Experience of Patients with Vascular Access for Hemodialysis VALE Project-Vascular Access Life Experience

Rationale & objective: For individuals with end-stage kidney disease (ESKD) undergoing hemodialysis (HD), vascular access (VA) is fundamental for extending their lives and enhancing their quality of life (QoL). Placing patients at the heart of dialysis access decisions is crucial, not just addressing immediate access requirements but also looking ahead to their future needs. To facilitate better, it’s essential to understand how various VA methods affect the patient’s overall experience.

Study design: Patient experiences with arteriovenous fistulas (AVFs), arteriovenous grafts (AVGs), and central venous catheters (CVCs) were investigated through individual, semi-structured phone interviews, which utilized a validated questionnaire as a framework.

Setting & participants: Adult ESKD patients undergoing HD for at least six months, including those with prior kidney transplants, were selected. Participants were over 18, ANED (National Association of Dialyzed and Transplanted) members, and volunteers.

Analytical approach: The study’s theoretical framework was built using grounded theory principles. Initial coding was based on themes from a validated questionnaire (Nordyke, et al. 2020), and further codes and subcodes were generated through inductive coding (MAXQDA-2022 software).

Results: The study found significant variation in VA types: 30.0% (N = 30) AVF only, 26.7% CVC to AVF, 13.3% AVF to CVC, 10.0% graft, 6.7% stable VA history, and 13.3% complex histories. Appropriate CVC discontinuation was low (10%). VA type significantly impacted social and daily activities/physical functioning, symptoms, and sleep. Younger patients (≤65%) experienced reduced QoL in work, family, and leisure. Reduced QoL stemmed from impaired daily activities, attention deficits, fear, anxiety, and worry. AVF had a greater impact than CVC and AVG in almost all domains. Patients preferred fistulas, regardless of HD years and geographical location.

Limitations: The absence of inclusion of patients from surgical hubs may not represent the real-world variety of Italian dialysis center VA protocols.

Conclusion: Healthcare providers should discuss VA options and their impact on QoL, considering patients’ life goals and preferences.

The chronic care model reported in the 2024-KDIGO (Kidney Disease: Improving Global Outcomes) guidelines [1] emphasizes, among factors of improvement of end-stage kidney disease (ESKD) outcomes, the presence of informed, activated patients and their performing productive interactions with a prepared, proactive multidisciplinary team. Besides, the 2019 Kidney Disease Outcomes Quality Initiative guidelines (2019-K-DOQI guidelines) [2] recommend that “each patient with progressive CKD … should have an individualized ESKD Life-Plan that is regularly reviewed, updated, and documented on their medical record”. The ESKD Life-Plan is a collaborative strategy between patients and a multidisciplinary team to manage ESKD. It begins before dialysis is needed and covers the entire journey from chronic kidney disease to ESKD. The plan considers individual needs and goals to optimize treatment choices and dialysis access. It’s a dynamic process, adapting to changes in the patient’s life and medical conditions. A patient-centered approach to dialysis access is critical, considering not only current access needs but also proactively planning for the next one. This approach goes beyond simply creating and maintaining access; it’s about tailoring a long-term strategy that aligns with the patient’s individual needs, preferences, and circumstances. This holistic, forward-thinking strategy is the core of the ESKD Life-Plan [2].

Vascular accesses (VA) are considered a lifeline by patients with ESKD. Diverse types of VAs are used to facilitate hemodialysis (HD) in patients with ESKD: arteriovenous fistulas (AVF), arteriovenous grafts (AVG), and central venous catheters (CVC). Selecting the “best” type of access is complex and requires a multidisciplinary approach, considering patient preferences and values, improving traceability of outcomes, and conducting cyclical reassessments. Patients often feel uninvolved in this process and are poorly informed about the risks and benefits of each type of VA [3]. A recent review showed that, although patient experience is very relevant, patient-reported outcomes are rarely used in the decision-making process [4].

In this framework, to assess real-world, patient-reported outcomes of patients with HD due to ESKD. A qualitative investigation was performed on a pool of Italian HD patients with ESKD and aimed at understanding their psychosocial experience, including physical function, emotional impact, family and social relationships, ability to work or attend school, sleep patterns, and interactions with HD centers. The research goals also included the time until HD access (“delay”).

Study design

Semi-structured one-to-one interviews were conducted via phone. The study followed the Consolidated Criteria for Reporting Qualitative Research reporting guideline [5]. Consent to participate was collected from patients based on the EU GDPR laws n. 2016/679 as participants were associated with ANED (Associazione Nazionale Emodializzati Dialisi e Trapianto).

