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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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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

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