Knee joint arthroplasty in a patient with haemophilia A and high inhibitor titre using recombinant factor VIIa (NovoSeven®): a new case report and review of the literature

Elective orthopaedic surgery is regularly withheld from patients with haemophilia and high inhibitor titre despite the presence of severe arthropathy and urgent medical need. A knee joint arthroplasty was performed in a patient with severe haemophilia A and a high inhibitor titre using recombinant factor VIIa (rFVIIa) as the sole coagulation factor. There was no abnormal bleeding during surgery although an increased blood loss through surgical drains did occur during the first 6 h postoperatively. Rehabilitation was started on day 1 and continued for 3 months. Walking commenced on day 4. After 1 year of follow-up, the clinical outcome of surgery was considered excellent with no pain, knee mobility at 0-5-90 degrees, and an International Knee Society score of 95/100. No rFVIIa-associated side-effects or thrombotic complications were reported. In conclusion, knee joint arthroplasty is now an option for haemophilia patients with a high inhibitor titre. An international review of all available data on elective orthopaedic surgery in inhibitor patients is required so that the optimal treatment regime can be defined and the short- and long-term risk-benefit ratio of surgery compared to that of noninhibitor patients.     

Elective surgery in patients with congenital coagulopathies and inhibitors: experience of the National Haemophilia Centre of Venezuela

Summary. Elective surgery in patients with congenital haemophilia with inhibitors carries a high risk of bleeding. However, inhibitor patients also have a high risk of haemarthroses and other orthopaedic complications, and surgery could improve their quality of life. Successful elective surgery has been reported in inhibitor patients under haemostatic cover with plasma‐derived activated prothrombin complex concentrate (pd‐aPCC) or recombinant activated factor VII (rFVIIa). Recombinant FVIIa has recently become available in Venezuela and, unlike pd‐aPCC, has not been associated with an anamnestic response. The aim of this study was to assess our experience using rFVIIa as a first‐line and sustained treatment in elective invasive surgical procedures at the National Haemophilia Centre in Venezuela. Surgical procedures were classified as major or minor, under haemostatic cover with rFVIIa. A total of 13 patients (12 with haemophilia A with high‐responding inhibitors and one with von Willebrand’s disease type 3) underwent a total of 19 surgical procedures under rFVIIa cover. Thirteen procedures were classified as major surgeries. Intraoperative haemostasis was achieved in the majority of patients. Only two patients required an additional dose of rFVIIa, at 30 min and 75 min, respectively, with good results. Postoperative haemostasis was considered effective in 16 of 18 (89%) of the procedures in haemophilia A patients. Treatment was considered to be ineffective in two patients because of excessive postoperative bleeding. Data from the study provide no safety concerns, and demonstrate that rFVIIa provides effective haemostatic cover in elective surgery in patients with inhibitors; research is ongoing to determine the optimal dose for such procedures.     

Methotrexate and early postoperative complications in patients with rheumatoid arthritis undergoing elective orthopaedic surgery

