Patient diversity and author representation in clinical studies supporting the Surviving Sepsis Campaign guidelines for management of sepsis and septic shock 2021: a systematic review of citations.

BACKGROUND: The generalizability of the Surviving Sepsis Campaign (SSC) guidelines to various patient populations and hospital settings has been debated. A quantitative assessment of the diversity and representation in the clinical evidence supporting the guidelines would help evaluate the generalizability of the recommendations and identify strategic research goals and priorities. In this study, we evaluated the diversity of patients in the original studies, in terms of sex, race/ethnicity, and geographical location. We also assessed diversity in sex and geographical representation among study first and last authors. METHODS: All clinical studies cited in support of the 2021 SSC adult guideline recommendations were identified. Original clinical studies were included, while editorials, reviews, non-clinical studies, and meta-analyses were excluded. For eligible studies, we recorded the proportion of male patients, percentage of each represented racial/ethnic subgroup (when available), and countries in which they were conducted. We also recorded the sex and location of the first and last authors. The World Bank classification was used to categorize countries. RESULTS: The SSC guidelines included six sections, with 85 recommendations based on 351 clinical studies. The proportion of male patients ranged from 47 to 62%. Most studies did not report the racial/ ethnic distribution of the included patients; when they did so, most were White patients (68-77%). Most studies were conducted in high-income countries (77-99%), which included Europe/Central Asia (33-66%) and North America (36-55%). Moreover, most first/last authors were males (55-93%) and from high-income countries (77-99%). CONCLUSIONS: To enhance the generalizability of the SCC guidelines, stakeholders should define strategies to enhance the diversity and representation in clinical studies. Though there was reasonable representation in sex among patients included in clinical studies, the evidence did not reflect diversity in the race/ethnicity and geographical locations. There was also lack of diversity among the first and last authors contributing to the evidence.

Left Atrial Remodeling in Patients With Severe Rheumatic Mitral Stenosis and Sinus Rhythm Using Two-Dimensional and Three-Dimensional Speckle Tracking Echocardiography.

Background: In mitral stenosis (MS), the combination of an increase in left atrium (LA) pressure and atrial inflammatory response is accompanied by increase in interstitial fibrosis of the atrial wall with disorganization of atrial muscle bundles, LA dysfunction and subsequently LA dilatation. We aimed to assess the effect of severe rheumatic MS on LA volumes and mechanics. Methods: We enrolled 40 patients with pure severe rheumatic MS and sinus rhythm as a patient group and 30 healthy subjects as a control group. All patient and control groups underwent two-dimensional (2D) transthoracic echo to measure left ventricle (LV) dimensions, function, LA deformations, estimated systolic pulmonary artery pressure (EPAP), and left ventricle global longitudinal strain (LV GLS). Also LA volumes and mechanics (LA strain during LV systole (reservoir function) and LV diastole (early = conduit, and late = booster pump = atrial contraction)) were measured by three-dimensional (3D) transthoracic echo; mitral valve (MV) area was measured by 3D transesophageal echo (as routine pre-percutaneous MV commissurotomy using multiplanar reconstruction in mid-esophageal apical long-axis view from LA prospective). Results: By 2D transthoracic echo, patient group revealed significantly lower all LA function vs. control group including LA strain during reservoir (24 ± 6 vs. 43 ± 3, P < 0.001), LA strain during conduit (-11 ± 3 vs. -25 ± 2, P < 0.001), and during booster pump (-13 ± 4 vs. -18 ± 1, P < 0.001). EPAP was significantly higher in patient group (48 ± 7 vs. 27 ± 4 in control group). LV GLS was significantly lower in patient group (-16±2% vs. -23±2% in control group). All 3D LA volumes were significantly higher in patient group than control group including maximum LA volume (LAVmax) (76 ± 18 vs. 50 ± 5, P < 0.001), indexed LA volume (LAVi) (44.6 ± 10.1 vs. 28.7 ± 3.7, P < 0.001), LV minimum volume (LAVmin) (51 ± 15 vs. 30 ± 4, P < 0.001), and LA volume pre atrial contraction (LAVpre A) (63 ± 15 vs. 41 ± 6, P < 0.001). Also, there was significantly decreased LA strain using 3D speckle tracking echo in patient group including systolic deformation of LA (reservoir function) (23 ± 6 vs. 41 ± 3, P < 0.001) and diastolic deformation, early diastole (conduit function) (-10 ± 2 vs. -24 ± 2, P < 0.001), and late diastole (booster pump function) (-13 ± 4 vs. -18 ± 1, P < 0.001). Conclusions: All LA function markedly reduced in pure severe rheumatic MS. The reduction of LA mechanics is directly related to the degree of reduction of the stenotic MV area. LV GLS significantly reduced in severe MS and its reduction is directly related to the degree of reduction of the stenotic MV area and the LAVi by 3D echo.

