BACKGROUND: Repair is preferable for children with mitral valve disease, but mitral valve replacement (MVR) is occasionally necessary. This report presents the results of a multiinstitutional Investigational Device Exemption trial of the 15-mm St Jude (SJM) mechanical mitral valve (Abbott Structural Heart).
METHODS: From May 2015 to March 2017, 23 children aged 0.4 to 27.4 months (mean, 7.8 months; 85% <1 year) weighing 2.9 to 10.9 kg (mean, 5.5 kg) at 15 centers underwent MVR with a 15-mm SJM mechanical mitral valve (intraannular, 45%; supraannular, 55%). A total of 21 (91%) of the children had undergone previous cardiac operations. Follow-up until death, valve explantation, or 5 years postoperatively was 100% complete.
RESULTS: There were 6 deaths, all in the first 12 months; no death was valve related. Four patients required a pacemaker (2 supraannular, 2 intraannular). Three patients had thrombosis requiring valve explantation at 13, 21, and 35 days postoperatively. Two of these 3 patients were receiving low-molecular-weight heparin for anticoagulation, and the third had factor V Leiden deficiency. There were 5 nonfatal bleeding complications within 4 months of MVR (1-year freedom from bleeding, 71.0%). The 1- and 5-year freedom from death or valve explantation was 71.0%.
CONCLUSIONS: In small children with severe mitral valve disease requiring MVR, the 15-mm SJM mechanical mitral valve provides satisfactory hemodynamics. Mortality and complications in these patients are not trivial. Low-molecular-weight heparin likely should be avoided as primary anticoagulation. Eventual valve replacement is inevitable.

OBJECTIVE: Infants with congenital heart disease and increased pulmonary blood flow frequently suffer from feeding difficulties and growth failure. Providing expressed breast milk by spoon has been hypothesised to decrease energy expenditure in these infants as compared to breastfeeding. This study assessed the effect of supplemental feeding of expressed breast milk on weight gain in infants with unoperated congenital heart disease.
METHODS: This was a prospective open-label randomised control trial. In total, 50 infants with post tricuspid left to right shunt were enrolled in the study. In the intervention group, apart from breastfeeding, a minimum predetermined volume of expressed breast milk was targeted to be given by spoon. 30-50 kcal/kg/day was given by expressed breast milk by spoon-feeding. In the control group, the infants were given at least 8 feeds per 24 hours by direct breastfeeding. Both groups were followed up for 1 month and assessed for weight gain.
RESULTS: Despite a high rate of protocol breach in both groups (30% overall), infants in the intervention group had better weight gain at one-month follow-up compared to those in the control group, 780 ± 300 versus 530 ± 250 gm (p = 0.01).
CONCLUSIONS: In infants with left to right shunts, supplemental feeding of expressed breast milk by spoon along with breastfeeding resulted in significantly higher average weight gain at 30 days compared to the control group who received breastfeeding alone. Future studies with larger sample sizes and longer follow-ups need to be done to confirm the findings of this study.

BACKGROUND: Respiratory Syncytial Virus (RSV) infections may lead to severe consequences in infants born preterm with breathing problems (such as bronchopulmonary dysplasia (BPD) and respiratory distress syndrome (RDS)) or congenital heart diseases (CHD). Since studies investigating the influence of different gestational age (WGA) and concomitant specific comorbidities on the burden of RSV infections are scarce, the present study aimed to better characterize these high-risk populations in the Italian context.
METHODS: This retrospective, longitudinal and record-linkage cohort study involved infants born between 2017 and 2019 in Lazio Region (Italy) and is based on data extracted from administrative databases. Each infant was exclusively included in one of the following cohorts: (1) BPD-RDS (WGA ≤35 with or without CHD) or (2) CHD (without BPD and/or RDS) or (3) Preterm (WGA ≤35 without BPD (and/or RDS) or CHD). Each cohort was followed for 12 months from birth. Information related to sociodemographic at birth, and RSV and Undetermined Respiratory Agents (URA) hospitalizations and drug consumption at follow-up were retrieved and described.
RESULTS: A total of 8,196 infants were selected and classified as 1,084 BPD-RDS, 3,286 CHD and 3,826 Preterm. More than 30% of the BPD-RDS cohort was composed by early preterm infants (WGA ≤ 29) in contrast to the Preterm cohort predominantly constitute by moderate preterm infants (98.2%), while CHD infants were primarily born at term (83.9%). At follow-up, despite the cohorts showed similar proportions of RSV hospitalizations, in BPD-RDS cohort hospitalizations were more frequently severe compared to those occurred in the Preterm cohort (p<0.01), in the BPD-RDS cohort was also found the highest proportion of URA hospitalizations (p<0.0001). In addition, BPD-RDS infants, compared to those of the remaining cohorts, received more frequently prophylaxis with palivizumab (p<0.0001) and were more frequently treated with adrenergics inhalants, and glucocorticoids for systemic use.
CONCLUSIONS: The assessment of the study clinical outcomes highlighted that, the demographic and clinical characteristics at birth of the study cohorts influence their level of vulnerability to RSV and URA infections. As such, continuous monitoring of these populations is necessary in order to ensure a timely organization of health care system able to respond to their needs in the future.

