2013 consensus statement for early reperfusion and pharmaco-invasive approach in patients presenting with chest pain diagnosed as STEMI (ST elevation myocardial infarction) in an Indian setting.

UNLABELLED: In India, the prevalence of ST elevation myocardial infarction (STEMI) is rising exponentially leading to cardiovascular morbidity and mortality. Despite advancement in reperfusion therapy (pharmacologic and interventional), the overall utilization, system of care and timely reperfusion remains suboptimal. JUSTIFICATION AND PURPOSE: Alarming treatment delays exist in patients presenting with chest pain observed in real-world and published evidences. Time to diagnose STEMI and initiation of reperfusion therapy at various first medical contacts in India is variable mandating immediate attention. We intend to provide evidence based explicit recommendations for practicing clinicians about time-dependent early management and the concept of pharmaco-invasive (PI) approach, contextualized to the situation in India. PROCESS: Pre-prepared guidance document by expert steering committee was discussed and commented by over 150 experts representing from 16 states in India at regional level. The moderators of these meetings arrived at a consensus on the evaluation and management of STEMI patients by PI approach to improve clinical outcomes. RECOMMENDATIONS: In addition to patient awareness and education for early symptom identification, education is required for general practitioners and physicians/intensivists to implement early time dependent STEMI management. Percutaneous Coronary Intervention (PCI) is the gold standard, yet it remains inaccessible to majority of patients, hence early reperfusion by initial use of fibrinolytics is recommended followed by coronary intervention. Fibrinolytics are easily available, economical and evaluated in several clinical studies and hence we recommend a PI approach (early fibrinolysis followed by PCI 3-24 hours later). We recommend a time guided 'Protocol/Plan of Action' for early fibrinolysis and implementing a PI approach at the level of general practitioners, non-PCI hospitals/nursing homes with intensive care facility and in PCI capable centers. For STEMI patients with symptom duration < 6 hours, we suggest administration of fibrinolytics either tenecteplase (Grade1A), reteplase (Grade1B), alteplase (Grade1C) or streptokinase (Grade 2B) alongside contemporary adjunctive medical therapy for PI approach. The aim of this Consensus Statement is * To provide explicit recommendations for practicing clinicians about the early management of STEMI and concept of pharmaco-invasive approach * To provide recommendations based on the best available evidences, contextualized to the situation in India. It must be recognized that even when randomized clinical trials have been undertaken, treatment options may be limited by resources. The Cardiocare STEMI experts realize that the recommended diagnostic examinations and treatment options may not be available or affordable in all parts of India. Cost-effectiveness is becoming an increasingly important issue when deciding upon therapeutic strategies. As always with guidelines/consensus statement, they are not prescriptive. Clinical scenario and patients vary so much from one another that individual care is paramount, and there is still an important place for clinical judgment, experience, and common sense. The mandate of the Cardiocare STEMI expert consensus is to recommend evidence-based standards of care, related targets and strategies for implementation of standards in the management of STEMI. CONTEXT AND USE: This document should be taken as consensus recommendations by qualified experts, not as rigid rules. It comprises of published evidence and may not cover every eventuality; new evidence is published every day. Furthermore, this should not be used as a legal resource, as the general nature cannot provide individualized guidance for all patients under all clinical circumstances.

A critical analysis of the noninferiority design of the TALENT trial.

In recent years, regulatory approval of stents has been based on studies that have a noninferiority design, which has its own inherent complexities. We critically appraise in this article, the TALENT trial that established the noninferiority of the Indian-manufactured Supraflex stent (a third-generation, sirolimus-eluting stent with an ultrathin strut thickness) compared with the Xience stent (an internationally available, everolimus-eluting stent with a thicker strut) for a device-oriented composite end point at the end of 12 months. Our analysis shows that if the risk ratio rather than absolute risk difference was used to calculate the noninferiority margin, we would obtain a value of 1.48 for the risk ratio. Supraflex would then be noninferior to Xience by 0.92 [95% confidence interval (CI) = 0.59 to 1.47]. The upper bound of the 95% CI of 1.47 is dangerously close to 1.48, indicating that the TALENT trial would just about manage to prove noninferiority.

Consensus and development of document for management of stabilized acute decompensated heart failure with reduced ejection fraction in India.

