Combined delivery approach of bone marrow mononuclear stem cells early and late after myocardial infarction: the MYSTAR prospective, randomized study.

BACKGROUND: Combined intracoronary and intramyocardial administration might improve outcomes for bone-marrow-derived stem cell therapy for acute myocardial infarction (AMI). We compared the safety and feasibility of early and late delivery of stem cells with combined therapy approaches. METHODS: Patients with left ventricular ejection fraction less than 45% after AMI were randomly assigned stem cell delivery via intramyocardial injection and intracoronary infusion 3-6 weeks or 3-4 months after AMI. Primary end points were changes in infarct size and left ventricular ejection fraction 3 months after therapy. RESULTS: A total of 60 patients were treated. The mean changes in infarct size at 3 months were -3.5 +/- 5.1% (95% CI -5.5% to -1.5%, P = 0.001) in the early group and -3.9 +/- 5.6% (95% CI -6.1% to -1.6%, P = 0.002) in the late group, and changes in ejection fraction were 3.5 +/- 5.6% (95% CI 1.3-5.6%, P = 0.003) and 3.4 +/- 7.0% (95% CI 0.7-6.1%, P = 0.017), respectively. At 9-12 months after AMI, ejection fraction remained significantly higher than at baseline in both groups. In the early and late groups, a mean of 200.3 +/- 68.7 x 10(6) and 194.8 +/- 60.4 x 10(6) stem cells, respectively, were delivered to the myocardium, and 1.30 +/- 0.68 x 10(9) and 1.29 +/- 0.41 x 10(9) cells, respectively, were delivered into the artery. A high number of cells was required for significant improvements in the primary end points. CONCLUSIONS: Combined cardiac stem cell delivery induces a moderate but significant improvement in myocardial infarct size and left ventricular function.

Design and rationale for the Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: a multicenter, prospective, randomized, single-blind trial comparing early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of nonselected autologous bone marrow cells to patients after acute myocardial infarction.

BACKGROUND: Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling. METHODS: The Myocardial Stem Cell Administration After Acute Myocardial Infarction Study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery. The primary end points are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated single photon emission computed tomography [SPECT] scintigraphy) 3 months after BM-SCs therapy. The secondary end points relate to evaluation of (1) the safety and feasibility of the application modes, (2) the changes in left ventricular wall motion score index (transthoracic echocardiography), (3) myocardial voltage and segmental wall motion (NOGA mapping), (4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and (5) the clinical symptoms (Canadian Cardiovascular Society [CCS] anina score and New York Heart Association [NYHA] functional class) at follow-up. Three hundred sixty patients are randomly assigned into 1 of 4 groups: group A, early treatment (21-42 days after AMI) with intracoronary injection; group B, early treatment with combined application; group C, late treatment (3 months after AMI) with intracoronary delivery; and group D, late treatment with combined administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients. CONCLUSIONS: The Myocardial Stem Cell Administration After Acute Myocardial Infarction Trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.

Current developments in interventional treatment of total terminal aortic occlusions--laser, stenting and balloon angioplasty: experience of cardiology clinic of Târgu-Mures.

UNLABELLED: The importance of interventional procedures in the complex treatment of peripheral arterial diseases is continuously increasing. In the current practice of our clinic, association of balloon angioplasty, laser angioplasty and arterial stenting in reconstruction of iliac arteries led to superior results in the latest years, these methods 11:42 PM 11:42 PM 11:42 PM being proved as an alternative to surgical interventions. In this article, we present several cases in which current indications for laser angioplasty were extended to target occlusions located in the terminal abdominal aorta. METHODS: 106 consecutive primary iliac interventions were performed on 88 patients with iliac or aortoiliac obstructive diseases, in the period September 2001 - October 2005, at the University of Medicine and Pharmacy of Târgu-Mures, Romania, Clinic of Cardiology. Five of these patients (4 males, 1 female) presented occlusions of terminal aorta, in whom interventional treatment (peripheral transluminal angioplasty, laser angioplasty and stenting) was performed. Three cases presented total occlusion of terminal aorta, without any visualization of iliac arteries, and 2 cases presented occlusion of one aortoiliac axis, starting from terminal aorta. RESULTS: In all cases, complete repermeabilisation of aortoiliac axes was achieved, without complications. In all patients we recorded a significant improvement of symptomatology, and arterial Doppler showed an increase of Doppler ankle/brachial index in average from 0.4 up to 0.95. No complications have been recorded so far. CONCLUSION: Extension of classical indications of interventional treatment for balloon and laser angioplasty to occlusions located in terminal aorta is possible when the procedure is performed by an experienced team. Interventional techniques, having a superior applicability in practice, good results, low complication rates, and decreasing the hospitalization times, could be applied in the future to a larger extent, targeting also aortic occlusions.