Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access : Clinical Journal of the American Society of Nephrology

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Moving Points in Nephrology

Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access

Beathard, Gerald A.; Lok, Charmaine E.; Glickman, Marc H.; Al-Jaishi, Ahmed A.; Bednarski, Donna; Cull, David L.; Lawson, Jeffery H.; Lee, Timmy C.; Niyyar, Vandana D.; Syracuse, Donna; Trerotola, Scott O.; Roy-Chaudhury, Prabir; Shenoy, Surendra; Underwood, Margo; Wasse, Haimanot; Woo, Karen; Yuo, Theodore H.; Huber, Thomas S.

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Clinical Journal of the American Society of Nephrology 13(3):p 501-512, March 2018. | DOI: 10.2215/CJN.11531116
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The Clinical Trial Endpoints for Dialysis Vascular Access project is part of the Kidney Healthcare Initiative (1,2), with a primary goal to identify appropriate clinical trial end points to help design clinical trials which would inform clinical, regulatory, and coverage decisions on new interventions, drugs, biologics, or devices relevant to hemodialysis vascular access. This manuscript summarizes key clinical trial end points that can be considered for these interventions relevant to the arteriovenous (AV) access, e.g., arteriovenous fistula (AVF) and arteriovenous graft (AVG). These end points align with the various phases of the AV-access life cycle (Figure 1, Table 1) that may be affected by new interventional studies. This paper will review the phases of an AV-access life cycle, highlight potential associated problems, and recommend relevant clinical trial end points that would be appropriate in interventional clinical trials addressing these problems.

Figure 1.:
Phases of arteriovenous access life cycle.
Table 1. - Arteriovenous access life cycle
Phase Definition Potential Problems End Point
Creation Patent AVF Inadequate vascular anatomy Meet definition of patent AV access
Patent AVG Patency failure
Hand ischemia
Maturation Physiologically mature AVF or mature AVG Failure or maturation Meet definition of physiologically mature AVF or mature AVG
Hand ischemia
Clinical use, initial Clinically functional AVF or clinically functional AVG Inability to cannulate AV access Meet definition of clinically functional AVF or clinically functional AVG
Inability of AV access to sustain blood flow adequate for dialysis
Clinical use, sustained Repetitive, routine use of AV access for dialysis Vascular stenosis Sustained, uninterrupted use of AV access for dialysis
Thrombosis Lack of interference with patient’s quality of life
Aneurysm formation
High blood flow
Hand ischemia
Poor patient quality of life
Dysfunctional Management of AV-access dysfunction Stenosis treatment failure Restore uninterrupted use of AV access for dialysis
Restore functionality of nonfunctional AV access Recurrent stenosis Minimize period of AV access dysfunction
Recurrent thrombosis Maximize use-life of AV access
Loss of AV access Minimize effect of AV-access dysfunction on patient’s quality of life
Ischemic tissue loss
AVF, arteriovenous fistula; AV, arteriovenous; AVG, arteriovenous graft.

Materials and Methods

Published practice guidelines, clinical studies, and other pertinent articles related to AV access were reviewed to develop a list of relevant terms. Using these terms and MEDLINE via PubMed, a literature search was conducted of publications related to AV-access definitions; AV-access creation, development, and maturation; and AV-access complications. Reference lists from relevant manuscripts were examined individually to identify additional pertinent publications. The titles and abstracts of all retrieved citations were reviewed and the full text of potential studies was reviewed by committee members and screened for inclusion.

Over 400 full-text articles were reviewed by committee members to establish a database for issues related to the various phases of an AV-access life cycle. We excluded case reports; otherwise, there were no restrictions on the study size or design. We also excluded studies without clear definitions of: (1) the clinical use(s) of the intervention; (2) outcomes or measurements of outcomes in the study; or (3) the types of AV access involved in the study. A standardized data sheet was utilized to extract pertinent information from the included studies. A review of clinical outcomes, their measurements, and all relevant study end points used in prior publications dealing with AV-access creation, maturation, use, and maintenance was conducted. Clinical trial end points important from the perspectives of patients, clinicians, and administrators were considered. We assessed the end points’ adequacy, strengths, and weaknesses; identified common terminology with a view toward maintaining consistency; and assessed the need for additional relevant end points.

Phases of AV-Access Life Cycle and Potential Problems

An interventional study might be designed to affect any point within the evolution of the AV-access life cycle, which has been divided into five distinct clinical phases designated as shown in Figure 1. Each of these carries with it the potential for problems (Table 1).

The first three phases also correspond to three AV-access developmental stages as shown in Figure 2. These three stages are more distinct and well differentiated for an AVF; however, they also characterize the evolution of an AVG. Time is not part of these definitions because it does not exert an influence on whether the outcome has been achieved.

Figure 2.:
Developmental stages of arteriovenous access. AV, arteriovenous; AVF, arteriovenous fistula; AVG, arteriovenous graft; —, no entry.

Phase 1—Creation

An AV communication is formed using either an autogenous vein or a graft. The clinical outcome for this phase is a patent AV access, either a stage 1 patent AVF or patent AVG. The attainment of this goal is demonstrated by the presence of blood flow which can be confirmed either directly using an imaging modality, or indirectly by physical examination (3).

Potential Problems.

Choice of AV Access.

In ideal circumstances, an AVF is the best choice for a dialysis access. However, it may not be possible to create an AVF in every patient; in some it may not be clinically appropriate, and some that are created are not successful. In many of these cases an AVG is placed depending upon individual circumstances (4,5).

Pediatric Patients.

The pediatric patient population with CKD is of special concern. In general, these patients have longer life expectancy than adult patients. Even if transplanted, the anticipated longevity of the graft is such that a return to hemodialysis can be expected. Therefore, optimal management of vascular access on the basis of long-term planning is essential. Despite this, most of these patients start dialysis with a catheter and continue with a catheter for long-term use. In contrast to decreasing use of catheters in all patients combined, catheter use in pediatric age incident patients increased from 2006 to 2014 (6). Compared with the adult CKD population, the accomplishment of a phase 1 AV access may require interventional studies that are specifically targeted toward this age group.

Hand Ischemia.

Dialysis access steal syndrome may appear immediately upon the creation of an AV access. In a meta-analysis involving 21 reports, 464 cases were tabulated (7). Acute dialysis access steal syndrome (occurring immediately postoperatively or within hours) was seen in 104 cases; 87% were in patients with an AVG.

Phase 2—Maturation

During this phase, the AV access evolves to one that has the potential for being used as a hemodialysis access. In the case of an AVF, the clinical outcome is a stage 2 physiologically mature AVF defined by objective demonstration using duplex ultrasound of a minimum access-vessel internal diameter ≥5 mm and an access blood flow ≥500 ml/min. The duration of this phase is measured in weeks, because most AVFs that mature will do so in 4–8 weeks (3,8–14).

The end point for an AVG is a stage 2 mature AVG. Multiple studies have shown a mature AVG to be clinically usable with a minimum access blood flow of 600 ml/min (15,16). The most commonly used material for an AVG is expanded polytetrafluoroethylene which typically requires a period of 3–6 weeks for wound healing, resolution of swelling, and incorporation of subcutaneous tissue. Although referred to as maturation, the process is obviously quite different from maturation of an AVF (15). With newer materials offering the benefit of early postoperative cannulation, an AVG can be ready for first cannulation (“mature”) after a period of hours to days (17,18).


