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

• Published in: Journal of the American College of Cardiology 2015-12, Vol.66 (23), p.2579-2589
• Main Authors: Netuka, Ivan, Sood, Poornima, Pya, Yuriy, Zimpfer, Daniel, Krabatsch, Thomas, Garbade, Jens, Rao, Vivek, Morshuis, Michiel, Marasco, Silvana, Beyersdorf, Friedhelm, Damme, Laura, Schmitto, Jan D
• Format: Article
• Language: English
• Subjects: 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
• ISSN: 1558-3597
• DOI: 10.1016/j.jacc.2015.09.083

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