Management of an anti-factor VIII inhibitor occurring during surgical procedure with continuous infusion of Novoseven??

Cognet, V; Petit, P; Massignon, Denis; Négrier, Claude

doi:10.1097/00001721-199804000-00012

Cited by 10 publications

(6 citation statements)

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“…Several reports have appeared demonstrating the favorable use of CI of rFVIIa in hemophilic inhibitor surgery. [37][38][39][40][41][42][43] At the start of surgery, a single bolus injection of about 90 g/kg b.w. has been administered.…”

Section: Continuous Infusion Of Rfviia During and After Surgerymentioning

confidence: 99%

Efficacy and Safety of Recombinant Factor VIIa in the Prophylaxis of Bleeding in Various Surgical Procedures in Hemophilic Patients with Factor VIII and Factor IX Inhibitors

Ingerslev

2000

Semin Thromb Hemost

110

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Patients with hemophilia may develop alloantibodies (inhibitors) directed toward the substitution factor. In the long term, this complication significantly affects around 15% of hemophilia A patients and 2-5% of hemophilia B patients suffering the severe class of disease (critical functional factor level <0.01 IU/mL). The typical consequence of a newly developed inhibitor is that the patient can no longer take advantage of the principles of modern hemophilia management, including safe and early treatment of bleeding and prophylactic use of concentrate in prevention of bleeding. Moreover, problems that are normally solved by means of a surgical procedure covered by the usual concentrate will be regarded as difficult and are likely to be associated with risk of untoward bleeding if high-titer inhibitors are present. Over the past decade, considerable experience has been collected illustrating that surgery may be performed quite safely in the patient with inhibitors if hemostasis is assisted by a new hemostatic agent, an activated recombinant factor VII molecule (rFVIIa). Although only one controlled randomized surgical study has been presented, cumulated data from this and from other, less formal studies on the use of rFVIIa in hemophilic inhibitor surgery have illustrated that a vast variety of different surgical procedures can be accomplished with none of the life-threatening bleeding complications that would be anticipated if no hemostatic treatment was administered. The aim of the present review is to present a multiplicity of surgical procedures that have been carried out during the clinical development of rFVIIa. Further, an update of 21 surgical procedures in inhibitor patients from the center of the author will be reviewed and discussed.

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Section: Continuous Infusion Of Rfviia During and After Surgerymentioning

confidence: 99%

Efficacy and Safety of Recombinant Factor VIIa in the Prophylaxis of Bleeding in Various Surgical Procedures in Hemophilic Patients with Factor VIII and Factor IX Inhibitors

Ingerslev

2000

Semin Thromb Hemost

110

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“…By cross-checking relevant articles, additional articles were added to the list in a non-standardized manner. Almost 60 articles were identified describing 332 EOS procedures [7,41,[43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58][60][61][62][63][64][65][66][67][68][69][73][74][75]. Based on the classification of Perez Bianco et al [70] in which synoviorthesis and arthrocentesis are classified as minor and all other procedures are classified as major, 210 (63%) of the procedures were major and 122 (37%) were minor EOS procedures.…”

Section: Discussionmentioning

confidence: 99%

“…However, the majority of data on the use of rFVIIa are derived from case studies. A number of case studies have reported on the successful use of rFVIIa as haemostatic cover during elective surgery in haemophilia patients with high‐titer inhibitors [7,8,10–58]. In addition, results from a recent cost–benefit analysis suggest that major knee surgery using rFVIIa in haemophilia patients with inhibitors may be cost‐effective because of the reduced number of bleedings or improved quality of life experienced by these individuals following surgery [59].…”

