Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure -1 year results from the Ce mark trial

• Published in: Journal of cardiothoracic surgery Vol. 12; no. 1; p. 23
• Main Authors: Krabatsch, Thomas, Netuka, Ivan, Schmitto, Jan D, Zimpfer, Daniel, Garbade, Jens, Rao, Vivek, Morshuis, Michiel, Beyersdorf, Friedhelm, Marasco, Silvana, Damme, Laura, Pya, Yuriy
• Format: Journal Article
• Language: English
• Published: England BioMed Central 04.04.2017; BMC
• Subjects: Adults; Bleeding; Blood flow; Bridges; Clinical trials; Equipment Design; Female; Flow paths; Follow-Up Studies; Heart; Heart diseases; Heart failure; Heart Failure - physiopathology; Heart Failure - therapy; Heart-Assist Devices; HeartMate 3; Hemodynamics - physiology; Hemolysis; Humans; Infections; LVAS; Magnetic levitation; Magnets; Male; Markets; Middle Aged; Patients; Prospective Studies; Quality of Life; Stroke; Thromboembolism; Thrombosis; Time Factors; Transplants & implants; Treatment Outcome; Ventricle; Heart failure; HeartMate 3; LVAS; Magnetic levitation
• ISSN: 1749-8090; 1749-8090
• DOI: 10.1186/s13019-017-0587-3

The HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility. The HeartMate 3 received market approval in the European Union in 2015 following completion of a multicenter study. After reaching the 6-month study endpoint, patients continue to be followed for 2 years with the 1-year results presented herein. A prospective, non-randomized study included adults with advanced heart failure and ejection fraction (EF) ≤ 25%, cardiac index (CI) ≤ 2.2 L/min/m2 while not on inotropes, or inotrope dependent, or on optimal medical management for 45/60 days. Fifty patients-54% bridge to transplant (BTT) and 46% destination therapy (DT)-were enrolled and implanted with the HeartMate 3. At baseline, 92% of the patients were INTERMACS profiles 2-4, with cardiac index 1.8 + 0.5 L/min/m and 58% were supported with inotropes. At 1 year, 74% of the patients remain on support, 18% expired, 6% transplanted, and 2% explanted. The adverse events include 12% gastrointestinal bleeding, 16% driveline infections, 18% strokes, and 2% outflow graft thrombosis. There was no hemolysis, pump thrombosis or pump malfunction through 1 year. The six-minute walk test distance increased from a mean of 273 m to 371 m (P <0.0001). EQ-5D quality-of-life score increased from a mean of 52.7 to 70.8 (P = 0.0006). The 1-year HeartMate 3 LVAS results show survival and adverse-event profile are similar to other approved devices, with no pump thrombosis or pump failure. Patient's functional status and quality of life significantly improved over time. Clinicaltrials.gov registration number: NCT02170363 . Registered June 19, 2014.