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Although entirely preventable, rheumatic heart disease (RHD), a disease of poverty and social disadvantage resulting in high morbidity and mortality, remains an ever-present burden in low-income and middle-income countries (LMICs) and rural, remote, marginalised and disenfranchised populations within high-income countries. In late 2021, the National Heart, Lung, and Blood Institute convened a workshop to explore the current state of science, to identify basic science and clinical research priorities to support RHD eradication efforts worldwide. This was done through the inclusion of multidisciplinary global experts, including cardiovascular and non-cardiovascular specialists as well as health policy and health economics experts, many of whom also represented or closely worked with patient-family organisations and local governments. This report summarises findings from one of the four working groups, the Tertiary Prevention Working Group, that was charged with assessing the management of late complications of RHD, including surgical interventions for patients with RHD. Due to the high prevalence of RHD in LMICs, particular emphasis was made on gaining a better understanding of needs in the field from the perspectives of the patient, community, provider, health system and policy-maker. We outline priorities to support the development, and implementation of accessible, affordable and sustainable interventions in low-resource settings to manage RHD and related complications. These priorities and other interventions need to be adapted to and driven by local contexts and integrated into health systems to best meet the needs of local communities.

Background:CHDs are one of the most frequent congenital malformations, affecting one in hundred live births. In total, 70% will require treatment in the first year of life, but over 90% of cases in low- and middle-income countries receive no treatment or suboptimal treatment. As a result, CHDs are responsible for 66% of preventable deaths due to congenital malformations in low- and middle-income countries. This study examines the unmet need of congenital cardiac care around the world based on the global burden of disease.Materials and methods:CHD morbidity and mortality data for 2006, 2011, and 2016 were collected from the Institute for Health Metrics and Evaluation Global Burden of Disease Results Tool and analysed longitudinally to assess trends in excess morbidity and mortality.Results:Between 2006 and 2016, a 20.7% reduction in excess disability-adjusted life years and 20.6% reduction in excess deaths due to CHDs were observed for children under 15. In 2016, excess global morbidity and mortality due to CHDs remained high with 14,788,418.7 disability-adjusted life years and 171,761.8 paediatric deaths, respectively. In total, 90.2% of disability-adjusted life years and 91.2% of deaths were considered excess.Conclusion:This study illustrates the unmet need of congenital cardiac care around the world. Progress has been made to reduce morbidity and mortality due to CHDs but remains high and largely treatable around the world. Limited academic attention for global paediatric cardiac care magnifies the lack of progress in this area.

Endorsement of global humanitarian interventions is based on either proven cost-effectiveness or perceived public health benefits. The cost-effectiveness and long-term benefits of global humanitarian pediatric cardiac surgery are unknown, and funding for this intervention is insufficient. To determine the cost-effectiveness of the intervention (multiple 2-week-long humanitarian pediatric cardiac surgery program assistance trips to various low- and middle-income countries [LMICs]) and to produce a measure of the long-lasting effects of global humanitarian programs. International, multicenter cost-effectiveness analysis of a cohort of children (aged <16 years) undergoing surgical treatment of congenital heart disease during 2015 in LMICs, including China, Macedonia, Honduras, Iran, Iraq, Libya, Nigeria, Pakistan, Russia, and Ukraine. The study also assessed estimated improvement in the United Nations Human Development Indicators (life expectancy, years of schooling, and gross national income) for each individual survivor, as a proxy for long-term benefits of the intervention. The primary outcome was cost-effectiveness of the intervention. The secondary outcomes were potential gains in life expectancy, years of schooling, and gross national income per capita for each survivor. During 2015, 446 patients (192 [43%] female; mean [SD] age, 3.7 [5.4] years) were served in 10 LMICs at an overall cost of $3 210 873. Of them, 424 were children. The cost-effectiveness of the intervention was $171 per disability-adjusted life-year averted. Each survivor in the cohort (390 of 424) potentially gained 39.9 disability-adjusted life-years averted, 3.5 years of schooling, and $159 533 in gross national income per capita during his or her extended lifetime at purchasing power parity and 3% discounting. Humanitarian pediatric cardiac surgery in LMICs is highly cost-effective. It also leaves behind a lasting humanitarian footprint by potentially improving individual development indices.

In countries with ample resources, no debate exists as to whether heart surgery should be provided. However, where funding is limited, what responsibility exists to care for children with congenital heart defects? If children have a \"right\" to surgical treatment, to whom is the \"duty\" to provide it assigned? These questions are subjected to ethical analysis. Examination is initially based on the four principles of medical ethics: autonomy, beneficence, non-maleficence, and justice. Consideration of beneficence and justice is expanded using a consequentialist approach. Social structures, including governments, exist to foster the common good. Society, whether by means of government funding or otherwise, has the responsibility, according to the means available, to assure health care for all based on the principles of beneficence, non-maleficence, and justice. In wealthy countries, adequate resources exist to fund appropriate treatment; hence it should be provided to all based on distributive justice. In resource-limited countries, however, decisions regarding provision of care for expensive or complex health problems must be made with consideration for broader effects on the general public. Preliminary data from cost-effectiveness analysis indicate that many surgical interventions, including cardiac surgery, may be resource-efficient. Given that information, utilitarian ethical analysis supports dedication of resources to congenital heart surgery in many low-income countries. In the poorest countries, where access to drinking water and basic nutrition is problematic, it will often be more appropriate to focus on these issues first. Ethical analysis supports dedication of resources to congenital heart surgery in all but the poorest countries.

