NEW ORLEANS — Patients with advanced heart failure implanted with a centrifugal-flow pump (HeartMate 3; St. Jude Medical) had fewer reoperations for pump malfunction or replacement than patients with an axial-flow pump (HeartMate II; St. Jude Medical), according to 6-month results from MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate3).1,2

Mandeep Mehra, MD, of Brigham and Women’s Hospital in Boston,  presented the MOMENTUM 3 (ClinicalTrials.gov identifier: NCT02224755) findings at the 2016 American Heart Association Scientific Sessions in New Orleans, which were simultaneously published in the New England Journal of Medicine.2

Left ventricular assist devices (LVADs) are used as a bridge to transplant (BTT) or as destination therapy (DT) in patients with advanced heart failure.1-4 Survival and quality of life have improved with the evolution of LVADs, but treatment with currently available LVADs is limited by infection, bleeding, neurological events, and pump thrombosis.1,2-4

HeartMate 3, a new LVAD with a centrifugal-flow design, may decrease the risk of pump thrombosis by reducing hemodynamic shear stress, stasis, and friction.1,3-4 In MOMENTUM 3, Dr Mehra and colleagues compared the safety and efficacy of HeartMate 3 with that of HeartMate II, an axial-flow pump approved for BTT and DT.1,5-6

A total of 294 patients were randomized in a 1:1 ratio to implantation with HeartMate 3 (n=152) or HeartMate II (n=142) in the short-term cohort of MOMENTUM 3. The composite primary end point was defined as survival free of disabling stroke (modified Rankin score >3) or reoperation to replace or remove the device at 6 months.1,2

More patients implanted with HeartMate 3 met the primary end point than patients implanted with HeartMate II (86.2% vs 76.8%; hazard ratio: 0.55; P <.001 for non-inferiority; P =.037 for superiority). Rates of reoperation to repair or replace the pump were significantly lower in the HeartMate 3 group than in the HeartMate II group (1% vs 8%; P =.002), which accounted for the superior outcomes with HeartMate 3.1,2

No patients implanted with HeartMate 3 experienced pump thrombosis, compared with 10% of patients implanted with HeartMate II (P <.0001). Rates of stroke and bleeding were similar in both groups.1,2

Dr Mehra concluded that HeartMate 3, a centrifugal-flow pump, was associated with better outcomes than HeartMate II, an axial-flow pump, largely due to the reduced need for reoperation for pump malfunction or replacement.1

Disclosures: The MOMENTUM 3 study was funded by St. Jude Medical. Dr Mehra serves as a consultant/advisory board member for Medtronic, TEVA, St. Jude Medical, Stealth Therapeutics, and Johnson & Johnson.

References

  1. Mehra MR, Naka Y, Uriel N, et al; on behalf of the MOMENTUM 3 Investigators. Multicenter study of MagLev technology in patients undergoing mechanical circulatory support therapy with HeartMate 3. Presented at the 2016 American Heart Association Scientific Sessions. November 12-16, 2016; New Orleans, LA.
  2. Mehra MR, Naka Y, Uriel N, et al; for the MOMENTUM 3 Investigators. A fully magnetically levitated circulatory pump for advanced heart failure. N Engl J Med. 2016 Nov 16. doi:10.1056/NEJMoa1610426 [Epub ahead of print].
  3. Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241-2251.
  4. Patel CB, Cowger JA, Zuckermann A. A contemporary review of mechanical circulatory support. J Heart Lung Transplant. 2014;33:667-674.
  5. Starling RC, Moazami N, Silvestry SC, et al. Unexpected abrupt increase in left ventricular assist device thrombosis. N Engl J Med. 2014;370:33-40.
  6. Kirklin JK, Naftel DC, Kormos RL, et al. Interagency registry for mechanically assisted circulatory support (INTERMACS) analysis of pump thrombosis in the HeartMat II left ventricular assist device. J Heart Lung Transplant. 2014;33:12-22.