HemoPlug

Solution to vascular access for kidney dialysis 

The challenge 

Chronic kidney disease is divided into five stages. The end stage often means patients need renal replacement therapy. They may be treated either by a transplant or by dialysis. There are two main types of dialysis: haemodialysis, which is more common, and peritoneal dialysis.  

Vascular access for haemodialysis is a lifesaving gateway to deliver treatment. There are two main options to implement extracorporeal circulation. This is the circulation of blood outside the body, which is required for dialysis.  

One way to implement extracorporeal circulation is arteriovenous fistula (AVF). Although this painful and difficult to implement, it is the option doctors usually choose. An alternative is central venous catheter (CVC), but this results in poor outcomes, including infections and dysfunction.[1] CVC can lead to hospitalisations, and even loss of life. It can also have a negative impact on a patient’s quality of life. Both techniques present a huge barrier for a greater adoption of self-care dialysis (especially at home).     

In Europe there are 352,000 patients treated with haemodialysis.[2] Despite its poor outcomes, CVC has a high prevalence rate of around 20% across Europe.[3] Quantitatively, CVC has the highest costs across all types of vascular access. This is largely due to infection rates. The estimated costs associated with hospitalisations due to CVC related infection ranging from €16 161,90 to €30 422,40.[4]  

Vascular access for patients on haemodialysis has historically been an area of unmet medical need. A 2017 survey listed better solutions for vascular access as a top priority in the area of haemodialysis for healthcare professionals and patients.[5]    

The solution 

The team behind HemoPlug have come up with an innovative valve system to solve the challenges of vascular access in haemodialysis. HemoPlug is a made up of uPlug and iPlug, which both use a unique valving system that promises to reduce complications during CVC. 

By allowing a contact-free connection for vascular access, HemoPlug has the potential to decrease infection rates. This in turn reduces the likelihood of thrombosis (formation of a blood clot within a blood vessel), which could be induced by endoluminal (within a tubular organ or structure) infections. 

uPlug, which stands for universal plug, is a CE marked medical device which offers an extension to any CVC. This technology enables an easy contact-free connection through a patented valving system. After removing the cap, the user connects a disposable plug to a socket. Unlike a regular CVC procedure, which requires many disconnections, uPlug allows dialysis to be done easily, without any disconnections. iPlug (which stands for implantable plug) uses the same valving system, with additional features. 

Expected impact 

HemoPlug will significantly reduce adverse events during CVCs, including unplanned and emergency hospitalisations, and in doing so will save costs. The time that doctors will save managing fewer complications can be allocated to other patients, helping to improve prevention stages and strengthen care pathways. 

Because it offers secure and easy-to-use vascular access, HemoPlug can enable the development of self-care haemodialysis (including home care). Home care is associated with a better quality of life and cost reductions. 

Having patients in better shape will enhance professional satisfaction of the healthcare team. These better outcomes will improve the daily life of nurses who will save time in preparation. Not needing to keep reconnecting the CVC will allow them focus on the patient.  

Ultimately, HemoPlug can promote better health for citizens and improve patient outcomes. It promises to minimise the burden of end stage renal disease on patients, improving their quality of life and giving them the possibility to be treated at home.  

HemoPlug can also contribute to a sustainable health economy in Europe as it offers the potential to create new jobs to develop, sell and manufacture the solution. 

External Partners

• UBIPLUG (lead partner)
• UCL (Université Catholique de Louvain)
• CHU CAEN (Centre Hospitalier Universitaire de Caen)

References

[1] van Oevelen, M. et al. (2019). Precurved non-tunnelled catheters for haemodialysis are comparable in terms of infections and malfunction as compared to tunnelled catheters: A retrospective cohort study, The Journal of Vascular Access, 20(3), 307-312. 

[2] European Renal Association – European Dialysis & Transplantation Association (ERA-EDTA) registry, Annual Report (2019). Table A.3.1 (607k prevalent patients on RRT) & Figure A.3.4 (58% treated by HD), Available at: https://www.era-online.org/registry/AnnRep2019.pdf 

[3] USRDS, Annual Report (2021). Figure 4.6, Available at: https://adr.usrds.org/2021/end-stage-renal-disease/4-vascular-access

[4] Nissenson, A.R. et al. (2005). Clinical and Economic Outcomes of Staphyloccus aureus Septicemia in ESRD Patients Receiving Hemodialysis, American Journal of Kidney Diseases, 46(2), 301-308. 

[5]  Evangelidis, N. et al. (2017). Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey, American Journal of Kidney Diseases, 70(4), 464-475.