Abstract
BackgroundThe 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.MethodsA 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.ResultsFifty 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/m2 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).ConclusionsThe 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.Trial registrationClinicaltrials.gov registration number: NCT02170363. Registered June 19, 2014.
Highlights
The HeartMate 3 Left Ventricular Assist System (LVAS)
Platelet activation, and cleaving of von Willebrand factor multimeres often occur during CFLVAD support and are important contributing factors to thrombosis, stroke, and gastrointestinal (GI) bleeding—adverse events that are the primary limitations of continuous-flow left ventricular assist device (CF-LVAD) support [8]
An artificial pulse allows for more complete washing of pump surfaces eliminating stasis as a cause of pump thrombosis and possibly other clinical benefits related to the pulse pressure
Summary
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. Circulatory support with a continuous-flow left ventricular assist device (CF-LVAD) restores circulation, preserves organ function, improves functional status and quality of life, and extends survival for patients with refractory advanced stage heart failure [1,2,3,4,5,6]. The HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St. Paul, MN) was designed for enhanced hemocompatibility by the integration of a fully magnetically levitated rotor for frictionless movement, wide blood flow gaps through the pump for lower shear stress, and textured blood-contacting inner and outer surfaces for establishing a tissue interface with blood [9, 10].
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