Successful AVF maturation is characterized by a continuous, progressive, and relatively rapid increase in access blood flow and access-vessel internal diameter sufficient to permit repetitive clinical use for hemodialysis. Studies have shown that access blood flow alone, or a combination of access blood flow and internal access-vessel diameter, are reliable indirect indicators of maturation and the future successful use of an AVF for hemodialysis (3,8–14) (Table 2). These metrics can be used as clinical trial outcomes to define a physiologically mature AVF. Predialysis AVF placement in patients with advanced CKD will predictably result in some patients having a physiologically mature AVF that will not be used for some period (19,20). Requiring clinical use as part of this definition would result in a penalty for enrolling predialysis patients, thus potentially limiting the eligible study population and in some cases introducing a case-selection bias.

Table 2. - Fistula maturation studies
Name Cases AVF Type Time (wk) iAVD (mm) Qa (ml/min) Metric Used Accuracy (%) Sensitivity (%) Specificity (%) PPV (%) NPV (%)
Wong (8) a 46 R-C 4 5.4 722 83
Lin (9) 74 (age>65) R-C 2 3.8 634 86
102 (age<65) R-C 2 3.6 750 90
Malovhr (11) a 102 R-C 3 420 93
Robbin (10) a 69 R-C (48) 4 4.0 500 Qa 75 75 75
U-A (21) iAVD 72 75 75
Both 95
Neither 67
Only Qa 70
Only iAVD 67
Back (13) 87 R-C (34) 5–8 500 b 67 38 90 75 64
B-C (33) 800 b 77 69 83 77 77
B-B (20)
Ives (12) 113 R-C (34) <8 (73%) c 400 b 53 89 87
B-C (79) 600 b 77
Ferring (3) 119 R-C (46) 4 5.0 550 Qa 67 65 87 37
U-A (73) iAVD 83 68 90 53
Zhu (14) 132 R-C 4 5.2 529 Qa 96 82
iAVD 71 80
Both 84 93
AVF, arteriovenous fistula; iAVD, access venous internal diameter; Qa, access blood flow; PPV, positive predictive value; NPV, negative predictive value; R-C, radial-cephalic fistula; U-A, upper arm; B-C, brachial-cephalic; B-B, brachial-basilic.
aSome information obtained from graphic data.
bValues are for total group.
ciAVD difference between successful and unsuccessful AVFs was not statistically significant.

An access blood flow of 400–500 ml/min has been shown to have an accuracy of 53%–93% (10–13), a sensitivity of 67%–96% (3,10,12–14), and a specificity of 65%–90% (10,12–14) for predicting clinical AVF maturation. Collectively, these studies suggest that a minimum access blood flow threshold of 500 ml/min is appropriate as an indirect measure of AVF maturation. Only one study evaluated forearm and upper-arm AVFs separately (12), and found that using a threshold access blood flow of 600 ml/min for brachial-cephalic AVF had a sensitivity and specificity of 89% and 87%, respectively, for clinical AVF maturation.

Even though an access blood flow of 350–500 ml/min has been reported in normally functioning AVFs (21), an access blood flow <400–500 ml/min has been associated with AVF thrombosis (22). A caveat is that this may relate to the prescribed dialysis blood flow rate prescribed for dialysis. A functioning fistula with an access blood flow of 350 ml/min might be acceptable with lower dialysis blood flow (e.g., 280 ml/min as with nocturnal hemodialysis) but would lead to recirculation in conventional hemodialysis, with a dialysis blood flow of ≥400 ml/min typically used in North America (23).

The site for an access blood flow measurement should be the brachial artery at least 5 cm proximal to the anastomosis, regardless of whether one is dealing with a radial or a brachial artery–based AVF (3,14,24,25). Because the incidence of high bifurcation of the brachial artery is significant (26,27), care must be taken to assure that the measurement is being made from the brachial artery.

Studies have reported that an access-vessel internal diameter threshold ranging from 4 to 5 mm correlates with success (Table 2); however, 5 mm should be adopted as the appropriate and more conservative end point to indirectly indicate AVF maturation (3,8,10,14). Combining both access blood flow and access vessel internal diameter (500 ml/min and 5 mm, respectively) was found to have a sensitivity of 84% and a specificity of 93% (14). Because access-vessel internal diameter criteria are based upon studies in which the measurements were performed without a tourniquet (3,8,14); this is recommended for defining an access as a physiologically mature AVF.

The increase in both access blood flow and access-vessel internal diameter defining an AVF’s maturation occurs rather rapidly; however, on the basis of studies evaluating these changes over time (10,14,28), it seems appropriate that when a time value is required, 4 weeks is an appropriate minimum.

AVG maturation is quite different than for an AVF. The diameter of the AVG is predetermined and access blood flow is very near its maximal level from the beginning. Thus, access blood flow and access-vessel internal diameter are not typically used as clinical trial end points for AVG. Nevertheless, in the optimal situation, remote upstream remodeling involving the feeding artery and downstream remodeling involving draining veins occur and importantly contribute to continued patency of the AVG.

Potential Problems.

Failure to Mature.

Although many cases can be salvaged (29,30), AVF failure-to-mature rates ranging from 20% to 60% have been reported (10,31–37). In 2014, 36% of created AVFs failed and the average time between placement and first use was 133 days (6). Many that are ultimately salvaged require more than one procedure to become clinically usable (38) and have a shortened primary patency rate, making repetitive interventions necessary for continued clinical use (39,40).

The incidence of primary AVG failure has been reported to be in the range of 4%–11% resulting from surgical problems, graft characteristics, patient demographics, and patient comorbidity (41–44).

A key challenge to comparing studies evaluating clinical outcomes in this maturation phase has been the wide variability in definitions of “maturation,” “primary failure,” and various AV-access patencies. In this Kidney Healthcare Initiative series, definitions of terms relevant for evaluating clinical outcomes in this and other AV-access phases have been standardized (45).


Although perioperative infection is uncommon with an AVF, a rate ranging from 1% to 3% has been reported for an AVG placed in the upper extremity, and rates >18% for those placed in the thigh (46,47).

Hand Ischemia.

Subacute dialysis access steal syndrome (delayed but within 1 month of surgery) may be seen during the maturation phase of AV-access development. In a meta-analysis involving 464 cases, 97 subacute cases occurred and 79% were associated with AVFs (7).

Phase 3—Clinical Use, Initial

This phase is characterized by use of the AV access for dialysis—a stage 3 clinically functional AVF or clinically functional AVG. This is defined as an AV access that can be cannulated with two dialysis needles for at least 75% of dialysis sessions within a 4-week period to achieve the prescribed dialysis.


Prior definitions indicating needle dimensions, dialysis blood-flow targets (e.g., >300 ml/min), and urea kinetic measurements (e.g., Kt/V) are not consistently applicable or feasible (48,49). For example, patients of small body habitus or those receiving prolonged dialysis (e.g., nocturnal or other slow continuous dialysis) can have well functioning fistulas using dialysis blood flow of 280 ml/min. This has been demonstrated in Japan, France, and Canada. Because more clinical trials need multisite international involvement, this is an important consideration for clinical trial end points and increased generalizability. Furthermore, the “timelessness” of definitions needs to be considered with newer dialysis machines and technologies (i.e., ones that use lower dialysis blood flow and dialysate flow rates).

The use of urea kinetic modeling is impractical and very costly (two blood samples per dialysis run) if one needs to collect this information in a minimum 75% of dialysis sessions within 4 weeks. Depending on the type of dialysis, spKt/V, eKt/V, weekly standard Kt/V, or the urea reduction ratio may be used and are associated with various inconveniences for patients (i.e., need to wait 30–60 minutes to collect the second urea measurement).

