Australian National Standards of Care for Childhood-onset Heart Disease (CoHD Standards). 1st Edition.

These first Australian National Standards of Care for Childhood-onset Heart Disease (CoHD Standards) have been developed to inform the healthcare requirements for CoHD services and enable all Australian patients, families and carers impacted by CoHD (paediatric CoHD and adult congenital heart disease [ACHD]) to live their best and healthiest lives. The CoHD Standards are designed to provide the clarity and certainty required for healthcare services to deliver excellent, comprehensive, inclusive, and equitable CoHD care across Australia for patients, families and carers, and offer an iterative roadmap to the future of these services. The CoHD Standards provide a framework for excellent CoHD care, encompassing key requirements and expectations for whole-of-life, holistic and connected healthcare service delivery. The CoHD Standards should be implemented in health services in conjunction with the National Safety and Quality Health Service Standards developed by the Australian Commission on Safety and Quality in Health Care. All healthcare services should comply with the CoHD Standards, as well as working to their organisation's or jurisdiction's agreed clinical governance framework, to guide the implementation of structures and processes that support safe care.

Combining proteins with n-3 PUFAs (EPA + DHA) and their inflammation pro-resolution mediators for preservation of skeletal muscle mass.

The optimal feeding strategy for critically ill patients is still debated, but feeding must be adapted to individual patient needs. Critically ill patients are at risk of muscle catabolism, leading to loss of muscle mass and its consequent clinical impacts. Timing of introduction of feeding and protein targets have been explored in recent trials. These suggest that "moderate" protein provision (maximum 1.2 g/kg/day) is best during the initial stages of illness. Unresolved inflammation may be a key factor in driving muscle catabolism. The omega-3 (n-3) fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are substrates for synthesis of mediators termed specialized pro-resolving mediators or SPMs that actively resolve inflammation. There is evidence from other settings that high-dose oral EPA + DHA increases muscle protein synthesis, decreases muscle protein breakdown, and maintains muscle mass. SPMs may be responsible for some of these effects, especially upon muscle protein breakdown. Given these findings, provision of EPA and DHA as part of medical nutritional therapy in critically ill patients at risk of loss of muscle mass seems to be a strategy to prevent the persistence of inflammation and the related anabolic resistance and muscle loss.

Transition to Value-based Healthcare: Development, Implementation, and Results of an Optimal Surgical Care Framework at a National Cancer Institute-designated Comprehensive Cancer Center.

BACKGROUND: The continued rise in healthcare expenditures has not produced commensurate improvements in patient outcomes, leading US healthcare stakeholders to emphasize value-based care. Transition to such a model requires all team members to adopt a new strategic and organizational framework. OBJECTIVE: To describe and report a strategy for the implementation of a novel patient-centered value-based "optimal surgical care" (OSC) framework, with validation and cost analysis in kidney surgery. DESIGN, SETTING, AND PARTICIPANTS: An observational study of care episodes at a single institution from 2014 to 2019 was conducted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multidisciplinary teams defined OSC by core and procedure-specific metrics using a combination of provider-based ("bottom-up") and "clinical leadership"-based ("top-down") strategies. Baseline OSC rates across were established, while identifying proportions of OSC achieved by coefficient of variation (CV) in total direct costs. Multivariable linear regression comparing cost between OSC and non-OSC encounters was performed, adjusting for patient characteristics. RESULTS AND LIMITATIONS: An analysis of 30 261 perioperative care episodes was performed. Following the implementation of an OSC framework, there was an increase in OSC rates across all procedure buckets using core (25%) and procedure-specific (26%) metrics. Among the tumors tested, kidney cancer surgical episodes held the highest OSC rate improvement (67%) with lowest variability in cost (CV 0.5). OSC was associated with significant total cost savings across all tumor types after adjusting for inflation (p < 0.05). Compared with non-OSC episodes, a significant reduction in the cost ratio of OSC was noted for renal surgery (p < 0.01), with estimated costs savings of $2445.87 per OSC encounter. CONCLUSIONS: Institutional change directing efforts toward optimizing surgical care and emphasizing value rather than focusing solely on expense reduction is associated with improved outcomes, while potentially reducing costs. The strategy for implementation requires serial performance analyses, engaging and educating providers, and continuous ongoing adjustments to achieve durable results. PATIENT SUMMARY: In this study, we report our strategy and outcomes for transitioning to a value-based healthcare model using a novel "optimal surgical care" framework at a National Cancer Institute-designated comprehensive cancer center. We observed an increase in optimal surgical care episodes across all specialties after 5 yr, with a potential associated reduction in cost expenditure. We conclude that the key to a successful and sustained transition is the implementation strategy, focusing on continual review and provider engagement.

