New 6-month data presented today on Abbott‘s (NYSE:ABT) HeartMate 3 left ventricular assist system indicated fewer adverse clotting and bleeding events than with its HearMate II.
Data came from a 6-month analysis of its pivotal Momentum 3 trial, a randomized, non-blinded study which aimed to compare the new HeartMate 3 system to the previous-generation HeartMate II.
Results from the trial were announced today at the International Society for Heart and Lung Transplantation in San Diego, and were published in the journal Circulation.
The new HeartMate 3 is designed to prevent thrombosis, according to researchers. The device is engineered to be less destructive to blood cells as they are moved through the pump and into the aorta with a frictionless rotor, wide gaps for permissive blood flow and reduced shear stress.
“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. No patients on the HeartMate 3 had pump-related clotting, requiring a pump reoperation. There was also no difference in disabling strokes, a typically devastating complication,” senior author Dr. Mandeep Mehra of the Brigham and Women’s Hospital Heart and Vascular Center said in a press release.
Data from the trial indicated a 69% rate of survival without any bleeding or clotting-related adverse events, compared to 55% for patients supported by the HeartMate II system.
Patients in the HeartMate 3 arm experienced fewer adverse events, according to the study, at 28% versus 38% for those on HeartMate II. Researchers indicated that patients on the HeartMate 3 had more bleeding events, but that they were less likely to be severe, while HeartMate II patients had both bleeding and clotting events.
There were 5 deaths in the 1st 30 days for patients with the HeartMate 3, while 9 were recorded for patients on the HeartMate II.
The systems were also rated using the HemoCompatibility Score novel scoring system aiming to quantify the burden of clotting or bleeding events and their clinical relevance.
“For the HCS, mild events, such as 2 or fewer non-surgical bleeding episodes, receive 1 point. A non- disabling stroke is assessed at 2 points. An operation to replace the device gets 3 points. A disabling stroke gets 4 points,” Dr. Nir Uriel of the University of Chicago said in a press release.
The HCS score for the HeartMate 3 was also better than those of its predecessor, at 101 and 137, respectively.
Study authors noted that the study had significant limitations, following a small number of patients for a limited time. Authors also noted that it is difficult to distinguish between late post-operative bleeding and pre-existing issues, and said that further analysis will be necessary.
