Experience of recombinant activated factor <scp>VII</scp> usage during surgery in patients with haemophilia with inhibitors

Polyanskaya, T. Yu.; Zorenko, V Yu; Карпов, Е. Е.; Сампиев, М. Т.; Mishin, G V; Vasiliev, D. K.

doi:10.1111/j.1365-2516.2012.02866.x

Cited by 12 publications

(7 citation statements)

References 16 publications

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“…Across all 35 publications, there was a wide range of surgical procedures categorized as being major or minor (Tables 1 and 2). 9,16 –42 Two articles defined surgical specialties (eg, orthopedic, cardiothoracic, neurosurgical), rather than individual procedures, as being major or minor. 18,40 In general, major surgical procedures were more likely to have been carried out under general anesthetic, while minor surgical procedures tended to be carried out under local anesthetic (Table 2).…”

Section: Resultsmentioning

confidence: 99%

Major and Minor Classifications for Surgery in People With Hemophilia: A Literature Review

Solimeno

Escobar²,

Krassova

et al. 2017

Clin Appl Thromb Hemost

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Agents that control bleeding and the usage of bypassing agents have made surgery an option to consider in people with hemophilia. However, the lack of consistent definitions for major or minor surgery may lead to inconsistencies in patient management. This literature review has evaluated how surgical procedures in people with hemophilia were categorized as major or minor surgery and assessed the consistency across publications. After screening 926 potentially relevant articles, 547 were excluded and 379 full-text articles were reviewed. Ninety-five articles categorized major or minor surgical procedures; of these, 35 publications categorized three or more major or minor surgical procedures and were included for analysis. Seven (20%) publications provided varying criteria for defining major or minor surgery, five of which defined surgery according to the level of surgical invasiveness. Across all 35 publications, there was considerable variance in the categorization of major and minor surgical procedures and some overlap in surgical nomenclature (eg, type of synovectomy, arthroscopy, and central venous access device insertion/removals). The lack of consistent guidance when referring to major or minor surgery in people with hemophilia needs to be addressed. Clear and consistent definitions, achieved by consensus and promoted by relevant international hemophilia committees, are desirable, to provide guidance on appropriate treatment, to increase the accuracy of trial data and may confound the interpretation of surgical outcomes.

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Section: Resultsmentioning

confidence: 99%

Major and Minor Classifications for Surgery in People With Hemophilia: A Literature Review

Solimeno

Escobar²,

Krassova

et al. 2017

Clin Appl Thromb Hemost

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“…Inhibitory antibodies to factor VIII (FVIII) or IX (FIX) are formed as notable complications in 10-30% and 2-5% of patients with hemophilia A and B, respectively [ 1 ]. This poses challenging problems for clinicians treating patients with hemophilia A or B undergoing surgical interventions in that inhibitors not only rapidly inactivate coagulation factordeficient concentrates but also stimulate the synthesis of new antibodies [ 2 ]. According to a recent European study [ 3 ], hemophilia patients with inhibitors are more vulnerable to arthropathy and orthopedic and musculoskeletal complications leading to a prolonged hospital stay and uncontrolled bleeding compared with those without inhibitors.…”

Section: Introductionmentioning

confidence: 99%

“…That is, prevention for bleeding should be considered during the perioperative period. Bypassing agents are used to control and prevent bleeding during the perioperative period in hemophilia patients with inhibitors [ 1 2 6 7 8 ]. Two types of bypassing agents are currently available in the clinical setting: activated prothrombin complex concentrates (APCC) (FEIB; Baxter, Vienna, Austria) and recombinant activated factor VII (rFVIIa) (NovoSeven; Novo Nordisk, Bagsvaerd, Denmark).…”

Section: Introductionmentioning

confidence: 99%

“…Two types of bypassing agents are currently available in the clinical setting: activated prothrombin complex concentrates (APCC) (FEIB; Baxter, Vienna, Austria) and recombinant activated factor VII (rFVIIa) (NovoSeven; Novo Nordisk, Bagsvaerd, Denmark). A few clinical studies have shown that bypassing agents can be safe, effective treatments to manage bleeding before and after surgery and to prevent bleeding in hemophilia patients with inhibitors [ 1 2 6 7 ]. However, the number of reported cases involving emergency conditions and elective surgeries remains limited, and a consensus regarding the efficacy and safety of bypassing agents is still needed.…”