In addition, adequacy of dialysis on the basis of urea kinetic modeling involves many factors besides the AV access. For example, if a patient leaves early for dialysis or clots their circuit, this may adversely affect the Kt/V but the fistula may be functioning perfectly, clinically. In these instances, such a criterion as part of the clinical trial end point for AV-access clinical usability would be unjust. A time factor is required for a workable definition because persistence of clinical utility is also critically important. Because of the possibility of operator error resulting in cannulation problems with any new AV access, a criterion of cannulation for 75% of dialysis sessions is felt to be reasonable. As stated, this important clinical trial end point definition captures what is clinically important for the patient and the clinician—sustained reliable use of the AV access to provide the prescribed dialysis.

Of note, clinical usability also depends upon patient-specific criteria that cannot be objectively quantified, such as an optimal depth, length, and location that allows it to be successfully cannulated. These and other considerations should be considered but might be difficult to capture as clinical trial end points.

Potential Problems.

Cannulation-Associated Problems.

A study of cannulation-related complications in 158 patients with a newly created AV access found complications in the majority of patients (50), with more than ten miscannulations occurring in 37% of AVFs, and 19% of AVGs. Excessive depth, suboptimal location, or inadequate length of the cannulation segment can result in unsuccessful cannulation and/or infiltration (51). Cannulating too early can also result in problems (52,53). Although not a consistent finding (54), cannulation earlier than 1 month has been reported to be associated with a high risk of AVF failure (53).

Phase 4—Clinical Use, Sustained

This phase is defined as continuous, effective, problem-free use of the AV access for hemodialysis. It begins once the AV access is deemed to be clinically functional and represents the ultimate criteria for judging success. Unfortunately, most cases will alternate between this phase and phase 5—dysfunction. The duration of this phase is indeterminate, limited only by the occurrence of problems and complications.

Potential Problems.

Stenosis and Thrombosis.

The most common complication associated with an AV access is venous stenosis which can lead to thrombosis, the most common cause of late AV-access loss (55). In a meta-analysis of AVF patency reports, it was determined that by 1 year, 40% of all AVFs either failed or required at least one intervention (19). When primary failure was included in the calculation of patency rate, the primary and cumulative patency rate was 60% and 71% at 1 year, and 51% and 64% at 2 years, respectively. In another meta-analysis on the basis of 34 relevant studies, the primary and cumulative patency rate for AVGs at 6 and 18 months was 58% and 33%, and 76% and 55%, respectively (56).

Percutaneous angioplasty has become the treatment of choice for venous stenosis. Although there are special categories of lesions that behave differently, peripheral draining vein stenotic lesions behave similarly in an AVF and an AVG. Angioplasty results for peripheral vein stenosis from a pooled cohort of 2166 cases from 15 published studies, including both AVFs and AVGs, showed a postintervention primary patency of 62% and a cumulative patency of 85% at 6 months (57–71).

A hemodynamically significant lesion can develop anywhere in the arterial tree from the ascending aorta to the arterial anastomosis. Reports of inflow stenosis in dysfunctional AVGs range between 14% and 42% (72–74), and between 6% and 18% in AVFs (55,73,75).

Over time, progressive stenosis can result in AV access thrombosis. In general, 100% of all thrombosed AVFs (55), and 85%–90% of AVGs (76), are associated with an anatomic lesion. The frequency of AVG thrombosis is approximately 1–1.5 per patient per year (76). The thrombosis rate for AVFs is reported to be approximately one-sixth that for an AVG (77).

In a study involving 380 cases of endovascular-treated AVG thrombosis, postintervention primary patency rates at 1, 2, 3, and 6 months, and 1 year were 66%, 52%, 44%, 31%, and 10%, respectively (78). AVF thrombosis treatment success can range from 88% to 100%, with postintervention primary patency rates ranging from 20% to 56% at 6 months and 27% to 40% at 1 year (64,79–83).

Aneurysms and Pseudoaneurysms.

Pseudoaneurysm formation in AVGs is a common cannulation-related complication (84), as is aneurysm formation in AVFs (56,85). Degenerative changes in the vein wall that characterize these anomalies generally result from the combination of repeated punctures and hemodynamic factors, such as downstream peripheral or central vein stenosis (84,86). As a pseudoaneurysm/aneurysm develops and expands, it can lead to complications such as pain, objectionable cosmetic appearance, difficult cannulation, risk of bleeding, and problems with access blood flow (84,86).


AV-access infection may present in the form of cellulitis, an abscess, septic emboli, bacteremia, and sepsis (87–89), and is a common cause of AVG loss (90,91). In a meta-analysis, it was found that the annual risk of a fatal infection with an AVG was 0.04, and 0.03 for an AVF. The relative risk for persons using an AVG versus an AVF was 1.36 (95% confidence interval, 1.17 to 1.58) for a fatal infection and 2.76 (95% confidence interval, 2.13 to 3.58) for a nonfatal infection (92).

High Blood Flow.

An AV access produces a hyperdynamic state that increases cardiac workload and exerts significant effects on cardiac systolic and diastolic performance (93). In 2014, 44% patients receiving dialysis were reported to have congestive heart failure (6). In addition, dialysis access steal syndrome can develop secondary to a high access–blood flow (94).

Problems associated with a high access–blood flow occur more commonly with an AVF (95). There are challenges when considering high access–blood flow in a clinical trial. First, there is no uniformly accepted definition of a high access–blood flow. Second, the access–blood flow level that is problematic will vary with each patient on the basis of comorbidities, especially the severity of cardiac and peripheral arterial disease. Perhaps the most objective criterion is the ratio of access blood flow to cardiac output, referred to as cardio-pulmonary recirculation. In a prospective study of 96 patients (96), access blood flow values ≥2.0 L/min predicted the occurrence of high-output cardiac failure with a sensitivity of 89% and specificity of 100%. Cardio-pulmonary recirculation values ≥20% had a sensitivity of 100% and a specificity of 74.7%.

Hand Ischemia.

Dialysis access steal syndrome can result in chronic hand ischemia (occurring >1 month postsurgery). In a series of 464 cases (7), chronic dialysis access steal syndrome was seen in 263 cases, 88% in patients with an AVF.

Patient Quality-of-Life Issues.

Vascular access type is an important determinant of quality of life for patients receiving dialysis. Reports indicate that patients prefer an AVF (97); however, preference does not infer that problems do not exist. For reasons that are not well understood, up to 30% of eligible patients refuse AVF creation (98). In a meta-analysis (99), six themes related to this issue were identified: (1) heightened vulnerability, (2) disfigurement, (3) mechanization of the body, (4) impingement on way of life, (5) self-preservation and ownership, and (6) confronting decisions and consequences.

In general, patients with AV access report pain with cannulation as their most common vascular access–related problem. Although studies indicate that cannulation is associated with an acceptable level of discomfort and a preference for an AVF (97,100), there are patients that report a debilitating fear of needles, pain, and dread of needle-associated complications (99). Those with central venous dialysis catheters have reported avoidance of needles as the best aspect of their access (101).

Phase 5—Dysfunction

This phase is defined as the occurrence of a problem that interferes with the routine use of the AV access, threatens patency or results in a loss of patency, presents a significant risk of medical complication, or adversely affects the patient’s sense of wellbeing. If the attributable problem can be resolved, the AV access returns to phase 4. Limiting the time spent in phase 5 is an important goal and timeliness in addressing problems is critically important.

Potential Problems.

AV-Access Maintenance Problems.

In contrast to the results obtained in the treatment of venous stenosis in general, there are subgroups that are more problematic. Central venous stenosis is a particularly serious problem. The reported technical success rate for angioplasty ranges from 70% to 90%, with a 6- and 12-month postintervention primary patency rate of 23%–63% and 12%–50%, respectively (57,59,102–107).

