Fig. 3.1
Trends in proportional vascular access type use among prevalent hemodialysis patients in the United States, 1998–2015. Abbreviations: AV arteriovenous (Data sources: ESRD National Coordinating Center [9]; and Finelli et al. [11]. No data on AV graft prevalence were available from 2010 to 2011; these data points are interpolated values)
Importantly, the FFI from its inception was based on the concept of continuous quality improvement (CQI). At its essence, the CQI involves an iterative process of development of guidelines, implementation in clinical practice, assessment of both process and clinical outcomes, and then revision and improvement of the initial guidelines and measures. Thus, monitoring and review of timeliness of placement of dialysis access, patency rates, and long-term CVC prevalence rates is a critical part of the FFI. The original 11 core change concepts of the FFI with the specific implementation steps which represent its roadmap to achieve the KDQOI vascular access recommendations are shown in Table 3.1. Since the initial change concepts were elaborated, an additional two have been added to advocate: (1) modifying hospital systems to detect chronic kidney disease and promote AV fistula planning and placement and (2) supporting patient efforts to enhance quality of life through self-management. Change concept #3, which advocates early referral of patients with advanced chronic kidney disease to a vascular surgeon for “fistula only” evaluation and timely placement, has been the subject of extensive debate and criticism, particularly among the nephrology community [15, 26]. Specifically, many voiced concerns at the time that the focus on “fistula only” evaluations would lead to placement of “inappropriate” fistulas at high risk of primary maturation failure in high-risk individuals instead of placement of a graft which may have a greater likelihood for successful use at dialysis initiation. Underlying these concerns was fear that such an advocacy message would not result in an overall reduction in CVC usage and in fact might lead to an increase in CVC prevalence [15].
Table 3.1
The Fistula First Initiative (FFI) 11 change concepts
Change concept | Implementation steps | |
|---|---|---|
1 | Routine CQI review of vascular access | Designate staff member in facility responsible for vascular access CQI Assemble multidisciplinary access CQI team Investigate and track all non-fistula access placements, and fistula failures |
2 | Timely referral to nephrologist | Primary care physicians utilize referral criteria to ensure timely referral Nephrologist documents fistula plan for all patients expected to require dialysis Designate nephrology staff person to educate patient and family to protect vessels |
3 | Early referral to surgeon for “Fistula only” evaluation and timely placement | Nephrologist/skilled nurse performs evaluation and exam prior to referral Nephrologist refers for vessel mapping prior to surgery referral Nephrologist refers patients for “fistula only” evaluation, no later than stage 4 chronic kidney disease If timely placement of fistula does not occur, nephrologist ensures that patient receives evaluation and placement at time of dialysis initiation with CVC |
4 | Surgeon selection based on best outcomes, willingness, and ability to provide access | Nephrologists communicate expectations to surgeons performing access surgery Surgeons are continuously evaluated on frequency, quality, and patency of access placements |
5 | Full range of surgical approaches to AV fistula evaluation and placement | Surgeons utilize current techniques for fistula placement, including vein transposition Surgeons ensure mapping is performed for any patient not clearly suitable based on exam |
6 | Secondary AV fistula placement in patients with AV grafts | Nephrologists evaluate AV graft patients for possible secondary fistula conversion Staff and nephrologists examine outflow vein of all graft patients during dialysis. Identify patients who may be suitable for elective secondary fistula conversion |
7 | AV fistula placement in patients with catheters | Regardless of prior access, all patients with CVCs are evaluated as soon as possible for fistula, including mapping Facility implements protocol to track all CVC patients for early removal |
8 | AV fistula cannulation training | Facility uses best cannulators and tools to teach cannulation Facility offers option of self-cannulation to patients who are interested |
9 | Monitoring and maintenance to ensure adequate access function | Nephrologist/surgeon conducts post-op evaluation in 4 weeks to detect early failure Nephrologists/surgeons/facilities adopt standard procedures for monitoring |
10 | Education for caregivers and patients | Routine facilities staff in-servicing and education in vascular access Facilities educate patients to improve quality of care and outcomes |
11 | Outcomes feedback to guide practice | Review data monthly or quarterly in staff meetings. Present and evaluate data trended over time for incident and prevalent rates of access use |
Trends in Vascular Access After the FFI
The years immediately following the rollout of the FFI saw a substantial increase in the proportion of prevalent HD patients using AV fistulas (Fig. 3.1), such that by August of 2005, the original target of 40 % set at the start of the FFI had been achieved, nearly a year prior to the projected schedule. It should be noted that the increase in use of AV fistulas, accompanied by a concomitant fall in AV graft prevalence, was ongoing even prior to implementation of the FFI. However, a well-recognized inflection point in the increased adoption of fistulas by prevalent HD patients is generally felt to be secondary to the effects of FFI [25]. In response to these observations, the FFI AVF target of 40 % was revised upward to 66 % where it stands today as a CMS national goal. The NKF-KDOQI vascular access guideline was also subsequently revised and updated in 2006, with a newly formulated structured approach to the type and location of long-term HD access, with the overall goal to optimize access survival and minimize complications [17]. The new access guidelines specifically promoted fistula placement first, followed by synthetic grafts if fistula placement was not possible. The guidelines also specifically noted that CVCs should be avoided for HD and used only when other options are not available. The new guidelines also specified that radiocephalic fistulas should be the first option considered followed by brachiocephalic, then transposed brachial basilica fistulas. The NKF-KDOQI guidelines have not been subsequently revised since 2006 and remain as the most recently updated HD vascular access clinical practice guidelines for practicing clinicians in the United States.
