus disease 2019 (COVID-19) had worsened the situation. Patients affected with COVID-19 with a previous history of comorbidities, such as COPD and chronic lung diseases, had the worst prognosis, resulting in adverse outcomes, such as acute respiratory distress syndrome (ARDS) and pneumonia. Immune modulation strategies have since gained a lot of traction amongst practitioners. Modulation of the immune system with Pidotimod along with standard-of-care (SOC) treatment has proven efficacious in the past two decades in patients with recurrent respiratory tract infections (RRTIs), bronchitis, COPD, and pneumonia. In this article, we have reviewed the current unmet needs in the management of COPD in India and evaluated the usage of Pidotimod in adult COPD patients based on expert panel discussion., (© Journal of the Association of Physicians of India 2011.)

Abnormal atrial mechanics in biventricular circulations have been associated with elevated left heart filling pressures. Similar associations in the Fontan circulation are unknown. The aim of this study was to examine the relationship between atrial mechanics and invasively assessed hemodynamic parameters late after the Fontan operation. Thirty-nine Fontan patients with echocardiographic and invasive hemodynamic studies done within 48 h were included and were compared to 40 age-matched healthy controls. Atrial and ventricular strain measurements were measured offline using 2-dimensional speckle-tracking. Mean age was 10.2 ± 6.7 years and 24 (62%) were male. Atrial strain measures were lower in Fontan patients compared to healthy controls. There was no significant association between atrial strain measurements and Fontan systemic ventricular filling pressures (SVFP) as indicated by pulmonary artery occlusion pressures, direct left atrial pressure or systemic ventricular end-diastolic pressure. Global atrial strain was not correlated with segmental atrial strain in the pulmonary venous atrium. Global atrial reservoir strain was positively correlated with pulmonary vascular resistance (r = 0.508, p = 0.045). Global atrial conduit strain was positively correlated with E/A ratio of the AV valve inflow (r = 0.555, p = 0.002). Atrial and ventricular strain measurements were not significantly correlated. In patients with a Fontan, global atrial function is significantly depressed, and is uncoupled from segmental left lateral atrial function. Global as well as segmental atrial mechanics are not significantly associated with SVFPs in Fontan patients. Instead, global atrial reservoir function appears to parallel pulmonary vascular resistance., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)

Background: Small bowel injuries are infrequent after blunt trauma and typically affect fixed segment. Untimely management of such injuries, results in high-output entero-cutaneous fistula which increases morbidity and mortality. Treatment of duodeno-jejunal flexure transection has been traditionally done by pyloric exclusion with gastrojejunostomy, but more recent evidence suggests that end-to-end anastomosis or primary closure may be equally effective in which duodeno-jejunal anastomosis is protected via an external tube duodenostomy. Objective: The objective of the study is to provide a modification to the technique of management of duodeno-jejunal flexure injury, avoiding external tube duodenostomy. Material and Methods: Patients admitted from July 1, 2015 to June 1, 2018 were identified and examined for duodeno-jejunal flexure transection. Non-accidental injury cases were excluded. Results: In the study period, a total of 10 patients were admitted with duodeno-jejunal flexure transection. All cases were admitted 24 hours after the injury and presented with shock. After fluid resuscitation and investigations, they were taken for urgent laparotomy. The whole of duodenum was mobilised, the transected ends were debrided and end-to-end duodenojejunal anastomosis was performed in two-layer fashion. An 18-French Nasojejunal (NJ) tube was placed beyond the anastomosis, and an 18-French nasogastric (NG) tube was placed in the stomach for gastric decompression. A feeding jejunostomy was performed in all cases. Both NG and NJ tubes were removed after bowel movements started and FJ was removed on first follow up. There was no incidence of duodenum related complications, and all were doing well on follow up. Discussion and conclusion: Placing the nasojejunal and nasogastric tube eliminates the need for duodenostomy and gastrostomy, respectively. This method protects the duodeno-jejunal anastomosis and decreases the incidence of duodenum-related complications., (Celsius.)

Background: Various clinical trials have established anti-inflammatory and antipyretic properties of Nimesulide in a controlled setting, however, the fever management in real-world settings is quite different., Objective: To assess the effectiveness of Nimesulide in acute fever management in real-world clinical practice., Methodology: A retrospective, multicenter study was conducted on electronic medical records (EMR) of 302 patients visiting out-patient departments at three centers between Jan 2016 and Jan 2020 and were prescribed Nimesulide for acute fever. The effectiveness of Nimesulide was analyzed as a change in fever from baseline to follow-up visit within 14 days and tolerability as the number of side effects captured post-Nimesulide ingestion., Results: The provisional diagnosis at the baseline visit reported major complaints like fever, fever with abdominal pain, body-ache, cough and myalgia. The mean baseline body temperature was 103.2±1.5°F with a mean duration of 4.4±2.8 days significantly (p 0.0001) decreased to 99.7±1.8°F on the administration of Nimesulide. The liver and the renal profiles were found to be normal on records, and the side effects such as nausea and dyspepsia were reported only in 2% of patients., Conclusion: Nimesulide was found to be well-tolerated and effective as an antipyretic for acute fever management in adults during short-term use in real-world clinical practice., (© Journal of the Association of Physicians of India 2011.)