OBJECTIVES: To determine whether continued methotrexate treatment increases the risk of postoperative infections or of surgical complications in patients with rheumatoid arthritis (RA) within one year of elective orthopaedic surgery. DESIGN: A prospective randomised study of postoperative infection or surgical complications occurring within one year of surgery in patients with RA who underwent elective orthopaedic surgery. SUBJECTS: 388 patients with RA who were to undergo elective orthopaedic surgery. Patients who were receiving methotrexate were randomly allocated to groups who either continued methotrexate (group A) or who discontinued methotrexate from two weeks before surgery until two weeks after surgery (group B). Their complication rates were compared with complications occurring in 228 patients with RA (group C) who were not receiving methotrexate and who also underwent elective orthopaedic surgery. MAIN OUTCOME MEASURES: Signs of postoperative infection were recorded, including rubor, discharge, systemic infection, and frequency of wound dehiscence as well as the incidence of any surgical complication requiring a secondary revision procedure that occurred within one year of surgery. The frequencies of flare up activity of RA at six weeks and six months after surgery were also recorded. A flare of rheumatoid disease was defined as an increase in joint pain in two or more joints notified by the patient as well as by an increase in articular index of at least 25% after surgery. RESULTS: Signs of infection or surgical complications occurred in two of 88 procedures in group A (2%), 11 of 72 procedures in group B (15%), and 24 of 228 (10.5%) procedures in group C. The surgical complication or infection frequency in group A was less than that in either group B (p<0.003) or group C (p=0.026). At six weeks after surgery there were no flares in group A, six flares in group B (8%), and six flares in group C (2.6%). Logistic regression analysis of the overall surgical complication rate in all the patients with RA studied showed that methotrexate, whether continued or discontinued before surgery, did not increase the early complication rate in the patients with RA who underwent elective orthopaedic surgery. Other drugs-penicillamine, indometacin, cyclosporin, hydroxychloroquine, chloroquine, and prednisolone-all did significantly increase the risk of infection or surgical complication after elective orthopaedic surgery. The risk of surgery was also increased in the presence of intercurrent chronic diseases-diabetes, hypertension, bronchiectasis, psoriasis, asthma, and ischaemic heart disease. CONCLUSION: Continuation of methotrexate treatment does not increase the risk of either infections or of surgical complications occurring in patients with RA within one year of elective orthopaedic surgery. Thus methotrexate treatment should not be stopped in patients whose disease is controlled by the drug before elective orthopaedic surgery.     

Delayed wound healing and postoperative surgical site infections in patients with rheumatoid arthritis treated with or without biological disease-modifying antirheumatic drugs

Biological disease-modifying antirheumatic drugs (bDMARDs) have become more popular for treating rheumatoid arthritis (RA). Whether or not bDMARDs increase the postoperative risk of surgical site infection (SSI) has remained controversial. We aimed to clarify the effects of bDMARDs on the outcomes of elective orthopedic surgery. We used multivariate logistic regression analysis to analyze risk factors for SSI and delayed wound healing among 227 patients with RA (mean age, 65.0 years; disease duration, 16.9 years) after 332 elective orthopedic surgeries. We also attempted to evaluate the effects of individual medications on infection. Rates of bDMARD and conventional synthetic DMARD (csDMARD) administration were 30.4 and 91.0 %, respectively. Risk factors for SSI were advanced age (odds ratio [OR], 1.11; P?=?0.045), prolonged surgery (OR, 1.02; P?=?0.03), and preoperative white blood cell count >10,000/μL (OR, 3.66; P?=?0.003). Those for delayed wound healing were advanced age (OR, 1.16; P?=?0.001), prolonged surgery (OR, 1.02; P?=?0.007), preoperative white blood cell count >10,000/μL (OR, 4.56; P?=?0.02), and foot surgery (OR, 6.60; P?=?0.001). Risk factors for SSI and medications did not significantly differ. No DMARDs were risk factors for any outcome examined. Biological DMARDs were not risk factors for postoperative SSI. Foot surgery was a risk factor for delayed wound healing.     

Analysis of perioperative clinical features and complications after orthopaedic surgery in rheumatoid arthritis patients treated with tocilizumab in a real-world setting: results from the multicentre TOcilizumab in Perioperative Period (TOPP) study

Objective

To evaluate perioperative changes in rheumatoid arthritis (RA) patients treated with tocilizumab.

Methods

We collected RA cases with tocilizumab and orthopaedic surgery from 1999 to 2010. Incidences of postoperative infections, delayed wound healing, and RA symptom flare-ups were extracted from the data for comparison with patients without these postoperative events. We also evaluated the changes in C-reactive protein (CRP) and body temperature in patients without postoperative complications with normal CRP before surgery, i.e., patients without postoperative events in whom the tocilizumab level was maintained, for each duration to discontinuation before surgery.

