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A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report
The investigators published the final analysis of the MOMENTUM 3 trial comparing the fully magnetically levitated centrifugal continuous-flow HeartMate 3 pump to the mechanical-bearing axial continuous-flow HeartMate II pump. The composite primary end point was survival at two years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at two years.
HeartMate 3 and HeartMate II were implanted in 516 and 512 patients, respectively. In the analysis of the primary end point, 397 patients (76.9%) with HeartMate 3, as compared with 332 (64.8%) with HeartMate II, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at two years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the HeartMate 3 group than in the HeartMate II group (12 patients [2.3%] versus 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The number of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in patients with HeatMate 3 comparted to patients with HeartMate II.
These data show that among patients with advanced heart failure, the fully magnetically levitated centrifugal-flow HeartMate 3 was associated with less frequent need for pump replacement and superior survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.