Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study

J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083.


Background: The HeartMate 3 left ventricular assist system (LVAS) is intended to provide long-term support to patients with advanced heart failure. The centrifugal flow pump is designed for enhanced hemocompatibility by incorporating a magnetically levitated rotor with wide blood-flow paths and an artificial pulse.

Objectives: The aim of this single-arm, prospective, multicenter study was to evaluate the performance and safety of this LVAS.

Methods: The primary endpoint was 6-month survival compared with INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)-derived performance goal. Patients were adults with ejection fraction ≤ 25%, cardiac index ≤ 2.2 l/min/m(2) without inotropes or were inotrope-dependent on optimal medical management, or listed for transplant.

Results: Fifty patients were enrolled at 10 centers. The indications for LVAS support were bridge to transplantation (54%) or destination therapy (46%). At 6 months, 88% of patients continued on support, 4% received transplants, and 8% died. Thirty-day mortality was 2% and 6-month survival 92%, which exceeded the 88% performance goal. Support with the fully magnetically levitated LVAS significantly reduced mortality risk by 66% compared with the Seattle Heart Failure Model-predicted survival of 78% (p = 0.0093). Key adverse events included reoperation for bleeding (14%), driveline infection (10%), gastrointestinal bleeding (8%), and debilitating stroke (modified Rankin Score > 3) (8%). There were no pump exchanges, pump malfunctions, pump thrombosis, or hemolysis events. New York Heart Association classification, 6-min walk test, and quality-of-life scores showed progressive and sustained improvement.

Conclusions: The results show that the fully magnetically levitated centrifugal-flow chronic LVAS is safe, with high 30-day and 6-month survival rates, a favorable adverse event profile, and improved quality of life and functional status. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363).

Keywords: HeartMate 3; hemolysis; pump; quality of life; thrombosis.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Cardiotonic Agents / therapeutic use
  • Equipment Design*
  • Female
  • Heart Failure* / diagnosis
  • Heart Failure* / mortality
  • Heart Failure* / physiopathology
  • Heart Failure* / surgery
  • Heart Transplantation / statistics & numerical data
  • Heart Ventricles / physiopathology*
  • Heart-Assist Devices*
  • Hemodynamics*
  • Humans
  • Long-Term Care / methods
  • Male
  • Middle Aged
  • Prospective Studies
  • Severity of Illness Index
  • Stroke Volume
  • Survival Analysis
  • Treatment Outcome


  • Cardiotonic Agents

Associated data

  • ClinicalTrials.gov/NCT02170363