Results

A total of 161 cases (n = 122) were collected. The patients had mean age of 56.9 years, and mean disease duration of 12.8 years at operation. Joint replacement surgery was performed in 89 cases. Three patients had postoperative infections (two superficial and one organ/space surgical-site infection), 20 had delayed wound healing, and 36 had RA symptom flare-ups. Delayed wound healing occurred most commonly in patients who underwent spinal surgery (P = 0.0061, versus patients without delayed wound healing). CRP levels were high when tocilizumab was restarted in patients with RA symptom flare-ups (P = 0.0010, versus patients without RA symptom flare-ups). Increased postoperative CRP was observed in patients without postoperative events when the duration from final tocilizumab infusion to surgery was long. The changes in body temperature showed a similar trend to CRP.

Conclusions

Although it has been demonstrated that infection rates in patients treated with tocilizumab are by no means high, incidence of delayed wound healing was significantly higher in cases with surgical interventions such as foot and spinal surgeries. Many patients treated with tocilizumab remained in a normal range of CRP even during the perioperative period. For prevention of perioperative complications, observation of postoperative conditions and surgical wounds, and subjective symptoms of patients are considered important.     

Cases of surgery in high-responder haemophilia patients

Summary.  We present 11 cases of surgery in haemophilia patients with inhibitors (high responders). They were: one haemorroidectomy, one vesical surgery in a high responder, one adenoidectomy, seven orthopaedic procedures (one bone fixation of a femoral neck fracture, four total knee arthroplasties, two total knee arthroplasties), and one retroperitoneal haematoma that required emergency surgery. We conclude that surgery in haemophilia patients with inhibitor can be considered feasible but nevertheless remains difficult. When applied to high-responding patients the treatment must take into account both the haemorrhagic risk and the risk of anamnestic response. Use of activated fractions as first-line therapy makes it possible (if the titre of the antibody allows it) to resort to conventional replacement therapy with FVIII or FIX concentrates. NovoSeven^® or FEIBA^® can be equally used as first-line therapy including therapy for major surgeries. It can be useful to alternate one with the other in case of occurrence of haemorrhagic complications.     

Major orthopaedic surgeries for haemophilia with inhibitors using rFVIIa

Summary. Between 2000 and 2008, 11 major orthopaedic surgeries for 7 congenital haemophilia patients with inhibitors were performed by the first author as the primary doctor using recombinant activated factor VII (rFVIIa). Orthopaedic surgical treatments were performed for six surgeries for four high‐responder haemophilia A patients, three surgeries for two high‐responder haemophilia B patients and two surgeries for one low‐responder haemophilia B patient. This low‐responder patient is allergic to factor IX products, so he usually uses rFVIIa as a haemostatic agent. All of the surgeries were major, such as joint arthroplasty, arthroscopic synovectomy, and a combination of both, and excellent surgical results were achieved. Seven cases were controlled by bolus infusion of rFVIIa, and the other four cases were controlled by combined bolus and continuous infusion of rFVIIa. An anti‐fibrolytic agent was used for all cases. There were no thrombogenic adverse effects, only two bleeding episodes. As for haemostatic control, nine surgeries were excellent, one was good and one was fair. This report is the largest clinical report on major orthopaedic surgeries at a single institute. We have concluded that the combination of bolus and continuous infusion of rFVIIa is safe and effective, and more convenient to administer than simple bolus infusion therapy to achieve haemostasis at peri‐operative periods. In addition, our data also concurs with the data of several previous reports which showed that orthopaedic surgery for haemophilia patients with inhibitors by means of rFVIIa is safe and effective.     

Routine application of the omental pedicle graft in 50 consecutive patients at risk for sternal wound infection

