Rationale, Design and Baseline Characteristics of a Randomized Controlled Trial of a Cardiovascular Quality Improvement Strategy in India: The C-QIP Trial.

BACKGROUND: Quality of chronic care for cardiovascular disease (CVD) remains suboptimal worldwide. The Collaborative Quality ImProvement (C-QIP) trial aims to develop and test the feasibility and clinical effect of a multicomponent strategy among patients with prevalent CVD in India. METHODS: The C-QIP is a clinic-based, open randomized trial of a multicomponent intervention vs usual care that was locally developed and adapted for use in Indian settings through rigorous formative research guided by Consolidated Framework for Implementation Research (CFIR). The C-QIP intervention consisted of 5 components: 1) electronic health records and decision support system for clinicians, 2) trained nonphysician health workers (NPHW), 3) text-message based lifestyle reminders, 4) patient education materials, 5) quarterly audit and feedback reports. Patients with CVD (ischemic heart disease, ischemic stroke, or heart failure) attending outpatient CVD clinics were recruited from September 2022 to September 2023 and were randomized to the intervention or usual care arm for at least 12 months follow-up. The co-primary outcomes are implementation feasibility, fidelity (ie, dose delivered and dose received), acceptability, adoption and appropriateness, measured at multiple levels: patient, provider and clinic site-level, The secondary outcomes include prescription of guideline directed medical therapy (GDMT) (provider-level), and adherence to prescribed therapy, change in mean blood pressure (BP) and LDL-cholesterol between the intervention and control groups (patient-level). In addition, a trial-based process and economic evaluations will be performed using standard guidelines. RESULTS: We recruited 410 socio-demographically diverse patients with CVD from 4 hospitals in India. Mean (SD) age was 57.5 (11.7) years, and 73.0% were males. Self-reported history of hypertension (48.5%) and diabetes (41.5%) was common. At baseline, mean (SD) BP was 127.9 (18.2) /76.2 (11.6) mm Hg, mean (SD) LDLc: 80.3 (37.3) mg/dl and mean (SD) HbA1c: 6.8% (1.6%). At baseline, the GDMT varied from 62.4% for patients with ischemic heart disease, 48.6% for ischemic stroke and 36.1% for heart failure. CONCLUSION: This study will establish the feasibility of delivering contextually relevant, and evidence-based C-QIP strategy and assess whether it is acceptable to the target populations. The study results will inform a larger scale confirmatory trial of a comprehensive CVD care model in low-resource settings. TRIAL REGISTRATION: Clinical Trials Registry India: CTRI/2022/04/041847; Clinicaltrials.gov number: NCT05196659.

Bradyarrhythmias in patients with COVID-19: A case series.

Novel coronavirus disease (COVID-19) can have variety of cardiac manifestations; however, less is known about the prevalence, clinical characteristics and outcomes of bradyarrhythmias in patients with COVID-19. In the present case series of bradyarrhythmia in patients with COVID-19, we report complete heart block requiring intervention in 5 patients and sinus node dysfunction in 2 patients.

Primary percutaneous intervention in an unusual vessel using an unusual technique: a case report.

Background: Primary percutaneous intervention (PPCI) of the saphenous vein graft (SVG) is associated with a high risk of distal embolization and no reflow, since SVG lesions are often very friable and have a large thrombotic burden. We report a case of successful PPCI of the SVG using guide catheter thrombectomy with novel double wire technique. Case summary: A 60-year-old male with a past history of coronary artery bypass grafting presented with acute thrombotic occlusion of the SVG to the obtuse marginal graft. Despite appropriate pharmacotherapy (GPIIb/IIIa inhibitors) and thrombosuction, there was a large residual thrombus burden with poor distal flow. In the present case, we decided to perform guide catheter thrombosuction. An exchange length floppy 0.014' wire was passed alongside the pre-existing wire and the 6 Fr JR guide catheter was exchanged for a less traumatic 5 Fr JR guide catheter over the exchange wire. The first wire was kept distally in the vessel along the guiding catheter to maintain the access to the graft vessel. The 5 Fr JR guide catheter was slowly advanced over the wire to the distal portion of the graft, keeping the other wire in the distal portion of the graft to maintain access. A large amount of thrombus was aspirated and the patient improved dramatically. Discussion: This double wire technique is an effortless and novel way to maintain access to the distal vasculature of the occluded artery, while the guide can be safely intubated deep into the coronary artery that helps in removing a very large amount of thrombus because of their larger internal lumen.

