Dialysis

A Person-Centered Approach to Kidney Care

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Summary

Person-centered care has been advanced as an effective framework for improving patient satisfaction. By considering biopsychosocial factors — including socioeconomic status, environment, intellectual development, health, cultural factors, and social interactions — such care can help optimize treatment outcomes, advance health equity, and decrease costs. However, these factors, adopted by the medical field and labeled social determinants of health, have been inconsistently evaluated, thereby missing an opportunity to truly understand the individual needing care. Furthermore, a balance of specific social determinants of health factors and assessments of cognition and functional status can improve understanding of a patient and their context. The authors explore new possibilities with a shift in assessment methodologies, using end-stage renal disease as a model, and present a vision for a more effective person-centered assessment model, which is increasingly possible — and needed — in the modern health care environment. A surprising finding from the qualitative interviews was the importance of social connections formed during in-center dialysis. Additional key considerations include financial barriers, transportation challenges due to financial and mobility limitation, housing insecurity, insufficient knowledge of kidney disease and treatment, and limited contact with nephrologists. This article proposes potential methods for improvement of care that can simultaneously improve patient engagement and outcomes.

Editors’ note: This case study is an early release from Volume 5, Issue 2 of NEJM Catalyst Innovations in Care Delivery. It will appear alongside other issue 5.2 articles in February 2024.

Person-centered care is particularly critical for those who experience chronic health conditions such as chronic kidney disease (CKD), which affects approximately 15% of adults in the United States and disproportionately affects people of low income and communities of color.1 Complicating care, up to 90% of people with CKD are unaware they have it. This is attributed to an absence of symptoms until later stages of the disease, which increases the likelihood of progression to kidney failure and end-stage renal disease (ESRD). Current treatments for ESRD include peritoneal dialysis, hemodialysis, and kidney transplant.

Total inflation-adjusted Medicare expenditures for patients with ESRD increased from $47.1 billion in 2010 to $53.0 billion in 2019.2 Between 2010 and 2020, inflation-adjusted per-patient-per-year spending for ESRD decreased from $96,451 to $79,439. The greatest decrease was in inpatient spending, to $25,313 in 2020 from $32,886 in 2010. Outpatient spending also decreased, to $27,973 in 2020 from $30,966 in 2010.

Although transplantation has the potential to significantly improve quality of life, reduce mortality, and decrease costs, only 13% of patients are deemed eligible for the transplant list, and there are no standardized protocols for selection, potentially revealing another selection bias in survival rates.2 Certain populations are disproportionately disadvantaged when it comes to being waitlisted. The following groups are significantly less likely to be listed for transplantation and hence many fewer receive transplants: older adults; Black, Latinx/Hispanic, Native American/Alaska Native, Native Hawaiian/Pacific Islander, and Asian American people; people of low income; and people with disabilities.3–6 In addition to these selection biases, such patients are also more likely to be dually eligible, that is, those who have insurance coverage by both Medicare and Medicaid, with low income (average less than $20,000 per year) and advanced age (≥65 years) or disability, and are likely to experience very different challenges than individuals covered by Medicare alone.

Needs-Finding in ESRD

In March 2023, the authors launched a quality improvement project focused on person-centered ESRD care delivery. This project was conducted as an independent study by researchers based at Stanford University’s Clinical Excellence Research Center in conjunction with DaVita Kidney Care. We developed a survey (Appendix) and worked from a list provided by DaVita Kidney Care of dually eligible patients who were receiving dialysis. We focused on dually eligible patients because there are approximately 12.3 million people7 in the United States who are dually eligible, and more than 30% of them experience CKD. In 2020, Medicare inflation-adjusted expenditures for ESRD beneficiaries with fee-for-service Medicare was $65,817, higher for Medicare Advantage beneficiaries at $75,263, and much higher for dually eligible beneficiaries at $94,532.2

Top themes identified by individuals undergoing dialysis treatment were related to food insecurity, low rates of home dialysis, transportation barriers, mobility limitations, housing insecurity, social isolation, and cognitive decline.

A semistructured survey was prepared with primarily open-ended questions that gauged patients’ dialysis experiences with respect to barriers to care they faced, knowledge barriers in ESRD/dialysis, perspectives on the practice of home dialysis, goals of care, and highlights in their care journey that could be used to shape improved care delivery. This approach was taken by examining the literature and adapting for qualitative surveys of patients’ experience in dialysis. From a list of 48, we successfully reached 28 patients, but only nine agreed to participate (Table 1). During interviews with this group, we found that the same general themes recurred and determined that we had reached a saturation of themes. This group included participants who resided in urban, suburban, or rural neighborhoods. Interviews were conducted via telephone. The duration of each interview ranged between 29 and 153 minutes (mean [standard deviation], 51.3 [40.3] minutes).

Table 1

Demographic Characteristics of ESRD Patient Interview Participants

Qualitative interviews with dually eligible ESRD patients were conducted to understand their multifaceted social needs. Interviews were conducted until saturation of themes was reached. Top themes identified by individuals undergoing dialysis treatment were related to food insecurity, low rates of home dialysis, transportation barriers, mobility limitations, housing insecurity, social isolation, and cognitive decline (Table 2).

Table 2

ESRD Patient Interview Participants, Needs Identified

Nearly all respondents expressed a belief that they were eating healthfully, while reporting diets consisting mostly of fast foods, frozen meals, and animal-based protein. Meal choices are often dictated by what individuals can afford with food assistance programs and/or can prepare with only a microwave or a limited cooking repertoire.8 However, all interviewees reported that they had been given “kidney-friendly” diet recommendations by clinicians, who often fail to consider the reality of the patient’s unique challenges, cultural factors, and preferences. Such a one-size-fits-all approach may limit the effectiveness of treatment plans, diminish rapport between patients and providers, and compound challenges, including limited patient engagement, fragmented care coordination, and suboptimal treatment outcomes.

