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Focusing on the disease through the patient’s lens, establishing well-functioning multidisciplinary teams, to potentially enhance both the patient’s journey and clinical outcomes got top billing at BD’s second EMEA End-Stage Kidney Disease (ESKD) Summit (9–10 May 2023, Milan, Italy). With a multispecialty faculty comprising 22 leading voices including nephrologists, vascular and transplant surgeons, and interventional radiologists (with a combined knowledge of over 400 years), selected from 12 countries, BD’s second edition of “The Changing Face of a Dialysis Patient” showed commitment to a new format of scientific peer-to-peer communication, characterised by open interaction and vibrant discussion. More than 30 presentations including challenging cases, 14 hands-on workshops and the participation of 200 attendees marked the event.
Scientific directors of the summit, interventional radiologist Fabrizio Fanelli (Florence, Italy) and vascular access and transplant surgeon Nicholas Inston (Birmingham, UK), welcomed delegates to a programme that encouraged placing patients at the heart of care in dialysis access creation, restoration and maintenance.
Disease overview and patient journey
Charting the various difficult terrains of end-stage kidney disease (ESKD) in the renal patient pathway, Inston said each person’s course depends on age, comorbidities, “events” and interventions that were influenced by decisions made by clinicians, and importantly, by patients. Even simple clinical decisions can have a disproportionate, and sometimes uncaptured, impact on a patient’s life, he underscored. “When a fistula does not work, clinicians may simply plan to create another one, but this might have major disruption on a patient’s life and can potentially create a very negative loop for patients as they have likely gone through six to 12 months of other procedures to get to this point,” he said.
Based on his clinical experience, Inston referenced the concept of “much more tailored” minimally disruptive medicine (MDM). In this context, “the appropriate focus of treatment is the situation and the individual tackled as a whole”. MDM aims to reduce workload and individualise treatment, taking into account the effects of, for instance, “12 hours of dialysis per week, transport, maintenance interventions, clinical appointments and possible surveillance on a person’s life and calendar”.
Is there a case for rebooting questionnaires?
Inston kickstarted a discussion of wide-ranging quality of life issues with questions such as: “Is measuring patients’ quality of life via questionnaires of any use? Are they representative or do they misguide us? Do we add to the patients’ workload with more surveys/ questions/studies? Are we considering what we can do to tailor care to the patient and reduce workload? And can minimally disruptive medicine be applied to dialysis care?”
Daniel Gallego, a patient advocate and president of the European Kidney Patient’s Federation, has been a kidney patient since 1993, undergoing haemodialysis since 1995. To Inston’s points, he responded: “Twenty years of in-centre haemodialysis is different from home haemodialysis or peritoneal dialysis. Health questionnaires have been decided by clinical professionals and they do not include components on self-esteem, physical appearance, or things that really matter to us. […] Many aspects that might improve the life or quality of life of patients are not really captured in the outcomes. […] And sometimes these are misguiding us.” He called for a redesign of the questions asked and the management of information gathered so that the right decisions for patients can be made. Gallego also placed the spotlight on including the perspective of care-partners and families who influence the quality of life experiences for patients.
Responding to a question from the audience on whether a patient can influence the final decision on treatment modality, Gallego pressed on to say that with enough information and involvement at every stage, yes, patients can be responsible for both the choice and consequences of that choice for their access.
Külli Kuningas, lead renal research nurse, Queen Elizabeth Hospitals, Birmingham, UK, then outlined the “Our Arteriovenous Fistula (AVF) Lives” project, a patient-led ethnographic research undertaking run by the hospital to capture more in-depth patient perspectives on living with vascular access for dialysis. Relying on primary source material in the form of video diaries and the filming of patients in their own environments without the use of questionnaires, researchers aim to analyse how patients describe their conditions and what is important to them, to capture a repository of “true patient perspective”.