Background:The perioperative complications rate in paediatric cardiac surgery, as well as the failure-to-rescue impact, is less known in low- and middle-income countries.Aim:To evaluate perioperative complications rate, mortality related to complications, different patients’ demographics, and procedural risk factors for perioperative complication and post-operative death.Methods:Risk factors for perioperative complications and operative mortality were assessed in a retrospective single-centre study which included 296 consecutive children undergoing cardiac surgery.Results:Overall mortality was 5.7%. Seventy-three patients (24.7%) developed 145 perioperative complications and had 17 operative mortalities (23.3%). There was a strong association between the number of perioperative complications and mortality – 8.1% among patients with only 1 perioperative complication, 35.3% – with 2 perioperative complications, and 42.1% – with 3 or more perioperative complications (p = 0.007). Risk factors of perioperative complications were younger age (odds ratio 0.76; (95% confidence interval 0.61, 0.93), previous cardiac surgery (odds ratio 3.5; confidence interval 1.33, 9.20), extracardiac structural anomalies (odds ratio 3.03; confidence interval 1.27, 7.26), concomitant diseases (odds ratio 3.23; confidence interval 1.34, 7.72), and cardiopulmonary bypass (odds ratio 6.33; confidence interval 2.45, 16.4), whereas the total number of perioperative complications per patient was the only predictor of operative death (odds ratio 1.89; confidence interval 1.06, 3.37).Conclusions:In a program with limited systemic resources, failure-to-rescue is a major contributor to operative mortality in paediatric cardiac surgery. Despite the comparable crude mortality, the operative mortality among patients with perioperative complications in our series was significantly higher than in the developed world. A number of initiatives are needed in order to improve failure-to-rescue rates in low- and middle-income countries.

The global burden of paediatric and congenital heart disease (PCHD) is substantial. We propose a novel public health framework with recommendations for developing effective and safe PCHD services in low-income and middle-income countries (LMICs). This framework was created by the Global Initiative for Children’s Surgery Cardiac Surgery working group in collaboration with a group of international rexperts in providing paediatric and congenital cardiac care to patients with CHD and rheumatic heart disease (RHD) in LMICs. Effective and safe PCHD care is inaccessible to many, and there is no consensus on the best approaches to provide meaningful access in resource-limited settings, where it is often needed the most. Considering the high inequity in access to care for CHD and RHD, we aimed to create an actionable framework for health practitioners, policy makers and patients that supports treatment and prevention. It was formulated based on rigorous evaluation of available guidelines and standards of care and builds on a consensus process about the competencies needed at each step of the care continuum. We recommend a tier-based framework for PCHD care integrated within existing health systems. Each level of care is expected to meet minimum benchmarks and ensure high-quality and family centred care. We propose that cardiac surgery capabilities should only be developed at the more advanced levels on hospitals that have an established foundation of cardiology and cardiac surgery services, including screening, diagnostics, inpatient and outpatient care, postoperative care and cardiac catheterisation. This approach requires a quality control system and close collaboration between the different levels of care to facilitate the journey and care of every child with heart disease. This effort was designed to guide readers and leaders in taking action, strengthening capacity, evaluating impact, advancing policy and engaging in partnerships to guide facilities providing PCHD care in LMICs.

Surgery for CHD has been slow to develop in parts of the former Soviet Union. The impact of an 8-year surgical assistance programme between an emerging centre and a multi-disciplinary international team that comprised healthcare professionals from developed cardiac programmes is analysed and presented.Material and methodsThe international paediatric assistance programme included five main components - intermittent clinical visits to the site annually, medical education, biomedical engineering support, nurse empowerment, and team-based practice development. Data were analysed from visiting teams and local databases before and since commencement of assistance in 2007 (era A: 2000-2007; era B: 2008-2015). The following variables were compared between periods: annual case volume, operative mortality, case complexity based on Risk Adjustment for Congenital Heart Surgery (RACHS-1), and RACHS-adjusted standardised mortality ratio. A total of 154 RACHS-classifiable operations were performed during era A, with a mean annual case volume by local surgeons of 19.3 at 95% confidence interval 14.3-24.2, with an operative mortality of 4.6% and a standardised mortality ratio of 2.1. In era B, surgical volume increased to a mean of 103.1 annual cases (95% confidence interval 69.1-137.2, p<0.0001). There was a non-significant (p=0.84) increase in operative mortality (5.7%), but a decrease in standardised mortality ratio (1.2) owing to an increase in case complexity. In era B, the proportion of local surgeon-led surgeries during visits from the international team increased from 0% (0/27) in 2008 to 98% (58/59) in the final year of analysis. The model of assistance described in this report led to improved adjusted mortality, increased case volume, complexity, and independent operating skills.