Serial evaluation of biventricular function in COVID-19 recovered patients using speckle tracking echocardiography.

OBJECTIVES: The persistence and outcomes following myocardial injury subsequent to coronavirus disease-2019 (COVID-19) infection has not been properly elucidated. We assessed sub-clinical bi-ventricular dysfunction using speckle tracking echocardiography (STE) in post COVID-19 patients. METHODS: A total of 189 subjects following recovery from COVID-19 infection were enrolled. Detailed echocardiography including STE along with clinical, hematological, biochemical and inflammatory parameters were assessed for all. Patients were divided into four groups (asymptomatic, mild, moderate and severe) based on severity of COVID-19 infection. Additionally, 90 healthy individuals were enrolled as controls. All these patients were followed up for one year following enrolment. RESULTS: Subclinical LV and right ventricle (RV) dysfunction were seen in 58 (30.7 %) and 55 (29.1 %) patients respectively at baseline. Significant difference was observed in mean LVGLS values among the three groups (mild: -21.5 ± 2.8 %; moderate: -17 ± 7.1 %; severe: -12.1 ± 4 %; P < 0.0001). Over a year of follow-up, significant improvement in LVGLS from baseline (-19.1 ± 5.8 %) was observed (-19.9 ± 4.6 %; P < 0.0001). Similarly, RVFWS (-23.5 ± 6.3 % vs -23.8 ± 5.8 %; P = 0.03) had significant improvement from baseline to one year of follow-up. Reduced LVGLS was reported in 12 (6.3 %) subjects while impaired RVFWS was documented in 10 (5.3 %) subjects at one year of follow-up. CONCLUSIONS: Subclinical LV and RV dysfunction were seen in nearly a third of recovered COVID-19 patients. Over a year of follow-up, significant improvement in subclinical LV and RV dysfunction was noted.

Endothelial nitric oxide synthase (eNOS) gene polymorphism (Glu298asp) and nitric oxide (NO) levels in patients with ST-segment elevation myocardial infarction (STEMI).

BACKGROUND: Genetic polymorphism in endothelial Nitric Oxide Synthase (eNOS) are associated with occurrence of multiple cardiovascular diseases (CVDs). METHODS: This study included 300 young ST-segment elevation myocardial infarction (STEMI) patients and 300 healthy controls. STEMI patients were divided into two groups: premature coronary artery disease [CAD] (STEMI<40 years of age) and older STEMI (>40 years of age). Genetic polymorphisms in the eNOS gene (894G/T) was evaluated in both subjects and controls. Plasma levels of nitric oxide (NO) were estimated for both patients as well as controls. RESULTS: Mean age of the study population was 49.7 ± 9.2 years with premature CAD being present in 58 (19.3 %) patients. No significant difference at genotypic (P = 0.589, odds ratio (OR) = 0.9, 95 % CI = 0.6-1.6) and allelic level (P = 0.173, OR = 1.2, 95 % CI = 0.9-1.4) was observed between STEMI patients and healthy controls. Genotype 894 TT had significantly higher frequency in STEMI patients >40 years (P = 0.047, OR: 2.5; 95 % CI = 1.0-6.0). No significant difference at genotypic (P = 0.279) and allelic level (P = 0.493) was observed between premature CAD (STEMI age <40 years) and healthy controls. NO levels (131 ± 59.6 µM vs 118.11 ± 49.96 µM; P = 0.001) was significantly higher in healthy controls as compared to STEMI patients >40 years of age (P= 0.001). CONCLUSION: There was significant association of eNOS gene polymorphism Glu298Asp with STEMI patients > 40 years. However, this association was not observed in premature CAD patients. Lower levels of NO in STEMI patients >40 years suggests its potential role as a marker of CVD.

