A new version of an implantable heart pump could cut the risk of blood clots, bleeding and stroke in patients with advanced heart failure, according to a study funded by the device's maker.
The study included more than a thousand patients who received either Abbott Inc.'s HeartMate 3 left ventricular assist device (LVAD) or the HeartMate II.
After two years, about 75 percent of those in the HeartMate 3 group were still alive, had not suffered a disabling stroke and did not require another operation to remove a malfunctioning device, compared with nearly 61 percent in the HeartMate II group, the study found.
"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," said lead study author Dr. Mandeep Mehra. He's medical director at the Heart and Vascular Center at Brigham and Women's Hospital in Boston.
The study was presented Sunday at the American College of Cardiology's Annual Scientific Session, in New Orleans, and published online in the New England Journal of Medicine.
In heart failure, damaged hearts become too weak to efficiently pump blood. The new and improved HeartMate should extend the lives of many heart failure patients, said one specialist unconnected to the study.
In 2001, Abbott introduced the HeartMate 1, the first-generation heart pump, explained Dr. Harold Fernandez, a cardiothoracic surgeon at Southside Hospital in Bay Shore, N.Y.
"Unfortunately, although this pump helped many patients, it would only last for about a year and a half before breaking down," he said.
"Then in 2008, there was the introduction of a new second-generation pump, HeartMate II, that was much smaller, and worked more efficiently than the first one," Fernandez said. "Now, we have the first longer studies showing that the new third-generation pump, HeartMate 3, is even smaller, works better, and has less complications than all the previous pumps."
The results of the new study are impressive, he said.
"In fact, these pumps are so good that the numbers are starting to look very close to the gold standard treatment, which is the heart transplant," Fernandez said.
The rate at which the pumps need to be replaced has plummeted. According to the study, the rate of pump replacement at two years was 2.3 percent in the HeartMate 3 group, compared to 11.3 percent in the HeartMate II group.
Blood clot dangers have also fallen: while nearly 14 percent of HeartMate II patients experienced pump-related clotting, these issues occurred in just 1.4 percent of HeartMate 3 patients, Mehra's group found.
With fewer clots, the odds for stroke fell, as well: disabling stroke occurred in 5 percent of HeartMate 3 patients, compared with 7.5 percent of HeartMate II patients.
Rates of any type of bleeding were about 44 percent for HeartMate 3 patients and 55 percent among Heartmate II patients, while rates of gastrointestinal bleeding were 24.5 percent and 31 percent, respectively.
Based on these findings, the HeartMate 3 LVAD should now be the standard of care for patients with advanced heart failure who do not respond to guideline-directed drug therapy, Mehra believes.
"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," Mehra said in an American College of Cardiology news release.
The HeartMate 3 was approved by 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.
As Fernandez pointed out, "heart failure is one of the most devastating conditions, affecting over 6 million patients in the United States with over half a million new cases each year."
But he said technological advances such as cardiac pumps are offering patients hope.
"This is a really exciting time, because the technology that until just a few years ago may have seemed as something from another planet, is now being used in our hospital to help the most ill patients who have a weak heart and who didn't have other options in the past," Fernandez said.
Dr. Sunny Intwala directs sports cardiology at Lenox Hill Hospital in New York City. He agreed with Fernandez, calling the HeartMate 3 "a significant step forward to provide select patients a safer device, which is associated with less risk of disabling strokes, need for pump or device replacement."
The U.S. National Heart, Lung, and Blood Institute has more on heart failure.