Evaluation of safety criteria for enoxaparin bridging in patients with left ventricular assist devices in an outpatient care setting

Background

Appropriate anticoagulation is crucial for the success of left ventricular assist device patients. Currently, there is no consensus on the optimal management of their subtherapeutic INR in ambulatory setting. Our goal is to evaluate both the short-term adverse events and long-term outcomes of enoxaparin bridging at a major transplant center, following the implementation of bridging safety criteria.

Methods

In total, 85 patients' medical records were reviewed between 7/2019 and 5/2022, with 51 patients meeting safety criteria were bridged with enoxaparin and 34 non-bridged. The primary endpoint was the occurrence of major bleeding/thrombosis events within 30 days of bridging. The secondary endpoint was freedom from events 30 days after enoxaparin initiation and overall patient survivability until the last follow-up.

Results

Within 30 days, no major bleeding/thrombotic events were noted. After 30 days, the major bleeding rate was 5.8% in bridged vs. 11.8% in non-bridged patients (p = 0.02). Overall, 3-year survival was 78% in the bridged vs. 49% in non-bridged patients (p < 0.001). In patients with no events, 3-year survival was 80% in bridged vs. 58% in non-bridged (p < 0.001). In the patients with bleeding events, 3-year survival was 55% in bridged vs. 51% in non-bridged (p = 0.11). At 1 year, freedom from bleeding in the bridged patients was 81% in patients with no events vs. 0% in those with an event (p < 0.0001).

Conclusion

When eligibility criteria for safe bridging were applied, the use of enoxaparin bridging was associated with no major bleeding/thrombotic events during bridging and improved 3-year survival in LVAD patients. Economically, using outpatient enoxaparin resulted in substantial healthcare savings, fewer readmissions, and improved quality of life.