ATLANTA and BROOKLYN PARK, Minn., March 12 /PRNewswire/ -- There is good news today for the approximately 1 million people hospitalized annually for heart failure in the United States.
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. Called UNLOAD, 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. Heart failure, a progressive and debilitating disease, leads to more than 1 million hospital admissions and $28 billion in healthcare costs annually in the United States.
Presented as part of the ACC's Late-Breaking Clinical Trials program, the study data show that hospitalized heart failure patients receiving ultrafiltration therapy as part of their care lost more weight and experienced greater net fluid loss than patients treated primarily with intravenous diuretics. At 90 days, the ultrafiltration group had significantly fewer: days in the hospital, rehospitalizations for heart failure, unscheduled heart failure office visits and emergency room visits.
The UNLOAD clinical trial (UltrafiltratioN versus IV Diuretics for Patients HospitaLized for Acute Decompensated Congestive Heart Failure) compared the long-term safety and efficacy of adjunct ultrafiltration therapy to the use of conventional drug therapy, i.e. intravenous diuretics, alone. 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.
"The positive results of the UNLOAD trial demonstrate that ultrafiltration treatment can relieve fluid overload quickly, safely and predictably, as well as lead to sustained clinical benefits," said Principal Investigator Maria Rosa Costanzo, M.D., Midwest Heart Specialists, Chicago, who presented the UNLOAD results. "Physicians' treatment options are no longer limited to the habitual and historical reliance solely on intravenous diuretics. This is an important breakthrough in the treatment of fluid overload."
Highlights of the UNLOAD study include statistically significant findings such as:
-- At 48 hours into treatment, the ultrafiltration group demonstrated a:
-- 38 percent greater weight loss over standard care; and
-- 28 percent greater net fluid loss over standard care.
-- At 90 days following hospital discharge, the ultrafiltration group
-- 43 percent reduction in patients requiring rehospitalizations for
heart failure over standard care;
-- 50 percent reduction in the total number of rehospitalizations for
heart failure over standard care;
-- 52 percent reduction in emergency department or clinic visits over
standard care; and
-- 63 percent 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.
"This important trial is an exciting milestone for CHF Solutions," said John Erb, chief executive officer of CHF Solutions, a Minneapolis-based medical device company and sponsor of the trial. In the UNLOAD trial, ultrafiltration was administered via the Aquadex FlexFlow(TM), a system developed and manufactured by CHF Solutions. "The study's findings validate what we have long believed: our system provides an innovative, device-based treatment for patients who experience fluid overload and endure repeated hospitalizations associated with fluid overload. Furthermore, the reduction in rehospitalizations and hospital days represents improvements in the quality of life for patients and their families, as well as large potential cost savings for the healthcare system."
Ultrafiltration performed with the Aquadex FlexFlow, a technologically sophisticated mechanical system, can remove up to a pound per hour of excess salt and water from the blood stream without clinically significant effects on kidney function, heart rate, blood pressure or electrolyte balance. The system is highly automated and used at many leading medical centers and outpatient clinics. Standard catheters inserted into peripheral or central veins connect the patient to the Aquadex FlexFlow. The Aquadex FlexFlow technology received 510(k) marketing clearance in June 2002.
Fluid Overload and Heart Failure
Fluid overload is a common medical problem that can derive from a variety of causes, including renal failure, post-surgical fluid overload, metabolic disease and congestive heart failure. Patients with heart failure represent the largest group of fluid-overloaded patients. Heart failure is the progressive inability of the heart to pump enough blood to support the vital organs and often leads to a buildup of fluid, causing swollen legs and arms, fatigue, and eventually excess fluid in the lungs and severe life-threatening shortness of breath. To date, intravenous diuretics have been the standard of care to treat fluid overload.
About CHF Solutions
CHF Solutions, based in Brooklyn Park, Minn., is a privately held manufacturer of innovative medical devices for cardiac care. The company's mission is to provide medical practitioners with innovative and proprietary solutions that enable the treatment of patients with unmet clinical needs. For additional information about CHF Solutions, the Aquadex FlexFlow and Aquapheresis(TM), visit http://www.chfsolutions.com .
CHF Solutions Inc.
CONTACT: John Erb, CEO, of CHF Solutions, +1-763-463-4600, mobile,+1-612-963-1982; or Nancy A. Johnson, +1-612-455-1745, mobile,+1-612-812-7568, firstname.lastname@example.org , or Kristen Spargo, +1-612-455-1741,mobile, +1-651-503-1231, email@example.com , both of Padilla SpeerBeardsley