Tricuspid Annular Plane Systolic Excursion (TAPSE) for the Assessment of Right Ventricular Function in Adult and Pediatric Cardiac Surgery: Modified Two-dimensional and M-mode TAPSE by Transesophageal Echocardiography Compared to M-mode TAPSE by Transthoracic Echocardiography.

OBJECTIVES: To compare transesophageal echocardiography-guided 2-dimensional and M-mode tricuspid annular plane systolic excursion (TAPSE) to transthoracic echocardiography (TTE)-guided M-mode TAPSE in terms of accuracy, interobserver, and intra-observer variability. DESIGN: A prospective, observational study. SETTING: Adult and pediatric operating rooms. PARTICIPANTS: Adult and pediatric patients (42 each) undergoing cardiac surgeries. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Modified midesophageal (Mod-ME), deep transgastric, and transgastric TAPSEs were analyzed for reliability and were compared to TTE TAPSE in both adult and pediatric groups. Modified ME TAPSE showed good method agreement with TTE TAPSE (bias = -0.97, p = 0.08 (adult); bias = 0.17, p = 0.71 [pediatric]), and showed a moderate correlation with right ventricular (RV) fractional area change (FAC) (r = 0.41, p = 0.006, [adult]; r = 0.57, p < 0.001, [pediatric]), with acceptable interobserver variability (percentage error =10.56 [adult]; 4.42 [pediatric]) and intraobserver variability (percentage error = 13.1 [adults]; 12.24 [pediatric]). Transgastric TAPSE poorly agreed with TTE TAPSE and had higher interobserver and intraobserver variability. Deep transgastric TAPSE had good method agreement with TTE TAPSE and had acceptable interobserver and intra-observer variability. CONCLUSIONS: Modified ME TAPSE is a reliable and reproducible measure of RV function before pericardiotomy in both adult and pediatric cardiac surgery. Right ventricular FAC values reflected the RV systolic function better than TAPSE after pericardiotomy. Deep transgastric TAPSE is reliable and reproducible but is less accurate than Mod-ME TAPSE.

Team based collaborative care model, facilitated by mHealth enabled and trained nurses, for management of heart failure with reduced ejection fraction in India (TIME-HF): design and rationale of a parallel group, open label, multi-centric cluster randomised controlled trial.

Background: Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care-coordination with different cadres of health care providers. We propose to develop a team based collaborative care model (CCM), facilitated by trained nurses, for management of HF with the support of mHealth and evaluate its acceptability and effectiveness in Indian setting. Methods: The proposed study will use mixed-methods research. Formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary-care hospitals) and more than 1500 HF patients will be conducted to assess the efficacy of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through both qualitative and quantitative process evaluation methods. Potential Impact: The TIME-HF trial will provide evidence on whether a CCM with mHealth support is effective in improving the clinical outcomes of HF with reduced ejection fraction in India. The findings may change the practice of management of HF in low and middle-income countries.

Assessment of the impact of heart failure on household economic well-being: a protocol.

Background: Heart failure (HF), which is an emerging public health issue, adversely affects the strained health system in India. The adverse impact of HF on the economic well-being has been narrated in various anecdotal reports from India, with affected individuals and their dependents pushed into the vicious cycle of poverty. There is limited research quantifying how HF impacts the economic well-being of households from low- and middle-income countries. Methods: We describe the methods of a detailed economic impact assessment of HF at the household level in India. The study will be initiated across 20 hospitals in India, which are part of the National heart Failure Registry (NHFR). The selected centres represent different regions in India, stratified based on the prevailing stages of epidemiological transition levels (ETLs). We will collect data from 1800 patients with acute decompensated HF and within 6-15 months follow-up from the time of initial admission. The data that we intend to collect will consist of a) household healthcare expenditure including out-of-pocket expenditure, b) financing mechanisms used by households and (c) the impoverishing effects of health expenditures including distress financing and catastrophic health expenditure. Trained staff at each centre will collect data by using a validated and structured interview schedule. The study will have 80% power to detect an 8% difference in the proportion of households experiencing catastrophic health expenditures between two ETL groups.  After considering a non-response rate of 5%, the target sample size is approximately 600 patients from each group and the total sample size is 1800 patients. Potential Impact: Our study will provide information on catastrophic health spending, distress financing and household expenditure in heart failure patients. Our findings will help policy makers in understanding the micro-economic impact of HF in India and aid in allocation of appropriate resources for prevention and control of HF.

The Upcoming Epidemic of Heart Failure in South Asia.

Currently, South Asia accounts for a quarter of the world population, yet it already claims ≈60% of the global burden of heart disease. Besides the epidemics of type 2 diabetes mellitus and coronary heart disease already faced by South Asian countries, recent studies suggest that South Asians may also be at an increased risk of heart failure (HF), and that it presents at earlier ages than in most other racial/ethnic groups. Although a frequently underrecognized threat, an eventual HF epidemic in the densely populated South Asian nations could have dramatic health, social and economic consequences, and urgent interventions are needed to flatten the curve of HF in South Asia. In this review, we discuss recent studies portraying these trends, and describe the mechanisms that may explain an increased risk of premature HF in South Asians compared with other groups, with a special focus on highly relevant features in South Asian populations including premature coronary heart disease, early type 2 diabetes mellitus, ubiquitous abdominal obesity, exposure to the world's highest levels of air pollution, highly prevalent pretransition forms of HF such as rheumatic heart disease, and underdevelopment of healthcare systems. Other rising lifestyle-related risk factors such as use of tobacco products, hypertension, and general obesity are also discussed. We evaluate the prognosis of HF in South Asian countries and the implications of an anticipated HF epidemic. Finally, we discuss proposed interventions aimed at curbing these adverse trends, management approaches that can improve the prognosis of prevalent HF in South Asian countries, and research gaps in this important field.

