BOCA RATON, FLA. – A new and smaller left ventricular assist device now in clinical trials is appropriate for most women and provides similar outcomes, compared with a larger device already used for patients with heart failure, according to a poster presentation at the annual meeting of the Heart Failure Society of America.
The large size of the original HeartMate XVE Left Ventricular Assist System (Thoratec Corp., Pleasanton, Calif.), which is currently approved as a bridge-to-transplant as well as a destination therapy, precluded its use in many women.
“The old device would not fit everyone,” Dr. Leway Chen said in an interview.
Only about 9%-16% of women with heart failure received a HeartMate XVE in published studies, said Dr. Chen, director of the heart failure and transplantation program at Strong Memorial Hospital, University of Rochester (N.Y.). Dr. Chen also is an investigator for Thoratec.
In this study, Dr. Chen and his associates assessed 34 patients–including 15 women–with advanced New York Heart Association class IV heart failure at 10 medical centers. All received the HeartMate II, a continuous-flow left ventricular assist device with one-third the mass of a typical implanted electric pulsatile device. The HeartMate II was implanted in each patient as a bridge to cardiac transplantation.
Etiologies of heart failure included ischemic cardiomyopathy, idiopathic cardiomyopathy, myocarditis, and peripartum cardiomyopathy. Median age was 49 years for women and 55 years for men. There was one transient ischemic attack and one stroke in a patient who fully recovered prior to implantation among the women; neither of these events occurred in men.
There were no device failures but minor malfunctions occurred in both groups, Dr. Chen said. “The adverse event numbers are too small to make a conclusion.”
Six women received a transplant and five had ongoing therapy after a median of 96 days with the device. Three men received a transplant and 10 continued therapy with the device after a median of 117 days. The longest duration of HeartMate II therapy was 577 days as of June 10, 2005, he said.
Regarding the HeartMate II, Dr. Chen said, “We really like it and expect good durability. There are other smaller devices, but this is the closest to market.” A phase II-III study of the device is underway, he added.