The prognostic role of liver volumetry in Fontan patients.

BACKGROUND AND HYPOTHESES: High venous pressures and associated hepatic congestion are important drivers for Fontan-associated liver disease. The prognostic significance of hepatomegaly as a marker of congestion however is not well defined and is further explored in this research study. METHODS: Fontan patients who have had liver ultrasound scans were identified from the Prince Sultan Cardiac Centre Fontan Database and had their anatomic, surgical, clinical histories abstracted from the electronic medical records following institutional ethics approval. Liver volumes were determined retrospectively from reviewing individual US images, and these, divided into tertiles, were analysed in the context of the predefined endpoints of (i) Primary - death or heart or liver transplantation, or (ii) Secondary - combined endpoint of death, transplantation, arrhythmia, or protein-losing enteropathy. RESULTS: Mean indexed liver volumes for the entire cohort (n = 199) were 1065.1 ± 312.1 ml/m2, range 387 to 2071 ml/m2. Patients with the largest liver volumes (highest tertile) were less likely to have a functioning fenestration compared to those in the lowest tertile 44% versus 56% p = 0.016 and experienced the highest burden of mortality and heart or heart-liver transplantation, p = 0.016, and were more likely to reach the composite endpoint of death, protein-losing enteropathy, arrhythmia, or transplantation, p = 0.010. Liver volumes had an overall predictive accuracy for the combined outcome of 61% (CI 53%, 67%, p = 0.009). CONCLUSIONS: Liver volumetry may serve as a potentially important congestion biomarker for adverse outcomes after the Fontan operation.

Detection of occult right ventricular dysfunction in young Egyptians with type 1 diabetes mellitus by two-dimensional speckle tracking echocardiography.

BACKGROUND: Type 1 diabetes mellitus (T1DM) is a common chronic disorder of childhood and adolescence. T1DM induced cardiomyopathy has a different entity than T2DM as it relies on different pathophysiological mechanisms, and rarely coexists with hypertension and obesity. Evaluation of right ventricular (RV) function in diabetic patients has been neglected despite the important contribution of RV to the overall cardiac function that affects the course and prognosis of diabetic cardiomyopathy (DCM). OBJECTIVE: To assess RV myocardial performance in asymptomatic T1DM using speckle tracking and standard echo parameters and correlate it with functional capacity using treadmill stress test. PATIENTS AND METHODS: Thirty-nine patients with TIDM (Group 1, mean age 18.2±1.7y, BMI=26.2±3.9kg/m2), without cardiac problems and 15 apparently healthy matched subjects as a control group (Group 2, mean age 18.8±2.3 y, BMI=22.8±3.3kg/m2) were enrolled. RV function was evaluated using conventional, tissue Doppler and 2D speckle tracking echocardiography (2D-STE). The peak RV global longitudinal strain (RV-GLS) was obtained. Functional capacity was assessed by treadmill exercise test and estimated in metabolic equivalent (METs). RESULTS: In this study; the diabetic group showed statistically highly significant decrease in the average RV-GLS (-14.0±6.9 in group 1 vs. -22.7±2.5 in group 2, P<0.001), significant decrease in RV S velocity (9.5±2.2 in group 1 vs. 11.5±1.8 in group 2, P<0.05), significantly reduced E/A ratio (1.0±0.2 in group 1 vs. 1.1±0.1 in group 2, P<0.05), and highly significant increased E/Em ratio (7.9±3.2 in group 1 vs. 5.2±0.7 in group 2, P<0.001). We did not found any significant differences between the two groups regarding the other echocardiographic or functional capacity parameters. CONCLUSION: In asymptomatic patients with T1DM, in addition to RV diastolic dysfunction, early (subclinical) RV systolic dysfunction is preferentially observed with normal RV and left ventricular (LV) ejection fraction (EF). 2D-STE has the ability to detect subclinical RV systolic dysfunction.