Tuberculosis and Diabetes in India: Stakeholder Perspectives on Health System Challenges and Opportunities for Integrated Care.

BACKGROUND: India has a dual burden of tuberculosis (TB) and diabetes mellitus (DM). Integrated care for TB/DM is still in the early phase in the country and can be considerably enhanced by understanding and addressing the challenges identified from stakeholders' perspectives. This study explored the challenges and opportunities at individual, health system and policy level for integrated care of TB/DM comorbidities in India. METHODS: We used an outlier case study approach and conducted stakeholder interviews and focus group discussions with relevant program personnel including field staff and program managers of TB and DM control programs as well as officials of partners in Indian states, Kerala and Bihar. RESULTS: The integrated management requires strengthening the laboratory diagnosis and drug management components of the two individual programs for TB and DM. Focused training and sensitization of healthcare workers in public and private sector across all levels is essential. A district level management unit that coordinates the two vertical programs with a horizontal integration at the primary care level is the way forward. Substantial improvement in data infrastructure is essential to improve decision-making process. CONCLUSION: Bi-directional screening and management of TB/DM comorbidities in India requires substantial investment in human resources, infrastructure, drug availability, and data infrastructure.

One-year clinical outcome of patients with nonvalvular atrial fibrillation: Insights from KERALA-AF registry.

BACKGROUND: We report patient characteristics, treatment pattern and one-year clinical outcome of nonvalvular atrial fibrillation (NVAF) from Kerala, India. This cohort forms part of Kerala Atrial Fibrillation (KERALA-AF) registry which is an ongoing large prospective study. METHODS: KERALA-AF registry collected data of adults with previously or newly diagnosed atrial fibrillation (AF) during April 2016 to April 2017. A total of 3421 patients were recruited from 53 hospitals across Kerala state. We analysed one-year follow-up outcome of 2507 patients with NVAF. RESULTS: Mean age at recruitment was 67.2 years (range 18-98) and 54.8% were males. Main co-morbidities were hypertension (61.2%), hyperlipidaemia (46.2%) and diabetes mellitus (37.2%). Major co-existing diseases were chronic kidney disease (42.1%), coronary artery disease (41.6%), and chronic heart failure (26.4%). Mean CHA2DS2-VASc score was 3.18 (SD ± 1.7) and HAS-BLED score, 1.84 (SD ± 1.3). At baseline, use of oral anticoagulants (OAC) was 38.6% and antiplatelets 32.7%. On one-month follow-up use of OAC increased to 65.8% and antiplatelets to 48.3%. One-year all-cause mortality was 16.48 and hospitalization 20.65 per 100 person years. The main causes of death were cardiovascular (75.0%), stroke (13.1%) and others (11.9%). The major causes of hospitalizations were acute coronary syndrome (35.0%), followed by arrhythmia (29.5%) and heart failure (8.4%). CONCLUSIONS: Despite high risk profile of patients in this registry, use of OAC was suboptimal, whereas antiplatelets were used in nearly half of patients. A relatively high rate of annual mortality and hospitalization was observed in patients with NVAF in Kerala AF Registry.

Kerala Atrial Fibrillation Registry: a prospective observational study on clinical characteristics, treatment pattern and outcome of atrial fibrillation in Kerala, India, cohort profile.