After cardiac surgery, healing can be delayed by sternal wound infection, particularly if mediastinitis develops. Because of the technical simplicity of omentopexy, we recommend the use during open-heart surgery of an omental pedicle graft in selected cases to prevent postoperative complications. This article describes our experience over a 4-month period (from 30 March 1989 through 2 August 1989) with this technique in 50 consecutive patients at moderate-to-high risk for postoperative sternal and mediastinal problems. The patients included 39 men (78%) and 11 women (22%), whose ages ranged from 22 to 83 years (mean, 55 years). Preoperative risk factors included extreme obesity, 13 patients (26%); chronic obstructive pulmonary disease, 13 patients (26%); diabetes mellitus, 6 patients (12%); obesity and diabetes, 8 patients (16%); and obesity, diabetes, and chronic obstructive pulmonary disease, 3 patients (6%). Operative risk factors included cardiac reoperation involving prolonged surgery, 6 patients (12%); bilateral mammary grafting, 17 patients (34%); and the need for prolonged (greater than 72-hour) mechanical respiratory assistance, 2 patients (4%). Three of the 50 patients (6%) were considered to be at moderate risk due to an increase in nosocomial infections at the time of their surgical procedures. Although the omentopexy itself caused no complications, 5 patients had major complications related to the cardiac procedure. Two of these patients died, for an operative mortality of 4%; death was caused by progressive peritonitis in 1 case and by cardiac tamponade in the other case. At least 2 of the remaining 3 patients withstood localized mediastinal infection and had thereafter an extremely benign postoperative course. We conclude that an omental pedicle graft, placed prophylactically in patients at risk for sternal wound infection, can serve as a valuable adjunct to healing after cardiac surgery.     

Complication rates of 127 surgical procedures performed in rheumatic patients receiving tumor necrosis factor alpha blockers

OBJECTIVE: Tumor necrosis factor (TNF) blockers have been reported to increase the risk of infections, thrombosis, and delayed healing. However, there is little data on the risk of complications after surgery in rheumatic patients receiving TNF blockers. The aim of this study was to assess the complication rate after surgery in such patients, to assess the effect of interrupting TNF blocker therapy, and to identify other potential predictors of complications. METHODS: This was a systematic, retrospective monocenter study of all patients treated with TNF blockers and who underwent surgery. Complications were recorded and complication rates were compared based on the type of surgery and the timing of the discontinuation of TNF blockers before surgery (above 2 or 5 half-lives). The complication rates were compared with those reported in the literature (orthopaedic procedures in RA patients: 7%, abdominal surgery: 13%). RESULTS: Between 1997 and 2004, 770 patients were treated with TNF blockers of whom 92 underwent surgery (127 surgical procedures). The most frequent underlying disease was rheumatoid arthritis (77%). Most of the surgical procedures were orthopaedic (85%). The complication rates for orthopaedic procedures and for abdominal procedures were 13% and 43%, respectively. The infection rate after orthopaedic procedures was 6.5%. Interrupting therapy before surgery did not significantly decrease the postoperative complication risk. There were no independent factors predicting complications. CONCLUSION: In daily practice the complication rate after surgery is high in patients treated with TNF blockers. Discontinuing TNF therapy before surgery should be considered, although this study did not clearly demonstrate its role.     

Should anti-TNF therapy be discontinued in rheumatoid arthritis patients undergoing elective orthopaedic surgery? A systematic review of the evidence

Anti-tumour necrosis factor (TNF) therapies have revolutionized the management of rheumatoid arthritis (RA). A high proportion of RA patients are now established users of anti-TNF agents. Unfortunately, many RA patients with longstanding disease still require elective orthopaedic procedures. Published studies on the influence of TNF antagonist on infection rates in RA patients undergoing surgery are conflicting. However, national registries of RA patients on anti-TNF reported an increased risk of infection. The risk of anti-TNF-related infection is highest at the start of treatment with frequent involvement of the skin and subcutaneous tissue. Infection at these sites could negatively influence the healing of surgical wound. Current guidelines suggest that treatment with biologics should be discontinued prior to surgery. Patients with established disease are more likely to flare compared to those with early disease on stopping treatment. Consequently, TNF blockers need to be reinstated promptly after surgery to avoid the risk of RA flare.     

