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Five Studies On Aquapheresis(TM) Therapy Presented At Heart Failure Society of America Annual Meeting

Posted on: Monday, 25 September 2006, 15:01 CDT

Five studies exploring different aspects of CHF Solutions'

unique form of ultrafiltration therapy to treat fluid overload in heart

failure patients (Aquapheresis™) were

presented in poster sessions at the Heart Failure Society of America

(HFSA) 2006 Annual Scientific Meeting in Seattle. The new studies expand

on, and are consistent with, findings from previous studies, most

recently, the landmark UNLOAD study.

"In hospitals across the nation, treating

fluid overload in heart failure patients is costly and outcomes often

fall short of physician expectations and patient needs,"

said John Erb, CEO of CHF Solutions. "Clinical

research to date has given us great confidence in the efficacy of

Aquapheresis therapy and our Aquadex FlexFlow™

system. These new studies help to validate the results of earlier

research and deepen our understanding of our approach. We are also

pleased that HFSA, as well as the American Heart Association and the

American College of Cardiology, now acknowledge ultrafiltration's

effectiveness and recommend its use in their treatment guidelines. This

expands our opportunity to improve outcomes and the quality of life for

patients while possibly reducing healthcare costs."

A brief summary of each of the five studies follows:

A study led by Drs. Syed Saghir, Santosh G. Menon and Eugene S. Chung

at Christ Hospital, Cincinnati, compared Aquapheresis with treatment

using usual care and treatment using usual care plus nesiritide, a

vasodilator. The study concluded that Aquapheresis appears to be a

more effective method to remove fluid volume and prevent hospital

readmissions in the following 30 days. This self-initiated study is

consistent with and helps to independently validate the previously

presented UNLOAD study results. (Poster #388)

At the University of Minnesota, a study led by Dr. Thom G.A. Dahle

reviewed outcomes of patients who underwent Aquapheresis therapy using

standard peripheral intravenous (PIV) catheters placed in the arms.

The study showed that large volumes of fluid can be reliably extracted

by Aquapheresis, over an extended time, with peripheral catheters. The

authors note that the ability to use peripheral IV catheters will

potentially allow this therapy "to be more

readily implemented in a variety of care settings."

(Poster #378)

A study led by Dr. Bradley Bart, Hennepin County Medical Center,

Minneapolis, showed that patients treated with Aquapheresis therapy

experienced greater weight loss than patients treated with IV

diuretics. They found no correlation between changes in creatinine in

the blood, an indication of kidney failure, and the level of fluid

loss, suggesting that mechanisms other than fluid volume removal cause

worsening renal function in heart failure patients. (Poster #375)

At Wayne State University, a study led by Dr. Maya E.

Guglin found similar changes in BNP (a peptide secreted in the heart

in response to excessive stretching) levels in the two groups, despite

greater weight and fluid loss with ultrafiltration than with IV

diuretics. They suggested that the measures of this biomarker cannot

detect the significant differences in volume removed by the two

therapies and that changes in BNP levels also lack the sensitivity to

predict re-hospitalizations for heart failure. (Poster #381)

At the University of Minnesota, a study led by Dr. Syed S. Ali found

that Aquapheresis extracts significantly more sodium per liter than IV

diuretics while simultaneously removing less potassium and magnesium,

reducing the need for supplements. This is consistent with previous

studies that have shown that ultrafiltration, differently from

diuretics, removes isotonic fluid and therefore the greatest possible

amount of sodium per unit of fluid withdrawn. (Poster #374)

About the UNLOAD study

UNLOAD is a randomized, multicenter study of 200 patients involving 28

hospitals and medical centers across the United States that details the

immediate and long-term benefits for heart failure patients receiving

Aquapheresis therapy to treat fluid overload. The UNLOAD 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

follow-up visits to physicians or hospitals. These landmark results were

first presented at the 2006 American College of Cardiology conference in

March. The study has been accepted by the Journal of the American

College of Cardiology and publication is expected fall 2006. For

more information about the UNLOAD study, go to www.chfsolutions.com/unload_lbct.html.

About Fluid Overload and Heart Failure

Fluid overload can be caused by many things, including problems with the

heart, kidneys, lungs or any combination of these vital organs. The

leading cause of fluid overload is congestive heart failure (CHF),

sometimes referred to as heart failure (HF). Heart failure is a

condition that affects approximately 5 million Americans and is

responsible for 1 million hospitalizations annually. More than 500,000

new cases of heart failure are diagnosed each year. The estimated

economic burden of heart failure care exceeds $28 billion annually in

the United States. Due to prolonged hospitalizations and high

readmission rates, many hospitals often lose more than $1,000 for each

heart failure patient admitted.

About Aquapheresis, the Aquadex FlexFlow and CHF Solutions

CHF Solutions' Aquapheresis therapy with the

Aquadex FlexFlow system allows physicians to remove the excess salt and

water in patients with fluid overload where, when and how they want.

Inpatient or outpatient, peripheral or central venous access, its low

blood flow, low extracorporeal blood volume, and precise removal rates

enable dependable fluid removal.

CHF Solutions, based in Brooklyn Park, Minn., is a privately held

manufacturer of medical devices for cardiac care. The company's

mission is to provide medical practitioners with innovative and

practical solutions that enable the treatment of patients with unmet

clinical needs. For more information, go to www.chfsolutions.com.

Source: Business Wire

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