Perioperative management and neuraxial analgesia in women with factor XI deficiency (<60 IU/dL): a French multicenter observational study of 314 pregnancies

• Published in: Research and practice in thrombosis and haemostasis Vol. 8; no. 4; p. 102462
• Main Authors: Flaujac, C., Faille, D., Lavenu-Bombled, C., Drillaud, N., Lasne, D., Billoir, P., Desconclois, C., Touzet, L., Lebreton, A., Diaz-Cau, I., d’Oiron, R., Giansily-Blaizot, M., Wibaut, B., Beurrier, P., Volot, F., Rugeri, L., Roussel-Robert, V., de Raucourt, E.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-05-2024
• Subjects: bleeding; epidural anesthesia; factor XI; observational study; spinal anesthesia; epidural anesthesia; spinal anesthesia; bleeding; factor XI; observational study
• ISSN: 2475-0379; 2475-0379
• DOI: 10.1016/j.rpth.2024.102462

Factor (F)XI deficiency is a rare bleeding disorder with a poor correlation between bleeding tendency and FXI level. Management of pregnant women with FXI deficiency is not clearly established, especially regarding neuraxial analgesia (NA).
A retrospective multicenter observational study was conducted in French hemostasis centers on pregnant women with FXI of <60 IU/dL.
Data to report were (i) FXI levels before pregnancy and at time of delivery, (ii) type of NA and delivery management modalities, and (iii) possible complications related to NA and bleeding complications.
Three hundred fourteen pregnancies in patients with FXI deficiency of <60 IU/dL were reported (from 20 centers); among them, 199 NA procedures have been completed (137 epidurals and 61 spinals, 1 had both). The period of childbirth was mostly from 2014 to 2020 (281/314; 89.5%). Congenital FXI deficiency was established with certainty by investigators in 32.8% patients (n = 103). Previous bleedings were described in 20.4% of the patients (64/314; 45.3% cutaneous, 31.3% gynecologic, and 15.6% postsurgical). Thirteen deliveries had an NA procedure with FXI of <30 IU/dL, 42 with FXI of 30-40 IU/dL, and 118 with FXI of 40-60 IU/dL. Median FXI levels at delivery in the epidural and spinal groups were not significantly different but were significantly lower in the group without NA by medical staff contraindications. There were no complications related to NA. A 17.5% postpartum hemorrhage or excessive postpartum bleeding incidence was reported, which is consistent with previous data.
Our data support the use of a 30 IU/dL FXI threshold for NA, as suggested by the French proposals published in August 2023.
•Factor (F)XI deficiency is a rare bleeding disorder with a poor correlation between bleeding tendency and FXI level. The management of FXI deficiency in pregnant women is not yet established, particularly with regard to neuraxial analgesia (NA).•We conducted an anonymous retrospective study from 2009 to 2020 of women with FXI activity level below 60 IU/dL before pregnancy and/or below 60 IU/dL at time of delivery in 20 French centers. Of the 314 reported pregnancies, 199 NA procedures were completed (137 epidurals and 61 spinals, 1 had both). There were no complications related to NA, and 173 NAs were allowed with known FXI levels at time of delivery ranging from 17 to 60 IU/dL with a mean FXI level at time of delivery of 44.2 ± 9.5 IU/dL.•Our results support the use of a 30 IU/dL threshold for NA (all types of NA in women with no bleeding history: spinal and epidural) at time of procedure or for catheter removal. However, we also reported a 17.5% incidence of postpartum hemorrhage or excessive postpartum bleeding, which is in accordance with previous studies. Our results now need to be confirmed by large prospective studies.