Orthopaedic Surgery Outcomes in Patients With Haemophilia A or B Treated With Extended Half-Life Recombinant Factor VIII and IX Fc Fusion Proteins: A Multicentre Prospective Study.

INTRODUCTION

Haemophilia A and B are hereditary bleeding disorders that require multidisciplinary perioperative management. Data on orthopaedic surgery outcomes with extended-half-life (EHL) recombinant Fc-fusion factor VIII (rFVIIIFc) and factor IX (rFIXFc) products remain limited.

AIMS: To evaluate the efficacy of EHL rFVIIIFc or rFIXFc in major orthopaedic surgery, focusing on haemostasis, safety and factor consumption.

METHODS

This prospective study involved persons with haemophilia A or B treated with rFVIIIFc or rFIXFc undergoing orthopaedic surgery.

RESULTS

Twenty major orthopaedic surgeries (2018-2023) were included in 19 persons with severe or moderate haemophilia A (n = 14) or B (n = 5), median age 46 years (range 26-60). Procedures included arthroplasty, arthrodesis, arthroscopic synovectomy, prosthetic revision of the knee or ankle, and removal of a femur fracture fixation device. Median hospital stay was 7 days (range 2-18). Median cumulative factor consumption was 300 and 388 IU/kg for haemophilia A and B, respectively. Haemostatic efficacy was rated as 'good' in 95% (n = 18) of cases, 'poor' in 5% (n = 1), and not documented in one case. Median haemoglobin (Hb) change was -2.0 g/dL (range -4.6 to +0.5); no transfusions were required. Complications were reported in 45% (n = 9) of cases (anaemia 40%; blood loss 5%) and managed with oral supplementation of iron and folates. No adverse events related to rFVIIIFc or rFIXFc administration were observed.

CONCLUSION

RFVIIIFc and rFIXFc provide effective haemostasis during orthopaedic surgery in patients with haemophilia A and B, with a favourable safety profile. Further multicentre studies are warranted to confirm these results and refine perioperative management guidelines.