AIM: Ensuring adherence to guideline-directed medical therapy (GDMT) is an effective strategy to reduce mortality and readmission rates for heart failure (HF). Use of a checklist is one of the best tools to ensure GDMT. The aim was to develop a consensus document with a robust checklist for stabilized acute decompensated HF patients with reduced ejection fraction. While there are multiple checklists available, an India-specific checklist that is easy to fill and validated by regional and national subject matter experts (SMEs) is required. METHODOLOGY: A total of 25 Cardiology SMEs who consented to participate from India discussed data from literature, current evidence, international guidelines and practical experiences in two national and four regional meetings. RESULTS: Recommendations included HF management, treatment optimization, and patient education. The checklist should be filled at four time points- (a) transition from intensive care unit to ward, (b) at discharge, (c) 1st follow-up and (d) subsequent follow-up. The checklist is the responsibility of the consultant or the treating physician which can be delegated to a junior resident or a trained HF nurse. CONCLUSION: This checklist will ensure GDMT, simplify transition of care and can be used by all doctors across India. Institutions, associations, and societies should recommend this checklist for adaptability in public and private hospital. Hospital administrations should roll out policy for adoption of checklist by ensuring patient files have the checklist at the time of discharge and encourage practice of filling it diligently during follow-up visits.

Cardiological society of India document on safety measure during echo evaluation of cardiovascular disease in the time of COVID-19.

An echocardiographic investigation is one of the key modalities of diagnosis in cardiology. There has been a rising presence of cardiological comorbidities in patients positive for COVID-19. Hence, it is becoming extremely essential to look into the correct safety precautions, healthcare professionals must take while conducting an echo investigation. The decision matrix formulated for conducting an echocardiographic evaluation is based on presence or absence of cardiological comorbidity vis-à-vis positive, suspected or negative for COVID-19. The safety measures have been constructed keeping in mind the current safety precautions by WHO, CDC and MoHFW, India.

Cardiological Society of India: Document on acute MI care during COVID-19.

The unprecedented and rapidly spreading Coronavirus Disease-19 (COVID-19) pandemic has challenged public health care systems globally. Based on worldwide experience, India has initiated a nationwide lockdown to prevent the exponential surge of cases. During COVID-19, management of cardiovascular emergencies like acute Myocardial Infarction (MI) may be compromised. Cardiological Society of India (CSI) has ventured in this moment of crisis to evolve a consensus document for care of acute MI. However, this care should be individualized, based on local expertise and governmental advisories.

A critical analysis of the COMPASS trial with respect to benefit-risk assessment using the numbers needed to treat: Applicability and relevance in Indian patients with stable cardiovascular disease.

The recently published Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial evaluated the hypothesis that rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary prevention. In India, stable cardiovascular disease occurs in a much younger age group relative to the rest of the world. Our critical analysis of COMPASS trial showed that the younger age group appeared to derive greater benefit from the rivaroxaban+aspirin combination (relative to aspirin alone) as seen with number needed to treat metrics as compared to the older age group.

Idiopathic right atrial aneurysm.

We are describing a rare report of right atrial (RA) aneurysm without any structural heart disease. We are also describing the MRI features of this anomaly. This is first kind of case report in world literature where only isolated RA aneurysm was found without any other structural heart disease.

Transdiaphragmatic intercostal hernia due to chronic cough.

Intercostal transdiaphragmatic hernia is a rarely reported lesion. Trauma is the commonest cause. We report a 75-year-old man who presented with transdiaphragmatic intercostal hernia due to chronic cough. He recovered after surgical repair.

Emergent balloon mitral valvotomy in patients presenting with cardiac arrest, cardiogenic shock or refractory pulmonary edema.