Section: Introductionmentioning

confidence: 99%

Elective orthopaedic surgery for haemophilia patients with inhibitors: single centre experience of 40 procedures and review of the literature

et al. 2011

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With the introduction of safe and effective factor VIII/IX-bypassing agents--recombinant activated factor VII (rFVIIa) and plasma-derived activated prothrombin complex concentrates (pd-APCC)--elective orthopaedic surgery (EOS) is a viable option for haemophilia patients with inhibitors. We report a series of patients with haemophilia and inhibitors undergoing EOS between 1997 and 2008 using bypassing agents to provide haemostatic cover. All inhibitor patients undergoing EOS and receiving rFVIIa, plasma-derived prothrombin complex concentrates (pd-PCC) or pd-APCC as haemostatic cover were included. Patients were operated on by the same surgeon and were managed by the same haemophilia treatment centre. Forty procedures (25 minor and 15 major) were conducted in 18 patients. Twenty-one minor cases were covered using rFVIIa, three with pd-PCC, and one with pd-APCC; all major cases were covered using rFVIIa. Bleeding was no greater than expected compared with a non-haemophilic population in all 25 minor procedures. In the major procedure group, there was no excessive bleeding in 40% of cases (6/15) and bleeding completely stopped in response to rFVIIa. For the remaining nine cases, bleeding response to rFVIIa was described as 'markedly decreased' or 'decreased' in 4/15 cases and 'unchanged' in 5/15 cases. Overall, efficacy of rFVIIa, based on final patient outcome, was 85%. One death occurred as a result of sepsis secondary to necrotizing fasciitis. Good control of haemostasis can be achieved with bypassing agents in haemophilia patients with inhibitors undergoing minor EOS; rFVIIa was used as an effective bypassing agent, enabling EOS in patients undergoing minor and major procedures.

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“…Only English language literature was considered. Fifty articles were subsequently identified [10–57]. Underlying coagulopathy and/or the results of rFVIIa treatment in congenital haemophilia patients with inhibitors could be ascertained in only 46 of the 50 articles identified.…”

Section: Methodsmentioning

confidence: 99%

Surgical Experience with rFVIIa (NovoSeven) in congenital haemophilia A and B patients with inhibitors to factors VIII or IX

2011

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Patients with congenital haemophilia with inhibitors are at risk of peri-operative bleeding complications, since replacement of the missing coagulation factor is ineffective, presenting a therapeutic challenge in elective or emergency surgery. Therefore, the management of peri-operative bleeding requires the use of bypassing agents, such as recombinant activated FVII (rFVIIa, NovoSeven(®) ). This article presents an updated evaluation of the safety and effectiveness of rFVIIa in the treatment of peri-operative bleeding in this patient population. Surgical and other medical procedures managed with rFVIIa from two randomized clinical trials, the Hemophilia Research Society/Hemophilia and Thrombosis Research Society (HRS/HTRS) registry databases and the medical literature were analysed. There were 395 rFVIIa-treated procedures (261 surgical, 89 dental and 45 other medical procedures) reported for 263 congenital haemophilia patients with inhibitors. In trials, initial rFVIIa dosing was 35-90 mcg kg(-1) bolus injection or 50 mcg kg(-1) h(-1) continuous infusion. Dosing in the registries and literature was more variable. Recombinant FVIIa effectiveness was comparable across data sources, with an overall rate of 84% (333/395). The incidence of thrombotic events was very low (0.4% of patients and 0.025% of procedures). Prior to the US approval of rFVIIa in 1999, surgical procedures in congenital haemophilia patients with inhibitors were often considered too risky. Recombinant FVIIa has consistently demonstrated effectiveness in treatment of bleeding in these patients during such procedures. Thrombotic events were rare. This analysis confirms the value of corroborating clinical trial results with post-marketing surveillance registries to assess small patient populations with clinically challenging management decisions.

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Management of an anti-factor VIII inhibitor occurring during surgical procedure with continuous infusion of Novoseven??

Cited by 10 publications

References 0 publications

Efficacy and Safety of Recombinant Factor VIIa in the Prophylaxis of Bleeding in Various Surgical Procedures in Hemophilic Patients with Factor VIII and Factor IX Inhibitors

Efficacy and Safety of Recombinant Factor VIIa in the Prophylaxis of Bleeding in Various Surgical Procedures in Hemophilic Patients with Factor VIII and Factor IX Inhibitors

Elective orthopaedic surgery for haemophilia patients with inhibitors: single centre experience of 40 procedures and review of the literature

Surgical Experience with rFVIIa (NovoSeven) in congenital haemophilia A and B patients with inhibitors to factors VIII or IX

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