Gallego stressed that patient-reported outcomes were received usually from articulate, perhaps educated respondents who have the luxury of time. A critical component will be to validate these responses so that they become applicable to patients who might have poor language skills, come from populations with different cultures and languages and to those who might never answer questionnaires. He also addressed the discussion point of disparities in guidelines by stating that a consensus was needed, without bias, on the right treatment. This sparked the question: should care be “guideline-driven” or “tailored to the individual patient”? “We need to adapt, because every single patient is unique,” said Gallego.
The ensuing panel discussion on harnessing multidisciplinary expertise into the care of patients with kidney disease painted the picture of a changing paradigm. In “the old days”, and according to the panel’s experience, the “thinkers” were the nephrologists and the “doers” interventionalists and surgeons. With nephrologists also embracing interventional skills, there is a merging of the “thinkers” and “doers” responsible for a patient’s access, but this varies considerably based on local expertise, the panel said. According to their experience, there was acceptance that the nephrologists and nurses were ‘closer’ to the kidney patient’s journey and pivotal in coordinating care within multidisciplinary teams. Longstanding relationships with the patient, underpinned by trust and time were also identified as central to the patient’s experience of care. The panel agreed that a close connection in the discussion between patients, nephrologists and vascular access teams was core to good patient care. “More than the specialties of clinicians, communication is the key, and having one person in charge, potentially a nurse or dialysis access coordinator, who communicates in simple language along the whole journey with patients, is vital,” offered Gallego.
Ounali Jaffer (interventional radiologist, London, UK), Fien Gryffoy (vascular surgeon, Antwerp, Belgium), Gürkan Sengölge (interventional nephrologist, Vienna, Austria) and Ioannis Griveas (nephrologist, Athens, Greece) contributed to the discussion.
Looks as well as books
Panos Kitrou (interventional radiologist, Patras, Greece) detailed the importance of the Haemodialysis Arteriovenous Access Cosmesis Scale (AVACS), which is a new measure for vascular access. While clinical decision-making is often based on the twin-pillars of safety and effectiveness, the impact that vascular access has on the patient is also very important, he said.
Research has shown that lumps, bulging and related tortuosity, “mega access”, access-related scarring and number of scars, and the noticeability of the vascular access have been identified as some issues that play on patients’ minds.
Kitrou noted that there is a paucity of reports about the effect of AV access cosmesis on patients’ quality of life, dialysis experience, and decision-making about choice of vascular access type and creation.
“The cosmetic effect has an influence on patients’ psychology and therefore on the type of vascular access selected,” Kitrou posited.
“Cosmesis in the context of access is defined as the preservation of, or change in, limb physical appearance after AV access creation. It is one of many important factors to be considered in choosing vascular access within the context of the patient’s ESKD Life-Plan. By creating a scoring instrument that allows stratification of cosmesis of AV accesses, factors that affect cosmesis can be assessed,” he informed delegates. “In doing so, both clinicians and patients will be better informed to make access decisions in line with a patient’s priorities,” he concluded.
New guidelines signal change
Narayan Karunanithy (interventional radiologist, London, UK) and José Ibeas (interventional nephrologist, Barcelona, Spain) then delved into the updates on the most recent guidelines.
The former unpicked the latest UK Kidney Association (UKKA) guidelines to point out that these guidelines, from the oldest continuously active nephrology society in the world, are not funded by any external organisation, commercial company or charity.
The recent haemodialysis access guideline update marks a considerable shift in how the organisation recommends that clinicians approach choices in vascular access for patients and does away with the idea of targets to place patient choice at the heart of vascular access creation and care. The team behind the guidelines have said it is a pragmatic guideline that had active representation from a variety of specialties but also three active patient representatives. “The guideline emphasises different patient characteristics rather than just saying: ‘This is the best access for you,” Interventional News was informed.
Karunanithy noted the endovascular-first approach to access dysfunction and that the additional value of covered stents and drug-coated balloons was discussed. Despite high-quality data in many areas, evidence gaps still exist, he pointed out.
