Predialysis Vascular Access Placement and Catheter Use at Hemodialysis Initiation.

BACKGROUND: Current guidelines encourage placement of an arteriovenous (AV) fistula in patients with advanced CKD to avoid initiation of hemodialysis with a central venous catheter. However, the relative merits of predialysis placement of an AV fistula or graft have been poorly studied. METHODS: This study included 380 patients (mean age 59±14 years, 73% Black patients, 51% male) from a large academic medical center who underwent predialysis placement of an AV fistula (286) or AV graft (94). The study quantified three end points: time from access placement to initiation of dialysis, likelihood of starting hemodialysis without a catheter, and number of vascular access procedures before dialysis initiation. RESULTS: The eGFR at access surgery was <10, 10-14, and ≥15 ml/min per 1.73 m 2 in 87 (23%), 179 (47%), and 114 (30%) patients, respectively. The median time from access surgery to hemodialysis initiation was 69, 156, and 429 days in patients with an eGFR of <10, 10-14, and ≥15 ml/min per 1.73 m 2 , respectively ( P < 0.001). Hemodialysis was initiated within 2 years of access surgery in 298 (78%) of the patients. Catheter-free hemodialysis initiation was higher in patients with an AV graft versus an AV fistula when the eGFR was <10 ml/min per 1.73 m 2 (88% versus 43%; odds ratio [OR], 9.10 [95% confidence interval, 2.74 to 26.4]) and when the eGFR was 10-14 ml/min per 1.73 m 2 (88% versus 54%; OR, 6.05 [2.35 to 15.0]) but similar when the eGFR was ≥15 ml/min per 1.73 m 2 (90% versus 75%; OR, 3.00 [0.48 to 34.9]). Patients undergoing an AV fistula were more likely to undergo an angioplasty (11% versus 0%, P < 0.001), surgical access revision (26% versus 8%, P < 0.001), a second access placement (16% versus 6%, P = 0.02), and a catheter insertion (32% versus 11%, P < 0.001). CONCLUSIONS: Among patients with CKD undergoing vascular access surgery when their eGFR was <15 ml/min per 1.73 m 2 , catheter use at dialysis initiation was much less likely when an AV graft, rather than an AV fistula, was placed.

The reasons for comparative effectiveness clinical trials of arteriovenous fistula versus graft strategy in older adults on hemodialysis with a catheter.

Clinicians and patients are guided by observational studies to make one of the most consequential decisions for patients with advanced kidney disease: the selection of the "right" hemodialysis vascular access. More than a decade ago, a call for randomized clinical trials was made to equitably compare clinical outcomes between arteriovenous (AV) fistulas (AVFs) and AV grafts (AVGs). Mounting evidence suggests that trade-offs between AVF- and AVGrelated outcomes are context dependent. In this article, we summarize four streams of evidence that collectively underpin the burden of equipoise between the two types of AV access in older adults with comorbidities who are on hemodialysis with a central venous catheter.

Vascular Access-Related Distal Ischemia Requiring Intervention: Frequency, Risk Factors, and Consequences.

BACKGROUND: Distal ischemia is a rare complication in patients undergoing placement of an arteriovenous (AV) fistula or AV graft. There are limited studies on its frequency, risk factors, clinical consequences, or feasibility of subsequent access. METHODS: A prospective vascular access database from a large academic medical center was queried retrospectively to identify 1498 patients (mean age 56±15 years, 48% female patients, 73% Black patients) undergoing placement of at least one vascular access from 2011 to 2020. For patients who developed access-related distal ischemia requiring surgical intervention, we determined the frequency of distal ischemia, clinical risk factors, and subsequent outcomes. RESULTS: Severe access-related distal ischemia occurred in 28 patients (1.9%; 95% confidence interval, 1.3% to 2.7%). The frequency was 0.2% for forearm AV fistulas, 0.9% for upper arm AV fistulas, 2.4% for forearm AV grafts, 2.2% for upper arm AV grafts, and 2.8% for thigh AV grafts. Risk factors independently associated with distal ischemia included female sex (odds ratio [OR], 3.64 [95% confidence interval, 1.52 to 8.72]), peripheral vascular disease (OR, 6.28 [2.84 to 13.87]), and coronary artery disease (OR, 2.37 [1.08 to 5.23]). Surgical interventions included ligation, excision, plication (banding), and other surgical procedures. Five patients developed tissue necrosis. A subsequent AV graft was placed in 13 patients, of whom only one (8%) developed distal ischemia requiring intervention. CONCLUSIONS: Access-related distal ischemia requiring intervention was rare in this study and more common in women and patients with peripheral vascular disease or coronary artery disease. In some cases, a subsequent vascular access could be placed with a low likelihood of recurrent distal ischemia.

