Clinical Report: Real-World Aspirin Avoidance After HeartMate 3 Implantation

Overview

PRAISE HM3 evaluates real-world adoption of aspirin avoidance and associated outcomes after HeartMate 3 (HM3) implantation using electronic health records from 30 US health systems. Aspirin use declines substantially after ARIES-HM3 publication but remains common, particularly among patients with vascular disease. After adjustment, early aspirin avoidance is not significantly associated with the composite outcome of death or major nonsurgical hemocompatibility-related adverse events.

Background

Durable left ventricular assist device (LVAD) therapy improves survival and quality of life in advanced heart failure. HM3 reduces pump thrombosis and other hemocompatibility-related complications compared with earlier devices, but major nonsurgical bleeding remains an important complication.

Historically, antithrombotic therapy combines vitamin K antagonist anticoagulation with aspirin. The randomized ARIES-HM3 trial demonstrates that aspirin avoidance with continued anticoagulation is noninferior for survival free of major nonsurgical hemocompatibility-related adverse events and reduces major bleeding without an observed increase in thromboembolic events. PRAISE HM3 examines how these findings translate into routine care.

Data Highlights

Key Findings

• Recorded early aspirin use in the overall LVAD cohort declines from 90.2% in 2023 to 55.7% in 2024 and 52.7% in 2025.

• Among 739 post-ARIES-HM3 recipients, 404 (54.7%) have recorded early aspirin use. Use is more common with prior PCI, coronary bypass surgery, stroke, or peripheral vascular disease: 67.1% versus 43.4% without these conditions.

• The 12-month composite outcome occurs in 29.3% with aspirin and 21.7% without recorded aspirin. The association is not significant after adjustment (HR for no recorded aspirin versus aspirin, 0.86; 95% CI, 0.61–1.22).

• Major nonsurgical bleeding occurs in 22.0% and 15.0%, respectively. The adjusted association is not significant (HR, 0.82; 95% CI, 0.54–1.26).

• Stroke occurs in 4.7% with aspirin and 2.7% without recorded aspirin; peripheral arterial thromboembolism occurs in 4.3% and 2.6%, respectively. Pump thrombosis occurs in 2 and 3 patients, respectively.

• Early aspirin exposure is determined from medication records on postoperative days 2–7. Outcome follow-up begins at day 14 among eligible, event-free patients.

Clinical Implications

The findings document incomplete adoption of aspirin avoidance and no detected safety signal discordant with ARIES-HM3. They do not establish comparative effectiveness, equivalence, or noninferiority.

Nonrandomized treatment selection, residual confounding, uncertain long-term aspirin exposure, algorithm-defined outcomes, rare thrombotic events, and unequal follow-up limit interpretation. Prior vascular-event timing is unavailable, preventing distinction between remote disease and recent antiplatelet indications.

The authors support distinguishing stable vascular history from recent vascular events requiring individualized management, together with surveillance for rare thrombotic complications.

Conclusion

Aspirin use declines after ARIES-HM3 but persists in approximately half of contemporary HM3 recipients, particularly those with vascular disease. Early aspirin avoidance is not associated with increased adjusted composite risk, and no excess stroke or peripheral arterial thromboembolism is observed.

Related Resources & Content

1. Aspirin and hemocompatibility events with a left ventricular assist device in advanced heart failure: The ARIES-HM3 randomized clinical trial — Mehra MR, Netuka I, Uriel N, et al.; JAMA; 2023;330:2171–2181.

2. Aspirin and hemocompatibility after LVAD implantation in patients with atherosclerotic vascular disease: A secondary analysis from the ARIES-HM3 randomized clinical trial — Gustafsson F, Uriel N, Netuka I, et al.; JAMA Cardiology; 2025;10:235–242.

3. Impact of atrial fibrillation, diabetes mellitus, and obesity on outcomes with aspirin avoidance and hemocompatibility with a left ventricular assist device: An analysis from the ARIES-HM3 trial — Uriel N, Netuka I, Jorde UP, et al.; Journal of Cardiac Failure; 2026;32:1224–1233.

4. Withdrawal of aspirin in patients with left ventricular assist device treated with vitamin K antagonists: Impact of anticoagulation quality in the randomized ARIES-HM3 trial — Connors JM, Gustafsson F, Uriel N, et al.; European Heart Journal; 2026;47:942–952.

5. Concomitant surgical procedures and aspirin avoidance with left ventricular assist device therapy — Pagani FD, Netuka I, Jorde UP, et al.; JACC: Heart Failure; 2025;13:102411.

6. Hemocompatibility outcomes with pharmacological therapy following LVAD implantation: Insights from the ARIES-HM3 trial — Katz JN, Connors JM, Pagani FD, et al.; JACC: Heart Failure; 2026;14:102769.