Assessing the Impact of High Photon Energy Wavelengths on the Treatment of Chronic Neck and Shoulder Pain.

The effect of low-level laser therapy with high photon energy wavelengths, green and violet, for treating chronic musculoskeletal pain was examined in the first-ever clinical trial of its kind. Participants (n = 43) underwent a single 13-minute laser session. The primary measure of effectiveness was the change in initial visual analog pain (VAS) scores observed three minutes posttreatment. The success of a participant was defined in advance as a reduction of ≥30% in VAS scores, while the success of the study was predetermined as achieving a 65 ± 5% success rate among individual participants. Results demonstrated subjects' VAS pain scores decreased from 71.79 to 34.02 (p < 0.0001), while most participants in the study (81.4%) achieved a ≥30% decrease in pain scores. The findings from this clinical investigation provided substantial support for the first Food and Drug Administration clearance (K221987) for the combined application of green and violet lasers.

A review of recent studies on the enrichment of eggs and poultry meat with omega-3 polyunsaturated fatty acids: novel findings and unanswered questions.

Studies from our laboratory over the past decade have yielded new information with regard to the dietary enrichment of eggs and poultry meat with omega-3 (n-3) polyunsaturated fatty acids (PUFA) but have also generated a number of unanswered questions. In this review, we summarize the novel findings from this work, identify knowledge gaps, and offer possible explanations for some perplexing observations. Specifically discussed are: 1) Why feeding laying hens and broilers an oil rich in stearidonic acid (SDA; 18:4 n-3), which theoretically bypasses the putative rate-limiting step in the hepatic n-3 PUFA biosynthetic pathway, does not enrich egg yolks and tissues with very long-chain (VLC; ≥20 C) n-3 PUFA to the same degree as obtained by feeding birds oils rich in preformed VLC n-3 PUFA; 2) Why in hens fed an SDA-rich oil, SDA fails to accumulate in egg yolk but is readily incorporated into adipose tissue; 3) How oils rich in oleic acid (OA; 18:1 n-9), when co-fed with various sources of n-3 PUFA, attenuates egg and tissue n-3 PUFA contents or rescues egg production when co-fed with a level of docosahexaenoic acid (DHA; 22:6 n-3) that causes severe hypotriglyceridemia; and 4) Why the efficiency of VLC n-3 PUFA deposition into eggs and poultry meat is inversely related to the dietary content of α-linolenic acid (ALA; 18:3 n-3), SDA, or DHA.

Effects of dietary copper and zinc hydroxychloride supplementation on bone development, skin quality and hematological parameters of broilers chickens.

This study was carried out to evaluate the effects of supplementation with different levels of copper (Cu) and zinc (Zn), using two mineral sources (sulphate and hydroxy forms), on the bone characteristics, skin strength/elasticity, and haematological parameters of broilers. A total of 1792 1-day-old male Cobb-500 broiler chickens were randomly distributed among eight dietary treatments, using Cu sulphate (CSM) or hydroxychloride (CHC), and Zn sulphate (ZSM) or hydroxychloride (ZHC). The dietary treatments were as follows: (1) low-CSM/high-ZSM, (2) high-CSM/high-ZSM, (3) low-CHC/low-ZHC, (4) low-CHC/medium-ZHC, (5) low-CHC/high-ZHC, (6) high-CHC/low-ZHC, (7) high-CHC/medium-ZHC, and (8) high-CHC/high-ZHC. On Day 42, blood samples were collected from one bird/pen to analyze the haematological parameters. Finally, two birds/pen were slaughtered, and the tibia and femur were collected to analyze the quality of bone and skin. The means were subjected to ANOVA and, when significant, compared by Tukey's test (p < 0.05) or Dunnett's (p < 0.05) test. The haematological parameters were not influenced by mineral supplementation. However, the inclusion of low ZHC enhanced the skin strength compared to high ZHC (p = 0.046). Furthermore, the bone mineral density of the tibia proximal epiphysis, tibia ash and tibia mineral content were positively improved with supplementation of low-CHC/medium-ZHC compared to high-CHC/medium-ZHC. This study demonstrated that hydroxy compounds are potential alternatives for replacing sulphate supplements in broiler diets. Moreover, among the Cu and Zn levels, the low CHC (15 mg/kg) and medium ZHC (100 mg/kg) improved bone development and skin integrity, suggesting that the combination of Cu and Zn can be a nutritional strategy to prevent the incidence of leg disorders in broilers.

