The Cardiology Society of India-Kerala Acute Heart Failure Registry: poor adherence to guideline-directed medical therapy.

AIMS: Data on the burden of acute heart failure (AHF) admissions, practice patterns, and outcomes are rare from India and other low- and middle-income countries. We aimed to describe the baseline characteristics, guideline-directed medical therapy (GDMT) prescribing patterns and 90-day mortality rates in patients admitted with AHF in Kerala, India. METHODS AND RESULTS: The Cardiology Society of India-Kerala Acute Heart Failure Registry (CSI-KHFR) is an observational registry from 50 hospitals in Kerala, India, with prospective follow-up. Consecutive patients with AHF, who consented to participate, were enrolled. The 2016 European Society of Cardiology criteria were used for the diagnosis of AHF. Kaplan-Meier survival analysis and Cox-proportional hazard models were used for data analysis. The variables in the MAGGIC risk score were used in the multivariable model. A total of 7507 patients with AHF (37% female) participated in the CSI-KHFR. The mean age was 64.3 (12.9) years. More than two-third had reduced ejection fraction (EF) (67.5%). Nearly one-fourth (28%) of patients with heart failure (HF) with reduced EF received GDMT. Overall, in-hospital and 90-day mortality rates were 7% and 11.6%, respectively. Prescriptions of different components of GDMT were independently associated with 90-day mortality. CONCLUSION: The CSI-KHFR recorded an in-hospital and 90-day mortality of 7% and 11.6%, respectively. Only one of four patients received GDMT. AHF mortality was independently associated with GDMT initiation. Quality improvement initiatives that focus on increasing GDMT prescription may improve the survival of HF patients in India.

Presentation, Management, and In-Hospital Outcomes of Patients with Acute Heart Failure in South India by Sex: A Secondary Analysis of a Prospective, Interrupted Time Series Study.

Background: Sex differences in presentation, management, and outcomes of heart failure (HF) have been observed, but it is uncertain whether these differences exist in South India. Objective: We describe sex differences in presentation, management, and in-hospital outcomes in patients hospitalized with HF in South India and explore sex-based differences in the effect of the quality improvement intervention in a secondary analysis of a prospective, interrupted time series study. Methods: The Heart Failure Quality Improvement in Kerala (HF QUIK) study evaluated the effect of a quality improvement toolkit on process of care measures and clinical outcomes in patients hospitalized with HF in eight hospitals in Kerala using an interrupted time series design from February 2018 to August 2018. The primary outcome was guideline-directed medical therapy (GDMT) at hospital discharge for patients with HF with reduced ejection fraction (HFrEF). We performed sex-stratified analyses using mixed effect logistic regression models. Results: Among 1,400 patients, 536 (38.3%) were female. Female patients were older (69.6 vs. 65 years, p < 0.001), were less likely to have an ischemic etiology of HF (control period: 78.2% vs. 87.5%; intervention period: 83.6% vs. 91.5%; p < 0.05 for both) and were less likely to undergo coronary angiography or percutaneous coronary intervention. The quality improvement intervention had similar effects on the odds of GDMT at discharge in females with HFrEF (adjusted OR 1.79, 95% CI 0.92, 3.47) and males with HFrEF (adjusted OR 1.68, 95% CI 1.07, 2.64, pinteraction = 0.69). Conclusions: We observed sex-specific differences in presentation and procedural management of patients with HF but no differences in the effect of the quality improvement intervention on discharge GDMT rates. Both male and female patients with HFrEF remained undertreated in the study intervention period, demonstrating the need for implementation strategies to close the HFrEF treatment gap in South India.

Effect of a quality improvement intervention for acute heart failure in South India: An interrupted time series study.

BACKGROUND: Although quality improvement interventions for acute heart failure have been studied in high-income countries, none have been studied in low- or middle-income country settings where quality of care can be lower. We evaluated the effect of a quality improvement toolkit on process of care measures and clinical outcomes in patients hospitalized for acute heart failure in 8 hospitals in Kerala, India utilizing an interrupted time series design from February 2018 to August 2018. METHODS: The quality improvement toolkit included checklists, audit-and-feedback reports, and patient education materials. The primary outcome was rate of discharge guideline-directed medical therapy for patients with heart failure with reduced ejection fraction. We used mixed effect logistic regression and interrupted time series models for analysis. RESULTS: Among 1400 participants, mean (SD) age was 66.6 (12.2) years, and 38% were female. Mean (SD) left ventricular ejection fraction was 35.2% (9.7%). The primary outcome was observed in 41.3% of participants in the intervention period and 28.1% of participants in the control period (difference 13.2%; 95% CI 6.8, 19.0; adjusted OR = 1.70; 95% CI 1.17, 2.48). Interrupted time series model demonstrated highest rate of guideline-directed medical therapy at discharge in the initial weeks following intervention delivery with a concomitant decline over time. Improvements were observed in discharge process of care measures, including diet counseling, weight monitoring instructions, and scheduling of outpatient clinic follow-up but not hospital length of stay nor inpatient mortality. CONCLUSIONS: Higher rates of guideline-directed medical therapy at discharge were observed in Kerala. Broader implementation of this quality improvement intervention may improve heart failure care in low- and middle-income countries.