Setting and participants

The patients were contacted and invited to participate by ANED based on a screener flowchart defined by the Authors. Inclusion criteria were: patients with ESKD, age ≥18 years, duration of HD of at least 6 months, any type of VA used, regardless of prior kidney transplantation. If interested in the study, they were required to sign the informed consent. Exclusion criteria were defined if one of the flowchart steps was denied.

Subsequently, the consecutively selected patients were invited to complete a semi-structured phone interview while maintaining anonymity.

Interview guide

The semi-structured interview was developed from Nordyke, et al. 2020 [2], a validated questionnaire on the impact of VA in HD. It included categories on: symptoms, physical function, activities of daily living, emotional impact, family and social relationships, ability to work or attend school, sleep, and vascular access control. Additional questions exploring the timing of VA decision-making and the barriers patients faced in their HD treatment were added to the original questionnaire. ANED finally approved the questionnaire in terms of languages and comprehensibility for patients.

Data collection

Data collection was performed by a single expert interviewer (SL), in the patient’s mother language (Italian), following the principles of Narrative Medicine [6]. SL had previous interactions with participants. The interviews were audio-recorded, transcribed verbatim, and stored in ANED databases.

Analysis

Interview transcripts were analyzed by SL between March and May 2023. A theoretical framework was developed using principles of grounded theory [7]. Consensus on this framework was reached after review by study team members to ensure that findings reflected the full range and depth of the data.

The results of the patients’ narratives were analyzed using grounded theory methodology supported by the MAXQDA software program (version 2022). Coding was based on Nordyke, et al. 2020 [2]. Further domains not included in the Nordyke, et al. 2020 were described if evident from the data. Results were described based on word frequency in the coding segments (domains and subdomains), and variables such as type of center, age, and HD years were provided as descriptive statistics.

Out of 32 total approached, 30 were interviewed. Reasons for non-participation included lack of interest (n = 2). The average interview was 35 minutes (SD 10.2 minutes).

The average age was 61 years (range 20-86 years), and 67% were men. The following characteristics were noted: 27% had previously undergone kidney transplantation; 70% lived with their families; 50% were employed, and 43% were retired. 7% reported being unable to work due to their ongoing dialysis. On average, patients had two vascular accesses before beginning HD (minimum of 1, maximum of 3).

Patients reported that they had been undergoing HD for an average of 9 years (range 1-46) at small public hospitals (37%) or large public hospitals (30%). The remaining cases were managed at large contracted private hospitals (7%), large private hospitals (7%), or small private hospitals (7%). Missing data amounted to 13% (Figure 1).

Vascular access pattern

Variability in the selection of VA is high, and detailed results are provided in Table 1.

Of the 30 patients interviewed, nine (30.0%) had only one AVF and been on dialysis for an average of 7.8 years (range 1-41 years). In three cases, the fistula was created beforehand due to underlying conditions (such as polycystic kidney) and subsequently mandated HD. One patient reported a positive experience with the fistula for 41 years, attributing its success to the expertise of the center performing the first access and the training provided to patients by hospital staff.

A total of 26.7% started on a CVC and switched to an AVF; they received dialysis on average for 8.7 years (range 1-30 years). In this cohort, the catheter was placed as an emergency measure or temporarily until the fistula matured (for a period ranging between 20 days and 4 months). In addition, the CVC was removed before fistula maturation if an infection or thrombosis occurred. In patients with a long history of dialysis and kidney transplantation, the fistula was closed despite patient preference due to concerns about potential cardiac problems.

A total of 13.3% of patients switched from AVF to CVC (average dialysis time 4 years, range 2-6 years) due to non-maturation and/or infection.

Only 10.0% of patients are currently receiving HD, or previously had a graft. Only one case had been explicitly chosen by the patient. In the other cases, the choice was dictated by clinical circumstances (such as a fistula being inappropriate). Lastly, two patients (6.7%) had a vascular history with two CVC or two AVF as the only access type. The remaining 13.3% reported a more complex history: problems from all types of access, such as CVC infection, graft closure, fistula thrombosis, and potential limb loss. In all the cases, patients complained of failures and inefficiency in the pattern of care. The use of stents was very limited: only one patient aged 56 years with AVF, who visited a large public hospital, and was experiencing renal transplant rejection after three years of treatment, received stenting

Vascular access selection

Patients appear to be aware of the reasons and steps behind the selection of the VA type, but the choice tends to be guided by hospital teams that are following protocols, organizational motives (i.e., CVC is the choice in emergencies), or by assessing the vascular morphology of the patient with scarce consideration of their lifestyle. In most cases, the patients had consciously and confidently accepted the type of access proposed by the center. The patients nevertheless reported that their expectations about access had been met (only 1 out of 30 complained of short-term graft durability). This behavior is likely explained by disease acceptance and the mandatory, lifesaving, permanent nature of HD.

