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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 F.D.A. 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 F.D.A. 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 F.D.A. 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 device maker 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 F.D.A. received 21 additional reports of heart-wall tears linked to patient deaths, according to Audra Harrison, a spokeswoman for the agency.
The F.D.A. 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 that 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 F. 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.”
Johnson & Johnson MedTech bought Abiomed in 2022. Dr. Seth D. Bilazarian, a senior vice president of Abiomed, said in a statement that 300,000 Impella devices had been used in patients worldwide in more than a decade. There were no reported instances of heart-wall perforations related to product design or manufacturing, he said.
“We are proud of the positive impact our technology is having on patients facing life-threatening conditions,” Dr. Bilazarian said.
Asked why Abiomed did not report the deadly risk earlier, Johnson & Johnson MedTech said it was putting broad improvements in place. The company said the heart-wall tears were rare and are a “known complication during invasive cardiology procedures.”
Since 2013, research has highlighted the potential for the device to sever vessels and cause serious bleeding.
F.D.A. records show that the company has attributed the heart-wall tears to “operator handling,” urging to couple use of the device with imaging tools to avoid puncturing delicate heart tissue. Older adults, women and people with heart disease are particularly at risk, the agency said.
The pumps are temporary implants, tailored to the right or left heart chamber with different levels of pumping power. They are often used after a patient has had a major heart attack and the heart loses its ability to move blood through the body. The devices tend to be used on very ill patients, many with a mortality risk of about 40 to 50 percent.
If a wall of the heart is torn by a device, “it’s a surgical emergency that very rarely people survive from,” said Dr. Boback Ziaeian, a cardiologist and an assistant professor of medicine at University of California, Los Angeles.
The F.D.A.’s new alert stems from a lengthy agency inspection last year at Abiomed’s Massachusetts headquarters that resulted in a warning letter in September. Inspectors turned up numerous complaints that the agency said should have been reported, and also discovered a bulletin dated October 2021 that outlined the tearing risk, according to the F.D.A.
The bulletin, which the company said it posted on its website and on an app, described the heart-wall perforations as a “rare complication” that was first noted in January 2018. Abiomed should have filed a “report of correction or removal” to the F.D.A. within 10 days of that notice, according to Ms. Harrison, the agency spokeswoman.
Abiomed said that it had incorporated advice on how to use the device safely in its physician training and that it had sent an alert letter to doctors late last December.
Dr. Bilazarian said that Abiomed counted all tears of walls in the heart’s left chamber that had occurred during a procedure “regardless of whether they were directly related to the patient outcome.”
The company initiated two other major warnings last year of Impella pumps that the F.D.A. deemed to be linked to risk of serious injury or death.
In June, the company warned that the pump could malfunction if it hit an artificial heart valve, linking it to four deaths and 26 injuries. The company also addressed that problem with an update to the device instructions, F.D.A. records show.
Impella heart pumps were first cleared for use in 2008, and their use was contested among cardiologists even before the recent spate of problematic reports. When the one model of the device was approved by the F.D.A. after additional review in 2015, company-sponsored studies found that 73 percent, or 44 of the 60 patients meeting the criteria for use, survived a month after the operation.
By 2022, a study mandated by the F.D.A. showed a similar outcome for 23 surviving patients in a group of 33. But of 70 other patients tracked in the same study, only 19 percent of them, or 13 people, survived a month after use of the Impella device.
The F.D.A. stood by the device but urged doctors not to use it in patients suffering from organ failure and major neurologic injury.
Impella devices have increasingly taken the place of intra-aortic balloon pumps, which were once used to pump blood through vessels of very sick patients and fell out of favor after a study in 2012 questioned their efficacy.
Yet several studies have since concluded that the Impella devices are associated with higher death rates than the balloon pumps — and with far more bleeding complications.
“When you go look at the quality of the evidence to support this device, it’s quite little to have for a high-risk device like this,” said Dr. Nihar Desai, the vice chief of cardiovascular medicine at Yale School of Medicine and an author of four studies on Impella devices.
The company has reported the benefits of deploying Impella devices in nonemergency procedures where doctors place stents, or tiny metal tubes, to open vessels near the heart. Other studies at a single hospital and with no comparison group have shown survival benefits.Supporters of the device say it can be helpful in certain patients.
Dr. Srihari S. Naidu, a professor of medicine at New York Medical College, said that Impella devices are valuable to have on hand. “The onus comes on us as physicians and the community to make sure that we’re approving the appropriate devices, we have enough evidence to support its 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 that he had not received funds from Abiomed.
Medicare pays hospitals about $71,000 each time the device is threaded into a patient’s veins. Medicare data for 2022, the most recent year available, shows that Abiomed spent $6.3 million on consulting, meals and research payments for doctors and grants of up to $50,000 to hospitals.
Those expenses were broken into about 24,000 payments, which were made to about 9,500 U.S. 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 driven by purchases of one Impella model listed in the recent alerts.
When reporting on outsize bleeding rates related to the Impella devices, Dr. Desai, of Yale, has also noted that its payments are far higher than the balloon pump, creating an urgent need for rigorous studies of how to best treat patients.
“You hate to think this is part of that story, but I think we would be naïve to think that that couldn’t be part of the story,” he said.
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