Heart failure patients show lower rates of stroke thanks to medical device

Heart failure patients at Brigham and Women’s Hospital had lower rates of blood clots and strokes thanks to a new medical device, findings show.

Launched in 2014, the Momentum 3 trial was designed to evaluate how many participants had not suffered a disabling stroke or had an operation to remove their device after two years. The trial included 366 patients, who were randomised to receive either a centrifugal flow pump or the axial flow pump.

The trial was comparing Abbott’s HeartMate 3 left ventricular assist system to the HeartMate II device.

The HeartMate 3 includes technologies that are intended to reduce the risk of complications. The magnetically levitated device pushes the blood using only its magnetism and is designed to reduce shear stress, which is thought to cause blood clots to form in pumps.

The findings show that patients who had received Abbott’s HeartMate 3 device had lower stroke rates compared to the HeartMate II.  

The research shows that 151 of 190 patients on the HeartMate 3 flow pump did not experience a disabling stroke or need a re-operation. This is compared to 106 of 176 patients who received the HeartMate II.

More so, only three people on the HeartMate 3 needed a re-operation compared the 30 on the axial pump.

A total of 366 patients were randomised to receive either the centrifugal flow pump or the axial flow pump. The research also highlights that deaths or disabling strokes were similar between the two groups but stroke rates were less frequent in the group with the HeartMate 3.

Results from the trial were presented at the American College of Cardiology by Mandeep R. Mehra, executive director of the Center for Advanced Heart Disease and medical director of the Heart & Vascular Center at Brigham and Women’s Hospital.

Speaking about the results, Mehra said: “This is a pivotal study in the field of advanced heart failure. Left ventricular assist devices have been in 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. 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.”

The Momentum 3 trial will move onto its next phase to evaluate 1,028 patients at the two-year mark to validate the current findings. Results from the study are expected by the end of 2019.

“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. Removing restrictions based on transplant status resulted in a unique study that has been extremely successful in its enrolment and highly expeditious in delivering results.” Mehra concluded.