The most common stenotic site in an AVG is at the venous anastomosis. This lesion is resistant to dilatation and associated with poor primary patency. In a pooled cohort of 456 cases derived from four studies, the technical success rate was 81%, and the postintervention primary and cumulative patency at 6 months were 55% and 76%, respectively (57,108–112).

Lesions referred to as “swing-point stenosis” are extremely problematic. In a study of 278 patients with AVF-associated venous stenosis, 46% fell into this category (113). These are lesions occurring where the course of the vein makes a sharp curved angle creating nonlaminar flow resulting in neointimal hyperplasia. There are three sites that qualify under the swing-point definition: (1) juxta-anastomotic stenosis which involves the first 2–3 cm proximal to the anastomosis, (2) the angle of transposition created when the basilic vein is transposed laterally and superficialized during access surgery, and (3) the cephalic arch. These swing-point lesions are resistant to dilatation and associated with an increased level of procedure-related complications (67,114,115).

Maintenance procedures can in themselves create problems. Angioplasty has been shown to increase the recurrence rate of venous stenosis (116–118). In addition, procedure-related complications can occur with any procedure, and may result in a loss of the AV access. The most frequently encountered complication with angioplasty is venous rupture occurring in 2%–6% of cases, leading to AV-access loss in 5%–30% of those in whom it occurs (64,119,120).

Stenotic lesions resistant to angioplasty therapy and their recurrence are major problems for the patient with an AV access (121,122). Repetitive angioplasty has been a cause for concern, because endothelial injury can result and potentiate neointimal hyperplasia, leading to a cycle of lesion recurrence (39,123).

The major problem encountered in phase 5 is loss of the AV access. Although maintenance procedures performed on AV access are generally successful (64), eventually a point is reached where the access either cannot or should not be salvaged. In a meta-analysis, the cumulative patency for a functioning AVF was 86% at 6 months and 77% at 18 months. The corresponding values for an AVG were 76% and 55%, respectively (56). In an AVF meta-analysis excluding primary failure, the pooled cumulative patency rate was 82% at 1 year and 73% at 2 years (19). In these AV-access case series, the most common event marking the end of cumulative patency was unresolved AV-access thrombosis.

Clinical Trial End Points

There is a potential for directing interventional trial outcomes toward any phase of the AV-access life cycle. However, it is anticipated that these trials can be classified into a limited number of categories (Table 3). In addition, the use of standardized definitions (45) is of critical importance and will facilitate trial design, implementation, analysis, interpretation, and comparison.

Table 3. - Intervention, drug, biologic, and device trial categories with suggested end points
Number Goal for Clinical Trial Primary End Points Secondary End Points a
1 Use IDBD to facilitate the creation of a phase 1 AV access (creation) b Development of a phase 1 AV access (creation) 1–5
2 Use of an IDBD to facilitate the maturation of a phase 1 AV access to a phase 2 AV access (maturation) Development of a phase 2 AV access (maturation) 1–8
3 Use of an IDBD to facilitate the conversion of a phase 2 AV access to a phase 3 AV access (clinical use, initial) Development of a phase 3 access (clinical use, initial) 2–8
4 Use of an IDBD (the intervention) to address the problem of malfunction or complication occurring in a phase 4 AV access (clinical use, sustained)
 a Use of an IDBD to prevent clinically significant stenosis in the hemodialysis access circuit Primary patency of AV access over a specified period 2–5, 9–11
 b Use of an IDBD to treat clinically significant stenosis (the target lesion) occurring within the hemodialysis access circuit Postintervention primary patency of target lesion over a specified period 2–5, 7–14
 c Use of an IDBD to prevent recurrent clinically significant stenosis in the hemodialysis access circuit Postintervention primary patency of target zone over a 12-mo period (a different period may be appropriate if justified in trial design) 2–5, 7–14
 d Use of an IDBD to prevent thrombosis of an AV access Postintervention primary patency of AV access over a 12-mo period (a different time period may be appropriate if justified in trial design) 2–5, 7–14
5 Use of an IDBD (the intervention) to prevent or treat a targeted complication of an AV access (aneurysm formation, dialysis access steal syndrome, infection, etc.) Freedom from targeted complication over a 12-mo period (a different time period may be appropriate if justified in trial design) 2–5, 7–14
6 Use of an IDBD (the intervention) to prolong phase 4 of AV access (clinical use, sustained) Cumulative patency of hemodialysis access circuit or time to occurrence of an event that would require an IDBD intervention 2–5, 9–11, 14
7 Use of an IDBD (the intervention) to prevent or improve a specific complication or adverse outcome reported by the patient related to an AV access (pain of cannulation, convenience of cannulation, cosmetic appearance, etc.) Failure to develop targeted patient-reported specific complication or adverse outcome over a specified period 2–5, 9–11, 14–16
IDBD, intervention, drug, biologic, device; AV, arteriovenous.
aSecondary end points: 1=Development of next phase in of AV-access life cycle. 2=Additional number of IDBD interventions required to achieve primary end point. 3=Incidence and types of IDBD complications. 4=Quality-of-life assessment of patients related to IDBD intervention and primary outcome. 5=Utilization of health care resources required to achieve primary end point. 6=Time required to achieve primary end point. 7=Incidence of catheter use. 8=Duration of hemodialysis catheter use and time that catheter is in place. 9=Postintervention primary patency of hemodialysis access circuit over specified period. 10=Postintervention cumulative patency of hemodialysis access circuit over specified period. 11=Time to access abandonment. 12=Postintervention assisted primary patency of target lesion over a specified period. 13=Postintervention cumulative patency of target lesion over specified period. 14=Postintervention assisted primary patency of hemodialysis access circuit over specified period. 15=Change in severity of the specific complication or adverse outcome. 16=Time to recurrence of a specific complication or adverse outcome.
bCompared with the adult CKD population, the accomplishment of this end point may be different for pediatric patients, requiring IDBD interventions that are specifically targeted to this age group.

The report of a clinical trial needs to provide information relative to both the safety and effectiveness of the intervention so that its risk-benefit relationship can be assessed. The presentation of data concerning issues such as anatomic success, device success, and procedure success are appropriate; however, clinical success demonstrating a definite clinical benefit to the patient is of paramount importance. End points related to interventional trials need to incorporate the economic effect of their use, the clinical relevance of the study, the ease of use/implementation, the consequences of this use, and the time required to realize their effect. The extent to which this information is provided will contribute to the degree of confidence in the results and conclusions of the trial.


G.A.B., consultant to Davita/Lifeline Vascular Access. T.S.H., Editorial Board of Journal of Vascular Surgery, Scientific Advisory Board of University of Michigan Cardiovascular Center. M.H.G., employee of Hancock Jaffe Labs, consultant to Merit Medical Systems, Inc., Proteon Therapeutics, and TVA Medical. A.A.A.-J., none. D.B., none. D.L.C., none. J.H.L., consultant to CR Bard, CryoLife, Inc., and InnAVasc Inc.; ownership interest in Humacyte, Inc., and InnAVasc Inc.; research funding from National Institutes of Health, W.L. Gore & Associates, Inc., CryoLife Inc., and Proteon Therapeutics; honoraria from W.L. Gore & Associates, Inc., CR Bard, and CryoLife Inc. T.C.L., consultant to Proteon Therapeutics. V.D.N., consultant to Ardea Biosciences. D.S., employee of Merit Medical Systems Inc. S.O.T., consultant to CR Bard, Peripheral Vascular, B Braun, Cook, Teleflex, MedComp, and Lutonix; patents and inventions—Teleflex, Cook. P.R.-C., consultant to W.L. Gore & Associates, Inc., Medtronic, Bard Peripheral Vascular, Cook, CorMedix, Fibrogen, and TVA; ownership interest in and Chief Scientific Officer and founder of Inovasc; research funding from Cook Medical (pending) and Bard Peripheral Vascular (pending); honoraria from W.L. Gore & Associates, Inc., Medtronic, Bard Peripheral Vascular, and Cook. S.S., speaker and/or training for W.L. Gore & Associates, Inc.; consultant to Lutonix, Inc., TVA Medical, Inc., and Vascular Therapies, Inc. M.U., consultant to CR Bard. H.W., consultant to Proteon Therapeutics, and Merit Medical Systems, Inc.; honorarium from Proteon Therapeutics. K.W., none. T.H.Y., none. C.E.L., consultant to W.L. Gore & Associates, Inc., Atrium.