Change in lifestyle leads to change in disease patterns from infectious diseases and malnutrition to degenerative diseases, such as coronary heart disease (CHD). The increasing prevalence of cardiovascular diseases among Indonesian workers and the general public will not only burden medical care expenses but also reduce work productivity, leading to more work-related injuries and work-related losses. The aim of this study was to determine the risk factors for CHD (age, sex, blood pressure, smoking, diabetes mellitus, body mass index, and weekly physical activity) and the CHD risk level among university workers. A cross-sectional study was conducted at workers at School of Medicine, Universitas Malikussaleh, Lhokseumawe, Indonesia. The risk level of CHD was calculated using Jakarta Cardiovascular Score and predicting model analyzed with multiple logistic regression model. Our data found that 58.2%, 25.5% and 16.3% of the university workers had low-, medium- and high-risk to have CHD. The final model indicted that the risk of heart disease was determined by gender, age, and the presence of hypertension and diabetes mellitus. Being male had odds ratio (OR) 30.84, aged >41 years old had OR 11.52, having hypertension had OR 4.87 and having diabetes mellitus had OR 13.99 for having high risk of CHD compared to female, those younger than 41 years old, having no hypertension and having no diabetes mellitus, respectively. In conclusion, our data suggests that more than 15% the respondents (university employees) have high risk of CHD and being male and older, and having hypertension and diabetes mellitus are associated with risk of CHD. Implantation of the preventive measures is therefore important to be implemented at the universities.

BACKGROUND: Tetralogy of Fallot is the most prevalent cyanotic CHD. With the advent of advanced surgical methods, the majority of tetralogy of Fallot patients reach adulthood. However, many need re-intervention for the residual anomalies including residual right ventricular outflow obstruction, pulmonary regurgitation, residual ventricular septal defects, and progressive aortic dilatation. Aortic dilation could lead to aortic regurgitation or dissection requiring surgical correction. In the current study, we aimed to determine the prevalence and outcomes of aortic root dilatation in adults with repaired tetralogy of Fallot in our tertiary care centre.
METHODS: In this retrospective study, 730 consecutive patients with history of repaired tetralogy of Fallot were included. Aortic diameter at the level of annulus, the sinus of Valsalva, sinotubular junction, and the ascending aorta as measured by echocardiography were evaluated. Prevalence of outcomes necessitating re-intervention including aortic regurgitation and dissection were recorded.
RESULTS: The mean size of annulus, sinus of Valsalva, sinotubular-junction, and ascending aorta in the latest available echocardiography of patients were 2.4+/-0.4 cm, 3.3+/-0.5 cm, 2.9+/-0.5cm, and 3.2+/-0.5cm, respectively. Prevalence of dilatation of sinus of Valsalva, dilation of Ascending aorta, sinotubular-junction, and aortic annulus was 28.7%, 21%, 8.3%, and 1 %, respectively. Five patients had severe aortic regurgitation (0.6%) and underwent surgical repair. One of these patients presented with acute aortic dissection.
CONCLUSIONS: Aortic dilation is common in tetralogy of Fallot but prevalence of redo surgery for aortic dilation, regurgitation, and adverse events including acute dissection is low.

