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Gustafsson, F; Shaw, S; Lavee, J; Saeed, D; Pya, Y; Krabatsch, T; Schmitto, J; Morshuis, M; Chuang, J; Damme, L; Zimpfer, D; Garbade, J.
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.
Eur Heart J. 2018; 39(37):3454-3460
Doi: 10.1093/eurheartj/ehy513
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PubMed
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- Co-authors Med Uni Graz
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Zimpfer Daniel
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- 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 (Δ6MWD 230 ± 191 m) as did QOL (ΔVAS 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.
- Find related publications in this database (using NLM MeSH Indexing)
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Adult - administration & dosage
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Aged - administration & dosage
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Female - administration & dosage
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Heart Failure - mortality, surgery
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Heart-Assist Devices - adverse effects, statistics & numerical data
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Humans - administration & dosage
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Male - administration & dosage
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Middle Aged - administration & dosage
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Postoperative Complications - epidemiology, mortality
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Prospective Studies - administration & dosage
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Registries - administration & dosage
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Treatment Outcome - administration & dosage
- Find related publications in this database (Keywords)
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Heart failure
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HeartMate 3 (TM)
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Left ventricular assist device
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Outcomes