Nav: Home

Novel heart pump shows superior outcomes in advanced heart failure

March 18, 2019

NEW ORLEANS (March 17, 2019) -- Severely ill patients with advanced heart failure who received a novel heart pump--the HeartMate 3 left ventricular assist device (LVAD)-- suffered significantly fewer strokes, pump-related blood clots and bleeding episodes after two years, compared with similar patients who received an older, more established pump, according to research presented at the American College of Cardiology's 68th Annual Scientific Session.

Based on these final findings, the HeartMate 3 LVAD should now be considered the standard of care for patients with advanced heart failure who do not respond to guideline-directed medical therapy, said Mandeep R. Mehra, MD, medical director of the Heart and Vascular Center, Brigham and Women's Hospital in Boston and lead author of the study.

"These final results from what is by far the largest LVAD trial ever conducted demonstrate the clinical superiority of the HeartMate 3 compared with its predecessor, the HeartMate II," Mehra said. "We have shown a decrease in adverse events that uniquely occur due to the interface between the patient and the mechanical pump. These include a consistent and reliable reduction in strokes of all kinds and severity with the HeartMate 3 but also a remarkable reduction in the rate of pump-related blood clots and significant reductions in all types of bleeding, especially gastrointestinal bleeding. In addition to having significantly lower rates of adverse events, patients who received the HeartMate 3 had a lower rate of readmission to the hospital and spent fewer days in the hospital when they were readmitted."

The HeartMate 3 is the first implantable mechanical heart pump to use fully magnetic levitation technology--which makes the pump frictionless without mechanical bearings--to push blood through the device and into the aorta, the body's central artery.

In advanced heart failure, the heart's main pumping chamber, the left ventricle, is too weak to pump oxygen-rich blood from the lungs throughout the body. An LVAD is designed to supplement the pumping ability of the weakened heart in late-stage heart failure. It is implanted in the left ventricle of the heart and then attached to the aorta, the main artery that sends blood to the rest of the body. The device is anchored to and powered by an external battery pack worn by the patient.

The trial, known as MOMENTUM-3, enrolled 1,028 patients at 69 centers in the U.S. Patients' median age was 60 years and 78 percent were men. All had severe heart failure that left them unable to engage in usual physical activity without discomfort. Most had symptoms of fatigue or shortness of breath even when resting. Most (85 percent) were receiving intravenous heart failure medication because pills alone no longer worked or caused intolerable adverse effects.

Some patients in the study needed an LVAD to sustain them until they were able to receive a heart transplant. Others, because of age or other health problems, were not candidates for a transplant and relied on an LVAD as lifelong therapy. Patients were randomly assigned to have either a HeartMate 3 or a HeartMate II surgically implanted. All patients received blood-thinning medications following surgery and were also taking 81 to 325 mg of aspirin daily. The trial was designed to include two pre-specified interim analyses and then a final analysis. The first interim analysis reported six-month outcomes in the first 294 patients and the second analyzed two-year outcomes for the first 366 patients enrolled; this data was presented at ACC's 2018 Annual Scientific Session.

The primary endpoint for the final analysis was survival at two years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary endpoint was the rate of device replacement at two years.

At two years, 74.7 percent of patients who received the HeartMate 3 met the primary endpoint, compared with 60.6 percent of those who received the HeartMate II, a 40 percent reduction in risk favoring the HeartMate 3. The rate of pump replacement at two years was 2.3 percent for patients receiving the HeartMate 3 and 11.3 percent for those who received the HeartMate II.

Pump clotting occurred in 1.4 percent of HeartMate 3 patients compared with 13.9 percent of HeartMate II patients. Five percent of HeartMate 3 patients experienced a disabling stroke compared with 7.5 percent of HeartMate II patients. Significantly fewer HeartMate 3 patients experienced episodes of any type of bleeding (43.7 percent) or gastrointestinal bleeding (24.5 percent) compared with HeartMate II patients (55 percent for any type of bleeding, 30.9 percent for gastrointestinal bleeding).

HeartMate 3 patients spent more days on LVAD support outside of hospital (a median of 48 more days in the Heartmate 3) and spent fewer days in the hospital after being readmitted (a median of 13 days, compared with a median of 18 days for HeartMate II patients).

Patients continued to be at increased risk for infections at two years of follow-up, Mehra said. He said that he and his colleagues are engaging with infectious disease experts to try to find ways of reducing susceptibility to infection in patients with advanced heart failure.

