FDA OKs updated label allowing aspirin to be dropped after LVAD implant
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Key takeaways:
- The FDA approved updated labeling to remove aspirin as part of routine care after implant of Abbott’s fully magnetically levitated LVAD.
- The approval was based on the positive results of the ARIES-HM3 trial.
Abbott announced the FDA approved elimination of aspirin as part of routine management from the label of its fully magnetically levitated left ventricular assist device.
The updated label is exclusively for the fully magnetically levitated LVAD (HeartMate 3, Abbott), the only commercially approved heart pump of its kind, according to a company press release.
“Since the inception of LVAD therapy in advanced HF, for many decades, we have always mandated aspirin use under the assumption that platelet interactions are important in this circulatory physiology,” Mandeep R. Mehra, MD, executive director of the Center for Advanced Heart Disease and the William Harvey Distinguished Chair at Brigham and Women’s Hospital, told Healio. “This has generally been true for some devices — such as the HeartWare HVAD (Medtronic) — but has never been tested conclusively with the HeartMate 3 pump, which is most forgiving in terms of thromboembolism risk.”
The approval was based on the results of the ARIES-HM3 trial, presented at the American Heart Association Scientific Sessions in November 2023.
ARIES-HM3 included 628 patients with advanced HF who were implanted with the fully magnetically levitated LVAD and took a vitamin K antagonist. Participants were randomly assigned to receive aspirin — standard practice for the past 40 years — or placebo, to determine whether change in medical therapy could improve bleeding, which had never previously been done, Mehra told Healio at the meeting.
As Healio previously reported, participants who received placebo experienced better survival free from major nonsurgical hemocompatibility-related adverse events and reduced bleeding after LVAD implant compared with the aspirin group.
“ARIES-HM3 has established that elimination of aspirin substantially decreases the rate of bleeding, a high residual risk issue with LVADs including the HeartMate 3. These findings were also generalizable across the board in patients who may have preexisting cerebrovascular, coronary or peripheral vascular disease or those who undergo concomitant procedures such as valve repair or bypass surgery during the LVAD implant with the HeartMate 3 device,” Mehra told Healio. “Thus, these findings usher an important era where removal of a previously mandated therapy yields lower rates of requiring testing for bleeding, reduced days in hospitalization — over 40% decrease — and even a lower cost of care. Importantly, a simple maneuver like eliminating aspirin shifts the balance of such therapy towards even greater cost-effectiveness.”
For more information:
Mandeep R. Mehra, MD, can be reached at 75 Francis St., Boston, MA 02115.
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