The results of the largest left-ventricular assist device (LVAD) study ever conducted are in for MOMENTUM 3.
The study that included more than 1,000 patients with severe congestive heart failure (CHF) has found that the HeartMate 3, a next-generation LVAD device, can significantly reduce the need for re-operations required for pump malfunction and lower the risk of bleeding events as well as strokes.
The researchers have found that HeartMate 3 is much safer and superior that HeartMate II is.
Dr. Mandeep R. Mehra, executive director of the Center for Advanced Heart Disease and medical director of the Heart & Vascular Center at Brigham and Women’s Hospital presented the results at the American College of Cardiology’s 68th Annual Scientific Session. Simultaneously, he published the results online in the New England Journal of Medicine.
Dr. Mehra said, “We are thrilled to have completed the largest LVAD trial in the world, to see that all of the early benefits we observed in interim analyses were sustained, and to report reductions in pump-related thrombosis, strokes and mucosal bleeding—three measures of hemocompatibility—compared to the previous generation of cardiac pump.”
He added, “Our results should spur confidence that we now have a much more forgiving pump and should provide reassurance to clinicians that we do not need to wait until a patient is ‘near death’ to consider this option for our patients.”
Abbott’s HeartMate 3 LVAD is a magnetically-levitated, continuous centrifugal-flow circulatory pump.
The study sponsored by Abbott Inc. compared its HeartMate 3 to the HeartMate II, which is a commercial axial flow pump. The study also analyzed and evaluated how many participants had not suffered a stroke or had a replacement or removal of a malfunctioning pump.
The study compared HeartMate 3 and HeartMate II in 1,028 patients. The investigators found that 76.9 percent of the patients (397 patients) in the HeartMate 3 group did not experience a need to undergo re-operation and had no disabling stroke when compared with patients in the HeartMate II group.
Only 12 patients who received the HeartMate 3 needed a re-operation than 57 patients who received HeartMate II.
HeartMate 3 reduced the risk of stroke by 58 percent, major bleeding by 36 percent, and gastrointestinal bleeding by 36 percent.
The magnetically-levitated centrifugal-flow circulatory pump includes certain technological adaptations that help reduce the risk of complications. HeartMate 3 runs like a bullet train. There are no mechanical bearing to its rotor; it just pushes the blood based on magnetism. This LVAD is designed to reduce stress and destruction of blood components that pass through the pump, preventing blood clots in the pump.
The researchers reckon that HeartMate 3 can prevent thrombosis events, two strokes, and bleeding events over a period of two years than HeartMate II.
Dr. Mehra said, “Until now, these devices have been considered less cost-effective, which has been a big issue outside of the U.S. Our evidence shows a decreased need for hospitalization and re-operations, indicating that the centrifugal-flow pump may be much more cost-friendly in the longer term.”
However, he noted that there are still some residual risks, including infections, which may occur in almost half of the patients. In addition, there could be low frequency, right-ventricular heart failure events. Dr. Mehra will lead a follow-up trial, which will specifically investigate these challenges and what type of modifications are needed to address and avert them.
