Identifying Major Barriers to Home Dialysis (The IM-HOME Study): Findings From a National Survey of Patients, Care Partners, and Providers.

RATIONALE & OBJECTIVE: Developing strategies to improve home dialysis use requires a comprehensive understanding of barriers. We sought to identify the most important barriers to home dialysis use from the perspective of patients, care partners, and providers. STUDY DESIGN: This is a convergent parallel mixed-methods study. SETTING & PARTICIPANTS: We convened a seven-member advisory board of patients, care partners, and providers who collectively developed lists of major patient/care partner-perceived barriers and provider-perceived barriers to home dialysis. We used these lists to develop a survey that was distributed to patients, care partners, and providers-through the American Association of Kidney Patients and the National Kidney Foundation. The surveys asked participants to: 1) rank their top three major barriers (quantitative); and 2) describe barriers to home dialysis (qualitative). ANALYTICAL APPROACH: We compiled a list of the top three patient/care partner-perceived and top three provider-perceived barriers (quantitative) and conducted a directed content analysis of open-ended survey responses (qualitative). RESULTS: There were 522 complete responses (233 providers; 289 patients/care partners). The top three patient/care partner-perceived barriers were: fear of performing home dialysis; lack of space; and the need for home-based support. The top three provider-perceived barriers were: poor patient education; limited mechanisms for home-based support staff, mental health, and education; and lack of experienced staff. We identified nine themes through qualitative analysis: limited education; financial disincentives; limited resources; high burden of care; built environment/structure of care delivery that favor in-center hemodialysis; fear and isolation; perceptions of inequities in access to home dialysis; provider perspectives about patients; and patient/provider resiliency. LIMITATIONS: This was an online survey that is subject to non-response bias. CONCLUSIONS: The top three barriers to home dialysis for patient/care partners and providers incompletely overlap, suggesting the need for diverse strategies that simultaneously address patient-perceived barriers at home and provider-perceived barriers in the clinic.

Funding Innovative Dialysis Technology in the United States: Home Dialysis and the ESRD Transitional Add-on Payment for New and Innovative Equipment and Supplies (TPNIES).

Innovative, patient-centered, and pragmatic dialysis technologies are urgently needed to accommodate the growing national interest in home dialysis use. To help achieve this goal, the US Centers for Medicare & Medicaid Services (CMS) are expanding reimbursement for eligible home dialysis machines through an existing payment mechanism, the transitional add-on payment for new and innovative equipment and supplies (TPNIES). This mechanism incentivizes the early adoption of innovative equipment into practice by reimbursing dialysis providers up to 26% of the total cost of approved home dialysis machines. Machines are evaluated for TPNIES eligibility using prespecified substantial clinical improvement (SCI) criteria that are derived from the Inpatient Prospective Payment System (for non-nephrology technologies). Although the SCI criteria may be suitable for some non-nephrology technologies, they have not been adapted to consider the unique and complex care inherent in home dialysis. Thus, many of the SCI criteria appear unsuitable for home dialysis machines. To better incentivize innovation, CMS should develop nephrology-specific transparent and pragmatic criteria for TPNIES. In this perspective, we provide an overview of the TPNIES payment mechanism, highlight areas of concern within the policy, and offer solutions for improving TPNIES that could better promote the adoption of new home dialysis machines.

Estimating Shortages in Capacity to Deliver Continuous Kidney Replacement Therapy During the COVID-19 Pandemic in the United States.

