ORLANDO – The HeartMate 3 magnetically levitated left ventricular assist (LVAD) device provided far superior outcomes, compared with the widely used HeartMate II axial-flow pump at 2 years of follow-up in patients with advanced heart failure in the large multicenter MOMENTUM 3 trial, Mandeep R. Mehra, MD, reported at the annual meeting of the American College of Cardiology.

HeartMate 3 recipients had a 90% lower risk of undergoing reoperation to replace or remove their device because of malfunction, and a stroke rate half that in the HeartMate II group.

“This was the lowest rate of stroke ever seen in any LVAD trial,” according to Dr. Mehra, medical director of the Brigham and Women’s Hospital Heart and Vascular Center, Boston, and professor of medicine at Harvard Medical School.

“We believe this is a practice-changing result in the field, and that the real implication of our findings is to reassure those who refer or treat patients with advanced heart failure that it is perhaps going to be ignorant not to refer patients for consideration for destination therapy,” he said at a press conference highlighting the MOMENTUM 3 results, also presented in a late-breaking clinical trials session.

The HeartMate 3 is a miniaturized centrifugal-flow device that fits entirely within the chest, whereas the HeartMate II requires creation of a pocket in the abdomen. The HeartMate 3 was designed to prevent pump thrombosis – a common limiting problem with the HeartMate II and other LVADs – by employing three innovations: use of wide blood-flow passages to reduce shear stress and minimize disruption of red blood cells as they pass through the pump; reliance on magnetic levitation technology to create a frictionless pump with no mechanical bearings, which are subject to wear and tear; and incorporation of an artificial fixed pulse that speeds up and slows every 2 seconds in order to minimize blood stasis, which promotes thrombosis, the cardiologist explained in a video interview.

MOMENTUM 3 is the largest-ever randomized trial of LVAD therapy, involving 1,028 advanced heart failure patients at 69 U.S. centers. The study population is a mix of bridge-to-transplant patients and others who weren’t eligible for heart transplantation and are using their device as lifelong destination therapy. In an earlier report on the first 294 patients to reach 6 months of follow-up post implantation, Dr. Mehra and his coinvestigators showed that the HeartMate 3 group had a significantly lower incidence of the composite endpoint of disabling stroke or reoperation to replace or remove the device (N Engl J Med. 2017 Feb 2;376[5]:440-50).

At ACC 2018, he presented the prespecified 2-year analysis of results in the first 366 patients to reach that benchmark. The rate of survival free of disabling stroke or reoperation for device malfunction was 79.5% in the HeartMate 3 group and 60.2% with the HeartMate II, for a highly significant 54% reduction in the risk of bad outcome. Reoperation for device malfunction occurred in 1.6% of HeartMate 3 patients versus 17% of those with a HeartMate II, for a 92% reduction in risk. Two-year survival was 82.8% in the HeartMate 3 group and 76.2% in HeartMate II recipients.

The overall stroke rate was 10% with the HeartMate 3, compared with 19% with the older, axial-flow LVAD. The incidence of disabling stroke was 3% in the HeartMate 3 group and similar at 2% with the HeartMate II; however, nondisabling stroke occurred in only 3% of HeartMate 3 recipients, compared with 14% of patients with the HeartMate II.

“There has always been this notion that, ‘There are so many complications with this device, so let’s suffer with the disease rather than suffer with the pump.’ Now we’re showing that you don’t suffer with the pump as with the earlier-generation devices. I think this is going to open the gates for more referrals and more opportunities for destination therapy in patients who are deemed ineligible for transplant,” Dr. Mehra predicted.

Discussant James L. Janzuzzi Jr., called the MOMENTUM 3 results “a very-much-needed step forward.”

“Perhaps the most dramatic observation in this study is the dramatic reduction in thrombosis events requiring reoperation. In essence, this problem was entirely prevented by the use of this magnetically levitated centrifugal-flow device. Reoperation for thrombosis accounted for two-thirds of the reoperations in the HeartMate II group and the rate was zero in the HeartMate 3 population. Essentially, with this technology we’ve addressed a very important unmet need by reducing the onset of pump thrombosis, which is the precursor to either pump dysfunction or embolic stroke,” commented Dr. Januzzi, professor of medicine at Harvard Medical School, Boston.

Given the 83% survival rate at 2 years in the HeartMate 3 group in the MOMENTUM 3 trial, the on-average 50% survival at 10 years for heart transplant recipients, and the perpetual enormous shortage of donor organs, it’s time to consider a randomized trial of an advanced LVAD such as the HeartMate 3 versus heart transplantation, with quality-of-life outcomes front and center, he asserted.

Dr. Mehra was all for the idea. He noted that within the community of physicians and surgeons who provide care for advanced heart failure patients there is a growing move to replace problematic axial-flow LVADs requiring reoperation with a HeartMate 3 upgrade.

The MOMENTUM 3 trial is funded by Abbott. Dr. Mehra reported receiving research funds from and serving as a consultant to the company.

Simultaneous with his presentation at ACC 2018, the 2-year results of MOMENTUM 3 were published online at NEJM.org (doi: 10.1056/NEJMoa1800866).

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SOURCE: Mehra M et al. ACC 18.

MOMENTUM 3 HeartMate 3 LVAD ‘practice changing’