Background. Although older adults encompass almost half of patients with advanced chronic kidney disease, it remains unclear which long-term hemodialysis vascular access type, arteriovenous fistula or arteriovenous graft, is optimal with respect to effectiveness and patient satisfaction. Clinical outcomes based on the initial AV access type have not been evaluated in randomized controlled trials. This pilot study tested the feasibility of randomizing older adults with advanced kidney disease to initial arteriovenous fistula versus graft vascular access surgery. Methods: Patients 65 years or older with pre-dialysis chronic kidney disease or incident end-stage kidney disease and no prior arteriovenous vascular access intervention were randomized in a 1:1 ratio to undergo surgical placement of a fistula or a graft after providing informed consent. Trial feasibility was evaluated as (i) recruitment of ≥70% of eligible participants, (ii) ≥50% to 70% of participants undergo placement of index arteriovenous access within 90 to 180 days of enrollment, respectively, (iii) ≥80% adherence to study-related assessments, and (iv) ≥70% of participants who underwent index arteriovenous access placement will have a follow-up duration of ≥12 months after index surgery date. Results: Between September 2018 and October 2019, 81% (44/54) of eligible participants consented and were enrolled in the study; 11 had pre-dialysis chronic kidney disease and 33 had incident or prevalent end-stage kidney disease. After randomization, 100% (21/21) assigned to arteriovenous fistula surgery and 78% (18/23) assigned to arteriovenous graft surgery underwent index arteriovenous access placement within a median (1st, 3rd quartile) of 5.0 (1.0, 14.0) days and 13.0 (5.0, 44.3) days, respectively, after referral to vascular surgery. The completion rates for studyspecific assessments ranged between 40.0 and 88.6%. At median follow-up of 215.0 days, 5 participants expired, 7 completed 12 months of follow-up, and 29 are actively being followed. Assessments of grip strength, functional independence and vascular access satisfaction were completed by >85% of patients who reached pre-specified post-operative assessment time point. Conclusions: Results from this study reveal it is feasible to enroll and randomize older adults with advanced kidney disease to one of two different arteriovenous vascular access placement surgeries. 4 The study can progress with minor protocol adjustments to a multisite clinical trial. Trial registration: Clinical Trials ID: NCT03545113. Registered June 4, 2018. Key Messages Regarding Feasibility 1) What uncertainties existed regarding the feasibility? No trial has objectively evaluated clinical outcomes in patients with advanced kidney disease based on the type of first hemodialysis arteriovenous vascular access placed. Hence, the feasibility of randomly assigning these patients to different surgical interventions for dialysis vascular access are unknown. Because this study focused on older patients with chronic disease, uncertaint...
Globally, the number of patients undergoing maintenance dialysis is increasing, yet throughout the world there is significant variability in the practice of initiating dialysis. Factors such as availability of resources, reasons for starting dialysis, timing of dialysis initiation, patient education and preparedness, dialysis modality and access, as well as varied "country-specific" factors significantly affect patient experiences and outcomes. As the burden of end-stage kidney disease (ESKD) has increased globally, there has also been a growing recognition of the importance of patient involvement in determining the goals of care and decisions regarding treatment. In January 2018, KDIGO (Kidney Disease: Improving Global Outcomes) convened a Controversies Conference focused on dialysis initiation, including modality choice, access, and prescription. Here we present a summary of the conference discussions, including identified knowledge gaps, areas of controversy, and priorities for research. A major novel theme represented during the conference was the need to move away from a "one-size-fits-all" approach to dialysis and provide more individualized care that incorporates patient goals and preferences while still maintaining best practices for quality and safety. Identifying and including patient-centered goals that can be validated as quality indicators in the context of diverse health care systems to achieve equity of outcomes will require alignment of goals and incentives between patients, providers, regulators, and payers that will vary across health care jurisdictions.
The views expressed in this commentary are solely the responsibility of the authors and they do not necessarily reflect the views, decisions, or policies of the institutions with which they are affiliated.
