This advertorial is sponsored by Laminate Medical Technologies
At the 2024 Charing Cross (CX) International Symposium (23–25 April, London, UK), the Vascular Access Masterclass Controversies session delved into the question, ‘We have new technology, but do we need it?’ Among the notable presentations, Ellen Dillavou (WakeMed Heart Center, Raleigh, USA), ignited discourse on whether extravascular support should redefine the standard of care in surgical fistula creation. Advocating for the adoption of the VasQ extravascular nitinol support by Laminate Medical Technologies, Dillavou underscored its potential to address numerous prevalent challenges in fistula creation, positioning it as a pivotal innovation in dialysis access.
“Sometimes, it is difficult to see a change in the standard of care as it happens,” Dillavou said as she began her presentation, acknowledging the gradual evolution of medical standards and drawing parallels with the transformative impact of guidelines such as those set forth by the Kidney Disease Outcomes Quality Initiative (KDOQI) in the USA. “We can look back in the USA and see that the KDOQI guidelines emphasising fistula use definitely changed the way we practiced. [They] made more fistulas available for standard use, but it came with costs like increased catheter use, more procedures per useable fistula and a decrease in primary patency results.” Dillavou emphasised the need for enhanced access solutions with fewer interventions, lower infection rates, and faster maturation, highlighting that “the VasQ device can solve a lot of these problems” by mitigating common issues encountered in standard fistulas, such as stenosis and aneurysmal dilation by “keeping the fistula at an optimal angle and offering support to that dissected area of the vein to counteract the shear stress”.
Central to her argument were compelling datasets supporting VasQ’s efficacy. Referencing studies including a randomised controlled trial by Nikolaos Karydis (at time of study publication, at Guy’s and St Thomas’ NHS Foundation Trust, London, UK) and research by Robert Shahverdyan (Asklepios Klinik Barmbek, Hamburg, Germany), Dillavou showcased consistent improvements in maturation rates and primary patency with VasQ utilisation. Furthermore, she presented findings from an ongoing study comparing VasQ to conventional methods, indicating superior functionality and patency outcomes with the device and pointed to Shahverdyan’s long-term success using the device as standard of care.
“When [Shahverdyan’s] practice shifted to using VasQ as part of his standard of care, he had a drastic reduction in primary failures and an increase in primary patency at six months”. Dillavou also referred to a study that she had contributed to comparing VasQ to historic controls. “In the USA, when we contrasted VasQ fistulas to historic controls, we found increased functionality at three and six months, and increased primary patency at all time-points. When we look at the body of literature in historic unsupported fistulas versus VasQ, we see a clear trend towards enhanced patient outcomes when they are externally supported.”
Beyond immediate postoperative benefits, Dillavou emphasised the long-term advantages of VasQ providing permanent structural support. Drawing from retrospective analyses, she illustrated reduced catheter days, decreased infection-related hospitalisations, and diminished incidences of complications such as steal syndrome and aneurysm formation. “This global view shows that patients have fewer catheter days and have fewer infection-related hospitalisations at one year. We also see that two years after creation with an external support device, we are seeing fewer instances of steal, and we’re seeing less aneurysmal formation,” said Dillavou.
Addressing concerns regarding costs, Dillavou highlighted substantial cost savings estimated based on the existing clinical data. The potential for significant healthcare expenditure reduction with VasQ integration has been replicated in multiple countries, such as the UK, Italy, Germany and the USA. She also highlighted that VasQ has now reached Asia with Yong Enming and Zhang Li (both Tan Tock Seng Hospital, Singapore), underscoring global interest in exploring both the clinical and economic implications of VasQ adoption.
Following Dillavou’s presentation, audience participation was invited leading to inquiries delving into technical considerations and comparative efficacy, with insights provided by panelists including experienced VasQ users like Shahverdyan and Nicholas Inston (University Hospitals Birmingham, Birmingham, UK).
Speaking to Renal Interventions regarding the role that VasQ has to play in the future of AVFs, Inston, the session’s moderator, said: “The signal coming from multiple global studies consistently shows that VasQ has better outcomes than those in traditional surgical studies. If we strive to improve the outcomes of AVFs, we need to take these data seriously”.
Shahverdyan also shared his thoughts on the device with Renal Interventions, saying: “Looking at our experience of over six years with almost 300 VasQ implants (mostly for radiocephalic AVF creation, which historically have shown to fail more commonly), and the existing evidence throughout the globe on the outcomes of VasQ device, it consistently demonstrates significantly better outcomes in dialysis patients with extremely low safety concerns: we have observed zero cases of infection, steal or juxta-anastomotic aneurysms. Hence, it is justified to say that we as caregivers should provide our patients with best possible treatment options and consider the application of the VasQ device as standard of care.”
The discourse surrounding VasQ at the CX Symposium underscores a paradigm shift in dialysis access management, with mounting evidence and key experts heralding its potential role as a transformative standard of care. Of course, skepticism still exists based on the bulk of VasQ’s evidence from observational studies, especially compared the numerous randomised-controlled studies for technologies like drug-coated balloons (DCBs). In response to comments regarding the level of evidence for VasQ in comparison to DCBs, Dillavou closed out the discussion by stating “there’s more agreement in the VasQ device than there is for DCBs”. This statement highlights that the strength of the VasQ data has been in the consistent clinical benefit across multiple studies in various countries that is not typically observed for many new technologies.
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