Transendocardial, autologous bone-marrow cell transplant in severe, chronic ischemic heart failure

Twenty-one patients were enrolled into this prospective, non-randomized, open-label, controlled study (first 14, treatment; last seven, control). Baseline evaluations included complete clinical and laboratory evaluations, exercise stress (ramp treadmill), two-dimensional Doppler echocardiogram, SPECT perfusion scan, and 24-hour Holter monitoring. Bone-marrow mononuclear cells were harvested, isolated, washed, and resuspended in saline for injection by NOGA catheter (15 injections of 0.2 cm3). Electromechanical mapping (EMM) was used to identify viable myocardium (unipolar voltage ≥ 6.9 mV) for treatment. Patients underwent 2-month noninvasive and 4-month invasive (treatment group only) follow-up using standard protocols and the same procedures as baseline. Patient population demographics and exercise test variables did not differ significantly between the treatment and control groups; only creatinine and BNP levels varied in laboratory evaluations. At 2 months, there was a significant reduction in total reversible defect within the treatment group and between the treatment and control groups (P = 0.02) on quantitative SPECT analysis. At 4 months, there was improvement in ejection fraction from a baseline of 20% to 29% (P = 0.003) and a reduction in ESV (P = 0.03) in the treated patients. EMM revealed significant mechanical improvement of the injected segments (P < 0.0005).In patients with chronic, ischemic heart failure, EMM technology was used to target viable, hibernating myocardium for transendocardial delivery of autologous bone-marrow mononuclear cells. At follow-up, treated patients had significantly improved myocardial perfusion and contractility.