RATIONALE & OBJECTIVE: During the coronavirus disease 2019 (COVID-19) pandemic, New York encountered shortages in continuous kidney replacement therapy (CKRT) capacity for critically ill patients with acute kidney injury stage 3 requiring dialysis. To inform planning for current and future crises, we estimated CKRT demand and capacity during the initial wave of the US COVID-19 pandemic. STUDY DESIGN: We developed mathematical models to project nationwide and statewide CKRT demand and capacity. Data sources included the Institute for Health Metrics and Evaluation model, the Harvard Global Health Institute model, and published literature. SETTING & POPULATION: US patients hospitalized during the initial wave of the COVID-19 pandemic (February 6, 2020, to August 4, 2020). INTERVENTION: CKRT. OUTCOMES: CKRT demand and capacity at peak resource use; number of states projected to encounter CKRT shortages. MODEL, PERSPECTIVE, & TIMEFRAME: Health sector perspective with a 6-month time horizon. RESULTS: Under base-case model assumptions, there was a nationwide CKRT capacity of 7,032 machines, an estimated shortage of 1,088 (95% uncertainty interval, 910-1,568) machines, and shortages in 6 states at peak resource use. In sensitivity analyses, varying assumptions around: (1) the number of pre-COVID-19 surplus CKRT machines available and (2) the incidence of acute kidney injury stage 3 requiring dialysis requiring CKRT among hospitalized patients with COVID-19 resulted in projected shortages in 3 to 8 states (933-1,282 machines) and 4 to 8 states (945-1,723 machines), respectively. In the best- and worst-case scenarios, there were shortages in 3 and 26 states (614 and 4,540 machines). LIMITATIONS: Parameter estimates are influenced by assumptions made in the absence of published data for CKRT capacity and by the Institute for Health Metrics and Evaluation model's limitations. CONCLUSIONS: Several US states are projected to encounter CKRT shortages during the COVID-19 pandemic. These findings, although based on limited data for CKRT demand and capacity, suggest there being value during health care crises such as the COVID-19 pandemic in establishing an inpatient kidney replacement therapy national registry and maintaining a national stockpile of CKRT equipment.

Hepatitis C virus infection in kidney transplantation-changing paradigms with novel agents.

Hepatitis C virus (HCV) is a common cause of increased morbidity and mortality in kidney transplant patients. It is associated with posttransplant glomerulonephritis, chronic allograft nephropathy, and New Onset Diabetes after Transplant (NODAT). In the past, HCV was difficult to treat due to the presence of interferon alpha-based therapies that were difficult to tolerate and were associated with adverse side-effects, such as the risk of rejection. With the advent of oral directly acting antiviral therapies, the landscape for HCV and transplantation has changed. These agents are highly effective and well tolerated with minimal side-effects. Sustained viral response rates in excess of 90% are achieved with most current treatment regimens active against all HCV genotypes. These new agents may show an improvement in graft and patient survival while essentially eliminating the risk of acute rejection from the use of prior interferon-based HCV therapies. These agents may also result in an improvement in organ allocation for HCV donor/HCV recipient transplantation. This review is meant to discuss the epidemiology of HCV, the new oral direct-acting antiviral agents (DAAs) and future opportunities for research in the field of HCV related transplantation.

Breaking down the complement system: a review and update on novel therapies.

PURPOSE OF REVIEW: The complement system represents one of the more primitive forms of innate immunity. It has increasingly been found to contribute to pathologies in the native and transplanted kidney. We provide a concise review of the physiology of the complement cascade, and discuss current and upcoming complement-based therapies. RECENT FINDINGS: Current agents in clinical use either bind to complement components directly or prevent complement from binding to antibodies affixed to the endothelial surface. These include C1 esterase inhibitors, anti-C5 mAbs, anti-CD20 mAbs, and proteasome inhibitors. Treatment continues to show efficacy in the atypical hemolytic uremic syndrome and antibody-mediated rejection. Promising agents not currently available include CCX168, TP10, AMY-101, factor D inhibitors, coversin, and compstatin. Several new trials are targeting complement inhibition to treat antineutrophilic cystoplasmic antibody (ANCA)-associated vasculitis, C3 glomerulopathy, thrombotic microangiopathy, and IgA nephropathy. New agents for the treatment of the atypical hemolytic uremic syndrome are also in development. SUMMARY: Complement-based therapies are being considered for targeted therapy in the atypical hemolytic uremic syndrome and antibody-mediated rejection, C3 glomerulopathy, and ANCA-associated vasculitis. A few agents are currently in use as orphan drugs. A number of other drugs are in clinical trials and, overall, are showing promising preliminary results.

Population-based estimation of renal function in healthy young Indian adults based on body mass index and sex correlating renal volume, serum creatinine, and cystatin C.

