Evaluation of Postoperative Thromboembolic Events in Orthotopic Heart Transplant Patients Receiving 4-Factor Prothrombin Complex Concentrate Monotherapy Versus Combination Therapy With Very Low-Dose Recombinant Activated Factor VII: A Retrospective Cohort Study.

OBJECTIVES

To explore whether the addition of very low-dose recombinant activated factor VII (rFVIIa) to 4-factor prothrombin complex concentrate (4F-PCC) increases postoperative thromboembolic events in patients undergoing orthotopic heart transplantation (OHT) complicated by severe coagulopathy.

DESIGN

Single-center, retrospective cohort study.

SETTING

Tertiary academic medical center in Boston, Massachusetts.

PARTICIPANTS

Adults (aged ≥ 18 years) who underwent OHT between January 1 and December 31, 2023, and received 4F-PCC, with or without rFVIIa, for perioperative coagulopathy.

INTERVENTIONS: Patients received either combination therapy with 4F-PCC and very low-dose rFVIIa (<20 μg/kg) or 4F-PCC monotherapy.

MEASUREMENTS AND MAIN

RESULTS

The primary outcome was the incidence of thromboembolic events within 30 days postoperatively or until discharge, whichever occurred first. Secondary outcomes included intraoperative transfusion requirements, perioperative hemostatic agent use, delayed chest closure due to coagulopathy, reoperation for bleeding, 12-hour chest tube output, 24-hour transfusion requirements, and in-hospital mortality. Among 56 patients, 15 received combination therapy with 4F-PCC and rFVIIa while 41 received 4F-PCC monotherapy. Thromboembolic events occurred in 53.3% of the combination group and 34.1% of the monotherapy group (p = 0.32).

CONCLUSIONS

The addition of very low-dose rFVIIa to 4F-PCC during OHT demonstrated a non-statistically significant increase in thrombotic events. As this was a single-center cohort study with a relatively small number of patients and an inability to control for severity of illness, these findings should be regarded as exploratory for future studies.