PURPOSE: Limited published data exist on the clinical epidemiology of atrial fibrillation (AF) in South Asia including India. Most of the published data are from the Western countries and the Far East. The Kerala AF registry was initiated to collect systematic, prospective data on clinical characteristics, risk factors, treatment pattern and outcomes of consecutive AF patients who consulted cardiologists across the state of Kerala, India. PARTICIPANTS: All newly diagnosed and previously reported patients aged ≥18 years with documented evidence of AF on ECG were included. Patients with transient AF due to infection, acute myocardial infarction, alcohol intoxication, metabolic abnormalities and AF seen in postoperative cases and critically ill patients with life expectancy less than 30 days were excluded. FINDINGS TO DATE: A total of 3421 patients were recruited from 53 hospitals across Kerala from April 2016 to April 2017. There were 51% (n=1744) women. The median age of the cohort was 65 (IQR 56-74) years. Hypertension, diabetes mellitus and dyslipidaemia were present in 53.8%, 34.5% and 42.2% patients, respectively. Chronic kidney disease was observed in 46.6%, coronary artery disease in 34.8% and heart failure (HF) in 26.5% of patients. Mean CHA2DS2-VASc score of the cohort was 2.9, and HAS-BLED score was 1.7. Detailed information of antithrombotic and antiarrhythmic drugs was collected at baseline and on follow-up. During 1-year follow-up, 443 deaths (12.9%) occurred of which 332 (9.7%) were cardiac death and 63 (1.8%) were due to stroke. There were 578 (16.8%) hospitalisations mainly due to acute coronary syndrome, arrythmias and HF. FUTURE PLANS: Currently, this is the largest prospective study on AF patients from India, and the cohort will be followed for 5 years to observe the treatment patterns and clinical outcomes. The investigators encourage collaborations with national and international AF researchers. TRIAL REGISTRATION NUMBER: CTRI/2017/10/010097.

Prognostic value of soluble ST2 biomarker in heart failure patients with reduced ejection fraction - A multicenter study.

OBJECTIVE: To study the prognostic value of soluble Suppression of Tumorigenicity-2 (sST2) in heart failure patients with reduced ejection fraction (HFrEF). METHODS: In this prospective, observational, multicenter study, patients with heart failure (HF) and left ventricular ejection fraction (LVEF) <50% were included. Clinical evaluation and serum levels of sST2 were estimated at five time points during follow up. Study endpoint was the relationship of baseline and serial sST2 concentration in the blood to the composite endpoints of cardiac death and re-hospitalization for worsening of HF during one year follow up period. RESULTS: A total of 141 patients were enrolled. The mean age was 60±10.4years. At baseline evaluation, 49.6% patients were in New York Heart Association (NYHA) class III and 36.2% in class IV. Adverse events were observed in 57 patients (40.4%); 25 (17.7%) were re-hospitalized due to worsening of HF and 32 (22.7%) died due to cardiac causes. The median value of baseline sST2 was 46.36ng/ml (IQR 31.30-78.38). sST2 concentration at baseline was significantly higher among patients with adverse events in comparison to patients without adverse events (p=<0.001). Receiver operating characteristic curve (ROC) for baseline sST2 concentration identified 49ng/ml as optimal cut-off value to predict cardiac death and re-hospitalization, with a sensitivity and specificity of 72% and 75%, respectively. CONCLUSION: In patients with HFrEF, sST2 concentration at baseline as well as on serial testing was significantly correlated with cardiac death and re-hospitalization for worsening of HF.

Initial experience with post Lariat left atrial appendage leak closure with Amplatzer septal occluder device and repeat Lariat application.

BACKGROUND: Left atrial appendage (LAA) ligation with the Lariat device is a therapeutic option to prevent thromboembolic stoke in patients with nonvalvular atrial fibrillation (AF) at high risk for systemic thromboembolization and bleeding related to use of anticoagulation. In rare cases, this procedure could leave the LAA incompletely ligated with continued risk of stroke. OBJECTIVE: The purpose of this study was to investigate the incidence and characteristics of LAA leak following ligation using the Lariat device and the feasibility of leak closure with the Amplatzer septal occluder device or a repeat Lariat application. METHODS: Seventy-one consecutive patients who underwent LAA ligation by the Lariat device were followed-up with transesophageal echocardiography to evaluate for the presence of appendage leaks, characterization of the leaks, and the presence of any thrombus. Patients with LAA leaks underwent definite closure of the leak. RESULTS: Six patients had LAA leaks with a mean leak size of 4.3 ± 0.6 mm. All leaks were concentric in nature. None of the patients had LAA thrombus. Leaks in 5 of these patients were successfully closed using an Amplatzer septal occluder device (St. Jude Medical); the leak in the sixth patient was closed using a repeat Lariat procedure. CONCLUSION: LAA leaks from incomplete ligation of the LAA following the Lariat procedure are not uncommon and could be successfully closed with an Amplatzer septal occluder device or a repeat Lariat procedure.