The 30-day mortality will be evaluated after the first 20 patients have been enrolled. If no more than 2 patients (I 0%) suffer a mortality within 30 days that is attributable to the therapy and not the underlying disease or unrelated to the therapy, we will continue to 50 patients. If 3 or more patients suffer a mortality within 30 days of the therapy that is directly attributable to the therapy, we will suspend accrual and will investigate the causes of the higher mortality.