Long‐term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure—two‐year results from the HeartMate 3 CE Mark Study

• Published in: European journal of heart failure 2019-01, Vol.21 (1), p.90-97
• Main Authors: Schmitto, Jan D., Pya, Yuriy, Zimpfer, Daniel, Krabatsch, Thomas, Garbade, Jens, Rao, Vivek, Morshuis, Michiel, Beyersdorf, Friedhelm, Marasco, Silvana, Sood, Poornima, Damme, Laura, Netuka, Ivan
• Format: Article
• Language: English
• Subjects: Heart failure; HeartMate 3; Left ventricular assist system; Magnetic levitation
• ISSN: 1388-9842; 1879-0844
• DOI: 10.1002/ejhf.1284

Aim This study aimed to assess safety and outcomes of patients, 2 years after implantation with the HeartMate 3 Left Ventricular Assist System. Methods and results This study included 50 adults with New York Heart Association (NYHA) class IIIB or IV symptoms or American College of Cardiology/American Heart Association stage D heart failure with an ejection fraction ≤25% and a cardiac index ≤2.2 L/min/m2 without inotropes, or inotrope‐dependent with optimal medical management, or listed for heart transplant. The median duration of left ventricular assist device support was 694 days (range: 19–833 days). At baseline, cardiac index was 1.8 ±0.5 L/min/m2, 58% of patients were receiving inotropes, and 92% were INTERMACS profiles 2–4. At 2 years, Kaplan–Meier survival was 74 ±6%, 5 (10%) patients were transplanted, and 32 patients (64%) remain with support. Adverse event rates include bleeding requiring surgery (16%), gastrointestinal bleeding (20%), driveline infection (24%), ischaemic stroke (16%), haemorrhagic stroke (8%), right heart failure (14%), and outflow graft thrombosis (2%). Notably, no haemolysis, pump thrombosis, or pump malfunction events occurred. At 2 years, 47% of patients remained in NYHA class I and 41% in NYHA class II (P