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.

Chromosome 22 microdeletion by F.I.S.H. in isolated congenital heart disease.

OBJECTIVE: To analyze the frequency of del22q11.2 in non-syndromic CHDs using classical cytogenetics and Fluorescence In Situ Hybridization (FISH) technique in Indian population. METHODS: 105 prospective cases which included 6 families with isolated, non-syndromic cardiac defects were analyzed clinically by a cardiologist and a geneticist. The cases were then subjected to karyotypic (classical cytogenetics) as well as FISH analysis. The efficacy of FISH technique was compared with inference drawn from classical cytogenetics. RESULTS: Karyotypic analysis of all the 105 patients revealed a normal chromosomal complement. Microdeletion 22q11.2 was observed in six patients (5.71%) by FISH studies. FISH studies were also performed on the parents of these six patients who revealed a normal chromosome 22. No correlation was found between clinical features (mild or unspecific) with 22q11.2 microdeletion. CONCLUSION: The testing for microdeletion 22q11.2 in isolated non-syndromic patients using FISH technique is mandatory even when mild/unspecific extracardiac abnormalities are seen in the patients.

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.

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.

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.

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.

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.

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.

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.

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.

Acute hemodynamic response to vasodilators in primary pulmonary hypertension.

Acute hemodynamic effects of high flow oxygen (O2) inhalation, sublingual isosorbide dinitrate (ISDN), intravenous aminophylline (AMN) and sublingual nifedipine (NIF) were studied in 32 patients with primary pulmonary hypertension (PPH). In 30 out of 32 patients the basal ratio of pulmonary to systemic vascular resistance (Rp/Rs) was > 0.5 (mean = 0.77 +/- 0.20). Oxygen caused significant decrease in the mean resistance ratio to 0.68 +/- 0.20 (p = 0.005). ISDN, AMN and NIF caused increase in the resistance ratio to 0.79 +/- 0.26; 0.78 +/- 0.26; and 0.80 +/- 0.23 respectively. O2, ISDN, AMN and NIF caused a fall of Rp/Rs in 21 (65.6%), 10 (31.2%), 10(31.2%) and 9(28.1%) patients respectively. Thus, of the four drugs tested high flow O2 inhalation resulted in fall of Rp/Rs in two thirds of patients whereas ISDN, AMN and NIF caused a mean rise in Rp/Rs. One third of patients did respond acutely to the latter three drugs. Acute hemodynamic studies are useful before prescribing vasodilators in patients with PPH since more of the commonly used drugs like ISDN, AMN, NIF could have detrimental hemodynamic responses in some patients. However, great caution should be exercised before performing hemodynamic study as the procedure has definite mortality and morbidity.

What should be called a brisk 'Y' descent?

Patients with pericardial constriction show a prominent 'y' descent in right atrial and vena caval pressure traces. In all earlier hemodynamic descriptions of constrictive pericarditis, the 'y' descent has been described as 'brisk', 'sharp' or 'rapid' but no effort has been made to quantify the same. In this study, we have tried to objectively evaluate and describe this 'y' descent by measuring its negative slope (-dy/dt) at its steepest portion. Forty one patients were studied hemodynamically, 9 with constrictive pericarditis (Group I) and 32 normals (Group II). The negative slope of the 'y' descent in patients with constrictive pericarditis (69.95 +/- 23.04 mm Hg) was found to be significantly greater than normals (35.13 +/- 7.84 mm Hg, p < 10(-6). Discriminant analysis was used to determine its sensitivity, specificity, predictive value and overall accuracy, in the diagnosis of pericardial constriction. Value of > or = 45 mm Hg/sec was found to have the highest overall accuracy (0.88). The correlation between the right ventricular end diastolic pressure and the slope of 'y' descent in patients with pericardial constriction (r = 0.66) and in normals (r = 0.60) was fair. It is concluded that -dy/dt is significantly different in patients with constrictive pericarditis as compared to normals. The diagnostic utility of this parameter needs to be evaluated in patients with equivocal clinical and hemodynamic data, in those with occult pericardial constriction and in post-pericardiectomy cases where the pressures do not normalise immediately after adequate pericardial resection.