Heart failure (HF) has emerged as a major epidemic, affecting between five and six million Americans, with 670,000 new diagnoses per year and more than 250,000 patients in the most advanced stages of the disease. Despite major therapeutic advances in other areas of cardiovascular medicine, the prognosis for advanced, medically refractory HF remains dismal, resulting in about 250,000 deaths a year. (See Exhibit 1.)
Transplantation remains the only cure for patients with end-stage disease, but less than 3,500 donor hearts are available annually worldwide, according to the International Society for Heart and Lung Transplantation....