Approximately 90% of all dually eligible patients in the United States receive dialysis in outpatient dialysis centers despite the goal of the U.S. Department of Health and Human Services of having 80% of patients with ESRD undergoing dialysis at home or receiving a transplant.9,10 In accordance with previous literature, we found that dually eligible patients were less likely to engage in home dialysis due to challenges related to social determinants of health (SDOH), such as housing instability, lack of resources or support systems, and limited health literacy.11,12 In addition, previously reported improved outcomes for home dialysis over in-center dialysis may be applicable only to specific subgroups of patients, such as those with significant support systems, stable housing, and those in better overall health, which often excludes dually eligible patients.13,14

As with nutrition recommendations, health care–centric assumptions about quality of life with different kidney care options might contradict an individual’s preferences; therefore, treatment options warrant tailoring to nuances not routinely captured in clinical settings.

Although in-center dialysis may pose a hardship, both in terms of time (three times a week, for several hours a day) and accessibility to patients who may have to travel 30–60 minutes in each direction to the nearest center, all of the dually eligible in-center interviewees stated that they preferred in-center dialysis for social connection; only one was open to in-home dialysis. Almost all (eight of nine) had to stop working due to dialysis, further limiting outside contact with other people. Interviewees expressed that they had formed strong friendships with staff and other patients through seeing them several times a week, over many years. For example, interviewees stated that staff would make ethnic, home-cooked meals to share; that talking with fellow dialysis patients was their social connection; and that seeing the same people multiple times a week for years was its own support group. Interviewees also stated that they utilized their dialysis time to learn about treatment options, or other tips, from fellow dialysis patients. As with nutrition recommendations, health care–centric assumptions about quality of life with different kidney care options might contradict an individual’s preferences; therefore, treatment options warrant tailoring to nuances not routinely captured in clinical settings. Ultimately, specific challenges and needs and preferences must be addressed if we are to advance kidney health for all patients.

Broadening Assessment to Include Cognitive and Functional Status

In addition to physical decline, CKD/ESRD has been linked to an increase in risk for cognitive decline, as have social isolation and loneliness, further emphasizing the importance of social engagement and the inclusion of cognitive and functional screening in addition to SDOH screening.15–17 Dually eligible individuals who experience cognitive challenges may have difficulty understanding their disease and treatment options. In interviews, some dually eligible patients (six of nine) expressed a lack of comprehension regarding what dialysis was or what dialysis entailed even after education by the dialysis center and/or clinicians, whereas others (two of eight) indicated that they preferred to be naive regarding their disease or treatments; many (six of nine) said that they hoped that providers would spend more time explaining procedures and treatments. Some (three of nine) patients expressed dismay at how dialysis has restricted their lives and daily activities. Persons living with a complicated disease such as ESRD and, in particular, those experiencing cognitive decline would uniquely benefit from increased time with clinicians so that the clinicians can check for comprehension and iterate the care plan, as needed and on a more timely basis.

A majority of interviewees (seven of nine) did not drive, which often was attributed to cognitive and mobility challenges, as well as financial and SDOH barriers. Functional difficulties with bathing, cooking, or other activities of daily living were also often reported (seven of nine). This was especially salient for those who lived alone or lacked support. Several of these patients (three of seven) relied on professional caregivers; some visited three or four times a week, which underscores the importance of understanding individual needs and barriers to engaging in critical health-promoting behaviors.

Understanding Context

Clinical, cognitive, and functional assessments can help to evaluate multidimensional risks for poor health outcomes, as well as provide opportunities for prevention and early intervention, especially for older adults who are more likely to experience a confluence of chronic conditions. Since December 2020, the Centers for Medicare & Medicaid Services (CMS) Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule (85 FR 82586, which was later incorporated into the pending proposed rule CMS-0057-P), has called for accelerating the adoption of standards related to social risk factor data. In the wake of these calls to action, nearly one-quarter of hospitals are now screening for SDOH.18,19 When used in tandem with cognitive and functional assessments, these tools have shown enormous potential for identifying and serving complex, high-needs populations such as dually eligible patients with ESRD. For example, health technology companies have already effectively used functional and cognitive screening data to show how these factors are predictive of ED visits.20

One critical finding was the disparity between clinical recommendations and the lived realities of patients, especially in terms of diet and treatment options.

CMS has expressed interest in improving best practices for collecting functional, cognitive, and social risk data; new technologies should be leveraged to efficiently capture such data across a range of contexts.21 Rather than merely combining lengthy combinations of cognitive and functional assessments with SDOH indicators, new approaches aligned with the realities of telehealth, asynchronous care, and remote patient monitoring present exciting prospects for reimagining the assessment and triage process. For example, artificial intelligence–assisted telehealth, which includes routine wellness questions and evaluates responses, can easily capture important health data for patients with ESRD, potentially predicting future health issues. In addition, experimental wearable devices that assess social engagement could provide a more holistic and continuous picture of patient health, improving accuracy and outcomes without overburdening clinicians.22

To craft such integrated assessments, several prerequisites should be considered:

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Instruments should capture functional, cognitive, and SDOH data across medical, social, and behavioral health domains, to improve health equity and promote shared decision-making.

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Ease of use, workflow integration, and clinical and patient acceptability of these instruments must be considered and codesigned.

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Streamlined screening instruments must be tied to modifiable outcomes of interest and be incentivized by informing standardized billing metrics.

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Instruments must practically incorporate medical, social, and behavioral health needs to better inform clinician treatment planning.

Looking Ahead

Moving forward, the potential of this pilot qualitative study to shape care delivery for dually eligible patients with ESRD is noteworthy, particularly given the relative dearth of studies examining this unique clinical and demographic intersection. Despite the small number of interviews, the sessions lasted on average nearly 1 hour and encouraged open-ended input from participants on their experience of care. One critical finding was the disparity between clinical recommendations and the lived realities of patients, especially in terms of diet and treatment options. Individuals additionally face unique challenges such as financial limitations or lack of social support, which can hinder adherence to home-based care plans.

Based on these insights, we recommend that clinicians engage in conscientious, thorough discussions with patients at the outset of treatment — taking into account their social, cultural, and personal circumstances — to ultimately improve outcomes and drive down costs in the long term. For instance, dietary recommendations should be not only “kidney friendly,” but also realistic and achievable within the patient’s means. Similarly, decisions about dialysis modalities should involve a detailed discussion about the patient’s living conditions and support systems. These practices are not just suggestions, but important steps toward truly person-centered care, ensuring that treatment plans are medically sound as well as practically feasible and aligned with individual preferences. Thus, the findings from the current study may reinforce critical practices and ongoing shifts in kidney care, including an improved focus on the social determinants of kidney health. Further, it may open new vistas into opportunities to improve staffing, processes, or clinical/SDOH-related activities.

