United States – Two kinds of implanted heart devices being used by patients with end-stage heart failure have been recalled at a strict FDA drug administration regulation level after having been revealed to be tied to 273 injuries and 14 deaths, the FDA says.
Devices Used for End-Stage Heart Failure Patients
The HeartMate II and HeartMate 3 devices are manufactured by the Thoratec Corp., which is a subsidiary of Abbott Laboratories. Around 14 thousand of the two devices are thought to be under recall process, while the two have not yet been banned from sale, as reported by HealthDay.
The HeartMate II and three are utilized for long-term and short-term support in adult patients with severe left ventricular heart failure,” the FDA explained in a statement. “It is also useful in the interim period during which the patient has been placed on a heart transplant list while helping the heart to recover, and ultimately as a permanent solution when a transplant is not possible.”
They take over the blood-pumping action of the left ventricle – the heart’s main pumping chamber. They reroute some of the blood that would normally go into the weakened chamber and send it into the aorta, through which it circulates to the rest of the body.
Nonetheless, it is a very rare scenario where a clot builds up from “biological stuff” which accumulates in a certain area of the devices.
Concerns Over Device Effectiveness and Safety
“This buildup can obstruct the device, making it less effective in helping the heart pump blood,” the FDA explained. “It can trigger alarms indicating low blood flow and affect the device’s ability to help the heart properly. The accumulation of biological material typically occurs over two years or more.”
In the lowest cases, it may contribute to injury or even death, according to the description in the report.
On February 19, Thoratec took urgent medical device action, and users were advised to watch out for reduced flow alarms, which are characteristic of the device working slowly, “as this is the first symptom of significant outflow obstruction,” according to the FDA.
If doctors are alerted, they could institute measures to improve blood flow, such as close monitoring of the patients or stent implantation.
The study, published in 2022 in the Journal of Thoracic and Cardiovascular Surgery, reported the occurrence of blockages in around 3% of patients with such devices, while the rate of these procedures is expected to increase with time.
The physicians who work with heart disease patients truly worry about this problem because patients who are in end-stage heart failure are left with few options if the HeartMate devices are taken off the market.
Physicians Express Concerns and Advocacy for Patients
Without these things, people are in danger of “when we are in trouble,” Dr. Francis Pagani, a cardiothoracic surgeon at the University of Michigan, told KFF News, as reported by HealthDay.
“It would be devastating to the patients not to have this option. It’s not a perfect option—no pump ever is—but this is as good as it’s ever been,” said Pagani, who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.