Mandeep R Mehra1, Daniel L Crandall2, Finn Gustafsson3, Ulrich P Jorde4, Jason N Katz5, Ivan Netuka6, Nir Uriel7, Jean M Connors8, Poornima Sood2, Gerald Heatley9, Francis D Pagani10. 1. Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. 2. Clinical Affairs Heart Failure, Abbott, Chicago, IL, USA. 3. Cardiology, Rigshospitalet, Copenhagen, Denmark. 4. Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Bronx, NY, USA. 5. Division of Cardiology, Duke University, Durham, NC, USA. 6. Department of Cardiovascular Surgery, IKEM, Prague, Czech Republic. 7. Heart Failure, Heart Transplant & Mechanical Circulatory Support, Columbia University Medical Center, New York, NY, USA. 8. Division of Hematology, Brigham and Women's Hospital, Boston, MA, USA. 9. Global Biometrics, Abbott, Chicago, IL, USA. 10. Department of Cardiac Surgery, University of Michigan, Ann Arbor, MI, USA.
Abstract
AIMS: Over decades, left ventricular assist device (LVAD) technology has transitioned from less durable bulky pumps to smaller continuous-flow pumps which have substantially improved long-term outcomes and quality of life. Contemporary LVAD therapy is beleaguered by haemocompatibility-related adverse events including thrombosis, stroke and bleeding. A fully magnetically levitated pump, the HeartMate 3 (HM3, Abbott, USA) LVAD, has been shown to be superior to the older HeartMate II (HMII, Abbott, USA) pump by improving haemocompatibility. Experience with the HM3 LVAD suggests near elimination of de-novo pump thrombosis, a marked reduction in stroke rates, and only a modest decrease in bleeding complications. Since the advent of continuous-flow LVAD therapy, patients have been prescribed a combination of aspirin and anticoagulation therapy on the presumption that platelet activation and perturbations to the haemostatic axis determine their necessity. Observational studies in patients implanted with the HM3 LVAD who suffer bleeding have suggested a signal of reduced subsequent bleeding events with withdrawal of aspirin. The notion of whether antiplatelet therapy can be avoided in an effort to reduce bleeding complications has now been advanced. METHODS: To evaluate this hypothesis and its clinical benefits, the Antiplatelet Removal and Hemocompatibility Events with the HeartMate 3 Pump (ARIES HM3) has been introduced as the first-ever international prospective, randomized, double-blind and placebo-controlled, non-inferiority trial in a patient population implanted with a LVAD. CONCLUSION: This paper reviews the biological and clinical role of aspirin (100 mg) with LVADs and discusses the rationale and design of the ARIES HM3 trial.
RCT Entities:
AIMS: Over decades, left ventricular assist device (LVAD) technology has transitioned from less durable bulky pumps to smaller continuous-flow pumps which have substantially improved long-term outcomes and quality of life. Contemporary LVAD therapy is beleaguered by haemocompatibility-related adverse events including thrombosis, stroke and bleeding. A fully magnetically levitated pump, the HeartMate 3 (HM3, Abbott, USA) LVAD, has been shown to be superior to the older HeartMate II (HMII, Abbott, USA) pump by improving haemocompatibility. Experience with the HM3LVAD suggests near elimination of de-novo pump thrombosis, a marked reduction in stroke rates, and only a modest decrease in bleeding complications. Since the advent of continuous-flow LVAD therapy, patients have been prescribed a combination of aspirin and anticoagulation therapy on the presumption that platelet activation and perturbations to the haemostatic axis determine their necessity. Observational studies in patients implanted with the HM3LVAD who suffer bleeding have suggested a signal of reduced subsequent bleeding events with withdrawal of aspirin. The notion of whether antiplatelet therapy can be avoided in an effort to reduce bleeding complications has now been advanced. METHODS: To evaluate this hypothesis and its clinical benefits, the Antiplatelet Removal and Hemocompatibility Events with the HeartMate 3 Pump (ARIES HM3) has been introduced as the first-ever international prospective, randomized, double-blind and placebo-controlled, non-inferiority trial in a patient population implanted with a LVAD. CONCLUSION: This paper reviews the biological and clinical role of aspirin (100 mg) with LVADs and discusses the rationale and design of the ARIES HM3 trial.
Authors: Noah Weingarten; Cindy Song; Amit Iyengar; David Alan Herbst; Mark Helmers; Danika Meldrum; Sara Guevara-Plunkett; Jessica Dominic; Pavan Atluri Journal: Indian J Thorac Cardiovasc Surg Date: 2022-09-21
Authors: Davor Milicic; Binyamin Ben Avraham; Ovidiu Chioncel; Yaron D Barac; Eva Goncalvesova; Avishai Grupper; Johann Altenberger; Maria Frigeiro; Arsen Ristic; Nicolaas De Jonge; Steven Tsui; Jacob Lavee; Giuseppe Rosano; Marisa Generosa Crespo-Leiro; Andrew J S Coats; Petar Seferovic; Frank Ruschitzka; Marco Metra; Stefan Anker; Gerasimos Filippatos; Stamatis Adamopoulos; Miriam Abuhazira; Jeremy Elliston; Israel Gotsman; Righab Hamdan; Yoav Hammer; Tal Hasin; Lorrena Hill; Osnat Itzhaki Ben Zadok; Wilfried Mullens; Sanemn Nalbantgil; Massimo Francesco Piepoli; Piotr Ponikowski; Luciano Potena; Arjang Ruhparwar; Aviv Shaul; Laurens F Tops; Stephan Winnik; Tiny Jaarsma; Finn Gustafsson; Tuvia Ben Gal Journal: ESC Heart Fail Date: 2021-09-14