Abbott has announced that the FDA has approved a label change for its HeartMate 3™ left ventricular assist device (LVAD), permitting the elimination of aspirin from the standard treatment regimen.

This update, also approved by regulatory agencies in Canada and the European Union, is expected to enhance patient outcomes for those using the HeartMate 3.

Blood thinners, including aspirin, have traditionally been prescribed to LVAD patients to mitigate the risk of blood clots. However, the ARIES-HM3 study examined the necessity of aspirin in the blood-thinning regimen for HeartMate 3 patients.

The study revealed that patients who did not take aspirin experienced nearly 40% fewer bleeding complications without an increased risk of blood clots, compared to those who continued aspirin therapy. Additionally, these patients spent fewer days in the hospital.

The findings from the ARIES-HM3 trial suggest that the conventional practice of prescribing aspirin to LVAD patients may not be necessary. Removing aspirin from the treatment regimen for HeartMate 3 patients appears to be a safe decision that reduces bleeding risks and the need for hospital visits.

Abbott’s HeartMate 3 device, which utilizes Full MagLev™ technology to minimize trauma to blood passing through the pump, is designed to improve patient survival and quality of life. This technology has resulted in the lowest rate of pump-related complications among blood pumps available on the market.

The elimination of aspirin from the regimen is expected to allow patients to enjoy a better quality of life with fewer concerns about bleeding events. The ARIES-HM3 trial is part of Abbott's ongoing efforts to enhance the management of patients with advanced heart failure.

The ARIES-HM3 trial, an international randomized study, compared HeartMate 3 patients who took aspirin with those who did not. The study found that patients who did not take aspirin experienced a nearly 40% reduction in bleeding events without an increased risk of thrombosis, leading to 47% fewer hospital days.

Clinicians are encouraged to tailor the pharmacological management of HeartMate 3 patients based on individual risks and benefits.
 

Source: abbott.mediaroom.com

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