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.

Case Report: Occurrence of Severe Thoracic Aortic Aneurysms (Involving the Ascending, Arch, and Descending Segments) as a Result of Fibulin-4 Deficiency: A Rare Pathology With Successful Management.

Aortic diseases requiring surgery in childhood are distinctive and rare. Very few reports in the literature account for the occurrence of multiple thoracic aortic aneurysms in the same pediatric patient because of a genetic cause. We report a rare occurrence of severe thoracic aortic aneurysms (involving the ascending, arch and descending aortic segments) with severe aortic insufficiency in a 7-year-old female child secondary to the extremely rare and often lethal genetic disorder, cutis laxa. She was eventually identified as a carrier of a homozygous EFEMP2 (alias FBLN4) mutation. This gene encodes the extracellular matrix protein fibulin-4, and its mutation is associated with autosomal recessive cutis laxa type 1B that leads to severe aortopathy with aneurysm formation and vascular tortuosity. Parents of the child were not known to be consanguineous. Significant symptomatic improvement in the patient could be discerned after timely intervention with the valve-sparing aortic root replacement (David V procedure) and a concomitant aortic arch replacement. This is a unique report with a successful outcome that highlights the occurrence of a rare hereditary aortopathy associated with a high morbidity and mortality, and the importance of an early diagnosis and timely management. It also offers insight to physicians in having a very broad differential and multimodal approach in handling rare pediatric cardio-pathologies with a genetic predisposition.

Compliance of Secondary Prevention Strategies in Coronary Artery Disease Patients with and without Diabetes Mellitus - A Cross-Sectional Analytical Survey from Kerala, India.

CONTEXT: There is limited data related to compliance of secondary prevention strategies for coronary artery diseases (CAD) among patients with and without diabetes. OBJECTIVES: The objective was to compare compliance to secondary prevention strategies for CAD including smoking cessation, weight management, blood pressure (BP) control, Low density lipoprotein (LDL) cholesterol control and adequate physical activity between patients with and without diabetes. SETTINGS AND DESIGN: This is a hospital-based cross-sectional analytical study. METHODS AND MATERIALS: The study questionnaire was used to collect data through interviews of CAD patients. Compliance to secondary prevention strategies was documented using European Society of Cardiology guidelines. STATISTICAL ANALYSIS: We used modified Poisson model to estimate adjusted prevalence ratios (Adj. PR) for estimating compliance. RESULTS: Among 1,206 participants with CAD, 609 (50.5%) had diabetes. The Adj. PR s for three targets - smoking cessation (Adj. PR 1.01, 95% CI 0.97, 1.06, P 0.50), ideal BMI (Adj. PR 0.99, 95% CI 0.92, 1.09, P 0.99) and adequate physical activity (Adj. PR 1.12, 95% CI 0.97, 1.29, P 0.12) showed no significant difference between the groups. There was poor BP control in patients with diabetes compared to those without the same (Adj. PR 0.19, 95% CI 0.15, 0.23, P < 0.0001). LDL cholesterol control was better in patients with diabetes in comparison to those without the same (Adj. PR 1.19, 95% CI 1.08, 1.31, P 0.0005). CONCLUSION: The compliance for secondary prevention of CAD among patients with diabetes is similar to those without diabetes except for poor control of hypertension and better control of LDL cholesterol.

Health-Related Quality of Life of Coronary Artery Disease Patients under Secondary Prevention: A Cross-Sectional Survey from South India.