Management of haemophilic patients with inhibitors in major orthopaedic surgery by immunadsorption, substitution of factor VIII and recombinant factor VIIa (NovoSeven®): a single centre experience

Inhibitors of factor VIII or FIX in haemophilic patients are a common and serious complication associated with an increased risk of life-threatening bleeding during elective surgery. Substitution therapy fails to be effective, therefore an alternative treatment is needed. We have performed six major elective orthopaedic interventions in four patients with haemophilia A and inhibitors. A preoperative immunadsorbant therapy with Therasorb to eliminate inhibitors was successful in four cases, but during FVIII substitution inhibitors increased on day 4 to day 6 after surgery, leading to decreasing FVIII levels. Therefore, therapy was changed to recombinant FVIIa (rFVIIa; NovoSeven). Two interventions had to be covered with sole rFVIIa therapy as immunadsorbant therapy failed to be effective in one case and the need for acute intervention did not allow pretreatment in the other. We did not see increased bleeding during or after surgery when compared to our experience with non-inhibitor haemophilic patients. In conclusion, a preoperative decrease of inhibitors from immunadsorbant therapy, perioperative substitution of FVIII and changing treatment to rFVIIa when inhibitors are increased, is a safe and economic therapy for guaranteeing haemostasis in major elective orthopaedic surgery. On the contrary, sole therapy with rFVIIa allows immediate surgical intervention without a long hospital stay prior to surgery and a need for laboratory monitoring of inhibitor titres and FVIII levels. Our findings support data previously published.     

Perioperative complications in elective surgery in patients with rheumatoid arthritis treated with biologics

Abstract

We retrospectively investigated the influence of biological agents on delayed wound healing and the occurrence of postoperative surgical site infection (SSI) in patients after surgery for rheumatoid arthritis. The patients were divided into two groups—those with and without treatment with biological agents (276 and 278 joints, respectively)—and adverse events (delay in wound healing and SSI) were investigated. Wound healing was delayed in 11.4% of total knee arthroplasty (TKA) operations, 16.7% of total ankle arthroplasty operations, and 9.7% of foot surgeries in the treatment group, and in 5.5% of TKA operations, 12.5% of total elbow arthroplasty operations, and 5.7% of foot surgeries in the non-treatment group. The difference in the incidence of delayed wound healing between the two groups was not statistically significant. In the treatment group, postoperative superficial and deep infection developed in one and two joints, respectively. In the non-treatment group, superficial infection developed in one joint. There was no statistically significant difference between the two groups. These findings suggest that the use of biological agents may not affect the incidence of postoperative adverse events related to wound healing and SSI.     

Perioperative complications in elective surgery in patients with rheumatoid arthritis treated with biologics

We retrospectively investigated the influence of biological agents on delayed wound healing and the occurrence of postoperative surgical site infection (SSI) in patients after surgery for rheumatoid arthritis. The patients were divided into two groups—those with and without treatment with biological agents (276 and 278 joints, respectively)—and adverse events (delay in wound healing and SSI) were investigated. Wound healing was delayed in 11.4% of total knee arthroplasty (TKA) operations, 16.7% of total ankle arthroplasty operations, and 9.7% of foot surgeries in the treatment group, and in 5.5% of TKA operations, 12.5% of total elbow arthroplasty operations, and 5.7% of foot surgeries in the non-treatment group. The difference in the incidence of delayed wound healing between the two groups was not statistically significant. In the treatment group, postoperative superficial and deep infection developed in one and two joints, respectively. In the non-treatment group, superficial infection developed in one joint. There was no statistically significant difference between the two groups. These findings suggest that the use of biological agents may not affect the incidence of postoperative adverse events related to wound healing and SSI.     

Orthopaedic surgery in haemophilic patients with inhibitors: an overview

Our experience and a review of the literature on inhibitors have shown that, with the availability of recombinant factor VIIa (rFVIIa), haemophilic patients with high inhibitor titres requiring elective orthopaedic surgery can undergo such surgery with a high expectation of success. The advent of rFVIIa has made major elective orthopaedic surgery possible in haemophilic patients with high-titre inhibitors, resulting in an improved quality of life. Recombinant FVIIa appears to be an efficient haemostatic product for surgery in patients suffering from haemophilia A and B with inhibitors. The series of major elective orthopaedic surgical procedures using rFVIIa (n=53) is the largest ever reported in haemophilic patients with inhibitors, despite the long-standing presence of other treatment modalities, such as high-dose human factor VIII (FVIII), porcine FVIII (n=8), and prothrombin complex concentrates/activated prothrombin complex concentrates (n=9). Thorough analysis of each case as part of a multidisciplinary team will allow us to perform elective orthopaedic procedures in patients with inhibitors.     

