Geisinger participates in national heart failure trial

March 28, DANVILLE – As the first medical center in the state to offer ultrafiltration therapy to treat fluid overload in patients with heart failure, Geisinger Medical Center was one of only 28 medical sites nationwide to participate in the landmark UNLOAD clinical trial to assess the effectiveness of that therapy.  Findings from that trial released recently at the 2006 American College of Cardiology (ACC) 55th Scientific Session Conference detailed the immediate and long-term benefits of ultrafiltration therapy. 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.

“It is gratifying to see that the results of this clinical trial reinforce what we’ve observed for several years,” said Henry Fesniak, MD, director of the cardiac function restoration program at Geisinger Medical Center. “Ultrafiltration therapy for patients experiencing fluid overload reduces rehospitalizations associated with fluid overload and improves the quality of life for patients and their families.”

Called UNLOAD (UltrafiltratioN versus IV Diuretics for Patients HospitaLized for Acute Decompensated Congestive Heart Failure), 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.
 
Dr. Fesniak has been using ultrafiltration with the Aquadex FlexFlow, a technologically sophisticated mechanical system, for three years. The device 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.
 
Presented as part of the ACC’s Late-Breaking Clinical Trials program, the study data shows 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.

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.  “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™, a system developed and manufactured by CHF Solutions.

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 demonstrated a:

   

  • 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.