Comparison of Ahiflower oil containing stearidonic acid to a high-alpha-linolenic acid flaxseed oil at two dietary levels on omega-3 enrichment of egg yolk and tissues in laying hens.

Enrichment of egg yolks with very long chain omega-3 fatty acids (VLCn-3 FA) is of interest because of their beneficial effects on human health. The ability of Ahiflower® oil (AHI; Buglossoides arvensis), which is naturally rich in stearidonic acid (SDA), and a high-alpha-linolenic acid (ALA) flaxseed (FLAX) oil to enrich eggs and tissues of laying hens with VLCn-3 FA was investigated. Forty 54-week-old Hy-Line W-36 White Leghorn hens were fed a diet that contained soybean oil (control; CON) or AHI or FLAX oils at 7.5 or 22.5 g/kg of the diet in substitution for the soybean oil for 28 days. Dietary treatments had no effects on egg number or components or follicle development. Total VLCn-3 FA contents of egg yolk, liver, breast, thigh, and adipose tissue were greater in the n-3 treatments compared to CON, with the greatest increase observed at the higher oil level, especially for AHI oil which had the greater VLCn-3 enrichment than FLAX in yolk (p < 0.001). Efficiency of VLCn-3 enrichment of egg yolks was decreased with n-3 oils and by increasing oil level with lowest efficiency at 22.5 g/kg FLAX. In conclusion, both SDA-rich (AHI) and ALA-rich (FLAX) oils increased VLCn-3 FA deposition into egg yolks and hens' tissues, but dietary AHI oil promoted a greater enrichment than comparative amounts of FLAX oil, especially in liver and egg yolks.

A Perspective on Current Therapeutic Molecule Screening Methods Against 'Candidatus Liberibacter asiaticus', the Presumed Causative Agent of Citrus Huanglongbing.

Huanglongbing (HLB), referred to as citrus greening disease, is a bacterial disease impacting citrus production worldwide and is fatal to young trees and mature trees of certain varieties. In some areas, the disease is devastating the citrus industry. A successful solution to HLB will be measured in economics: citrus growers need treatments that improve tree health, fruit production, and most importantly, economic yield. The profitability of citrus groves is the ultimate metric that truly matters when searching for solutions to HLB. Scientific approaches used in the laboratory, greenhouse, or field trials are critical to the discovery of those solutions and to estimate the likelihood of success of a treatment aimed at commercialization. Researchers and the citrus industry use a number of proxy evaluations of potential HLB solutions; understanding the strengths and limitations of each assay, as well as how best to compare different assays, is critical for decision-making to advance therapies into field trials and commercialization. This perspective aims to help the reader compare and understand the limitations of different proxy evaluation systems based on the treatment and evaluation under consideration. The researcher must determine the suitability of one or more of these metrics to identify treatments and predict the usefulness of these treatments in having an eventual impact on citrus production and HLB mitigation. As therapies advance to field trials in the next few years, a reevaluation of these metrics will be useful to guide future research efforts on strategies to mitigate HLB and vascular bacterial pathogens in other perennial crops.

Trends and perspectives on the commercialization of bioactive glasses.

At least 25 bioactive glass (BG) medical devices have been approved for clinical use by global regulatory agencies. Diverse applications include monolithic implants, bone void fillers, dentin hypersensitivity agents, wound dressing, and cancer therapeutics. The morphology and delivery systems of bioactive glasses have evolved dramatically since the first devices based on 45S5 Bioglass®. The particle size of these devices has generally decreased with the evolution of bioactive glass technology but primarily lies in the micron size range. Morphologies have progressed from glass monoliths to granules, putties, and cements, allowing medical professionals greater flexibility and control. Compositions of these commercial materials have primarily relied on silicate-based systems with varying concentrations of sodium, calcium, and phosphorus. Furthermore, therapeutic ions have been investigated and show promise for greater control of biological stimulation of genetic processes and increased bioactivity. Some commercial products have exploited the borate and phosphate-based compositions for soft tissue repair/regeneration. Mesoporous BGs also promise anticancer therapies due to their ability to deliver drugs in combination with radiotherapy, photothermal therapy, and magnetic hyperthermia. The objective of this article is to critically discuss all clinically approved bioactive glass products. Understanding essential regulatory standards and rules for production is presented through a review of the commercialization process. The future of bioactive glasses, their promising applications, and the challenges are outlined. STATEMENT OF SIGNIFICANCE: Bioactive glasses have evolved into a wide range of products used to treat various medical conditions. They are non-equilibrium, non-crystalline materials that have been designed to induce specific biological activity. They can bond to bone and soft tissues and contribute to their regeneration. They are promising in combating pathogens and malignancies by delivering drugs, inorganic therapeutic ions, and heat for magnetic-induced hyperthermia or laser-induced phototherapy. This review addresses each bioactive glass product approved by regulatory agencies for clinical use. A review of the commercialization process is also provided with insight into critical regulatory standards and guidelines for manufacturing. Finally, a critical evaluation of the future of bioactive glass development, applications, and challenges are discussed.