Consensus recommendations for the use of FEIBA® in haemophilia A patients with inhibitors undergoing elective orthopaedic and non‐orthopaedic surgery

A growing number of publications have described the efficacy and safety of FEIBA as a first‐line haemostatic agent for surgical procedures in haemophilia A patients with high‐responding FVIII inhibitors. The aim of this study was to provide practical guidance on patient management and selection and also to communicate a standardized approach to the dosing and monitoring of FEIBA during and after surgery. A consensus group was convened with the aims of (i) providing an overview of the efficacy and safety of FEIBA in surgery; (ii) sharing best practice; (iii) developing recommendations based on the outcome of (i) and (ii). To date there have been 17 publications reporting on the use of FEIBA in over 210 major and minor orthopaedic and non‐orthopaedic surgical procedures. Haemostatic outcome was rated as ‘excellent’ or ‘good’ in 78–100% of major cases. The reporting of thromboembolic complications or anamnestic response to FEIBA was very rare. Key to the success of FEIBA as haemostatic cover in surgery is to utilize the preplanning phase to prepare the patient both for surgery and also for rehabilitation. Haemostatic control with FEIBA should be continued for an adequate period postoperatively to support wound healing and to cover what can in some patients be an extended period of physiotherapy. Published data have demonstrated that FEIBA can provide adequate, well tolerated, peri and postoperative haemostatic cover for a variety of major and minor surgical procedures in patients with haemophilia A. The consensus recommendations provide a standardized approach to the dosing and monitoring of FEIBA.     

Longer operative time is the risk for delayed wound healing after forefoot surgery in patients with rheumatoid arthritis

Objectives. Forefoot deformities are common in patients with rheumatoid arthritis (RA) and often require operative treatment. There is a high rate of delayed wound healing after foot surgery, especially among patients with RA. The aim of this study was to identify risk factors of delayed wound healing in RA patients who had undergone forefoot surgery.

Methods. This study was a retrospective observational study designed to analyze the outcomes of all consecutive RA patients who had undergone toe arthroplasty from April 2010 through May 2014 at a single institute. Putative risk factors for delayed wound healing were assessed using univariate logistic regression analysis. Variables with α = 0.1 were then subjected to stepwise multivariate logistic regression analysis.

Results. A total of 192 RA patients (192 feet) were included in this study. Delayed wound healing was seen in 40 feet (40/192 [20.8%]). A stepwise multivariate logistic regression analysis revealed that longer operative time was the risk factor associated with delayed wound healing in RA patients undergoing forefoot surgery (p = 0.028, odds ratio = 1.19 [per 10 min], 95% confidence interval [CI]: 1.07–1.32).

Conclusions. This finding emphasizes the importance of preventing operative complications during forefoot surgery.     

Recombinant activated factor VII for haemophilia patients with inhibitors undergoing orthopaedic surgery: a review of the literature

Summary.  Arthropathy is prevalent in patients with haemophilia and inhibitors and is a major source of pain and disability, significantly reducing quality of life. Recombinant activated factor VII (rFVIIa; NovoSeven^®) is one of the treatments available for acute life-threatening bleeding episodes in haemophilia patients with inhibitors. It has also been used successfully in a range of orthopaedic surgical procedures in these patients. This is a review of published data on elective orthopaedic procedures in haemophilia patients with inhibitors under cover of rFVIIa from January 2002 to November 2006. Articles were retrieved from MEDLINE using specified search parameters. Twelve articles covering a total of 80 orthopaedic procedures were identified. In the vast majority of cases, rFVIIa provided safe and effective haemostatic cover during orthopaedic surgery with no bleeding complications. There was variation in the administered dose, although the majority of patients were treated with 90 μg kg⁻¹ bolus followed by either continuous infusion or bolus infusion. Of those cases reporting bleeding complications, most were considered to be related to an inadequate amount of rFVIIa. The cumulative experience presented here suggests that rFVIIa is safe and effective for providing adequate haemostatic cover for haemophilia patients with inhibitors undergoing orthopaedic surgery. The optimal dosing regimen and mode of administration has yet to be identified. Further controlled trials are needed to confirm these experiences.     

