Optimizing Surgical Approaches for Patients with Inherited Factor VII Deficiency

Authors: García-Jaén, P; Martín de Bustamante, José Manuel; Mendoza-Martínez, A; Galván-Platas, S; Monleón-Gil, R; Calzadilla-Román, KS; Nicolás-Boluda, C; Rey-Bua, B; Puerta-Vázquez, C; Zapata-Tapia, E; Cortés-Rodríguez, M; Hortal, A; Martínez-Robles, V; Cebeira, MJ; García Díaz, C; Rodríguez-Alen, A; Aguilar-Franco, C; Marcellini, S; Fernández-Fontecha, EM; Dávila-Valls, J; Valle-Herrero, S; Benito, R; Bermejo, N; Calvo Villas, JM; Álvarez Román, MT; González-Porras, JR; Bastida, JM

Affiliations: Servicio de Hematología, Complejo Asistencial Universitario de Salamanca (CAUSA), Instituto de Investigación Biomédica de Salamanca (IBSAL), Universidad de Salamanca (USAL), Salamanca, Spain. Servicio de Hematología, Hospital Universitario La Paz, Madrid, Spain. Servicio de Hematología, Hospital Universitario Miguel Servet, Zaragoza, Spain. Servicio de Hematología, Hospital San Pedro de Alcántara, Cáceres, Spain. Servicio de Oncología Radioterápica, Complejo Asistencial Universitario de Salamanca (CAUSA), Salamanca, Spain.

Publication: Thrombosis and Haemostasis; 2025

ABSTRACT: Background Inherited Factor VII deficiency (FVIID) presents a highly variable bleeding phenotype. The weak correlation between plasma FVII levels (FVII:C) and bleeding severity results in diverse management strategies and complicates surgical decision-making. Objectives To describe surgical management and bleeding outcomes in patients with FVIID, and to identify key decision-making variables and predictors of surgical bleeding. Patients/Methods We conducted a multicenter, retrospective study of 380 surgeries performed in 215 patients with FVIID. Patients were classified by FVII:C levels as mild, moderate, or severe deficiency. Bleeding score (BS) was defined according to ISTH-BAT. Surgeries were categorized as low-risk (LR) or highrisk ((HR) for bleeding. A decision-tree simulation was performed. Results Most patients had mild FVIID (76%), and 69% of surgeries were classified as LR. Prophylactic treatment with tranexamic acid (TA) and/or rFVIIa was administered in 43.9% of LR and 61% of HR surgeries. Prophylaxis was given to 73.9% of moderate/severe and 41% of mild FVIID patients, especially for HR procedures. FVII:C levels and surgical bleeding risk were key factors that influenced the selection of treatment. The overall bleeding rate was 3.1% (HR: 6.8%; LR: 1.5%). Most bleeding events occurred in mild FVIID patients with BS≥3, without prophylaxis or treated with TA alone. Our algorithm recommends hemostatic treatment for HR surgeries and LR procedures when bleeding score is ≥3. Conclusions FVII:C levels and surgery type influence prophylactic hemostatic treatment strategies. Patients with mild FVIID, higher BS, and no hemostatic treatment had a greater risk of bleeding. Bleeding score and procedural risk were identified as predictors of surgical bleeding.