Prospective evaluation of venous access difficulty and a near-infrared vein visualizer at four French haemophilia treatment centres.

Although a serious impediment in haemophilia patients, difficulty accessing peripheral veins has received little attention in clinical studies. New peripheral vein visualization devices could potentially ameliorate difficult venous access (DVA), but their utility remains unproved. The study aim was to survey the frequency, causes and clinical manifestations of DVA and evaluate the clinical utility of a near-infrared (NIR) vein visualizer. In this multicentre prospective study, methods, difficulties and outcomes of venous access were assessed for a single venipuncture in consecutive patients. The impact of an NIR vein visualizer on vein localization, the number of venipuncture attempts and patient stress and pain was determined. Among 450 total patients enrolled, venous access was judged to be difficult in 165 (36.7%), most often because of poor vein condition, young patient age, overweight and difficulty in finding veins. Of the patients with DVA, difficulty in locating veins was encountered in 82.4%, and more than one venipuncture attempt was required in 24.8%. Veins were difficult to locate in significantly fewer DVA patients (P = 0.002) when the NIR vein visualizer was used (76.0%) than not used (92.3%). Pain during venipuncture in DVA patients was also significantly less common (P = 0.019) with use of the NIR vein visualizer (34.0% vs. 55.4%). No effect was observed on venipuncture attempts. DVA affects more than one-third of patients at haemophilia treatment centres. An NIR vein visualizer showed significant promise for facilitating vein location and mitigating patient pain in those patients.

FEIBA in the treatment of acquired haemophilia A: results from the prospective multicentre French 'FEIBA dans l'hémophilie A acquise' (FEIBHAC) registry.

Factor VIII inhibitor bypass activity (FEIBA) is a recommended first-line bypassing agent for bleeding episodes in patients with acquired haemophilia A (AHA). Due to the low incidence of AHA, available clinical data on FEIBA treatment are limited. The study aim was to delineate practice patterns in FEIBA treatment of AHA patients, the haemostatic efficacy of FEIBA, including criteria for its assessment, and safety. A prospective registry was established of AHA patients receiving FEIBA for bleeding episodes or prophylaxis at the time of invasive procedures. Data were collected at 16 participating centres in France. Patients were followed up for 3 months. Haemostatic efficacy, FEIBA regimen and FEIBA-related adverse events were documented. Thirty-four patients averaging 81.8 years old with standard deviation (SD) 8.1 years were included in the study: 33 for acute bleeding and one for haematoma evacuation. The mean initial dose of FEIBA for acute bleeding was 75.4 U kg(-1) (SD, 7.7 U kg(-1) ), most often administered twice daily, and the median duration of FEIBA treatment was 4.0 days (interquartile range, 2.2-8.0 days). FEIBA was effective in managing 88.0% of bleeding episodes (95% confidence interval, 75.8-94.5%). No baseline variables influencing treatment response could be identified. The sensitivity and specificity of an objective haemostatic efficacy scale in predicting sequential investigator assessments of haemostatic efficacy were 45.3% and 84.1% respectively. Four patients experienced a total of six serious adverse events possibly related to FEIBA. In the first prospective study specifically focused on FEIBA treatment of patients with AHA, 88.0% of bleeding episodes were effectively managed.