Microeconomic Costs, Insurance, and Catastrophic Health Spending Among Patients With Acute Myocardial Infarction in India: Substudy of a Randomized Clinical Trial.

Importance: Ischemic heart disease is the leading cause of death in India, and treatment can be costly. Objective: To evaluate individual- and household-level costs and impoverishing effects of acute myocardial infarction among patients in Kerala, India. Design, Setting, and Participants: This investigation was a prespecified substudy of the Acute Coronary Syndrome Quality Improvement in Kerala study, a stepped-wedge, cluster randomized clinical trial conducted between November 2014 and November 2016 across 63 hospitals in Kerala, India. In this cross-sectional substudy, individual- and household-level cost data were collected 30 days after hospital discharge from a sample of 2114 respondents from November 2014 to July 2016. Data were analyzed from July through October 2018 and in March 2019. Exposures: Health insurance status. Main Outcomes and Measures: The primary outcomes were detailed direct and indirect cost data associated with acute myocardial infarction and respondent ability to pay as well as catastrophic health spending and distress financing. Catastrophic health spending was defined as 40% or more of household expenditures minus food costs spent on health, and distress financing was defined as borrowing money or selling assets to cover health costs. Hierarchical regression models were used to evaluate the association between health insurance and measures of financial risk. Costs were converted from Indian rupees to international dollars (represented herein as "$"). Results: Among 2114 respondents, the mean (SD) age was 62.3 (12.7) years, 1521 (71.9%) were men, 1144 (54.1%) presented with an ST-segment elevation myocardial infarction, and 1600 (75.7%) had no health insurance. The median (interquartile range) expenditure among respondents was $480.4 ($112.5-$1733.0) per acute myocardial infarction encounter, largely driven by in-hospital expenditures. There was greater than 15-fold variability between the 25th and 75th percentiles. Individuals with or without health insurance had similar monthly incomes and annual household expenditures, yet individuals without health insurance had approximately $400 higher out-of-pocket cardiovascular health care costs (median [interquartile range] total cardiovascular expenditures among uninsured, $560.3 [$134.1-$1733.6] vs insured, $161.4 [$23.2-$1726.9]; P < .001). Individuals without health insurance also had a 24% higher risk of catastrophic health spending (adjusted risk ratio, 1.24; 95% CI, 1.07-1.43) and 3-fold higher risk of distress financing (adjusted risk ratio; 3.05; 95% CI, 1.45-6.44). Conclusions and Relevance: The results of this study indicate that acute myocardial infarction carries substantial financial risk for patients in Kerala. Expansion of health insurance may be an important strategy for financial risk protection to disrupt the poverty cycle associated with cardiovascular diseases in India.

Availability, Sales, and Affordability of Tobacco Cessation Medicines in Kerala, India.

BACKGROUND: India is the world's second largest consumer of tobacco, but tobacco cessation remains uncommon due, at least in part, to underutilization of cessation pharmacotherapy. We evaluated the availability, sales, and affordability of nicotine replacement therapy, bupropion, and varenicline in the South Indian state of Kerala to understand potential reasons for underutilization. METHODS AND RESULTS: From November 2016 to April 2017, we collected data on availability, inventory, and pricing of cessation medication through a cross-sectional survey of 199 public, semiprivate (Karunya), and private pharmacies across 5 districts in Kerala using World Health Organization/Health Action International methodology. Revenue and sales data were obtained from the latest Pharmatrac medication database. We assessed affordability using individual- and household-level income and expenditure data collected from November 2014 to November 2016 through the Acute Coronary Syndrome Quality Improvement in Kerala randomized trial. Cessation medications were not available in public hospitals (0%, n=58) nor in public specialty centers (0%, n=10) including those designated to provide cessation services. At least 1 cessation medicine was available at 63% of private pharmacies (n=109) and 27% of Karunya (semiprivate) pharmacies (n=22). Among the 75 pharmacies that stocked cessation medications, 96% had nicotine replacement therapy, 28% had bupropion, and 1% had varenicline. No outlets had sufficient inventory for a patient to purchase a 12-week treatment regimen. There were an estimated 253 270 treatment regimens sold throughout India and 14 092 in Kerala in 2013 to 2014. Treatment regimens cost 1.9 to 13.0× the median amount spent on smoked tobacco and between 8% and 52% of nonsubsistence income. CONCLUSIONS: Tobacco cessation medications are unavailable in the Kerala public sector and have limited availability in the private and semiprivate sectors. When available, medications are unaffordable for most patients. Addition of tobacco cessation medication onto national and state essential medicines lists may help increase access. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02256657.