Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy
Pagani F.D. Netuka I. Jorde U.P. Katz J.N. Gustafsson F. Connors J.M. Uriel N. Soltesz E.G. Ivak P. Bansal A. Bitar A. Vega J.D. Goldstein D. Danter M. Pya Y. Ravichandran A. Conway J. Adler E.D. Chung E.S. Grinstein J. Dirckx N. Iravani B. Mehra M.R.
July 2025Elsevier Inc.
JACC: Heart Failure
2025#13Issue 7
Background: ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) demonstrated that aspirin avoidance with a fully magnetically levitated HeartMate 3 (HM3) left ventricular assist device (LVAD) reduces bleeding complications and does not increase thromboembolism. Whether a concomitant surgical procedure modifies the observed safety and benefits remains uncertain. Objectives: This prespecified analysis of ARIES-HM3 studied clinical outcomes when concomitant surgical procedures are performed during LVAD implantation with excluding aspirin but maintaining a vitamin K antagonist. Methods: Among 628 patients randomized to receive either placebo or aspirin with a vitamin K antagonist, 589 (296 placebo and 293 aspirin) contributed to the primary endpoint analysis. Sub-categorization with receiving a concomitant surgical procedure (valvular procedure/coronary artery bypass grafting or nonvalvular procedure) was done and the composite primary endpoint of survival free from major nonsurgical (>14 days postimplant) hemocompatibility-related adverse events at 12 months was assessed. Results: There were 155 (52%) and 145 (49%) concomitant procedures in placebo and aspirin arms, respectively. The percentage of subjects achieving primary endpoint success was higher with the placebo group in patients with a concomitant procedure, and no interaction was observed on primary outcomes between those with and without concomitant surgical procedures (Pint = 0.231, 0.298, and 0.735 for any procedure, valvular/coronary artery bypass grafting, and nonvalvular procedures, respectively). There was a similar reduction in nonsurgical major hemorrhagic events with placebo compared with aspirin, observed in patients with or without any concomitant procedure: 0.64 (95% CI: 0.44-0.94) and 0.66 (95% CI: 0.46-0.93). Conclusions: Our findings support the safety and efficacy of aspirin avoidance from the antithrombotic regimen in HM3 LVAD patients undergoing concomitant surgical procedures. (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump [ARIES-HM3]; NCT04069156)
aspirin , heart failure , hemocompatibility , left ventricular assist device , mechanical circulatory support
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University of Michigan, Ann Arbor, MI, United States
Institute for Clinical and Experimental Medicine, Prague, Czech Republic
Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, New York, NY, United States
Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine and Bellevue Hospital, New York, NY, United States
Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
Department of Medicine, Brigham and Womens Hospital, Harvard Medical School, Boston, MA, United States
Division of Cardiology, Columbia University Irving Medical Center, New York-Presbyterian Hospital, New York, NY, United States
Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, United States
Department of Cardiothoracic Surgery, Ochsner Clinic Foundation, New Orleans, LA, United States
Emory University Hospital, Atlanta, GA, United States
Kansas University Medical Center, Kansas City, KS, United States
Research Department of University Medical Center (Heart Center), Astana, Kazakhstan
Ascension St Vincent, Indianapolis, IN, United States
Stollery Childrens Hospital, University of Alberta, Edmonton, AB, Canada
Division of Cardiology, Department of Medicine, University of California-San Diego, San Diego, CA, United States
The Lindner Research Center at The Christ Hospital, Cincinnati, OH, United States
University of Chicago, Chicago, IL, United States
Abbott, Chicago, IL, United States
University of Michigan
Institute for Clinical and Experimental Medicine
Division of Cardiology
Division of Cardiology
Rigshospitalet
Department of Medicine
Division of Cardiology
Thoracic and Cardiovascular Surgery
Department of Cardiothoracic Surgery
Emory University Hospital
Kansas University Medical Center
Research Department of University Medical Center (Heart Center)
Ascension St Vincent
Stollery Childrens Hospital
Division of Cardiology
The Lindner Research Center at The Christ Hospital
University of Chicago
Abbott
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