A problematic 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 a warning about its risk of puncturing a heart wall.
The tiny Impella pumps, about the width of a candy cane, pass through blood vessels to take over the work of the heart in patients undergoing complex procedures or with life-threatening conditions.
The FDA said the device’s maker, 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 formal warning to hospitals and doctors.
The alert is the latest in a series of concerns raised in recent years about the deadly side effects of heart devices, especially those that take over the heart’s role in blood circulation. It is the third major FDA action on an Impella device in a year.
A series of studies suggested that Impella heart devices increase the risk of death in patients with unstable medical conditions. Meanwhile, the device maker has spent millions of dollars promoting the device and providing consulting payments to cardiologists and grants to hospitals.
Since Abiomed’s first notification of Impella complications in October 2021, the FDA has received 21 additional reports of heart wall tears linked to patient deaths, according to Audra Harrison, a spokeswoman for the agency.
The FDA described the notice sent last week as the most serious kind of action it could take on a product that could lead to death or serious injury, short of pulling it from the market. The notice still allows the device to be used, with a hazard notice requested for the 243-page instruction manual that comes with 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 seemed alarming to some cardiologists. Some doctors said the role of the pumps is already being questioned, citing a lack of high-quality studies to prove whether the devices do more good than harm. Some also questioned whether the call for increased caution in a dense instruction booklet would prevent the deaths.
“I think cardiologists are already extremely cautious,” said Dr. Rita F. Redberg, a cardiologist and professor at the University of California, San Francisco, who has been critical of the devices. “Saying you’re dealing with 49 deaths by saying ‘look out’ doesn’t address the problem at all.”
Johnson & Johnson MedTech bought Abiomed in 2022. Dr. Seth D. Bilazarian, senior vice president of Abiomed, said in a statement that 300,000 Impella devices had been used on patients worldwide in more than a decade. There were no reports of heart wall perforations related to the product’s design or manufacture, he said.
“We are proud of the positive impact our technology is having on patients facing life-threatening conditions,” said Dr. Bilazarian.
Asked why Abiomed didn’t report the fatal risk sooner, Johnson & Johnson MedTech said it was implementing broad improvements. The company said the heart wall tears were rare and are a “known complication during invasive cardiac procedures.”
As of 2013, research has pointed to the device’s potential to cut blood vessels and cause severe bleeding.
FDA filings show the company attributed the heart wall tears to “operator manipulation,” urging that the device be used in conjunction with imaging tools to avoid puncturing sensitive heart tissue. The elderly, women and people with heart disease are at particular risk, the agency said.
Pumps are temporary implants, adapted to the right or left heart chamber with different levels of pumping power. They are often used after a patient has suffered a severe heart attack and the heart loses its ability to move blood around the body. The devices tend to be used in very sick patients, many with a mortality risk of about 40 to 50 percent.
If a heart wall is torn by a device, “it’s an emergency surgery that very rarely people survive,” said Dr. Boback Ziaeian, a cardiologist and assistant professor of medicine at the University of California, Los Angeles.
The FDA’s new warning stems from a lengthy agency inspection last year at Abiomed’s Massachusetts headquarters that resulted in a warning letter in September. Inspectors presented numerous complaints that the agency said should have been reported and also discovered a bulletin dated October 2021 that described the risk of tearing, according to the FDA
The bulletin, which the company said it posted on its website and an app, described the heart wall perforations as a “rare complication” first noted in January 2018. Abiomed should have submitted a “correction report or removal” to the FDA within 10 days of that notification, according to Ms. Harrison, the agency’s spokeswoman.
Abiomed said it had incorporated advice on how to use the device safely into its doctors’ training and had sent a warning letter to doctors late last December.
Dr. Bilazarian said Abiomed measured all tears in the walls of the heart’s left chamber that occurred during a procedure “regardless of whether they were directly related to patient outcome.”
The company launched two other major warnings last year for Impella pumps that the FDA determined were linked to a risk of serious injury or death.
In June, the company warned that the pump could malfunction if it hit an artificial heart valve, which it linked to four deaths and 26 injuries. The company also addressed that problem with an update to the device’s instructions, FDA filings show.
Impella heart pumps were first approved for use in 2008, and their use was controversial among cardiologists even before the recent flurry of problematic reports. When one model of the device was approved by the FDA after additional review in 2015, company-sponsored studies found that 73 percent, or 44 of 60 patients who met the criteria for use, survived a month after surgery.
By 2022, an FDA-mandated study showed similar outcomes for 23 surviving patients in a group of 33. But Of the 70 other patients followed in the same study, only 19 percent of them, or 13 people, survived a month after using the Impella device.
The FDA stood by the device but urged doctors not to use it in patients suffering from organ failure and severe neurological injury.
Impella devices are increasingly replacing intra-aortic balloon pumps, which were once used to pump blood through the vessels of very sick patients and fell out of favor after a 2012 study questioned their effectiveness.
However, several studies have since concluded that Impella devices are associated with higher death rates than balloon pumps—and with far more bleeding complications.
“When you look at the quality of evidence supporting this device, it’s very little to have for a high-risk device like this,” said Dr. Nihar Desai, the vice chair of cardiovascular medicine at Yale School of Medicine and author of four Impella device studies.
The company has touted the benefits of developing Impella devices in non-urgent procedures where doctors insert stents, or tiny metal tubes, to open vessels near the heart. Other studies in a single hospital and without a comparison group have shown survival benefits. Proponents of the device say it may be helpful in some patients.
Dr. Srihari S. Naidu, professor of medicine at New York Medical College, said the Impella devices are valuable to have on hand. “The onus is on us as physicians and the community to make sure that we approve the right devices, that we have enough evidence to support their use, that we use it in the areas where we have the most evidence, and that we develop the skill set that keeps it safe,” he added. .
Dr Naidu said he had not received any money from Abiomed.
Medicare pays hospitals about $71,000 each time the device is used on a patient. Medicare figures for 2022, the most recent year available, show Abiomed spent $6.3 million on consulting services, meals and research payments for doctors and grants of up to $50,000 to hospitals.
These costs were divided into approximately 24,000 payments, which were made to approximately 9,500 US cardiologists who perform surgery. The company has made similar payments since at least 2016, spending $3.7 million to $7.5 million each year.
Johnson & Johnson MedTech bought Abiomed, which primarily sold Impella devices, in late 2022 for $16.6 billion. Johnson & Johnson reported $1.3 billion in sales of the devices for 2023 in a securities filing, largely due to purchases of an Impella model cited in recent notices.
In reporting high bleeding rates associated with the Impella devices, Dr. Desai, of Yale, also noted that its payouts are much higher than the balloon pump, creating an urgent need for rigorous studies on how best to treat patients.
“You hate to think that’s part of this story, but I think we’d be naive to think that this couldn’t be part of the story,” he said.