Section: Introductionmentioning

confidence: 99%

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The efficacy of bypassing agents in surgery of hemophilia patients with inhibitors

Jang

Park

2015

Blood Res

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BackgroundInhibitory antibodies to factor VIII (FVIII) or IX (FIX) are important issues when managing patients with hemophilia A or B. Advances in bypassing agents such as recombinant activated FVII (rFVIIa) and activated prothrombin complex concentrates (APCC) have enabled the aggressive management of hemophilia with inhibitors during emergency or elective surgery. This study provides an updated evaluation of the safety and effectiveness of bypassing agents in treating perioperative bleeding.MethodsWe reviewed the records of hemophilia patients with inhibitors who underwent surgery between May 2008 and July 2014 using bypassing agents or high-dose FVIII concentrates at a single center.ResultsIn total, 36 surgeries (24 orthopedic, 12 other) were conducted in 18 hemophilia patients with inhibitors. The median inhibitor titer at surgery was 14 (range, 0.7-1,900) Bethesda units. Most patients had high-responding inhibitors. In total, 25 patients received APCC, 9 with rFVIIa initially. In most cases, bleeding stopped or was well controlled; however, bleeding in 6 patients was controlled using sequential bypassing therapy. Hemostatic efficacy of bypassing agents in various surgeries, based on the final patient outcome, was 94.4% (34/36). Among 5 emergency surgeries, 2 deaths occurred.ConclusionGood control of hemostasis can be achieved using bypassing agents in hemophilia patients with inhibitors who are undergoing surgery. Thorough planning is needed before elective surgery and more active and aggressive management may be needed for emergency surgery. Use of bypassing agents can facilitate safe and successful surgeries in hemophilia patients with inhibitors.

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“…The use of rFVIIa in open surgery in a patient with haemophilia and inhibitors was first reported in 1988 . Subsequently, a prospective double‐blind randomised dose‐finding surgical trial comparing rFVIIa 35 μg/kg vs. 90 μg/kg , and a number of retrospective reports, has established the safety and efficacy of rFVIIa for EOS in patients with inhibitors . Overall, these reports showed that rFVIIa is efficacious in controlling haemostasis peri‐ and post‐operatively in patients with inhibitors in both major and minor surgical procedures (Table ).…”

Section: Haemostatic Therapy and Outcomes In Eosmentioning

confidence: 99%

Optimising musculoskeletal care for patients with haemophilia

Carção

Hilliard

Escobar³

et al. 2015

European J of Haematology

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Despite recent improvements in the quality of care and treatment outcomes for haemophilia, joint disease remains a major concern for patients with and without inhibitors. Most bleeding episodes occur in the musculoskeletal system, and recurrent bleeding may result in progressive joint damage, leading to haemophilic arthropathy. Consequently, early identification and management of musculoskeletal bleeding episodes are important to prevent crippling deformities and dysfunction. Management strategies should aim at optimising joint function by reducing the frequency of, and preventing, joint bleeds. Although prophylactic factor replacement is proven to be effective in reducing bleeding frequency into joints and preserving musculoskeletal function in patients without inhibitors, the role for prophylaxis (with bypassing agents) in patients with inhibitors remains unclear. The available bypassing agents, activated prothrombin complex concentrate and recombinant activated factor VII (rFVIIa), are currently the standard of care for acute bleeding episodes in patients with high-titre inhibitors. These agents also prevent bleeding during elective orthopaedic surgery (EOS) in this patient population. This review discusses published data and uses illustrative cases to describe effective strategies for assessing joint health and maintaining optimal musculoskeletal care, focusing on the use of rFVIIa for haemostatic control in haemarthroses and when EOS is required in patients with inhibitors.

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Experience of recombinant activated factor VII usage during surgery in patients with haemophilia with inhibitors

Cited by 12 publications

References 16 publications

Major and Minor Classifications for Surgery in People With Hemophilia: A Literature Review

Major and Minor Classifications for Surgery in People With Hemophilia: A Literature Review

The efficacy of bypassing agents in surgery of hemophilia patients with inhibitors

Optimising musculoskeletal care for patients with haemophilia

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