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A six-month analysis of the pivotal MOMENTUM 3 trial found that patients implanted with the new HeartMate 3 left ventricular assist system (LVAS) had fewer adverse clotting and bleeding events than patients implanted with the control, HeartMate II LVAS.
In this randomized, non-blinded study, a multi-institutional team found that 69 percent of the 151 patients who received Abbott's Heartmate 3 survived without any bleeding or clotting-related adverse events, compared to 55 percent of those who received the Heartmate II. Both devices are made by Abbott.
The results were announced April 6 in a late-breaking session at the 2017 meeting of the International Society for Heart and Lung Transplantation (ISHLT) in San Diego and simultaneously published in the journal Circulation.
The researchers also devised a novel scoring system the HemoCompatibility Score (HCS) to quantify the burden of such events and their clinical relevance. Lower scores are better.
"For the HCS, mild events, such as two or fewer non-surgical bleeding episodes, receive one point," explained Nir Uriel, MD, professor of medicine and director of the heart failure, transplant and mechanical circulatory support programs at the University of Chicago. "A non-disabling stroke is assessed at 2 points. An operation to replace the device gets 3 points. A disabling stroke gets 4 points."
Patients with HeartMate 3 had fewer of these adverse events 28 percent of patients versus 38 percent for those on HeartMate II. Those on HeartMate 3 tended to have bleeding events, which are less likely to be severe. Those on HeartMate II had both bleeding and clotting events. They spent more time in the hospital.
There were 14 deaths overall in the first 30 days on the pump. Five of those patients were on the HeartMate 3; nine were on the HeartMate II.
The HeartMate 3 consequently scored numerically better on the HCS, collecting only 101 points, compared to 137 points acquired by the smaller group on HeartMate II. Those in whom the HCS score was higher, however, were less healthy overall. They were older, and also less likely to take aspirin to prevent blood clots.
Two thirds of the patients on the HeartMate 3 had no adverse events for six months, compared to half of those on the HeartMate II.
Overall, "patients implanted with the HeartMate 3 gained a significant increase in freedom from adverse events, driven predominantly by a reduction in non-disabling strokes and complete absence of pump thrombosis, compared with the HeartMate II," said senior author Mandeep R. Mehra, MD, medical director of the Brigham and Women's Hospital Heart and Vascular Center and chairman of the publications committee for MOMENTUM 3.
"No patients on the HeartMate 3 had pump-related clotting, requiring a pump reoperation," Mehra noted. "There was also no difference in disabling strokes, a typically devastating complication."
The Heartmate 3 has certain potential advantages because it was "designed to prevent thrombosis," Uriel explained. It was engineered to be less destructive to blood cells as they are swept through the pump and into the aorta. "It has a frictionless rotor, wide gaps for permissive blood flow and reduced shear stress," he said.
The study has significant limitations, the authors note. It followed a small number of patients for a limited time. It is difficult to distinguish between late post-operative bleeding, pre-existing issues such as a bleeding gastric ulcer, and early pump-related blood loss. The MOMENTUM 3 trial is "evaluating its long-term outcomes and hemocompatibility-related adverse-event profiles," Mehra said. "These will become clearer in subsequent analyses."
More UChicago Medicine News from ISHLT 2017
UChicago Medicine was well-represented at ISHLT 2017, with six invited talks, 23 oral abstract presentations and 22 posters. Below is a sample of the activity of our researchers at the conference:
Nir Uriel - Optimizing Unloading with Right Heart Catheterization Ramp Studies: This talk is being given in the opening session of the conference, and will summarize our group's research into the hemodynamics of patients supported by left ventricular assist devices (LVADs) Previously Published in JACC Heart Failure (December 2015)
Nir Uriel - The Future of MCS Therapy Japanese MCS Session: This talk is being presented to members of the Japanese MCS society, and will summarize recent advances in the field, including the MOMENTUM 3 Trial (New England Journal of Medicine, November 2016)
Gabriel Sayer - Hemodynamics of Cardiogenic Shock: This talk is being presented as part of a cardiogenic shock symposium, and will summarize how to choose the appropriate device for cardiac support in cardiogenic shock
Laura Lourenco - Strategies for Desensitization of the Heart Transplant Candidate: This talk is being presented by our transplant pharmacist at a symposium on antibodies in cardiac transplantation, and will review the currently available therapies for reducing antibody levels prior to transplant to increase the chances of successful transplantation
Oral Research Presentations:
Nir Uriel - Hemocompatibility Related Outcomes in the Multicenter Study of Maglev Technology in Patients Undergoing Mechanical Circulatoru Support Therapy with HeartMate 3 (MOMENTUM 3) Pivotal Trial: This talk is one of the centerpieces of the meeting, and will be presented in a plenary session, and be accompanied by a simultaneous publication in Circulation. This is an analysis of the MOMENTUM 3 Trial that evaluates the risk of events related to hemocompatibility (bleeding and clotting) in patients with the HeartMate 3 LVAD compared to the HeartMate 2 LVAD.
