MOMENTUM 3 trial of left ventricular assist device (LVAD)

HeartMate 3 is a fully magnetically levitated centrifugal flow intrathoracic left ventricular assist device. It has wider blood flow pathways compared to its predecessor Heartmate II. It has been engineered to have friction-free movement and intrinsic pulsatility to reduce shear stress and stasis of blood. Heartmate II is an axial continuous-flow pump which requires thoracoabdominal placement [1]. MOMENTUM 3 trial compared HeartMate 3 with HeartMate II, either as a bridge to transplantation or as a destination therapy in 1028 patients with advanced-stage heart failure. Shear stress created by continuous flow pumps can lead to degradation of high-molecular-weight multimers of von Willebrand factor. This has been implicated in the development of arteriovenous malformations in the mucosa causing bleeding. Survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device was the composite primary endpoint of MOMENTUM 3 trial.

Primary endpoint was achieved in 76.9% of the centrifugal-flow pump group, compared 64.8% in the axial-flow group. Pump replacement was lower in the centrifugal flow group. Major bleeding and gastrointestinal bleeding and stroke of any severity were also lower in a number of events per patient-year basis. Five year outcomes of the study were published in 2022 [2]. Per-protocol analyses found that receipt of a fully magnetically levitated centrifugal-flow LVAD was associated with a better composite outcome and higher likelihood of overall survival at 5 years.

References

1. Mehra MR, Uriel N, Naka Y, Cleveland JC Jr, Yuzefpolskaya M, Salerno CT, Walsh MN, Milano CA, Patel CB, Hutchins SW, Ransom J, Ewald GA, Itoh A, Raval NY, Silvestry SC, Cogswell R, John R, Bhimaraj A, Bruckner BA, Lowes BD, Um JY, Jeevanandam V, Sayer G, Mangi AA, Molina EJ, Sheikh F, Aaronson K, Pagani FD, Cotts WG, Tatooles AJ, Babu A, Chomsky D, Katz JN, Tessmann PB, Dean D, Krishnamoorthy A, Chuang J, Topuria I, Sood P, Goldstein DJ; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Left Ventricular Assist Device – Final Report. N Engl J Med. 2019 Apr 25;380(17):1618-1627. doi: 10.1056/NEJMoa1900486. Epub 2019 Mar 17. PMID: 30883052.
2. Mehra MR, Goldstein DJ, Cleveland JC, Cowger JA, Hall S, Salerno CT, Naka Y, Horstmanshof D, Chuang J, Wang A, Uriel N. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. 2022 Sep 27;328(12):1233-1242. doi: 10.1001/jama.2022.16197. PMID: 36074476; PMCID: PMC9459909.