August 22, 2024- Abbott announced that the U.S. Food and Drug Administration (FDA) has approved a change to its label that will help patients who receive a HeartMate 3™ left ventricular assist device (LVAD, or heart pump) experience superior clinical outcomes by eliminating aspirin as part of routine patient management. The labeling update is exclusively for patients with an Abbott HeartMate 3 heart pump and has also been approved by regulatory agencies in Canada and the European Union.
Blood thinners have historically been used by patients receiving LVADs as a means to reduce the risk of blood clots associated with the use of a blood pump implant. The ARIES-HM3 study was designed to help clinicians understand whether aspirin is needed as part of a blood thinning regimen for HeartMate 3 patients.
The ARIES-HM3 trial showed that patients who received an Abbott HeartMate 3 heart pump but didn’t take aspirin as part of their blood-thinning medication regimen had nearly 40% fewer complications from bleeding without increasing the risk of forming a blood clot compared to patients who also received a HeartMate 3 but did take aspirin.