Rivaroxaban in Rheumatic Heart Disease-Associated Atrial Fibrillation.

BACKGROUND: Testing of factor Xa inhibitors for the prevention of cardiovascular events in patients with rheumatic heart disease-associated atrial fibrillation has been limited. METHODS: We enrolled patients with atrial fibrillation and echocardiographically documented rheumatic heart disease who had any of the following: a CHA2DS2VASc score of at least 2 (on a scale from 0 to 9, with higher scores indicating a higher risk of stroke), a mitral-valve area of no more than 2 cm2, left atrial spontaneous echo contrast, or left atrial thrombus. Patients were randomly assigned to receive standard doses of rivaroxaban or dose-adjusted vitamin K antagonist. The primary efficacy outcome was a composite of stroke, systemic embolism, myocardial infarction, or death from vascular (cardiac or noncardiac) or unknown causes. We hypothesized that rivaroxaban therapy would be noninferior to vitamin K antagonist therapy. The primary safety outcome was major bleeding according to the International Society of Thrombosis and Hemostasis. RESULTS: Of 4565 enrolled patients, 4531 were included in the final analysis. The mean age of the patients was 50.5 years, and 72.3% were women. Permanent discontinuation of trial medication was more common with rivaroxaban than with vitamin K antagonist therapy at all visits. In the intention-to-treat analysis, 560 patients in the rivaroxaban group and 446 in the vitamin K antagonist group had a primary-outcome event. Survival curves were nonproportional. The restricted mean survival time was 1599 days in the rivaroxaban group and 1675 days in the vitamin K antagonist group (difference, -76 days; 95% confidence interval [CI], -121 to -31; P<0.001). A higher incidence of death occurred in the rivaroxaban group than in the vitamin K antagonist group (restricted mean survival time, 1608 days vs. 1680 days; difference, -72 days; 95% CI, -117 to -28). No significant between-group difference in the rate of major bleeding was noted. CONCLUSIONS: Among patients with rheumatic heart disease-associated atrial fibrillation, vitamin K antagonist therapy led to a lower rate of a composite of cardiovascular events or death than rivaroxaban therapy, without a higher rate of bleeding. (Funded by Bayer; INVICTUS ClinicalTrials.gov number, NCT02832544.).

Mortality and Morbidity in Adults With Rheumatic Heart Disease.

Importance: Rheumatic heart disease (RHD) remains a public health issue in low- and middle-income countries (LMICs). However, there are few large studies enrolling individuals from multiple endemic countries. Objective: To assess the risk and predictors of major patient-important clinical outcomes in patients with clinical RHD. Design, Setting, and Participants: Multicenter, hospital-based, prospective observational study including 138 sites in 24 RHD-endemic LMICs. Main Outcomes and Measures: The primary outcome was all-cause mortality. Secondary outcomes were cause-specific mortality, heart failure (HF) hospitalization, stroke, recurrent rheumatic fever, and infective endocarditis. This study analyzed event rates by World Bank country income groups and determined the predictors of mortality using multivariable Cox models. Results: Between August 2016 and May 2022, a total of 13 696 patients were enrolled. The mean age was 43.2 years and 72% were women. Data on vital status were available for 12 967 participants (94.7%) at the end of follow-up. Over a median duration of 3.2 years (41 478 patient-years), 1943 patients died (15% overall; 4.7% per patient-year). Most deaths were due to vascular causes (1312 [67.5%]), mainly HF or sudden cardiac death. The number of patients undergoing valve surgery (604 [4.4%]) and HF hospitalization (2% per year) was low. Strokes were infrequent (0.6% per year) and recurrent rheumatic fever was rare. Markers of severe valve disease, such as congestive HF (HR, 1.58 [95% CI, 1.50-1.87]; P < .001), pulmonary hypertension (HR, 1.52 [95% CI, 1.37-1.69]; P < .001), and atrial fibrillation (HR, 1.30 [95% CI, 1.15-1.46]; P < .001) were associated with increased mortality. Treatment with surgery (HR, 0.23 [95% CI, 0.12-0.44]; P < .001) or valvuloplasty (HR, 0.24 [95% CI, 0.06-0.95]; P = .042) were associated with lower mortality. Higher country income level was associated with lower mortality after adjustment for patient-level factors. Conclusions and Relevance: Mortality in RHD is high and is correlated with the severity of valve disease. Valve surgery and valvuloplasty were associated with substantially lower mortality. Study findings suggest a greater need to improve access to surgical and interventional care, in addition to the current approaches focused on antibiotic prophylaxis and anticoagulation.

Feasibility and sustainability of an interactive team-based learning method for medical education during a severe faculty shortage in Zimbabwe.

