The U.S. Food and Drug Administration (FDA) recently issued new warnings about the “serious adverse events” associated with left ventricular assist devices (LVADs). The dangers include blood clots inside its pump, a high rate of strokes and” bleeding complications.” Any can quickly lead to death.
The FDA has only approved two implantable LVADs – The HeartMate II Ventricular Assist System, made by the Thoratec Corporation, and the HeartWare HVAD, manufactured by HeartWare, Inc. It approved the Thoratec HeartMate II in 2008 for BTT (bridge-to-transplant) patients awaiting a heart transplant. In 2010, the FDA approved it for DT implantation (destination therapy) - permanent implantation in patients who are not eligible for a heart transplant. In 2012, the FDA approved The HeartWare HVAD for BTT only.
How do LVADs work?
LVADs consist of a “blood pump, power pack and controller.” The power-pack and controller are connected to the pump but remain outside the body. The pump is surgically implanted in the heart’s left ventricle and the aorta in patients with non-reversible left ventricle failure. The left ventricle normally pumps oxygenated blood through the aorta - the largest artery in the body –to the head, neck, arms and major organs in the body. LVADs take over when the heart is failing, making them “life-saving devices” whose benefits still outweigh their risks, according to the FDA.
WebMD also notes that doctors had little to offer patients with severe, chronic heart failure to save their lives until LVADs were approved by the FDA.
Serious LVAD side effects more frequent than expected
Despite their benefits, new studies and reports show that the serious and deadly side effects of LVADs are more frequent than originally anticipated. According to the alert recently released by the FDA, the rate of blood clots in the HeartMate II is “as high as 8.4% of implanted devices at three months and 6% of implanted devices at 6 months…compared to 1.6% of implanted devices at one year during the BTT clinical trial and 3.8% of implanted devices at 2 years during the DT clinical trial.” The FDA alert warns that blood clots in the pump “…can lead to death” or require costly surgery to replace it.
Twenty-eight percent of patients with HVAD pumps had “one or more strokes” over two years compared to 12.1 percent among patients” with a Heartmate II implant. As the FDA alert points out, strokes result in death or permanent impairment. A 2014 article in The New England Journal of Medicine called the increases “unexpected and abrupt” resulting in “substantial morbidity and mortality.” Fifteen physicians co-authored the NEJM report.
Lawsuits are now being filed against LVADs
Anyone who has been harmed by an LVAD, or who has lost a loved one when it malfunctioned, is entitled to justice. The Wayne Wright law firm has successfully represented victims injured by medical devices with hidden side effects for more than 40 years. Wayne Wright has been voted one of the Top 100 Trial lawyers in the United States. Consultation are free and no fees are due until cases are won.