The final results are for MOMENTUM 3, the largest LVAD study ever conducted. The study of more than 1,000 patients with severe heart failure not only confirms that the HeartMate 3, a next generation LVAD device, significantly reduces the need for reoperation due to pump malfunction, but also lowers the risk of bleeding events and bleeding to the HeartMate II. The findings were presented in a late breaking clinical study at the 68th annual scientific meeting of the American College of Cardiology by Mandeep R. Mehra, executive director of the Center for Advanced Heart Disease and medical director of the Heart & Vascular Center at Brigham and Women's Hospital and simultaneously published online in the New England Journal of Medicine .
"We are thrilled to have completed the world's largest LVAD study to see that all the early results we found in interim analyzes have been preserved, and that reductions in pump-related thrombosis, strokes, and mucosal bleeding have been reported ̵
MOMENTUM 3, sponsored by Abbott Inc., compared the Abbott's HeartMate 3 left ventricular assistance system, a magnetic centrifugal pump with a centrifugal pump, to the HeartMate II, a commercially available axial pump. The study looked at how many participants did not experience a disabling stroke, or performed a replacement or removal operation, two years after receiving the device.
A total of 1028 patients were randomized to receive either the centrifugal flow pump or the axial pump pump. The team found that 397 patients (76.9 percent) in the centrifugal pump group did not have a disabling stroke or had to be reoperated, compared to 332 (64.8 percent) in the axial pump group. Only 12 people who received the centrifugal pump had to be renewed compared to 57 who received the axial pump. The centrifugal pump reduced the risk of stroke by 58 percent, the main hemorrhage by 36 percent and the gastrointestinal bleeding by 36 percent. Infection rates and rates of right heart failure did not differ between the two groups.
MOMENTUM 3 was launched in 2014 and should dramatically reduce the time frame for clinical trials. All patients with refractory heart failure who needed a heart pump were eligible for the study, regardless of whether the pump was intended as a bridge to transplantation or as a target therapy. Based on the first six-month interim analysis of the study, HeartMate 3 was approved by the FDA in 2017 for use as a short-term instrument, such as a bridge to transplantation. Supported by the second interim results of MOMENTUM 3, the pump was approved by the FDA last autumn as a long-term use device, for example, for patients with advanced heart failure who are not eligible for a heart transplant.
The HeartMate 3 includes several technological adjustments designed to reduce the risk of complications. The completely magnetic levitating device runs like a bullet train – its rotor has no mechanical bearings and pushes the blood only with magnetism. It is designed to reduce shear stress and the destruction of blood elements as they pass through the pump, which is believed to cause blood clots to form in pumps.
Reducing bleeding events, reoperation and strokes could result in significant cost savings. The team calculated that in each of ten patients implanted with the centrifugal pump, 2.2 pump thrombosis events, two strokes and 6.8 bleeding events would be averted over a two year period compared to the axial pump.
"Until now, these devices are considered less economical, which is a big problem outside the US," Mehra said. "Our evidence shows that the need for hospitalization and reoperation has dropped, suggesting that the centrifugal pump can be much more cost effective in the longer term."
Mehra points out that residual risks, including infections, persist in nearly 50 percent of patients. Many, but not all, of these infections occur at the entry point of the catenary that powers the device. In addition, low-frequency right ventricular heart failure may occur. Mehra will now chair a follow-up study that specifically looks at these challenges and what modifications can be made to them.
New heart pump device improves long-term outcome for patients with heart failure
Brigham and gynecological clinic
New cardiac pump clinically superior, safer for patients (2019, March 17)
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