To the Editor: Stem cell therapy has shown potential benefit in heart failure caused by ischemic heart disease (1). There is no data on the role of stem cell therapy in nonischemic dilated cardiomyopathy. We undertook a pilot study of intracoronary stem cell implantation in patients with dilated cardiomyopathy.From a cohort of 44 patients, 24 were randomly allocated to the stem cell therapy arm and 20 to the control arm. All patients were having dilated cardiomyopathy with an ejection fraction (EF) of Յ35%, were New York Heart Association (NYHA) functional class II or more symptomatic for more than 6 months, had normal coronary arteries, and had no other comorbidities such as chronic renal or liver failure or any malignancy.Patients in the treatment arm underwent bone marrow aspiration (50 to 60 ml) from the iliac crest. Mononuclear cells were separated from the bone marrow using Ficoll density gradient separation. The mononuclear cells constituted 89 Ϯ 2% of the cells, were 28 Ϯ 16 million /ml, and CD 34ϩ cells were 1.6 million/ml. The viability of these cells was 99 Ϯ 1%. The patients then underwent right heart catheterization and endomyocardial biopsy from the right side of the interventricular septum. The coronary sinus was then engaged using a Swan-Ganz catheter (Arrow International, Reading, Pennsylvania) that was passed up the coronary sinus, and the balloon was inflated. This was done so that the coronary circulation was slowed and the stem cells would get more time to transmigrate into the myocardium. Once the coronary sinus catheter was inflated, the stem cells were slowly injected into the coronary arteries by hooking the arteries with a Judkins catheter. Two-thirds of the mononuclear cell concentrate was injected into the left coronary artery and one-third was injected into the right coronary artery. The coronary sinus balloon was kept inflated for 3 min during the intracoronary injection. The patients were kept under monitoring for 24 h with electrocardiographic monitoring and serial cardiac enzymes. Follow-up was done at 1 week, 1 month, and then every 3 months for 1 year. At 3 months, Holter monitoring, an echocardiogram, and an endomyocardial biopsy were repeated. An echocardiogram was also repeated at 1 year. Left ventricular function assessment was performed offline by the modified Simpson method by 2 observers blinded to the underlying treatment. All patients were on the maximum tolerated doses of angiotensin-converting enzyme inhibitors and beta-blockers. Diuretic doses (including frusemide and torsemide, and spironolactone) were adjusted to ensure the absence of pedal edema. Informed consent was obtained from all patients, including control patients. The end points of the study were: 1) change in NYHA functional class, 2) a change in left ventricular function, 3) mortality, and 4) endomyocardial biopsy and histopathologic evaluation.Continuous variables were compared by a Wilcoxon 2-sample test (for within-group differences) and the Mann-Whitney U test (between-group differences). Differences...
The great majority of myocardial tissues in cyanotic tetralogy of Fallot indicates pre-existing ultrastructural hypertrophic and degenerative changes. The changes are more pronounced in older patients subjected to long-standing cyanosis and pressure overload and may account for or may coexist with the higher incidence of myocardial dysfunction and ventricular arrhythmia.
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