Daniel Zimpfer1, Finn Gustafsson2, Evgenij Potapov3, Yuriy Pya4, Jan Schmitto5, Michael Berchtold-Herz6, Michiel Morshuis7, Steven M Shaw8, Diyar Saeed9, Jacob Lavee10, Gerald Heatley11, Carlo Gazzola11, Jens Garbade12. 1. Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna, Waehringer Guertel, 18-20 A-1090 Vienna, Austria. 2. Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 3. German Heart Center, Berlin, Germany. 4. National Research Cardiac Surgery Center, Nur-Sultan, Kazakhstan. 5. Hannover Medical School, Hannover, Germany. 6. Universitatsklinik Freiburg, Freiburg, Germany. 7. Department of Cardiothoracic Surgery, Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany. 8. Manchester University NHS Foundation Trust, Manchester, UK. 9. Cardiovascular Surgery, University Hospital of Dusseldorf, Dusseldorf, Germany. 10. Heart Transplantation Unit, Leviev Heart Center, Sheba Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 11. Abbott, Chicago, IL, USA. 12. University Department of Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany.
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. Published on behalf of the European Society of Cardiology. All rights reserved.
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. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Madina R Zhalbinova; Saule E Rakhimova; Ulan A Kozhamkulov; Gulbanu A Akilzhanova; Galina K Kaussova; Kenes R Akilzhanov; Yuriy V Pya; Joseph H Lee; Makhabbat S Bekbossynova; Ainur R Akilzhanova Journal: J Pers Med Date: 2022-05-04
Authors: Lieke Numan; Faiz Z Ramjankhan; Daniel L Oberski; Martinus I F J Oerlemans; Emmeke Aarts; Monica Gianoli; Joris J Van Der Heijden; Nicolaas De Jonge; Niels P Van Der Kaaij; Christiaan L Meuwese; Mostafa M Mokhles; Anne-Marie Oppelaar; Eric E C De Waal; Folkert W Asselbergs; Linda W Van Laake Journal: ESC Heart Fail Date: 2021-02-26
Authors: Peng Fang; Jianjun Du; Andrea Boraschi; Silvia Bozzi; Alberto Redaelli; Marianne Schmid Daners; Vartan Kurtcuoglu; Filippo Consolo; Diane de Zélicourt Journal: Front Cardiovasc Med Date: 2022-03-11
Authors: Kevin Willy; Christian Ellermann; Florian Reinke; Benjamin Rath; Julian Wolfes; Lars Eckardt; Florian Doldi; Felix K Wegner; Julia Köbe; Nexhmedin Morina Journal: J Cardiovasc Dev Dis Date: 2022-08-10
Authors: Mandeep R Mehra; Joseph C Cleveland; Nir Uriel; Jennifer A Cowger; Shelley Hall; Douglas Horstmanshof; Yoshifumi Naka; Christopher T Salerno; Joyce Chuang; Christopher Williams; Daniel J Goldstein Journal: Eur J Heart Fail Date: 2021-05-18 Impact factor: 15.534