When Dr. Robert Kormos, a cardiothoracic surgeon, began his career 30 years ago, he would dream of extending the lives of his patients who were often battling advanced heart failure. Now, as division vice president of medical device company Abbott, that is no longer a dream.
Newly released data by Chicago-based Abbott shows that its HeartMate 3 heart pump does just what he dreamed of: the left ventricular assist device (LVAD) extends survival by at least five years for patients with advanced heart failure.
“For me as a surgeon, this dream has now been met,” Kormos said.
The data comes from the MOMENTUM 3 trial, which studied more than 1,000 patients in what Abbott is billing as the largest randomized clinical trial of patients living with an LVAD. Abbott received approval from the Food and Drug Administration for HeartMate 3 in 2018, but was asked to follow the patients for five years, Kormos said. Patients in the study were randomized with either receiving the HeartMate 3 or Abbott’s older heart pump, HeartMate II.
It is the first LVAD trial to examine five-year outcomes and surpasses a previous Abbott study on HeartMate 3, which recorded a survival time of two years. The study also found that the HeartMate 3 had an improved survival rate of 58%, compared 44% with HeartMate II. Further, the device reduced morbidity and mortality compared to HeartMate II. This was largely because of a reduction in deaths from stroke, clotting and bleeding.
“It’s important to understand that the reason this device is so successful is because it reduced the mortality from complications that typically end people’s lives with heart pumps,” Kormos said. “That was greatly reduced in this trial compared to other trials and in the HeartMate II, and that includes blood clots forming in the pump, thrombosis, it includes stroke and bleeding.”
He added that the findings are significant as the population of people the study was performed on would not survive more than nine months in most cases. The heart pump is not only a short-term option for those waiting for transplants, but also a long-term one for those who don’t qualify for transplants.
Other companies in the heart pump device market include Abiomed, Medtronic and Teleflex Incorporated, according to Markets and Markets. But one unique benefit of the HeartMate 3 is that it sits in the chest cavity where the heart is, so surgeons don’t need to create extra areas to implant the device, Kormos said.
Armed with these results, the company will work to educate physicians, patients and hospital administrators about the benefits of the HeartMate 3. For hospital administrators, the message will be about cost management, Kormos said. Reimbursement of the device is dependent on local market factors and a patient’s insurance plan.
“We need to educate and make sure that hospital administrators understand that this is a cost-effective therapy,” he said. “It keeps people out of the hospital. If you fix their heart failure and you make them mobile, which this does, then that reduces the chronic rehospitalization from heart failure.”
He added that while the study shows promising results for HeartMate 3, work needs to be done to make utilization equitable across all populations.
“What’s concerning to me is that regionally across the United States, the use of this therapy is not uniform,” Kormos said. “In other words, look at the population of patients that get these devices: only about 30% of them are African American or Black. We know that the utilization of this type of therapy in the South is not as great as it is in, say, the Northeast … So we have some work to do in terms of the equity of the utilization of these therapies.”
Magicmine, Getty Images