Compare CPM-RMI trial: intramyocardial transplantation of autologous bone marrow-derived cd133+ cells and mononuclear cells during coronary artery bypass grafting in patients with recent myocardial infarction: a phase II/III, multicenter, placebo-controlled, randomized, double-blind clinical trial

Objective: The regenerative potential of bone marrow-derived mononuclear cells [MNCs] and CD133+ stem cells in the heart varies in terms of their pro-angiogenic effects. This phase II/III, multicenter and double-blind trial is designed to compare the functional effects of intramyocardial autologous transplantation of both cell types and placebo in patients with recent myocardial infarction [RMI] post-coronary artery bypass graft

Materials and Methods: This was a phase II/III, randomized, double-blind, placebo-controlled trial COMPARE CPM-RMI [CD133, Placebo, MNCs - recent myocardial infarction] conducted in accordance with the Declaration of Helsinki that assessed the safety and efficacy of CD133 and MNCs compared to placebo in patients with RMI. We randomly assigned 77 eligible RMI patients selected from 5 hospitals to receive CD133+ cells, MNC, or a placebo. Patients underwent gated single photon emission computed tomography assessments at 6 and 18 months post-intramyocardial transplantation. We tested the normally distributed efficacy outcomes with a mixed analysis of variance model that used the entire data set of baseline and between-group comparisons as well as within subject [time] and group×time interaction terms

Results: There were no related serious adverse events reported. The intramyocardial transplantation of both cell types increased left ventricular ejection fraction by 9% [95% confidence intervals [CI]: 2.14% to 15.78%, P=0.01] and improved decreased systolic wall thickening by -3.7 [95% CI: -7.07 to -0.42, P=0.03]. The CD133 group showed significantly decreased non-viable segments by 75% [P=0.001] compared to the placebo and 60% [P=0.01] compared to the MNC group. We observed this improvement at both the 6- and 18-month time points

Conclusion: Intramyocardial injections of CD133+ cells or MNCs appeared to be safe and efficient with superiority of CD133+ cells for patients with RMI. Although the sample size precluded a definitive statement about clinical outcomes, these results have provided the basis for larger studies to confirm definitive evidence about the efficacy of these cell types

Transcatheter closure of atrial septal defect with amplatzer septal occluder in adults: immediate, short, and intermediate-term results

The transcatheter closure of the atrial septal defect [ASD] has become an alternative technique to surgical procedures. The aim of this study was to assess the immediate, short, and intermediate-term results of the transcatheter closure of the secundum ASD with the Amplatzer Septal Occluder [ASO] in adult Iranian patients. Between December 2004 and July 2008, the transcatheter closure of the ASD using the ASO was attempted in 58 consecutive, adult patients. The mean age of the patients was 37.1 +/- 12.7 years [range = 19 - 75 years]. All the procedures were performed under local anesthesia with transthoracic or transesophageal echocardiography and fluoroscopic guidance. The stretched diameter of the ASD was determined with a balloon sizing catheter, and device selection was based on and matched to the stretched diameter of the septal defect. Transthoracic echocardiography was performed immediately after the release of the device and before discharge. Further follow-up at one month, six months, and yearly thereafter included physical examination, electrocardiography, and transthoracic echocardiography. The mean ASD diameter, as measured by esophageal echocardiography, was 24.8 +/- 5.4 mm [range = 13 - 34 mm]. The mean stretched diameter, as measured by the balloon catheter, was 27.1 +/- 6.4 mm [range = 12.5 - 39 mm]. Deployment of the ASO was successful in 52 [89.6%] patients and failed in 6 [10.4%]. Four patients experienced severe complications, 1 had tamponade requiring drainage, 2 had device embolization to the left atrium and right ventricular outflow tract, and 1 had late wire fracture [surgical removal and repair of the ASD]. The position of two large devices [34 mm and 36 mm] was considered unsuitable and unstable after implantation and resulted in the removal of these devices. Minor complications included transient complete atrioventricular block in 1 patient, paroxysmal supra tachycardia in 3 patients, atrial flutter in 1 patient, and angina pectoris with transient ST elevation in 2 patients. The mean follow-up period was 32.5 +/- 18.5 months. Echocardiography at 24 hours, 1 month, 6 months, and 12 months after the procedure showed residual shunts in 11 [21%], 3 [5.8%], 2 [3.8%], and 2 [3.8%] patients, respectively. At follow-up [12.8 months to 48.5 months, mean +/- SD = 32.5 +/- 18.5 months], complete closure was documented in 50 [96.2%] of the 52 cases. At the end of the follow-up, 2 [3.8%] patients had residual shunts: The shunt was moderate in 1 [1.9%] patient and small in the other [1.9%]. The overall success rate of the transcatheter closure of the ASD was 86% [50 of 58 cases]. The transcatheter closure of the secundum ASD in our adult patient population using the ASO was associated with high degrees of success, minimal procedural complication rates, and excellent short and midterm results. The use of this device, however, requires thorough attention in that the procedure may be ineffective or the device may embolize. Further experience and long-term follow-up are required before a widespread clinical use can be recommended

Transcatheter closure of patent ductus arteriosus using the amplatzer ductal occluder: early results and midterm follow-up

The transcatheter closure of patent ductus arteriosus has advanced rapidly with improvements in device designs. The aim of this study was to analyze the safety, efficacy, and early and intermediate follow-up results of the percutaneous closure of persistent ductus arteriosus [PDA] with the Amplatzer ductal occluder [ADO] in children. Between May 2004 and March 2007, fifty patients between 7 months and 20 years of age underwent the transcatheter closure of PDA, using the ADO. The mean PDA diameter at its narrowest segment [pulmonary end] was 7.35 +/- 2.57 mm [range: 4 to 16mm]. Follow-up evaluations were performed via echocardiography at 24 hours, and 1, 3, 6, and 12 months and then yearly after implantation. Successful immediate occlusion of PDA was achieved in 42 [84%] of the 50 cases. In 5 cases, there were trivial intraprosthetic residual shunts. In addition, there was a small residual shunt in one case, left pulmonary artery narrowing in one case, and embolization of the device immediately after the procedure in one case. At 24 hours, color Doppler flow mapping revealed complete closure in all except one case with a small shunt. At 3 months' follow-up, occlusion was complete in all the patients. At a median follow-up of 17 months [range: 3 months to 32 months], all the patients had complete closure. We conclude that although the transcatheter closure of PDA using the ADO is a highly effective and safe treatment for most patients, several complications including embolization and left pulmonary artery narrowing may occur in certain cases