Background: Several clinical and cardiac magnetic resonance (CMR)-derived parameters have been shown to be associated with death or heart transplant late after the Fontan operation., Objectives: The objective of this study was to identify the relative importance and interactions of clinical and CMR-based parameters for risk stratification after the Fontan operation., Methods: Fontan patients were retrospectively reviewed. Clinical and CMR parameters were analyzed using univariable Cox regression. The primary endpoint was time to death or (listing for) heart transplant. To identify the patients at highest risk for the endpoint, classification and regression tree survival analysis was performed, including all significant variables from Cox regression., Results: The cohort consisted of 416 patients (62% male) with a median age of 16 years (25th, 75th percentiles: 11, 23 years). Over a median follow-up of 5.4 years (25th, 75th percentiles: 2.4, 10.0 years) after CMR, 57 patients (14%) reached the endpoint (46 deaths, 7 heart transplants, 4 heart transplant listings). Lower total indexed end-diastolic volume (EDV i ) was the strongest predictor of transplant-free survival. Among patients with dilated ventricles (EDV i  ≥156 ml/BSA 1.3 ), worse global circumferential strain (GCS) was the next most important predictor (73% vs. 44%). In patients with smaller ventricles (EDV i  <156 ml/BSA 1.3 ), New York Heart Association functional class ≥II was the next most important predictor (30% vs. 4%)., Conclusions: In this cohort of patients late after Fontan operation, increased ventricular dilation was the strongest independent predictor of death or transplant (listing). Patients with both ventricular dilation and worse GCS were at highest risk. These data highlight the value of integrating CMR and clinical parameters for risk stratification in this population., Competing Interests: Funding Support and Author Disclosures This study was supported by Evan’s Heart Fund (Boston, Massachusetts) and the Ter Meulen Grant of the Royal Netherlands Academy of Arts and Sciences (Amsterdam, the Netherlands), and the Dekker Grant of the Nederlandse Hartstichting (Den Haag, the Netherlands). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Patients with repaired Tetralogy of Fallot (ToF), a congenital heart defect which includes a ventricular septal defect and severe right ventricular outflow obstruction, account for the majority of cases with late-onset right ventricle (RV) failure. Current surgery procedures, including pulmonary valve replacement (PVR) with right ventricle remodeling, yield mixed results. PVR with active band insertion was hypothesized to be of clinical usage on improving RV function measured by ejection fraction (EF). In lieu of risky open-heart surgeries and experiments on animal and human, computational biomechanical models were adapted to study the impact of PVR with five band insertion options. Cardiac magnetic resonance (CMR) images were acquired from seven TOF patients before PVR surgery for model construction. For each patient, five different surgery plans combined with passive and active contraction band with contraction ratio of 20, 15, and 10% were studied. Those five plans include three single-band plans with different band locations; one plan with two bands, and one plan with three bands. Including the seven no-band models, 147 computational bi-ventricle models were constructed to simulate RV cardiac functions and identify optimal band plans. Patient variations with different band plans were investigated. Surgery plan with three active contraction bands and band active contraction ratio of 20% had the best performance on improving RV function. The mean ± SD RV ejection fraction value from the seven patients was 42.90 ± 5.68%, presenting a 4.19% absolute improvement or a 10.82% relative improvement, when compared with the baseline models (38.71 ± 5.73%, p = 0.016). The EF improvements from the seven patients varied from 2.87 to 6.01%. Surgical procedures using active contraction bands have great potential to improve RV function measured by ejection fraction for patients with repaired ToF. It is possible to have higher right ventricle ejection fraction improvement with more bands and higher band active contraction ratio. Our findings with computational models need to be further validated by animal experiments before clinical trial could become possible., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer AR-A declared a past collaboration with the authors TG and RR to the handling editor., (Copyright © 2021 Yu, del Nido, Geva, Yang, Wu, Rathod, Huang, Billiar and Tang.)

Objectives: This study describes a single center experience with the use of cardiac resynchronization therapy (CRT) in a difficult patient population, including single systemic right ventricles (RVs), subpulmonary RVs, and left ventricles (LVs) with right bundle branch block (RBBB)., Background: CRT remains challenging in the congenital heart disease population., Methods: Consecutive patients undergoing resynchronization of single RVs, subpulmonary RVs, or LVs in the setting of RBBB were identified between 2016 and 2019. Patients who had CRT performed for complete heart block or had <3 months of follow-up were excluded. Patients underwent pre-procedural advanced imaging by echocardiogram, computed tomography, or cardiac magnetic resonance to assess ventricular function and synchrony; intraoperative mapping was performed to identify optimal lead placement., Results: All patients undergoing resynchronization presented with at least moderate systolic ventricular dysfunction in the setting of intrinsic atrioventricular nodal conduction and RBBB. Seven patients were identified. Two patients underwent CRT of a single RV, 3 with subpulmonary RVs and 2 with systemic LVs. The median age at CRT was 5 years (range 0.6 to 48 years). The median follow-up was 9 months (range 3 to 18 months). The median baseline QRS duration was 180 ms (range 115 to 260ms). Post-CRT, the QRS duration decreased by a median of 34% (range 19% to 38%). All patients had improvement in their systolic ventricular function., Conclusions: Targeted resynchronization in systemic and subpulmonary RVs can be used to improve ventricular function and heart failure in the congenital heart disease population. Similar techniques can be applied to successfully treat patients with LV dysfunction and RBBB and improve their long-term outcomes., Competing Interests: Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)