The label expansion eliminates aspirin as part of routine patient management. This update exclusively applies to patients with a HeartMate 3 pump and also has Canadian and European approval.
HeartMate 3 helps the heart pump blood when it fails to pump blood effectively on its own. The devices work by mimicking the pumping function of the heart’s left ventricle. The devices divert blood from the weakened left ventricle and propel it into the body’s main artery to help circulate blood throughout the body.
Historically, patients receiving LVADs used blood thinners to reduce the risk of blood clots associated with the implant. The ARIES-HM3 study demonstrated that patients who received Abbott’s 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 those who received the HeartMate 3 but did take the aspirin.
ARIES-HM3 also found that patients avoiding aspirin post-implant experienced reduced days in the hospital compared to daily aspirin-takers.
“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,” said Keith Boettiger, VP of Abbott’s heart failure business. “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.”
A positive for the Abbott HeartMate 3 pump
A number of issues have contributed to hurdles for the adoption of LVADs, which has proven a challenge since they hit the market.
Abbott previously shared research demonstrating that HeartMate 3 can extend the lives of advanced heart patients by at least five years. However, Abbott estimates the U.S. has 15,000 advanced heart failure patients managed with inotropic therapies alone. They have a projected median lifespan of under one year.
Eliminating aspirin clears one of the adoption hurdles, according to Dr. Mandeep R. Mehra, executive director of the Center for Advanced Heart Disease and the William Harvey Distinguished Chair at Brigham and Women’s Hospital in Boston, MA and the principal investigator of the ARIES-HM3 trial.
“Aspirin, along with warfarin, has traditionally been mandated for advanced heart failure patients living with an LVAD, but whether it contributes to excessive bleeding has been uncertain. The ARIES-HM3 trial, in which aspirin was removed from the medication regimen, provided important data challenging the assumption that patients with a heart pump must take aspirin daily,” said Mehra. “With this labeling change, physicians can avoid using aspirin in patients receiving the HeartMate 3 LVAD, a decision that is safe, and decreases bleeding and its associated hospital visits.”
However, Abbott has run into trouble recently with its HeartMate 3. Earlier this year, the company initiated a Class I recall of its the LVAD’s implant kit. That recall — a correction, not a product removal — had two associated deaths. It also followed another Class I recall for some HeartMate II and HeartMate 3 systems in 2023.
Abbott’s HeartMate pumps are currently the only LVADs available on the U.S. market. Medtronic stopped selling its HVAD in June 2021 due to mounting issues with the platform.