OBJECTIVE: To assess whether competing risks help explain why regions with initially high serum cholesterol have higher mortality from coronary heart disease (CHD) and lower mortality from stroke and other major heart diseases, while the reverse is found for those with initially lower serum cholesterol.
METHODS: Ten cohorts of men (N = 9063) initially aged 40-59 in six countries were examined and followed for fatal outcomes for 60 years. Major cardiovascular disease (CVD) groups were CHD, stroke, and other Heart Diseases of Uncertain Etiology (HDUE), or the combination of stroke and HDUE (STHD), along with all other causes of death. Fine-Gray competing risk analysis was applied with CHD versus all other causes of death or STHD (direct mode) and all other causes of death or STHD versus CHD (inverse mode), and the effects of 19 covariates (of which 3 references) on the cause-specific hazard of the outcomes were assessed, thus investigating potential etiologic roles. A systematic comparison with results obtained by running the Cox model in direct and inverse modes with the same end-point results was also performed and illustrated graphically.
RESULTS: CHD mortality is bound to different risk factor relationships when compared with all other causes of death and with STHD. The role of serum cholesterol is crucial since, in both comparisons, by Fine-Gray, its coefficients are positive and significant for CHD and negative and significant for all other causes of death and STHD. Risk factor capabilities in specific outcome types of the CVD domain (CHD versus STHD) are different depending on the outcome types considered. Risk factor coefficients are smaller in Fine-Gray modelling and larger in the Cox model. Fine-Gray detects different risk factors whose coefficients may have opposite algebraic signs.
CONCLUSIONS: This is the first report whereby a large group of risk factors are investigated in connection with life-long CVD outcomes by Fine-Gray competing risk analysis, and a systematic comparison is performed with results obtained by Cox models in both direct and inverse modes. Subtypes of CVD mortality should be summed with full awareness that some risk factors vary by pathology, and they should at least be disentangled into CHD and STHD.

OBJECTIVE: This study examined the relationship between changes in physical activity and their impact on exercise capacity and health-related quality of life over a 3-year span in patients with CHD.
METHODS: We evaluated 99 young patients with CHD, aged 13-18 years at the outset. Physical activity, health-related quality of life, and exercise capacity were assessed via questionnaires and peak oxygen uptake measurements at baseline and after 3 years; changes in measures were estimated between the two time points and categorised into quartiles. Participants were stratified according to achieved (active) or not-achieved (inactive) recommended levels of physical activity (≥150 minutes/week) at both time points.
RESULTS: Despite increases in physical activity, exercise capacity, and health-related quality of life over 3 years, the changes were not statistically significant (all p > 0.05). However, a positive association was found between physical activity changes and exercise capacity (ß = 0.250, p = 0.040) and health-related quality of life improvements (ß = 0.380, p < 0.001). Those with the most pronounced physical activity increase showed notable exercise capacity (p < 0.001) and health-related quality of life increases (p < 0.001) compared with patients with the largest decline in physical activity. The active-inactive category demonstrated a notable decline in exercise capacity compared to the active-active group, while the inactive-active group showed health-related quality of life improvements.
CONCLUSIONS: Over 3 years, increased physical activity was consistently linked to increases in exercise capacity and health-related quality of life in patients with CHD, highlighting the potential of physical activity augmentation as an intervention strategy.

OBJECTIVE: Feeding difficulties after congenital heart surgery are a common concern for caregivers of children with CHD. Insight into the intricacies of their experience is lacking. With a better understanding, healthcare providers can continue to optimize the approach and support mechanisms for these families. This study will explore the psychosocial impacts on caregivers, define barriers to care, and identify areas to improve their care.
METHODS: This mixed-methods study combined semi-structured interviews with surveys. Purposive sampling targeted caregivers of a child who underwent heart surgery and was discharged with alternative enteral feeding access. A hybrid inductive-deductive methodology was used to analyse interview transcripts. Survey scores were compared to interview content for concordance.
RESULTS: Fifteen interviews were conducted with socio-demographically diverse caregivers. Feeding difficulties were often identified as their greatest challenge, with the laborious feeding schedule, sleep deprivation, and tube management being common contributors. Most caregivers described feeling overwhelmed and worried. Time-intensive feeding schedules and lack of appropriate childcare options precluded caregivers\' ability to work. Barriers to care included imperfect feeding education, proximity of specialist clinics, and issues with medical supply companies. Caregiver proposals for improved care addressed easing the transition home, improving emotional support mechanisms, and intensifying feeding therapy for expedited tube removal.
CONCLUSIONS: This study describes the psychosocial toll on the caregiver, typical barriers to care, and ideas for improved provision of care. These themes and ideas can be used to advance the family-centered approach to feeding difficulties after heart surgery.

