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

Ivan Netuka, Poornima Sood, Yuriy Pya, Daniel Zimpfer, Thomas Krabatsch, Jens Garbade, Vivek Rao, Michiel Morshuis, Silvana Marasco, Friedhelm Beyersdorf, Laura Damme, Jan D. Schmitto

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141 Citations (Scopus)

Abstract

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/m2 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)

Original languageEnglish
Pages (from-to)2579-2589
Number of pages11
JournalJournal of the American College of Cardiology
Volume66
Issue number23
DOIs
Publication statusPublished - 15 Dec 2015
Externally publishedYes

Keywords

  • HeartMate 3
  • hemolysis
  • pump
  • quality of life
  • thrombosis

Cite this

Netuka, I., Sood, P., Pya, Y., Zimpfer, D., Krabatsch, T., Garbade, J., Rao, V., Morshuis, M., Marasco, S., Beyersdorf, F., Damme, L., & Schmitto, J. D. (2015). Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF A Multicenter Study. Journal of the American College of Cardiology, 66(23), 2579-2589. https://doi.org/10.1016/j.jacc.2015.09.083