Plasma levels of carboxylic acids are markers of early kidney dysfunction in young people with type 1 diabetes.

BACKGROUND: We compared plasma metabolites of amino acid oxidation and the tricarboxylic acid (TCA) cycle in youth with and without type 1 diabetes mellitus (T1DM) and related the metabolites to glomerular filtration rate (GFR), renal plasma flow (RPF), and albuminuria. Metabolites associated with impaired kidney function may warrant future study as potential biomarkers or even future interventions to improve kidney bioenergetics. METHODS: Metabolomic profiling of fasting plasma samples using a targeted panel of 644 metabolites and an untargeted panel of 19,777 metabolites was performed in 50 youth with T1DM ≤ 10 years and 20 controls. GFR and RPF were ascertained by iohexol and p-aminohippurate clearance, and albuminuria calculated as urine albumin to creatinine ratio. Sparse partial least squares discriminant analysis and moderated t tests were used to identify metabolites associated with GFR and RPF. RESULTS: Adolescents with and without T1DM were similar in age (16.1 ± 3.0 vs. 16.1 ± 2.9 years) and BMI (23.4 ± 5.1 vs. 22.7 ± 3.7 kg/m2), but those with T1DM had higher GFR (189 ± 40 vs. 136 ± 22 ml/min) and RPF (820 ± 125 vs. 615 ± 65 ml/min). Metabolites of amino acid oxidation and the TCA cycle were significantly lower in adolescents with T1DM vs. controls, and the measured metabolites were able to discriminate diabetes status with an AUC of 0.82 (95% CI: 0.71, 0.93) and error rate of 0.21. Lower glycine (r:-0.33, q = 0.01), histidine (r:-0.45, q < 0.001), methionine (r: -0.29, q = 0.02), phenylalanine (r: -0.29, q = 0.01), serine (r: -0.42, q < 0.001), threonine (r: -0.28, q = 0.02), citrate (r: -0.35, q = 0.003), fumarate (r: -0.24, q = 0.04), and malate (r: -0.29, q = 0.02) correlated with higher GFR. Lower glycine (r: -0.28, q = 0.04), phenylalanine (r:-0.3, q = 0.03), fumarate (r: -0.29, q = 0.04), and malate (r: -0.5, q < 0.001) correlated with higher RPF. Lower histidine (r: -0.28, q = 0.02) was correlated with higher mean ACR. CONCLUSIONS: In conclusion, adolescents with relatively short T1DM duration exhibited lower plasma levels of carboxylic acids that associated with hyperfiltration and hyperperfusion. TRIAL REGISTRATION: ClinicalTrials.gov NCT03618420 and NCT03584217 A higher resolution version of the Graphical abstract is available as Supplementary information.

Feeding laying hens docosa hexaenoic acid-rich microalgae oil at 40 g/kg diet causes hypotriglyceridemia, depresses egg production, and attenuates expression of key genes affecting hepatic triglyceride synthesis and secretion, but is rescued by dietary co-supplementation of high-oleic sunflower oil.

