Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry
Schmitto J.D. Shaw S. Garbade J. Gustafsson F. Morshuis M. Zimpfer D. Lavee J. Pya Y. Berchtold-Herz M. Wang A. Gazzola C. Potapov E. Saeed D.
21 February 2024Oxford University Press
European Heart Journal
2024#45Issue 8613 - 625 pp.
Background and Aims HeartMate 3 (HM3) is a fully magnetically levitated continuous flow left ventricular assist device, which received CE marking in 2015. The ELEVATE Registry was initiated to collect real-world outcomes in patients treated with HM3 post-CE Mark approval. Methods A total of 540 subjects implanted at 26 centres between March 2015 and February 2017 were included in this registry. Of these, 463 received the device as a primary implant (primary implant cohort, PIC), 19 as a pump exchange (pump exchange cohort), and in 58 patients, only anonymized survival data were collected (anonymized cohort, AC). Patients in the PIC contributed to the baseline demographics, survival, adverse events, quality of life (QoL) (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the AC contributed only to survival. Results Primary implant cohort patients had a mean age of 56 years and were predominantly male (89%) with 48% ischaemic aetiology. The majority of subjects was designated bridge to transplant (66%) and had INTERMACS Profiles 1–3 (70%). At baseline, the subjects had poor functional capacity (104 ± 140 m) and impaired QoL (35 ± 19 points). The overall survival rate of the PIC was 63.3% and survival free of stroke was 58.1% at 5 years. Significant improvements in functional capacity and QoL were observed and maintained for 5 years (301 ± 131 m and 64 ± 20 points, respectively). Conclusions Real-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, reductions in adverse events for patients in the extended follow-up and improved QoL and functional capacity were observed at 5 years in this patient population with advanced heart failure.
Cardiac surgery , Chronic heart failure , Heart failure , HeartMate 3 , HF surgery , Left ventricular assist device , Mechanical circulatory support
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Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, OE 6210, Carl-Neuberg-Str. 1, Hannover, 30625, Germany
The Transplant Centre, Manchester University NHS Foundation Trust, Wythenshawe Hospital, Manchester, United Kingdom
Department of Cardiothoracic Surgery, Klinikum Links der Weser, Bremen, Germany
Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
Department of Cardiothoracic Surgery, Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany
Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria
Heart Transplantation Unit, Leviev Heart Center, Sheba Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
National Research Center for Cardiac Surgery, Nur-Sultan, Kazakhstan
Department of Cardiac Surgery, University Hospital of Freiburg, Freiburg, Germany
Abbott, Chicago, IL, United States
German Heart Center Berlin, Berlin, Germany
Department for Cardiac Surgery, Heart Center, Leipzig, Germany
Department of Cardiac
The Transplant Centre
Department of Cardiothoracic Surgery
Department of Cardiology
Department of Cardiothoracic Surgery
Department of Surgery
Heart Transplantation Unit
National Research Center for Cardiac Surgery
Department of Cardiac Surgery
Abbott
German Heart Center Berlin
Department for Cardiac Surgery
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