An international coalition of vascular access surgeons, nephrologists, researchers and industry partners has launched the Fight Fibrin Sheath (FFS) campaign, a clinician-led action group working collaboratively to advance research, education and innovation relating to fibrin sheath formation, and to improve vascular access outcomes for dialysis patients worldwide.
Fibrin sheath is a near-universal complication of dialysis catheters; a fibrous, protein-based build-up that begins to form around a central venous catheter (CVC) within hours of insertion in almost every patient.
Left unaddressed, it restricts blood flow, triggers repeated clinical intervention and shortens the working life of the catheters that hundreds of thousands of dialysis patients rely on to stay alive. First documented more than 40 years ago, it has long been managed as a routine, unavoidable side effect of catheter use rather than treated as a problem that clinical practice and device technology should be solving.
“What shocked us is the lack of solutions that surgeons had to this problem,” said Arjun Luthra, Commercial Director at BioInteractions, a company that provides biocompatible coatings for medical devices, speaking to Med-Tech Insights. “We thought that a coating might be an optimal solution, but there’s absolutely nothing, and that was the biggest shock.”
Nick Inston, Consultant Vascular Access Surgeon at Queen Elizabeth Hospital Birmingham, and spokesperson for the Fight Fibrin Sheath campaign, explains how all the available data points to a glaring opportunity for the renal and dialysis community to address: “Fibrin sheath is a massive issue that no-one is talking about, hence our desire to start a campaign to tackle it once and for all. Fibrin sheath develops in 80–100% of CVCs within the first week of insertion. This directly affects the 50–75% of dialysis patients who begin treatment on a catheter, the majority of whom still need one for their primary vascular access six or more months later.
“But fibrin sheath isn’t a new phenomenon. Recent research among clinicians worldwide found that fibrin sheath is the dominant failure mode in catheter care, and our collective confidence in preventing it is lower than for any other complication we face.
“The harsh truth is that CVCs have been vilified despite their continued importance. It’s hugely frustrating and patients should be angry. We say it’s time for the community, including industry to start looking at catheters again. The current situation is unacceptable and why this campaign exists.”
The FFS campaign brings clinicians, researchers, patient advocates and device manufacturers together around a shared, evidence-led agenda: to fund and conduct further research into fibrin sheath prevention, to raise awareness of its impact among patients and policymakers, and to press device manufacturers to step up innovation efforts. Clinicians can sign the FFS pledge to lend their weight to the strength of feeling among surgical, nursing and other practitioners who encounter this issue every day.
Luthra also told Med-Tech Insights: “The patients don’t need to be going through these issues, and that’s why we really support the Fight Fibrin Sheath campaign with Nick and all of his colleagues. We want to bring that knowledge to the forefront of everyone’s mind and bring awareness to the patients. The clinicians already have the awareness, but we also want to bring the awareness to the OEMs, right? Because this is a problem that their patients and their customers are facing. It’s something that is preventable, and there is a solution today that can do it.”
The campaign is supported by “FFS Champions” drawn from across clinical practice, patient advocacy and industry. These include the Vascular Access Society, European Kidney Patients Federation, Dialysis Catheter Collaborative and BioInteractions Ltd, with an open invitation to any and all similar bodies and organisations to join the fight, take action and help spread the word.
Full details of the FFS campaign and its goals are available at www.fightfibrinsheath.com
