The US Food and Drug Administration (FDA) has issued a warning about potential adverse events linked to the Thoratec HeartMate II) and other left Ventricular Assist Devices (LVADs). Specifically, the FDA is concerned about Thoratec HeartMate II adverse events including bleeding complications and an increased risk of blood clots inside the Thoratec pump.
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Thoratec HeartMate II Left Ventricular Assist Device
Left Ventricular Assist Devices (LVADs) are implanted to help the left ventricle of a patient with advanced heart failure circulate blood throughout the body. In such patients, the device—which includes a blood pump, power pack, and controller—is attached to the patient's left ventricle and aorta via the blood pump, while the power pack and controller remain outside the body.
Patients are approved for LVADs in two scenarios: 1. As Bridge-To-Transplant (BTT), where the patient is at risk of death from left ventricular heart failure while waiting for a transplant from a donor heart, or 2. As Destination Therapy (DT), where the patient has end-stage left ventricular heart failure and is not a candidate for heart transplant.
Thoratec HeartMate II Pump Thrombosis
In August 2015, the FDA warned that it had received reports of pump thrombosis—blood clots inside the blood pump—linked to the use of the Thoratec HeartMate II. According to the FDA, it had received reports patients experienced pump thrombosis earlier than anticipated based on data from clinical trials. One study reportedly suggested pump thrombosis could occur in 8.4 percent of implanted devices as early as three months after implantation, while another suggested pump thrombosis in 6 percent of devices at 6 months. In clinical trials, only 1.6 percent of implanted devices experienced pump thrombosis at one year (in the bridge-to-transplant trial) and in the destination therapy trial, pump thrombosis occurred in 3.8 percent of devices at two years.
Pump thrombosis is a life-threatening complication that can require surgery to replace the pump.
On August 5, 2014, the FDA approved updated labels for the HeartMate II that included the risk of pump thrombosis.
Thoratec HeartMate II Bleeding
During the same warning, the FDA noted that bleeding complications had been l inked to the Thoratec HeartMate II device, though the exact cause of the bleeding was not known.
Thoratec HeartMate II Deaths
According to an FDA alert (3/5/14), as of March 2014, four people had died and five more lost consciousness or suffered a decrease in blood flow while attempting to switch to a backup system controller. Switching the controller requires patients to disengage their pump. Two of the patients who died reportedly attempted to switch the system controller while alone and without contacting their health care provider.
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