The primary goal of this study was to investigate the effect of feeding White Leghorn hens graded levels of a docosahexaenoic acid (DHA)-rich microalgae oil (MAO) on productive performance and enrichment of eggs with very long-chain (VLC) omega-3 (n-3) polyunsaturated fatty acids (PUFA). Forty-nine-week-old hens (8 per diet) were fed the following diets for 28 d: 1) A corn-soybean meal-based diet with no supplemental oil (CON); 2) CON + 10 g/kg MAO; 3) CON + 20 g/kg MAO; 4) CON + 30 g/kg MAO; 5) CON + 40 g/kg MAO; 6) CON + 40 g/kg MAO + 20 g/kg high-oleic sunflower oil (HOSO); and 7) CON + 40 g/kg MAO + 40 g/kg HOSO. Diets 6 and 7 were included because we previously reported that co-feeding high-oleic acid oils with n-3 PUFA-containing oils attenuated egg yolk n-3 PUFA contents vs. feeding hens the n-3 oils alone. All data were collected on an individual hen basis. Egg VLC n-3 PUFA enrichment plateaued, in terms of statistical significance, at the 30 g/kg MAO level (266 mg/yolk). Hens fed 40 g/kg MAO had greatly attenuated measures of hen performance, marked liver enlargement, an altered ovarian follicle hierarchy, greatly lowered circulating triglyceride levels, and depressed hepatic expression of key genes involved in triglyceride synthesis and secretion. As compared to hens fed 40 g/kg MAO alone, feeding hens 40 g/kg MAO co-supplemented with HOSO (Diets 6 and 7) restored egg production, ovarian morphology, and all other measures of hen productive performance to CON levels, elevated plasma triglyceride levels, prevented liver enlargement, and increased the hepatic expression of key genes involved in triglyceride synthesis and secretion. In conclusion, MAO can greatly enrich hens' eggs with VLC n-3 PUFA, but its recommended dietary inclusion should not exceed 20 g/kg. This would allow for near-maximal yolk VLC n-3 PUFA enrichment without impairing hen productive performance, altering the ovarian follicle hierarchy or, based on the work of others, presumably imparting off-flavors in the egg.

Mechanistic Understanding of the Effects of Pectin on In Vivo Starch Digestion: A Review.

Obesity and type II diabetes are closely related to the rapid digestion of starch. Starch is the major food-energy source for most humans, and thus knowledge about the regulation of starch digestion can contribute to prevention and improved treatment of carbohydrate metabolic disorders such as diabetes. Pectins are plant polysaccharides with complex molecular structures and ubiquitous presence in food, and have diverse effects on starch digestion. Pectins can favorably regulate in vivo starch digestion and blood glucose level responses, and these effects are attributed to several reasons: increasing the viscosity of digesta, inhibiting amylase activity, and regulating some in vivo physiological responses. Pectins can influence starch digestion via multiple mechanisms simultaneously, in ways that are highly structure-dependent. Utilizing the multi-functionalities of pectin could provide more ways to design low glycemic-response food and while avoiding the unpalatable high viscosity in food by which is commonly caused by many other dietary fibers.

A Road Map for Academic Developmental-Behavioral Pediatric Practices to Increase Access.

ABSTRACT: There are currently at least 19 million children and adolescents in the United States with disorders of development (learning disorders, attention-deficit/hyperactivity disorder, intellectual disabilities, autism, motor incoordination/cerebral palsy, etc.) and only approximately 800 board-certified developmental-behavioral pediatricians (DBPs) practicing nationally. Given the astronomical mismatch between the number of children and adolescents with developmental disorders and the number of board-certified DBPs, developmental-behavioral pediatric consultations are likely the most inaccessible in all of medicine. With the goal of increasing access to these consultations, an academic developmental-behavioral practice in a large urban hospital system developed a longitudinal "Road Map," led by our team of social workers, which is designed to provide such services while continuing to focus DBP efforts on initial consultative evaluation and diagnosis of as many children as possible. The programs that this new Road Map has provided have allowed the DBP practice not only to increase access to developmental evaluations but also to provide more holistic and targeted care from the point of being added to the waiting list and then throughout the life span at vital transition periods. Especially given the extreme mismatch between the scarce number of practicing DBPs and the prodigious number of pediatric patients with disorders of development, our hope is that other centers will consider replicating this innovative care model to address the ever-growing need for specialized DBP consultation and longitudinal wraparound care for our patients and families.

Randomized, Placebo-Controlled Phase 2b Study to Evaluate the Safety and Efficacy of Recombinant Human Lecithin Cholesterol Acyltransferase in Acute ST-Segment-Elevation Myocardial Infarction: Results of REAL-TIMI 63B.