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.

Health-Related Quality of Life at 30 Days Among Indian Patients With Acute Myocardial Infarction.

BACKGROUND: Despite a high cardiovascular disease burden, data on patient-reported health status outcomes among individuals with cardiovascular disease in India are limited. METHODS AND RESULTS: Between November 2014 and November 2016, we collected health-related quality of life data among 1261 participants in the ACS QUIK trial (Acute Coronary Syndrome Quality Improvement in Kerala). We used a translated, validated version of the Seattle Angina Questionnaire administered 30 days after discharge for acute myocardial infarction, wherein higher scores represent better health status. We compared results across sex, myocardial infarction type, and randomization status using regression models that account for clustering and temporal trends. Mean (SD) age was 60.8 (13.7) years, 62% were men, and 63% presented with ST-segment-elevation myocardial infarction. More than 2 out of 5 respondents (44%) experienced angina 30 days after hospitalization, but most (68% of respondents with angina; 27% of the total sample) experienced it less than once per week (Seattle Angina Questionnaire angina frequency score 60). Respondents rated high median (interquartile range [IQR]) scores for angina frequency (100.0 [80.0-100.0]) overall with similar unadjusted scores by sex, but between-hospitality variability was high. Median (IQR) physical limitation scale response was 58.3 (41.7-77.8), which is consistent with limitations in moderate- and high-intensity activities at 30-day follow-up. Older respondents had more angina frequency and physical limitations and lower treatment satisfaction and quality of life. Women had greater physical limitations (median [IQR], 52.8 [38.9-72.2] for women versus median [IQR], 61.1 [44.4-80.6] for men; P<0.01). Overall treatment satisfaction was high with median (IQR) score, 81.3 (75.0-93.8), but overall quality of life was lower with median (IQR) score, 66.7 (50.0-83.3). Allocation to the quality improvement intervention group had the strongest direct association with higher quality of life (difference, 4.2; P=0.03), but overall effects were modest. CONCLUSIONS: This study represents the largest report of quality of life among myocardial infarction survivors in India with variability across age, sex, and quality improvement intervention status. Wide variability demonstrated across hospitals warrants further study. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02256657.

Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial.

Importance: Wide heterogeneity exists in acute myocardial infarction treatment and outcomes in India. Objective: To evaluate the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in Kerala, a southern Indian state. Design, Setting, and Participants: Cluster randomized, stepped-wedge clinical trial conducted between November 10, 2014, and November 9, 2016, in 63 hospitals in Kerala, India, with a last date of follow-up of December 31, 2016. During 5 predefined steps over the study period, hospitals were randomly selected to move in a 1-way crossover from the control group to the intervention group. Consecutively presenting patients with acute myocardial infarction were offered participation. Interventions: Hospitals provided either usual care (control group; n = 10 066 participants [step 0: n = 2915; step 1: n = 2649; step 2: n = 2251; step 3: n = 1422; step 4; n = 829; step 5: n = 0]) or care using a quality improvement tool kit (intervention group; n = 11 308 participants [step 0: n = 0; step 1: n = 662; step 2: n = 1265; step 3: n = 2432; step 4: n = 3214; step 5: n = 3735]) that consisted of audit and feedback, checklists, patient education materials, and linkage to emergency cardiovascular care and quality improvement training. Main Outcomes and Measures: The primary outcome was the composite of all-cause death, reinfarction, stroke, or major bleeding using standardized definitions at 30 days. Secondary outcomes included the primary outcome's individual components, 30-day cardiovascular death, medication use, and tobacco cessation counseling. Mixed-effects logistic regression models were used to account for clustering and temporal trends. Results: Among 21 374 eligible randomized participants (mean age, 60.6 [SD, 12.0] years; n = 16 183 men [76%] ; n = 13 689 [64%] with ST-segment elevation myocardial infarction), 21 079 (99%) completed the trial. The primary composite outcome was observed in 5.3% of the intervention participants and 6.4% of the control participants. The observed difference in 30-day major adverse cardiovascular event rates between the groups was not statistically significant after adjustment (adjusted risk difference, -0.09% [95% CI, -1.32% to 1.14%]; adjusted odds ratio, 0.98 [95% CI, 0.80-1.21]). The intervention group had a higher rate of medication use including reperfusion but no effect on tobacco cessation counseling. There were no unexpected adverse events reported. Conclusions and Relevance: Among patients with acute myocardial infarction in Kerala, India, use of a quality improvement intervention compared with usual care did not decrease a composite of 30-day major adverse cardiovascular events. Further research is needed to understand the lack of efficacy. Trial Registration: clinicaltrials.gov Identifier: NCT02256657.