Delays in switching from CVC to AVF/AVG and vice versa were specifically reported by three patients, regardless of the number of years on HD or the type of VA. When asked about their preference, patients reported preferring fistulas, with one patient mentioning grafts and no mention of CVC. AVF was preferred regardless of years on HD or geographical location. Native fistula was mentioned as preferable. A qualitative analysis from patient narratives reported concerns about:

• CVC: potential infections
• AVF: infection, thrombosis, bumping, swelling, pressure, and cannulation (needle size)
• AVG: positioning, duration, and maturation

Patient populations were variable in relation to sex, age, and factors such as year on HD, type of HD, and location of HD center.

A qualitative analysis from patient narratives reported that patients mostly collect information from physicians and the web; their patient support groups also play a relevant role.

Patient populations were variable in relation to sex, age, and factors such as year on HD, type of HD, and location of HD center. Analysis from patient narratives reported that the patient experienced VA-related adverse events (Table 2). Skin disorders are reported to be mostly related to skin sensitivity. Cases of thrombosis, potentially causing steal syndrome in the most severe instances, were mostly resolved by removing the AVF and replacing it with a CVC; stenting was only used in one case. Episodes of infections were reported when CVC was used, prompting physicians to switch to AVF. CVC was replaced with a graft in only one instance. Physicians switched from AVF to CVC when infections or thrombosis occurred, apparently regardless of the patient’s clinical history or preference. This is confirmed in two interviews with patients with complex clinical histories, both having undergone transplantation and having a long history of HD. In one case, stenting solved the adverse event and enabled HD at home (with patient satisfaction); in the other case, the AVF failed, and a CVC was ultimately used (with patient discontent).

Experience at hemodialysis centers

Patients expressed concerns about various aspects of HD centers, regardless of center type or duration of HD treatment. Issues included difficulties in accessing centers due to parking shortages, lack of dedicated spaces, and the inability to undergo HD at home. Some patients felt inadequately supported by physicians (lack of empathy) and/or nurses (lack of focus on patient training for daily life with venous access). Others noted a lack of psychological support and dissatisfaction with inadequate CVC dressing protocols that were not focused on the patients’ needs. Conversely, positive experiences were often reported with small public hospitals where patients received appropriate and empathetic support from physicians and nurses (e.g., training with blunt needles) (Table 3).

Vascular access-specific health-related quality of life impact

Health-Related Quality of Life (HRQoL) was assessed according to Nordyke, et al. 2020 [4]. Six domains and 21 subdomains were initially defined, but an additional 11 subdomains emerged from the research interviews. These additional subdomains were: namely attention, carrying weights, change in diet and cooking, caregiver, rage, embarrassment, resignation/acceptance, dizziness/pressure disorders, limitation of Activities of Daily Living (ADLs), flushing/itching, and impact with others.

A total of 317 segmented codes were analyzed to assess the impact of VA on patient HRQoL. Results are depicted in Figure 2.

The social/role function (32% of segmented codes in all documents) was mainly influenced by recreation and travel (21%), family impact/play (19%), and work/school (18%). Time burden (15%), relationships with others (9%), appearance/clothing (8%), social avoidance (7%), and physical intimacy (3%) were also notable.

The burden of ADLs/physical function (24%) included housework (25%), attention to daily activities (23%), showers/hygiene, carrying weight, and change in diet and cooking (each 15%), and caregiver (8%).

The emotional impact (23%) encompassed resignation/acceptance (40%), worry/anxiety (23%), fear (22%), embarrassment (11%), and rage (4%).

Vascular accesses had less impact on physical symptoms (10%), with patients reporting manageable bruising/swelling, dizziness/pressure disorders, and pain on cannulation or limitation in movement. Health care interactions (7%) and sleep (4%) were of lesser impact.

Younger patients (≤65 years, i.e., 60% of participants) experienced a major impact on work, recreation/travel, and family subdomains. They suffered particularly from impairments relating to homework/ADLs and attention subdomains, as well as feelings of fear, anxiety/worry, but mostly resignation/acceptance (Figure 3).