Trends in Vascular Access Among Patients Initiating Hemodialysis in the US.

This cohort study uses the US Renal Data System database to analyze trends in vascular access among more than 600 000 patients who initiated hemodialysis from 2015 to 2020.

Effects of a More Selective Arteriovenous Fistula Strategy on Vascular Access Outcomes.

SIGNIFICANCE STATEMENT: The optimal choice of vascular access for patients undergoing hemodialysis-arteriovenous fistula (AVF) or arteriovenous graft (AVG)-remains controversial. In a pragmatic observational study of 692 patients, the authors found that among patients who initiated hemodialysis with a central vein catheter (CVC), a strategy that maximized AVF placement resulted in a higher frequency of access procedures and greater access management costs for patients who initially received an AVF than an AVG. A more selective policy that avoided AVF placement if an AVF was predicted to be at high risk of failure resulted in a lower frequency of access procedures and access costs in patients receiving an AVF versus an AVG. These findings suggest that clinicians should be more selective in placing AVFs because this approach improves vascular access outcomes. BACKGROUND: The optimal choice of initial vascular access-arteriovenous fistula (AVF) or graft (AVG)-remains controversial, particularly in patients initiating hemodialysis with a central venous catheter (CVC). METHODS: In a pragmatic observational study of patients who initiated hemodialysis with a CVC and subsequently received an AVF or AVG, we compared a less selective vascular access strategy of maximizing AVF creation (period 1; 408 patients in 2004 through 2012) with a more selective policy of avoiding AVF creation if failure was likely (period 2; 284 patients in 2013 through 2019). Prespecified end points included frequency of vascular access procedures, access management costs, and duration of catheter dependence. We also compared access outcomes in all patients with an initial AVF or AVG in the two periods. RESULTS: An initial AVG placement was significantly more common in period 2 (41%) versus period 1 (28%). Frequency of all access procedures per 100 patient-years was significantly higher in patients with an initial AVF than an AVG in period 1 and lower in period 2. Median annual access management costs were significantly higher among patients with AVF ($10,642) versus patients with AVG ($6810) in period 1 but significantly lower in period 2 ($5481 versus $8253, respectively). Years of catheter dependence per 100 patient-years was three-fold higher in patients with AVF versus patients with AVG in period 1 (23.3 versus 8.1, respectively), but only 30% higher in period 2 (20.8 versus 16.0, respectively). When all patients were aggregated, the median annual access management cost was significantly lower in period 2 ($6757) than in period 1 ($9781). CONCLUSIONS: A more selective approach to AVF placement reduces frequency of vascular access procedures and cost of access management.

Ovulation and birth after administration of progesterone trigger-two case reports.

PURPOSE: To determine whether using progesterone as a trigger of a gonadotropin surge will induce ovulation and a competent corpus luteum. METHODS: Patients were administered 5 or 10 mg of progesterone intramuscularly when the leading follicle reached preovulatory size. RESULTS: We demonstrate that progesterone injections result in classical ultrasonographic hallmarks of ovulation about 48 h later and the formation of a corpus luteum competent to support pregnancy. CONCLUSION: Our results support further exploration of using progesterone to trigger a gonadotropin surge in assisted human reproduction.

Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial.

