Transradial access for coronary diagnostic and interventional procedures: Consensus statement and recommendations for India: Advancing Complex CoronariES Sciences through TransRADIAL intervention in India – ACCESS RADIAL™: Clinical consensus recommendations in collaboration with Cardiological Society of India (CSI)

Radial access for cardiac catheterization and intervention in India has been growing steadily over the last decade with favorable clinical outcomes. However, its usage by interventional cardiologists varies greatly among Indian operators and hospitals due to large geographic disparities in health care delivery systems and practice patterns. It also remains unclear whether the advantages, as well as limitations of transradial (TR) intervention (as reported in the western literature), are applicable to developing countries like India or not. An evidence-based review involving various facets of radial procedure for cardiac catheterization, including practical, patient-related and technical issues was conducted by an expert committee that formed a part of Advancing Complex CoronariES Sciences through TransRADIAL intervention (ACCESS RADIAL™) Advisory Board. Emerging challenges in redefining TR management based on evidence supporting practices were discussed to formulate these final recommendations through consensus.

Efficacy of stem cell in improvement of left ventricular function in acute myocardial infarction - MI3 Trial.

Background & objectives: Acute myocardial infarction (AMI) is characterized by irreparable and irreversible loss of cardiac myocytes. Despite major advances in the management of AMI, a large number of patients are left with reduced left ventricular ejection fraction (LVEF), which is a major determinant of short and long term morbidity and mortality. A review of 33 randomized control trials has shown varying improvement in left ventricular (LV) function in patients receiving stem cells compared to standard medical therapy. Most trials had small sample size and were underpowered. This phase III prospective, open labelled, randomized multicenteric trial was undertaken to evaluate the efficacy in improving the LVEF over a period of six months, after injecting a predefined dose of 5-10 × 108 autologous mononuclear cells (MNC) by intra-coronary route, in patients, one to three weeks post ST elevation AMI, in addition to the standard medical therapy. Methods: In this phase III prospective, multicentric trial 250 patients with AMI were included and randomized into stem cell therapy (SCT) and non SCT groups. All patients were followed up for six months. Patients with AMI having left ventricular ejection fraction (LVEF) of 20-50 per cent were included and were randomized to receive intracoronary stem cell infusion after successfully completing percutaneous coronary intervention (PCI). Results: On intention-to-treat analysis the infusion of MNCs had no positive impact on LVEF improvement of ≥ 5 per cent. The improvement in LVEF after six months was 5.17 ± 8.90 per cent in non SCT group and 4.82 ± 10.32 per cent in SCT group. The adverse effects were comparable in both the groups. On post hoc analysis it was noted that the cell dose had a positive impact when infused in the dose of ≥ 5 X 108 (n=71). This benefit was noted upto three weeks post AMI. There were 38 trial deviates in the SCT group which was a limitation of the study. Interpretation & conclusions: Infusion of stem cells was found to have no benefit in ST elevation AMI. However, the procedure was safe. A possible benefit was seen when the predefined cell dose was administered which was noted upto three weeks post AMI, but this was not significant and needs confirmation by larger trials.

Metabolic syndrome & Framingham Risk Score Observations from a coronary angiographic study in Indian patients.

Background & objectives: Metabolic syndrome (MS) is an important determinant of cardiovascular (CV) risk. Framingham Risk Scores (FRS) often underestimate the CV risk in Asians, younger patients and those with MS. Asians often develop coronary artery disease (CAD) at a younger age and also have a high prevalence of MS. Only limited data are available on the relationship between MS and FRS in such patients and the present study was undertaken to report on this aspect in an Indian patient population with angiographically documented CAD. Methods: Two hundred patients undergoing coronary angiography during a three months study period were included. Diagnosis of MS was based on modified south Asian guidelines. Results: Of the 200 patients (age 56.5 ± 8.6 yr) undergoing coronary angiography, MS was diagnosed in 77 per cent n=154; abdominal obesity, low HDL and hypertension were the commonest of the diagnostic criteria of MS, being present in >70 per cent cases. Patients with MS had significantly higher mean FRS than those without MS (15.1 vs 8.65, P<0.0001). Most patients with MS (74%, n=148) had an intermediate to high 10-year CV risk (>10%) as estimated by FRS. The proportion of patients with MS progressively increased in those with low, intermediate and high FRS (61, 87 and 92%, respectively). Though the prevalence of MS was uniformly similar (74-84%) in all age groups (<45, 45-55, 55-65 and > 65 yr, respectively), amongst those <45 yr, none of the patients could be categorized as having high CV risk as estimated by FRS despite having angiographic CAD, highlighting the limitation of age dependence of FRS. Interpretation & conclusions: MS is common in Indian patients with angiographically documented CAD; most patients with MS have 10-year risk of >10 per cent as estimated by FRS. Though MS is uniformly prevalent across all age groups, using the FRS may underestimate the CV risk in Indian patients despite documented CAD. These findings have significant implications for Asian patients with CAD in whom onset of CAD is often at a younger age than their Western counterparts. There should be continued health care emphasis on detection of MS and intensification of targeted preventive strategies.