Our experience suggests that a thorough and empathetic understanding of the individual’s socioeconomic background, cultural influences, and personal preferences is critical.

In addressing the optimal mix of care delivery methods for patients with ESRD, it is important to consider the individualized needs of each patient, particularly those who are dually eligible. Our findings underscore the need for a more nuanced approach to care delivery. For instance, although at-home dialysis offers convenience and comfort, it may not be suitable for patients facing social isolation or financial barriers that may preclude ease of application in the home. In-clinic dialysis, on the other hand, may provide essential social interaction and support, but may present transportation and mobility challenges. Lastly, although kidney transplantation is the most desirable option for many, its limited availability and eligibility criteria make it an inaccessible choice for a significant portion of patients. Therefore, we recommend a person-centered framework in which care delivery is tailored based on a comprehensive assessment of each individual’s medical, social, and personal needs. This approach would enable more effective and personalized treatment plans, enhancing both outcomes and quality of life.

In implementing a person-centered care model for ESRD, particularly for dually eligible individuals, health care providers may encounter several challenges. First, accurately assessing and integrating individual needs and preferences into care plans can be complex, given the diverse and often underrepresented backgrounds of these individuals. Our experience suggests that a thorough and empathetic understanding of the individual’s socioeconomic background, cultural influences, and personal preferences is critical. This may require additional training for health care providers in cultural competence and communication skills. Furthermore, it is critical to measure what matters and to concretely identify the full breadth of the individual experience for those who engage in dialysis.

To this end, the creation of integrated assessment instruments that more effectively capture the whole person — including the full spectrum of lived experiences, context, and behaviors — offers much promise in building person-centered care models. For clinicians, improved assessments that consider clinical, cognitive, functional, and social determinants of health can improve the identification of clinical risks without additional burden and enable earlier, upstream intervention. For health plans and the government, standardized novel data collection instruments can foster progress toward value-based care and national policy goals. For individuals, such as those with ESRD, more holistic measures and new technologies can help with the efficient capture of the full depth and breadth of an individual’s experience and better align health care with what matters most to patients.

However, challenges lie in the adoption of new technologies for patient monitoring and data collection. Although these technologies offer promising avenues for enhancing care, their integration into existing health care systems can be hindered by logistical, financial, and technical barriers. To address these challenges, we recommend collaborative efforts involving multidisciplinary teams, including IT specialists, to ensure smooth technology integration and staff training. Health care organizations should consider pilot-testing these technologies in selected patient groups to identify and address potential issues before wider implementation. Finally, maintaining consistent and open communication throughout this process is vital to ensure that needs and concerns are continually addressed, fostering trust and engagement in the care journey.

In Acute Kidney Disease, SGLT2 inhibitors Were All-Around Protective

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Risk of all-cause mortality, MAKE, and MACE were significantly reduced

A computer rendering of a transparent body with the kidneys highlighted.

SGLT2 inhibitors significantly lowered the risk of death, major adverse kidney events (MAKE), and major adverse cardiovascular events (MACE) in people with type 2 diabetes and acute kidney disease, according to a cohort study.

Compared with nonusers, SGLT2 inhibitor users had a 5-year all-cause mortality rate of 9.0% versus 18.7%, which translated into a 31% lower risk of mortality (adjusted HR 0.69, 95% CI 0.62-0.77) over a median 2.3-year follow-up, Vin-Cent Wu, PhD, of the National Taiwan University Hospital in Taipei, and colleagues found.

SGLT2 users also had significantly lower rates for MAKE (9.5% vs 21%) and MACE (13.5% vs 25.8%), which yielded 38% (aHR 0.62, 95% CI 0.56-0.69) and 25% lower risks (aHR 0.75, 95% CI 0.65-0.88), respectively, the researchers noted in JAMA Network Openopens in a new tab or window.

“Given that the current management of acute kidney disease primarily relies on conservative approaches, such as monitoring, medication adjustments, and minimizing kidney-stressing procedures or treatments, there has been a notable absence of targeted pharmacotherapy to offer protection to these patients,” Wu told MedPage Today. He added that this class of drugs has already been well-established to slow kidney function decline and the risk of death in those with chronic kidney disease. At the moment, a few FDA approved SGLT2 inhibitors have diabetes, kidney, and cardiovascular protection indications, including empagliflozin (Jardiance)opens in a new tab or window, dapagliflozin (Farxiga)opens in a new tab or window, and canagliflozin (Invokana).

The current findings add to the argument that this medication class also holds benefits for patients with acute kidney disease, said Wu. “Given the potential contribution of acute kidney disease to the rise in the burdens of MACEs and MAKEs, it is crucial for clinicians to consider using SGLT2 inhibitors to address this growing public health concern.”

Researchers identified 230,366 patients with acute kidney disease (average age 67.1) from the TriNetX global healthcare database who were admitted to targeted healthcare organizations. Among this patient population, only 5,319 (2.3%) were on an SGLT2 inhibitor, which Wu called a “relatively low” number, particularly given the fact that current guidelinesopens in a new tab or window recommend the use of SGLT2 inhibitors in patients with existing kidney disease. “This underscores the need for increased awareness and greater consideration of this critical issue in clinical decision-making,” he pointed out.

Inclusion criteria included a type 2 diabetes diagnosis and having received dialysis during hospitalization. Those who received postdischarge redialysis or who died within 3 months were excluded. MAKEs were defined as redialysis, dialysis dependence, or mortality, and MACEs were defined as cerebral infarction, hemorrhagic stroke, acute myocardial infarction, cardiogenic shock, or mortality.

At baseline, people on SGLT2 inhibitors had slightly higher average HbA1c levels (8.4% vs 7.9%), eGFR (76.9 vs 73.9 mL/min/1.73m2), and BMI (32.3 vs 30.4). More SGLT2 users were also on angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.

Despite the many protective benefits of SGLT2 inhibitors in this population, the researchers did find a higher risk for diabetic ketoacidosis (AHR 1.36, 95% CI 1.00-1.85) and osteoporotic fractures (AHR 1.39, 95% CI 1.04-1.85).