Valluvan Jeevanandam - First in Human experience with the intravascular assist system (IVAS): The first report from a study being run by the University of Chicago, investigating the first-in-human experience of a new cardiac support device (NuPulse) being used as a bridge to heart transplantation. This study will soon become a multicenter study run by the University of Chicago that will determine if this device can obtain FDA approval.
Gabriel Sayer - 3D Echocardiography and Shape Analysis Changes Following Left Ventricular Assist Device Implantation: The Effect of Unloading on Reverse Remodeling: An investigation of changes in heart size and shape following LVAD surgery. Manuscript is under preparation and will be submitted shortly.
Sirtaz Adatya - Hypercoaguable syndromes and Thromboembolic Events in the PREVENT Study: An analysis of the association of clotting disorders with clotting events after LVAD implantation in a multicenter study.
Gene Kim - Platelet Gene Expression Before and After LVAD: These are the final results of a prospective study that evaluated changes in gene expression following LVAD implantation.
Teruhiko Imamura - Decoupling between PAD and PCWP as Predictor of LVAD survival: An analysis of changes in hemodynamics during LVAD speed changes and how they predict long-term outcomes including survival. The paper has been accepted to Circulation Heart Failure. Dr. Imamura is our heart failure research fellow.
Jon Grinstein - Randomized Study of Biventricular Pacing in LVAD Patients: This is an initial report of a single-center randomized study being run by our group at the University of Chicago investigating the use of biventricular pacing in LVAD patients. Dr. Grinstein is one of our heart failure fellows.
Jon Grinstein - VT Ablation in LVAD Patients Increases the Risk for Thromboembolic Events: This is a retrospective analysis of the incidence of thromboembolic events in our LVAD patients following a procedure to ablate ventricular arrhythmias.
Ben Chung - ROCK Activity as a Predictor for Cellular and Humoral Rejection: Results of a prospective study looking at the utility of an inflammatory marker in the blood to predict heart transplant rejection. Dr. Chung is one of our heart failure fellows.
Colleen Juricek - Predictors of hemodynamic Response with Intraaortic Balloon Pump: A study from our experience with subclavian intraaortic balloon pumps, aassessing the predictors of success with this therapy. Colleen is one of our Nurse Practitioners.
Luise Holzhauser - The Consequences of Retained Pacemaker Leads Post-Transplant: This study is being presented by one of the Internal Medicine Residents who works with our group. It evaluates the risk of having a pacemaker wire left inside the body following heart transplant.
Amrish Deshmukh - Left Atrial Appendage Occlusion is Associated with Decreased Thromboembolic Events in LVAD Patients: This research is also presented by one of our residents. This is a retrospective analysis of the consequences of removing the left atrial appendage during LVAD surgery in terms of thromboembolic events
Sirtaz Adatya - Noninvasive measurement of lung fluid content using remote dielectric sensing. A prospective evaluation of a new vest that can measure the fluid content of the lungs noninvasively.
Annie Nguyen - Association of G-CSF Use and Cellular Rejection in Heart Transplant Patients. A retrospective analysis of the risk of heart transplant rejection after the use of the drug, G-CSF, to treat low white blood cell counts.
Nikhil Bassi - Acute Cellular Rejection in Heart Transplant Recipients May Not Be Acute After All. Retrospective analysis of the ability of intracardiac hemodynamics to predict heart transplant rejection.
The HeartMate study was funded by Abbott, Abbott Park, IL. Additional authors were Paolo C. Colombo, MD; Joseph C. Cleveland, MD; James W. Long, MD; Christopher Salerno, MD; Daniel J. Goldstein, MD; Chetan B. Patel, MD; Gregory A. Ewald, MD; Antone J. Tatooles, MD; Scott C. Silvestry, MD; Ranjit John, MD; Christiano Caldeira, MD; Valluvan Jeevanandam, MD; Andrew J. Boyle, MD; Kartik S. Sundareswaran, PhD; and Poornima Sood, MD.
John Easton is a senior science writer at UChicago Medicine.