Related Experiment Video
Updated: May 15, 2025
Insertion, Maintenance, and Removal of the Percutaneous Dual Lumen Cannula Right Ventricular Assist Device
Published on: July 20, 2022
Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy
Francis D Pagani1, Ivan Netuka2, Ulrich P Jorde3
1University of Michigan, Ann Arbor, Michigan, USA.
Insights
Aspirin avoidance in HeartMate 3 (HM3) left ventricular assist device (LVAD) patients undergoing concomitant surgery is safe and effective. This strategy reduces bleeding without increasing thromboembolic events, supporting its clinical use.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Clinical Trials
Background:
- The ARIES-HM3 trial showed aspirin avoidance with HeartMate 3 (HM3) left ventricular assist device (LVAD) reduces bleeding without increasing thromboembolism.
- The impact of concomitant surgical procedures on these outcomes was previously uncertain.
Purpose of the Study:
- To assess clinical outcomes of aspirin avoidance in HM3 LVAD patients who underwent concomitant surgical procedures.
- To evaluate the safety and efficacy of excluding aspirin while maintaining a vitamin K antagonist during LVAD implantation with concurrent surgeries.
Main Methods:
- A prespecified analysis of the ARIES-HM3 trial involving 628 patients randomized to placebo or aspirin with a vitamin K antagonist.
- Patients were sub-categorized based on whether they underwent concomitant surgical procedures (valvular/CABG or non-valvular).
- The primary endpoint was survival free from major nonsurgical hemocompatibility-related adverse events at 12 months.
Main Results:
- No significant interaction was observed between concomitant procedures and primary outcomes (Pint > 0.05 for all categories).
- A similar reduction in nonsurgical major hemorrhagic events was observed with placebo versus aspirin in patients with or without concomitant procedures.
- The percentage of subjects achieving primary endpoint success was higher in the placebo group among those with concomitant procedures.
Conclusions:
- Aspirin avoidance is safe and effective in HM3 LVAD patients, even when undergoing concomitant surgical procedures.
- This antithrombotic strategy supports reduced bleeding complications without compromising safety.
- Findings support the exclusion of aspirin in the antithrombotic regimen for HM3 LVAD patients with concurrent surgeries.
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).