Predictors of postoperative complications in the patient with diabetes mellitus

BACKGROUND: Since patients with diabetes mellitus have increased rates of cardiovascular morbidity and mortality, it is critical to evaluate cardiovascular risk perioperatively. Although several preoperative risk indices have been developed, including the Goldman and Detsky indices, none have been designed specifically for diabetic patients. In this study, we attempted to identify predictors of postoperative cardiac and noncardiac complications in diabetic patients undergoing elective general surgery. STUDY DESIGN: A cohort of 107 diabetic patients undergoing elective surgery was assembled. Basic demographic and clinical data were recorded perioperatively, and all patients were followed up prospectively daily for 7 days postoperatively. Patients were interviewed at 5 years postoperatively. Univariate and multivariate analyses were performed to identify predictors of postoperative complications and long-term cardiac and vascular morbidity and mortality. RESULTS: Total cardiac complications and myocardial infarction were predicted by the Goldman index. Wound complications were not predicted by any of the variables studied. At 5 years postoperatively, cardiac and vascular deaths and events were predicted by age, history of myocardial infarction or stroke, presence of vascular disease, Goldman index, duration of diabetes or hypertension, Charlson comorbidity score, and postoperative myocardial infarction or cardiac arrest. Blood sugar control during surgery was not predictive of any short- or long-term cardiovascular complications. CONCLUSIONS: Total cardiac complications had a significant preoperative predictor: the Goldman index. Both preoperative and postoperative variables and indices predicted long-term cardiac and vascular complications. Further study is necessary to investigate these relationships to better assess and manage the diabetic patient in the perioperative setting.     

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

Inhibitor development is one of the most challenging complications of haemophilia management. Haemostatic control in patients with haemophilia with inhibitors can be difficult, and is especially risky in those undergoing surgical interventions. Most haemophilia patients with inhibitors suffer from chronic joint disease requiring surgical correction due to recurrent bleeding episodes. The aim of this study was to assess the use of recombinant activated factor VII (rFVIIa) as haemostatic therapy during orthopaedic surgery in haemophilia patients with inhibitors. A series of case reports was retrospectively collected to describe clinical experience of rFVIIa use in inhibitor patients undergoing a range of orthopaedic surgical procedures at a single centre. All surgeries were performed using standard methods. All patients received rFVIIa at a starting dose of 120 μg kg^?1 with the subsequent regimens depending on the type of surgery. rFVIIa provided effective haemostasis in 23 patients with haemophilia A and inhibitors (15 with high inhibitor titres) undergoing orthopaedic surgery. The majority (70%) of surgical procedures were major (joint and extra‐articular surgery). The doses and intervals of rFVIIa treatment used varied depending on the severity of bleeding, and the type (major or minor) or site of surgery. In all cases, administration of rFVIIa achieved good haemostasis. In all 23 patients with haemophilia with inhibitors, rFVIIa treatment in orthopaedic interventions proved to be an efficient haemostatic agent, providing effective intra‐operative and postoperative haemostasis.     

ESOS: a European study on the orthopaedic status of patients with haemophilia and inhibitors

Summary.  Published studies highlight the paucity of data relating to orthopaedic health and quality of life in haemophilia patients with inhibitors. A European Study on the Orthopaedic Status of Patients with Haemophilia and Inhibitors (ESOS) has been set up to address this lack of data. This cross-sectional retrospective study aims to enrol 400 patients from 50 sites in nine European countries. The primary outcome measure of the study is the burden of orthopaedic complications in patients with severe haemophilia and inhibitors. The data that will be generated should demonstrate the high level of arthropathy in haemophilia patients with inhibitors and show the need to focus on improving orthopaedic health in this rare, but particularly vulnerable, patient population.