Published online ahead of print. Publication date available at

See related articles, “Clinical Trial End Points for Hemodialysis Vascular Access: Background, Rationale, and Definitions,” “Recommended Clinical Trial End Points for Dialysis Catheters,” and “FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access,” on pages , and , respectively.

This article contains supplemental material online at


1. Archdeacon P, Shaffer RN, Winkelmayer WC, Falk RJ, Roy-Chaudhury P: Fostering innovation, advancing patient safety: The kidney health initiative. Clin J Am Soc Nephrol 8: 1609–1617, 2013
2. Linde PG, Archdeacon P, Breyer MD, Ibrahim T, Inrig JK, Kewalramani R, Lee CC, Neuland CY, Roy-Chaudhury P, Sloand JA, Meyer R, Smith KA, Snook J, West M, Falk RJ: Overcoming barriers in kidney health-forging a platform for innovation. J Am Soc Nephrol 27: 1902–1910, 2016
3. Ferring M, Henderson J, Wilmink T: Accuracy of early postoperative clinical and ultrasound examination of arteriovenous fistulae to predict dialysis use. J Vasc Access 15: 291–297, 2014
4. Leake AE, Yuo TH, Wu T, Fish L, Dillavou ED, Chaer RA, Leers SA, Makaroun MS: Arteriovenous grafts are associated with earlier catheter removal and fewer catheter days in the United States Renal Data System population. J Vasc Surg 62: 123–127, 2015
5. Lok CE, Sontrop JM, Tomlinson G, Rajan D, Cattral M, Oreopoulos G, Harris J, Moist L: Cumulative patency of contemporary fistulas versus grafts (2000-2010). Clin J Am Soc Nephrol 8: 810–818, 2013
6. U.S. Renal Data System: Annual Data Report. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2016.
7. Scheltinga MR, van Hoek F, Bruijninckx CM: Time of onset in haemodialysis access-induced distal ischaemia (HAIDI) is related to the access type. Nephrol Dial Transplant 24: 3198–3204, 2009
8. Wong V, Ward R, Taylor J, Selvakumar S, How TV, Bakran A: Factors associated with early failure of arteriovenous fistulae for haemodialysis access. Eur J Vasc Endovasc Surg 12: 207–213, 1996
9. Lin SL, Huang CH, Chen HS, Hsu WA, Yen CJ, Yen TS: Effects of age and diabetes on blood flow rate and primary outcome of newly created hemodialysis arteriovenous fistulas. Am J Nephrol 18: 96–100, 1998
10. Robbin ML, Chamberlain NE, Lockhart ME, Gallichio MH, Young CJ, Deierhoi MH, Allon M: Hemodialysis arteriovenous fistula maturity: US evaluation. Radiology 225: 59–64, 2002
11. Malovrh M: Native arteriovenous fistula: Preoperative evaluation. Am J Kidney Dis 39: 1218–1225, 2002
12. Ives CL, Akoh JA, George J, Vaughan-Huxley E, Lawson H: Pre-operative vessel mapping and early post-operative surveillance duplex scanning of arteriovenous fistulae. J Vasc Access 10: 37–42, 2009
13. Back MR, Maynard M, Winkler A, Bandyk DF: Expected flow parameters within hemodialysis access and selection for remedial intervention of nonmaturing conduits. Vasc Endovascular Surg 42: 150–158, 2008
14. Zhu YL, Ding H, Fan PL, Gu QL, Teng J, Wang WP: Predicting the maturity of haemodialysis arteriovenous fistulas with colour Doppler ultrasound: A single-centre study from China. Clin Radiol 71: 576–582, 2016
15. Akoh JA: Prosthetic arteriovenous grafts for hemodialysis. J Vasc Access 10: 137–147, 2009
16. Monroy-Cuadros M, Yilmaz S, Salazar-Bañuelos A, Doig C: Independent prediction factors for primary patency loss in arteriovenous grafts within six months. J Vasc Access 13: 29–35, 2012
17. Al Shakarchi J, Houston G, Inston N: Early cannulation grafts for haemodialysis: A systematic review. J Vasc Access 16: 493–497, 2015
18. Aitken E, Thomson P, Bainbridge L, Kasthuri R, Mohr B, Kingsmore D: A randomized controlled trial and cost-effectiveness analysis of early cannulation arteriovenous grafts versus tunneled central venous catheters in patients requiring urgent vascular access for hemodialysis. J Vasc Surg 65: 766–774, 2017
19. Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM: Patency rates of the arteriovenous fistula for hemodialysis: A systematic review and meta-analysis. Am J Kidney Dis 63: 464–478, 2014
20. Lee T, Thamer M, Zhang Y, Zhang Q, Allon M: Outcomes of elderly patients after predialysis vascular access creation. J Am Soc Nephrol 26: 3133–3140, 2015
21. Bay WH, Henry ML, Lazarus JM, Lew NL, Ling J, Lowrie EG: Predicting hemodialysis access failure with color flow Doppler ultrasound. Am J Nephrol 18: 296–304, 1998
22. Tessitore N, Bedogna V, Verlato G, Poli A: The rise and fall of access blood flow surveillance in arteriovenous fistulas. Semin Dial 27: 108–118, 2014
23. Available at: DOPPS Practice Monitor: Prescribed blood flow rate, continuous, national sample ( Accessed March 8, 2017.
24. Jemcov TK: Morphologic and functional vessels characteristics assessed by ultrasonography for prediction of radiocephalic fistula maturation. J Vasc Access 14: 356–363, 2013
25. Chowdhury S, Goss D, Mistry H, Stephenson MA, Seed P, Deane C, Valenti D: Duplex ultrasound volumetric flow analysis before and after hemodialysis in patients with brachio-cephalic fistulae. J Vasc Access 14: 342–347, 2013
26. McCormack LJ, Cauldwell EW, Anson BJ: Brachial and antebrachial arterial patterns; a study of 750 extremities. Surg Gynecol Obstet 96: 43–54, 1953
27. Rodríguez-Niedenführ M, Vázquez T, Nearn L, Ferreira B, Parkin I, Sañudo JR: Variations of the arterial pattern in the upper limb revisited: A morphological and statistical study, with a review of the literature. J Anat 199: 547–566, 2001
28. Lomonte C, Casucci F, Antonelli M, Giammaria B, Losurdo N, Marchio G, Basile C: Is there a place for duplex screening of the brachial artery in the maturation of arteriovenous fistulas? Semin Dial 18: 243–246, 2005
29. Asif A, Roy-Chaudhury P, Beathard GA: Early arteriovenous fistula failure: A logical proposal for when and how to intervene. Clin J Am Soc Nephrol 1: 332–339, 2006
30. Beathard GA, Arnold P, Jackson J, Litchfield T; Physician Operators Forum of RMS Lifeline: Aggressive treatment of early fistula failure. Kidney Int 64: 1487–1494, 2003
31. Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group: Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: A randomized controlled trial. JAMA 299: 2164–2171, 2008