OBJECTIVES: The present study was performed to determine the outcome of emergent balloon mitral valvotomy (BMV) in patients with cardiac arrest, pulmonary edema or cardiogenic shock. BACKGROUND: In India, many patients with mitral stenosis present in critical condition. They have high mortality despite surgical relief. The role of BMV in such patients is ill-defined. METHODS: Of 558 patients undergoing BMV between January 1993 and December 1994, 40 presented with cardiogenic shock, cardiac arrest or pulmonary edema refractory to medical treatment and underwent emergent BMV (group I). Elective BMV was performed in the remaining 518 patients (group II). RESULTS: Age ([mean +/- SD] 40 +/- 13 vs. 31 +/- 9 years, p < 0.05), incidence of atrial fibrillation (35% vs. 11%, p < 0.05), pulmonary artery systolic pressure (PAsP) (64 +/- 14 vs. 51 +/- 12 mm Hg, p < 0.001) and mitral valve (MV) score (7.4 +/- 1.2 vs. 6.4 +/- 1, p < 0.001) were higher and MV area lower (0.74 +/- 0.17 vs. 0.86 +/- 0.14 cm2, p < 0.001) in group I patients. After emergent BMV in group I, mitral regurgitation occurred in 15%, and the mortality rate was 35%. Stepwise logistic regression analysis identified MV score > or =8 (p = 0.008), PAsP > or =65 mm Hg (p = 0.023) and cardiac output < or =3.151 liters/min (p = 0.001) as significant predictors of a fatal outcome. Follow-up of 1 to 16 months (median 8) was available in 20 of 26 survivors in group I, of whom 15 were asymptomatic. The gain in MV area and the decrease in transmitral gradient and PAsP obtained immediately after BMV persisted during the follow-up period. CONCLUSIONS: Emergent BMV is feasible in critically ill patients. In-hospital survivors have excellent clinical and hemodynamic status at intermediate follow-up.

Indigenous recombinant streptokinase vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial.

BACKGROUND: Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK). AIM: To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK) and natural streptokinase (Streptase, n-SK). SETTINGS AND DESIGN: Double blind, randomized, non-inferiority, multicentric, parallel study. MATERIALS AND METHODS: Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V(1)-V(6) or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > or = 50% ST segment were used to assess reperfusion. STATISTICAL ANALYSIS: Difference in the groups was assessed by chi-square or paired t test as required. Probability value < 0.05 was considered significant with 95% confidence interval. RESULTS: Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group) and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58) and 69.4% (34) patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%), hypotension in 3 (3.6%), nausea in 2 (2.4%) patients. Minor bleeding were seen in 4 (4.8%) of patients. CONCLUSION: Indigenous recombinant Streptokinase (r-SK) is as efficacious as natural streptokinase (n-SK) in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile.

Results of Micro stent implantations in coronary lesions of various complexity.

Micro stents appear to be especially suitable for the safe treatment of complex coronary lesions and adverse vessel morphology. Stenting of lesions with type C morphology is associated with a higher restenosis rate than stenting of less complex coronary obstructions.

Interruption of the aortic arch with associated cardiac anomalies. Survival to adulthood.

Interruption of the aortic arch is a rare and usually lethal cardiac malformation. We report a rare case of a patient with IAA distal to the left subclavian artery associated with double outlet right ventricle, subaortic VSD and patent DA who survived to adulthood. In this patient, the complete diagnosis was made by cardiac catheterization and angiocardiography. We discuss the probable mechanisms, diagnostic problems and therapeutic implications of such long survival.

Phaeohyphomycotic ulcer caused by Phialophora verrucosa: successful treatment with itraconazole.

We report the first well documented case of subcutaneous phaeohyphomycotic infection caused by Phialophora verrucosa in India. Examination of the biopsied tissue from an ulcerating lesion on the shin of the left leg of a 45-year-old woman from Bombay, India, showed numerous dematiaceous, septate, branching hyphal elements and thick-walled cells characteristic of phaeohyphomycosis. Cultures of the scrapings from the lesion and of the biopsied tissue yielded a pigmented fungus that was identified as P. verrucosa. Initial treatment with fluconazole followed by oral itraconazole for 30 days and local application of a copper sulphate solution resulted in complete resolution of the lesion. Treatment with itraconazole was continued for an additional 3 months after complete healing. No new lesions developed and the patient did not show jaundice, hepatosplenomegaly or any other signs of toxicity.

Electrocardiographic differentiation between right coronary and left circumflex coronary arterial occlusion in isolated inferior wall myocardial infarction.

The presence of atrioventricular block and ST segment elevation in lead V4R accurately predicts right coronary artery occlusion in patients with inferior wall myocardial infarction. However, these electrocardiographic signs are absent in the majority of patients with inferior myocardial infarction. We studied ST segment elevation in leads II and III, ST segment in lead I and T wave polarity in lead V4R in order to differentiate between right coronary artery and left circumflex coronary artery occlusions in 104 patients with inferior myocardial infarction who subsequently underwent coronary angiography. The ST segment elevation was greater in lead III than in lead II when the right coronary artery was the culprit vessel and vice versa when the left circumflex was the culprit vessel (p < 0.001). An upright T wave in lead V4R and ST segment depression in lead I was common when the right coronary artery was the culprit vessel and not seen with left circumflex occlusion (p < 0.001). ST segment elevation in lead III was higher than in lead II with a sensitivity of 99 percent and a specificity of 100 percent for diagnosing right coronary artery as the culprit vessel. ST segment elevation in lead II was higher than in lead III with a sensitivity of 93 percent and a specificity of 100 percent in identifying the left circumflex as the culprit vessel. Thus, these signs are very useful in identifying the culprit vessel in inferior myocardial infarction.

