Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Zimpfer, D; Gustafsson, F; Potapov, E; Pya, Y; Schmitto, J; Berchtold-Herz, M; Morshuis, M; Shaw, SM; Saeed, D; Lavee, J; Heatley, G; Gazzola, C; Garbade, J.
Two-year outcome after implantation of a full magnetically levitated left ventricular assist device: results from the ELEVATE Registry.
Eur Heart J. 2020; 41(39):3801-3809
Doi: 10.1093/eurheartj/ehaa639
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- Leading authors Med Uni Graz
- Zimpfer Daniel
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- Abstract:
- AIMS: The ELEVATE Registry was designed to study long-term outcomes with the Heartmate 3 (HM3), a fully magnetically levitated centrifugal ventricular assist device, in a real-world population following CE-mark approval. METHODS AND RESULTS: A total of 540 patients, implanted in Europe and the Middle East were followed in ELEVATE. The registry included 463 patients receiving the HM3 as primary implant (Primary Implant Cohort), 19 patients underwent a pump upgrade from another device (Pump Exchange Cohort) and 58 patients who had experienced an outcome before having the possibility to sign the Informed Consent, for which only outcome data were collected (Anonymized Cohort). Data collection included demographics, survival, adverse events, EQ-5D Visual Analog Score quality of life (EQ-5D VAS QOL) questionnaire, and 6-min walk distance (6MWD). Mean age was 55.6 ± 11.7 years (89% male, 48% ischaemic cardiomyopathy). Seventy per cent of patients were in INTERMACS Profile 1-3 and 12.7% were on temporary mechanical circulatory support. Primary Implant Cohort survival was 83% after 2 years. In the Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation Primary Implant Cohort, strokes were observed in 10.2%, gastrointestinal bleedings in 9.7%, pump thrombosis in 1.5%, and outflow graft twists in 3.5%. Heartmate 3 implantation resulted in a significant and sustained improvement of functional capacity and QOL. CONCLUSION: In a real-world population, cohort implanted with the HM3 left ventricular assist device we demonstrate good long-term survival, sustained improvement of functional capacity, and low rates of adverse events (including pump thrombosis). CLINICALTRIALS.GOV IDENTIFIER: NCT02497950.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult - administration & dosage
- Aged - administration & dosage
- Europe - administration & dosage
- Female - administration & dosage
- Heart Failure - therapy
- Heart-Assist Devices - administration & dosage
- Humans - administration & dosage
- Male - administration & dosage
- Middle Aged - administration & dosage
- Middle East - administration & dosage
- Prospective Studies - administration & dosage
- Quality of Life - administration & dosage
- Registries - administration & dosage
- Treatment Outcome - administration & dosage
- Find related publications in this database (Keywords)
- Heart failure
- HeartMate 3 TM
- Left ventricular assist device
- Outcomes