MOMENTUM 3 found that advanced heart-failure patients with an implanted centrifugal-flow circulatory pump had lower rates of pump-related blood clots and stroke.
Mandeep R. Mehra, MD
New findings, presented by Mandeep Mehra, MD, Brigham and Women’s Hospital, at the American College of Cardiology’s 67th Annual Scientific Session, revealed that patients who received a novel centrifugal-flow pump had significantly lower rates of pump-related blood clots and stroke.
Mehra provided long-term information from the MOMENTUM 3 trial about survival, stroke rates and durability of a novel centrifugal-flow pump compared with a commercial axial flow pump for heart-failure patients.
MOMENTUM 3, launched in 2014, was designed to dramatically reduce the overall timeline for clinical trials. All patients with refractory heart failure who needed a cardiac pump were eligible for the trial regardless of whether the pump was planned to bridge transplantation or destination therapy.
“This is a pivotal study in the field of advanced heart failure,” Mandeep R. Mehra, MD, executive director, Center for Advanced Heart Disease, Medical director, Heart and Vascular Center, Brigham and Women’s Hospital, said in a statement. “Left ventricular assist devices have been in the development for 40 years and there have been improvements in their technology but several challenges exist, including problems of blood clots forming in these devices, requiring device replacement.”
Abbott Inc.’s HeartMate 3 Left Ventricular Assist System, a magnetically-levitated continuous centrifugal-flow circulatory pump, was assessed in the MOMENTUM 3 trial in comparison to the HeartMate II.
MOMENTUM 3 evaluated the number of participants, 2 years after receiving the device, had not suffered a disabling stroke or had an operation to replace or remove a malfunctioning device.
“The field has been trying to engineer devices that could obviate some or all of these problems, and we report today on some important advances,” Mehra said.
In the trial, 366 patients were randomized to receive either the centrifugal flow pump or the axial flow pump.
The findings concluded that 151 of the 190 patients on the pump did not experience a disabling stroke or need a re-operation (79.5%) compared to 106 of 176 of the patients (60.2%) on the axial pump.
Only 3 of those who received the centrifugal-flow pump needed a re-operation as opposed to 30 who received the axial pump.
In those patients that received the centrifugal-flow pump, no re-operations occurred due to blood clots. Overall, deaths or disabling strokes were similar between the 2 groups, but stroke rates were less frequent in the centrifugal-flow pump group. Researchers noted that bleeding and infection rates were no different between the groups.
“Traditional trials must undergo safety testing, followed by testing in healthier populations, and it can be over a decade before the broader population has access to such therapies,” Mehra, the president of the Heart Failure Society of America (HFSA) concluded. “Removing restrictions based on transplant status resulted in a unique study that has been extremely successful in its enrollment and highly expeditious in delivering results.”
HeartMate 3 includes several technological adaptations that are intended to reduce risk of complications. The device is designed to reduce shear stress, which is thought to cause blood clots to form in pumps.
"In the last several years, LVAD implantation can lead to increased quality of life, but is still fraught with complications, such as pump thrombosis," Sanjeev Gulati, MD, medical director of heart failure and transplant services at Sanger Heart & Vascular Institute, said in a statement. "With MOMENTUM 3, we can see that there is more benefit that we even expected with the fully magnetic levitated device. I believe this is another major step in evolving the field by further reducing the risk of LVAD implants, which leads to a better quality of life for our patients."
MOMENTUM 3, in the next phase, will evaluate 1028 patients at the 2-year mark, further validating the current findings. The results are expected by end of 2019.
Related Coverage >>>