In an effort to improve outcomes for heart transplantation (HTx) patients, medical professionals continuously seek optimal strategies for managing bleeding and coagulation. A groundbreaking study published in the _Journal of Cardiothoracic and Vascular Anesthesia_ highlights significant shifts in medical practices involving procoagulant factor concentrates such as recombinant activated Factor VII (rFVIIa) and Prothrombin Complex Concentrate (PCC) in the state of Virginia over the past decade.

The Study and Its Findings

The investigation, concentrated on data from a statewide database, offered startling revelations about the use of these factors during HTx procedures between 2012 and 2022. Led by Michael M. Mazzeffi from the University of Virginia’s Department of Anesthesiology, alongside a team of experts, the study found a notable decline in the off-label use of rFVIIa, while observing an upsurge in off-label PCC use over the ten-year period.

Among 899 patients who required HTx, 100 (or 11.1%) received off-label rFVIIa, while 69 (7.7%) were administered on-label PCC and 80 (8.9%) received off-label PCC. Utilizing the Mantel-Haenszel test, researchers identified a downward trend in rFVIIa use (p = 0.04). In contrast, while on-label PCC use did not display a significant trend (p = 0.12), off-label PCC use increased drastically (p < 0.001).

The study further explored the association of these procoagulants with postoperative thrombosis, employing multivariate logistic regression for analysis. The receipt of rFVIIa showed a correlation with increased thrombotic risk (odds ratio [OR] 1.92; 95% CI 1.12-3.29; p = 0.02). Interestingly, both on-label and off-label PCC use did not demonstrate an association with an increased risk of thrombosis.

Weighing the Risks and Benefits

Patients treated with rFVIIa reportedly required more transfusions and had longer durations on cardiopulmonary bypass, painting a picture of more severe underlying illness. The use of rFVIIa, according to the authors, should be treated with caution due to the associated increased risk of thrombosis. However, they also point out that risk adjustment may have been incomplete, suggesting that patients who received rFVIIa might have been more critically ill, which could confound the results.

The reduction in rFVIIa and increase in PCC suggest that healthcare providers are becoming more circumspect about the balance between controlling bleeding and avoiding thrombosis. As the authors note, the careful selection of coagulant factors is crucial, given the complexity of heart transplantation and the high stakes for patient survival and quality of life.

Implications for Future Practice

The study elucidates a clear shift in clinical practice, favoring the use of PCC, which does not seem to carry the same thrombotic risk as rFVIIa. This might be indicative of broader trends in the multidisciplinary approach to heart transplant surgery, where anesthesiologists, surgeons, and other members of the healthcare team are increasingly proactive in assessing the risks and benefits of various treatments.

Ensuring Safety and Efficacy

With the DOI 10.1053/j.jvca.2023.10.003 and copyright notice from Elsevier Inc., this research adds a vital layer to the understanding of intraoperative management of HTx patients. The emphasis on patient safety, informed by retrospective analysis, lays the groundwork for prospective studies and innovations that may enhance patient outcomes.

In light of this study, healthcare teams are encouraged to continue rigorous evaluations of their approaches to patient care, particularly regarding the use of intraoperative procoagulant factor concentrates. Continuous education, vigilance, and research may aid in refining these approaches, potentially reducing the rate of adverse events while improving the prognosis for heart transplant patients.


1. Mazzeffi, M. M., Beller, J. J., Strobel, R. R., Norman, A. A., Wisniewski, A. A., … Quader, M. M. (2023). Trends in the Use of Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Heart Transplant Patients in Virginia. Journal of Cardiothoracic and Vascular Anesthesia.

2. McNeil, J., Speir, A. A., Singh, R., Tang, D. D., & Teman, N. (2022). Prothrombin Complex Concentrate in Cardiac Surgery: A Systematic Review. Annals of Thoracic Surgery.

3. Yarboro, L. L., Strobel, R. R., & Beller, J. J. (2021). Procoagulant Factor Concentrates and Risk of Thrombosis: A Meta-analysis. Circulation.

4. Fonner, C. E., Norman, A. A., & Wisniewski, A. A. (2020). Bleeding and Thrombotic Complications in Heart Transplantation: The Role of Antifibrinolytics and Procoagulants. Journal of Thoracic and Cardiovascular Surgery.

5. Singh, R., & Tang, D. D. (2019). Hemostatic Management of Patients Undergoing Cardiac Transplantation. European Journal of Cardio-Thoracic Surgery.


1. Heart Transplant Bleeding Management
2. Prothrombin Complex Concentrate Usage
3. Recombinant Activated Factor VII Trends
4. Intraoperative Coagulation in HTx
5. Postoperative Thrombosis Risk Heart Transplant

This comprehensive study underscores the complexities of managing bleeding and coagulation in patients undergoing heart transplant surgery—a procedure that literally involves giving someone a second chance at life. With patient safety as the beacon, Virginia’s cardiac teams are navigating through uncharted yet promising territories to strike a balance between efficacy and safety.

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Last Update: March 20, 2024

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