Breakthrough bleed management: Retrospective surgical data 23

  • At the time of the primary analyses across HAVEN 1-4, 31.6% (126/399) participants who received HEMLIBRA® had at least one surgery 1

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Retrospective descriptive analysis of FVIII use during surgical procedures in HAVEN 3

Retrospective surgical experience in adults and adolescents without FVIII inhibitors. 23

  • Cutoff date was February 2018 for HAVEN 3
  • Analysis of the use of FVIII for surgeries or procedures was not an objective of the pivotal study, and there is limited experience from the clinical trial (N=152). Due to the limited sample size and lack of statistical control, no conclusions should be drawn regarding FVIII use during these procedures

Perioperative management with FVIII was determined based on the investigators' discretion.

  • Surgeries included 23:
    • 1 knee arthroscopy synovectomy, 1 biceps femoris tear repair, 1 total ankle arthroplasty, and 1 total hip replacement
    • 10 minor orthopedic procedures
    • 14 gastrointestinal procedures
    • 17 dental procedures, including: 2 root canal procedures, 1 dental avulsion, 1 invasive dental procedure, 1 dental implant, 2 teeth descalings, 1 full mouth debridement, 5 tooth extractions/exodontias/odontectomies, 3 dental restorations, and 1 right maxillary subperiosteal abscess
    • 5 other procedures

*One patient with a historical, large retroperitoneal pseudo-tumor, which required 90 minor procedures, was excluded from the analysis. 23
One patient had both major and minor procedures. 23
Received preventative perioperative dose(s) of FVIII. 23

Retrospective review of BPA use during surgical procedures in HAVEN 1 and 2

Retrospective surgical experience in pediatric, adult, and adolescent patients with FVIII inhibitors. 19

  • Cutoff dates were April 2017 for HAVEN 1 and May 2017 for HAVEN 2
  • Analysis of the use of BPAs for minor surgeries or procedures was not an objective of HAVEN 1 (N=109) or HAVEN 2 (N=68), and there is limited experience from the clinical trials. Due to the limited sample size and lack of statistical control, no conclusions should be drawn regarding BPA use during these procedures. 
  • Management of perioperative BPA treatment was determined based on the investigators’ discretion
  • Surgeries included:
    • 1 right knee arthroscopy, synovectomy, debridement of arthrofibrosis, and chondroplasty
    • 1 laparoscopic appendectomy
    • 9 central venous access device–related procedures
    • 6 tooth extractions and 12 other minor surgical procedures

§Three surgeries resulting in post-operative bleeding were treated with rFVIIa. 19
Eighteen minor procedures were managed with preventative perioperative doses of FVIII (either short-acting or long-acting FVIII). 2
aPCC=activated prothrombin complex concentrate; BPA=bypassing agent; FVIII=factor VIII; rFVIIa=activated recombinant factor VII.

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