It is accepted treatment to give vasopressin to adults in postcardiotomy shock, but such use in children is controversial. Cardiopulmonary bypass is presumed to attenuate the normal endogenous vasopressin response to shock. We hypothesized that levels of vasopressin in children are altered by bypass, and that children having low endogenous levels perioperatively are more likely to develop hypotension, or require vasopressors. Serial levels of vasopressin were assessed prospectively in children undergoing bypass at a single center. Of 61 eligible patients, we enrolled 39 (63%). Their median age was 5 months. The mean level of vasopressin prior to bypass was 18.6 picograms per millilitre, with an interquartile range from 2.6 to 11.4. Levels of vasopressin peaked during bypass at 87.1, this being highly significant compared to baseline (p < 0.00005), remained high for 12 hours at a mean of 73.5, again significantly different from baseline (p = 0.002), were falling at 24 hours, with a mean of 28.1 (p = 0.04), and had returned to baseline by 48 hours, when the mean was 7.4 (p = 0.3). Age, gender, and the category for surgical risk had no influence on the levels of vasopressin. There was no statistically significant relationship between the measured levels and hypotension or the requirement for vasopressors, although a few persistently hypotensive patients had high levels subsequent to bypass. Higher levels correlated with higher levels of sodium in the serum (r(s) = 0.37, p < 0.00005), higher osmolality (r(s) = 0.37, p < 0.00005), and positive fluid balance (r(s) = 0.23, p < 0.008). Preoperative use of inhibitors of angiotensin converting enzyme, preoperative congestive cardiac failure, and longer periods of bypass predicted higher levels during the first eight postoperative hours. Children do not have deficient endogenous levels of vasopressin following bypass, and lower levels are not associated with hypotension. Any therapeutic efficacy of infusion of vasopressin for post-cardiotomy shock in children is likely due to reasons other than physiologic replacement.

The use of reference materials (RM) is one of the principal tools used for assurance and quality control in food microbiology laboratories. In Brazil, Anvisa RDC n degree 12/01 specifies the enumeration of coagulase-positive staphylococcus (CPS) as one of the parameters for evaluating cheese quality. The main challenge in the production of RM destined for microbiological assays is the natural instability of the microorganisms, which makes it difficult to develop and maintain them. This study aimed to produce a quantitative RM for use in enumeration assays of CPS in cheese matrixes. A sample of an ultra-filtered cheese with a CPS count of <10 CFU/g and a total n degree of viable aerobes of 1.2 10 super( 3) CFU/g was used as the matrix to produce the RM. The matrix was distributed in flasks, contaminated with specific concentrations of the target bacteria and submitted to freeze-dryilng. Sucrose was used as the cryo-protector. The RM produced was considered homogeneous and stable at less than or equal to -70 degree C during the entire study period (10 months). The material was shown to be stable at 4, 25, 30 and 35 degree C for 4 days, although the results indicated a decrease in cell concentration at 35 degree C. At -20 degree C the RM was stable for 48 days. It was concluded that the material showed all the necessary requirements for a quality RM and could be transported to the laboratories taking part in a proficiency test at up to 35 degree C for up to 4 days, since the results indicated maintenance of the cell concentrations during this period. This is the first study to describe a methodology for producing MR containing CPS in a cheese matrix.

The use of reference materials (RM) is one of the principal tools used for assurance and quality control in food microbiology laboratories. In Brazil, Anvisa RDC n° 12/01 specifies the enumeration of coagulase-positive staphylococcus (CPS) as one of the parameters for evaluating cheese quality. The main challenge in the production of RM destined for microbiological assays is the natural instability of the microorganisms, which makes it difficult to develop and maintain them. This study aimed to produce a quantitative RM for use in enumeration assays of CPS in cheese matrixes. A sample of an ultra-filtered cheese with a CPS count of <10 CFU/g and a total n° of viable aerobes of 1.2 × 10^sup 3^ CFU/g was used as the matrix to produce the RM. The matrix was distributed in flasks, contaminated with specific concentrations of the target bacteria and submitted to freeze-dryilng. Sucrose was used as the cryo-protector. The RM produced was considered homogeneous and stable at ≤ -70°C during the entire study period (10 months). The material was shown to be stable at 4, 25, 30 and 35 °C for 4 days, although the results indicated a decrease in cell concentration at 35 °C. At -20 °C the RM was stable for 48 days. It was concluded that the material showed all the necessary requirements for a quality RM and could be transported to the laboratories taking part in a proficiency test at up to 35 °C for up to 4 days, since the results indicated maintenance of the cell concentrations during this period. This is the first study to describe a methodology for producing MR containing CPS in a cheese matrix. [PUBLICATION ABSTRACT]