Six-month outcomes after treatment of advanced heart failure with a full magnetically levitated continuous flow left ventricular assist device: Report from the ELEVATE registry

Finn Gustafsson, Steven Shaw, Jacob Lavee, Diyar Saeed, Yuriy Pya, Thomas Krabatsch, Jan Schmitto, Michiel Morshuis, Joyce Chuang, Laura Damme, Daniel Zimpfer, Jens Garbade

Research output: Contribution to journalArticlepeer-review

Abstract

Aims The ELEVATE registry was planned to study post-approval outcomes with HeartMate 3™ (HM3), a fully magnetically levitated continuous flow left ventricular assist device (LVAD). Methods and results A total of 482 patients provided consent to participate in ELEVATE (enrolled cohort). Data collection included baseline demographics, survival, adverse events, quality of life (QOL) [EuroQoL-5 Dimensions visual analogue scale (VAS), and 6-minute walk distance (6MWD)]. An additional 58 patients were implanted with HM3 during the same period but expired or were explanted prior to consent, and only survival data were collected (anonymized cohort). We report the 6-month outcomes of the patients who received HM3 as their primary implant (n = 463) and the survival of the 540 patients in the full cohort (enrolled + anonymized). Baseline characteristics included a mean age of 55.6 ± 11.7 years, 89% male, 48% ischaemic aetiology, and 70% on inotropes. The majority of patients (66%) were bridge-to-transplantation (BTT) and 32% were INTERMACS profile 1-2. Full cohort survival at 6 months was 82 ± 2%. In the enrolled primary implant patients, there was no incidence of pump thrombosis, major bleeding was 25%, major infection 35%, and any stroke type 5%. Functional capacity improved significantly (6MWD 230 ± 191 m) as did QOL (VAS 31 ± 23). Freedom from unplanned rehospitalizations at 6 months was 68 ± 2%. Conclusion The 6-month outcomes of the HM3 LVAD demonstrate a highly reliable, thrombosis free, device with low incidence of stroke and improved functional capacity, and QOL. ClinicalTrials. gov Identifier NCT02497950.

Original languageEnglish
Pages (from-to)3454-3460
Number of pages7
JournalEuropean Heart Journal
Volume39
Issue number37
DOIs
StatePublished - 1 Oct 2018

Keywords

  • Heart failure
  • HeartMate 3™
  • Left ventricular assist device
  • Outcomes

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