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The critically ill patients with advanced heart failure who received a new heart pump – the left ventricular badist device (LVAD) HeartMate 3 – suffered much less from cerebrovascular accidents, blood clots related at the pump and haemorrhagic episodes after two years, compared to similar patients who received older treatment. , a more well-established pump, according to a study presented at the American College of Cardiology & # 39; s 68th Annual scientific session.
Based on these final conclusions, the HeartMate 3 LVM should now be considered the gold standard treatment for advanced heart failure patients who do not respond to recommended medical treatment, said Mandeep R. Mehra, MD, Cardiovascular Medical Director. . Center, Brigham and Women's Hospital in Boston and lead author of the study.
"These end results of what is by far the largest LVAD trial ever conducted demonstrate the clinical superiority of HeartMate 3 over its predecessor, the HeartMate II," said Mehra. "We have shown a decrease in the number of adverse events that occur solely because of the interface between the patient and the mechanical pump.These include a consistent and reliable reduction in strokes of any type and any seriousness 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, particularly gastrointestinal bleeding. significantly lower adverse events, patients receiving the HeartMate 3 had a lower readmission rate to the hospital and spent fewer days at the hospital.the hospital when they were readmitted ".
The HeartMate 3 is the first implantable mechanical heart pump to use fully magnetic levitation technology – which allows the frictionless pump to operate without mechanical bearings – to pbad blood through the device and into the aorta , the central artery of the body.
In case of advanced heart failure, the main pumping chamber of the heart, 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 capacity of the weakened heart in cases of advanced 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 docked to and powered by an external battery carried by the patient.
The trial, known as MOMENTUM-3, included 1,028 patients in 69 centers in the United States. The median age of the patients was 60 years and 78% were men. All had severe heart failure that prevented them from engaging in normal physical activity without discomfort. Most had symptoms of fatigue or shortness of breath, even at rest. Most (85%) received medications for intravenous heart failure because the pills alone were no longer working or they were causing intolerable side effects.
Some patients in the study needed an LVAD to maintain them until they could receive a heart transplant. Others, because of their age or other health problems, were not candidates for a transplant and were relying on LVAD as a lifelong treatment. Patients were randomized to have a HeartMate 3 or HeartMate II implanted surgically. All patients received anticoagulants after surgery and also took 81 to 325 mg of aspirin daily. The test was designed to include two predetermined interim badyzes and then a final badysis. The first interim badysis reported results at six months for the first 294 patients and the second badysis at two years for the first 366 patients enrolled. these data were presented at the 2018 Annual Scientific Session of ACC.
The primary endpoint of the final badysis was two-year survival without disabling stroke or new surgery to replace or remove a defective device. The primary secondary endpoint was the device replacement rate after two years.
After two years, 74.7% of patients receiving HeartMate 3 met the primary endpoint, compared with 60.6% of patients receiving HeartMate II, a 40% reduction in risk for HeartMate 3. The the two-year pump was 2.3% for patients receiving HeartMate 3 and 11.3% for those receiving HeartMate II.
Pump coagulation occurred in 1.4% of HeartMate 3 patients compared with 13.9% of HeartMate II patients. Five percent of HeartMate 3 patients had a disabling stroke, compared to 7.5% of HeartMate II patients. Many fewer HeartMate 3 patients experienced episodes of bleeding (43.7%) or gastrointestinal bleeding (24.5%) compared to HeartMate II patients (55% for any type of bleeding and 30.9% for gastrointestinal bleeding).
HeartMate 3 patients spent more days on LVAD outside the hospital (a median of 48 days in Heartmate 3) and spent fewer days in the hospital after being readmitted ( a median of 13 days, compared to a median of 18 days for HeartMate Patients II).
Patients continued to be at increased risk of infections after two years of follow-up, Mehra said. He stated that he and his colleagues were collaborating with infectious disease experts to try to find ways to reduce susceptibility to infection in patients with advanced heart failure.
The research team plans to continue to follow MOMENTUM-3 patients for at least three years to monitor their long-term survival. In addition, they are developing a new trial that will examine how to optimize the medical treatment of patients with advanced heart failure. For example, if episodes of bleeding could still be reduced by stopping aspirin daily or by switching from warfarin, a traditional anticoagulant, to a new anticoagulant medication.
The HeartMate 3 received approval from the US 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 with heart failure. patients who are not candidates for a heart transplant.
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