Finn Gustafsson1, Steven Shaw2, Jacob Lavee3, Diyar Saeed4, Yuriy Pya5, Thomas Krabatsch6, Jan Schmitto7, Michiel Morshuis8, Joyce Chuang9, Laura Damme9, Daniel Zimpfer10, Jens Garbade11. 1. Rigshospitalet, Department of Cardiology, University of Copenhagen 9 Blegdamsvej, Copenhagen, Denmark. 2. Manchester University NHS Foundation Trust, Southmoor Road, Manchester, UK. 3. Heart Transplantation Unit, Sheba Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Hasomer, Ramat Gan, Israel. 4. Cardiovascular Surgery, University Hospital of Duesseldorf, Moorenstrasse 5, Dusseldorf, Germany. 5. National Research Cardiac Surgery Center, 38 Turan Street, Astana, Kazakhstan. 6. German Heart Center, Augustenburger Platz 1, Berlin, Germany. 7. Hannover Medical School, Carl-Neuberg Strasse 1, Hannover, Germany. 8. Department of Cardiothoracic Surgery, Herz- und Diabeteszentrum NRW, Georgstrasse 11, Bad Oeynhausen, Germany. 9. Abbott, Abbott Park Road, Abbott Park, Chicago, IL, USA. 10. Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Waehringer Guertel 18-20, Vienna, Austria. 11. Department of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Struempellstr. 39, Leipzig, Germany.
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.
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.
Authors: Omar Saeed; Paolo C Colombo; Mandeep R Mehra; Nir Uriel; Daniel J Goldstein; Joseph Cleveland; Jean M Connors; Samer S Najjar; Nahush A Mokadam; Aditya Bansal; Daniel L Crandall; Poornima Sood; Ulrich P Jorde Journal: J Heart Lung Transplant Date: 2020-03-20 Impact factor: 10.247
Authors: Jan F Gummert; Axel Haverich; Jan D Schmitto; Evgenij Potapov; René Schramm; Volkmar Falk Journal: Dtsch Arztebl Int Date: 2019-12-13 Impact factor: 5.594
Authors: Binyamin Ben Avraham; Marisa Generosa Crespo-Leiro; Gerasimos Filippatos; Israel Gotsman; Petar Seferovic; Tal Hasin; Luciano Potena; Davor Milicic; Andrew J S Coats; Giuseppe Rosano; Frank Ruschitzka; Marco Metra; Stefan Anker; Johann Altenberger; Stamatis Adamopoulos; Yaron D Barac; Ovidiu Chioncel; Nicolaas De Jonge; Jeremy Elliston; Maria Frigeiro; Eva Goncalvesova; Avishay Grupper; Righab Hamdan; Yoav Hammer; Loreena Hill; Osnat Itzhaki Ben Zadok; Miriam Abuhazira; Jacob Lavee; Wilfried Mullens; Sanemn Nalbantgil; Massimo F Piepoli; Piotr Ponikowski; Arsen Ristic; Arjang Ruhparwar; Aviv Shaul; Laurens F Tops; Steven Tsui; Stephan Winnik; Tiny Jaarsma; Finn Gustafsson; Tuvia Ben Gal Journal: ESC Heart Fail Date: 2021-09-14
Authors: Rocco Edoardo Stio; Marina Comisso; Luca Paolucci; Silvio Coletta; Vincenzo Cesario; Michele Gioia; Marco Stefano Nazzaro; Guglielmo Saitto; Carlo Contento; Emilio D'Avino; Francesco De Felice; Domenico Gabrielli; Francesco Musumeci Journal: Int J Environ Res Public Health Date: 2022-05-14 Impact factor: 4.614
Authors: Nicholas McNamara; Harry Narroway; Michael Williams; John Brookes; James Farag; David Cistulli; Paul Bannon; Silvana Marasco; Evgenij Potapov; Antonio Loforte Journal: Ann Cardiothorac Surg Date: 2021-03
Authors: Evgenij V Potapov; Christiaan Antonides; Maria G Crespo-Leiro; Alain Combes; Gloria Färber; Margaret M Hannan; Marian Kukucka; Nicolaas de Jonge; Antonio Loforte; Lars H Lund; Paul Mohacsi; Michiel Morshuis; Ivan Netuka; Mustafa Özbaran; Federico Pappalardo; Anna Mara Scandroglio; Martin Schweiger; Steven Tsui; Daniel Zimpfer; Finn Gustafsson Journal: Eur J Cardiothorac Surg Date: 2019-08-01 Impact factor: 4.191
Authors: Kevin Damman; Stan A J van den Broek; Gianclaudio Mecozzi; Joep M Droogh; Ethel Metz; Annemieke Oude Lansink; Jan A Krikken; Michiel E Erasmus; Michiel Kuijpers Journal: Neth Heart J Date: 2022-04-05 Impact factor: 2.854