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Updated: Mar 21, 2026

In Vitro Thrombosis Test for Ventricular Assist Devices
Published on: March 21, 2025
Relationship Between Anticoagulation Intensity and Thrombotic or Bleeding Outcomes Among Outpatients With
Michael E Nassif1, Shane J LaRue2, David S Raymer1
1From the Division of Cardiology, Department of Medicine (M.E.N., S.J.L., E.N., J.M.V., G.A.E.) and Department of Medicine (D.S.R., B.F.G.), Washington University School of Medicine, St. Louis, MO.
Insights
Lowering anticoagulation intensity (INR) below 2.0 in continuous-flow left ventricular assist device (CF-LVAD) patients increases thrombotic events. Optimal INR for CF-LVAD patients is 2.6 to balance risks.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Device Technology
Background:
- Continuous-flow left ventricular assist devices (CF-LVADs) are crucial for heart failure management.
- Previous research suggested lower target International Normalized Ratio (INR) values (<2.5) for CF-LVAD patients.
- Recent data indicate a rise in pump thrombosis, particularly within six months post-implantation.
Purpose of the Study:
- To evaluate thrombotic and bleeding outcomes in CF-LVAD patients based on anticoagulation intensity.
- To determine the relationship between INR levels and adverse events in CF-LVAD recipients.
- To identify an optimal INR range for managing CF-LVAD patients.
Main Methods:
- Retrospective review of 249 CF-LVAD outpatients (January 2005 - August 2013).
- Analysis of 10,927 INR measurements using Poisson models to assess event rates.
- Multivariate Cox proportional hazard models adjusted for clinical factors.
Main Results:
- During a mean follow-up of 17.6 months, 46 thrombotic events occurred.
- Highest thrombotic event rates were observed at INR <1.5 (0.40 events/patient-year) and 1.5-1.99 (0.16 events/patient-year).
- INR was inversely associated with thrombotic events (HR 0.40; P=0.002); optimal INR was 2.6.
Conclusions:
- INR is inversely related to thrombotic events in CF-LVAD patients.
- INR values below 2.0 are associated with increased thrombotic events.
- An INR of 2.6 is suggested as optimal for balancing thrombotic and bleeding risks in CF-LVAD patients.
Background:
We evaluated thrombotic and bleeding outcomes in patients with continuous-flow left ventricular assist devices (CF-LVADs), stratified by anticoagulation intensity. Previous studies of outpatients with CF-LVADs have suggested that target international normalized ratio (INR) values <2.5 (range, 2-3) may be used. However, recent studies reported an increase in pump thrombosis among CF-LVADs, especially within the first 6 months of implant.
Methods And Results:
We retrospectively reviewed 249 outpatients at our center who received a CF-LVAD between January 2005 and August 2013. Using Poisson models, we analyzed their 10 927 INRs to determine INR-specific rates of thrombotic (ischemic stroke and suspected pump thrombosis) and hemorrhagic (gastrointestinal bleeding and hemorrhagic stroke) events occurring outside of the hospital. In multivariate analyses, we adjusted for age, sex, atrial fibrillation, coronary disease, and LVAD type as time-dependent Cox proportional hazard models. During a mean follow-up of 17.6±13.6 months, thrombotic events occurred in 46 outpatients. The highest event rate (0.40 thrombotic events per patient-year) was in the INR range of <1.5, but INR values of 1.5 to 1.99 also had high rates (0.16 thrombotic events per patient-year). INR was inversely associated with thrombotic events (hazard ratio, 0.40; 95% confidence interval, 0.22-0.72; P=0.002). The optimal INR based on weighted mortality of thrombotic and bleeding events was 2.6.
Conclusions:
INR is inversely related to thrombotic events occurring outside of the hospital among patients supported with CF-LVADs. INR values <2.0 increase the rate of thrombotic events occurring outside of the hospital among patients supported with CF-LVADs.
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