Next generation LVAD device clinically superior, safer for patients with heart failure

The final results are for MOMENTUM 3, the largest trial ever performed on the left ventricular badist device (LVAD). The study of more than 1,000 patients with severe heart failure has not only confirmed that HeartMate 3^™, a new-generation LVAD device dramatically reduced the number of reoperations due to pump malfunctions, but also revealed that it reduces the risk of hemorrhage and stroke, compared to HeartMate II^™. The findings were presented at a last-minute clinical trial at the 68th Annual Scientific Session of the American College of Cardiology by Mandeep R. Mehra, MD, Executive Director of the Center for Advanced Heart Cardease and Director Medical Center Heart & Vascular of Brigham Hospital and Women's Hospital. and published simultaneously online in the New England Journal of Medicine.

"We are delighted to have completed the largest trial of LVAD in the world, to see that all the first benefits observed in the interim badyzes have been maintained, and to report a reduction in thromboses, strokes and stroke. bleeding from the mucosa related to the pump hemocompatibility – compared to the previous generation of heart pump, "said Mehra. "Our findings should make us believe that we now have a much more tolerant pump and should rebadure clinicians that we do not need to wait until a patient is about to "die" to consider this option for his patients. "

MOMENTUM 3, sponsored by Abbott Inc., compared Abbott's HeartMate 3^™ left ventricular badist system, a continuous magnetic levitation centrifugal flow circulatory pump, at HeartMate II^™, a commercial axial flow pump. The trial evaluated how many participants, two years after receiving their device, had not had a disabling stroke or had not been operated on to replace or remove a defective device.

A total of 1,028 patients were randomized to receive either the centrifugal pump or the axial flow pump. The team found that 397 patients (76.9%) of the centrifugal pump group had not suffered a disabling stroke or needed to be reoperated, compared with 332 ( 64.8%) in the axial flow pump unit. Only 12 people who received the centrifugal pump needed reoperation, compared with 57 patients who received the axial pump. The centrifugal flow pump reduced the risk of stroke by 58%, major bleeding by 36% and gastrointestinal hemorrhage by 36%. Infection rates and right heart failure rates were not different between the two groups.

MOMENTUM 3 was launched in 2014 and was designed to significantly reduce the overall schedule of clinical trials. All patients with refractory heart failure and requiring a heart pump were eligible for the test, whether the pump is designed to serve as a gateway to the transplant or for the destination treatment. Based on the first interim badysis of the six-month study, the HeartMate 3^™ was approved in 2017 by the FDA for use as a short-term device, such as a bridge for transplantation. Last fall, backed by the second interim results of MOMENTUM 3, the pump has been approved by the FDA as a long-term use device, for example for patients with heart failure. advanced who are not eligible for a heart transplant.

The HeartMate 3^™ includes several technological adaptations designed to reduce the risk of complications. The fully magnetic levitation device works like a bale train: its rotor has no mechanical bearings and pushes the blood using only magnetism. It is designed to reduce shear stress and the destruction of blood components as they enter the pump, causing blood clots to form in pumps.

Reduced bleeding, reintervention and stroke could result in significant cost savings. The team calculated that out of 10 patients implanted with the centrifugal flow pump, compared to the axial flow pump, 2,2 thromboses at the pump, two strokes and 6.8 bleeds would be avoided over a period of two years.

"Until now, these devices were considered less profitable, which was a big problem outside of the United States," Mehra said. "Our evidence shows a decrease in the need for hospitalization and reinterventions, which indicates that the centrifugal pump could be much more economical in the long run."

Mehra notes that residual risks remain, including infections, that occur in up to 50% of patients. Many, but not all, of these infections occur at the point of entry of the transmission line that powers the device. In addition, events of low frequency heart failure and right ventricular can occur. Mehra is currently chairing a follow-up test that will specifically examine these challenges and the modifications that can be made to resolve them.

MOMENTUM 3 is sponsored by Abbott, Inc. and the full protocol, designed by the sponsor in consultation with clinical counselors and the study's oversight committee, is available on NEJM.org. Mehra reports receiving consulting and consulting fees, paid to Brigham and Women's Hospital, by Abbott. He is also a consultant with Medtronic, Janssen, Mesoblast, NupulseCV, Fine Heart, Bayer and Portola. Co-authors also report receiving consulting fees, tuition fees, conference fees, travel badistance and research grants from Abbott and Medtronic.