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Originally published September 10, 2024
Last updated September 19, 2024
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FDA’s Class I recall of the HeartMate 3 left ventricular assist device (LVAD) this April raised questions about whether the device is safe to implant in patients. Cardiac experts from Keck Medicine of USC explain why the HeartMate 3 remains a lifesaver for many patients with end-stage heart failure.
For patients with end-stage heart failure who aren’t eligible for a heart transplant, an LVAD can help the heart’s main pumping chamber, the left ventricle, pump blood long-term. Meanwhile, for patients who are awaiting a transplant, an LVAD serves as a stopgap.
FDA’s recall of the HeartMate 3 points to an issue with the device: extrinsic outflow graft obstruction. Over time, biological material can build up between the pump and the outflow bend relief tube, obstructing the outflow of blood. This event not only triggers a “low-flow alarm” alerting the patient that their pump is not working, but “in worst cases,” FDA’s announcement states, it “could result in death.”
Physicians from advanced specialty cardiac centers like the USC Cardiac and Vascular Institute, part of Keck Medicine, tend to have more experience with the HeartMate 3 than other physicians. These specialists have long known about the risk of extrinsic outflow graft obstruction. They know what to watch for and what to do if it occurs.
“Outflow graft obstruction is a known procedural complication,” says Raymond C. Lee, MD, a cardiac surgeon with the USC Cardiac and Vascular Institute.
“The external outflow graft obstruction is something that’s been known for many years,” agrees transplant cardiologist Ajay S. Vaidya, MD.
As Vaidya explains, “Our center has robust clinical pathways developed in case we encounter this. We’re very confident in being able to both diagnose and treat it. It can be fixed through revision surgery or by replacing the outflow graft.”
USC Cardiac and Vascular Institute specialists also know that the risk of extrinsic outflow graft obstruction is extremely low, he says. “Fortunately, extrinsic outflow graft obstruction is very rare. It is estimated to occur at a rate of only 0.24% two years after LVAD implantation and at a rate of 2.06% five years after implantation.”
In fact, physicians who likely benefit most from FDA’s warning are those with less experience using the device. HeartMate 3 LVADs are still uncommon at non-specialty centers, and these physicians may not know about extrinsic outflow graft obstruction risk and how to handle it.
Indeed, Vaidya says, “FDA wanted to ensure that the physicians implanting this device are aware of the issue so that they can deal with it appropriately in surgery.”
The HeartMate 3 is still in the market. FDA’s recall does not remove it from clinical use. This is important because the HeartMate 3 is a critical treatment for heart-failure patients.
“This device is the gold standard for the field,” Lee says. “It is the only FDA-approved device we have on the market for a durable LVAD.”
“HeartMate 3 LVADs are the gold standard of care in durable mechanical support that allows patients with end-stage heart failure to go home and live a life with minimal or no symptoms, and to have a much greater survival rate than that of other patients with end-stage heart failure,” Vaidya adds.
The USC Cardiac and Vascular Institute will continue using the HeartMate 3. “We can still implant these devices, and they’re overall very safe and effective in this population,” Vaidya says.
Both say the USC Cardiac and Vascular Institute has never experienced extrinsic outflow graft obstruction in its years of using the HeartMate 3. “We have never encountered this as a center. We don’t anticipate encountering it very often, if at all,” Vaidya says. “We’ve also talked to colleagues across the country, and they’ve rarely seen this. It is not a major issue.”
So far, the center’s patients have not questioned the safety of the device. “I would tell a patient who is concerned that this is a very rare complication,” Vaidya says. “It would not be an issue we foresee impacting their quality of life or their outcome after an LVAD implant.”
“FDA’s recall could scare some of the lay public, people who don’t know the details about the device,” Lee says. “But for people who work in the field, it is not a novel concern.”
“I think the HeartMate 3 is still a very good device, and it will get better over time,” he concludes. “This known but uncommon complication will not preclude us from using the device.”
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