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.
Background: Heart failure (HF) is a multi-morbid chronic condition, which adversely affects the quality of life of the affected individual. Engaging the patient and their caregivers in self-care is known to reduce mortality, rehospitalisation and improve quality of life among HF patients. The PACT-HF trial will answer whether clinical benefits in terms of mortality and hospitalisation outcomes can be demonstrated by using a pragmatic design to explore the specific effects of physical activity, and cognitive behavioural therapy in HF patients in India. Methods: We will conduct a 2 × 2 factorial, randomized, open-label trial, which aims to see if rehabilitation strategies of structured physical activity training and cognitive behavioural therapy for depression and self-management reduce the risk of repeat hospitalisation and deaths in HF patients in India. Patients will be randomised to (1) physical activity + usual care (2) cognitive behaviour therapy + usual care, (3) physical activity + cognitive behaviour therapy + usual care, and (4) usual care at 1:1:1:1 ratio. Time to mortality will be the primary outcome. A composite of mortality and hospitalisation for HF will be the main secondary outcome. Additional secondary outcomes will include 'days alive and out of hospital', cumulative hospitalisation, quality of life, Minnesota Living with Heart Failure questionnaire score, depression score, six minutes walking distance, handgrip strength, and adherence to medicines and lifestyle. The effects of intervention on the primary outcome will be estimated from Cox proportional hazard models. For the continuous secondary outcome variables, differences between randomised groups will be estimated from linear mixed models or generalised estimating equations (GEE) as appropriate. Discussion: PACT-HF is designed to provide reliable evidence about the balance of benefits and risks conferred by physical activity and cognitive behavioural therapy-based cardiac rehabilitation for those with HF, irrespective of their initial disease severity.
BACKGROUND: Sex-based differences have been found in outcomes following ST-segment myocardial infarction (STEMI). Studies assessing sex-based differences in STEMI among Indian patients have reported conflicting results. METHODS: A prospective multicenter registry of consecutive patients with STEMI who presented to percutaneous coronary intervention (PCI)-capable hospitals in the Indian state of Kerala between June 2013 and March 2017 was used to assess 1-year outcomes. The primary endpoint was a composite of major adverse cardiac events (MACE), including death, stroke, nonfatal myocardial infarction, and rehospitalization for heart failure. Outcomes of 2 sex-based propensity score-matched groups were compared. RESULTS: We included 3194 patients (19.4% women). Women presenting with STEMI were older, had more traditional cardiovascular risk factors, and were more likely to be classified as living in poverty. After propensity-score matching, women experienced greater incidence of MACE (20.9% vs 14.3%, P < 0.01), primarily driven by increased 1-year mortality (14.3% vs 8.6%, P < 0.01). Women were more likely to experience prehospital delays, compared with men. Although reperfusion rates were similar between the groups, men were more likely than women to undergo reperfusion within the first 12 hours of chest pain onset. Among patients undergoing primary PCI, women were more likely to have delayed PCI than were men (80.2% vs 72.9%, P = 0.03). Procedural characteristics were similar between groups. CONCLUSIONS: Women in this cohort experienced higher incidence of MACE at 1 year, compared to men, primarily owing to increased mortality. Timeliness of reperfusion appears to be the primary factor impacting differences in outcomes between the 2 groups and may represent an attractive target for quality-improvement initiatives.
