Monday March 27, 2006
The ‘UNLOAD’ Study
New findings from the UNLOAD study, announced at the 2006 American College of Cardiology (ACC) 55th Scientific Session Conference in Atlanta, detail immediate and long-term benefits for heart failure patients receiving ultrafiltration therapy to treat fluid overload. This is the first randomized clinical study to compare the safety and efficacy of a non- drug-based option with standard intravenous diuretic drug therapy to treat heart failure patients. UNLOAD stands for UltrafiltratioN versus IV Diuretics for Patients HospitaLized fOr Acute Decompensated Congestive Heart Failure. This prospective, randomized multi-center trial compared the immediate and long-term effects of early ultrafiltration alone, versus intravenous diuretics alone, on weight loss, symptoms and hospitalizations of patients with decompensated heart failure and fluid overload. The ultrafiltration therapy used in the trial was administered via the Aquadex FlexFlow(TM). The Aquadex FlexFlow is a mechanical system that can remove up to one liter of excess fluid from the body in two hours, or more than a gallon in eight hours. The system received marketing clearance from the U.S. Food and Drug Administration in 2002. A Standard catheter is inserted into peripheral or central vein, which connects the patient to the Aquadex FlexFlow.
Two hundred patients were enrolled at 28 medical sites. In this prospective trial, patients were randomized and placed in either the ultrafiltration group or the intravenous diuretics group, and assessed at entry and at intervals out to 90 days. There was no difference in renal function between the groups. Highlights of the UNLOAD study include statistically significant findings such as:
At 48 hours into treatment, the ultrafiltration group demonstrated a:
38% greater weight loss over standard care; and
28% greater net fluid loss over standard care.
At 90 days following hospital discharge, the ultrafiltration group demonstrated a:
43% reduction in patients requiring rehospitalizations for CHF over standard care;
50% reduction in the total number of rehospitalizations for CHF over standard care.
52% reduction in ER or clinic visits over standard care and
63% total reduction in days rehospitalized for heart failure over standard care.
The benefits in weight loss and in reduction of rehospitalization were seen in all subgroups analyzed.
The cost of the device is about $10,000, and each filter runs about $800.