Fistula First Initiative

History and Necessity for Fistula First Vascular Access Care before 1997 The arteriovenous fistula (AVF) was first described and used as a reliable form of hemodialysis (HD) vascular access (VA) by Brescia et al. (1) in 1966. Improvements in dialysis technology and the expansion of dialysis eligibility (e.g., inclusion of patients with diabetes) resulted in a rapid growth of the ESRD population. Many of these patients benefited from the development of prosthetic grafts when autogenous AVF were not feasible (2–5). In the mid-1980s, permanent catheters (central venous catheters [CVC]) in the internal jugular vein became a means of prolonging temporary access (6–8) and dramatically increased in use. The cumulative effect was a reduction in AVF use and an increase in graft and CVC use in the 1990s. This was associated with increased patient care costs; for example, up to 73% of patients were hospitalized to initiate dialysis and almost invariably had a temporary CVC inserted. VA was a major cause of morbidity and mortality (9), with HD access failure accounting for the most frequent cause of hospitalizations (10) and complications accounting for 14% of all ESRD expenses ($1 billion annually) (9). 1997 to 2003: Critical Events That Affected VA Care In an effort to improve VA outcomes, the National Kidney Foundation published the Kidney Disease Outcomes Quality Initiative (K/DOQI) Clinical Practice Guidelines for Vascular Access in 1997. The goal was to optimize management of VA through a set of evidence- and opinion-based based guidelines (10). In the following year, Centers for Medicare and Medicaid Services (CMS; the government-reimbursement agency for Medicare-insured patients) developed ESRD clinical performance measures (CPM) based on the K/DOQI VA guidelines, in response to the Balanced Budget Act of 1997 (11). VA-related CPM include (1) the proportion of HD patients with AVF, (2) the proportion of HD patients with a CVC, and (3) monitoring arteriovenous grafts for stenosis. The overriding goal of the CPM was to improve patient care and reduce costs. In 2002, the total Medicare costs for the ESRD program were $17 billion, an increase of 11% over costs in 2001 (11); VA procedures increased by four times since 1991 and approached $200 million (12). Nephrologists in the United States had to care for 340,000 patients who were receiving dialysis in more than 4500 facilities. Fistula First: A Landmark Initiative to Improve VA Care In 2003, the CMS and the ESRD networks jointly formed and implemented a National Vascular Access Improvement Initiative called the Fistula First Initiative (FFI) (13). The primary goal of this continuous quality improvement (CQI) project was to increase the appropriate use of AVF for HD access and to reach or exceed the K/DOQI guidelines of 50% in incident and 40% in prevalent patients (14). The recently revised goal is to have 65% of prevalent patients using an AVF by 2009 (13). The basis of the FFI, the CQI process, is important to review. The PDSA model of improvement is based on four basic elements: Plan–Do–Study–Act (Figure 1). The cycle begins with an improvement plan and ends with actions based on the learning gained from the Plan, Do, and Study phases. The FFI Workgroup determined the Plan, and the ESRD networks diligently implemented the plan in the Do phase. The Study, or analysis, phase not only evaluates whether the change was an improvement but also acknowledges, synthesizes, and considers new knowledge gained. The results of this evaluation will determine changes to be made in the Act phase, completing the cycle. The FFI Workgroup has already acted by increasing the target for prevalent AVF (from 40 to 65%), seemingly without complete consideration of the findings in the study phase, because the total impact of increasing AVF to the original 40% target is unclear. AVF have been promoted as the “best form of HD VA” on the basis of their superior patency, low complication and procedure rates, and subsequent low overall cost. Recall that the data on which the FFI and K/DOQI guidelines were based are now more than a decade old. Are these premises still valid in the 2007 Fistula First environment? The purpose of this article is to review the intended and unintended consequences of the FFI and to highlight the need for continual reevaluation by examining the impact of FFI on other ESRD care indicators and its effect on systemwide health care and specific patient costs, hospitalizations, and complications. Impact of the FFI The FFI should be applauded for its enthusiasm, resources provided, and positive impact on many programs. For example, the 2005 CPM Annual Report demonstrated that 39% of prevalent patients from a select sample were using an AVF during their last HD session (October through December 2004) (15). Individual programs have demonstrated even more impressive increases in AVF placement and use (Table 1). FFI provided motivation and support in the form of educational materials, tools to track outcomes, and a clearly outlined process through 11 “Change Concepts” to achieve the CPM targets. FFI brought VA to the forefront of HD care, has become internationally known, and is a “household” term in most US dialysis communities. In the United States, the proportion of patients who start HD with an AVF has remained unchanged at approximately 14% (15) since 1997; however, when “incidence” is redefined as any patient who initiated HD between January 1 to August 31 of a given year (data abstracted from October through December in respective year), a positive linear trend toward increasing AVF is seen (15) (Figure 2). From the perspective of the FFI, they have been successful in increasing the numbers of AVF created and achieving the 40% AVF prevalence rate (Table 1). The prevalent rate was reported as 41% as of January 2006 (13). Their success has prompted them to increase the AVF prevalence goal to >65%. However, creating fistulas may not be the critical challenge. The true challenge is achieving 65% functioning fistulas in today's dialysis patient. Several decades ago, AVF had acceptable primary