New International Guidelines Support Early Goal Directed Therapy to Treat Sepsis

ORLANDO, Fla. -- An international coalition of critical care specialists has unveiled the first-ever global guidelines for the aggressive identification, management and treatment of sepsis, a widespread bloodstream infection that kills more than 1,400 people each day and costs the U.S. economy approximately $17 billion each year.

The Surviving Sepsis Campaign, created by the European Society of

Intensive Care Medicine, the International Sepsis Forum, and the Society of

Critical Care Medicine (SCCM) to raise awareness and reduce mortality related

to sepsis, released the guidelines at SCCM's 33rd Annual Congress

yesterday, Feb. 24, 2004. The campaign is urging doctors, governments and health agencies worldwide to adopt the practices outlined in the guidelines, which include

early and aggressive monitoring of a patient's vital signs.

The guidelines encourage the practice of Early Goal Directed Therapy

(EGDT), developed by Dr. Emanuel Rivers of Detroit's Henry Ford Hospital, as a

way to aggressively manage and treat sepsis. A November 2001 study published

in the New England Journal of Medicine reported that early monitoring of a

patient's oxygen saturation (ScvO2), in conjunction with other hemodynamic

parameters, was instrumental in managing patients with severe sepsis and

septic shock. In the New England Journal of Medicine study, Rivers used a

central venous oximetry catheter as part of an EGDT protocol that resulted in

a 34 percent lower in-hospital mortality rate, less severe organ dysfunction,

and a 3.8 day reduction in average hospital stays for patients surviving to

discharge. Edwards Lifesciences Corporation, a global leader in

medical technologies to treat advanced cardiovascular disease and the world's

leader in hemodynamic monitoring, developed the PreSep catheter that is being

used in the EGDT protocol.

"The Surviving Sepsis Campaign's efforts to spread awareness of sepsis and

establish global guidelines for its management are critical to saving

thousands of lives each year," said Anita B. Bessler, Edwards' corporate vice

president of global franchise management. "We believe implementation of Early

Goal Directed Therapy could reduce the number of deaths from sepsis by as much

as 25 percent in the next five years."

Severe sepsis, the spread of an infection to the bloodstream resulting in

abnormal blood oxygen levels, and its severest form, septic shock, are among

the leading causes of death in the United States. According to the SCCM,

severe sepsis is the leading cause of death in non-coronary intensive care

units and claims more lives than breast, colon/rectal, pancreatic, and

prostate cancer combined. There are more than 750,000 estimated cases in the

U.S. each year, and the incidence of sepsis is expected to continue

increasing. The condition is believed to affect as many as 18 million people

worldwide each year.

Treating severe sepsis has been estimated to cost as much as $17 billion

in the U.S. annually. The average severely septic U.S. patient is

hospitalized for 19.6 days, at an average cost of $22,100. According to the

Rivers study, EGDT's 3.8 day reduction in average hospital stays for patients

surviving to discharge could significantly reduce healthcare costs by as much

as $12,000 per patient.

Source: Edwards Lifesciences Corporation