This population-based prospective study was undertaken in Mahatma Gandhi Medical College to estimate the renal function in young healthy Indian adults. A young healthy heterogeneous Indian cohort comprising 978 individuals, predominantly medical students, was assessed by a detailed questionnaire, and variables such as height, weight, body mass index (BMI), birth weight, and blood pressure were documented. Laboratory investigations included serum creatinine, serum cystatin C, blood sugar, urine protein, and imaging of the kidneys with ultrasound. The mean age of the cohort was 25±6 years, comprising 672 males and 306 females. The estimated glomerular filtration rates (eGFRs) by the Cockcroft-Gault formula for BMI <18.5 kg/m2, 18.5-24.99 kg/m2, 25-29.99 kg/m2, and ≥30 kg/m2 were 71.29±10.45 mL/min, 86.38±13.46 mL/min, 98.88±15.29 mL/min, and 109.13±21.57 mL/min, respectively; the eGFRs using cystatin C for the four groups of BMI were 84.53±18.14 mL/min, 84.01±40.11 mL/min, 79.18±13.46 mL/min, and 77.30±10.90 mL/min, respectively. This study attempts to establish a normal range of serum creatinine and cystatin C values for the Indian population and shows that in young healthy Indian adults, eGFR and kidney volume vary by BMI and sex.

What is the optimal approach to a non- culprit stenosis after ST-elevation myocardial infarction - Conservative therapy or upfront revascularization? An updated meta-analysis of randomized trials.

BACKGROUND: Non-culprit percutaneous coronary intervention (PCI) during a ST-segment elevation myocardial infarction (STEMI) remains controversial. We performed a meta-analysis of the published literature comparing a strategy of complete revascularization (CR) with culprit or target vessel revascularization (TVR)-only after STEMI in patients with multi-vessel disease. METHODS: We searched PubMed/Medline, Cochrane, EMBASE, Web of Science, CINAHL, Scopus and Google-scholar databases from inception to March-2016 for clinical trials comparing CR with TVR during PCI for STEMI. Mantel-Haenszel risk ratio (MH-RR) with 95% confidence intervals (CI) for individual outcomes was calculated using random-effects model. RESULTS: A total of 7 randomized trials with 2004 patients were included in the final analysis. Mean follow-up was 25.4months. Major adverse cardiac events (MACE) (MH-RR: 0.58, 95% CI: 0.43-0.78, P<0.001), cardiac deaths (MH-RR: 0.42, 95% CI: 0.24-0.74, P=0.003) and repeat revascularization (MH-RR: 0.36, 95% CI: 0.27-0.48, P<0.001) were much lower in the CR group when compared to TVR. However, there was no significant difference in the risk of all-cause mortality (0.84, 95% CI: 0.57-1.25, P=0.394) or recurrent MI (MH-RR: 0.66, 95% CI: 0.34-1.26, P=0.205) between the two groups. CR appeared to be safe with no significant increase in adverse events including stroke rates (MH-RR: 2.19, 95% CI: 0.59-8.12, P=0.241), contrast induced nephropathy (MH-RR: 0.73, 95% CI: 0.34-1.57, P=0.423) or major bleeding episodes (MH-RR: 0.72, 95% CI: 0.34-1.54, P=0.399). CONCLUSIONS: CR strategy in STEMI patients with multivessel coronary artery disease is associated with reduction in MACE, cardiac mortality and need for repeat revascularization but with no decrease in the risk of subsequent MI or all-cause mortality. CR was safe however, with no increase in adverse events including stroke, stent thrombosis or contrast nephropathy when compared to TVR.

Is there a genetic predisposition to new-onset diabetes after kidney transplantation?

Kidney transplant recipients may develop new-onset diabetes after transplantation (NODAT) and transplant-associated hyperglycemia (TAH) (NODAT or new-onset impaired glucose tolerance-IGT). We studied 251 consecutive renal transplant South Asian recipients for incidence of NODAT and its risk factors between June 2004 and January 2009. Pre-transplant glucose tolerance test (GTT) identified non-diabetics (n = 102, IGT-24, NGT-78) for analysis. Baseline immunosuppression along with either cyclosporine (CsA) (n = 70) or tacrolimus (Tac) (n = 32) was given. Patients underwent GTT 20 days (mean) post-transplant to identify NODAT, normal (N) or IGT. TAH was observed in 40.2% of the patients (40% in CsA and 40.6% in Tac) (P = 0.5). NODAT developed in 13.7% of the patients (12.9% in CsA and 15.6% in Tac) (P = 0.5). Overall, Hepatitis C (P = 0.007), human leukocyte antigen (HLA) B52 (P = 0.03) and lack of HLA A28 (A68/69) (P = 0.03) were associated with TAH. In the Tac group, higher Day 1 dosage (P <0.001), HLA A1 (P = 0.04), B13 (P = 0.03) and lack of DR2 (P = 0.004) increased the risk of TAH. In the CsA group, HLA A10 (P = 0.03), failure of triglyceride (P = 0.001) or low-density lipoprotein (LDL) (P = 0.03) to lower or high-density lipoprotein to rise (P = 0.001), and higher post-transplant LDL (P <0.001) and cholesterol levels (P = 0.02) were associated with NODAT or TAH. Post-transplant fasting plasma glucose on Day 1 had sensitivity-54.5%, specificity-50.1%, positive predictive value-18.1% and negative predictive value-84.8% for detecting NODAT. In conclusion, there is a genetic predisposition to NODAT and TAH in South Asia as seen by the HLA associations, and a predisposition exists to the individual diabetogenic effects of Tac and CsA based on HLA type. This could lead to more careful selection of calcineurin inhibitors based on HLA types in the South Asian population.