BACKGROUND: Health-related quality of life (HRQOL) is emerging as an important outcome among patients with documented coronary artery disease (CAD). The primary objective of this study was to report the HRQOL of CAD patients under secondary prevention-related treatment and follow-up using the 36-Item Short Form (SF-36) tool. METHODS: This was an analytical cross-sectional survey done in a hospital/clinic setting. We recruited CAD patients 30 to 80 years old with 1 to 6 years of follow-up. Patients self-reported HRQOL using SF-36. RESULTS: We recruited 1206 patients, among whom 879 (72.9%) were male. The mean age of patients was 61.3 (9.6) years. Mean (± standard deviation) scores for physical functioning, role limitations due to physical health, pain, and general health were 66.48 ± 29.41, 78.96 ± 28.01, 80.96 ± 21.15, and 51.49 ± 20.19, respectively. The scores for role limitations due to emotional problems, energy/fatigue, emotional well-being, and social functioning were 76.62 ± 28.0, 66.18 ± 23.92, 76.91 ± 20.47, and 74.49 ± 23.55. In subgroup analysis, age, sex, type of CAD, and treatment showed no significant association with any of the 8 domains of QOL. In addition, hypertension and diabetes showed no significant association with the individual domains of HRQOL. CONCLUSION: Patients with coronary artery disease under secondary prevention-related treatment have suboptimal HRQOL under both physical and mental domains. The role of demographic factors, comorbidities, disease subtypes, and treatment options in modifying HRQOL among patients with CAD appears to be minimal.

Compliance to secondary prevention strategies for coronary artery disease: a hospital-based cross-sectional survey from Ernakulam, South India.

OBJECTIVES: The primary objective of the study was to report the compliance to secondary prevention strategies for coronary artery disease (CAD), such as smoking cessation, weight management, low-density lipoprotein (LDL) cholesterol control, blood pressure control, glycaemic control, physical activity and cardiovascular drug therapy from a resource-limited setting. DESIGN: Analytical cross-sectional survey with data collection using questionnaire administered by study personnel. SETTING: Institutional-two tertiary care hospitals and two cardiology clinics. PARTICIPANTS: Patients in the age group of 30-80 years with documented CAD with a minimum of 1 year and a maximum of 6 years of follow-up after diagnosis. MAIN OUTCOME MEASURES: The main outcome measures were the prevalence of individual compliance to secondary prevention strategies for CAD such as smoking cessation, weight management, LDL cholesterol control, blood pressure control, glycaemic control, physical activity and cardiovascular drug therapy. The secondary outcomes were the association of secondary prevention strategies with age, sex, domicile, socioeconomic status, insurance and type of treatment. RESULTS: We recruited a total of 1206 patients among whom 879 (72.9%) were males. The median age of patients was 62 (14) years. The compliance to smoking cessation was 93.86% (95% CI 91.66% to 96.06%), ideal body mass index was 63.76% (95% CI 61.05% to 66.47%), blood pressure control was 65.11% (95% CI 62.42% to 67.80%), LDL compliance was 36.50% (95% CI 33.18% to 39.82%), diabetes control was 51.23% (95% CI 46.10% to 56.36%) and adequate physical activity was 39.22% (95% CI 36.46% to 41.98%)respectively. Reported compliance for cardiovascular drugs therapy was 96% for antiplatelets, 89.4% for statins, 68.2% for beta blockers, 37.7% for renin angiotensin aldosterone system blockers, 81.28% for oral hypoglycaemic agents and 22% for insulin therapy. CONCLUSION: Compliance to secondary prevention strategies for CAD in resource limited settings are moderate. This needs further improvement for better outcomes related to CAD in future.

Aortic pulse wave velocity and its relationship with complexity of coronary artery disease based on SYNTAX score.

