HeartMate II LVAD Clinical Evidence | Abbott
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HeartMate II Studies

MOMENTUM 3: A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report

Mehra MR, Uriel N, Yoshifumi N, et al.
HeartMate II was the LVAD used as a control in this pivotal trial. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.) The axialflow pump, which has the most implants and longest follow-up period for any LVAD in use today, performed well, with the following key data points at 2 years:


Survival – 76.7%

76.7%


Incidence of stroke – 19.4%

19.4%


Incidence of GI bleeding – 30.9%

30.9%

The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications

Teuteberg JJ, Cleveland JC, Cowger J, et al.
Real-world outcomes for HeartMate II LVAD were observed in the 2019 STS Intermacs annual report (Ann Thorac Surg 2020;109:649- 60), and were consistent with data observed in clinical trials at 2 years:


Survival –
72%

72%


Freedom from stroke – 82%

82%


Freedom from GI bleed – 67%

67%

Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results

Starling RC, Estep JD, Horstmanshof DA, et al.
Survival on original therapy with improvement in 6-min walk distance was superior with left ventricular assist device (LVAD) compared with optimal medical management (OMM) at 2 years. Reduction in key adverse events beyond 1 year was observed in the LVAD group. The ROADMAP trial provides risk-benefit information to guide patient- and physician-shared decision making for elective LVAD therapy as a treatment for heart failure. (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients [ROADMAP]; NCT01452802). (J Am Coll Cardiol HF 2017;)


Key data points:

  • Better survival on original therapy with improvement in functional status for HeartMate II LVAD vs OMM
  • More HeartMate II LVAD patients met primary endpoint (alive at 2 years and 6MWD improvement of at least 75 m)
  • Functional class and QoL improvements
  • Significantly more HeartMate II LVAD patients vs OMM were alive with improvements in functional capacity, quality of life, and depression vs OMM

Indications, Safety & Warnings

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