Epidemiological profile and clinical outcomes of very young (<35 years) and young (35-50 years) patients with STEMI: Insights from the NORIN STEMI registry.

BACKGROUND: Despite significant progress in primary prevention, rates of myocardial infarction (MI) in South Asian population is alarmingly high. OBJECTIVES: We sought to compare risk factor profiles and outcomes between individuals with ST-Segment Elevation Myocardial Infarction (STEMI) in young (<50 years) and old (≥50 years) age groups. METHODS: North India STEMI Registry (NORIN-STEMI) is a prospective observational registry of patients hospitalised with STEMI. We conducted a study of young patients (<50 years) regarding their risk factors for coronary artery disease (CAD), in-hospital and 30-day mortality and compared with their older counterpart. RESULTS: Among 5335 patients enrolled, 1752 (32.8%) were young and were 19 years younger than the older cohort. Major risk factors in young patients were physical inactivity (75.1%) and alcohol intake (67.8%). Higher prevalence of tobacco use (66.6% vs 52.4%), but lower prevalence of diabetes (16% vs 26.3%) and hypertension (18.5% vs 29.9%) were seen in young STEMI. Young patients were less likely to die both in-hospital (5.9% vs 10.0%) and at 30-days (11.1% vs 16.2%). Left ventricular ejection fraction (LVEF) < 30% at admission [OR: 8.00, 95% confidence interval (CI): 4.60-13.90, P < 0.001 in-hospital, OR: 3.92, 95% CI: 2.69-5.73 at 30-days] and female sex were strongest predictors of mortality. CONCLUSIONS: Young STEMI patients constituted one-third of total cohort. Most of them were tobacco consumers with lesser prevalence of diabetes and hypertension. They were less likely to die both in-hospital and at 30 days because of earlier presentation to a health care facility and hence a relatively preserved LVEF.

Novel lipid biomarkers and associated gene polymorphism in young ST-segment elevation myocardial infarction.

BACKGROUND: There is an increasing prevalence of coronary artery disease (CAD) in younger individuals. Lipid biomarkers such as lipoprotein-a (Lp-a), Apo A1, Apo B and Paraoxonase-1 (PON1) serve as important risk predictors for development of CAD. There is little evidence regarding the role of lipid biomarkers and their genetic polymorphisms in young (<50 years) ST-segment elevation myocardial infarction (STEMI) patients. METHODS: This study included 110 young (18-50 years) STEMI patients and 110 healthy controls. Serum levels of Apo A1, Apo B, Paraoxonase-1 (PON-1) and Lipoprotein-associated phospholipase A2 (Lp-PLA2) were estimated for both patients as well as controls. Additionally, genetic polymorphisms in the Apo A1 (75G/A) and the PON1 (Q192R) genes were evaluated. RESULTS: Serum levels of apo B (101.31 ± 27.58 vs 75.31 ± 18.77 mg/dl; p < 0.0001), Lp(a) [87.56 ± 74.28 vs 25.81 ± 24.66 mg/dl, p < 0.0001] and Lp-PLA2 [5.97 ± 1.39 vs 3.49 ± 1.27 ng/mL, p < 0.0001] were significantly higher in patients as compared to controls. Serum levels of Apo A1 [44.76 ± 35.65 vs 95.97 ± 29.89; p < 0.0001] and PON1 [2.63 ± 1.5 vs 3.87 ± 1.47 ng/mL, p < 0.0001] were significantly lower in cases as compared with controls. Additionally, patients with genetic polymorphisms in the Apo A1 (75G/A) and the PON1 (Q192R) gene had an increased risk of STEMI. CONCLUSION: Lipid biomarkers such as Apo A1, Apo B and PON1 and their genetic polymorphism are associated with the susceptibility for STEMI in young individuals.

