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Presentation Details
| Surgery in the Emicizumab Era: Real-World Evidence from the Mid-Atlantic Region Jan G.Kuhn1, Erika J.Martin1, Regina Butler2, Susan Gallagher2, Lisa Maiale-Howell2, J.Nathan Hagstrom3, Elle Levy4, Dyanne Morris5, Margy Sennett6. 1Virginia Commonwealth University, Richmond, VA, USA.2Children's Hospital of Philadelphia, Philadelphia, PA, USA.3Lehigh Valley Health Network, Allentown, PA, USA.4Children’s National Hospital, Washington, DC, USA.5University of Pennsylvania, Philadelphia, PA, USA.6University of Virginia, Charlottesville, VA, USA |
Abstract
Background:
Emicizumab (Emi) is a bispecific monoclonal antibody that mimics factor VIII function and provides effective prophylaxis for patients with hemophilia A, with or without inhibitors. While Emi significantly reduces spontaneous bleeding, it does not fully normalize hemostasis and interferes with standard coagulation assays, complicating perioperative management. Despite its growing use, real-world data on surgical outcomes in Emi-treated patients remain limited. Objectives:
To evaluate bleeding and clotting outcomes in patients on Emi undergoing surgery and invasive procedures, and to analyze the relationship between the use of factor concentrates, bypassing agents, and/or antifibrinolytics and surgical bleeding complications. Methods:
In 2021, the Mid-Atlantic Region Hemophilia Treatment Centers (MAR) partnered with the American Thrombosis and Hemostasis Network (ATHN) to develop data validation forms using de-identified ATHN dataset (ADS) from ATHN Clinical Manager, reducing data entry burden. Demographic and clinical data, including inhibitor status, medication use, surgery type, and bleeding outcome, were analyzed monthly by the project subcommittee. Clusters of surgeries and procedures with similar bleeding risks have emerged. To date, these included dental surgeries, gastrointestinal scopes, total joint replacements, skin surgeries, circumcisions, orthopedic scopes or biopsies, and central line placements or removals. Data analysis was descriptive with total number of days of product coverage by surgery. This includes the increasing use of long-acting factor concentrates. Results:
As of December 2025, 149 surgeries were performed in 107 patients across 11 centers. Most patients had severe FVIII deficiency (81%), and 29% reported a current or historical inhibitor. Excessive bleeding occurred in 8 cases (5.4%), primarily in dental procedures. No bleeding was reported in any of the single tooth extractions, despite significant variation in product usage. Bleeds occurred after multiple dental extractions in both inhibitor and non-inhibitor patients. Gastrointestinal scopes, orthopedic surgeries, circumcisions, and skin procedures had no bleeding events. GI scopes with biopsy averaged 2 days of factor or bypass therapy and 3.4 days of antifibrinolytics, while circumcisions consistently involved ≥5 days of antifibrinolytics. Minor skin lesion excisions required one day of factor therapy and no antifibrinolytics. More complex skin surgeries such as Mohs procedures, scar revisions, and cyst excisions typically required 4 days of factor therapy, with scar revision and Mohs surgery also needing extended antifibrinolytic coverage of 5 to 6 days. No bleeding occurred in total joint replacements or revisions; however, the latter generally used fewer days of factor. Use of factor concentrate varied widely in orthopedic scopes, biopsies and injections. Of the 18 orthopedic procedures, only 3 reported receiving antifibrinolytic agents which may reflect underreporting or minimal use. Overall, product usage varied widely, but excessive bleeding remained infrequent. Conclusions:
The MAR Emi Surgery and Procedure Project underscores the value of real-world data in guiding perioperative management for Emi-treated patients. While bleeding risks remain, especially in certain procedures, careful use of factor concentrate and antifibrinolytic therapies appears effective. Continued data collection and analysis are essential to refine best practices and support clinical decision-making in this evolving therapeutic landscape and may have implications for other non-factor therapeutics.
No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.
Emicizumab (Emi) is a bispecific monoclonal antibody that mimics factor VIII function and provides effective prophylaxis for patients with hemophilia A, with or without inhibitors. While Emi significantly reduces spontaneous bleeding, it does not fully normalize hemostasis and interferes with standard coagulation assays, complicating perioperative management. Despite its growing use, real-world data on surgical outcomes in Emi-treated patients remain limited. Objectives:
To evaluate bleeding and clotting outcomes in patients on Emi undergoing surgery and invasive procedures, and to analyze the relationship between the use of factor concentrates, bypassing agents, and/or antifibrinolytics and surgical bleeding complications. Methods:
In 2021, the Mid-Atlantic Region Hemophilia Treatment Centers (MAR) partnered with the American Thrombosis and Hemostasis Network (ATHN) to develop data validation forms using de-identified ATHN dataset (ADS) from ATHN Clinical Manager, reducing data entry burden. Demographic and clinical data, including inhibitor status, medication use, surgery type, and bleeding outcome, were analyzed monthly by the project subcommittee. Clusters of surgeries and procedures with similar bleeding risks have emerged. To date, these included dental surgeries, gastrointestinal scopes, total joint replacements, skin surgeries, circumcisions, orthopedic scopes or biopsies, and central line placements or removals. Data analysis was descriptive with total number of days of product coverage by surgery. This includes the increasing use of long-acting factor concentrates. Results:
As of December 2025, 149 surgeries were performed in 107 patients across 11 centers. Most patients had severe FVIII deficiency (81%), and 29% reported a current or historical inhibitor. Excessive bleeding occurred in 8 cases (5.4%), primarily in dental procedures. No bleeding was reported in any of the single tooth extractions, despite significant variation in product usage. Bleeds occurred after multiple dental extractions in both inhibitor and non-inhibitor patients. Gastrointestinal scopes, orthopedic surgeries, circumcisions, and skin procedures had no bleeding events. GI scopes with biopsy averaged 2 days of factor or bypass therapy and 3.4 days of antifibrinolytics, while circumcisions consistently involved ≥5 days of antifibrinolytics. Minor skin lesion excisions required one day of factor therapy and no antifibrinolytics. More complex skin surgeries such as Mohs procedures, scar revisions, and cyst excisions typically required 4 days of factor therapy, with scar revision and Mohs surgery also needing extended antifibrinolytic coverage of 5 to 6 days. No bleeding occurred in total joint replacements or revisions; however, the latter generally used fewer days of factor. Use of factor concentrate varied widely in orthopedic scopes, biopsies and injections. Of the 18 orthopedic procedures, only 3 reported receiving antifibrinolytic agents which may reflect underreporting or minimal use. Overall, product usage varied widely, but excessive bleeding remained infrequent. Conclusions:
The MAR Emi Surgery and Procedure Project underscores the value of real-world data in guiding perioperative management for Emi-treated patients. While bleeding risks remain, especially in certain procedures, careful use of factor concentrate and antifibrinolytic therapies appears effective. Continued data collection and analysis are essential to refine best practices and support clinical decision-making in this evolving therapeutic landscape and may have implications for other non-factor therapeutics.
No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.