BACKGROUND: In 2010, in the midst of the human immunodeficiency virus (HIV) epidemic in Zimbabwe, 69% of faculty positions in the Department of Medicine of the University of Zimbabwe College of Health Sciences (UZ-CHS) were vacant. To address the ongoing need to train highly skilled HIV clinicians with only a limited number of faculty, we developed and implemented a course for final-year medical students focused on HIV care using team-based learning (TBL) methods. METHODS: A competency-based HIV curriculum was developed and delivered to final-year medical students in 10 TBL sessions as part of a 12 week clinical medicine attachment. A questionnaire was administered to the students after completion of the course to assess their perception of TBL and self-perceived knowledge gained in HIV care. Two cohorts of students completed the survey in separate academic years, 2011 and 2012. Descriptive analysis of survey results was performed. RESULTS: Ninety-six of 120 students (80%) completed surveys. One hundred percent of respondents agreed that TBL was an effective way to learn about HIV and 66% strongly agreed. The majority of respondents agreed that TBL was more stimulating than a lecture course (94%), fostered enthusiasm for the course material (91%), and improved teamwork (96%). Students perceived improvements in knowledge gained across all of the HIV subjects covered, especially in challenging applied clinical topics, such as management of HIV antiretroviral failure (88% with at least a "large improvement") and HIV-tuberculosis co-infection (80% with at least a "large improvement"). CONCLUSIONS: TBL is feasible as part of medical education in an African setting. TBL is a promising way to teach challenging clinical topics in a stimulating and interactive learning environment in a low-income country setting with a high ratio of students to teachers.

Acceptability of a community health worker- led health literacy intervention on lifestyle modification among hypertensive and diabetes patients in the City of Harare, Zimbabwe.

Deploying community health workers (CHWs) is a vital strategy to improve health at a community level in low- and middle-income countries. Whilst there is substantial evidence on the effectiveness of CHWs interventions, there is a need for more research on the mechanisms through which these interventions work. Understanding the acceptability of these interventions is one way of assessing the mechanisms through which they work. This article examines the acceptability of a community health worker- led health literacy intervention on lifestyle modification among hypertensive and diabetes patients based on the perspectives of the CHWs, community nurses and diabetes and hypertensive patients. A qualitative study was imbedded within a cluster randomized trial to assess the effectiveness community health worker- led health literacy intervention on lifestyle modification among hypertensive and diabetes patients in the City of Harare, Zimbabwe. Data were gathered through semi-structured interviews with 3 community health nurses and 15 diabetes and hypertension patients as well as 2 focus group discussions with CHWs. Data were analyzed manually using the thematic analysis method. There was consensus that the intervention had many benefits amongst CHWs and community nurses. However, among patients, there were mixed perceptions regarding the benefits of the intervention. The main challenges that were mentioned by CHWs include resistance to advice by patients, insufficient resources, and lack of acceptance at some of the patient's homes. All participants believed the intervention was acceptable. Our study provides vital information that should be considered in upscaling CHW led interventions.

Effects of a Community Health Worker-Led Health Literacy Intervention on Lifestyle Modification Among Patients With Hypertension and Diabetes in the City of Harare, Zimbabwe: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Hypertension and diabetes are among the most common noncommunicable diseases in Zimbabwe. These 2 conditions are largely prevented and controlled by lifestyle modifications, such as healthy eating habits, physical activity, and avoiding the use of tobacco and alcohol. OBJECTIVE: This study aims to evaluate the effects of a community health worker (CHW)-led health literacy intervention on lifestyle modification among patients with diabetes and hypertension in the City of Harare, Zimbabwe, in terms of (1) adherence to recommended lifestyle changes, (2) blood pressure and blood glucose levels, and (3) medication adherence. METHODS: This is a 6-month-long cluster randomized controlled trial, which will be conducted in primary health care clinics in the city of Harare. A total of 14 clinics will be randomly allocated into either the intervention or control group. A total of 680 (49 participants per clinic) adult patients with hypertension and diabetes will be enrolled for the trial. Participants in the intervention arm will receive a simple health literacy intervention on lifestyle modification, which will be delivered by trained CHWs, while those in the control arm will receive usual care. The intervention consists of 4 face-to-face interactive educational sessions and monthly support visits by trained CHWs and will be carried out over a period of 6 months. The primary study outcomes will be blood pressure and blood glucose levels and levels of adherence to the recommended lifestyle modifications. Other outcomes will include adherence to medication. Data management and analysis will be done using Epi Info software, and the data will be analyzed using the intention-to-treat principle. RESULTS: Recruitment of study participants commenced on June 1, 2023, and was completed on July 30, 2023. Baseline data are being collected after participants' recruitment, and the final data collection will be completed by January 31, 2024. CONCLUSIONS: There is an information dearth regarding the effectiveness of CHW-led interventions for the management and control of hypertension in Zimbabwe. Our study offers an opportunity to show the effectiveness of CHWs in addressing the gaps in the management of hypertension and diabetes. The findings from our study will provide crucial evidence on the effectiveness and feasibility of a simple intervention delivered by CHWs in resource-constrained areas. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47512.