Clinical Profiles, Outcomes, and Sex Differences of Patients With STEMI: Findings From the NORIN-STEMI Registry.

Background: Low- and middle-income countries account for most of the global burden of coronary artery disease. There is a paucity of data regarding epidemiology and outcomes for ST-segment elevation myocardial infarction (STEMI) patients in these regions. Objectives: The authors studied the contemporary characteristics, practice patterns, outcomes, and sex differences in patients with STEMI in India. Methods: NORIN-STEMI (North India ST-Segment Elevation Myocardial Infarction Registry) is an investigator-initiated prospective cohort study of patients presenting with STEMI at tertiary medical centers in North India. Results: Of 3,635 participants, 16% were female patients, one-third were <50 years of age, 53% had a history of smoking, 29% hypertension, and 24% diabetes. The median time from symptom onset to coronary angiography was 71 hours; the majority (93%) presented first to a non-percutaneous coronary intervention (PCI)-capable facility. Almost all received aspirin, statin, P2Y12 inhibitors, and heparin on presentation; 66% were treated with PCI (98% femoral access) and 13% received fibrinolytics. The left ventricular ejection fraction was <40% in 46% of patients. The 30-day and 1-year mortality rates were 9% and 11%, respectively. Compared with male patients, female patients were less likely to receive PCI (62% vs 73%; P < 0.0001) and had a more than 2-fold greater 1-year mortality (22% vs 9%; adjusted HR: 2.1; 95% CI: 1.7-2.7; P < 0.001). Conclusions: In this contemporary registry of patients with STEMI in India, female patients were less likely to receive PCI after STEMI and had a higher 1-year mortality compared with male patients. These findings have important public health implications, and further efforts are required to reduce these gaps.

Prevalence and prognostic implications of reduced left ventricular ejection fraction among patients with STEMI in India.

AIMS: To describe clinical characteristics and outcomes for those with STEMI and reduced left ventricular ejection fraction (LVEF) in low-income and middle-income countries (LMICs). METHODS AND RESULTS: Adults presenting with STEMI to two government-owned tertiary care centres in Delhi, India were prospectively enrolled in the North India ST-elevation myocardial infarction (NORIN-STEMI) registry. LVEF was evaluated at presentation and clinical characteristics were compared across LVEF categories. Overall, 3597 patients were included, of whom 468 (13%) had LVEF >50%, 1482 (41%) had mildly reduced LVEF (40-49%), 1357 (38%) had moderately reduced LVEF (30-39%), and 290 (8%) had severely reduced LVEF (<30%). Presentation delay >24 h, prior MI, and hyperlipidaemia were associated with decreasing LVEF category. Although most patients with reduced LVEF were discharged on appropriate guideline-directed therapies, adherence at 1 year was low (ACE inhibitor/ARB 91% to 41%, beta blocker 98% to 78%, aldosterone receptor antagonist 69% to 6%). After multivariable adjustment, a Cox regression model showed moderately reduced LVEF (HR 1.77, 95% CI 1.20, 2.60) and severely reduced LVEF (HR 3.63, 95% CI 2.41, 5.48) were associated with increased risk of all-cause mortality compared with LVEF ≥50%. CONCLUSIONS: On presentation for STEMI, almost 90% of NORIN-STEMI participants had at least mildly reduced LVEF and almost half had LVEF <40%. Patients with LVEF <40% had significantly higher risk of mortality at 1 year, and adherence to guideline-directed therapies at 1 year was poor. Systematic initiatives to improve access to timely revascularization and guideline-directed therapies are essential in advancing STEMI care in LMICs.

Susceptibility of CTLA-4 -1661A/G polymorphism towards severity of rheumatic heart disease.

