The first device of its kind to be approved by the U.S. Food and Drug Administration (FDA) for advanced heart failure, the HeartMate II LVAD is the most widely used1 LVAD with over 26,600 patients worldwide.2
HOW AN LVAD CAN HELP HEART FAILURE PATIENTS
The HeartMate II LVAD can restore quality to the lives of advanced heart failure patients. A study showed that over 80 percent of HeartMate II LVAD device recipients were virtually free of heart failure symptoms at six months, and remained so for two years.3 Before the study, they had started out with severe symptoms, even at rest.
The HeartMate II LVAD is small enough to fit people of many sizes and ages, and is proven to work for many years. There are even several HeartMate II LVAD patients on support for more than 10 years.2
COMPLICATIONS AND RISKS
Complications of LVAD surgery are similar to the potential complications of a open-heart surgery procedure. You will be asked to sign a surgical consent form prior to the operation, as well as a consent form for blood transfusions. An LVAD should not be used in patients who cannot tolerate or are allergic to anticoagulation therapy. Common side effects include death, bleeding, cardiac arrhythmia, local infection, respiratory failure, device malfunction, sepsis, right heart failure, driveline or pump pocket infection, renal failure, stroke, neurologic dysfunction, psychiatric episode, peripheral thromboembolic event, hemolysis, hepatic dysfunction, device thrombosis and myocardial infarction.
Consult your doctor about all possible benefits and risks of an LVAD.
See important safety information.
REFERENCES
1. Abbott data on file. SJM-HM-0618-0119. Based on the number of patient implants worldwide.
2. Abbott data on file. SJM-HM-1016-0031(3).
3. Park, S. J., Milano, C. A., Tatooles, A. J., Rogers, J. G., Adamson, R. M., Steidley, E., … Slaughter, M. S. (2012). Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circulation: Heart Failure, 5, 241-248. http://dx.doi.org/10.1161/CIRCHEARTFAILURE.111.963991