Ibeas then turned to the most recent guidelines from the European Renal Association (ERA), European Society for Vascular Surgery (ESVS), Kidney Disease Outcomes Quality Initiative (KDOQI) and El Grupo Español Multidisciplinar del Acceso Vascular (GEMAV) to distil the areas of commonality and dissonance in their recommendations.
“According to my experience, evidence-based medicine is subject to the influence of several factors, that is, the methodology, perspective of the specialty, geographical area or health management system; and the values and circumstances of the patient […] and to their interpretation,” he said.
“[…] the most important point is the effort for consensus on the one hand and generating evidence in the areas of conflict on the other. When reading the guidelines, it is convenient to understand how each recommendation in each guide is justified. In this way, the clinician can generate his own critical judgment and contribute to the implementation of the guidelines in his environment in the most rational way. That can benefit the ultimate recipient of the guidelines, the patient,” Ibeas said.
Lean, clean and controlled: New tools for healthcare
Fanelli then brought to the fore an award-nominated project at the Careggi University Hospital, Florence, Italy, that applied lean management concepts to the patient’s journey. This approach seeks to define the process and the problem; measure performance; analyse the process for issues and root causes; improve by determining and implementing actions; and exercise control to maintain the improvement. When applied to endovascular procedures, lean management resulted in improved capacity and productivity; reduced procedure time; lowered operator stress; improved quality and reduced hospital stay.
“Lean healthcare is used in a growing number of hospitals to increase efficiency and quality of care. In healthcare organisations, it attempts to empower staff to generate continuous improvement through incremental but regular improvements in work processes. Periodic, detailed and specific feedback is extremely important to decrease complication rates and increase the service quality,” he shared.
Within the endoAVF creation session, Matteo Tozzi (vascular surgeon, Varese, Italy) presented a novel case report of Wavelinq endoAVF creation using carbon dioxide (CO2) contrast.
Detailing the clinical benefit of preserving residual renal function (RRF) in dialysis patients, Tozzi commented that those with residual renal function had better control of serum potassium and sodium, acid-base status and volemia.
Outlining his goals for the case, Tozzi explained that he planned distal injection through a drug-coated balloon or plain balloon to use CO2-viscosity wisely and enable a faster procedure with reduced risk and complexity.
His take-home message from this innovative approach to imaging: There was no damage on kidney residual function in chronic kidney disease patients and no damage on kidney residual function in kidney replacement therapy patients. “Non-iodinated contrast can be used in the implementation of [an] endovascular approach for vascular access creation,“ he submitted.
Tobias Steinke (vascular surgeon, Düsseldorf, Germany) then doubled down on the reasons for pursuing an endovascular creation strategy. He stated: “EndoAVF systems are designed to be less invasive and maybe to last longer; reduce the rate of primary failure and enable more medical specialties to participate in the creation of AVF, which can be relevant in areas underserved by vascular surgery.”
“Based on my experience, attempts to optimise perioperative haemodynamic conditions, regional blocks and endovascular technique modifications are worthwhile to improve fistula outcome and have the potential to increase the number of functional endoAVFs,” he underlined.
Yousof Al Zahrani (interventional radiologist, Riyadh, Saudi Arabia) then detailed the simplicity of his experience from learning to mastering WavelinQ in a hospital setting that caters for 2,100 beds with the expertise of 12 interventional radiologists, four neuroradiologists, two paediatric interventional radiologists and six fellows.
In pursuing an endoAVF creation programme, the team has performed 32 percutaneous procedures, with the majority of patients undergoing a WavelinQ procedure under regional anaesthesia.
“Procedural success was 85%, with successful cannulation achieved in 88% with a time to cannulation of four to eight weeks. There were no device-related complications and reinterventions were needed in five patients (18%),” he detailed.