32. Ascher E, Gade P, Hingorani A, Mazzariol F, Gunduz Y, Fodera M, Yorkovich W: Changes in the practice of angioaccess surgery: Impact of dialysis outcome and quality initiative recommendations. J Vasc Surg 31: 84–92, 2000
33. Lok CE, Oliver MJ: Overcoming barriers to arteriovenous fistula creation and use. Semin Dial 16: 189–196, 2003
34. Ernandez T, Saudan P, Berney T, Merminod T, Bednarkiewicz M, Martin PY: Risk factors for early failure of native arteriovenous fistulas. Nephron Clin Pract 101: c39–c44, 2005
35. Patel ST, Hughes J, Mills JL Sr: Failure of arteriovenous fistula maturation: An unintended consequence of exceeding dialysis outcome quality Initiative guidelines for hemodialysis access. J Vasc Surg 38: 439–445, discussion 445, 2003
36. Lok CE, Allon M, Moist L, Oliver MJ, Shah H, Zimmerman D: Risk equation determining unsuccessful cannulation events and failure to maturation in arteriovenous fistulas (REDUCE FTM I). J Am Soc Nephrol 17: 3204–3212, 2006
37. Hodges TC, Fillinger MF, Zwolak RM, Walsh DB, Bech F, Cronenwett JL: Longitudinal comparison of dialysis access methods: Risk factors for failure. J Vasc Surg 26: 1009–1019, 1997
38. Falk A: Maintenance and salvage of arteriovenous fistulas. J Vasc Interv Radiol 17: 807–813, 2006
39. Lee T, Tindni A, Roy-Chaudhury P: Improved cumulative survival in fistulas requiring surgical interventions to promote fistula maturation compared with endovascular interventions. Semin Dial 26: 85–89, 2013
40. Harms JC, Rangarajan S, Young CJ, Barker-Finkel J, Allon M: Outcomes of arteriovenous fistulas and grafts with or without intervention before successful use. J Vasc Surg 64: 155–162, 2016
41. Raju S: PTFE grafts for hemodialysis access. Techniques for insertion and management of complications. Ann Surg 206: 666–673, 1987
42. Wada H, Ierardi RP, Coll D, Matsumoto T: Immediate postoperative complications following hemodialysis access procedures. Int Surg 81: 99–101, 1996
43. Hakaim AG, Scott TE: Durability of early prosthetic dialysis graft cannulation: Results of a prospective, nonrandomized clinical trial. J Vasc Surg 25: 1002–1005, discussion 1005–1006, 1997
44. Polo JR, Ligero JM, Diaz-Cartelle J, Garcia-Pajares R, Cervera T, Reparaz L: Randomized comparison of 6-mm straight grafts versus 6- to 8-mm tapered grafts for brachial-axillary dialysis access. J Vasc Surg 40: 319–324, 2004
45. Shenoy S, Allon M, Beathard G, Lok C, Brouwer D, Dember L, Glickman M, Huber T, Roy-Chaudhury P, Work J, West M, Wasse M: Clinical trial endpoints for dialysis vascular access: A Kidney Healthcare Initiative project. Clin J Am Soc Nephrol 12: 490–494, 2017
46. Ryan SV, Calligaro KD, Scharff J, Dougherty MJ: Management of infected prosthetic dialysis arteriovenous grafts. J Vasc Surg 39: 73–78, 2004
47. Lazarides MK, Georgiadis GS, Nikolopoulos ES: Surgical intervention for vascular access infection. In: Best Practice in Vascular Access, edited by Totdoir J, Turin, Italy, Edizioni Minerva Medical, 2010, pp 151–159
48. NKF-DOQI Clinical Practice Guideline for Vascular Access: Guideline 12: Recirculation methodology, limits, evaluation and follow up. Am J Kidney Dis 30[Suppl 3]: S165–S166, 1997
49. Dember LM, Imrey PB, Beck GJ, Cheung AK, Himmelfarb J, Huber TS, Kusek JW, Roy-Chaudhury P, Vazquez MA, Alpers CE, Robbin ML, Vita JA, Greene T, Gassman JJ, Feldman HI; Hemodialysis Fistula Maturation Study Group: Objectives and design of the hemodialysis fistula maturation study. Am J Kidney Dis 63: 104–112, 2014
50. van Loon MM, Kessels AG, van der Sande FM, Tordoir JH: Cannulation practice patterns in haemodialysis vascular access: Predictors for unsuccessful cannulation. J Ren Care 35: 82–89, 2009
51. Shenoy S: Innovative surgical approaches to maximize arteriovenous fistula creation. Semin Vasc Surg 20: 141–147, 2007
52. Rayner HC, Pisoni RL, Gillespie BW, Goodkin DA, Akiba T, Akizawa T, Saito A, Young EW, Port FK: Creation, cannulation and survival of arteriovenous fistulae: Data from the Dialysis Outcomes and Practice Patterns Study. Kidney Int 63: 323–330, 2003
53. Ravani P, Brunori G, Mandolfo S, Cancarini G, Imbasciati E, Marcelli D, Malberti F: Cardiovascular comorbidity and late referral impact arteriovenous fistula survival: A prospective multicenter study. J Am Soc Nephrol 15: 204–209, 2004
54. Pisoni RL, Young EW, Mapes DL, Keen ML, Port FK: Vascular access use and outcomes in the U.S., Europe, and Japan: Results from the Dialysis Outcomes and Practice Patterns Study. Nephrol News Issues, 17: 38–43, 47, 2003
55. Turmel-Rodrigues L, Mouton A, Birmelé B, Billaux L, Ammar N, Grézard O, Hauss S, Pengloan J: Salvage of immature forearm fistulas for haemodialysis by interventional radiology. Nephrol Dial Transplant 16: 2365–2371, 2001
56. Huber TS, Carter JW, Carter RL, Seeger JM: Patency of autogenous and polytetrafluoroethylene upper extremity arteriovenous hemodialysis accesses: A systematic review. J Vasc Surg 38: 1005–1011, 2003
57. Beathard GA: Percutaneous transvenous angioplasty in the treatment of vascular access stenosis. Kidney Int 42: 1390–1397, 1992
58. Mori Y, Horikawa K, Sato K, Mimuro N, Toriyama T, Kawahara H: Stenotic lesions in vascular access: Treatment with transluminal angioplasty using high-pressure balloons. Intern Med 33: 284–287, 1994
59. Beathard GA: The treatment of vascular access graft dysfunction: A nephrologist’s view and experience. Adv Ren Replace Ther 1: 131–147, 1994
60. Kanterman RY, Vesely TM, Pilgram TK, Guy BW, Windus DW, Picus D: Dialysis access grafts: Anatomic location of venous stenosis and results of angioplasty. Radiology 195: 135–139, 1995
61. Lumsden AB, MacDonald MJ, Kikeri DK, Harker LA, Allen RC: Hemodialysis access graft stenosis: Percutaneous transluminal angioplasty. J Surg Res 68: 181–185, 1997
62. Longwitz D, Pham TH, Heckemann RG, Hecking E: [Angioplasty in the stenosed hemodialysis shunt: Experiences with 100 patients and 166 interventions]. Rofo 169: 68–76, 1998
63. Lilly RZ, Carlton D, Barker J, Saddekni S, Hamrick K, Oser R, Westfall AO, Allon M: Predictors of arteriovenous graft patency after radiologic intervention in hemodialysis patients. Am J Kidney Dis 37: 945–953, 2001