CONTEXTE: Des différences entre les sexes ont été constatées dans les résultats obtenus à la suite d'un infarctus du myocarde avec élévation du segment ST (STEMI). Des études évaluant les différences entre les sexes parmi des patients indiens ayant subi un STEMI ont produit des résultats contradictoires. MÉTHODOLOGIE: Un registre multicentrique et prospectif de patients consécutifs qui ont subi un STEMI et se sont présentés dans des hôpitaux où pouvait être pratiquée une intervention coronarienne percutanée (ICP) dans l'État indien du Kerala entre juin 2013 et mars 2017 a été utilisé pour évaluer les résultats à 1 an. Le paramètre d'évaluation principal regroupait des événements cardiaques indésirables majeurs (ECIM) comprenant le décès, l'accident vasculaire cérébral, l'infarctus du myocarde non fatal et la réhospitalisation pour cause d'insuffisance cardiaque. Les résultats de deux groupes appariés selon les scores de propension en fonction du sexe ont été comparés. RÉSULTATS: Nous avons inclus 3 194 patients (19,4 % de femmes). Les femmes qui avaient subi un STEMI étaient plus âgées, présentaient des facteurs de risque cardiovasculaire plus classiques et étaient plus susceptibles d'appartenir à la catégorie des personnes vivant dans la pauvreté. Après l'appariement selon les scores de propension, l'incidence des ECIM était plus élevée chez les femmes (20,9 % vs 14,3 %, p < 0,01), surtout en raison d'une mortalité accrue à 1 an (14,3 % vs 8,6 %, p < 0,01). Les femmes étaient plus susceptibles de subir des retards avant l'hospitalisation que les hommes. Bien que les taux de reperfusion étaient semblables dans les groupes étudiés, les hommes étaient plus susceptibles que les femmes de subir une reperfusion dans les 12 premières heures suivant l'apparition de la douleur thoracique. Parmi les patients ayant subi une ICP primaire, les femmes étaient plus susceptibles d'être touchées par un retard d'intervention que les hommes (80,2 % vs 72,9 %, p = 0,03). Les caractéristiques de l'intervention étaient similaires dans les groupes étudiés. CONCLUSIONS: L'incidence des ECIM à 1 an au sein de cette cohorte était plus élevée chez les femmes que chez les hommes, surtout en raison d'une mortalité accrue. La rapidité de la reperfusion semble être le principal facteur ayant des répercussions sur les différences de résultats entre les deux groupes et pourrait représenter une cible intéressante dans le cadre d'initiatives d'amélioration de la qualité.
BACKGROUND: Myocardial inflammation often complicates leptospirosis, a re-emerging global zoonosis. Leptospirosis associated myocardial dysfunction is equivocal and the pattern of cardiac involvement may not differ from that of sepsis associated myocarditis. METHODS: We prospectively compared cardiac involvement in 113 intensive care unit patients with severe leptospirosis to 31 patients with sepsis syndrome using a comprehensive assessment comprising of clinical presentation, electrocardiography, two-dimensional echocardiography (with global longitudinal strain calculation), and cardiac biomarker evaluation. Binomial logistic regression was performed to identify independent predictors of left ventricular systolic dysfunction in leptospirosis. RESULTS: Compared to sepsis syndrome, leptospirosis patients were younger, had higher body mass index measurements and were more likely to be smokers. Electrocardiography abnormalities were common and similar in both groups. Myocardial systolic dysfunction was common in both groups (leptospirosis: 55.86% vs sepsis syndrome: 51.61%, p=0.675) with subclinical left ventricular systolic dysfunction (characterized by abnormal global longitudinal strain and normal left ventricular ejection fraction) being most frequent followed by isolated right ventricular systolic dysfunction, isolated left ventricular systolic dysfunction, and bi-ventricular systolic dysfunction (leptospirosis: 31.43%, 18.42%, 13.16%, 10.53%, respectively; sepsis syndrome: 22.22%, 12.00%, 12.00%, 8.00%, respectively (p>0.05 for each comparator)). Leptospirosis patients had a trend towards greater troponin-T elevation (61.0% vs 40.0%, p=0.057). ST-segment elevation and elevated troponin were independent predictors of reduced left ventricular ejection fraction in leptospirosis. CONCLUSIONS: Cardiac involvement in leptospirosis appears to be similar to that of sepsis syndrome, with myocardial systolic dysfunction being common. As such, clinical vigilance pertaining to cardiac status is paramount in these high-risk patients.