When the researchers looked at specific subgroups, they found the reduction in mortality risk was seen regardless of whether patients were also on insulin, renin-angiotensin aldosterone system blockers, or diuretics. Patients with more advanced kidney disease, no hypertension, and those not taking other diabetic agents had greater reduction of mortality and MAKE risk.

When discussing the thinking behind this study, Wu explained that this group recently conducted a network meta-analysisopens in a new tab or window and found that the use of empagliflozin or dapagliflozin yielded superior renal protection in patients with diabetes and also significantly reduced the risk of acute kidney injury. “The incidence of acute kidney disease following acute kidney injury is approximately 33.6% and it can occur without identifiable preceding acute kidney injury. The development of acute kidney disease is associated with increased risks of chronic kidney disease, dialysis, and mortality.”

The researchers noted that most patients included were white, which could limit how generalizable the findings are to other racial and ethnic groups. Also, the baseline differences in SGLT2 users’ comorbidities and medication use also may have biased the findings.

Women at higher risk of all-cause mortality in first 5 years after starting dialysis

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Compared with men, women are at a higher risk of all-cause mortality in the first 5 years following dialysis initiation, according to data published in the American Journal of Kidney Diseases.

Further, the two most common causes of death among patients with kidney disease regardless of sex were CVD and dialysis withdrawal.

Infographic showing most common causes of death
While women experienced a lower risk of CVD-related mortality compared with men, they experienced a greater risk of infection-related and dialysis withdrawal-related mortality. Data were derived from Lim WH, et al. Am J Kidney Dis. 2022;doi:10.1053/j.ajkd.2022.07.007.

“Although prior studies have examined the effects of age and era on the survival trends in patients with kidney failure relative to the general population, data relating to the potential interactive effects between sex and patient characteristics, such as age, ethnicity and era of commencing dialysis on cause-specific death in incident dialysis patients with kidney failure, remain unknown,” Wai H. Lim, PhD, from the department of renal medicine at Sir Charles Gairdner Hospital in Australia, and colleagues wrote. They added, “As sex is already identified as a major risk factor for all-cause death in patients with kidney failure, this study aimed to assess the relationship between sex and cause-specific mortality in incident dialysis patients, and to determine the interactions between era, age gradient, ethnicity and sex on cause-cause deaths.”

In a retrospective cohort study, researchers examined data for 53,414 patients (39% were women) who had initiated dialysis in Australia and New Zealand between 1998 and 2018.

Data were derived from the Australia and New Zealand Dialysis and Transplant registry, and researchers followed patients from the commencement of dialysis until kidney transplantation, death on dialysis or Dec. 31, 2018, whichever came first.

Researchers considered the primary outcomes of the study to be cause-specific mortality of cardiovascular-related, infection-related and dialysis withdrawal-related mortality on dialysis. Using cause-specific proportional hazards models, researchers measured the associations between sex, cause-specific and all-cause mortality while focusing on the first 5 years following initiation of dialysis.

After a median of 2.8 years follow-up, 51% of the patients died. Researchers identified the two most common causes of death as CVD (18%), followed by dialysis withdrawal (16%). Analyses revealed women were more likely to die in the first 5 years after dialysis initiation compared with men. While women experienced a lower risk of CVD-related mortality compared with men, they experienced a greater risk of infection-related and dialysis withdrawal-related mortality.

“Our study findings are particularly important as this may form the focus of future studies and targeted policies designed to reduce the survival disparity in female patients with kidney failure. However, it is essential to examine whether the sex differences in cause-specific mortality are apparent in other countries with dissimilar health care structures and resources, which may then provide additional insight into the explanation contributing to this difference in health outcomes among dialysis patients,” Lim and colleagues wrote. “Research addressing the sex-disparities in the pattern and contributing factors of cause-specific mortality in patients with kidney failure remains inadequate but is critical to delineating clear evidence relating to the benefit of targeted interventions to improve health outcomes in this population.”

Patients with advanced CKD can experience improved quality of life without using dialysis

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Patients with advanced chronic kidney disease who choose not to use dialysis can survive many years with improvements to their mental health, in addition to stable physical health and quality of life until late into the illness, data show.

However, researchers found several patients used acute care services and there were significant disparities in access to end-of-life care. Researchers noted more research is needed to optimize outcomes among patients who are not treated with dialysis.

“Prior systematic reviews and meta-analyses reflect only a small fraction of the patients who forgo dialysis described in the literature and provide only a limited view of the clinical course of patients to guide ongoing management and anticipatory guidance to patients who have already decided that they will not pursue dialysis,” Susan P. Y. Wong, MD, MS, from the division of nephrology at the University of Washington in Seattle, and colleagues wrote. “To support a deeper understanding of the long-term outcomes of patients with advanced CKD who do not pursue dialysis, we performed a systematic review of longitudinal studies reporting survival, use of health care resources, quality of life and end-of-life care of patients with advanced CKD who did not pursue dialysis.”

The systematic review comprised of 41 cohort studies and 5,102 adults with advanced kidney disease who did not utilize dialysis. Researchers collected baseline data in addition to patterns of end-of-life care for patients who died during follow-up using a standardized data extraction form. Rather than meta-analyze data, researchers opted to synthesis the reported outcomes.

Among the 34 studies that provided information on survival, researchers found the range of medial survival was 1 to 41 months based on the baseline mean eGFR range of 7 mL/min/1.73 m² to 18 mL/min/1.73 m². Analyses revealed patients underwent approximately one to two hospital admissions, six to 16 in-hospital days, seven to eight clinical visits and two ED visits per year.

During a period of 8 to 24 months, researchers recorded improved mental well-being, and stable physical well-being and overall quality of life until late into patients’ illness.

Among patients who died before follow-ups, researchers observed that 20% to 76% enrolled in hospice, 27% to 68% died in a hospital and 12% to 71% died at home. Similarly, 57% to 76% of patients were hospitalized, and 4% to 47% underwent an invasive procedure during their final month of life.

Researchers noted more studies are needed to optimize the outcomes among patients who choose not to use dialysis.