AIM: Genetic contribution in acute rheumatic fever (ARF)/rheumatic heart disease (RHD) has been suggested but not according to severity of the valve involvement. This study attempts to identify the relevance of CTLA-4 polymorphism with severity of the disease. METHODS: In a case-control design, 291 healthy controls and 83 patients were genotyped for association between RHD and single-nucleotide polymorphisms -1661A/G of CTLA-4. RESULTS: Segregation of patients on the basis of severity i.e., MVL (Mitral Valve Lesion) and CVL (Combined Valve Lesion) revealed that the frequency of CTLA-4 -1661G allele depleted as the disease progressed to CVL (p < 0.05). Patients in the age group of 31-45 years were significantly more susceptible (p < 0.046). Whereas, female patients were more susceptible than the male patients. CONCLUSION: Our study suggests the risk associated with decreased frequency of CTLA-4 -1661G allele in the CVL group and in females.

Cystic mass in interventricular septum; a rare presentation of sinus of Valsalva aneurysm.

A young male presented with progressively increasing breathlessness for one year. Echocardiography showed a cystic echolucent cavity in interventricular septum communicating with sinus of Valsalva. A diagnosis of unruptured aneurysm of Valsalva dissecting into the interventricular septum was made. This complication is extremely rare and early recognition may prevent a potential catastrophe.

Risk factors for myocardial infarction in very young South Asians.

PURPOSE OF REVIEW: It is only over the last few decades that the impact of coronary artery disease (CAD) in very young South Asian population has been recognized. There has been a tremendous interest in elucidating the causes behind this phenomenon and these efforts have uncovered several mechanisms that might explain the early onset of CAD in this population. The complete risk profile of very young South Asians being affected by premature CAD still remains unknown. RECENT FINDINGS: The existing data fail to completely explain the burden of premature occurrence of CAD in South Asians especially in very young individuals. Results from some studies identified nine risk factors, including low consumption of fruits and vegetables, smoking, alcohol, diabetes, psychosocial factors, sedentary lifestyle, abdominal obesity, hypertension and dyslipidemia as the cause of myocardial infarction in 90% of the patients in this population. Recent large genome-wide association studies have discovered the association of several novel genetic loci with CAD in South Asians. Nonetheless, continued scientific efforts are required to further our understanding of the causal risk factors of CAD in South Asians to address the rising burden of CVD in this vulnerable population. SUMMARY: In this review, we discuss established and emerging risk factors of CAD in this population.

Epidemiological profile and management patterns of acute myocardial infarction in very young patients from a tertiary care center.

BACKGROUND: Cardiovascular disease is the leading cause of death in India. Previously it was thought to be a disease of the elderly but now an epidemiological transition is being seen with increasing incidence in the very young adults as well. Such patterns are not well studied in the South East Asian population. OBJECTIVE: To study the epidemiological profile of very young (≤35 years) adults presenting with an acute myocardial infarction (AMI) in comparison with an older cohort. METHODOLOGY: The present study included all patients presenting with AMI to the emergency or to the out-patient department of the G B Pant Institute of Postgraduate Medical Education and Research (GIPMER), New Delhi between January 2014 and October 2015. A total of 102 subjects ≤35 years with AMI comprised the study subjects (cases) and were compared with 104 subjects >35 years old with AMI (Controls). RESULTS & CONCLUSION: Most of the very young AMI patients presented with an anterior wall ST segment elevation myocardial infarction, a stable hemodynamic profile, single vessel disease and better left ventricular ejection fraction as compared with controls. Most of the patients were from urban and semi-urban areas, middle and lower middle socioeconomic status and were smokers but lacked other traditional risk factors.

Restoration of vision by endovascular revascularization in Takayasu arteritis: A case series.

Takayasu arteritis (TA) is a rare, inflammatory vasculitis affecting aorta and its branches. Stenotic occlusive lesions of multiple arch arteries can cause severe cerebral ischemia leading to impaired vision. We present three consecutive young patients of TA with severe diminution of vision on upright posture, where we attempted restoration of sight by improving cerebral blood flow by percutaneous endovascular revascularization. All three patients could be successfully revascularized with substantial improvement in vision. There was no complication. On follow up, one patient developed recurrence of visual symptoms due to restenosis, which was successfully treated by cutting balloon angioplasty. The objective of this case series is to highlight the role of endovascular techniques in reversing visual loss in such situations. .