Low infection rate in Arrow Lionheart* Euro...( t study results can be compared to the ...),Health

t study results can be compared to the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial of the Thoratec Corporation Heartmate*, a left ventricular assist device that requires cables that run from the inside of the body, through the skin, to the external power source. (NEJM, 2001;345:1435).

The rate of sepsis, or major infection, was .60 per patient year in the REMATCH trial, and only .17 per patient year in the LionHeart trial. That means that, each year, a patient had a 60 percent chance of major infection with Heartmate, and only a 17 percent chance of major infection with the LionHeart. In the LionHeart trial, there were no deaths due to infection related to the device as opposed to 20 deaths related to device infection in the REMATCH trial.

Local infection rate was .39 per patient year in the REMATCH trial, and .17 per patient year in the CUBS trial of the LionHeart. The device infection rate was .41 per patient year in REMATCH, and .17 per patient year in CUBS. Infection in the pump was .23 in REMATCH, and 0 in CUBS.

"LionHeart had a lower infection rate than other heart assist devices that require lines or cables protruding through the skin," said Walter E. Pae, Jr., M.D., professor of surgery, Penn State Milton S. Hershey Medical Center and principal investigator for both the U.S. and European trials. "Because there is nothing through the skin, it also allows patients to detach from the power source for short periods to bathe or swim, improving their quality of life."

When looking at how the devices functioned, the REMATCH trial reported a rate of malfunction of .75 per patient year for HeartMate. The CUBS trial showed a rate of malfunction in the LionHeart of .34 per patient year.

"Importantly, no one during the whole CUBS trial had to have a pump changed during the duration of the trial, whereas pump changes were not infrequent during the REM
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Contact: Valerie Gliem
vgliem@psu.edu
814-865-9481
Penn State
12-Nov-2003

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