Regarding the three most relevant domains, the results are comparable with those reported by Nordyke et al. 2020. However, differences in the social/role function, ADLs/physical function, and emotional impact were observed, particularly in appearance/clothing (8 mentions versus 33 mentions, respectively), social avoidance (7 versus 29, respectively), and work/play (19 versus 5, respectively). These variations in worry/anxiety (17 versus 75, respectively) may likely be attributed to differences in the sample characteristics.

Which type of access had a greater impact on the most relevant domains?

From patient narratives, AVF is reported to negatively affect patients’ lives more than other types of vascular access.

As reported in Figure 4, AVF had a greater adverse impact than CVC and AVG on the social/role function, particularly in terms of relationships with others, time burden, recreation/travel, work/school, and family impact/play. Additionally, AVF had a greater adverse impact than CVC on appearance/clothing, as patients had to conceal their AVF more frequently due to visible swelling. The impact of AVG on the social/role function domain was extremely low.

AVF also affected ADLs/physical function more than CVC and AVG in terms of attention, carrying weights, and caregiver requirements. Patients with AVF who required caregiver assistance were often older (>80 years) or, if younger (>50 years), preferred support with ADLs. However, experiences involving diet and cooking were reported in relation to HD rather than vascular access. An impact on showers/hygiene was reported only for CVC. Housework and other ADLs were mostly reported to be more difficult due to HD rather than vascular access; however, AVF posed a risk of contamination (e.g., when cooking), and CVC posed a risk if accessories were dropped.

Furthermore, AVF had a greater impact on the emotional domain compared to CVC and AVG. Feelings of resignation/acceptance were often associated with HD and, consequently, the impact of vascular access. Embarrassment affected more patients with AVF due to curiosity from others concerning AVF swelling. Worry/anxiety and fear were also greater and primarily linked to the duration of treatment and infections or AVF failure. AVF also affected sleep due to limited arm motion, while patients with CVC needed to consider the impact of access-related self-care due to the size of bandages and patches.

Figure 4 illustrates the impact of vascular access on health domains.

Regarding physical symptoms, such as bleeding, numbness/tingling, pain during dialysis, dizziness/pressure disorders, and redness/itching, the impact of AVF was greater than CVC and AVG. The lowest rate of physical symptoms was reported for AVG.

As reported in international data [4], vascular access impacts HRQoL in Italian HD patients with ESKD, mostly in the social, ADLs/physical function, and emotional domains.

Unlike other cultural contexts, acceptance of and resignation to lifelong HD and the increased attention needed in activities of daily living with VA were added as subdomains of impairment by Italian patients. Common subdomains of major concern to patients are time burden, recreation/travel, and fear and worry/anxiety concerning infections and the duration of use of medical devices. In terms of patterns, patients mostly accept the decisions made by health care providers on VA selection, relying on and trusting in their choice. Their preferences do not appear to be considered, with all participants reporting a preference for AVF and none preferring CVC. Though at present, CVC is still largely used in clinical practice (10% reported a delay in CVC removal). Besides, the 2019-K-DOQI guidelines [2] indicate that the patient’s clinical evaluation (i.e., microcirculation) should be performed, yet not always experienced in the CVC implant, as reported from patients’ words. The preference for home HD is never discussed, nor is the possibility of stenting in case of thrombosis. Consequently, VA history could become more complex, and VA patterns prove to be beyond the patient’s control. As an example, the fistula could be locked after a renal transplant and needs to be reopened in case of transplant rejection, thus significantly impacting quality of life. Furthermore, appropriate care concepts impact the quality of the VA experience: for example, a native fistula and patient training on fistula management could boost the probability of a longer fistula duration and increase patient reassurance. The results are consistent with recent literature findings: HRQoL has been shown to predict mortality in patients receiving maintenance HD; VA is critical in these patients. Multivariable analyses showed that the overall score, social functioning score, and the dialysis-related complication score of the VA questionnaire influenced HRQoL in the study population [6]. Furthermore, total HRQoL scores and scores on the physical and mental component domains were significantly higher in the satisfied VA group than in the dissatisfied group at baseline. Wu, et al. 2024 data also suggested a significant association between VA satisfaction and HRQoL in maintenance HD patients. Surgeons and nephrologists should therefore incorporate patient satisfaction into VA surgical decision-making [8].

