乌鸦传媒

The centrifugal-flow HeartMate 3 left ventricular assist device (LVAD) was associated with better 2-year outcomes for advanced heart failure patients when compared with the older axial-flow HeartMate II pump, according to the MOMENTUM 3 trial.

Freedom from disabling stroke or reoperation for pump malfunction 2 years after implantation was 79.5% with the newer pump and 60.2% with HeartMate II (P<0.001 both for noninferiority and superiority).

Reoperation for pump malfunction (1.6% versus 17.0%, P<0.001) was the main driver of this difference between the groups, Mandeep Mehra, MD, of Brigham and Women's Hospital in Boston, and colleagues reported online in the . This was not changed from previously-reported data from 6 months.

Replacement in the three patients in the HeartMate 3 was performed due to a drive-line communication fault causing electrical failure, a drive-line infection, and an obstructive outflow-graft twist. In contrast, most of the 30 HeartMate II recipients who got LVAD replacement needed it for pump thrombosis or severe hemolysis. There were two cases of confirmed or suspected pump thrombosis with HeartMate 3, but neither required reoperation.

"As low-intensity anticoagulation regimens are examined with the centrifugal-flow pump, close monitoring for such events will be essential," the authors cautioned nonetheless.

Additionally, rates of death or disabling stroke were similar in the two groups. However, HeartMate 3 significantly reduced the overall incidence of stroke by 2 years to 10.1% versus 19.2% for HeartMate II (P=0.02), with similar reductions in ischemic and hemorrhagic strokes.

The analysis of MOMENTUM included 366 patients (72 patients in addition to the 294 in the 6-month analysis) with New York Heart Association class IIIb or IV heart failure refractory to medical treatment. Participants were randomized to the centrifugal-flow pump (n=190) or to the axial-flow pump (n=176).

While HeartMate 3 is FDA for use in advanced heart failure patients as bridge-to-transplant or bridge to myocardial recovery, the trial also included use as destination therapy.

Limitations to the study included the lack of blinding, although Mehra's group noted that it seems unlikely that the decision to reoperate would be swayed by knowledge of the device used.

The findings were presented at the American College of Cardiology meeting in Orlando simultaneously with publication.

Comment