MOMENTUM 3 TRIAL

Final Report of the Two-Year Principal Outcomes in the MOMENTUM 3 Full Cohort

Mehra, M.R., Uriel, N., Naka, Y., Cleveland, J.C., Yuzefpolskaya, M., …Goldstein, D.J., for the MOMENTUM 3 Investigators. (2019). A Fully Magnetically Levitated Left Ventricular Assist Device – Final Report. N Engl J Med. https://www.doi.org/10.1056/NEJMoa1900486

The data from two-year followup of the MOMENTUM 3 full cohort demonstrates:

• Clinical superiority of the HeartMate 3 LVAS when compared to the HeartMate II LVAS
• Significantly less frequent rate for pump replacement with HeartMate 3 LVAS
• Significantly lower rate of stroke and disabling stroke with HeartMate 3 LVAS
• Significantly lower rate of GI bleeding with HeartMate 3 LVAS
• Significantly lower rate of pump thrombosis with HeartMate 3 LVAS

Effect Of Aspirin Dose On Hemocompatibility-Related Outcomes

Saeed, O., Colombo, P.C., Mehra, M.R., ...Jorde, U.P. (2020). Effect of aspirin dose on hemocompatibility-related outcomes with a magnetically levitated left ventricular assist device: An analysis from the MOMENTUM 3 study. J Heart Lung Transplant. https://www.jhltonline.org/article/S1053-2498(20)31427-3/fulltext

This analysis of HM3-supported patients in the MOMENTUM 3 full cohort demonstrates:

• Subjects receiving low-dose aspirin (81 mg) were more likely to be older and designated as destination therapy compared to subjects receiving usual-dose aspirin (325 mg)
• A similar proportion of patients in the usual-and low-dose groups met the primary endpoint of hemocompatibility-related outcomes at 2 years
• No differences in survival free from hemorrhagic or thrombotic events between the usual- and low-dose groups

Infection-Related Outcomes

Patel., C.B., Blue, L., Cagliostro, B., ...Mehra, M.R. (2020). Left Ventricular Assist Systems and Infection-Related Outcomes: A Comprehensive Analysis of the MOMENTUM 3 Trial. J Heart Lung Transplant. https://www.jhltonline.org/article/S1053-2498(20)31428-5/fulltext

This analysis of the MOMENTUM 3 full cohort demonstrates:

• Major infections occurred in over half of the subjects
• The most common type of infection were those of a local nature and unrelated to pump components
• Predictors of infection included female gender, pre-implant use of IABP, pre-implant history of cardiac surgery, and obesity.

Clinical Outcomes by Intended Goal of Therapy in the MOMENTUM 3 Full Cohort

Goldstein, D.J., Naka, Y., Horstmanshof, D., ...Mehra, M.R. (2019). Association of Clinical Outcomes with Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Support Therapy with HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial. JAMA Cardiology.
https://jamanetwork.com/journals/jamacardiology/fullarticle/2758869

This analysis of the MOMENTUM 3 full cohort demonstrates the following:

• Pre-implant strategy designations are dynamic and unpredictable
• Adverse event profiles are similar for patients regardless of pre-implant strategy
• Pre-implant strategy was not a determining factor in primary endpoint outcomes

Hemocompatibility Related Outcomes at Two Years in the MOMENTUM 3 Full Cohort

Uriel, N., Mehra, M.R., Naka, Y., Boyle, A., …Cleveland, J.C., for the MOMENTUM 3 Investigators. (2019). Long-Term Burden of Hemocompatibility Related Adverse Events in the MOMENTUM 3 Trial: Final Analysis of the 1028 Patient Cohort. Presented at ISHLT 2019 Annual Meeting, Orlando, FL.

This analysis of the MOMENTUM 3 full cohort demonstrates the following:

• The HeartMate 3 LVAS is clinically superior and more hemocompatible compared to the HeartMate II LVAS
• HeartMate 3 patients experience an overall halving of the burden of hemocompatibility related adverse events compared to HeartMate II LVAS

HeartMate 3 Surgical Implant Technique and Outcomes in the MOMENTUM 3 Full Cohort

Salerno, C., Naka, Y., Silvestry, S.C., Goldstein, D.J., …Long, J.W., for the MOMENTUM 3 Investigators. (2019). HeartMate 3 Surgical Implant Technique and Outcomes in the MOMENTUM 3 Trial. Presented at ISHLT 2019 Annual Meeting, Orlando, FL.

This analysis of the MOMENTUM 3 full cohort demonstrates the following:

• Apical cuff attachment, coring location, and driveline management did not significantly impact survival or key adverse events in the full cohort
• Sew then Core was not associated with a lower stroke risk than Core then Sew
• Similar excellent results can be obtained with HeartMate 3 LVAS despite significant variability in surgical implant techniques

HeartMate 3 LVAS Outflow Graft Twist Occlusion in the MOMENTUM 3 Full Cohort

Mehra, M.R., Salerno, C., Naka, Y., Uriel, N., Cleveland, J.C., Horstmanshof, D., and Goldstein, D.J., for the MOMENTUM 3 Investigators. (2018). A tale of the twist in the outflow graft: An analysis from the MOMENTUM 3 trial. J Heart Lung Transplant, 37 (11), 1281-4. https://www.jhltonline.org/article/S1053-2498(18)31615-2/fulltext

Reports have surfaced of a twist within the outflow graft of the HeartMate 3 LVAS, which have caused disruption in pump flow and required surgical correction. This article analyzes outflow graft twist occlusion in the MOMENTUM 3 trial experience and its clinical presentation.