EXECUTIVE SUMMARY
The CEDIT assessed the value of the therapeutic method called « aquapheresis », process aiming to reduce in a non-pharmacological way the fluid overload of patients with congestive heart failure.
Technical aspects: The term « ultrafiltration » designates the water extraction from the vascular system via a membrane, either by hemodialysis or by haemofiltration. The term « aquapheresis » refers to a haemofiltration specifically performed using the Aquadex FlexFlow™ system, a portable device produced by the manufacturer Gambro. This is a less constraining technique characterized by a low extracorporeal blood volume of about 35 ml, a blood flow rate of 10 to 40 ml / min and an extraction rate which can be adjusted between 10 and 500 ml per hour, the blood is withdrawn and infused via peripheral veins.
Clinical aspects: Ultrafiltration was tested in several clinical studies (some using the aquapheresis system Aquadex FlexFlow™), reporting advantages but also drawbacks compared to diuretic therapy. No study showed a superior clinical benefit versus diuretics. According to current American and European guidelines, ultrafiltration appears beneficial to patients with acute congestive heart failure resistant to diuretics or for whom they are counter indicated. Yet there is no consensual definition of what resistance to diuretics means, which continues to be a clinical judgment. Studies on the use of ultrafiltration in chronic heart failure open favorable prospects for research.
Economic aspects: According to the manufacturer, a disposable kit for a maximum service life of 72 hours, costs about € 700. The most likely DRG code associated with the use of aquapheresis in French hospitals would be « plasma ultrafiltration session » (FEJF009 of the French CCAM) priced at € 44.53, which covers only partially the cost of this procedure but was used only in 52 cases (for 36 patients) during 2014 at the Paris University Hospital (AP-HP). No French economic evaluation is currently available. From an economic point of view, the interest of aquapheresis would be based on a reduction in hospital stay and the number of re-hospitalizations, but this has not been clearly demonstrated due to the fragile results observed in clinical studies. (E.g. a different result between the Canadian and the British health economic analyzes) and extrapolation difficulties to the French health care system.
Organizational aspects: The acquisition of the aquapheresis must involve a multidisciplinary analysis within the hospital (cardiologists, anesthetists, transfusion specialists, etc.) and specific training of staff involved has to be ensured. It seems that aquapheresis can be performed under certain conditions in outpatient healthcare facilities, such as day hospital.
Recommendations of CEDIT:
- Give the possibility to AP-HP to acquire and use the system of aquapheresis Aquadex FlexFlow™, for patients with congestive heart failure who have a contraindication or resist to drug treatment, in particular diuretics. Indeed, for these patients, the aquapheresis would satisfy a medical need not completely covered and would be a useful therapeutic alternative.
- This technology should be installed in a limited number of centers treating this kind of patients and where the organizational constraints and the cooperation between different health professionals leave room for hope of favorable results.
- According to available economic data, the cost of care involving this technology would exceed that of the French CCAM procedure for this activity. In the event that this technology is adopted on a larger scale, an action aimed at upgrading the procedure or the corresponding DRG could be considered.
- Despite already available research, a study to better define the use of aquapheresis and identify patients who could benefit the most of this technology would be useful. If a national evaluation was to be considered, a PHRC with economic secondary criteria or a PRME would be suitable for evaluating aquapheresis at this stage of development.