This research did not specifically include patients from surgical hubs; the research objective reflected the real-life variability of center types. This could imply increasing heterogeneity in VA protocols. Nevertheless, the pattern of VA use in this study partially matches results obtained from other research on 3,451 HD patients in regional administrative databases representative of the Italian territory [4]: CVC use prevailed (33.1% CVC, 14.7% AVF, and 0.8% AVG) when a single VA was used (30% used AVF in this research); in case of more than one VA type, 20% - 25% of patients alternate CVC/AVF use in both studies, while AVG is mostly selected after experiencing CVC/AVF. These patterns suggest partial application of the 2019-K-DOQI guidelines recommending arteriovenous access (AVF or AVG) in preference to CVC in most incidents and prevalent HD cases due to the lower infection risk associated with VA use [2]. Long-term CVC use is recommended only if multiple prior arteriovenous accesses failed with no available options or valid patient preference, and when the use of an arteriovenous access would severely limit QoL or achievement of life goals. Patients should be properly informed of patient-specific risks and the benefits of potential and reasonable access options. In general, no decision about a single VA creation or placement should be made in isolation or independent of the patient’s overall ESKD life plan. However, this study demonstrated a misalignment between clinical practice and patient preferences and experience, as demonstrated by the large use of AVF, which is the VA with a major impact on QoL, the delay in the CVC removal, and the lack of acknowledgment about the graft.

Qualitative research was selected as the preferred method for describing the impact of health care technologies and/or treatments on patients’ lives, based on the assumption that narration is an essential human prerequisite and is part of the health care pattern [9]. This could be considered a limitation in the representativeness of the study sample for ESKD patients. However, the sample size of this research confers with current qualitative literature [4,10]. Robustness is achieved, moreover, through the use of a validated questionnaire [4].

Lastly, recent qualitative literature findings demonstrated that dialysis-related decisions need to involve shared decision-making on VA, and that a timely, tailored, and balanced exchange of information between patients and their care team is required [10]. Research demonstrated that opportunities to revisit the VA decision before and after starting dialysis helped prepare patients for their access and promoted ongoing alignment between patients’ care priorities and treatment plans. Where shared decision-making was undermined, HD via catheter ensued as the most readily available VA option [10].

Active participation of patients, in accordance with their preferences and requirements, should be encouraged due to the significant impact of vascular access on various aspects of a patient’s QoL, encompassing social/role dynamics, activities of daily living, and both physical and emotional functions. This finding underscores the necessity to redefine and thoroughly discuss VA protocols within the scientific community, involving patients in the co-creation process.

Additionally, increasing awareness and use of grafts among patients and healthcare professionals is crucial, as grafts have the potential to significantly improve quality of life. The use of AVG and stenting techniques, compared to AVF and CVC, has been linked to improved quality of life for patients, due to a reduction in infections and complications, as well as better mobility [11-13]. The spread of home HD as a potential treatment option is also to be considered for minimizing the adverse effects on QoL.

Furthermore, enhancing collaboration with patient associations is essential to increasing patient health literacy and awareness regarding VA, thereby facilitating informed decision-making when selecting or changing the VA. Nephrologists should assume a predominant role in the provision of VA care and maintain close interdisciplinary collaboration with other specialties to ensure the delivery of optimal, multidisciplinary patient care [14].

Authors’ contributions

Research idea and Study design: SM, SL; data acquisition: SL; data analysis/interpretation: SL, SM; statistical analysis: SL; supervision or mentorship: SM. Each author contributed important intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions about the accuracy or integrity of any portion of the work are appropriately investigated and resolved.

Support

W. L. GoRe & Associati S.r.l provided financial support for this project.

The funders did not have any role in study design, collection, analysis, interpretation of data, or the decision to submit the report for publication.

Financial disclosure: Dr. Mangano reports serving as a consultant for W. L. Gore & Associati S.r.l and Fresenius. Dr. Lopatriello reports having served as a scientific consultant for several companies, including Helaglobe S.r.l employee at the time of the manuscript drafting.

The need to understand patients’ perspectives on vascular access and its impact on daily life was identified and initiated by W. L. Gore & Associati S.r.l., represented by Dr. Geraldo Tadinho Monteverde Spencer, Dr. Marzia Martoni, and Dr. Francesca Di Stasi, who provided the initial impetus for this project. ANED (Associazione Nazionale Emodializzati Dialisi e Trapianto) played a crucial role in contacting its members and obtaining their informed consent for participation. Helaglobe S.r.l. is acknowledged as the employer of SL, the author of this manuscript.

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