Balloon-expandable covered stent repair of massive abdominal pseudoaneurysm.

Pseudoaneurysms of descending aorta have usually been treated surgically or using self expanding endovascular stent grafts through open femoral arteriotomy. Here we report an unusual case of massive abdominal peseudoaneurysm in a young woman who was managed successfully with balloon-expandable covered stent deployed percutaneously.

Prevention of atherosclerosis progression using atorvastatin in normolipidemic coronary artery disease patients--a controlled randomized trial.

BACKGROUND: Statins have been known to reduce progression of atherosclerosis when used in high dosage in patients with elevated cholesterol. A large majority of Indian patients, however, develop coronary artery disease with average or below average cholesterol level. There is insufficient data on effect of low-dose statins on progression of atherosclerosis in such patients with normal/average lipid levels. METHODS AND RESULTS: In this prospective study, 150 patients with angiographically proven coronary artery disease and baseline total cholesterol <200 mg/dl and low-density lipoprotein cholesterol <130 mg/dl were randomized to treatment with low-dose atorvastatin (10 mg) or placebo. Both groups were comparable in demographic characteristics. Progression of atherosclerosis was assessed using carotid intima media thickness as surrogate marker using standard protocol on B-mode ultrasound including common carotid artery, common carotid bifurcation and internal carotid artery measurements. Follow-up study for carotid intima media thickness was done at end of one year. A decrease in mean maximum carotid intima media thickness was recorded for all the three carotid segments individually from basal to end of one year in atorvastatin group [common carotid artery -0.008 mm (p = 0.01), common carotid bifurcation-0.022 mm (p = 0.001), internal carotid artery -0.009 mm (p = 0.01)] while the same showed an increase in placebo group [common carotid artery +0.011 mm (p = NS), common carotid bifurcation +0.013 mm (p=NS), internal carotid artery +0.007 mm (p=NS)]. The average mean carotid intima media thickness (all three segments included) decreased from 0.739 +/- 0.114 mm to 0.726 +/- 0.115 mm (difference -0.013 mm) in statin group and increased from 0.733 +/- 0.124 mm to 0.742 +/- 0.117 mm (difference + 0.009 mm) in placebo group (p < 0.001). Along side, there was a reduction in the total cholesterol from 144 +/- 26 mg/dl to 130 +/- 18 mg/dl (decreased arrow 9.7%, p = 0.05) and in low-density lipoprotein cholesterol from 86 +/- 24 mg/dl to 74 +/- 19 mg (decreased arrow 13.9%, p = 0.05) in study group and an increase in total cholesterol from 148 +/- 32 mg/dl to 154 +/- 8 mg/dl (increased arrow 4.05%, p=NS) and in low-density lipoprotein cholesterol from 84 +/- 19 mg/dl to 87 +/- 16 mg/dl (increased arrow 3.57%, p=NS) in placebo group at end of one year (p=NS). No adverse effects of statins were reported in the treatment arm. CONCLUSIONS: We conclude that low-dose statins reduce progression of atherosclerosis as observed by carotid intima media thickness in Indian patients with known coronary heart disease and normal lipid values independent of lipid lowering. The study favors use of this therapy in patients with normal/below average cholesterol levels.

Sonographically guided thrombin injection for the treatment of femoral artery pseudoaneurysm.