BACKGROUND: High-density lipoprotein plays a key role in reverse cholesterol transport. In addition, high-density lipoprotein particles may be cardioprotective and reduce infarct size in the setting of myocardial injury. Lecithin-cholesterol acyltransferase is a rate-limiting enzyme in reverse cholesterol transport. MEDI6012 is a recombinant human lecithin-cholesterol acyltransferase that increases high-density lipoprotein cholesterol. Administration of lecithin-cholesterol acyltransferase has the potential to reduce infarct size and regress coronary plaque in acute ST-segment-elevation myocardial infarction. METHODS: REAL-TIMI 63B (A Randomized, Placebo­controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction) was a phase 2B multinational, placebo-controlled, randomized trial. Patients with ST-segment-elevation myocardial infarction within 6 hours of symptom onset and planned for percutaneous intervention were randomly assigned 2:1 to MEDI6012 (2- or 6-dose regimen) or placebo and followed for 12 weeks. The primary outcome was infarct size as a percentage of left ventricular mass by cardiac MRI at 10 to 12 weeks, with the primary analysis in patients with TIMI Flow Grade 0 to 1 before percutaneous intervention who received at least 2 doses of MEDI6012. The secondary outcome was change in noncalcified plaque volume on coronary computed tomographic angiography from baseline to 10 to 12 weeks with the primary analysis in patients who received all 6 doses of MEDI6012. RESULTS: A total of 593 patients were randomly assigned. Patients were a median of 62 years old, 77.9% male, and 95.8% statin naive. Median time from symptom onset to randomization was 146 (interquartile range [IQR], 103-221) minutes and from hospitalization to randomization was 12.7 (IQR, 6.6-24.0) minutes, and the first dose of drug was administered a median of 8 (IQR, 3-13) minutes before percutaneous intervention. The index myocardial infarction was anterior in 69.6% and TIMI Flow Grade 0 to 1 in 65.1% of patients. At 12 weeks, infarct size did not differ between treatment groups (MEDI6012: 9.71%, IQR 4.79-16.38; placebo: 10.48%, [IQR, 4.92-16.61], 1-sided P=0.79. There was also no difference in noncalcified plaque volume (geometric mean ratio, 0.96 [95% CI, NA-1.10], 1-sided P=0.30). There was no significant difference in treatment emergent serious adverse events. CONCLUSIONS: Administration of MEDI6012 in patients with acute ST-segment-elevation myocardial infarction did not result in a significant reduction in infarct size or noncalcified plaque volume at 12 weeks. MEDI6012 was well tolerated with no excess in overall serious adverse events. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03578809.

New insights into the unique nature of colorectal cancer peritoneal metastases-rethinking HIPEC.

Colorectal peritoneal metastases (CRPM) can be resistant to the chemotherapy agent (oxaliplatin) most employed, up until recently, as hyperthermic intraperitoneal chemotherapy (HIPEC). Glutathione-mediated inactivation of oxaliplatin can be substantially reduced by genomic deletion of the gene or pharmacological inhibition of glutamate-cysteine ligase in CRPM tumouroids. These discoveries may rekindle the enthusiasm for HIPEC in concert with cytoreductive surgery, which has been employed to manage patients with this once-nihilistic form of stage-IV disease.

Myocardial ATP depletion detected noninvasively predicts sudden cardiac death risk in patients with heart failure.

BACKGROUNDSudden cardiac death (SCD) remains a worldwide public health problem in need of better noninvasive predictive tools. Current guidelines for primary preventive SCD therapies, such as implantable cardioverter defibrillators (ICDs), are based on left ventricular ejection fraction (LVEF), but these guidelines are imprecise: fewer than 5% of ICDs deliver lifesaving therapy per year. Impaired cardiac metabolism and ATP depletion cause arrhythmias in experimental models, but to our knowledge a link between arrhythmias and cardiac energetic abnormalities in people has not been explored, nor has the potential for metabolically predicting clinical SCD risk.METHODSWe prospectively measured myocardial energy metabolism noninvasively with phosphorus magnetic resonance spectroscopy in patients with no history of significant arrhythmias prior to scheduled ICD implantation for primary prevention in the setting of reduced LVEF (≤35%).RESULTSBy 2 different analyses, low myocardial ATP significantly predicted the composite of subsequent appropriate ICD firings for life-threatening arrhythmias and cardiac death over approximately 10 years. Life-threatening arrhythmia risk was approximately 3-fold higher in patients with low ATP and independent of established risk factors, including LVEF. In patients with normal ATP, rates of appropriate ICD firings were several-fold lower than reported rates of ICD complications and inappropriate firings.CONCLUSIONTo the best of our knowledge, these are the first data linking in vivo myocardial ATP depletion and subsequent significant arrhythmic events in people, suggesting an energetic component to clinical life-threatening ventricular arrhythmogenesis. The findings support investigation of metabolic strategies that limit ATP loss to treat or prevent life-threatening cardiac arrhythmias and herald noninvasive metabolic imaging as a complementary SCD risk stratification tool.TRIAL REGISTRATIONClinicalTrials.gov NCT00181233.FUNDINGThis work was supported by the DW Reynolds Foundation, the NIH (grants HL61912, HL056882, HL103812, HL132181, HL140034), and Russell H. Morgan and Clarence Doodeman endowments at Johns Hopkins.