In a session examining restoration of dysfunctional AVF, Jose M Abadal, president of the Spanish Interventional Radiology society (SERVEI; Madrid, Spain) shared his approach to percutaneous angioplasty (PTA) balloon selection based on the type of stenosis. He exhorted that the degree of stenosis was not enough of a measure, but that the type of stenosis is vital in determining the choice of device. In his centre, choice rests on a combination of medical evidence, cost containment and a clinical practice that is heavily reliant on Doppler ultrasound use. He reminded delegates that the technique of PTA is still variable, quipping “standardisation is clearly reserved for cardiologists”. Abadal stated that plain balloon angioplasty is the first choice followed by a double whammy of angioplasty then drug-eluting balloon. Ultra-high pressure balloons are the first choice and in case of recoil either these or scoring balloons are applied, with stent grafts only selected if there is a clear indication. “Ultrasound is mandatory for sizing and new Doppler ultrasound criteria will be used to determine technical success,” he noted.
Joseph Touma (vascular surgeon, Paris, France) spoke on his centre’s experience of drug-coated balloon in fistula maintenance and Luka Novosel (interventional radiologist, Zagreb, Croatia) updated on the AVF cohort of the Lutonix AV Global registry, drawing out the patient and procedural variables of the study.
In the maintenance session for dysfunctional AVF, Griveas described the access life circuit that begins with vascular access stenosis. “Drug-releasing balloons can be a useful therapeutic option for patients with AVF stenosis due to accelerated endothelial hyperplasia. The use of paclitaxel-coated balloons helps reduce the risk of restenosis of arteriovenous anastomoses and is a safe, minimally invasive and immediate solution to AVF management,” he quoted from a paper published by his group in Nephrology Dialysis Transplantation in 2020.
Jaffer opened the second day’s plenary with a general introduction around the pathology of lesions making the point that “veins are not arteries”. It is important to drill-down into why stenoses occur, he said. “Lesion characteristics can be complex. A UK expert consensus approach for managing symptomatic arteriovenous fistula (AVF) stenosis in haemodialysis patients, published in CardioVascular and Interventional Radiology in 2021, recommends that if a patient requires four or more interventions for the same stenosis in a 12-month period (or three or more in a six-month period), a multidisciplinary meeting and patient discussion on access options should be triggered. For de novo stenosis, plain balloon or high-pressure balloon angioplasty are acceptable first interventions. Bare metal stents have a place only for central region stenosis and if there is recurrence between three and 12 months, consider a drug-coated balloon,” he reported.
This was followed by Kitrou presenting on endovascular treatment of dysfunctional AVF including an algorithm option and Jamal Al Koteesh (interventional radiologist, Al Ain, United Arab Emirates) presenting cases of complex AVF lesions.
Karunanithy then described to delegates why covered stents are key to haemodialysis access salvage.
Katarzyna Kolasa (health economist, Warsaw, Poland) presented findings from a literature review to examine whether covered stents are a cost-effective choice to treat AVF stenosis in haemodialysis patients.
Setting out that only 35% of haemodialysis patients remain alive after five years of treatment, Kolasa pointed out that these survival rates remain worse than those for many common cancers.
AVF is the preferred access choice, and vascular access-related complications and interventions account for almost one-third of hospital admissions among patients receiving dialysis, she said.
To mitigate against the high economic burden associated with AVF stenosis, early consideration of additional procedures along with angioplasty in the course of treatment and postponing additional procedures until it is absolutely necessary have the greatest potential to produce long-term savings, she commented.
Identifying the clinical evidence required for budget holders to ensure funding of covered stents for AVF stenosis, Kolasa said real-world data confirming that the covered stents lower the risk of reintervention, economic modelling data showing the same findings and more such data verifying long-term outcomes for patients would be valuable tools.
“As the outcomes of haemodialysis patients are variably monitored, there is a need for country-specific data collection efforts to inform reimbursement decisions in order to improve access to treatment,” she said.
Inston and Fanelli summed up the discussions when they told Renal Interventions: “The ESKD summit brings together the multidisciplinary team to consider more than just procedures and devices. It approaches treatments as more than just isolated procedures, and consciously reframes these in the context of a patient’s journey. This journey may have one clinician at the centre or have multiple inputs into treatments, but it is one that has a profound impact on each individual patient and their families. We feel that the summit achieved this vision by using a patient-centred approach.”