64. Beathard GA, Litchfield T; Physician Operators Forum of RMS Lifeline, Inc: Effectiveness and safety of dialysis vascular access procedures performed by interventional nephrologists. Kidney Int 66: 1622–1632, 2004
65. Suzuki K, Narimatsu Y, Ido K, Ogawa K, Tanimoto A, Hashimoto S, Hiramatsu K, Deguchi N: [Percutaneous transluminal angioplasty for stenotic dialysis arterio-venous fistulas]. Nihon Igaku Hoshasen Gakkai Zasshi 52: 344–350, 1992
66. Lay JP, Ashleigh RJ, Tranconi L, Ackrill P, Al-Khaffaf H: Result of angioplasty of brescia-cimino haemodialysis fistulae: Medium-term follow-up. Clin Radiol 53: 608–611, 1998
67. Turmel-Rodrigues L, Pengloan J, Baudin S, Testou D, Abaza M, Dahdah G, Mouton A, Blanchard D: Treatment of stenosis and thrombosis in haemodialysis fistulas and grafts by interventional radiology. Nephrol Dial Transplant 15: 2029–2036, 2000
68. Rajan DK, Bunston S, Misra S, Pinto R, Lok CE: Dysfunctional autogenous hemodialysis fistulas: Outcomes after angioplasty--are there clinical predictors of patency? Radiology 232: 508–515, 2004
69. Maeda K, Furukawa A, Yamasaki M, Murata K: Percutaneous transluminal angioplasty for Brescia-Cimino hemodialysis fistula dysfunction: Technical success rate, patency rate and factors that influence the results. Eur J Radiol 54: 426–430, 2005
70. Wu CC, Lin MC, Pu SY, Tsai KC, Wen SC: Comparison of cutting balloon versus high-pressure balloon angioplasty for resistant venous stenoses of native hemodialysis fistulas. J Vasc Interv Radiol 19: 877–883, 2008
71. Yang TY, Cheng HW, Weng HH, Chang ST, Chung CM, Ko YS: Percutaneous transluminal angioplasty for radial-cephalic fistulae with stenosis at the arteriovenous junction. Am J Med Sci 343: 435–439, 2012
72. Khan FA, Vesely TM: Arterial problems associated with dysfunctional hemodialysis grafts: Evaluation of patients at high risk for arterial disease. J Vasc Interv Radiol 13: 1109–1114, 2002
73. Asif A, Gadalean FN, Merrill D, Cherla G, Cipleu CD, Epstein DL, Roth D: Inflow stenosis in arteriovenous fistulas and grafts: A multicenter, prospective study. Kidney Int 67: 1986–1992, 2005
74. Duijm LE, Liem YS, van der Rijt RH, Nobrega FJ, van den Bosch HC, Douwes-Draaijer P, Cuypers PW, Tielbeek AV: Inflow stenoses in dysfunctional hemodialysis access fistulae and grafts. Am J Kidney Dis 48: 98–105, 2006
75. Romero A, Polo JR, Garcia Morato E, Garcia Sabrido JL, Quintans A, Ferreiroa JP: Salvage of angioaccess after late thrombosis of radiocephalic fistulas for hemodialysis. Int Surg 71: 122–124, 1986
76. Beathard G: Complications of Vascular Access, New York, New York, Marcel Dekker, Inc, 2000
77. Beathard G: Complications of vascular access. In: Complications of Dialysis – Recognition and Management, edited by Lameire N, Mehta R, New York, Marcel Dekker, Inc, 2000, pp 1–27
78. Beathard GA: Thrombolysis versus surgery for the treatment of thrombosed dialysis access grafts. J Am Soc Nephrol 6: 1619–1624, 1995
79. Schon D, Mishler R: Salvage of occluded autologous arteriovenous fistulae. Am J Kidney Dis 36: 804–810, 2000
80. Schon D, Mishler R: Pharmacomechanical thrombolysis of natural vein fistulas: Reduced dose of TPA and long-term follow-up. Semin Dial 16: 272–275, 2003
81. Turmel-Rodrigues L, Pengloan J, Rodrigue H, Brillet G, Lataste A, Pierre D, Jourdan JL, Blanchard D: Treatment of failed native arteriovenous fistulae for hemodialysis by interventional radiology. Kidney Int 57: 1124–1140, 2000
82. Huang HL, Chen CC, Chang SH, Hung KC, Hsieh IC, Chang HJ, Wen MS, Fang JT: Combination of duplex ultrasound-guided manual declotting and percutaneous transluminal angioplasty in thrombosed native dialysis fistulas. Ren Fail 27: 713–719, 2005
83. Shatsky JB, Berns JS, Clark TW, Kwak A, Tuite CM, Shlansky-Goldberg RD, Mondschein JI, Patel AA, Stavropoulos SW, Soulen MC, Solomon JA, Kobrin S, Chittams JL, Trerotola SO: Single-center experience with the arrow-trerotola percutaneous thrombectomy device in the management of thrombosed native dialysis fistulas. J Vasc Interv Radiol 16: 1605–1611, 2005
84. Florescu MC, Qiu F, Plumb TJ, Fillaus JA: Endovascular treatment of arteriovenous graft pseudoaneurysms, indications, complications, and outcomes: A systematic review. Hemodial Int 18: 785–792, 2014
85. Salahi H, Fazelzadeh A, Mehdizadeh A, Razmkon A, Malek-Hosseini SA: Complications of arteriovenous fistula in dialysis patients. Transplant Proc 38: 1261–1264, 2006
86. Balaz P, Björck M: True aneurysm in autologous hemodialysis fistulae: Definitions, classification and indications for treatment. J Vasc Access 16: 446–453, 2015
87. Spergel LM, Ravani P, Roy-Chaudhury P, Asif A, Besarab A: Surgical salvage of the autogenous arteriovenous fistula (AVF). J Nephrol 20: 388–398, 2007
88. Fong IW, Capellan JM, Simbul M, Angel J: Infection of arterio-venous fistulas created for chronic haemodialysis. Scand J Infect Dis 25: 215–220, 1993
89. Churchill DN, Taylor DW, Cook RJ, LaPlante P, Barre P, Cartier P, Fay WP, Goldstein MB, Jindal K, Mandin H, McKenzie JK, Muirhead N, Parfrey PS, Posen GA, Slaughter D, Ulan RA, Werb R: Canadian hemodialysis morbidity study. Am J Kidney Dis 19: 214–234, 1992
90. Cull JD, Cull DL, Taylor SM, Carsten CG 3rd, Snyder BA, Youkey JR, Langan EM 3rd, Blackhurst DW: Prosthetic thigh arteriovenous access: Outcome with SVS/AAVS reporting standards. J Vasc Surg 39: 381–386, 2004
91. Schutte WP, Helmer SD, Salazar L, Smith JL: Surgical treatment of infected prosthetic dialysis arteriovenous grafts: Total versus partial graft excision. Am J Surg 193: 385–388, discussion 388, 2007
92. Ravani P, Palmer SC, Oliver MJ, Quinn RR, MacRae JM, Tai DJ, Pannu NI, Thomas C, Hemmelgarn BR, Craig JC, Manns B, Tonelli M, Strippoli GF, James MT: Associations between hemodialysis access type and clinical outcomes: A systematic review. J Am Soc Nephrol 24: 465–473, 2013
93. Wasse H, Singapuri MS: High-output heart failure: How to define it, when to treat it, and how to treat it. Semin Nephrol 32: 551–557, 2012
94. Schanzer H, Schwartz M, Harrington E, Haimov M: Treatment of ischemia due to “steal” by arteriovenous fistula with distal artery ligation and revascularization. J Vasc Surg 7: 770–773, 1988
