Five-year mortality and readmission rates in patients with heart failure in India: Results from the Trivandrum heart failure registry.

INTRODUCTION: Heart failure (HF) has emerged as an important and increasing disease burden in India. We present the 5-year outcomes of patients hospitalized for HF in India. METHODS: The Trivandrum Heart Failure Registry (THFR) recruited consecutive patients admitted for acute HF among 16 hospitals in Trivandrum, Kerala in 2013. Guideline-directed medical therapy (GDMT) was defined as the combination of beta-blockers (BB), renin angiotensin system blockers (RAS), and mineralocorticoid receptor antagonists (MRA) in patients with HF with reduced ejection fraction (HFrEF, EF < 40%) at discharge. We used Cox proportional hazards models and Kaplan-Meier survival plots for analysis. The MAGGIC risk score variables were included as exposure variables. RESULTS: Among 1205 patients [69% male, mean (SD) age = 61.2 (13.7) years], HFrEF constituted 62% of patients and among them, 25% received GDMT. The 5-year mortality rate was 59% (n = 709 deaths), and median survival was 3.1 years. Sudden cardiac death and pump failure caused 46% and 49% of the deaths, respectively. In the multivariate Cox model, components of GDMT associated with lower 5-year mortality risks were discharge prescription of BB, RAS blocker, and MRA. Older age, lower systolic blood pressure, NYHA class III or IV, and higher serum creatinine were also associated with higher 5-year mortality. CONCLUSIONS: Three out of every 5 patients had died during 5-years of follow-up with a median survival of approximately 3 years. Lack of GDMT in patients with HFrEF and frequent readmissions were associated with higher 5-year mortality. Quality improvement programmes with strategies to improve adherence to GDMT and reduction in readmissions may improve HF outcomes in this region.

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.

Remote ischemic preconditioning for prevention of contrast induced nephropathy-Insights from an Indian study.

OBJECTIVES: To study if four cycles of remote ischemic preconditioning (RIPC) could offer protection against contrast induced nephropathy (CIN) and post procedural renal dysfunction in high risk patients undergoing percutaneous coronary intervention (PCI). METHODS: This was a prospective single blind randomized sham controlled trial where patients undergoing coronary angioplasty with stage III chronic kidney disease were randomized into sham preconditioning and remote ischemic preconditioning. The primary outcome was the reduction in the incidence of CIN. The secondary outcomes were the maximum improvement in eGFR, maximum reduction in serum creatinine and composite of requirement of hemodialysis, death and rehospitalization for heart failure up to 6 weeks after PCI. RESULTS: Eleven out of fifty patients in the study group developed CIN (22%) compared to eighteen out of the fifty control patients (36%) (p=0.123). There was a statistically significant improvement in the post procedure creatinine values at 24h (p=0.013), 48h (p=0.015), 2 weeks (p=0.003), 6 weeks (p=0.003) and post procedure glomerular filtration rate (eGFR) values at 24h (p=0.026), 48h (p=0.044), 2 weeks (p=0.015) and 6 weeks (p=0.011) in study group compared to control group. The secondary outcome composite of requirement of hemodialysis, death and rehospitalization for heart failure was not statistically significant (p: 0.646). CONCLUSION: RIPC does not result in significant reduction of CIN. However RIPC helps in the prevention of post procedural worsening in eGFR and serum creatinine even up to 6 weeks.

Coronary angioplasty in spontaneous coronary artery dissection-Strategy and outcomes.

OBJECTIVE: To study the clinical, angiographic and technical characteristics of patients with spontaneous coronary artery dissection (SCAD) undergoing percutaneous coronary intervention (PCI). METHODS: This was a retrospective single center study where patients with angiographically confirmed SCAD undergoing PCI over a period of 4 years (2013-2017) were analyzed. We also sought to identify the clinical and angiographic predictors of procedural failure during PCI. RESULTS: There were a total of 42 patients with angiographically confirmed SCAD during the study period of which 16 patients (38.1%) underwent PCI. 14 out of the 16 patients (87.5%) taken up for PCI had technical success. In all patients the lesion was initially attempted to cross with a floppy wire and if unsuccessful it was escalated to a hydrophilic wire and finally to a stiff wire The SCAD lesion was crossed with a floppy wire in 71.4% of patients, with a hydrophilic wire in 14.2% and a stiff wire in 7.1% of patients. Wire escalation was required in 5 patients (31.3%) and in 60% of cases there was a technical success after wire escalation. Presence of diabetes mellitus, hypertension, dyslipidemia, smoking, coexisting atherosclerosis, diffuse nature of the lesion, and baseline Thrombolysis in Myocardial Infarction (TIMI)≤2 flow did not predict procedural failure during PCI. CONCLUSION: PCI in SCAD is associated with a fair rate of technical success in our population. Choosing an initial floppy wire and then escalating to a hydrophilic wire followed by a stiff wire is an optimal revascularization strategy.

