A safety and feasibility study of cell therapy in dilated cardiomyopathy

The aim of this study was to determine if bone marrow mononuclear cell (BMMC) transplantation is safe for moderate to severe idiopathic dilated cardiomyopathy (IDC). Clinical trials have shown that this procedure is safe and effective for ischemic patients, but little information is available regarding non-ischemic patients. Twenty-four patients with IDC, optimized therapy, age 46 ± 11.6 years, 17 males, NYHA classes II-IV, and left ventricular ejection fraction <35 percent were enrolled in the study. Clinical evaluation at baseline and 6 months after stem cell therapy to assess heart function included echocardiogram, magnetic resonance imaging, cardiopulmonary test, Minnesota Quality of Life Questionnaire, and NYHA classification. After cell transplantation 1 patient showed a transient increase in enzyme levels and 2 patients presented arrhythmias that were reversed within 72 h. Four patients died during follow-up, between 6 and 12 weeks after therapy. Clinical evaluation showed improvement in most patients as reflected by statistically significant decreases in Minnesota Quality of Life Questionnaire (63 ± 17.9 baseline vs 28.8 ± 16.75 at 6 months) and in class III-IV NYHA patients (18/24 baseline vs 2/20 at 6 months). Cardiopulmonary exercise tests demonstrated increased peak oxygen consumption (12.2 ± 2.4 at baseline vs 15.8 ± 7.1 mL·kg-1·min-1 at 6 months) and walked distance (377.2 ± 85.4 vs 444.1 ± 77.9 m at 6 months) in the 6-min walk test, which was not accompanied by increased left ventricular ejection fraction. Our findings indicate that BMMC therapy in IDC patients with severe ventricular dysfunction is feasible and that larger, randomized and placebo-controlled trials are warranted.

A safety and feasibility study of cell therapy in dilated cardiomyopathy.

The aim of this study was to determine if bone marrow mononuclear cell (BMMC) transplantation is safe for moderate to severe idiopathic dilated cardiomyopathy (IDC). Clinical trials have shown that this procedure is safe and effective for ischemic patients, but little information is available regarding non-ischemic patients. Twenty-four patients with IDC, optimized therapy, age 46 ± 11.6 years, 17 males, NYHA classes II-IV, and left ventricular ejection fraction <35% were enrolled in the study. Clinical evaluation at baseline and 6 months after stem cell therapy to assess heart function included echocardiogram, magnetic resonance imaging, cardiopulmonary test, Minnesota Quality of Life Questionnaire, and NYHA classification. After cell transplantation 1 patient showed a transient increase in enzyme levels and 2 patients presented arrhythmias that were reversed within 72 h. Four patients died during follow-up, between 6 and 12 weeks after therapy. Clinical evaluation showed improvement in most patients as reflected by statistically significant decreases in Minnesota Quality of Life Questionnaire (63 ± 17.9 baseline vs 28.8 ± 16.75 at 6 months) and in class III-IV NYHA patients (18/24 baseline vs 2/20 at 6 months). Cardiopulmonary exercise tests demonstrated increased peak oxygen consumption (12.2 ± 2.4 at baseline vs 15.8 ± 7.1 mL·kg⁻¹·min⁻¹ at 6 months) and walked distance (377.2 ± 85.4 vs 444.1 ± 77.9 m at 6 months) in the 6-min walk test, which was not accompanied by increased left ventricular ejection fraction. Our findings indicate that BMMC therapy in IDC patients with severe ventricular dysfunction is feasible and that larger, randomized and placebo-controlled trials are warranted.

[Association between carotid and coronary atherosclerosis. Evaluation of carotid arteries by echography with Doppler]. / Associação entre as ateroscleroses carotideana e coronariana. Avaliação pela ecografia com Doppler das carótidas.

PURPOSE: To evaluate the association between carotid and coronary atherosclerosis and other conditions related to the prevalence of carotid disease. METHODS: Duplex scanning of carotid arteries was performed in 130 patients (70 males and 60 females), with ages between 26 and 89 years-old. Accordingly to the presence of ischemic heart disease, they were divided in 3 groups: I) with proved ischemic heart disease; II) with low probability of disease and III) with high probability of disease. The carotid atherosclerosis was classified as absent (normal result), mild (obstruction below 30%), moderate (30-49%), moderate/severe (50-74%), severe (> 75%), and total occlusion (abnormal results) by Doppler criteria. RESULTS: Normal carotids were found in 44 (33.9%), mild atherosclerosis in 68 (52.3%), moderate in 7 (5.4%), moderate/severe in 5 (3.8%), severe in 5 (3.8%) and total occlusion in 1 (0.8%) of the 130 patients. The prevalence of the disease increased with age (31.2% in patients until 54 years-old, 66.3% in those with age between 55 and 76 years-old, and 88% in those with 77 years-old or more), and it was higher in males than females (75.7% x 55%). All the differences were of statistical significance. In the 48 patients of group I, 41 (85.4%) had abnormal carotids (26 mild, 6 moderate, 3 moderate/severe, 5 severe, and 1 total), whereas in the 64 patients of group II, 27 (42.2%) were abnormals (24 mild, 1 moderate, and 2 moderate/severe), significant difference with p < 0.001. This significant difference persisted when the groups II and III were joined, and 45 (54.9%) of 82 patients had abnormal carotids. All the patients with severe obstruction of carotid arteries (6 patients) had severe coronary obstruction. CONCLUSION: The prevalence of carotid atherosclerosis was high, in 66.2% of the patients. It increased with age, and it was higher in males than females. There was statistically significant association between carotid and coronary atherosclerosis, and the presence of severe carotid obstruction was related to presence of severe coronary obstruction.