Transcatheter fenestration of a total cavopulmonary connection baffle.

Transcatheter creation of a de novo fenestration of a total cavopulmonary connection baffle has not been previously reported from India. We present our experience with such a procedure in a 4-year-old child with recurrent pleural effusions in the early postoperative period.

Multicentric, clinical trial of S-Amlodipine 2.5 mg versus Amlodipine 5 mg in the treatment of mild to moderate hypertension--a randomized, double-blind clinical trial.

OBJECTIVE: To compare the efficacy and tolerability of 2.5 mg of S-Amlodipine with 5 mg of Amlodipine in the treatment of mild to moderate hypertension in a double blind, double dummy, randomized, comparative clinical trial. METHOD AND MATERIALS: Two hundred OPD patients (97 women and 103 men) with mean age 53.4 +/- 5.58 years, with stage I and stage 2 hypertension were enrolled for the study after obtaining informed written consent. Twelve patients were dropped out as lost to follow up. Ninety seven patients in the S-Amlodipine 2.5 mg treatment group and ninety one patients in the Amlodipine 5 mg treatment group completed the study. Those with a history of angina pectoris, myocardial infarction or recent cerebrovascular accident in the past six months and those with stage 3 and stage 4 hypertension were excluded from the study. Those showing a history of secondary hypertension were also excluded from the study. For the first two weeks all patients received dummy tablets of both S-Amlodipine and Amlodipine, as a wash out therapy and to get the actual blood pressure reading. After two weeks, enrolled patients received a preparation containing either S-Amlodipine (containing 2.5 mg of S-Amlodipine) and dummy tablets of Amlodipine or Amlodipine besylate (containing 5 mg of racemic Amlodipine) and dummy tablets of S-Amlodipine once daily for a period of six weeks. RESULTS: The results were analyzed by Student's 't' test The reduction in the average systolic and diastolic blood pressure, in the standing, supine and sitting postures in the S-Amlodipine group as well as in the Amlodipine group after six weeks of treatment was highly significant (P < or = 0.0001). The baseline values for average systolic blood pressure in standing, supine and sitting positions in the S-Amlodipine 2.5 mg treatment group were found to be 164.12 +/- 10.28, 165.72 +/- 10.88 and 165.24 +/- 10.66 mm of Hg respectively, which after treatment of six weeks changed to 144.9 +/- 7.4, 146.04 +/- 8.56 and 145.36 +/- 8.32 mm of Hg. The baseline values for average systolic blood pressure in standing, supine and sitting positions in the Amlodipine 5 mg treatment group were found to be 164.57 +/- 10.36, 166.47 +/- 10.58 and 165.81 +/- 10.54 mm of Hg respectively, which after treatment of six weeks changed to 154.42 +/- 6.33, 147.23 +/- 7.11 and 146.57 +/- 7.54 mm of Hg. The baseline values for average diastolic blood pressure in standing, supine and sitting positions in the S-Amlodipine 2.5 mg treatment group were found to be 99.63 +/- 6.22, 101.13 +/- 7.18 and 100.59 +/- 6.6 mm of Hg respectively, which after treatment of six weeks changed to 86.0 +/- 4.70, 87.18 +/- 5.20 and 86.27 +/- 5.68 mm of Hg. While the baseline values for average diastolic blood pressure in standing, supine and sitting positions in the Amlodipine 5 mg treatment group were found to be 98.95 +/- 5.54, 100.86 +/- 6.71 and 100.38 +/- 6.38 mm of Hg respectively, which after treatment of six weeks changed to 86.19 +/- 4.77, 87.52 +/- 5.44 and 87.33 +/- 5.98 mm of Hg. However the difference in the average reduction in systolic and diastolic blood pressures, in the two treatment groups, in the sitting, supine and the standing positions was not found to be statistically significant (p > 0.1) (CI = 0.95). There was no statistically significant change in the levels of serum creatinine, SGOT, SGPT, HDL, LDL, triglyceride and total cholesterol in patients receiving Amlodipine 5 mg. The reduction in total cholesterol as well as triglyceride level in the S-Amlodipine 2.5 mg treatment group was found to be greater but it failed to show any statistically significant difference. CONCLUSION: S-Amlodipine 2.5 mg is found to be equivalent in its efficacy and tolerability when compared to Amlodipine 5 mg in the treatment of mild to moderate hypertension.