The most striking trend in vascular access distribution among prevalent ESRD patients over the past decade since implementation of the FFI is a continuation of the marked transition from graft dominance to fistula dominance among individuals in the United States undergoing maintenance HD. As shown in Fig. 3.1, in the last years of the twentieth century, over 50 % of prevalent HD patients were dialyzing using synthetic AV grafts, and less than 30 % of patients were using AV fistulas. By the time of the promulgation of the FFI change concepts and stakeholder engagement in 2003, the gap between these two numbers had closed substantially to 40 % and 34 %, respectively. Following 2003, the trend of increasing fistula prevalence and decreasing graft prevalence continued in a nearly linear fashion until 2011 when data from the FFI has demonstrated a relative plateau of these prevalence rates at 60–63 % for fistulas and 18–19 % for grafts.
In contrast to these dramatic changes in prevalent usage rates for fistulas and grafts, the use of CVCs for long-term HD access has shown far less fluctuation. As shown in Fig. 3.1, prior to implementation of the FFI, a slow upward trend in CVC prevalence was evident that continued through 2005 and approached a nationwide prevalence of 30 %. In spite of early concerns among some observers that the FFI strategy might paradoxically increase CVC use among prevalent HD patients, by 2008 these rates had started to show a slow decline, which continued over the subsequent 4–5 years. Like fistulas and grafts, however, the proportion of maintenance HD patients utilizing CVCs has plateaued in recent years, with the most recent data from the FFI indicating a point prevalent proportion of 19–20 %. Similarly, data from the ESRD Networks has shown that the percent of patients with a CVC in use for greater than or equal to 90 days (a clinical performance measure tracked by CMS and the metric for which the NKF-KDOQI threshold of 10 % pertains) has declined only very slightly over the past 10 years and continues to hover just above 10 %.
In contrast to the distribution of vascular access types used by prevalent ESRD patients, the distribution of access use by incident patients starting maintenance HD in the United States is markedly different and of note has shown remarkably little change over the past decade even in the face of the FFI (Fig. 3.2). Data from the most recent US Renal Data System Annual Data Report, which includes data through 2012, shows that 81 % of all incident HD patients in the United States commence dialysis using a CVC, compared to 17 % using a fistula, and only 3 % using an AV graft. These numbers are not dissimilar from the 83, 13, and 4 % a decade ago, even at the height of FFI outreach to dialysis stakeholders. There is substantial geographic variation in the distribution of HD vascular access at dialysis initiation in the United States; Fig. 3.3 shows state-level estimates for the percentage of incident HD patients starting dialysis with an AV fistula. The highest rates of AV fistula use at dialysis initiation are in the Northwestern and Northeastern states, while the lowest rates are in the Southwestern, Southern, and Southeastern states.
Fig. 3.2
Trends in proportional vascular access type use at hemodialysis initiation, 2006–2012. Abbreviations: AV arteriovenous (Data source: USRDS 2014 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD)
Fig. 3.3
Geographic variation in the percentage of arteriovenous fistula use at HD initiation, March 2015. Abbreviations: ESRD end-stage renal disease, HD hemodialysis (Data source: ESRD National Coordinating Center [9])
The Transition to “Catheter Last”
Over the past 3–4 years, recognition of the plateauing proportion of prevalent HD patients using fistulas as well as the persistently and unacceptably high proportion of incident HD patients starting dialysis with CVCs has led to calls to reorient the FFI to include not only a primary focus on promoting AV fistulas but also a renewed emphasis on discouraging and seeking alternatives to long-term CVC use [6, 25]. Such calls have been accompanied by evidence from accumulating research suggesting that in some cases, outcomes for patients utilizing fistulas and grafts may be approximately comparable. Research focused on vascular access in elderly patients suggested that clinical outcomes for older individuals using AV grafts may equal those achieved by individuals using fistulas, at least in part due to a high rate of primary fistula maturation failure [8, 12, 14]. For patients dialyzing with CVC, multiple groups have recently demonstrated that changing to an AV access is associated with significantly lower risk for death and that risk estimates associated with an AV fistula versus an AV graft are similar if not equal [4, 13]. Currently, the national prevalence of CVC use for greater than 90 days without a maturing AV access in place of 10.5 % still stubbornly exceeds the NKF-KDOQI clinical outcome goal of less than 10 % established over a decade ago. As a symbol of shifting national policy priorities regarding vascular access in HD patients, and in response to the above observations and to expert opinion, CMS and ESRD Networks renamed the FFI as the Fistula First Catheter Last (FFCL) Coalition to emphasize the dual importance of both goals.
The reasons for persistently high rates of CVC use among prevalent and incident HD patients in the United States even in the face of an aggressive campaign to reduce their use are likely complex and multifactorial. One possible explanation is a high and increased number of patients initiating dialysis with preexisting comorbid disease, such as diabetes, congestive heart failure, and atherosclerotic cardiovascular disease that limit fistula placement and maturation. This explanation is only partly supported by the available data, as in fact AV fistula maturation rates have increased in parallel with fistula prevalence over the past decade. Another possible explanation may include persistently low rates of early referral and consultation with a nephrologist for patients with advanced chronic kidney disease who subsequently developed ESRD, which limit the ability to accomplish timely vascular surgery referral and fistula or graft placement. Data from the US Renal Data System show that the percentage of ESRD patients initiating maintenance HD who had received care from a nephrologist at least 12 months prior to initiation was only 33 % in 2012, although this was an increase of 29 % from 2005 [24]. Even among HD patients who have been followed by a nephrologist for greater than 12 months prior to initiating dialysis, however, less than 50 % start dialysis with a permanent arteriovenous access. The FFI has had a profound impact on the distribution and trends in vascular access type over the past decade in the United States. The next phase of the FFI, now the FFCL Coalition, will focus on trying to improve these measures in an effort to work toward reducing CVC usage to as low a level as possible and thereby improving outcomes for patients living with ESRD.
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