As one of the limited highly select centers in the United States participating in the clinical trial program of the HeartMate 3™ centrifugal-flow chronic left ventricular assist system, the Brigham and Women’s Hospital (BWH) Heart & Vascular Center was among the first to implant this potentially game-changing technology in mechanical circulatory support.
This year, the U.S. Food and Drug Administration gave the go-ahead to broaden enrollment of the U.S. clinical trial to include more than 1,000 patients at up to 60 clinical sites. Mandeep R. Mehra, MD, Executive Director of the Center for Advanced Heart Disease and Medical Director of the Heart & Vascular Center, is one of four national principal investigators leading the trial and chair of the publications and presentations committee.
The HeartMate 3 LVAS is a third-generation mechanical circulatory support device, engineered with the promise for enhanced hemocompatibility. It features a centrifugal-flow durable left ventricular assist system that utilizes fully magnetically levitated technology designed to lower adverse event rates, especially hemocompatibility complications (i.e. thrombosis). Evidence of enhanced hemocompatibility was demonstrated in the first 50 patients receiving the HeartMate 3 at 10 centers in Europe, Australia and Canada, where no device thromboses occurred and no pump exchanges were required in the first six months post implantation.
“The HeartMate 3 technology includes several design features aimed at enhancing durability and hemocompatiblity,” said Dr. Mehra. “A miniaturized centrifugal flow device gives it a smaller profile and fewer moving parts than previous generation left ventricular assist devices, which also helps with ease of surgical placement.” He explained that, “Magnetic levitation technology spins the rotor and keeps it in a stable position at a broad range of speeds, while the internal pulsatility with automatic changes in speed produces an intrinsic pulse to minimize pump stasis.”
In addition, large gaps between the rotor and the pump housing allow for improved blood flow with minimized shear stress on blood components and internal sintering with textured titanium microspheres creates a more biocompatible surface. “HeartMate 3 can be used either as a short term device to bridge patients to transplantation or as a long-term lifetime therapy,” said Dr. Mehra.
With Dr. Mehra participating as national co-principal investigator of the MOMENTUM 3 (Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3) clinical trial, the Center for Advanced Heart Disease is at the forefront of evaluating this technology in the largest LVAD clinical trial to date. More than 1,000 patients with advanced heart failure will be randomized to either the Heart- Mate 3 or its predecessor, the HeartMate II device, to evaluate survival free from device replacement and debilitating stroke in both the short term (six months) and long term (two years).
This pivotal non-inferiority trial will start with 294 patients followed for six months to evaluate the short-term indication of bridge-to-transplantation therapy, after which an additional 72 patients will be added (total of 366) and followed for two years to evaluate long-term use as a destination therapy. Beyond the pivotal trial cohort, approximately 600 additional patients will be enrolled to assess the superiority of HeartMate 3 to HeartMate II on pre-specified secondary endpoints.
“The all-comers population of advanced stage heart failure patients in this trial is somewhat unique for an LVAD trial, where typically devices are studied either for use as bridge-to- transplantation or for destination therapy,” explained Dr. Mehra. “But patients do not always fit neatly into these two categories, nor do they always remain in their initially assigned category. Research shows that about one-third of patients initially slated to undergo heart transplantation remain on LVAD support for more than two years, and nearly half of these patients may be eventually removed from the transplant list.”
In addition, among patients who undergo LVAD implantation, those who are ineligible for transplantation tend to have modestly poorer outcomes compared with transplant candidates, who are typically younger and have fewer co-morbidities
The Center for Advanced Heart Disease at BWH is an internationally-recognized center of excellence in the diagnosis and treatment of heart failure and its complications. Areas of strength include the management of chronic heart failure across the spectrum of disease severity, judicious utilization of mechanical circulatory support and cardiac transplantation, cardiovascular genetics (including inherited cardiomyopathies such as hypertrophic cardiomyopathy), cardio-oncology, and pulmonary hypertension/right heart failure.
As well, the Center has taken a leadership role in the national registry for mechanical circulatory support (INTERMACS) representing over 15,000 patients in the United States, the parallel registry for medical outcomes (MEDAMACS) in patients progressing toward mechanical circulatory support.
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