BACKGROUND: Treatment of end-stage kidney disease (ESKD) with hemodialysis requires surgical creation of an arteriovenous (AV) vascular access-fistula (AVF) or graft (AVG)-to avoid (or limit) the use of a central venous catheter (CVC). AVFs have long been considered the first-line vascular access option, with AVGs as second best. Recent studies have suggested that, in older adults, AVGs may be a better strategy than AVFs. Lacking evidence from well-powered randomized clinical trials, integration of these results into clinical decision making is challenging. The main objective of the AV Access Study is to compare, between the two types of AV access, clinical outcomes that are important to patients, physicians, and policy makers. METHODS: This is a prospective, multicenter, randomized controlled trial in adults ≥ 60 years old receiving chronic hemodialysis via a CVC. Eligible participants must have co-existing cardiovascular disease, peripheral arterial disease, and/or diabetes mellitus; and vascular anatomy suitable for placement of either type of AV access. Participants are randomized, in a 1:1 ratio, to a strategy of AVG or AVF creation. An estimated 262 participants will be recruited across 7 healthcare systems, with average follow-up of 2 years. Questionnaires will be administered at baseline and semi-annually. The primary outcome is the rate of CVC-free days per 100 patient-days. The primary safety outcome is the cumulative incidence of vascular access (CVC or AV access)-related severe infections-defined as access infections that lead to hospitalization or death. Secondary outcomes include access-related healthcare costs and patients' experiences with vascular access care between the two treatment groups. DISCUSSION: In the absence of studies using robust and unbiased research methodology to address vascular access care for hemodialysis patients, clinical decisions are limited to inferences from observational studies. The goal of the AV Access Study is to generate evidence to optimize vascular access care, based on objective, age-specific criteria, while incorporating goals of care and patient preference for vascular access type in clinical decision-making. TRIAL REGISTRATION: This study is being conducted in accordance with the tenets of the Helsinki Declaration, and has been approved by the central institutional review board (IRB) of Wake Forest University Health Sciences (approval number: 00069593) and local IRB of each participating clinical center; and was registered on Nov 27, 2020, at ClinicalTrials.gov (NCT04646226).

Racial Disparities in Arteriovenous Fistula Use Among Hemodialysis Patients: The Role of Surgeon Supply.

Introduction: Factors contributing to racial disparities in arteriovenous fistula (AVF) use among hemodialysis (HD) patients remain poorly defined. We evaluated whether the Black/White race disparity in AVF use is affected by vascular access surgeon supply. Methods: Using Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb) and Medicare claims data from the US Renal Data System (USRDS), competing risk analyses of all US patients initiating HD with a central venous catheter (CVC) from 2016 to 2017 (n = 100,227) were performed. The likelihood of successful AVF use was compared between Black and White patients after adjusting for vascular access surgeon supply. Results: Compared with the first (lowest) quartile of surgeon supply, higher supply levels were associated with modestly increased adjusted likelihoods of overall AVF use: 4% (95% CI 1.4%-7.2%), 4% (95% CI 1.4%-7.1%), and 3% (0.0%-6.1%) for second, third, and fourth quartiles, respectively. Although areas with lower surgeon supply had a higher proportion of Black patients, residing in areas with a greater surgeon supply was not significantly associated with a mitigation in racial disparity. Specifically, compared with White patients, Black patients were 10% (95% CI 7%-13%) and 8% (95% CI 5%-11%) less likely to have successful AVF use in lower and higher surgeon supply areas, respectively. Conclusion: Regions with lower surgeon supply had a higher proportion of Black dialysis patients. However, racial disparities in AVF use among patients initiating HD with a CVC were similar in regions with a high and low surgeon supply. Other patient, provider, and practice factors should be evaluated toward mitigating lower rates of AVF use among Black HD patients.

De Novo Central Vein Stenosis in Hemodialysis Patients Following Initial Tunneled Central Vein Catheter Placement.

Background: Central vein stenosis (CVS) is a common complication in hemodialysis patients following tunneled central venous catheter (CVC) insertion. Little is known about its incidence, association with patient characteristics, or relationship with duration of CVC placement. We systematically evaluated central vein stenosis in hemodialysis patients receiving their first CVC exchange at a large medical center. Methods: All new hemodialysis patients underwent an ultrasound before their internal jugular tunneled CVC placement, to exclude venous stenosis or thrombosis. After the initial CVC insertion, if the patients were referred for CVC exchange due to dysfunction, a catheterogram/venogram was performed to assess for hemodynamically significant (≥50%) central vein stenosis. During a 5-year period (January 2016 to January 2021), we quantified the incidence of CVS in patients undergoing CVC exchange. We also evaluated the association of central vein stenosis with patient demographics, comorbidities, and duration of CVC dependence before exchange. Results: During the study period, 273 patients underwent exchange of a tunneled internal jugular vein CVC preceded by a catheterogram/venogram. Hemodynamically significant CVS was observed in 36 patients (13%). CVS was not associated with patient age, sex, race, diabetes, hypertension, coronary artery disease, peripheral artery disease, or CVC laterality. However, the frequency of CVS was associated with the duration of CVC dependence (26% versus 11% for CVC duration ≥6 versus <6 months: odds ratio (95% CI), 3.17 (1.45 to 6.97), P=0.003). Conclusions: Among incident hemodialysis patients receiving their first tunneled internal jugular CVC exchange, the overall incidence of de novo hemodynamically significant central vein stenosis was 13%. The likelihood of CVS was substantially greater in patients with at least 6 months of CVC dependence.