Predictors of contrast induced nephropathy and the applicability of the Mehran risk score in high risk patients undergoing coronary angioplasty-A study from a tertiary care center in South India.

OBJECTIVE: To study the incidence and predictors of Contrast induced nephropathy (CIN) in high risk patients undergoing coronary angioplasty. To study the applicability of the Mehran Risk Score (MRS) in the prediction of CIN in our population. METHODS: This was a prospective observational study where patients with an estimated glomerular filtration rate (eGFR) between 30 and 60ml/mt undergoing elective percutaneous coronary intervention (PCI) over a period of 15 months were evaluated prospectively for the development of CIN. The patients who developed CIN were then analysed for the presence of specific risk factors. The patients were categorized into the 4 risk groups based on the MRS. RESULTS: 100 high risk patients underwent PCI during the study period. The incidence of CIN was 29%. On multivariate analysis, the presence of anemia (p=0.007), increased contrast volume usage (as defined by >5* B.Wt/S.cr) (p=0.012) and usage of loop diuretics (p=0.033) were independently found to confer a significant risk of CIN. In patients belonging to the high Mehran risk group (MRS10- 15) and very high risk group (MRS >15) the risk of CIN was 3 fold (OR: 3.055, 95% CI: 1.18-7.94, p=0.022) and 24 fold (OR: 24, 95% CI: 2.53-228.28, p=0.006) higher respectively when compared to intermediate and low risk patients (MRS <10). CONCLUSION: The incidence of CIN in high risk patients undergoing PCI is substantially higher in our population compared to similar studies in the west. The MRS risk prediction is pertinent even in an Indian population.

In-Hospital and Three-Year Outcomes of Heart Failure Patients in South India: The Trivandrum Heart Failure Registry.

BACKGROUND: Long-term data on outcomes of participants hospitalized with heart failure (HF) from low- and middle-income countries are limited. METHODS AND RESULTS: In the Trivandrum Heart Failure Registry (THFR) in 2013, 1205 participants from 18 hospitals in Trivandrum, India, were enrolled. Data were collected on demographics, clinical presentation, treatment, and outcomes. We performed survival analyses, compared groups and evaluated the association between heart failure (HF) type and mortality, adjusting for covariates that predicted mortality in a global HF risk score. The mean (standard deviation) age of participants was 61.2 (13.7) years. Ischemic heart disease was the most common cause (72%). The in-hospital mortality rate was higher for participants with HF with reduced ejection fraction (HFrEF; 9.7%) compared with those with HF with preserved ejection fraction (HFpEF; 4.8%; P = .003). After 3 years, 540 (44.8%) participants had died. The all-cause mortality rate was lower for participants with HFpEF (40.8%) compared with HFrEF (46.2%; P = .049). In multivariable models, older age (hazard ratio [HR] 1.24 per decade, 95% confidence interval [CI] 1.15-1.33), New York Heart Association functional class IV symptoms (HR 2.80, 95% CI 1.43-5.48), and higher serum creatinine (HR 1.12 per mg/dL, 95% CI 1.04-1.22) were associated with all-cause mortality. CONCLUSIONS: Participants with HF in the THFR have high 3-year all-cause mortality. Targeted hospital-based quality improvement initiatives are needed to improve survival during and after hospitalization for HF.

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.

Angiographic predictors of success in antegrade approach of Chronic Total Occlusion interventions in a South Indian population in the contemporary era.