OBJECTIVE: Necrotising enterocolitis is linked with altered intestinal microbiota, and caesarean birth is associated with imbalance of newborn intestinal microbiome. We aimed to investigate the role of delivery mode (vaginal or caesarean) and gestational age in the development of necrotising enterocolitis among term-born neonates (≥ 37 weeks) with CHD.
METHODS: Case-control study. We studied all newborns with CHD who underwent cardiac surgery during the neonatal (≤ 28 days of age) period, between 2007 and 2017. Totally, 60 cases of necrotising enterocolitis were matched (by year of birth and type of congenital heart lesion) with 180 controls (1:3 ratio). Multivariable conditional logistic regression was used to assess the study question.
RESULTS: The overall prevalence of necrotising enterocolitis was 6.3% in term-born newborns with CHD. Neonates with a left-ventricular outflow tract lesion or single ventricle lesion accounted for 55% (n = 33) of cases. 62% (n = 37) cases were in the modified Bell\'s stage 2 or more for necrotising enterocolitis classification. In multivariable modelling, gestational age at birth was not associated with the development of necrotising enterocolitis [adjusted odds ratio per week increase, 95% confidence interval: 1.20 (0.90-1.60)]. Birth by caesarean delivery (compared to vaginal) was strongly associated with development of necrotising enterocolitis [adjusted odds ratio (95% confidence interval): 2.64 (1.31-5.29)]. We failed to identify an association between preoperative enteral nutrition and necrotising enterocolitis.
CONCLUSIONS: This study showed a high risk of necrotising enterocolitis in newborns with critical CHD born via caesarean. This information is important given the high prevalence of planned birth by caesarean in newborns with CHD.

BACKGROUND: Many current studies have claimed that the actual risk of heart disease among women is equal to that in men. Using a large machine learning algorithm (MLA) data set to predict mortality in women, data mining techniques have been used to identify significant aspects of variables that help in identifying the primary causes of mortality within this target category of the population.
OBJECTIVE: This study aims to predict mortality caused by heart disease among women, using an artificial intelligence technique-based MLA.
METHODS: A retrospective design was used to retrieve big data from the electronic health records of 2028 women with heart disease. Data were collected for Jordanian women who were admitted to public health hospitals from 2015 to the end of 2021. We checked the extracted data for noise, consistency issues, and missing values. After categorizing, organizing, and cleaning the extracted data, the redundant data were eliminated.
RESULTS: Out of 9 artificial intelligence models, the Chi-squared Automatic Interaction Detection model had the highest accuracy (93.25%) and area under the curve (0.825) among the build models. The participants were 62.6 (SD 15.4) years old on average. Angina pectoris was the most frequent diagnosis in the women\'s extracted files (n=1,264,000, 62.3%), followed by congestive heart failure (n=764,000, 37.7%). Age, systolic blood pressure readings with a cutoff value of >187 mm Hg, medical diagnosis (women diagnosed with congestive heart failure were at a higher risk of death [n=31, 16.58%]), pulse pressure with a cutoff value of 98 mm Hg, and oxygen saturation (measured using pulse oximetry) with a cutoff value of 93% were the main predictors for death among women.
CONCLUSIONS: To predict the outcomes in this study, we used big data that were extracted from the clinical variables from the electronic health records. The Chi-squared Automatic Interaction Detection model-an MLA-confirmed the precise identification of the key predictors of cardiovascular mortality among women and can be used as a practical tool for clinical prediction.