Feasibility of Creation of an Endovascular Arteriovenous Fistula in Patients Undergoing Preoperative Vascular Mapping.

Background: The first endovascular arteriovenous fistula (endoAVF) device (WavelinQ), a novel percutaneous technique of AVF creation, was approved by the Food and Drug Administration in 2018 and has been placed in a small number of United States patients on hemodialysis. It is unknown how often patients with advanced CKD have vascular anatomy suitable for WavelinQ creation. The goal of this study was to determine the proportion of patients with vascular anatomy suitable for WavelinQ creation and to assess patient characteristics associated with such suitability. Methods: All patients referred for vascular access placement at a large academic medical center underwent standardized preoperative sonographic vascular mapping to assess suitability for an AVF. During a 2-year period (March 2019 to March 2021), we assessed the suitability of the vessels for creation of WavelinQ. We then compared the demographic characteristics, comorbidities, and vascular mapping measurements between patients who were or were not suitable for WavelinQ. Results: During the study period, 437 patients underwent vessel mapping. Of these, 51% of patients were eligible for a surgical AVF, and 32% were eligible for a WavelinQ AVF; 63% of those suitable for a surgical AVF were also suitable for a WavelinQ AVF. Patients with a vascular anatomy suitable for WavelinQ were younger (age 55±15 versus 60±14 years, P=0.01) but similar in sex, race, diabetes, hypertension, coronary artery disease, and peripheral artery disease. Conclusions: Among patients with CKD with vascular anatomy suitable for a surgical AVF, 63% are also suitable for a WavelinQ endoAVF. Older patients are less frequently suitable for WavelinQ.

Arteriovenous Fistula Maturation, Functional Patency, and Intervention Rates.

Importance: National initiatives have emphasized the use of autogenous arteriovenous fistulas (AVFs) for hemodialysis, but their purported benefits have been questioned. Objective: To examine AVF usability, longer-term functional patency, and remedial procedures to facilitate maturation, manage complications, or maintain patency in the Hemodialysis Fistula Maturation (HFM) Study. Design, Setting, and Participants: The HFM Study was a multicenter (n = 7) prospective National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases cohort study performed to identify factors associated with AVF maturation. A total of 602 participants were enrolled (dialysis, kidney failure: 380; predialysis, chronic kidney disease [CKD]: 222) with AVF maturation ascertained for 535 (kidney failure, 353; CKD, 182) participants. Interventions: All clinical decisions regarding AVF management were deferred to the individual centers, but remedial interventions were discouraged within 6 weeks of creation. Main Outcomes and Measures: In this case series analysis, the primary outcome was unassisted maturation. Functional patency, freedom from intervention, and participant survival were summarized using Kaplan-Meier analysis. Results: Most participants evaluated (n = 535) were men (372 [69.5%]) and had diabetes (311 [58.1%]); mean (SD) age was 54.6 (13.6) years. Almost two-thirds of the AVFs created (342 of 535 [64%]) were in the upper arm. The AVF maturation rates for the kidney failure vs CKD participants were 29% vs 10% at 3 months, 67% vs 38% at 6 months, and 76% vs 58% at 12 months. Several participants with kidney failure (133 [37.7%]) and CKD (63 [34.6%]) underwent interventions to facilitate maturation or manage complications before maturation. The median time from access creation to maturation was 115 days (interquartile range [IQR], 86-171 days) but differed by initial indication (CKD, 170 days; IQR, 113-269 days; kidney failure, 105 days; IQR, 81-137 days). The functional patency for the AVFs that matured at 1 year was 87% (95% CI, 83.2%-90.2%) and at 2 years, 75% (95% CI, 69.7%-79.7%), and there was no significant difference for those receiving interventions before maturation. Almost half (188 [47.5%]) of the AVFs that matured had further intervention to maintain patency or treat complications. Conclusions and Relevance: The findings of this study suggest that AVF remains an accepted hemodialysis access option, although both its maturation and continued use require a moderate number of interventions to maintain patency and treat the associated complications.

Arteriovenous Fistula Nonmaturation: What's the Immune System Got to Do with It?