Chronic Total Occlusion (CTO) intervention is a challenging area in interventional cardiology. Presently about 70% of CTO interventions are successful. MATERIALS AND METHODS: This was a single center prospective study of a cohort of all patients undergoing percutaneous coronary intervention (PCI) as elective or adhoc procedure for CTO from August 2014 to June 2015. Only antegrade CTO interventions were included. In all patients the following data were recorded. RESULTS: A total of 210 (8.9% of total PCI (2353) during the study period) CTO patients were followed up. The mean age was 56.54±8.9. In the study sixty nine patients (32.9%) presented with chronic stable angina and rest of the patients had history of acute coronary syndrome of which 22.9% (n=48) had unstable angina (UA) or non ST elevation myocardial infarction (NSTEMI) and 44.2% (n=93) had ST Elevation Myocardial Infarction (STEMI). In those with history of ACS, 64.78% (n=92) had ACS during the previous year and remaining 35.22% (n=49) had ACS prior to that. Single vessel CTO was seen in 89.5% (n=188) and two vessel CTO in 10.5% (n=22). LAD was involved in 36.7% (n=77), RCA in 48.1% (n=101), and LCX in 15.2% (n=32). Procedural success in the first attempt was 68.1% (n=143), which increased to 71.42% (n=150) after the second attempt. CTO interventions were more frequently successful when the calcium was absent or minimal (p-0.05), CTO length was <10mm (p<0.01) and good distal reformation (p<0.01).

Open-labeled randomized controlled trial to evaluate the 1-year clinical outcomes of polymer-free sirolimus-eluting coronary stents as compared with biodegradable polymer-based sirolimus-eluting coronary stents.

BACKGROUND: Head to head trials of clinical outcomes of sirolimus eluting polymer free vs. biodegradable polymer stents are lacking. METHODS: Single centre prospective open labeled randomised controlled clinical trial. Basis for sample size calculation was the rate of MACE from the ISAR TEST 3 trial in which the absolute difference was 10.25% with a standard deviation of 0.24. Assuming null hypothesis, 80% power and 5% alpha error, to detect a 10% difference, adjusting for 10% loss of follow up, sample size was 204. INCLUSION CRITERIA: Patients with stable coronary artery disease or recent acute coronary syndrome ( >1 week from the date of STEMI), being taken up for elective angioplasty. END POINTS: Primary end point was MACE at 1 year and secondary end points at the end of 1 year were cardiac death, urgent target lesion revascularization, acute coronary syndrome, stroke and in-stent re-stenosis. RESULTS: 204 patients were enrolled between January 2013 to July 2014, 91 in the polymer-free group and 113 in the biodegradable polymer group. Baseline characteristics were comparable between both groups. 21 patients (10.29%), were lost to follow up. MACE at 1 year were comparable in both the groups 3 of 85(3.52%) in the polymer-free group and 3 of 98(3.06%) in the biodegradable polymer group, p = 0.859. The secondary end points were also comparable between the two groups- Death- 1 of 85(1.17%) vs. 2 of 98(2.04%), p = 0.646, Stroke 0 of 85 vs. 2 of 98(2.04%), p = 0.185 and acute coronary syndrome - 2 of 85(2.35%) vs. 1 of 98(1.02%), p = 0.204. There were no instances of urgent target lesion re-vascularisation or definite stent thrombosis in either groups. In stent re-stenosis was found in 7 of 85(8.2%) in the polymer-free group vs. 6 of 98(6.12%) in the biodegradable polymer group. CONCLUSION: The 1 year MACE rates are comparable in patients who underwent elective coronary revascularization using sirolimus eluting polymer-free and biodegradable polymer stents.

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.

One-year mortality outcomes and hospital readmissions of patients admitted with acute heart failure: Data from the Trivandrum Heart Failure Registry in Kerala, India.

