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 x 10(8) autologous mononuclearcells (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 10(8) (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.
Lt Col Navreet Singh *, Gp Capt Hemant Madan , Brig Y.K. Arora, VSM, Brig Rajat Dutta , Col Sunil Sofat , Col Prashant Bhardwaj, VSM, Rahul Sharma , Gp Capt D.S. Chadha , Col A.K. Ghosh , Lt Col Sanjeev Sengupta f Classified Specialist (Cardiology), CH (SC), Pune-40, India b Senior Advisor (Cardiology), Army Hosp (R&R), New Delhi, India Consultant (Cardiology), Base Hosp, Delhi Cantt, India Consultant (Cardiology), Army Hosp (R&R), New Delhi, India Resident (Cardiology), Army Hosp (R&R), New Delhi, India Classified Specialist (Cardiology), MH (CTC), Pune-40, India
BACKGROUND:Radiofrequency catheter ablation is an emerging curative modality of treatment for several types of cardiac arrhythmias. The aim of our study was to evaluate our experience of electrophysiology procedures over a 10-year-period and compare it with the published literature.METHODS AND RESULT:All patients undergoing cardiac electrophysiology and radiofrequency ablation procedures during the period from 01 January 2003 to 30 April 2012 were included in this study. The study analyzed 892 patients of which atrioventricular nodal reentrant tachycardia (AVNRT) was n = 513 (57.5%), accessory pathways n = 230 (25.8%), atrial tachycardia n = 26 (2.9%), atrial flutter n = 15 (1.7%), atrial fibrillation = 9 (1.0%), ventricular tachycardia n = 37 (4.2%) and diagnostic studies n = 62 (6.9%). Three-dimensional electro-anatomic mapping was performed in n = 17 (1.9%). The success rate was 99% with AVNRT, 94% with accessory pathway, 81% with atrial tachycardia, 64% with ventricular tachycardia and 34% with atrial fibrillation. The major and serious complications rate was 0.45%.CONCLUSIONS:The procedural success rate and the complication rate in this real-world study of the Armed Forces were comparable/superior to the reported literature.