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Objectives: There is a paucity of data on the outcome of left-sided cardiac valve surgery for infective endocarditis in South Africa. It is hypothesized that outcomes may be poorer compared to international standards due to differences in disease burden, timing of surgery, organism prevalence, and co-morbidities. Method: This is a retrospective study of 160 patients with left heart valve endocarditis who underwent cardiac surgery from January 2010 to December 2019. Demographic, operative, and admission-related parameters were assessed to determine their association with all-cause mortality during the early post-operative (<30 days) and late post-operative (>30 days) periods. Results: Early post-operative mortality (<30 days) was 8.8% and late post-operative mortality (>30 days) was 13.1%. Late survival showed 77.5% of the patients were alive with a mean follow-up period of 41 months. Increased age (p = 0.04), critical illness (p < 0.001), and higher urgency of intervention (p < 0.001) were associated with higher early post-operative mortality. Peri-operative organ failure, including cardiac (p = 0.025), renal (p = 0.016), and respiratory failure (p < 0.001), contributed significantly to both early and late mortality. Pre-operative antibiotics for fewer days (p = 0.024), ongoing sepsis (p = 0.022), and para-valvular extension (p = 0.046) were associated with higher early mortality. Conclusions: Infective endocarditis is a common indication for cardiac valve surgery in South Africa. Goal-directed medical management and clinical optimization prior to surgery were crucial to achieving better outcomes. Salvage procedures and critical illness with organ failure prior to surgery were associated with poorer outcomes. Despite unique challenges, cardiac surgery for infective endocarditis at Tygerberg Hospital compares favorably to international standards. [ABSTRACT FROM AUTHOR]

Aims: Biochemical markers are fundamental in cardiac evaluation, and various novel assays have recently been discovered. We prospectively evaluated the hearts of newly diagnosed people living with human immunodeficiency virus (PLWH) using cardiac biomarkers, compared them with human immunodeficiency virus (HIV)‐uninfected controls, and correlated our prospective findings with cardiovascular magnetic resonance imaging (CMR). Methods and results: Newly diagnosed, antiretroviral therapy (ART)‐naïve PLWH were recruited along with HIV‐uninfected, age‐matched, and sex‐matched controls. All participants underwent measurement of high‐sensitivity cardiac troponin T (hs‐cTnT), N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP), soluble ST2 (sST2), and galectin‐3, as well as a CMR study with multiparametric mapping. The HIV group started ART and was re‐evaluated 9 months later. The cardiac biomarkers and their correlation with CMR parameters were evaluated in and between groups. Compared with controls (n = 22), hs‐cTnT (4.0 vs. 5.1 ng/L; P = 0.004), NT‐proBNP (23.2 vs. 40.8 ng/L; P = 0.02), and galectin‐3 (6.8 vs. 9.0 ng/mL; P = 0.002) were all significantly higher in the ART‐naïve group (n = 73). After 9 months of ART, hs‐cTnT (5.1 vs. 4.3 ng/L; P = 0.02) and NT‐proBNP (40.8 vs. 28.5 ng/L; P = 0.03) both decreased significantly and a trend of decrease was seen in sST2 (16.5 vs. 14.8 ng/L; P = 0.08). Galectin‐3 did not demonstrate decrease over time (9.0 vs. 8.8 ng/mL; P = 0.6). The cardiac biomarkers that showed the best correlation with CMR measurements native T1, T2, and extracellular volume were NT‐proBNP (rs ≥ 0.4, P < 0.001) and galectin‐3 (rs ≥ 0.3, P < 0.01). Conclusions: Our cardiac biomarker data support the presence of subclinical myocardial injury, remodelling, and fibrosis at HIV diagnosis, and ART had a positive influence on these blood markers. It remains unclear if the underlying pathological processes were fully addressed by ART. The ability of cardiac biomarkers to detect and track tissue abnormalities diagnosed with CMR showed promise. With additional research, this could lead to improvements in screening and monitoring myocardial abnormalities, even in CMR‐limited settings. [ABSTRACT FROM AUTHOR]

Competing Interests: The authors report no conflicts of interest related to this work.

Introduction: The commonly used frequentist paradigm of null hypothesis statistics testing with its reliance on the p-value and the corresponding notion of 'statistical significance' has been under ongoing criticism. Misinterpretation and misuse of the p-value have contributed to publication bias, unreliable studies, frequent false positives, fraud and mistrust in results of scientific studies. While p-values themselves are still useful, part of the problem may be the confusion between statistical and clinical significance. In randomised controlled trials of health interventions, this confusion could lead to erroneous conclusions about treatment efficacy, research waste and compromised patient outcomes. The extent to which clinical and statistical significance of published randomised clinical trials do not match is not known. This is a protocol for a methodological study to understand the extent of the problem of disparities between statistical and clinical significance in published clinical trials, and to identify and assess the factors associated with discrepant results in these studies., Methods and Analysis: A methodological survey of published randomised controlled trials is planned. Trials published between 2018 and 2022 and their protocols will be searched and screened for inclusion, with a planned sample size of 500 studies. The reported minimum clinically important difference, the study effect size and confidence intervals will be used to assess clinical importance of trial results. Comparison of statistical significance and clinical importance of the trial results will be used to determine disparity. Data will be analysed to estimate the outcomes, and factors associated with disparate study results will be assessed using logistic regression analysis., Ethics and Dissemination: Ethical approval for the study has been granted by Stellenbosch University's Health Research Ethics Committee. This is part of a larger study towards a PhD in Biostatistics and will be disseminated as a thesis, conference abstract and peer-reviewed manuscript., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)