The formation of pseudoaneurysm in the femoral artery after cardiac catheterization is a well-recognized complication occurring in 1%-4% of cases. It is traditionally managed surgically and has a high morbidity. Prolonged ultrasound-guided compression of the neck of the pseudoaneurysm, and ultrasound-guided injection of thrombin into the aneurysm are newer modalities of treatment especially for small aneurysms. We describe the case of a giant pseudoaneurysm of the right femoral artery, post-arteriography, which was successfully managed with ultrasonographically guided percutaneous thrombin injection.

A tertiary care hospital-based study of conventional risk factors including lipid profile in proven coronary artery disease.

BACKGROUND: The prevalence and mortality rates of coronary artery disease have been known to be higher in the Indian than the Western population. Most data on lipid levels in Indians have been obtained from studies on migrant Asian Indians. There are insufficient data on lipid profile and other conventional risk factors in Indian patients living within India. METHODS AND RESULTS: The study included 2656 consecutive patients who underwent coronary angiography between March 1998 and February 2002. Of these, 2399 subjects had angiographically proven coronary artery disease (group 1) while 257 had normal coronary arteries (group 2). Lipid values were measured in the fasting state on the morning the coronary angiography was done. Patients receiving lipid-lowering agents, those having renal, hepatic or thyroid disorders, patients presenting within 8 weeks after acute myocardial infarction, and patients who were taking noncardiac drugs that affect the lipid profile were excluded from the study. Other conventional risk factors were also recorded. In subjects with coronary artery disease and normal coronary arteries, the levels of mean total cholesterol recorded were 178.5+/-42.1 mg/dl v. 154.1+/-40.2 mg/dl (p<0.001), high-density lipoprotein cholesterol 30.6+/-9 mg/dl v. 27.3+/-6.8 mg/dl (p<0.001), low-density lipoprotein cholesterol 109.8+/-35.4 mg/dl v 93.6+/-33.9 mg/dl (p<0.001), and triglyceride 190.7+/-95.4 mg/dl v. 157.6+/-73.5 mg/dl (p<0.001), respectively. In subgroup analysis by age, the younger coronary artery disease group (< or = 40 years) had significantly higher total and low-density lipoprotein cholesterol levels than the older group (> 40 years), viz. 194.6+/-51.4 mg/dl v. 176.3+/-40.2 mg/dl (p<0.001), and 118.3+/-39.6 mg/dl v. 108.7+/-36.1 mg/dl (p=0.001). Triglyceride levels were not significantly different [211.7+/-105.1 mg/dl v. 187.8+/-93.6 mg/dl (p=ns)], being equally high in both subgroups and, although high-density lipoprotein cholesterol levels were different, this difference was minimal, being equally low in both [32.7+/-9.5 mg/dl v. 30.3+/-9.0 mg/dl (p=ns)]. In the subgroup analysis of those with coronary artery disease, diabetics had significantly lower total cholesterol [174+/-41.1 mg/dl v. 180.4+/-42.4 mg/dl (p<0.001)] and low-density lipoprotein cholesterol levels [105.8+/-34 mg/dl v. 111.5+/-35.8 mg/dl (p<0.001)] than non-diabetics, whereas triglyceride and high-density lipoprotein cholesterol levels were not significantly different, triglycerides being equally high in both [186.2+/-95.5 mg/dl v. 192.5+/-95.2 mg/dl (p=ns)], and high-density lipoprotein equally low in both [30.9+/-9.3 mg/dl v. 30.5+/-9 mg/dl (p=ns)]. The commonest associated conventional risk factor in diabetics was hypertension and, in the younger age group (< or = 40 years), it was smoking and a positive family history of premature coronary artery disease. CONCLUSIONS: We conclude that in north Indians, coronary artery disease occurs at much lower levels of total cholesterol and low-density lipoprotein cholesterol than other populations, and high triglyceride and low high-density lipoprotein levels are more of a universal phenomenon in this population. Younger patients have a more atherogenic lipid profile than the older subgroup with coronary artery disease, and smoking and a family history of premature coronary artery disease are the most common associated risk factors. Total cholesterol levels seem to play a lesser role in the occurrence of coronary artery disease in diabetics, the presence of which is in itself overwhelming for the occurrence of coronary artery disease.