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Study Summary

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The HeartMate 3 left ventricular assist device is an intrathoracic, fully magnetically levitated centrifugal-flow pump with wide blood flow paths and intrinsic pulsatility, engineered to prevent pump thrombosis, a complication encountered in 10-20% of patients with the HeartMate 2 axial-flow device. The MOMENTUM3 trial enrolled 366 advanced systolic heart failure patients who were randomized in a nonblinded fashion to receive the centrifugal or axial-flow pump as a bridge to transplant or destination therapy. At 2 years, nearly 80% of the HeartMate 3 cohort and 60% of the HeartMate 2 cohort had survived free of disabling stroke (Rankin score >3) or reoperation to replace the device (HR 0.46; 95% CI 0.31-0.69; p <0.001). The difference was driven by reoperation for pump malfunction (see accompanying Hurst’s Central Illustration), as 3 patients required reoperation in the HeartMate 3 group compared to 30 patients in the HeartMate 2 group. The overall rate of any Rankin score stroke was lower with the HeartMate 3 pump (10.1% vs. 19.2%, P = 0.02). Rates of survival, disabling stroke, and other device-related complications were similar between groups.

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Heartmate 2 versus Heartmate 3 LVAD in Heart Failure

Commentary

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Study Strengths: MOMENTUM 3 is the largest randomized LVAD trial to date wherein the HeartMate 3 LVAD met criteria for both noninferiority and superiority compared to the HeartMate 2 axial-flow device with respect to the composite endpoint of survival free of disabling stroke or need for reoperation. An intention to treat analysis was performed to minimize bias. Patients in both groups had similar antiplatelet and anticoagulation regimens with similar INR levels and blood pressures achieved. Worst case sensitivity analyses were performed wherein patients who were not implanted or underwent transplantation were considered treatment failures and the results were largely unchanged.

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Study Limitations: Investigators and patients were not blinded to which device they were randomized to, which always risks the introduction of bias. The results of the trial are almost entirely driven by the need for reoperation for pump thrombosis. There was no difference in mortality, disabling stroke, exercise capacity, quality of life or any of the other frequently encountered device-related complications of gastrointestinal bleeding, infection, right heart failure, or arrhythmias.

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Next Steps/Clinical Perspective: These results show that the newest centrifugal LVAD confers a nearly 80% 2-year survival free from disabling stroke or need for reoperation, a rate that approaches survival conferred by heart transplantation. Next steps will be focused on reducing other commonly encountered adverse events of gastrointestinal bleeding, infection, right heart failure, and drive-line infection, with an increased focus on improving quality of life. Analysis of the entire cohort of over 1100 patients is eagerly awaited and expected in 2019.

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