Optimal management of hyperphosphatemia in end-stage renal disease: an Indian perspective.

There has been an exponential increase in the incidence of diabetes and hypertension in India in the last few decades, with a proportional increase in chronic kidney disease (CKD). Preventive health care and maintenance of asymptomatic chronic disease such as CKD are often neglected by patients until they become symptomatic with fluid retention and uremia. Management of hyperphosphatemia in CKD remains one of the challenges of nephrology in India for this reason, as it is almost completely asymptomatic but contributes to renal osteodystrophy, metastatic vascular calcification, and acceleration of cardiovascular disease. Lack of understanding of the dangers of asymptomatic hyperphosphatemia, the huge pill burden of phosphate binders, difficulty with dietary and dialysis compliance, and most importantly, the added expense of the drugs places additional road blocks in the treatment of hyperphosphatemia at a population level in developing countries like India. In this review we seek to address the contribution of hyperphosphatemia to adverse outcomes and discuss economic, cultural, and societal factors unique to the management of phosphate levels in Indian patients with advanced CKD.

Recurrent renal allograft dysfunction due to ureteric stenosis in a patient with the BK virus infection.

Diseases of the genitourinary tract in association with the BK virus (BKV) infection are increasing among renal allograft recipients. We herewith report a young, female renal transplant recipient who presented with allograft dysfunction secondary to proximal ureteric stenosis. The allograft function improved dramatically after correction and stenting of the stenosis. Our case suggests that screening for BKV infection should be an integral part of evaluation of allograft dysfunction.

Nutritional status in stage V dialyzed patient versus CKD patient on conservative therapy across different economic status.

BACKGROUND: This aim of this multi-centric cross-sectional study was to assess the nutritional status in Indian chronic kidney disease (CKD) patients and to compare the nutritional indicators between stage 5 dialyzed (CKD-D) patients below the poverty line (BPL), and stage 3-4 non-dialyzed (CKD-ND) patients above (APL) and below the poverty line. METHODS: Patients were selected from a government medical college hospital, a charity-based outpatient dialysis unit, and a non-profit tertiary care center. The study groups included BPL CKD-ND (n = 100), BPL CKD-D (n = 98), and APL CKD-ND (n = 92) patients, based on a cut-off of per capita income US $1.25 a day. Patients were enquired by a qualified renal dietitian about their pattern of diet, and daily energy and protein intake by 24 h recall method. Anthropometric measurements and biochemical investigations were made and compared. RESULTS: Nutritional indicators were low in all three groups compared to those prescribed by European Best Practice Guidelines (EBPG). BPL CKD-D patients had low serum albumin levels (32.44444 ± 6.279961 g/L; p = 0.017) and 41.83% of them were underweight. The APL CKD-ND group registered the lowest mean daily energy (22.576 ± 6.289 kcal/kg/day) and protein intake (0.71 ± 0.06 g/kg/day), due to dietary restrictions imposed on them by themselves and unqualified renal dietitians. The APL group had better indicators of nutritional status in terms of mid-upper arm circumference (p = 0.001), triceps skin fold thickness (p < 0.001), and serum hemoglobin (p < 0.001). CONCLUSION: Several nutritional parameters were below the recommended international guidelines for all the three groups, though the high income group had better parameters from several indicators. There is an urgent need for nutritional counseling for CKD-D and CKD-ND patients.