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

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.

Cardiac prostheses‐related hemolytic anemia

“…The reported incidence of hemolysis with the HeartMate II (HMII; Thoratec, Pleasanton, California) is approximately 13% to 18% . However, early experience with the third generation magnetically levitated left ventricular assist devices (LVAD) (HeartMate III) revealed very low (<1%) rates of hemolysis . Similarly, the novel TORVAD toroidal‐flow LVAD has shown negligible rates of hemolysis in pre‐clinical testing .…”

LVAD Pump Flow Does Not Adequately Increase With Exercise

“…LVADs increase perfusion, reduce pulmonary pressures, improve quality of life, and submaximal exercise capacity compared to pre LVAD condition . Significant improvements in NYHA functional class from NYHA class prior to LVAD implant of IIIb‐IV to I–II after 1 year were reported . LVAD patients from our center perform cardiac rehabilitation to restore and improve aerobic work capacity, physical strength, and mobility after LVAD implantation .…”

Artificial shear stress effects on leukocytes at a biomaterial interface

“… Although the most recent device in clinical trials, HeartMate 3 (HM3, Abbott Laboratories, Lake Bluff, IL, USA), has successfully tackled pump thrombosis, other complications such as infection, ischemic stroke, and gastrointestinal bleeding remain. Infection rates have been deemed lowered in second‐generation pumps with approximately 7% of HeartMate II (HMII; Abbott Laboratories, Lake Bluff, IL, USA) and HVAD (HeartWare Inc, Framingham, MA, USA) patients being affected. However, recent data from HeartMate 3 patients has shown an increased rate of 22%–36%.…”