failure rates of approximately 10% (16–19) and 1-yr primary patency rates between 70 and 80%. Now, primary failure rates range between 30 and 70% and have primary patency rates of 40 to 70% (20–24). Primary failure is due to early thrombosis and failure of the fistula to mature (FTM). The increase in AVF attempts and subsequent increase in FTM rates may have partly contributed to a higher use of CVC (25). A recent report demonstrated a greater dependence on CVC 90 d after HD initiation (60%) compared with a decade ago (46%) (26) and a lower conversion to grafts (25%) than previously noted (40%), implicating the use of CVC as a bridge until AVF maturation. Indeed, several clinical factors that are associated with increased risk for AVF failure are the identical factors that are associated with CVC use (23,27–29). These consistently include older age, coronary artery disease, and peripheral vascular disease (PVD). This makes “pathophysiologic sense” because adequate inflow and output are required for AVF maturation and would be hampered by the diseased vasculature, represented by atherosclerosis/arteriosclerosis. Other factors found in the literature, such as female gender and diabetes, are inconsistent predictors of fistula FTM and can be explained by their incorporation into coronary artery disease and PVD in multivariate analysis using data sets of appropriate size (23,30). It is not surprising that the primary failure rate is high, given the aging dialysis population and their accompanying comorbidities. Primary failures require significant interventions and costs to attain acceptable AVF cumulative survival; 24 to 42% of all AVF (31–33) will require intervention to facilitate maturation. Although approximately 70 to 80% will be successful (32,34,35), it will take an additional 3 mo, on average, until the AVF are sufficiently developed for cannulation (31). The greatest rate of CVC use after AVF creation has been reported at 6 mo (36). The timeline corresponds to the following sequence: AVF creation, discovery and confirmation of primary failure, intervention, and eventual maturation and use. Active research is required to determine factors that predispose to fistula primary failure and strategies to prevent and treat it to increase the numbers of functioning prevalent fistulas. Impact on ESRD Indicators An equally important ESRD indicator and CPM goal is to have <10% prevalent CVC. Since the introduction of the FFI, there has been a disturbing and progressive increase in CVC use, which may or may not be related to the high primary failure rate. In North America, the majority of patients continue to initiate HD with a CVC, even with AVF planning or creation (15,37,38). In 2006, 82% of patients in the United States initiated dialysis with a catheter (39). The percentage of patients who use a CVC as their first HD access has continued to grow since 1998 (15,40) while incident and prevalent graft use has (15,40) 3 and This trend in increasing CVC use, reduction in graft use, and AVF use has been in other However, and AVF prevalence rates were already high have not demonstrated an impressive increase in AVF (Figure In there is a increase in CVC and reduction in AVF in with previously high AVF rates, such as and This a given fistulas may not be a target of The of VA is and is a of specific patient and health that target not A to AVF and CVC reduction is however, the an and need to and to a reduction in use is associated with increased morbidity and In a of all US dialysis CVC for of all It has been approximately of patients who use a CVC a or hospitalizations have increased by 50% in than a are associated with an increased risk for failure, and for the The risk for a in dialysis patients is times that of the population with CVC associated with the greatest risk for and mortality The of CVC use at any and increased mortality is the most to reduce CVC use. grafts with CVC increases the overall risk for and mortality in the dialysis population. It has been demonstrated that from a CVC to an AVF or graft the risk for mortality Other significant consequences of using CVC include quality of lower rates compared with grafts and AVF that may reduce dialysis and the development of venous stenosis. has been reported in 40% of patients who may AVF creation or its maturation. Indeed, it has been that patients who have had a CVC before AVF creation have AVF compared with patients who not a CVC The given to FFI may have to the to the CPM indicator to reduce CVC. In the most recent CPM patient or the CVC target of <10% of patients initiated HD with a CVC, and its use at 90 with a prevalent rate of (15) 10% increase from The primary for CVC use were AVF or grafts or created by for the AVF to mature (15). when an AVF was approximately to of patients also required the use of a CVC (36). These for CVC use have remained unchanged in the However, there are data on the perspective on VA A recent study of patients who dialysis with a CVC found that the patient on they were using a CVC were from that of the health care For example, of access was noted as a by of patients and only by the VA a in or knowledge in with a AVF, reported and access to CMS of HD patients who use CVC them and to have a that may be in HD et al. found that of HD patients permanent access educational The a CVC is in the a patient will to AVF creation or use. study that for CVC use found that only of CVC dependence was associated with access use Impact on the Care The cumulative costs have not been but include the increasing of fistulas and their the increase in CVC use. The majority of the of an AVF is in the and procedures required to support AVF In this to facilitate AVF maturation is not from that of a successful graft in the first year graft in the first In the United States, the of AVF creation and its complications is The CVC procedure is creation of an AVF that intervention to facilitate its maturation and use of a CVC until the AVF is will a of AVF primary failure the costs are more than of CVC complications not However, AVF intervention is and in approximately of patients to achieve FFI An AVF that