The research team plans to continue to follow the MOMENTUM-3 patients for at least another three years to monitor their long-term survival. Additionally, they are developing a new trial that will examine how to optimize medical therapy for patients with advanced heart failure--for example, whether bleeding episodes might be further reduced by discontinuing daily aspirin or switching from the traditional blood thinner warfarin to newer blood-thinning medications.
-end-
The HeartMate 3 received approval from the U.S. Food and Drug Administration in August 2017 for short-term use in patients awaiting a heart transplant and in October 2018 for long-term use in patients who are not candidates for a heart transplant.

The MOMENTUM-3 study was funded by Abbott, Inc.

The study was simultaneously published online in the New England Journal of Medicine at the time of presentation.

The ACC's Annual Scientific Session will take place March 16-18, 2019, in New Orleans, bringing together cardiologists and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention. Follow @ACCinTouch, @ACCMediaCenter and #ACC19 for the latest news from the meeting.

The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its more than 52,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.

American College of Cardiology

Related Gastrointestinal Bleeding Articles:

Should patients continue blood thinners after experiencing gastrointestinal bleeding?
Anticoagulants and antiplatelet drugs, which are blood thinners such as warfarin and aspirin, are commonly taken to reduce the risk of potentially fatal blood clots, but they carry an increased risk of gastrointestinal bleeding.
Higher salt intake can cause gastrointestinal bloating
A study led by researchers at the Johns Hopkins Bloomberg School of Public Health found that individuals reported more gastrointestinal bloating when they ate a diet high in salt.
Investigators explore temperature-triggered devices for gastrointestinal therapies
Investigators from Brigham and Women's Hospital and MIT are designing devices that can be triggered by the ingestion of a warm liquid to break down into smaller segments that can be excreted.
New therapeutic strategy to prevent gastrointestinal disease
In a study published in Nature Medicine, the researchers report new evidence suggesting that specifically targeting MLCK1 may be effective in both preventing and treating gastrointestinal disease by preserving and restoring barrier function, respectively.
Edible antibodies to treat and prevent gastrointestinal disorders
Therapeutic antibodies are increasingly being used in the clinic for the treatment of various diseases.
PPIs combined with oral anticoagulants reduce risk of gastrointestinal bleeding
A Vanderbilt University Medical Center (VUMC) study published today in JAMA shows that patients already at higher risk for gastrointestinal bleeding gain a marked protection from this risk when they take a proton pump inhibitor (PPI) in combination with an oral anticoagulant.
The incidence of gastrointestinal disease increases with heat and cold
In Spain, hospital admissions related to these infections increase by 21 percent at high temperatures and 7 percent at cold temperatures.
Patient-derived organoids may help personalize the treatment of gastrointestinal cancers
A new BJS (British Journal of Surgery) review highlights the potential of 3-D organoid models derived from patient cells to help personalize therapy for individuals with gastrointestinal cancers.
Cloudy water linked to gastrointestinal illnesses
A review of studies from both North America and Europe found links between acute gastrointestinal illness, which typically includes diarrhea and vomiting, and cloudy drinking water.
Two new studies offer insights into gastrointestinal dysfunction in Parkinson's patients
Constipation is one of the most common non-motor related complaints affecting Parkinson's disease (PD) patients.
More Gastrointestinal Bleeding News and Gastrointestinal Bleeding Current Events

Top Science Podcasts

We have hand picked the top science podcasts of 2019.
Now Playing: TED Radio Hour

Risk
Why do we revere risk-takers, even when their actions terrify us? Why are some better at taking risks than others? This hour, TED speakers explore the alluring, dangerous, and calculated sides of risk. Guests include professional rock climber Alex Honnold, economist Mariana Mazzucato, psychology researcher Kashfia Rahman, structural engineer and bridge designer Ian Firth, and risk intelligence expert Dylan Evans.
Now Playing: Science for the People

#541 Wayfinding
These days when we want to know where we are or how to get where we want to go, most of us will pull out a smart phone with a built-in GPS and map app. Some of us old timers might still use an old school paper map from time to time. But we didn't always used to lean so heavily on maps and technology, and in some remote places of the world some people still navigate and wayfind their way without the aid of these tools... and in some cases do better without them. This week, host Rachelle Saunders...
Now Playing: Radiolab

Dolly Parton's America: Neon Moss
Today on Radiolab, we're bringing you the fourth episode of Jad's special series, Dolly Parton's America. In this episode, Jad goes back up the mountain to visit Dolly's actual Tennessee mountain home, where she tells stories about her first trips out of the holler. Back on the mountaintop, standing under the rain by the Little Pigeon River, the trip triggers memories of Jad's first visit to his father's childhood home, and opens the gateway to dizzying stories of music and migration. Support Radiolab today at Radiolab.org/donate.