A Web-Based Health Application to Translate Nutrition Therapy for Cardiovascular Risk Reduction in Primary Care (PortfolioDiet.app): Quality Improvement and Usability Testing Study.

BACKGROUND: The Portfolio Diet, or Dietary Portfolio, is a therapeutic dietary pattern that combines cholesterol-lowering foods to manage dyslipidemia for the prevention of cardiovascular disease. To translate the Portfolio Diet for primary care, we developed the PortfolioDiet.app as a patient and physician educational and engagement tool for PCs and smartphones. The PortfolioDiet.app is currently being used as an add-on therapy to the standard of care (usual care) for the prevention of cardiovascular disease in primary care. To enhance the adoption of this tool, it is important to ensure that the PortfolioDiet.app meets the needs of its target end users. OBJECTIVE: The main objective of this project is to undertake user testing to inform modifications to the PortfolioDiet.app as part of ongoing engagement in quality improvement (QI). METHODS: We undertook a 2-phase QI project from February 2021 to September 2021. We recruited users by convenience sampling. Users included patients, family physicians, and dietitians, as well as nutrition and medical students. For both phases, users were asked to use the PortfolioDiet.app daily for 7 days. In phase 1, a mixed-form questionnaire was administered to evaluate the users' perceived acceptability, knowledge acquisition, and engagement with the PortfolioDiet.app. The questionnaire collected both quantitative and qualitative data, including 2 open-ended questions. The responses were used to inform modifications to the PortfolioDiet.app. In phase 2, the System Usability Scale was used to assess the usability of the updated PortfolioDiet.app, with a score higher than 70 being considered acceptable. RESULTS: A total of 30 and 19 users were recruited for phase 1 and phase 2, respectively. In phase 1, the PortfolioDiet.app increased users' perceived knowledge of the Portfolio Diet and influenced their perceived food choices. Limitations identified by users included challenges navigating to resources and profile settings, limited information on plant sterols, inaccuracies in points, timed-logout frustration, request for step-by-step pop-up windows, and request for a mobile app version; when looking at positive feedback, the recipe section was the most commonly praised feature. Between the project phases, 6 modifications were made to the PortfolioDiet.app to incorporate and address user feedback. At phase 2, the average System Usability Scale score was 85.39 (SD 11.47), with 100 being the best possible. CONCLUSIONS: By undertaking user testing of the PortfolioDiet.app, its limitations and strengths were able to be identified, informing modifications to the application, which resulted in a clinical tool that better meets users' needs. The PortfolioDiet.app educates users on the Portfolio Diet and is considered acceptable by users. Although further refinements to the PortfolioDiet.app will continue to be made before its evaluation in a clinical trial, the result of this QI project is an improved clinical tool.

Six Months After the Patients Stayed Home: A Nationwide Study of Cardiac Mortality and Readmissions Following the First Wave of the COVID-19 Pandemic in Malta.