“Our findings challenge the common misconception that the only alternative to dialysis for many patients with advanced CKD is no care or death. Despite the advanced ages and significant comorbid burden of cohorts in this study, most patients survived several years after the decision to forgo dialysis was made. We also found that mental well-being improved over time and that physical well-being and overall quality of life were largely stable until late in the illness course,” Wong and colleagues wrote. “These findings not only suggest that conservative kidney management may be a viable and positive therapeutic alternative to dialysis, but they also highlight the strengths of its multidisciplinary approach to care and aggressive symptom management.”

PERSPECTIVE

 Dale Lupu, MPH, PhD)

Dale Lupu, MPH, PhD

Patients with advanced CKD who are deciding whether to start dialysis or pursue a treatment approach called active medical management without dialysis (AMMWD), also known as conservative kidney management, generally want to know, “How long will I live with each treatment approach? What will my quality of life be like? What will my end-of-life experience be?” The JAMA Network Open article “Long-term Outcomes Among Patients with Advanced Kidney Disease Who Forgo Maintenance Dialysis,” by Wong and co-authors providers a distillation of current evidence helpful for advising patients on these questions. They conducted a systematic review of 41 longitudinal cohort studies of adult patients with advanced CKD who chose not to pursue maintenance dialysis, a treatment course they term conservative care. It is telling that their search strategy included more than 20 different terms to describe what they call conservative care. AMMWD is the term recommended in the clinical practice guideline Shared Decision-Making in the Appropriate Initiation of and Withdrawal from Dialysis and preferred by patient advisors to the Coalition for Supportive Care of Kidney Patients. One wonders if, in addition to the other recommendations the authors make, the field would advance faster if this patient-preferred terminology was used consistently.

Prior systematic reviews and meta-analysis have included only studies that directly compare patients on dialysis to patients treated without dialysis, but this misses other evidence in the literature about the outcomes for patients choosing AMMWD. This review helps paint a more complete picture of the natural history of patients choosing AMMWD, thus helping clinicians provide information patients want as they consider their treatment options. There were no studies from North America, highlighting how underdeveloped both the practice and the science is for this treatment option in the United States. 

In terms of prognosis, the wide variability in survival across study cohorts stood out. Median survival in each cohort ranged from 1 to 41 months as measured from a baseline mean estimated GFR ranging from 7 mL/min/1.73 m2 to 19 mL/min/1.73 m2. Although the range was large, it is worth noting that most studies reported median survival of at least a year. Of the 34 studies reporting survival, 15 reported median survival of 12 to 23 months; 10 studies reported median survival of 24 months or more. While predicting prognosis for any single patient is always difficult (whether the patient chooses dialysis or AMMWD), this information reinforces that, as a population, it is reasonable to expect patients choosing AMMWD to have a good chance of living a year or more.

In terms of the quality of the time lived with kidney failure while receiving AMMWD, this study reinforces that quality of life typically remains stable. Of special interest, mental well-being improved in the four studies that used either the SF-36 or the kidney disease-related quality of life -short form to measure it. Physical symptoms tended to worsen late in the disease course, consistent with other studies which have described a “symptom cliff” in the last 2 to 3months of life with kidney failure. 

I heartily concur with the authors’ conclusion that their findings (my emphasis added) “underscore the need to develop models of care that optimize outcomes for members of this population who have the potential to live well and for quite some time without dialysis.” Two resources for clinicians and health systems wishing to implement systematic delivery of non-dialytic medical management are the conservative kidney management pathway website developed by the University of Alberta (https://www.ckmcare.com/)1 and the AMMWD toolkit developed by the Coalition for Supportive Care of Kidney Patients (https://go.gwu.edu/ammwd).2

References:

1. Davison SN, et al. Clin J Am Soc Nephrol.2019;doi:10.2215/CJN.10510917.

2. Lupu D, Moss AH. Semin Nephrol. 2021;doi:10.1016/j.semnephrol.2021.10.010.

Plant-based diets may help reduce phosphorous levels for patients on dialysis

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Plant-based diets may be a helpful strategy for patients on dialysis to lower their phosphorous levels, according to a speaker at the virtual Annual Dialysis Conference.

Shivam Joshi

“Plant-based diets have historically been avoided or neglected in the use of our patients with kidney disease, especially those on dialysis, for a variety of reasons including issues related to potassium and inadequate protein,” Shivam Joshi, MD, a clinical assistant professor of medicine at Bellevue Hospital and NYU Grossman School of Medicine, said. “However, recent research suggests this risk may be overstated.”

a bowl with salad and chickpeas
Source: Adobe Stock

According to Joshi, plant-based diets can include a flexible diet that doesn’t cut out all animal products, but limits intake compared to the standard American diet. Therefore, Joshi said, it is possible to eat a plant-based diet on dialysis and consume enough protein. Similarly, the risk of consuming too much protein is unlikely since plant-based phosphate is mostly bound as phytates which means it is not absorbable.

“It’s possible to take any diet and make it unhealthy or inadequate,” Joshi said.

Joshi referenced a study that showed plant-based foods that report high potassium levels are often juices, sauces and dried fruits but not unprocessed plant-based foods. Factors that can reduce an increase in serum potassium in patients with end-stage kidney disease who follow a plant-based diet include fiber, colonic secretion of potassium, intracellular movement of potassium and bioavailability.

Another study Joshi referenced compared serum phosphate levels among vegetarian and non-vegetarian patients with ESKD. The results showed vegetarian patients recorded significantly lower serum phosphate levels.

“Maintaining protein while reducing phosphorus may be achieved through a plant-based diet due to the low bioavailability of these foods, especially if they’re unprocessed the low phosphomimic index of these foods. Plant-based diets may provide lower protein compared to animal-based diets or the standard American diet, but overall, they have not been shown to affect nutrition or to have caused a deficiency. Potassium levels do not appear to increase within those consuming a plant-based diet on dialysis,” Joshi said. “More research is certainly needed.”

Oral anticoagulants may be harmful in patients with AF on dialysis

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Among patients with atrial fibrillation on long-term dialysis, oral anticoagulants were not associated with decreased risk for thromboembolism and some of them elevated risk for bleeding, according to a meta-analysis.

