NEW ORLEANS — Among patients with advanced heart failure who needed a heart pump or transplant, the HeartMate 3 (Abbott) magnetically levitated centrifugal flow left ventricular assist device (LVAD) outperformed the earlier HeartMate II axial flow device in the final analysis of 2-year data from the MOMENTUM 3 trial.
In the full cohort of 1028 patients randomized to the two devices, more patients who received the newer- than the older-generation LVAD were alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (77% vs 65%; P < .001).
Preliminary data from a subset of patients had previously shown that the newer device outperformed the older device for this combined study end point, largely driven by a reduction in pump thrombosis.
The analysis of the complete 2-year data "shows that we now have a more forgiving pump," Mandeep R. Mehra, MD, Brigham and Women's Hospital and Harvard University, Boston, summarized during a late-breaking trial session here at the American College of Cardiology 68th Annual Scientific Session (ACC.19).
The trial was also simultaneously published online March 17 in the New England Journal of Medicine.
This is the largest study to date of an LVAD, Mehra said, and it showed that, compared with patients who were implanted with the forerunner pump, those who received the newer pump had less need for device replacement, fewer strokes, less bleeding, fewer cardiac arrhythmias, and less rehospitalization.
This is a study that "will make a difference in the heart failure field and highlights the importance of product development," said panelist Clyde W. Yancy, MD, Northwestern University, Chicago.
81% Survival Out to 2 Years
"We were thrilled to see that both pumps performed well in maintaining survival of 81% out to 2 years — a survival that parallels that with heart transplant," Mehra said in reply to a question from panelist Anita Deswal, MD, Baylor College of Medicine, Houston.
"In the old days...2 years felt like an entire life prolongation for patients who were otherwise going to die within weeks," Mehra noted at a press briefing.
"Now we have enough evidence that we need to start thinking about whether this is equivalent to heart transplantation in some highly selected patients, and it is time to think about longer-term follow-up."
The researchers plan to study 5-year outcomes, and some heart failure patients have already had these implants for more than 4 years.
More research is aso needed, Mehra said, to find ways to "reduce infections, one of the main causes of death, along with stroke and right heart failure."
Patients with advanced heart failure now have "an option that can give them very good quality of life, together with many years of life," coauthor Nir Uriel, MD, University of Chicago, told theheart.org | Medscape Cardiology.
Going forward, "we want to [do a better job to] identify patients who can benefit from this technology" and refer them to heart failure specialists.
If they are implanted with the pump, they can still go on to receive a heart transplant later, he noted.
1020 LVADs Implanted
From 2014 to 2016, MOMENTUM 3 enrolled 1028 patients with advanced heart failure who were candidates for an LVAD at 69 sites in the United States and randomly assigned them to receive the centrifugal flow pump (516 patients) or the axial flow pump (512 patients). The 1020 implantations were performed by 126 surgeons. Eight patients — one in the centrifugal flow group and seven in the axial flow group — did not undergo implantation per protocol.
Mean age in the stuffy cohort was 60 years; 80% of the patients were men, 68% were white, and about 84% were on intravenous inotropic agents.
The pump was intended as destination therapy in 61% of the patients, a bridge to transplant in 22%, and a bridge to candidacy for transplant in 17%.
As reported earlier, a prespecified analysis of 2-year outcomes in 366 patients showed that pump thrombosis leading to malfunction was lower with the centrifugal flow pump.
The analysis of the complete dataset revealed that at 2 years, relative risk for the combined outcome of death, disabling stroke, or reoperation to remove or replace a malfunctioning device was 16% lower with the newer pump than with the older pump (P < .0001).
Patients who received the newer device were much less likely to have a pump that had suspected or confirmed thrombosis (1.4% vs 14%; P < .001) or to have the device replaced (2.3% vs 11.3%; relative risk, 0.21; P < .001).
They were also less likely to have a stroke (10% vs 19%; P < .001), bleeding (44% vs 55%; P < .001), or gastrointestinal hemorrhage (25% vs 31%; P < .001).
"We saw a marked elimination of pump thrombosis," and not only a global reduction in strokes, but a reduction in different stroke types (hemorrhagic, ischemic, or disabling), Mehra stressed.
"This is the lowest stroke [rate] noted in a left ventricular assist device therapy group ever done," he said. "One of the vexing complications — gastrointestinal bleeds — was also decreased significantly in favor of the new pump."
Moreover, he added, "I'd like to point out that 80% of patients achieved resolution of their heart failure state to NYHA class I or II."
There were no significant between-group differences in patients stratified by age, sex, race, intended use of therapy, or baseline disease severity, which suggests "that the findings are applicable across the broad spectrum" of patients, such as those enrolled in this trial.
Implant This LVAD in Less Sick Patients?
"Now that we've heard [about] elimination of pump exchange and thrombosis...what are your thoughts about moving this to a less-ill patient population, [INTERMACS] class 3b, if you will?" Yancy wanted to know.
"I would caution the use of those data to guide the movement to a low-risk population or less-ill population," Mehra replied. "However, I believe...that we do need to think about expanding this technology and studying" this more forgiving pump in patients "who are not yet ionotropic bound and those who are suffering the consequences of heart failure."
The main causes of death in this trial "still were related to right heart failure, infection, and stroke. We've done well with strokes; we should do even better. But as we start to move this information into the less sick, more ambulatory population, I think that we need to think of more [advances] in technology that reduce the risk of infection."
The trial was funded by Abbott. Mehra is a consultant for Abbott, Portola, Bayer, and Xogenex; a trial steering committee member for Medtronic and Janssen; a scientific advisory board member for NupulseCV and FineHeart; a DSMB member for Mesoblast; and receives travel support from Abbott. Uriel receives research grants from Abbott and Medtronic and is a consultant for Abbott and Medtronic. Disclosures for other authors are listed with the article.
American College of Cardiology (ACC) 68th Annual Scientific Session: Abstract 405-14. Presented March 17, 2019.
N Engl J Med. Published online March 17, 2018. Full text
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Cite this: Heartmate 3 LVAD Impresses in Final MOMENTUM 3 Data - Medscape - Mar 26, 2019.