Background The first COVID-19 wave resulted in a significant decline in acute cardiac admissions (ACAs) and delays to hospital presentation in Malta, as well as an excess of out-of-hospital cardiac arrests. The aim was to investigate the impact of the observed delays in presentation in 2020 on mortality and cardiac readmissions at six months. Methods All ACAs between 28th February and 30th April 2020 (first wave of COVID-19 in Malta) were included, and the corresponding 2019 period was used as a control. ACA was defined as an unplanned admission of an adult (aged ≥16 years) under the care of a cardiologist. Outcomes over the six months following the index ACA included death, cardiac readmission, and planned cardiac intervention at discharge. The term 'death' referred to all-cause mortality. Cardiac readmissions referred to unplanned admissions for acute cardiac pathology following the index ACA. During sub-analyses, ACAs were divided into acute coronary syndrome (ACS) and non-ACS. A first analysis compared the frequency of deaths, cardiac readmissions, and planned interventions between the 2019 and 2020 cohorts. A second analysis investigated differences in six-month survival and freedom from readmission between the two cohorts. Both analyses were followed by a sub-analysis. Results There were 330 ACAs among the 2019 cohort and 220 in 2020. There were no significant differences between the 2019 and 2020 cohorts in all-cause mortality (2019, 8.8% vs 2020, 8.2%, p=0.466) and Kaplan-Meier survival estimates at a six-month follow-up (2019, 169.06 days (95% CI 164.95-173.17) vs 2020, 168.27 days (95% CI 162.82-173.72), p=0.836), including subgroup analysis for non-ACS (2019, 168.52 days (95% CI 163.08-173.96) vs 168.11 days (95% CI 160.93-175.30), p=0.952) and ACS patients (169.81 days (95% CI 163.54-176.09) in 2019 vs 168.45 days (95% CI 160.17-176.73) in 2020, p=0.739). A significantly higher number of patients from the 2019 cohort (75/319, 23.5%) required readmission compared to 2020 (32/212; 15.1%) (p=0.02). Similarly, there was shorter freedom from cardiac readmission among 2019 patients (mean 150.98 days (95% CI 144.63-157.33)) compared to 2020 patients (mean 158.66 days (95% CI 151.58-165.74, p=0.024). During sub-analysis, the difference in freedom from readmission was significant only for non-ACS patients (mean of 145.45 days (95% CI 136.58-154.32) in 2019 vs 158.92 days (95% CI 149.19-168.64) in 2020, p=0.018). Analysis of cardiac interventions during the six months post-index ACA discharge showed significantly more planned cardiac interventions in 2019 (52/319; 16.3%) compared to 2020 (20/212; 9.4%) (p=0.027). Conclusions A delay in presentation of ACAs during COVID-19 in Malta resulted in lower readmission rates and increased freedom from readmissions, with no excess in all-cause mortality at a six-month follow-up. The reasons for the optimistic outcomes of patients admitted during the first wave of COVID-19 may be multifactorial. Reasons may include ongoing fear of hospital presentation, a more holistic approach to patients' in-hospital care during 2020 aimed at reducing further hospital contact post-discharge, and a selection bias secondary to an excess of out-of-hospital cardiac arrests during the initial wave of COVID-19. Further studies will be required to truly assess the collateral impact of non-COVID-19-related illness. Public education on cardiovascular health is vital and must be emphasized during the pandemic.

Improving Access and Decreasing Healthcare Utilization for Patients With Acute Spine Pain: Five-Year Results of a Direct Access Clinic.

INTRODUCTION: Spine pain is one of the largest and costliest burdens to our healthcare systems. While evidence-based guidelines for spine pain have been established, and continue to evolve, the actual management of this condition continues to burden the healthcare system. This has led to increased costs due to inefficient entry to healthcare, utilization of treatments unsupported by clinical guidelines, and patient navigation through our healthcare systems. The purpose of this study was to assess the healthcare utilization and related outcomes for Active Duty Service Members (ADSM) receiving healthcare services in a novel acute spine pain clinic (ASPC) during the first 5 years of operation at a large Military Treatment Facility. MATERIALS AND METHODS: In 2014 the Physical Medicine and Rehabilitation and Physical Therapy (PT) services designed a novel acute spine clinic intended to directly receive ADSM with acute spine symptoms for an initial evaluation by a Physical Therapist. The inclusion criteria into the ASPC were: ADSM, pain less than or equal to 7 days, no more than three prior episodes of acute spine pain in the past 3 years, and not currently receiving care from Chiropractic, Pain Management, or PT services. The exclusion criteria were: significant and/or progressive neurological deficits, bowel or bladder dysfunction, unstable vital signs or fever, hematuria or extensive trauma. RESULTS: A total of 1,215 patients presented to the ASPC for evaluation between 2014 and 2019. The most common chief complaint was acute pain in the lumbar spine (73%), followed by cervical spine pain (15%), and thoracic spine pain (12%) represented the fewest. The average number of PT visits per patient was 3.5 (range 1-13) with 61.1% utilizing three or fewer visits. Over 95% of cases returned to work the same day as their initial evaluation. Sixty-six percent returned to work without restriction the same day as their initial evaluation. Light duty recommendations were provided to 412 (33.9%) patients ranging from one to 30 days, with greater than 85% of the light duty being less than 14 days. Recommendations to not return to work (sick-in-quarters) were issued to 56 (4.6%) patients. The sick-in-quarters recommendations were for a 24-hour period in 48 cases, 48 hours for seven cases, and 72 hours for one case. All encounters in which the patient first sought care at the ASPC for low back pain met the Healthcare Effectiveness Data Set standard for low back pain care of having no imaging within 28 days of the first encounter for nonspecific low back pain. A medical record review of 100 randomly selected patients within 12 months of the initial evaluation demonstrated decreased utilization of medication, imaging, and referral to surgical services. CONCLUSIONS: This innovative approach demonstrates the potential benefits of rapid access to treatment and education for patients with acute spine pain by a Physical Therapist. Modeling this approach at Military Treatment Facilities may lead to decreased utilization of medications, radiology services, specialty care referrals, and reduced cost of care provided to individuals with acute spine pain.