In this population, warfarin, dabigatran (Pradaxa, Boehringer Ingelheim) and rivaroxaban (Xarelto, Janssen) were associated with greater bleeding risk compared with apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) and no anticoagulant.

According to the meta-analysis published in the Journal of the American College of Cardiology, apixaban and warfarin were not associated with reduced risk for ischemic stroke and/or systemic thromboembolism compared with no anticoagulant (HR for apixaban 5 mg = 0.59; 95% CI, 0.3-1.17; HR for apixaban 2.5 mg = 1; 95% CI, 0.52-1.93; HR for warfarin = 0.91; 95% CI, 0.72-1.16). According to the meta-analysis, ischemic outcomes for dabigatran and rivaroxaban were not available.

Moreover, apixaban 5 mg was associated with lower risk for all-cause mortality compared with warfarin, apixaban 2.5 mg and no anticoagulant (HR vs. warfarin = 0.65; 95% CI, 0.45-0.93; HR vs. apixaban 2.5 mg = 0.62; 95% CI, 0.42-0.9; HR vs. no anticoagulant = 0.61; 95% CI, 0.41-0.9).

In addition, researchers noted that warfarin was associated with elevated risk for major bleeding compared with apixaban 5 mg, apixaban 2.5 mg and no anticoagulant (HR vs. apixaban 5 mg = 1.41; 95% CI, 1.07-1.88; HR vs. apixaban 2.5 mg = 1.4; 95% CI, 1.07-1.82; HR vs. no anticoagulant = 1.31; 95% CI, 1.15-1.5).

“Our study did not reveal the efficacy to prevent stroke and/or systemic thromboembolism of apixaban 5 mg/2.5 mg against no anticoagulant, whereas it revealed less bleeding than warfarin,” Toshiki Kuno, MD, PhD, resident in the department of medicine at the Icahn School of Medicine at Mount Sinai, and colleagues wrote. “Moreover, apixaban 5 mg twice daily was associated with a reduction in mortality compared with no anticoagulant. Because warfarin was not associated with lower stroke and showed higher risk of bleeding, further randomized controlled trials are needed to assess the feasibility of apixaban 5 mg twice daily compared with no anticoagulant to use in patients with AF on long-term dialysis.”

Findings for dabigatran, rivaroxaban

In other findings, dabigatran and rivaroxaban were also associated with greater risk for major bleeding than apixaban and no anticoagulant.

Researchers identified 16 eligible observational studies that assessed patients with AF who were on long-term dialysis. Of these studies, two investigated the efficacy and safety of direct oral anticoagulants.

“Although these results should be interpreted cautiously because of high heterogeneity, warfarin, dabigatran and rivaroxaban might not be preferred options because of their increased risk of bleeding in patients with AF on long-term dialysis,” the researchers wrote. “Further study is warranted to establish the benefit-to-risk ratio of oral anticoagulants in patients with AF on long-term dialysis.”

Knowledge gaps in dialysis and AF

“The network meta-analysis by Kuno et al has highlighted once again the existing evidence vacuum for the provision of oral anticoagulants to dialysis recipients with nonvalvular AF. For patients and their clinicians, this is especially distressing because the stakes of providing, or withholding, oral anticoagulants are conceivably so high,” Ron Wald, MDCM, MPH, of the division of nephrology at St. Michael’s Hospital at the University of Toronto, and colleagues wrote in a related editorial. “Recently completed and ongoing trials will hopefully advance the quality of evidence in this area with the ultimate goal of resolving one of the most vexing dilemmas faced by clinicians who care for patients on maintenance dialysis.” – by Scott Buzby

Alfacalcidol Does Not Lower CV Risk in Dialysis, Trial Suggests

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Alfacalcidol does not reduce the risk for cardiovascular events in patients without secondary hyperparathyroidism undergoing maintenance hemodialysis compared with usual care, the Japan Dialysis Active Vitamin D (J-DAVID) trial has found. But experts question the generalizability of the findings.

During a median of 4 years, the composite outcome of select cardiovascular events was 21.1% in those who took oral alfacalcidol, a vitamin D receptor agonist (VDRA), compared with 17.9% in the usual-care group, a difference that was not statistically different.

“[O]ral alfacalcidol compared with usual care did not reduce the risk of a composite measure of select cardiovascular events. These findings do not support the use of vitamin D receptor activators for patients such as these,” the researchers write.

The study, by Tetsuo Shoji, MD, PhD, from the Department of Vascular Medicine, Osaka City University Graduate School of Medicine, Japan, and colleagues, was published online December 10 in JAMA.

The study was conducted in Japan, and the results are not generalizable to other countries, Rasheeda K. Hall, MD, MBA, MHS, and Julia J. Scialla, MD, MHS, from the Department of Medicine, Duke University School of Medicine, Durham, North Carolina, write in an accompanying editorial.

“Although the use of phosphate binders, VDRAs, and cinacalcet in Japan are comparable to the use in the United States, dialysate calcium and selection of calcium-based vs non–calcium-based phosphate binders tends to be higher in Japan. These patterns were observed in the J-DAVID trial, with approximately 70% of participants using dialysate calcium of 3.0 mEq/L and approximately 80% using calcium-based phosphate binders,” Hall and Scialla explain.

“These practices may be so different from those in the United States and internationally that generalization is not feasible,” they continue.

No Difference in Cardiovascular Outcomes

Vitamin D activation is impaired and cardiovascular risk is elevated in patients with chronic kidney disease. Observational studies have suggested that VDRAs reduce this risk, but the approach had not been tested in randomized trials.

Therefore, Shoji and colleagues conducted a randomized, open-label, blinded endpoint trial that compared the effect of the oral VDRA alfacalcidol with usual care (no VDRAs) on cardiovascular events in patients without secondary hyperparathyroidism receiving maintenance hemodialysis at 108 dialysis centers. For the patients in the study, serum intact parathyroid hormone levels were ≤180 pg/mL.

The investigators randomly assigned 976 patients to receive either alfacalcidol, beginning at a dose of 0.5 μg per day (n = 495) or usual care (n = 481). The intention-to-treat analysis included 964 patients, of whom 944 (97.9%) completed the trial. The median age of the participants was 65 years, and 386 were women (40.0%).

