Is a future without needles or pain possible in dialysis? Christina Gilchrist, a person living with kidney disease, hopes so.
At the Dialysis Vascular Access Workshop, held on May 6, 2024, in Washington, DC, Gilchrist emphasized the critical impact of vascular access on her daily life, explaining that patients on dialysis want and need needleless access to reduce pain and improve their quality of life. “For patients, our access affects our lives every single day,” she relayed to workshop participants, who included physicians, innovators, and industry leaders, during the patient perspectives panel. “I want something that does not hurt. I am in pain every single day. There's not 1 day that goes by that I feel like a billion bucks. So please, let's get rid of the needles.”
Diagnosed with kidney disease at age 12 and facing kidney failure at 22, due in part to severe preeclampsia during her first pregnancy, Gilchrist's future looked starkly different from the one she had planned. In need of immediate dialysis for her failing kidneys after the birth of her child, she underwent a vascular procedure to create a fistula. After years of on- and off-again dialysis and two kidney transplants that resulted in rejection, Gilchrist joined the ranks of patients in need of lifelong dialysis. Along the way, she experienced various types of accesses, from fistulas and peritoneal dialysis catheters to a central venous catheter for home hemodialysis.
The workshop, hosted by the Kidney Health Initiative (KHI), fostered candid discussions with a clear message: Patients do not want to live at the mercy of their vascular accesses or dialysis needs. They need needleless access, durability, and more freedom to live their lives without the constraints of dialysis.
“Our vascular accesses and dialysis are our lifeline and our curse,” stated Vanessa Evans, MA, director of patient advocacy at Fresenius Medical Care. Evans brought one of the day's most unique perspectives as both a long-time patient on dialysis and a vocal advocate for innovation. She highlighted the stagnation in vascular access innovation despite substantial national spending on kidney diseases, pointing out that although the nation spends nearly $7 billion each year on kidney diseases, vascular access for dialysis has not changed much in over 60 years.
Meeting of the minds
During her welcome message, Vandana Dua Niyyar, MD, FASN, professor of medicine in the Division of Nephrology at Emory University, Atlanta, GA, and a member of the Devices Committee of the KHI Board of Directors, implored the room of attendees to challenge the status quo. “By bringing this group of like-minded individuals together, we can look forward to innovation that will change and optimize dialysis access care.”
Niyyar emphasized the importance of incorporating the patient perspective early in the development process and ensuring that the patient voice is the guiding force for innovation and advancement. She further noted that dialysis access care remains fragmented. There is a tremendous need to convert the existing dialysis access care silos into an integrated multidisciplinary approach to overcome dialysis access-related challenges.
Niyyar, however, remains confident that platforms like KHI and ASN's Transforming Dialysis Access Together initiative will build on their foundational work in this area and bring unique and diverse perspectives together to solve the pressing issues facing patients undergoing dialysis. “I encourage innovators and industry leaders to remain vocal and diligent in pushing innovation forward.”
Road to needleless access
Addressing the intricacies of device development that combines patient needs with affordable, accessible, and reimbursable technology, innovators presented promising designs throughout the day aimed at achieving needleless access and solutions for preventing infection, another obstacle patients face with vascular access.
Dialysis-X, for example, highlighted its needle-free access device, a one-time surgical implant designed to reduce complications for patients undergoing hemodialysis. Several other start-up companies, including Healionics Corp.; VenoStent, Inc.; and Kuleana Technology, presented needleless access products and infection-prevention technologies in the very early stages of development.
Although the new technologies differed in scope, the consensus among the innovation teams was similar: the end products must improve patients’ quality of life. To get there, they acknowledged the importance of collaborating and involving patient perspectives and feedback early in the development process.
Prabir Roy-Chaudhury, MD, PhD, FASN, ASN president-elect, highlighted the exciting advancements in vascular access therapies, noting the potential for significant clinical paradigm shifts in his keynote presentation on Options and Opportunities for Dialysis Vascular Access. “This is an incredibly exciting time for vascular access. There are many different therapies out there, either in clinical trials or being used clinically that are focused on vascular access. This was not so 10 years ago.”
Challenges and roadblocks to overcome
The journey to needleless access involves overcoming challenges such as high-development costs and funding needs, regulatory and reimbursement hurdles, and the diverse needs of patients undergoing hemodialysis.
Agreeing that patients are at the center of everything they do, the panel of innovators also emphasized the importance of enrolling patients in clinical trials, collecting evidence-based information, and the need for a centralized registry for dialysis access outcomes as avenues for securing the investments and reimbursements needed to bring products to market.
Accessibility and usability of new devices and technologies were also highlighted in the day's discussions. Industry leaders and clinicians agreed that with dialysis access being so complex, any device must be usable by the most and least experienced vascular access surgeons. Manisha Dadhania, MBA, vice president of global marketing at Mozarc Medical and member of the Devices Committee of the KHI Board of Directors, explained that with several vascular surgeons and interventional radiologists dedicated to performing vascular access surgery, addressing varying skillsets among surgeons is important as new products are rolled out. “Making sure that we’re investing in the initial and ongoing training and education for all clinicians is critical so that these devices are accessible to all patients,” she said.
Addressing the fragmentation raised earlier by Niyyar, standardizing training and improving patient education were also noted by patients, industry experts, and care practitioners as solutions to work toward. In breakout focus groups, patients noted that because training varies from clinician to clinician and clinic to clinic, the techniques used in dialysis centers around the country also vary. On the product side, developers acknowledged the requirement for technology that eliminates the need for ongoing training and education and products that are easier to use for patients and practitioners.
Looking at the promising new devices currently in development, Dadhania believes that it is also important to take incremental steps toward future innovations. “Needleless access is where we want to get to as quickly as possible for the patients, but along the way, there are going to be other innovations that will help patient outcomes,” she said, noting that identifying technologies that are accessible in other countries that could be brought to market in the United States could be a step in the right direction.
Call to action
Evans urged attendees to create a clear roadmap for action now. She said that the roadmap should include building core teams that collaborate and work together to find solutions to some of the obstacles to innovation, including regulation, reimbursement, and funding, noting that there needs to be a focus on three I's: investment, interest, and innovation.
“There has been dialysis access innovation over the years, but we haven't come as far as we need to because of operational challenges and roadblocks put into place by the payer system. This meeting made it very clear that we have a call to action. We must work together to break down the barriers that exist so that more innovation can take place,” Evans stated.
The call to action also emphasized the importance of keeping the patient at the essence of all novel dialysis access developments. For Gilchrist, sharing her journey was a huge step forward to putting the patient experience at the heart of future innovation. She reminded participants that patients need needleless, painless, and discrete vascular accesses. “We want freedom in our lives,” she emphasized.
Niyyar concluded the workshop with optimism for the future. Facilitating collaboration between clinicians and innovators and placing the patient at the center of everything will “allow us to ultimately optimize dialysis care and get to the ideal of having an access that is a lifeline that lasts a lifetime. We must provide the right access for the right patient for the right reasons at the right time.”
“We can do all of this if we work together,” she said. “The more we collaborate, the more we innovate.”
