Abbott has announced that the US Food and Drug Administration (FDA) has approved a new labelling update for the HeartMate 3 heart pump, allowing for the removal of aspirin from routine patient management.
This update for the implantable left ventricular assist device (LVAD) has also received approval from regulatory agencies in Canada and the European Union.
According to Abbott, patients with LVADs have traditionally been prescribed blood thinners, including aspirin, to manage the risk of blood clots associated with the device.
The ARIES-HM3 trial, an international and randomised study, compared the effects of aspirin 100mg/day versus a placebo, combined with vitamin-K antagonist (VKA) therapy, in advanced heart failure patients newly implanted with HeartMate 3.
The study found that patients who did not use aspirin experienced nearly 40% fewer bleeding complications without a higher risk of blood clot formation compared to those who received aspirin. Additionally, avoiding aspirin was associated with a reduction in hospitalisation days.
The HeartMate 3 heart pump is designed to support individuals with weakened hearts and features magnetic levitation technology. This design utilises magnetic forces to suspend the device’s rotor, thereby minimising trauma to the blood and improving patient survival and quality of life.
Abbott heart failure business vice president Keith Boettiger said: “Removing aspirin from the medication regimen for the HeartMate 3 is a simple change that means people with an Abbott LVAD can focus on the things they love and spend less time worrying about and tending to bleeding events.
“Through research such as the ARIES-HM3 trial, we continue to rewrite the book on the management of patients with advanced heart failure and focus on bringing life-enhancing benefits to people who rely on our devices to survive.”
Abbott claimed that the HeartMate 3 LVAD, with its magnetic levitation flow technology, marks a notable advancement in LVAD therapy. This technology ensures gentle blood handling, which helps to reduce complications and adverse events related to hemocompatibility.
The device is used to provide both short- and long-term mechanical circulatory support for patients with advanced heart failure.