“All participants were eligible to receive any medications other than VDRAs, including phosphate binders and cinacalcet, for standard medical care as recommended by the JSDT [Japanese Society for Dialysis Therapy] Clinical Practice Guidelines,” the researchers explain.

Cardiovascular events, the primary composite outcome, occurred in 103 of 488 patients (21.1%) in the alfacalcidol group, compared with 85 of 476 patients (17.9%) in the usual-care group (absolute difference, 3.25%; 95% confidence interval [CI], −1.75% to 8.24%; hazard ratio [HR], 1.25; 95% CI, 0.94 – 1.67; P = .13). This difference was not statistically significant.

The secondary outcome of all-cause mortality did not differ significantly between the groups (18.2% vs 16.8%, respectively; HR, 1.12; 95% CI, 0.83 – 1.52; P = .46).

Among those in the alfacalcidol group, 76.0% experienced serious adverse events (SAEs), including cardiovascular-related (40.8%), infection-related (13.1%), and malignancy-related SAEs (4.5%).

Among those in the usual-care group, 79.2% experienced SAEs, including events that were cardiovascular- (40.1%), infection- (13.2%), and malignancy-related (4.4%).

“The number of cardiovascular SAEs was higher than the number of occurrences of the primary outcome because some participants had more than 2 cardiovascular SAEs,” the researchers explain.

Predefined laboratory abnormalities differed between the two groups. Corrected serum calcium levels >10.0 mg/dL and phosphate levels >6.0 mg/dL occurred more frequently in the group that received alfacalcidol compared with the control group. Intact parathyroid hormone levels >240 pg/mL occurred less commonly, especially during the first year of follow-up.

Generalizability May Be Limited

“[T]he results cannot be generalized to patients with secondary hyperparathyroidism or to non-Japanese populations, particularly not to US patients undergoing hemodialysis, who have much higher levels of intact PTH [parathyroid hormone] than the participants of this trial,” the researchers note.

Hall and Scialla reiterate that point. “As the J-DAVID investigators acknowledge, VDRAs may plausibly yield different results when accompanied by less calcium loading in the form of dialysate and exogenous calcium,” they write.

The editorialists say that although the researchers excluded patients “with clear indications or contraindications for VDRAs,” approximately one third of participants crossed over during the study; 35% of patients in the usual-care group and 32% of those in the alfacalcidol group dropped out of their assigned treatment. The study did not account for this in power calculations, they explain.

“In addition, the composite cardiovascular end point in the J-DAVID trial was broad. Although this broad end point may improve power for the study, the pathophysiology of many of the end point components, such as sudden cardiac death, peripheral amputation, and stroke, including hemorrhagic stroke, may be heterogeneous and not clearly modified by 1,25[OH]2D-responsive pathways,” Hall and Scialla observe.

“Future studies are needed, both observational and randomized, to understand who should be treated with VDRAs, to what biochemical target levels patients should be treated, and what therapeutic combinations of VDRAs and mineral metabolism cointerventions should be used to prevent CVD in patients with ESKD [end-stage kidney disease] undergoing hemodialysis,” they conclude.

No more dialysis, Scientists Have Developed A Bionic Kidney! 

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Natural remedies are indeed very powerful, but there are times when we have to turn to modern technology. Dialysis patients can’t live without the treatment, but their suffering is enormous.

Many of them must wait for years to get a kidney transplant and live normally, with seemingly no other solution on the horizon. However, there’s finally a light in the dark tunnel – scientists from the University of California at San Francisco, USA, have developed the world’s first bionic kidney which can replace damaged kidneys easily and effectively.

Natural remedies are indeed very powerful, but there are times when we have to turn to modern technology. Dialysis patients can’t live without the treatment, but their suffering is enormous.

Many of them must wait for years to get a kidney transplant and live normally, with seemingly no other solution on the horizon. However, there’s finally a light in the dark tunnel – scientists from the University of California at San Francisco, USA, have developed the world’s first bionic kidney which can replace damaged kidneys easily and effectively.

The bionic kidney is a perfect replica of our kidneys. It consists of numerous microchips and is moved by the heart. Like the normal kidneys, it is able to filter waste and toxins from the bloodstream.

The project was unveiled by Willian Vanderbilt Fissels and Shuvo Roy from the University of California, offering renewed hope for millions of kidney dialysis patients. Now, some of you may be wondering “But, what if the body rejects it?”, but, the scientists assure us that the chances of rejection are zero! Incredible, right?

This is because the bionic kidney is made from renal cells. The first prototype is the size of a coffee cup and can balance the levels of sodium and potassium in the body while regulating blood pressure.

The project is wonderful news for any dialysis patient. In the beginning (November 2015), the scientists received $6 million from the Institute of Biomedical Imaging and Bioengineering, and it’s safe to say that the money were well spent.

The scientists have high hopes for the bionic kidney, and the lead researcher, Dr. Victor Gura, says that the device will be available for sale in only 2 years.

The bionic kidney is a perfect replica of our kidneys. It consists of numerous microchips and is moved by the heart. Like the normal kidneys, it is able to filter waste and toxins from the bloodstream.

  The project was unveiled by Willian Vanderbilt Fissels and Shuvo Roy from the University of California, offering renewed hope for millions of kidney dialysis patients. Now, some of you may be wondering “But, what if the body rejects it?”, but, the scientists assure us that the chances of rejection are zero! Incredible, right?

This is because the bionic kidney is made from renal cells. The first prototype is the size of a coffee cup and can balance the levels of sodium and potassium in the body while regulating blood pressure.

The project is wonderful news for any dialysis patient. In the beginning (November 2015), the scientists received $6 million from the Institute of Biomedical Imaging and Bioengineering, and it’s safe to say that the money were well spent.

The scientists have high hopes for the bionic kidney, and the lead researcher, Dr. Victor Gura, says that the device will be available for sale in only 2 years.

Source:medicalonline1.com

Could wearable ‘artificial kidney’ change dialysis?

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A small, experimental wearable device has moved a step closer to helping patients who rely on kidney dialysis, according to a report.

Victor Gura fits a "wearable artificial kidney," which filters a patient's blood continuously.

For patients with kidney failure, the common treatment is to be hooked up to a dialysis machine at a hospital or clinic several times a week. In addition to the inconvenience, patients develop buildup of fluids and minerals between dialysis sessions, which can result in high blood pressure and breathing problems and require severe dietary restrictions.