BACKGROUND: Aortic pulse wave velocity (APWV), a marker of arterial stiffness, was found to be a good predictor for the presence of incipient vascular disease and cardiovascular events in observational studies. APWV measured by echo Doppler is a simple and readily available method comparable with other costlier and complex modalities of APWV measurement like MRI, Complior method or applanation tonometry. AIMS AND OBJECTIVES: No previous studies have demonstrated a relationship between APWV findings and the complexity of coronary artery disease (CAD). Our aim was to examine the relationship between APWV findings and the severity of SYNTAX scores (SX scores). METHODS: 500 patients who had undergone APWV measurements and elective coronary angiography from September 2012 to June 2013 were taken. Pulsed Doppler ultrasound (6.6 MHZ) probe with ECG synchronisation was used to calculate APWV. SYNTAX scoring was performed by observers who were blinded to APWV values. RESULTS: A significant, nearly linear correlation between APWV and advancing CAD (p<0.0001) was observed. Patients with dual-vessel and triple-vessel disease had significantly higher APWV than patients without CAD. It was also found that mean APWV values were significantly more in patients with high or intermediate SX scores than in patients with low SX scores. The Fischer's linear discriminant analysis showed a cut-off value of APWV for predicting the possibility of having CAD to be >11.5 m/s. CONCLUSIONS: APWV has predictive value for the SX score. A positive relation exists between aortic stiffening and coronary atherosclerosis and APWV measured by 2D Doppler is a good predictor of advancing CAD.

A study of ECG pattern, cardiac structural abnormalities and familial tendency in patients with early repolarisation syndrome in South India.

BACKGROUND: Early repolarisation (ER) on ECG, which was initially believed to be benign, has of late been considered otherwise. Brugada syndrome has recently been thought to be an extension of the ER spectrum, and the familial tendency of the ER pattern is being highlighted. With attention being drawn to ER's association with idiopathic ventricular fibrillation (VF), the prognosis and lineage of patients with an ER pattern are under scrutiny. AIMS: To analyse ER patterns on ECG, their presence in first-degree relatives and their association with structural heart disease. To classify different types of ER and estimate the prevalence of the high-risk notch/slur pattern in the population studied. METHODS: We screened all patients presenting to our department from December 2011 to July 2014 for ER patterns. We excluded patients with other causes of ST elevation that mimicked the ER pattern, those aged <18 years, and those not willing to participate in the study. A complete physical examination, 12-lead ECG and echocardiography were performed on all study patients. Willing first-degree relatives were screened with a 12-lead ECG. Of the 963 patients with ER that we initially screened, 843 completed the study. A total of 4116 relatives were screened. RESULTS: Of the 843 patients who completed the study, 687 (81.5%) were male and 156 (18.5%) were female. The majority were asymptomatic (70.11%), but had been referred for ECG abnormalities. Fifteen patients with chest pain were inadvertently thrombolysed and were later diagnosed to have ER. Their ER pattern was exaggerated during chest pain, which made this error highly likely. Among the 48 patients who had acute coronary syndrome (ACS), ER pattern was noticed in a different lead than those affected by ACS. Of these, 27 (56.25%) had ventricular tachycardia/VF during the acute phase. Six patients had electrical storm without evidence of ACS, and all had a global ER pattern with prominent notching/slurring on baseline ECG. The most common type of ER pattern was type I (lateral leads; 55.87%). Twenty-one patients had a Brugada pattern. Of all the patients with ER, only a third (34.16%) had the possibly high-risk notched/slurred ECG pattern. The majority (82.92%) had a structurally normal heart. We found that mitral valve prolapse (MVP), as assessed by >2 mm leaflet prolapse from the annulus, was more common in patients with ER (11.39%). Of the 4116 relatives screened, 2625 (63.78%) had an ER pattern; a quarter of family members had the inferolateral variety and over 60% of relatives had the lateral variety. We also noticed different ER patterns in the same family. CONCLUSIONS: We found that exaggeration of the ER pattern during chest pain may lead to inadvertent thrombolysis. A notched/slurred ER pattern is found in only a third of patients, who need to be grouped separately, as they may constitute a high-risk category. Patients with ER had MVP at a higher prevalence (almost double) than the general population, probably explaining the high incidence of sudden cardiac death associated with MVP. A familial tendency to an ER pattern was found in more than half of first-degree relatives, with different ER patterns, even the Brugada pattern, found in the same family. This may be because Brugada and other ER patterns belong to the same spectrum and may share the same prognosis. Thus we conclude that further studies regarding ER, its association with MVP, risk stratification by notched ECG pattern, and familial distribution along with gene analysis are warranted.