• Cardiology Genomics
• Cardiology Clinical Trials
• Heart Failure

Injecting autologous stem cells directly into the hearts of patients with heart failure improves hemodynamic function, quality of life, and survival, according to new results from the STAR Heart study. The open-label, nonrandomized study is the largest trial to date that has compared stem cell transplantation with standard therapy for patients with chronic heart failure due to ischemic heart disease.

The STAR Heart study included 391 patients with chronic heart failure, defined as a left ventricular ejection fraction (LVEF) ≤35%. All patients experienced myocardial infarction (MI) that was treated by percutaneous coronary intervention (PCI) for a mean of 8.5 years prior to study enrollment. A total of 191 patients agreed to undergo treatment with autologous stem cell transplantation, and the remaining 200 patients acted as controls. All patients were also receiving optimal medical therapy for heart failure.

The transplant procedure involved harvesting autologous stem cells from the bone marrow and delivering these cells (mean, 66 million) directly into the area of ischemic damage via intracoronary balloon catheter. Patients were examined at 3 months, 12 months, and 5 years after transplantation. Dr. Bodo-Eckehard Strauer, Heinrich-Heine-University of Duesseldorf, Duesseldorf, Germany, reported long-term results from the study.

Within 3 months, patients in the transplant group showed improvements in LV performance compared with baseline, including a 22% improvement in cardiac index (p<0.01), 15.4% increase in exercise capacity (p<0.01), 11% increase in peak oxygen update (p<0.05), and 6.3% increase in oxygen pulse (p<0.05). LVEF also increased by 22.4%, from 29.4% at baseline to 36% at 3 months (p<0.01). By comparison, all hemodynamic parameters worsened in the control group, including a 0.5% absolute reduction in LVEF (p<0.05).

Patients in the transplant group sustained significant improvements in all measures of hemodynamics, exercise capacity, LV contractility, and LV geometry through the 5-year follow-up period. This included a 25.1% increase in LVEF (p<0.01), a 4.9% reduction in end diastolic volume (p<0.5), a 13.7% reduction in end systolic volume (p<0.01), and a 15.1% increase in shortening velocity (p<0.01). Patients in the control group showed a significant deterioration in each of these measures from baseline to 5 years (p<0.05 for all) despite optimal medical therapy.

Improvements in LV performance were associated with prolonged survival among stem cell recipients. At 5 years, 184 of 191 patients were alive in the transplant group, compared with 168 of 199 control patients (p<0.01). Overall, these findings suggest a promising role for autologous stem cell transplantation in improving cardiac function and survival among patients with ischemic cardiomyopathy.

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