Critical Illness , Echocardiography/methods , Electrocardiography , Heart Ventricles/diagnostic imaging , Leptospirosis/diagnosis , Myocarditis/diagnosis , Female , Humans , Male , Middle Aged , Prognosis , Prospective Studies
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.
Angina Pectoris/diagnosis , Myocardial Infarction/diagnosis , Quality of Life , Aged , Angina Pectoris/epidemiology , Angina Pectoris/therapy , Female , Health Status , Health Status Indicators , Humans , India/epidemiology , Male , Middle Aged , Myocardial Infarction/epidemiology , Myocardial Infarction/therapy , Patient Satisfaction , Quality Improvement , Quality Indicators, Health Care , Randomized Controlled Trials as Topic , Surveys and Questionnaires , Time Factors , Treatment Outcome
BACKGROUND: Epidemiological data on pulmonary hypertension (PH) are scarce from developing countries including India. METHODS: We established a multi-center registry of PH, the PRO-KERALA registry, in Kerala, India. Fifty hospitals enrolled consecutive adult (>18â¯years) patients for one year. Echocardiographic criteria (right ventricular systolic pressure - RVSPâ¯>â¯50â¯mmHg) or invasively obtained mean pulmonary artery pressureâ¯>â¯25â¯mmHg was the criteria for entry. RESULTS: There were 2003 patients (52% Women, mean age 56⯱â¯16.1â¯years) enrolled. The mean RVSP was 68.2 (SDâ¯=â¯17.9) mmHg. Majority of the study participants (59%) belonged to group 2 of the WHO Nice Classification 2013 (PH secondary to left heart disease). One-fifth (21.2%) belonged to group 1, while 13.3%, 3.8% and 2.4% of the study population belonged to groups 3, 4 and 5 respectively. More than a quarter (27%) reported PH due to left heart disease with valvular disease etiology; while 20.7% had coronary artery disease. The other common etiological factors were chronic obstructive pulmonary disease (10.6%), congenital heart disease (14.6%), idiopathic pulmonary hypertension (5.8%), and chronic thromboembolic pulmonary hypertension (3.8%). Only one of two patients with pulmonary artery hypertension was receiving PH specific therapies. The use of combination therapy was negligible and PH-specific therapies were prescribed off-label to a small proportion of patients too. CONCLUSION: PRO-KERALA is the first PH registry from South Asia and the second largest globally. Left heart diseases attribute to three fifths of patients with PH. Utilization rates of PH specific drug therapies are remarkably lower than the Western population.
Hypertension, Pulmonary/epidemiology , Hypertension, Pulmonary/therapy , Registries , Adult , Aged , Female , Follow-Up Studies , Humans , Hypertension, Pulmonary/diagnosis , India/epidemiology , Male , Middle Aged
Acute popliteal artery thrombosis is a rare complication following total knee arthroplasty (TKA), with sequelae including critical limb ischaemia and amputation. We report the case of a 54-year-old woman who developed acute popliteal artery thrombosis following TKA, presenting 2â weeks after the initial symptoms. While such cases have been traditionally managed with surgical thrombectomy or bypass grafting, percutaneous aspiration thrombectomy is an emerging alternative management strategy in the early postoperative period. However, in patients in whom intervention is delayed, the efficacy of percutaneous aspiration thrombectomy is not known. Our patient had complete resolution of thrombus following percutaneous thrombus aspiration, angioplasty and tirofiban administration. Prompt diagnosis and early percutaneous intervention may avert critical limb ischaemia in patients presenting with popliteal artery thrombosis following TKA.
Arterial Occlusive Diseases/etiology , Arthroplasty, Replacement, Knee/adverse effects , Endovascular Procedures/methods , Popliteal Artery , Postoperative Complications , Thrombectomy/methods , Thrombosis/etiology , Angiography , Arterial Occlusive Diseases/diagnosis , Arterial Occlusive Diseases/surgery , Female , Follow-Up Studies , Humans , Middle Aged , Thrombosis/diagnosis , Thrombosis/surgery , Time Factors , Ultrasonography, Doppler, Color
