Harnessing Patients’ Wishes to Drive Vascular Access Innovation

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Terry Litchfield, MPH, draws on five decades of experience when she argues for a more patient-centered approach to developing new vascular access options. Her experience stretches back to when her late husband Gerald started dialysis in 1968, and it continues in her current role as a consultant on patient-centered vascular access and as a Kidney Health Initiative (KHI) Patient and Family Partnership Council member.

“It was newsworthy in 1968 when someone started dialysis,” Litchfield said. “I’m very pleased to say dialysis sustained his life for a long time. We lived overseas; have machine, will travel.”

Now, she wants to make sure other patients have the opportunity to have full and fulfilling lives with the help of innovative vascular access options that meet their individual needs. Doing that, she notes, will require physicians and device makers to re-center their care processes around what’s most important to patients. Litchfield spoke to Kidney News about how clinicians, researchers, regulators, and device developers are working to meet that demand. She also participated in the Novel Therapies for Vascular Access panel at Kidney Week 2018.

Priority disconnect

Too often, clinicians’ and patients’ vascular access priorities don’t align. Litchfield noted, for example, that women have told her they are very concerned about body image and scarring on the arms. One woman confided to her that someone asked her if she was a cutter.

“What is really important to patients is often trivial to providers,” Litchfield said.

The data backs her up. A recent survey of kidney patients and clinicians found that patients ranked catheter thrombosis, selection of vascular access type, clinician training in vascular access, and infections as their top priorities. Litchfield explained that patients want to avoid being hospitalized, they want a choice of access, and they want to know their clinician will do a good job. While providers agree about infection and access choice, they rank many patients’ top priorities near the bottom of their lists.

“Providers want to preserve veins or keep existing accesses at all costs,” she said. “I maintain vehemently quality of life trumps all.”

Prabir Roy-Chaudhury, MD, PhD, chief of the division of nephrology at the University of Arizona, also emphasized the disconnect, citing data that patients rate the ability to travel, dialysis-free time, and not being washed out as higher than death, while physicians put things like death and drops in blood pressure high on the list despite their low ranking on patients’ lists.

To help resolve this disconnect, Litchfield recommended that clinicians and device developers involve patients and patient organizations in the earliest stages of developing new vascular access options and keep them looped in throughout the process. This will help them make sure they build in patient priorities like fewer surgeries and interventions, smaller needles, hassle-free access, preserved body image, and a better quality of life.

“They want a better quality of life through less impact,” Litchfield said.

Patients should be involved in study design to ensure that the questions being asked are relevant to them, she said. Patients who choose to participate should have clear and easy-to-understand consent forms, their transportation and other participation needs should be considered, and when the study is done they should be looped back in on the results.

Roy-Chaudhury agreed with the importance of engaging patients throughout the development process. He called it a “bedside to bench to bedside” approach, and said it is key to breaking the cycle of “a lack of innovation in vascular access that results in poor quality and outcomes at a very high cost burden.”

Collaborative solutions

Collaborative efforts are currently underway to accelerate the development of new, more patient-centered vascular access options and to optimize the safety of existing options.

“The challenges of getting an innovative access device to the market are considerable,” said Robert Lee, MD, medical officer in the US Food and Drug Administration’s (FDA) Vascular Surgery Devices Branch.

But a March 2018 publication from the Kidney Health Initiative’s (KHI) vascular access work group may help streamline the process by suggesting standardized endpoints for vascular access studies that have been shaped by input from the FDA, patients, device makers, and nephrologists.

“The standardized definition of clinical trial endpoints proposed by the work group are a positive step toward harmonizing outcomes in vascular access reporting,” Lee said.

He noted that the FDA has begun using real-world data to evaluate new vascular access options by creating registries to track patient outcomes after a device becomes available. The agency has already used this approach in the evaluation of two vascular access devices, Lee said.

“This has shifted some of the balance of evidence collection to post-market clinical data that would have been tough to gather in a traditional clinical trial setting,” he said.

The FDA is also increasingly partnering with patients, Lee said, noting the agency’s patient advisory committee and partnership with ASN in KHI. The agency looks to patient preferences to guide its regulatory decisions. Lee explained that patients may be willing to accept a higher level of risk associated with new devices if they place a very high value on the potential benefits of the device.

“Patient preference information may be particularly useful in evaluating a device when patient decisions are preference-sensitive,” he said, for example, in situations where multiple comparable options are available or when patients’ views about the benefits or acceptable risks associated with a device vary.

The US Centers for Disease Control and Prevention (CDC) and ASN have also undertaken an effort to reduce infections by ensuring that more clinicians follow their evidence-based guidelines for vascular access care. Alan Kliger, MD, clinical professor of medicine at Yale University, noted that infections claim the lives of 8000 to 10,000 patients on dialysis each year, accounting for 10% of dialysis-related deaths.

“Central venous catheters are a major source of this morbidity and mortality, caused by infection,” Kliger noted. Yet, many clinicians aren’t using proven techniques to prevent them. Nephrologists Transforming Dialysis Safety (NTDS), a collaboration between ASN and the CDC, includes a vascular access working group. NTDS plans to release an interactive curriculum for clinicians in 2019, and is also working with the CDC to develop new procedures to identify bloodstream infections and recommendations for drawing blood cultures.

Kliger acknowledged that sharing best practices isn’t enough. In busy dialysis units, standard procedures may be bypassed in a crunch, he noted. So, the CDC has provided funding for NTDS to hire human factors engineers to evaluate vascular access procedures at six dialysis facilities and suggest ways of re-engineering the process to be safer.

“Significant progress can be made,” Kliger said. “But we need to provide that platform for collaborations where patients come together, caregivers come together, policymakers come together, [and] industries come together in order to find the right solutions for the future.”

Innovative access

Both Roy-Chaudhury and Litchfield are optimistic about emerging vascular access options. Litchfield noted that the FDA approved two devices to create percutaneous arteriovenous fistulas in 2018. Roy-Chaudhury explained the devices use magnets and radio frequency electrodes to create a connection between artery and vein without the need for surgery. He noted he has worked with companies developing the devices.

“No surgical scar or tissue trauma at the creation of the fistula site,” he said. “No operating room hassles.”

Both noted there are other promising devices in the pipeline. Ultimately, Roy-Chaudhury said, having a large menu of options that can be matched to patients’ needs and desires will be essential.

“We need to individualize [patients’] vascular access care by pairing specific novel patient-centered therapies with specific clinical and biological phenotypes in order to get the best results for individual patients,” he said.

March 2019 (Vol. 11, Number 3)

References

1. van der Veer S, et al. Setting priorities for optimizing vascular access decision making—An international survey of patients and clinicians. PLoS One 2015; 10:e0128228; DOI:10.1371/journal.pone.0128228

2. Urquhart-Secord R, et al. Patient and caregiver priorities for outcomes in hemodialysis: An international nominal group technique study. Am J Kidney Dis 2016; 68:444–454.

3. Surendra S, et al. Clinical trial end points for hemodialysis vascular access: Background, rationale, and definitions. Clin J Am Soc Nephrol 2018; 13:490–494.