At the November 2016 American Heart Association Scientific Sessions in New Orleans, Mandeep R. Mehra, MD, Executive Director of the Center for Advanced Heart Disease and Medical Director of the Heart & Vascular Center at Brigham and Women’s Hospital, announced groundbreaking results of the first primary endpoint from the MOMENTUM 3 clinical trial. The results were published simultaneously online in the New England Journal of Medicine and will appear in a future issue of the publication.
MOMENTUM 3 (Multi-center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) is the largest and fastest enrolling left ventricular assist device trial to date. Dr. Mehra is the national co-principal investigator and Chair of the Publications Committee of this randomized study evaluating a novel centrifugal flow pump (HeartMate 3™ left ventricular assist system) compared with a commercial axial flow pump (HeartMate II™ left ventricular assist system) in patients with advanced heart failure at 69 experienced centers throughout the United States.
The primary endpoint of this study was a composite of survival at six months, free of disabling stroke or reoperation to replace or remove the device. In this six-month pre-specified Intent to Treat analysis, patients were enrolled regardless of whether the pump was intended as bridge to transplantation or destination therapy.
“This study is a practice changer in the ventricular assist device arena and a culmination of what we have learned over more than two decades of research and innovation,” said Dr. Mehra. “It represents an incremental benefit for our patients in need of left heart support to relieve their suffering from advanced heart disease.”
The adaptive and pragmatic style of MOMENTUM 3 has enabled the research team to dramatically reduce the overall trial timeline from the typical seven-to-nine years to two years by applying the therapy to an all-comer patient population with refractory heart failure in need of a circulatory support pump regardless of transplant candidacy. Traditional trials in this arena first undergo safety testing followed by testing younger populations with less co-morbidity who are candidates for a heart transplantation. Typically, the broad population of patients ineligible for transplantation must wait for several years before application of such therapy.
“This is important to our patient population, as one third of patients do not fall neatly into bridge-to-transplant or destination therapy, 28 percent of patients who are initially deemed transplant eligible are still on LVAS support after two years, and over 40 percent of patients are removed from the transplant list over time due to complications or clinical preference,” said Dr. Mehra. “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.”
For the pivotal six month analysis, 294 patients were enrolled, with 152 receiving the HeartMate 3 centrifugal flow pump and 142 receiving the HeartMate II axial flow pump between September 2014 and October 2015 at 47 of the 69 sites. The primary outcome of survival with no disabling stroke or reoperation to replace or remove the device was met in 86 percent of patients who received the new centrifugal flow pump and 77 percent of patients who received the axial flow pump.
While there was no statistical difference between the devices in terms of deaths or disabling strokes, reoperation for pump malfunction was significantly less with the centrifugal flow pump. No pump thrombosis occurred in the centrifugal flow pump during the six-month study period compared with 18 cases in 14 patients who received the axial flow pump, representing a 45 percent improvement in favor of the centrifugal flow pump.
To date, 1,028 patients total have been enrolled in the full cohort of the MOMENTUM 3 trial. In May 2015, the trial began its expansion phase and completed enrollment by August 2016. The MOMENTUM 3 trial’s analysis at 24 months will provide long-term information about survival, stroke rates, and durability of the new device.
The HeartMate 3 is a revolutionary fully magnetically levitated frictionless pump without mechanical bearings that is designed to reduce sheer stress on blood elements and avoid pump thrombosis. Although this pump is smaller in profile than the HeartMate II pump, this pump includes wider blood-flow passages that reduce wear and tear on circulating blood cells. The novel device is also programmable to change the pump seed, which allows for an artificial pulse that is asynchronous with the patient’s native heartbeat to reduce stasis within the pump. The pump’s compact size enables it to be placed directly in the chest rather than in the abdominal cavity area.
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