BACKGROUND: There are sparse data on outcomes of patients with heart failure (HF) from India. The objective was to evaluate hospital readmissions and 1-year mortality outcomes of patients with HF in Kerala, India. METHODS: We followed 1,205 patients enrolled in the Trivandrum Heart Failure Registry for 1 year. A trained research nurse contacted each participant every 3 months using a structured questionnaire which included hospital readmission and mortality information. RESULTS: The mean (SD) age was 61.2 (13.7) years, and 31% were women. One out of 4 (26%) participants had HF with preserved ejection fraction. Only 25% of patients with HF with reduced ejection fraction received guideline-directed medical therapy at discharge. Cumulative all-cause mortality at 1 year was 30.8% (n = 371), but the greatest risk of mortality was in the first 3 months (18.1%). Most deaths (61%) occurred in patients younger than 70 years. One out of every 3 (30.2%) patients was readmitted at least once over 1 year. The hospital readmission rates were similar between HF with preserved ejection fraction and HF with reduced ejection fraction patients. New York Heart Association functional class IV status and lack of guideline-directed medical treatment after index hospitalization were associated with increased likelihood of readmission. Similarly, older age, lower education status, nonischemic etiology, history of stroke, higher serum creatinine, lack of adherence to guideline-directed medical therapy, and hospital readmissions were associated with increased 1-year mortality. CONCLUSIONS: In the Trivandrum Heart Failure Registry, 1 of 3 HF patients died within 1 year of follow-up during their productive life years. Suboptimal adherence to guideline-directed treatment is associated with increased propensity of readmission and death. Quality improvement programs aiming to improve adherence to guideline-based therapy and reducing readmission may result in significant survival benefits in the relatively younger cohort of HF patients in India.

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.

Rheumatic Heart Disease in Kerala: A Vanishing Entity? An Echo Doppler Study in 5-15-Years-Old School Children.

Background. Early detection of subclinical rheumatic heart disease by use of echocardiography warrants timely implementation of secondary antibiotic prophylaxis and thereby prevents or retards its related complications. Objectives. The objective of this epidemiological study was to determine prevalence of RHD by echocardiography using World Heart Federation criteria in randomly selected school children of Trivandrum. Methods. This was a population-based cross-sectional screening study carried out in Trivandrum. A total of 2060 school children, 5-15 years, were randomly selected from five government and two private (aided) schools. All enrolled children were screened for RHD according to standard clinical and WHF criteria of echocardiography. Results. Echocardiographic examinations confirmed RHD in 5 children out of 146 clinically suspected cases. Thus, clinical prevalence was found to be 2.4 per 1000. According to WHF criteria of echocardiography, 12 children (12/2060) were diagnosed with RHD corresponding to echocardiographic prevalence of 5.83 cases per 1000. As per criteria, 6 children were diagnosed with definite RHD and 6 with borderline RHD. Conclusions. The results of the current study demonstrate that echocardiography is more sensitive and feasible in detecting clinically silent RHD. Our study, the largest school survey of south India till date, points towards declining prevalence of RHD (5.83/1000 cases) using WHF criteria in Kerala.

Clinical presentation, management, in-hospital and 90-day outcomes of heart failure patients in Trivandrum, Kerala, India: the Trivandrum Heart Failure Registry.

OBJECTIVE: To evaluate the presentation, management, and outcomes of patients hospitalized for heart failure (HF) in Trivandrum, India. METHODS: The Trivandrum Heart Failure Registry (THFR) enrolled consecutive admissions from 13 urban and five rural hospitals in Trivandrum with a primary diagnosis of HF from January to December 2013. Clinical characteristics at presentation, treatment, in-hospital outcomes, and 90-day mortality data were collected. 'Guideline-based' medical treatment was defined as the combination of beta-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and aldosterone receptor blockers in patients with left ventricular systolic dysfunction (LVSD). RESULTS: We enrolled 1205 cases (834 men, 69%) into the registry. Mean (standard deviation) age was 61.2 (13.7) years. The most common HF aetiology was ischaemic heart disease (IHD) (72%). Heart failure with preserved ejection fraction (≥45%) constituted 26% of the population. The median hospital stay was 6 days (interquartile range = 4-9 days) with an in-hospital mortality rate of 8.5% (95% confidence interval 6.9-10.0). The 90-day all-cause mortality rate was 2.43 deaths per 1000 person-days (95% confidence interval 2.11-2.78). Guideline-based medical treatment was given to 19% and 25% of patients with LVSD during hospital admission and at discharge, respectively. Older age, lower education, poor ejection fraction, higher serum creatinine, New York Heart Association functional class IV, and suboptimal medical treatment were associated with higher risk of 90-day mortality. CONCLUSION: Patients hospitalized with HF in the THFR were younger, more likely to be men, had a higher prevalence of IHD, reported longer length of hospital stay, and higher mortality compared with published data from other registries. We also identified key areas for improving hospital-based HF medical care in Trivandrum.