“I was very frustrated — I still am — because for decades, we’ve been doing dialysis with big machines that prolong the life of the patient a little bit … and in addition, they have a lousy quality of life,” said Victor Gura, an associate clinical professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.

Gura and his colleagues are developing the Wearable Artificial Kidney, or WAK, which would filter a patient’s blood continuously, instead of a few times a week. “This is to reduce a lot of the complications that make patients sick … (and) to give patients back their life,” such as allowing them to have jobs again, he said.

The researchers presented the results of a small trial of the device on Saturday at Kidney Week, the annual meeting of the American Society of Nephrology. The trial involved seven patients in Seattle with end-stage kidney disease who wore the device for 24 hours. During that time, the device removed water and salts from the blood at the same rate as healthy kidneys, and patients did not complain of discomfort or experience side effects, Gura said.

New rules give hope to people waiting for donated kidneys

The current research has not been published in a peer-reviewed journal and should be considered preliminary; however, Gura and his colleagues have previously published studies of patients wearing WAK devices for up to eight hours.

Participants in the current and previous trials were able to sleep with the devices, and should be able to take showers and carry out other normal activities, Gura said.

“We encouraged patients to eat bananas and mashed potatoes and drink orange juice, (and) they enjoyed ice cream and cheesecake, which they couldn’t before,” Gura said. Normally, these foods would be off-limits because they can lead to a dangerous buildup of potassium and phosphorus between dialysis sessions.

However, the device had one important pitfall: Two of the seven patients stopped wearing it before the 24 hours were up because it stopped working properly. Gura and his colleagues are working to correct technical problems before they start their next trial, which will probably involve a group of patients wearing the device for a week.

“Getting the machine to be reliable and consistent is going to be (Gura’s) greatest challenge. … I’ll be convinced when they can keep patients stable for seven or 14 days,” said Leslie Spry, medical director for the Dialysis Center of Lincoln in Lincoln, Nebraska, and spokeswoman for the National Kidney Foundation, a patient advocacy organization.

The WAK device weighs 10 pounds, though Gura and his colleagues are working to get it down to 5 pounds, and patients in the study wore them on their belts. The device connects to a large vein in the body via a catheter and, similar to a conventional dialysis machine, contains filters that separate water, salts and minerals out of the blood.

Users would have to remove the WAK from the catheter once a week to replace the filter and add chemicals once per day to purify the water that is filtered out. Other than those steps, the device would take care of itself, running on 9-volt batteries.

“Anytime you maintain a connection with a machine to your blood vessel system, infection is going to be your No. 1 enemy,” Spry said, adding that he will be interested to see whether patients in longer-lasting trials develop infections. However, it would be “very possible” to teach patients to maintain their devices properly, just as those with home dialysis machines do, he added.

Home dialysis machines have alleviated some of the burden of treatment, allowing patients to receive dialysis up to seven days a week, Spry said. He has helped develop these machines and is a part-time employee of Nx Stage, which makes dialysis machines. However, these machines do not allow continuous dialysis, and patients use them for only up to eight hours a day (in the case of nocturnal machines), he added.

Although other wearable dialysis devices have been researched over the years, the WAK is the only one for which there are published clinical trials, Gura said.

If the researchers continue to receive funding to conduct clinical trials and further develop the technology, Gura estimates that WAK devices could be available for patients in two years.

The U.S. Food and Drug Administration announced last month that it would expedite the approval of the device once studies are able to demonstrate safety and efficacy.

Bone Loss May Indicate Poor Heart Health in Dialysis Patients

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High parathyroid hormone levels and bone loss may predict progression of coronary artery calcification (CAC) in patients receiving dialysis, according to a study published online April 2 in the Journal of the American Society of Nephrology.

“We discovered that high parathyroid hormone and the consequential bone loss are major risk factors for progression of vascular calcifications,” Hartmut H. Malluche, MD, from the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington, commented in a news release.

“These two factors were heretofore not appreciated and were independent from traditional known risk factors,” he added.
Elevated parathyroid hormone levels cause the release of calcium from bone, leading to bone loss and thinning. Most patients receiving dialysis for chronic kidney disease have CAC. CAC increases the risk for cardiovascular events, which in turn cause the majority of deaths in patients with CKD, the authors note.

Therefore, Dr Malluche and colleagues recommend monitoring bone loss with measurements of parathyroid hormone or bone mineral density (BMD) as a way to predict progression of CAC in patients receiving dialysis.

Between August 2009 and April 2013, the researchers enrolled 213 participants from 38 dialysis centers in Kentucky. Participants underwent measurement of routine laboratory tests, serum markers of bone metabolism, and CAC at baseline and 1 year. The researchers also evaluated BMD at both points using dual-energy X-ray absorptiometry scans and quantitative computed tomography. They assessed CAC using multislide computed tomography of the heart and CAC square root of coronary artery calcification volume, an analytic technique that accounts for variability in scanning.

About 80% of participants had CAC at baseline, and almost 50% of these had measurements suggesting high risk for cardiovascular events. One third of participants had osteoporosis.

Independent positive predictors of baseline CAC included coronary artery disease, diabetes, length of time receiving dialysis, age, and concentration of fibroblast growth factor 23, which regulates serum phosphate levels and helps maintain bone strength. In contrast, BMD of the spine inversely predicted baseline CAC.
CAC progression at 1 year occurred among three quarters of the 122 patients who completed the study. Independent risk factors for CAC progression included age, osteoporosis (β = 4.6; 95% confidence interval, 1.8 – 7.5; P = .002), and baseline total or whole parathyroid hormone more than nine times the normal value, after adjusting for age (β = 6.9; 95% confidence interval, 2.4 – 11.4; P = .003).

The researchers note several limitations for the study, including exclusion of about 20% of screened patients because of severe comorbidities or impaired mental status. In addition, the prospective, short-term nature of the study precluded determination of disease mechanisms and long-term relationships.

Dr Malluche noted in the press release that important links may exist between the level of calcification in bones and calcifications in blood vessels.

“Studies need to be done to find out whether prevention of bone loss will reduce progression of vascular calcifications,” he emphasized.