Catheter used in early, aggressive treatment for sepsis.

Emergency room patients treated with a catheter that measured their central venous oxygen saturation (ScvO2) as part of an early, aggressive regimen for severe sepsis and septic shock had better overall outcomes, including lower mortality rates and shorter hospital stays, than patients receiving standard care, according to research presented by Dr. Emanuel Rivers of Henry Ford Hospital (Detroit, MI) at the 40th Anniversary Symposium on Critical Care, Trauma and Emergency Medicine in Las Vegas. Severe sepsis, the spread of an infection to the bloodstream resulting in imbalanced blood oxygen levels, and its severest form, septic shock, are among the leading causes of death in the United States.

The research, also published in the November 8, 2001 issue of The New England Journal of Medicine, involved a study of 263 patients treated for severe sepsis or septic shock presenting to Henry Ford's Emergency Department during a three-year period. Nearly half of those patients were treated through an aggressive intervention method called Early Goal-Directed Therapy (EGDT) using a catheter from Edwards Lifesciences Corporation (Irvine, CA; 949-250-6826) capable of continuously measuring a patient's ScvO2. Low ScvO2 is a key indicator of the blood oxygen imbalance associated with severe sepsis and septic shock, which can contribute significantly to multiple organ failure and death. The remaining patients in the study received standard care, which focused on more routine measurements, such as vital signs, central venous pressure and urinary output.

The study showed that patients receiving EGDT had a lower in-hospital mortality rate -- 30.5 percent compared to 46.5 percent among those receiving standard care; lower incidences of organ failure; and shorter hhospital stays -- 14.6 days compared to 18.4 days for those receiving standard care.

"This study clearly shows the value of treating patients with severe sepsis or septic shock earlier and more aggressively in the ER, during the critical 'golden hours' when patients' eventual outcomes often hang in the balance," said Dr. Rivers, who led the study, which builds on earlier work by Professor Konrad Reinhart of the University of Jena (Germany), showing the value of ScvO2 measurement as a diagnostic tool. "Interestingly, certain elements of EGDT, including catheterization to continuously monitor oxygen saturation, are fairly common in Intensive Care Units," Rivers added. "This study shows how effective the approach can be when applied at the earliest stages of care."

The Edwards catheter used in the study is now available in limited commercial release in the United States, and the company also is exploring its potential application in Europe.

Edwards Lifesciences is a leader in advanced cardiovascular disease treatments and the number-one heart valve company in the world. Edwards focuses on four main cardiovascular disease states: heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure. The company's global brands, which are sold in over 80 countries, include Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty.

Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty are trademarks of Edwards Lifesciences.