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.

Procedural Volume and Outcomes After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction in Kerala, India: Report of the Cardiological Society of India-Kerala Primary Percutaneous Coronary Intervention Registry.

Background There are limited data to inform policy mandating primary percutaneous coronary intervention (PPCI) volume benchmarks for catheterization laboratories in low- and middle-income countries. Methods and Results This prospective state-wide registry included ST-segment-elevation myocardial infarction patients with symptoms of <12 hours, or with ongoing ischemia at 12 to 24 hours, reperfused with PPCI. From June 2013 to March 2016, we recruited 5560 consecutive patients. We categorized hospitals on the basis of annual PPCI volumes into low, medium, and high volume (<100, 100-199, and ≥200 PPCIs per year, respectively). Kaplan-Meier curves and Cox regression models were used to examine the association between PPCI volume and 1-year mortality. Among 42 recruiting hospitals, there were 24 (57.2%) low-volume, 8 (19%) medium-volume, and 10 (23.8%) high-volume hospitals. The median (25th-75th percentile) TIMI (Thrombolysis in Myocardial Infarction) ST-segment-elevation myocardial infarction risk score was 3 (2-5). Cardiac arrest before admission occurred in 4.2%, 2.1%, and 2.9% of cases at low-, medium-, and high-volume hospitals, respectively (P=0.02). Total ischemic time differed significantly among low-volume (median [25th-75th percentile], 3.5 [2.4-5.5] hours), medium-volume (median, 3.8 [25th-75th percentile, 2.58-6.05] hours), and high-volume hospitals (median, 4.16 [25th-75th percentile 2.8-6.3] hours) (P=0.01). Vascular access was radial in 61.5%, 71.3%, and 63.2% of cases at low-, medium-, and high-volume hospitals, respectively (P=0.01). The observed 1-year mortality rate was 6.5%, 3.4%, and 8.6% at low-, medium- and high-volume hospitals, respectively (P<0.01), and the difference did not attenuate after multivariate adjustment (low versus medium: hazard ratio [95% CI], 1.80 [1.12-2.90]; high versus medium: hazard ratio [95% CI], 2.53 [1.78-3.58]) (P<0.01). Conclusions Low- and middle-income countries, like India, may have a nonlinear relationship between institutional PPCI volume and outcomes, partly driven by procedural variations and inequalities in access to care.

The design and rationale of the primary angioplasty registry of Kerala.

BACKGROUND: ST-elevation myocardial infarction (STEMI) continues to be a major cause of cardiovascular mortality in Kerala, India. Timely primary percutaneous coronary intervention (PCI) is the recommended reperfusion strategy for STEMI. There is limited data on the safety, effectiveness, equity and efficiency of regional primary PCI services in India. METHODS/DESIGN: The primary angioplasty registry of Kerala is a clinician-initiated prospective state-wide longitudinal hospital-based registry of patients undergoing primary PCI for STEMI. The registry aims to document the efficacy and safety of the real world use of primary PCI in Indian patients presenting with STEMI, in order to achieve regional adoption of global standard performance indicators. In addition, the registry would analyze procedural variations in the performance of primary PCI and assess its impact on relevant patient centered outcomes. We plan to enroll 6000 STEMI patients, undergoing primary PCI, across 48 hospitals. These patients would be followed up for a minimum of 1year. CONCLUSIONS: The primary angioplasty registry of Kerala would help analyze the quality and outcomes of primary PCI services in Kerala, thereby yielding insights that can help limit unacceptable procedural variations in the performance of primary PCI. Identifying deviations from guideline based therapies can form the basis of quality improvement programs, which in turn will enable hospitals to achieve better patient outcomes.

Population access to reperfusion services for ST-segment elevation myocardial infarction in Kerala, India.

BACKGROUND: Population access to timely reperfusion is a decisive factor in determining the success and acceptability of any regional system of ST-segment elevation myocardial infarction (STEMI) care. We sought to determine the proportion of population of the southern Indian state of Kerala having timely access to STEMI reperfusion. METHODS: We identified the STEMI reperfusion facilities available at all acute-care hospitals, in Kerala, by conducting a cross-sectional survey. We mapped the geographical catchment areas of these hospitals using historical travel speeds and appropriate Geospatial Information Systems (GIS) analyses. Subsequently, using block level population data, we estimated the proportion of the population residing within these geographies. RESULTS: We estimated that 23.33 million people, forming 69.84% of the state population, resided in the green zone (within half-hour travel distance of a percutaneous coronary intervention [PCI]-capable hospital), which covered 47.94% of the geographical area of the state. Outside this green zone, 21.87% of the state population resided within 1hr travel distance of a thrombolysis-capable hospital. Finally, 8.28% of the state population resided in the red zone, where access to any reperfusion-capable hospital took >1hr, which covered 22.15% of the geographical area of the state. CONCLUSIONS: A majority of the population of Kerala had timely access to PCI-capable hospitals. GIS-based mapping of Indian states, in terms of access to STEMI reperfusion, may help devise protocols to achieve seamless transfer of patients to reperfusion-capable hospitals. Such regionalization of STEMI care would enhance organizational synergies to achieve better access to reperfusion, especially in remote areas.

A rare malady with a rarer complication.

Isolated ventricular noncompaction (IVNC) is an unclassified cardiomyopathy characterized by prominent intraventricular trabeculations separated by deep intertrabecular recesses. Although microvascular dysfunction is known, myocardial infarction is rare and usually seen as a consequence of coincidental coronary artery disease. We report the case of a 19-year-old male patient who presented to us with symptoms and signs of heart failure. Echocardiography revealed IVNC with severe left ventricular dysfunction. He was put on medical treatment including oral anticoagulants. Six months later, he came to our emergency department with anterior wall STEMI. Coronary angiogram revealed thrombotic occlusion of distal LAD, which resolved completely with tirofiban and heparin. Coronary thromboembolism due to blood stasis in the left ventricular cavity has not been previously documented in IVNC.