View the INAHTA Brief
The CEDIT, the hospital based HTA agency of the Paris University Hospital (AP-HP), has already assessed Vivostat® in 2006 and concluded at the time that the available data was insufficient to recommend its dissemination for clinical practice. However, in order to encourage the evaluation of innovative medical devices, the CEDIT has recommended its use to be undertaken into a clinical study, allowing a possible later dissemination and use. This clinical study was not realized. Eight years later, the CEDIT assessed again the usefulness of the autologous fibrin sealant Vivostat® produced by Vivostat A/S.
Technical aspects: the surgical haemostatic agents have either a human origin (fibrin sealants), or a synthetic, animal or vegetal one, and have the legal status of drugs (medicines) or medical devices. Vivostat® is a medical device made on autologous human fibrin (extracted from the own blood of the patient). Its preparation takes 23 minutes before the surgical intervention and 120 ml of the patient’s blood, and leads to a 4 to 6 ml fibrin sealant product. According to the 2006 assessment report of CEDIT, Vivostat® could have a better immediate adhesion and in vitro elasticity than other fibrin sealants. Moreover, at the time, the application system of Vivostat® blocked less frequently than other systems and the precision of use seemed better.
Clinical aspects: few clinical studies and data were published since the 2006 report of CEDIT and the 2011 report on surgical hemostatic agents released by the French National Authority of Health (HAS). The clinical studies available with fibrin sealants show that their use provides a modest benefit in terms of aerostasis and hemostasis (blood loss reduced on average by 160 ml per intervention according to a Cochrane revue). For Vivostat®, the absolute benefit will thus be around 40 ml. No clinical study currently shows a better efficacy or safety compared with other fibrin sealants. The autologous nature of this product is used to emphasize its safety (less infectious and immunological side effects), but no scientific data supports this assumption. Besides, for this product whose preparation has to be anticipated, the necessity to select before the surgical intervention the patients most likely to benefit (on criteria not yet standardized) will influence the effectiveness of this product. At AP-HP, Vivostat® was used these last years by two hospitals (Pitié and HEGP) at around ten patients per year.
Economic aspects: according to the available data, the equipment needed for the preparation of Vivostat® would call up around 40,000 euros (24,000 in the 2006 CEDIT’s report). Moreover, each single use kit would cost between 400 and 500 euros (360 at 440 in the 2006 report). The price of the other fibrin sealants with the status of drugs (medicines) is negotiated among firms and hospitals. No economic evaluation study on Vivostat® was found. Given the current clinical data available, a superior cost of Vivostat® would be a sign of an unfavorable cost-effectiveness ratio in regard with other fibrin sealants. Moreover, the necessity to anticipate its preparation for a use that is then not certain would diminish the cost-effectiveness ratio in real clinical practice.
Organizational aspects: the use of Vivostat® into the operating room involves the presence and the maintenance of different devices and machines directly or indirectly (sterilization) needed, a more complex process than the storage and the use of other fibrin sealants which are virtually ready to be used.
Recommendations of CEDIT:
- Few data are available on Vivostat® compared with that published for other fibrin sealants. Moreover, no clinical study directly compared Vivostat® to these products. Vivostat® is thus a medical device whose clinical, economic and organizational benefits are not currently proved.
- Nevertheless, this product being considered as potentially interesting by surgeons, CEDIT considers that the use of Vivosta® should be made possible at AP-HP, providing that it is carried out into a randomized comparative clinical study, or at least into a cohort study compared with historical or contemporary references.
- For this study, the manufacturer is invited to provide the devices and machines needed. The costs involved to set up and manage the clinical study could be discussed as part of the procedure recently put in place at AP-HP in order to encourage the evaluation of innovative medical devices. If the possibility of a submission for a national call of proposals is favored, a “Programme de Recherche Médico-Economique” (PRME) seems compatible to the current stage of development of Vivostat®