In order for a patient to be recommended for destination therapy with an LVAD, he/she will have presented with end-stage heart failure, and will be ineligible for a transplant due to age, additional health problems, or other complications.
[5][6] In 2000, the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial was conducted.
REMATCH was a multi-center study supported by the National Heart, Lung, and Blood Institute to compare long-term implantation of left ventricular assist devices with optimal medical management for patients with end-stage heart failure who require, but do not qualify to receive cardiac transplantation.
Based on the results of this study, the U.S. Food and Drug Administration (FDA) granted a Premarket Approval for the Thoratec HeartMate XVE LVAD to be used for destination therapy.
[7][8] Most LVADs are implanted in scheduled operations and require careful preparation of the patient for surgery, including an assessment by an anesthesiologist.
[citation needed] Other adverse effects included bleeding, infection and lengthened hospital stays.
The REMATCH study randomly assigned 129 patients with Class IV end-stage heart failure who were ineligible for cardiac transplantation.