FDA: Heart pump linked to deaths
A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart.
The tiny Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions.
The FDA said the manufacturer of the device, Abiomed, should have notified the agency more than two years ago, when the company first posted an update on its website about the perforation risk. Such a notice, the FDA added, would have led to a much broader official agency warning to hospitals and doctors.
The alert is the latest of concerns raised in recent years about the deadly side effects of cardiac devices, especially those that take over the heart’s role in circulating blood. It is the third major FDA action for an Impella device in a year.
A series of studies suggested that the Impella heart devices heighten the risk of death in patients with unstable medical conditions. Meanwhile, the devicemaker has spent millions of dollars promoting the device and awarding consulting payments to cardiologists and grants to hospitals.
Since Abiomed’s first notice about the Impella’s complications in October 2021, the FDA received 21 additional reports of heart wall tears linked to patient deaths, according to Audra Harrison, a spokesperson for the agency.
The FDA classified the alert sent last week as the most serious type of action it could take for a product that can result in death or serious injury, short of removal from the market. The alert still permits use of the device, with an update on the risks requested for the 243-page instruction manual that accompanies the pump.
There are currently 66,000 Impella pumps in the United States and 26,000 such devices in Australia, Canada, France, India and other countries.
The number of Impella-related injuries struck some cardiologists as troubling. Some doctors said the role of the pumps was already being questioned, citing a lack of high-quality studies that would establish whether the devices offered more benefit than harm. Some also questioned whether the call for enhanced caution in a dense instruction booklet would prevent deaths.
“I think cardiologists are already extremely careful,” said Dr. Rita Redberg, a cardiologist and a professor at the University of California, San Francisco, who has been critical of the devices. “To say that you’re addressing 49 deaths by saying, ‘Be careful,’ is not addressing the problem at all.”