Restenosis after coronary stenting--incidence and predictors.

OBJECTIVE: To determine the intermediate term outcome after coronary artery stenting. METHODS: The six month angiographic and clinical follow-up of 92 consecutive patients (94 lesions) undergoing successful coronary stenting was performed. Multiple variables were analyzed for predicting restenosis. RESULT: The mean age was 49.7 +/- 8.5 years. There were 73 males and 19 females. Coronary artery involvement was left anterior descending artery (LAD) in 67%, left circumflex artery (LCx) in 16.5% and right coronary artery (RCA) in 16.5%. The pre-procedure mean reference diameter was 3.1 +/- 0.38 mm, minimal luminal diameter (MLD) was 0.47 +/- 0.28 mm and percentage diameter stenosis (DS) was 85 +/- 9%. Post procedure MLD improved to 3.1 +/- 0.4 mm with an acute gain of 2.6 +/- 0.4 mm and residual DS of only 3 +/- 3%. Clinical and angiographic variables were correlated with restenosis assessed as both binary and continuous variables. Angiographic follow-up could be obtained in 55 out of 92 patients (60%) and 86 patients (88%) had a clinical follow-up. Angiographic restenosis (> 50% diameter stenosis) was present in 12 (22%) patients, seven of whom required a repeat angioplasty procedure. There was no death. At follow-up, the MLD was 2.1 +/- 0.93 and the DS was 32 +/- 29% with a lumen loss of 0.92 +/- 0.84 mm. Only 14 (16%) of patients had angina and stress test was positive in 21 (23%). Hypercholesterolemia (p < 0.001) and female gender (p < 0.05) were independently associated with high lumen loss. CONCLUSION: Intracoronary stenting in an unselected patient group is associated with a 22% restenosis rate. Hypercholesterolemia and female gender are associated with higher restenosis.

Radiofrequency ablation for accessory pathways: success and variants.

INTRODUCTION: Radiofrequency ablation (RFA) is currently being advocated as the first line of therapy for symptomatic and drug refractory arrhythmias mediated by accessory pathways (APs). However, a large database on RFA for APs from India is still lacking. METHODS: Four hundred thirty-four patients (298 males, (69%)), with APs who underwent RF ablation between January, 1998 and May, 2001 were included. The success and variants were evaluated retrospectively from the data. RESULTS: The mean age was 36 +/- 11 years. There were 314 (73%) patients with WPW syndrome while the other 120 (27%) had concealed APs. Documented tachycardia was noted in 406 (91%) patients. Forty-six (11%) patients had associated structural heart disease (Ebstein's anomaly in 18). The procedure was successful in 414 (97%) of 425 patients in whom it was attempted. Of those unsuccessful, five had epicardial APs, four had multiple APs and two had immediate recurrence of APs. RFA was not attempted in nine parahissian pathways. Additional mechanisms were seen in 48 (11%) patients with WPW syndrome (14 (4.4%) AV nodal reentrant tachycardias, 16 (5%) additional concealed APs and 18 (5.7%) multiple APs). Coronary sinus diverticulum were detected in 23 (7.3%) patients, and Mahaim-like APs were diagnosed in 24 (6\8%) patients. The procedural and fluoroscopy time was 96 +/- 41 and 19 +/- 13 minutes, respectively. There were no deaths; three patients developed pericardial tamponade, which was promptly treated by pericardiocentesis. CONCLUSION: Radiofrequency ablation is a safe and effective treatment for AP mediated tachycardia, especially for younger patients and children in whom life-long drug therapy may not be best option.

Pre-natal echocardiographic diagnosis and neonatal balloon dilatation of severe valvar pulmonic stenosis.

A case is presented below where pre-natal echocardiographic diagnosis of critical pulmonic valvar stenosis was made at 36 weeks of gestation. In view of the severe heart failure, successful balloon valvotomy was performed on day 4 of life. The child was asymptomatic at one month follow-up.