Background: Arteriovenous fistula (AVF) nonmaturation is a persistent problem, particularly among female and Black patients. Increasingly, the immune system has been recognized as an important contributor to vascular disease, but few studies have examined immune factors relative to AVF maturation outcomes. This study evaluated the association of serum panel reactive antibodies (PRA), a measure of immune system reactivity assessed in patients undergoing kidney transplant evaluation, with AVF nonmaturation. Methods: We identified 132 patients at our institution who underwent surgical AVF placement between 2010-2019 and had PRA testing within 1 year of AVF creation. Multivariable logistic regression was used to determine the association of patient demographic and clinical factors, class I and class II PRA levels, and preoperative arterial and venous diameters with AVF maturation outcomes. Results: AVF nonmaturation was more likely in females than males (44% versus 20%, P=0.003) and in Black than white patients (40% versus 13%, P=0.001). Class II PRA was higher in females than males (12%±23% versus 4%±13%, P=0.02). In the multivariable model, AVF nonmaturation was associated with class II PRA (adjusted odds ratio [aOR], 1.34 per 10% increase; 95% confidence interval [95% CI], 1.04 to 1.82, P=0.02) and Black race (aOR, 3.34; 95% CI, 1.02 to 10.89, P=0.03), but not with patient sex or preoperative arterial or venous diameters. Conclusions: The association of elevated class II PRA with AVF nonmaturation suggests the immune system may play a role in AVF maturation outcomes, especially among female patients.

Racial Disparities in the Arteriovenous Fistula Care Continuum in Hemodialysis Patients.

BACKGROUND AND OBJECTIVES: Arteriovenous fistulas are the optimal vascular access type for patients on hemodialysis. However, arteriovenous fistulas are used less frequently in Black than in White individuals. The arteriovenous fistula care continuum comprises a series of sequential steps. A better understanding is needed of where disparities exist along the continuum in order to mitigate racial differences in arteriovenous fistula use. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Using Medicare claims data from the United States Renal Data System, longitudinal analyses of patients ≥67 years initiating hemodialysis with a central venous catheter between July 1, 2010 and June 30, 2012 were performed. Three patient cohorts were identified: patients initiating hemodialysis with a catheter (n=41,814), patients with arteriovenous fistula placement within 6 months of dialysis initiation (n=14,077), and patients whose arteriovenous fistulas were successfully used within 6 months of placement (n=7068). Three arteriovenous fistula processes of care outcomes were compared between Blacks and Whites: (1) arteriovenous fistula creation, (2) successful arteriovenous fistula use, and (3) primary arteriovenous fistula patency after successful use. RESULTS: An arteriovenous fistula was placed within 6 months of dialysis initiation in 37% of patients initiating dialysis with a catheter. Among the patients with arteriovenous fistula placement, the arteriovenous fistula was successfully used for dialysis within 6 months in 48% of patients. Among patients with successful arteriovenous fistula use, 21% maintained primary arteriovenous fistula patency at 3 years. After adjusting for competing risks, Black patients on hemodialysis were 10% less likely to undergo arteriovenous fistula placement (adjusted subdistribution hazard ratio, 0.90; 95% confidence interval, 0.87 to 0.94); 12% less likely to have successful arteriovenous fistula use after placement (adjusted subdistribution hazard ratio, 0.88; 95% confidence interval, 0.83 to 0.93); and 22% less likely to maintain primary arteriovenous fistula patency after successful use (subdistribution hazard ratio, 0.78; 95% confidence interval, 0.74 to 0.84). CONCLUSIONS: Lower arteriovenous fistula use among Blacks older than 67 years of age treated with hemodialysis was attributable to each step along the continuum of arteriovenous fistula processes of care.

KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update.

The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) has provided evidence-based guidelines for hemodialysis vascular access since 1996. Since the last update in 2006, there has been a great accumulation of new evidence and sophistication in the guidelines process. The 2019 update to the KDOQI Clinical Practice Guideline for Vascular Access is a comprehensive document intended to assist multidisciplinary practitioners care for chronic kidney disease patients and their vascular access. New topics include the end-stage kidney disease "Life-Plan" and related concepts, guidance on vascular access choice, new targets for arteriovenous access (fistulas and grafts) and central venous catheters, management of specific complications, and renewed approaches to some older topics. Appraisal of the quality of the evidence was independently conducted by using a Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, and interpretation and application followed the GRADE Evidence to Decision frameworks. As applicable, each guideline statement is accompanied by rationale/background information, a detailed justification, monitoring and evaluation guidance, implementation considerations, special discussions, and recommendations for future research.