Heme oxygenase (HO) catalyzes the degradation of heme to biliverdin, iron, and CO. The inducible isoform (HO-1) has been implicated as a modulator of the inflammatory response. HO-1 activity can be induced by hemin and inhibited with zinc protoporphyrin IX (ZnPP). Using these reagents, we assessed the possibility that HO-1 modulates the inflammatory response by altering the expression of endothelial cell adhesion molecules. Endotoxin (lipopolysaccharide, LPS)-induced expression of P- and E-selectin expression was quantified in different vascular beds of the rat using the dual radiolabeled monoclonal antibody technique. Pretreatment with hemin attenuated, whereas ZnPP treatment exacerbated, the increased selectin expression normally elicited by LPS. Biliverdin, at an equimolar dosage, was as effective as hemin in attenuating LPS-induced selectin expression in the lung, kidneys, liver, and intestines. These findings indicate that the anti-inflammatory properties of HO-1 may be related to an inhibitory action of P- and E-selectin expression in the vasculature. Biliverdin (or its metabolite, bilirubin), rather than CO, may account for this action of HO-1 on endothelial cell adhesion molecule expression.
The optimal vascular access for elderly patients remains a challenge due to the difficulty balancing the benefits and risks in a population with increased comorbidity and decreased survival. Age is commonly associated with failure to mature in fistula and decreased rates of primary and secondary patency in both fistula and grafts. In the elderly, at 1 and 2-years, primary patency rates range from 43% to 74% and 29% to 67%, respectively. Secondary patency rates at 1 and 2-years range from 56% to 82% and 44% to 67% respectively. Cumulative fistula survival is no better than grafts survival when primary failures are included. Several observational studies consistently demonstrate a lower adjusted mortality among those using a fistula compared to a catheter (1–3)(1–3) however catheter use in the elderly is increasing in most countries with the exception of Japan. Both guidelines and quality initiatives do not acknowledge the trade-offs involved in managing the elderly patients with multiple chronic conditions and limited life expectancy or the value that patients place on achieving these outcomes(4)(4). The framework for choice of vascular access presented in this article considers: 1) likelihood of disease progression before death 2) patient life expectancy, 3) risks and benefits by vascular access type and 4) patient preference. Future studies evaluating the timing and type of vascular access with careful assessments of complications, functionality, cost benefit, and patients’ preference will provide relevant information to individualize and optimize care to improve morbidity, mortality, and quality of life in the elderly patient.
While hemodialysis access ligation has been used to manage pacemaker (PM) and implantable cardioverter-defibrillator (ICD) lead-induced central venous stenosis (CVS), percutaneous transluminal balloon angioplasty (PTA) has also been employed to manage this complication. The advantages of PTA include minimal invasiveness and preservation of arteriovenous access for hemodialysis therapy. In this multi-center study we report the patency rates for PTA to manage lead-induced CVS. Consecutive PM/ICD chronic hemodialysis patients with an arteriovenous access referred for signs and symptoms of CVS due to lead-induced CVS were included in this analysis. PTA was performed using the standard technique. Technical and clinical success was examined. Technical success was defined as the ability to successfully perform the procedure. Clinical success was defined as the ability to achieve amelioration of the signs and symptoms of CVS. Both primary and secondary patency rates were also analyzed. Twenty-eight consecutive patients underwent PTA procedure. Technical success was 95%. Postprocedure clinical success was achieved in 100% of the cases where the procedure was successful. The primary patency rates were 18% and 9% at 6 and 12 months, respectively. The secondary patency rates were 95%, 86%, and 73% at 6, 12, and 24 months, respectively. On average, 2.1 procedures/year were required to maintain secondary patency. There were no procedure-related complications. This study finds PTA to be a viable option in the management of PM/ICD lead-induced CVS. Additional studies with appropriate design and sample size are required to conclusively establish the role of PTA in the management of this problem.
Introduction Gender disparities in income continue to exist, and many studies have quantified the gap between male and female workers. These studies paint an incomplete picture of gender income disparity because of their reliance on notoriously inaccurate or incomplete surveys. We quantified gender reimbursement disparity between female and male healthcare providers using objective, non-self-reported data and attempted to adjust the disparity against commonly held beliefs as to why it exists. Methods We analysed over three million publicly available Medicare reimbursement claims for calendar year 2012 and compared the reimbursements received by male and female healthcare providers in 13 medical specialties. We adjusted these reimbursement totals against how hard providers worked, how productive each provider was, and their level of experience. We calculated a reimbursement differential between male and female providers by primary medical specialty.
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