Replacement Therapy for Minor Surgery and Invasive Procedures in Factor VII Deficiency: The STER Experience

Surgical bleeding is among the most frequent symptoms in Factor VII (FVII) deficient patients: in an analysis by our group, post-surgical bleeding was reported in 24% of cases (Mariani G. et al. Thromb Haemost 2005;93:481). A recent retrospective study showed a similar prevalence of surgical bleeding (15%) with a significant relation between this type of bleeding, deep hematomas and a FVII coagulant activity (FVIIc) of less than 7% (Benlakal F et al. J Thromb Haemost 2011;9:1149). Little is known about prevention of bleeding in ‘minor surgical interventions’, important tools in modern medicine, bearing not a negligible risk of bleeding, as local hemostasis may not always be punctually achieved.

Analysis of Replacement Therapy (RT) for minor surgeries in patients with FVII deficiency, prospectively reported in the Seven treatment Evaluation Registry (STER). Clinicaltrials.gov identifier: NCT01269138.

Analysis of RTs used in 38 minor surgical procedures (34 patients; FVIIc:<1–20%). Minor surgical procedures were defined as suggested by Kitchens (Surgery and hemostasis. Textbook of Consultative Hemostasis and Thrombosis. 2007).

Reported interventions included: oral surgery (n=15), endoscopic biopsies (n=7), catheter insertions (n=3), ear-nose-throat and head-neck (n=5), mixed type (n=8). RT schedules were based on recombinant-activated FVII (rFVIIa; n=29), plasma-derived FVII (pdFVII; n=8), or Fresh-Frozen-Plasma (n=1). One-day RT schedule was employed in 27 procedures, 2–10 days in 11 procedures. Total doses ranged from 7.2–510 μg/kg (rFVIIa) and 9–300 IU/kg (pdFVII). FFP was given at a total dose of 50 ml/kg (1-day treatment, split into 4 doses of 12.5 ml). Antifibrinolytics were administered together with RT in 16 procedures (11 dental) for a minimum of 1 day to a maximum of 7 days. No bleeding nor thrombotic events occurred; one patient developed an inhibitor (Table 1).

For most of the uncomplicated minor surgery procedures (single dental extractions, catheter insertions, endoscopic biopsies), one-day RT is sufficient with low to medium doses of rFVIIa (median 25 μg/Kg/bw) or pdFVII (median 18.5 UI/Kg/bw), possibly with more than one administration. In complicated and more elaborate interventions, longer-lasting RT schedules and higher doses may be needed.

No relevant conflicts of interest to declare.