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MOMENTUM 3: Newer LVAD improves 2-year outcomes in advanced HF
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ORLANDO, Fla. — A continuous centrifugal-flow fully magnetically levitated pump engineered to prevent thrombosis conferred better outcomes at 2 years than another axial-flow pump with a mechanical bearing in patients with advanced HF requiring a left ventricular assist device, researchers reported at the American College of Cardiology Scientific Session.
In an intention-to-treat analysis, patients assigned the newer device (HeartMate 3, Abbott/St. Jude Medical) achieved the primary endpoint of survival free from death, disabling stroke or reoperation due to a malfunctioning device at 2 years more often than patients assigned the older axial continuous-flow pump (HeartMate II, Abbott/St. Jude Medical). The rates of the primary endpoint were 79.5% vs. 60.2%, respectively (lower confidence boundary, 9.8 percentage points; HR = 0.46; 95% CI, 0.31-0.69).
Reoperation for pump malfunction occurred in 1.6% of the centrifugal group vs. 17% of the axial group (HR = 0.08; 95% CI, 0.03-0.27).
While rates of death and disabling stroke did not differ between the groups, overall stroke was lower in the centrifugal group (10.1% vs. 19.2%; HR = 0.47; 95% CI, 0.27-0.84).
Suspected pump thrombosis occurred in 1.1% of patients from the centrifugal group vs. 15.7% of those in the axial group (HR = 0.06; 95% CI, 0.01-0.26).
The results built upon and were consistent with 6-month results from the MOMENTUM 3 trial presented in November 2016, and were simultaneously published in The New England Journal of Medicine.
“We now have a device that is particularly forgiving on the endpoint of hemocompatibility-related adverse effects,” Mandeep R. Mehra, MD, professor of medicine at Harvard Medical School and medical director of the Heart and Vascular Center at Brigham and Women's Hospital, told Cardiology Today. “Not only did we show incredible durability of this device out to 2 years, particularly of the endpoint of pump thrombosis-related device malfunction, but have now, for the first time in the LVAD literature, shown a reduction in stroke rates, both of which are hemocompatibility-related problems.”
The researchers enrolled 366 patients with advanced HF refractory to guideline-directed medical therapy (mean age, 60 years; 80% men) from 69 U.S. centers. Patients were eligible regardless of whether they needed LVAD as a destination therapy or a bridge to transplantation.
The trial was designed for noninferiority, but “there turned out to be even more clinical benefit than expected,” Sanjeev Gulati, MD, medical director of heart failure and transplant service at Sanger Heart & Vascular Institute, Atrium Health, said in an interview. “The fully magnetically levitated device, with the changes to the pump, starts to address the hematologic complications associated with LVAD implantation.”
The next steps, Gulati said, include “making the device fully implantable, to get rid of the driveline and other extra accessories, that not only would make the quality of life of the patients better, but would also reduce the complication risk from infection. Making the devices smaller so it does not require a complex surgery to implant them would also reduce surgery and hospitalization time.”
The HeartMate 3 LVAD has a CE Mark and is FDA-approved for short-term (bridge-to-transplant) use in the United States. The MOMENTUM 3 data will be submitted to the FDA to support consideration of a long-term (destination therapy) indication for this device, according to a company press release. – by Erik Swain
References:
Mehra MR, et al. Late-Breaking Clinical Trials III. Presented at: American College of Cardiology Scientific Session; March 10-12, 2018; Orlando, Fla.
Mehra MR, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1800866.
Disclosures: The study was funded by Abbott/St. Jude Medical. Gulati reports consulting and speaking for Abbott. Mehra reports he received nonfinancial and other support from Abbott/St. Jude Medical and personal fees from Bayer, Janssen, Medtronic, Mesoblast, NuPulse CV and Portola.
Perspective
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J. Eduardo Rame, MD, MPhil
It was reassuring that the 6-month results held, namely that pump thrombosis and the need for pump exchange remain near zero. Also encouraging is that the stroke rate remains low. Interestingly, at 6 months, there was no difference between the two pumps with respect to stroke rate, but that tells us how important it is to look at the long-term data.
This gives advanced HF physicians confidence that we can improve our patients’ quality of life, decrease their adverse events, improve their functional capacity and give them more life. Notably, this was the first LVAD trial to include both bridge-to-transplant and destination therapy, designed to mimic what we are doing in real life.
The 10% rate of stroke over 2 years is acceptably low given the current methods that we use to treat these patients. But it needs to be lower. Let’s push the envelope to 5%. We have seen improvements in stroke rate with another centrifugal-flow LVAD (HVAD, Medtronic). In the ENDURANCE Supplemental study, BP monitoring appears to have made an impact, and there may have been 30% to 40% more room to improve BP in certain individuals. We should have a clinical strategy designed to lower the stroke risk even more. We also need to look into the mechanisms of the strokes that occur in these patients. Does it have to do with BP? Does it have to do with the way the brain auto-regulates due to the continuous flow of blood in patients with these devices? If so, there are ways to enhance cardiac recovery and function.
We need to make pumps that do not clot. Now that we have an incredible bar of a near-zero rate of pump exchange, thanks to a near- or at-zero rate of pump thrombosis, we need to continue to understand how to improve the devices even further.
MOMENTUM 3 has an extended-access protocol, so we will be able to learn how stable these events remain, and also how they may be improved upon. The Society of Thoracic Surgeons/INTERMACS registry for post-approval tracking can produce some important observations, not just in terms of event rates, but how these devices behave as we take on a sicker population that maybe hasn’t been studied yet. In this registry, we will be looking to define adverse events carefully, so we can leverage all that data to decrease the adverse events that are still plaguing our patients.
Importantly, there was no difference between the devices in gastrointestinal bleeding. That rate needs to be decreased. The evolution of pump technology may not improve that outcome. We may not understand what is causing GI bleeding in these patients. This may be an opportunity for a fresh look at new mechanisms for GI bleeding. Approximately one-quarter of patients in both groups had GI bleeding, and we need to know more about who is at risk for it.
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