PB1145 - Real World Experience of perioperative haemostasis with Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in people with Haemophilia A (PWHA)

Tuesday, July 12, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Presenting Author(s)

Moninne Murray

Non-Consultant Hospital Doctor
St. James's Hospital, Dublin, Ireland
Dublin 16, Dublin, Ireland

Co-Author(s)

SB

Sara Bocchinfuso

Medical Student
Trinity College Dublin, The University of Dublin
Dublin, Dublin, Ireland
MO

Mairead O'Donovan

Non Consultant Hospital Doctor
St James's Hospital, Dublin, Ireland
Dublin, Dublin, Ireland
ES

Evelyn Singleton

National Coordinator of coagulation factor concentrates,Clinical nurse manager (CNM3)
National Coagulation Centre ,St James's Hospital,Dublin8
Dublin, Dublin, Ireland
JB

Julie Benson

Clinical Nurse Manager
St James's Hospital, Dublin, Ireland
Dublin, Dublin, Ireland
NL

Niamh Larkin

Advanced Nurse Practitioner
St. James's Hospital, Dublin
Dublin, Dublin, Ireland
MB

Mary Byrne

Coagulation Laboratory Chief
National Coagulation Centre, St James's Hospital, Dublin
Dublin, Dublin, Ireland
MM

Mark McGowan

Physiotherapist in National Coagulation Centre, Ireland
St James's Hospital, Dublin, Ireland
Dublin, Dublin, Ireland
SR

Sheila Roche

Physiotherapist in National Coagulation Centre, Ireland
St James's Hospital, Dublin, Ireland
Dublin, Dublin, Ireland
KR

Kevin Ryan

Consultant Haematologist
National Coagulation Centre, St James's Hospital, Dublin
Dublin, Dublin, Ireland
Niamh O'Connell, MD

St. James Hospital
Dublin, Ireland

Background: In Ireland, since 2018, recombinant factor VIII Fc fusion protein (rFVIIIFc) is used exclusively for perioperative haemostasis in people with haemophilia A (PWHA).

Aims: To evaluate real-world surgical outcomes in PWHA (≥18 years) who received rFVIIIFc for surgical haemostasis.

Methods: Single centre, retrospective review of all PWHA who underwent major and minor surgical procedures between January 2018 and September 2021 and who received rFVIIIFc perioperatively for haemostasis.

Results: 24 major and 225 minor procedures were managed with rFVIIIFc in 105 PWHA (96 male and 9 female). Major procedures included 16 orthopaedic and 8 other procedures which were undertaken in people with severe (n=7), moderate (n=5) and mild (n=9) haemophilia. The median pre-operative dose was 46.5 IU/kg (range 21-58 IU/kg), resulting in a median pre-operative FVIII:C level of 1.2 IU/mL (range 0.8-1.98 IU/mL). A second infusion on the day of surgery was given if the postoperative FVIII:C level was < 0.9 IU/mL (8/24 procedures). Median number of perioperative infusions was 8 (range 3-22) and the total median rFVIIIFc consumption in severe, moderate and mild HA was 388 IU/kg (194-654 IU/kg), 250 IU/kg (165-257 IU/kg) and 93 IU/kg (range 58-247 IU/kg), respectively. Haemostasis was rated as excellent in 23/24 major procedures and good in one total knee replacement due to excess postoperative blood loss, though not requiring red cell transfusion.

225 minor procedures were undertaken in people with severe (n=38), moderate (n=11) and mild (n=42) haemophilia. These included 48 dental, 52 orthopaedic, 59 endoscopic, and 66 non-categorised procedures. Most minor procedures required a single infusion of rFVIIIFc, with bleeding complications in < 1% of minor procedures. A transient inhibitor ( < 0.5 BU) was detected in one patient four weeks post procedure but was not present on repeat testing.

Conclusion(s): Perioperative surgical haemostasis with rFVIIIFc is effective and safe in real-world conditions in PWHA.