95. Bourquelot P: Access flow reduction for cardiac failure. J Vasc Access 17[Suppl 1]: S60–S63, 2016
96. Basile C, Lomonte C, Vernaglione L, Casucci F, Antonelli M, Losurdo N: The relationship between the flow of arteriovenous fistula and cardiac output in haemodialysis patients. Nephrol Dial Transplant 23: 282–287, 2008
97. Kosa SD, Bhola C, Lok CE: Measuring patient satisfaction with vascular access: Vascular access questionnaire development and reliability testing. J Vasc Access 16: 200–205, 2015
98. Xi W, Harwood L, Diamant MJ, Brown JB, Gallo K, Sontrop JM, MacNab JJ, Moist LM: Patient attitudes towards the arteriovenous fistula: A qualitative study on vascular access decision making. Nephrol Dial Transplant 26: 3302–3308, 2011
99. Casey JR, Hanson CS, Winkelmayer WC, Craig JC, Palmer S, Strippoli GF, Tong A: Patients’ perspectives on hemodialysis vascular access: A systematic review of qualitative studies. Am J Kidney Dis 64: 937–953, 2014
100. Chow J, Rayment G, San Miguel S, Gilbert M: A randomised controlled trial of buttonhole cannulation for the prevention of fistula access complications. J Ren Care 37: 85–93, 2011
101. Bay WH, Van Cleef S, Owens M: The hemodialysis access: Preferences and concerns of patients, dialysis nurses and technicians, and physicians. Am J Nephrol 18: 379–383, 1998
102. Glanz S, Gordon DH, Lipkowitz GS, Butt KM, Hong J, Sclafani SJ: Axillary and subclavian vein stenosis: Percutaneous angioplasty. Radiology 168: 371–373, 1988
103. Kovalik EC, Newman GE, Suhocki P, Knelson M, Schwab SJ: Correction of central venous stenoses: Use of angioplasty and vascular Wallstents. Kidney Int 45: 1177–1181, 1994
104. Quinn SF, Schuman ES, Demlow TA, Standage BA, Ragsdale JW, Green GS, Sheley RC: Percutaneous transluminal angioplasty versus endovascular stent placement in the treatment of venous stenoses in patients undergoing hemodialysis: Intermediate results. J Vasc Interv Radiol 6: 851–855, 1995
105. Dammers R, de Haan MW, Planken NR, van der Sande FM, Tordoir JH: Central vein obstruction in hemodialysis patients: Results of radiological and surgical intervention. Eur J Vasc Endovasc Surg 26: 317–321, 2003
106. Surowiec SM, Fegley AJ, Tanski WJ, Sivamurthy N, Illig KA, Lee DE, Waldman DL, Green RM, Davies MG: Endovascular management of central venous stenoses in the hemodialysis patient: Results of percutaneous therapy. Vasc Endovascular Surg 38: 349–354, 2004
107. Bakken AM, Protack CD, Saad WE, Lee DE, Waldman DL, Davies MG: Long-term outcomes of primary angioplasty and primary stenting of central venous stenosis in hemodialysis patients. J Vasc Surg 45: 776–783, 2007
108. Beathard GA: Gianturco self-expanding stent in the treatment of stenosis in dialysis access grafts. Kidney Int 43: 872–877, 1993
109. Hoffer EK, Sultan S, Herskowitz MM, Daniels ID, Sclafani SJ: Prospective randomized trial of a metallic intravascular stent in hemodialysis graft maintenance. J Vasc Interv Radiol 8: 965–973, 1997
110. Haskal ZJ, Trerotola S, Dolmatch B, Schuman E, Altman S, Mietling S, Berman S, McLennan G, Trimmer C, Ross J, Vesely T: Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med 362: 494–503, 2010
111. Maya ID, Allon M: Outcomes of thrombosed arteriovenous grafts: Comparison of stents vs angioplasty. Kidney Int 69: 934–937, 2006
112. Kakisis JD, Avgerinos E, Giannakopoulos T, Moulakakis K, Papapetrou A, Liapis CD: Balloon angioplasty vs nitinol stent placement in the treatment of venous anastomotic stenoses of hemodialysis grafts after surgical thrombectomy. J Vasc Surg 55: 472–478, 2012
113. Badero OJ, Salifu MO, Wasse H, Work J: Frequency of swing-segment stenosis in referred dialysis patients with angiographically documented lesions. Am J Kidney Dis 51: 93–98, 2008
114. Rajan DK, Clark TW, Patel NK, Stavropoulos SW, Simons ME: Prevalence and treatment of cephalic arch stenosis in dysfunctional autogenous hemodialysis fistulas. J Vasc Interv Radiol 14: 567–573, 2003
115. Beaulieu MC, Gabana C, Rose C, MacDonald PS, Clement J, Kiaii M: Stenosis at the area of transposition - an under-recognized complication of transposed brachiobasilic fistulas. J Vasc Access 8: 268–274, 2007
116. Heerwagen ST, Hansen MA, Schroeder TV, Ladefoged SD, Lönn L: Endovascular treatment of hemodialysis arteriovenous fistulas: Is immediate post-interventional blood flow a predictor of patency. J Vasc Access 13: 315–320, 2012
117. Clark TW, Hirsch DA, Jindal KJ, Veugelers PJ, LeBlanc J: Outcome and prognostic factors of restenosis after percutaneous treatment of native hemodialysis fistulas. J Vasc Interv Radiol 13: 51–59, 2002
118. Neuen BL, Gunnarsson R, Webster AC, Baer RA, Golledge J, Mantha ML: Predictors of patency after balloon angioplasty in hemodialysis fistulas: a systematic review. J Vasc Interv Radiol 25: 917–924, 2014
119. Kornfield ZN, Kwak A, Soulen MC, Patel AA, Kobrin SM, Cohen RM, Mantell MD, Chittams JL, Trerotola SO: Incidence and management of percutaneous transluminal angioplasty-induced venous rupture in the “fistula first” era. J Vasc Interv Radiol 20: 744–751, 2009
120. Pappas JN, Vesely TM: Vascular rupture during angioplasty of hemodialysis raft-related stenoses. J Vasc Access 3: 120–126, 2002
121. Yan Y, Clark TW, Mondschein JI, Shlansky-Goldberg RD, Dagli MS, Soulen MC, Stavropoulos SW, Sudheendra D, Mantell MP, Cohen RD, Kobrin S, Chittams JL, Trerotola SO: Outcomes of percutaneous interventions in transposed hemodialysis fistulas compared with nontransposed fistulas and grafts. J Vasc Interv Radiol 24: 1765–1772; quiz 1773, 2013
122. Sidhu A, Tan KT, Noel-Lamy M, Simons ME, Rajan DK: Does Technical success of angioplasty in dysfunctional hemodialysis accesses correlate with access patency? Cardiovasc Intervent Radiol 39: 1400–1406, 2016
123. Chang CJ, Ko PJ, Hsu LA, Ko YS, Ko YL, Chen CF, Huang CC, Hsu TS, Lee YS, Pang JH: Highly increased cell proliferation activity in the restenotic hemodialysis vascular access after percutaneous transluminal angioplasty: Implication in prevention of restenosis. Am J Kidney Dis 43: 74–84, 2004

arteriovenous fistula; arteriovenous graft; hemodialysis access; vascular access; clinical trial

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