Abstract

Abstract 1262

Introduction:

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.

Aim:

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.

Methods:

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).

Results:

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).

Table 1.

Type of intervention, replacement therapy schedules and outcome

Minor Surgery ProceduresnReplacement Therapy (RT)RT daysTotal n. of dosesTotal dose μg/Kg IU/KgAnti- FibrinolyticsAdverse events
Oral Surgery + Multiple extractions rFVIIa 7 pdFVII 1 1–4 2–10 rFVIIa 19–60 pdFVII 9.3 5/8 Inhibitor (1 case) 
Single extractions rFVIIa 6 pdFVII 1 1–2 rFVIIa 14–110 pdFVII 300 6/7 NO 
ENT and Head & Neck rFVIIa 4 pdFVII 1 1–10 1–16 rFVIIa 7.2–510 pdFVII 112 2/5 NO 
Catheters pdFVII 2 FFP 1 1–4 pdFVII 18–29 FFP 50 ml/Kg NO NO 
Endoscopic biopsies rFVIIa 7 1–7 rFVIIa 10–300 2/7 NO 
Mixed rFVIIa 5 pdFVII 3 1–9 1–16 rFVIIa 15–60 pdFVII 60–370 1/8 NO 
Minor Surgery ProceduresnReplacement Therapy (RT)RT daysTotal n. of dosesTotal dose μg/Kg IU/KgAnti- FibrinolyticsAdverse events
Oral Surgery + Multiple extractions rFVIIa 7 pdFVII 1 1–4 2–10 rFVIIa 19–60 pdFVII 9.3 5/8 Inhibitor (1 case) 
Single extractions rFVIIa 6 pdFVII 1 1–2 rFVIIa 14–110 pdFVII 300 6/7 NO 
ENT and Head & Neck rFVIIa 4 pdFVII 1 1–10 1–16 rFVIIa 7.2–510 pdFVII 112 2/5 NO 
Catheters pdFVII 2 FFP 1 1–4 pdFVII 18–29 FFP 50 ml/Kg NO NO 
Endoscopic biopsies rFVIIa 7 1–7 rFVIIa 10–300 2/7 NO 
Mixed rFVIIa 5 pdFVII 3 1–9 1–16 rFVIIa 15–60 pdFVII 60–370 1/8 NO 
Conclusion:

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.

Disclosures:

No relevant conflicts of interest to declare.

Author notes

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Asterisk with author names denotes non-ASH members.