can be created and without intervention is the most but such a in only 40% of an AVF is it has the and of all The use of before fistula functioning increases the risk for complications. complications a to the care For example, the of HD in the United States has been to be as high as with an of approximately of patients who use a CVC have a or that the costs of creating and access the of CVC, because costs are patients have rate was in the first year in patients who used It is as a of the to data on access hospitalizations, or in Impact on the The First In the most recent K/DOQI VA 2006, the that fistula first at all may not be the most or for that a AVF is the not the of an AVF with a at from a of the FFI Workgroup and the K/DOQI for the should be on patient care, because it is is for the and the of Fistula First with the high rate of fistula primary failure and the increasing CVC rate and its associated are to patients to review the on which fistulas were the AVF as access with the and the complications of any form of vascular and a such as from the guidelines on which the FFI is However, is AVF superior to graft This can and on many the of access and the and and of the For example, the K/DOQI VA guidelines that AVF have patency and complication study patency rate of grafts was than that for superior graft cumulative patency compared with The data from this the significant impact of early AVF early failures are not AVF and grafts have Indeed, the of data cumulative from access creation to can have a significant impact on the that of AVF is superior to primary or (Figure and or are higher in AVF than in grafts when early failures or failures of AVF maturation are but this is not true for cumulative patency when early are in the analysis et al. found a superior patency rate with grafts and an identical cumulative patency when compared with have demonstrated this which is due to in primary failure rates of AVF compared with grafts and whether these failures are in of For the important of primary failure, the in AVF is with the need for greater monitoring and intervention to facilitate maturation and early However, AVF are the is because of their low complication rate. approximately of AVF are without intervention after creation the procedure rate is to procedures AVF required for maturation or procedures access year an AVF is the rate from to and is required in approximately 50% of AVF This to interventions for graft the required for grafts access year between and to greater than for In fistulas require up to times more interventions for grafts can require up to times more interventions for to achieve cumulative (Figure are required to the cumulative intervention and rates in in Access is without patient have previously demonstrated an between AVF use and a patient However, for AVF was not associated with mortality in a study of incident dialysis patients The impact of or CVC use was not for and may have a to AVF use. It is that there is the fistula is the to of the should be made to of grafts in to reduce CVC and increase The FFI that new graft be a failure and appropriate may be and the K/DOQI on which the FFI was based on in the only of AVF grafts were found to have patency The of required to achieve patency were in and the of were in grafts have also found that when grafts are more with intervention with a patency rate compared with in AVF have also superior graft primary and patency compared with AVF when it is a access Indeed, with care, graft has in the decade and can exceed K/DOQI patency rates CVC, have demonstrated that is in patients who using AVF and grafts These data should not be as that access is superior to with the that compared fistulas study require that they be with It as a that there is which access has superior patency and the need for to this graft use have been found to have higher rates of complications such as and have a greater risk for compared with AVF they have required more interventions to and thrombosis however, with the introduction of the CPM indicator of monitoring and intervention, thrombosis rates are now low for Access Improvement Although the FFI has had many there have been as the in CVC use. in the FFI CQI process, the goal is to study and to improve VA and patient Fistula First with and of the 11 The FFI 11 “Change Concepts” that are However, should also a PDSA process to appropriate when For example, the FFI the use of their Fistula the first is to determine vein vein without This may not to all and patients and may the creation of The to strategies to AVF may have a critical evaluation of these It is important to that that demonstrated the of to were not and were published with the of AVF The on which a is for AVF creation by are not Many should be and using as a should be may the use of that would have been acceptable by clinical several recent demonstrated significant between and AVF primary failure even when it not improve the maturation rate of AVF Primary failure with in that vascular as in that not has been to have a 70 to 80% success rate in adequate AVF The than use of on patients be by has resulted in the creation of AVF in 80% of with patency rates A that this to patients be and with CVC, or of vein may not only reduce patient and but also to from to access creation to HD initiation with a CVC with its impact on subsequent AVF patency and a Fistula FFI has a critical to AVF FFI a to new AVF to for at to before Although there has been the use of maturation and its impact on AVF there is a need to determine by clinical and not on from AVF Clinical by has been to AVF 80% of the and is by the The FFI of of cannulation with only the to new This may have a positive impact on the of significant with its complications of CVC use, greater and complications The to complications is approximately million Do a Although the FFI an AVF to a patient (e.g., risk factors for CVC use and AVF have a graft than to an AVF, the need for a CVC This would greater to the such that an AVF can be created when the graft than to this to Fistula increased its prevalent AVF rate to and its CVC rate to This is also a in patients to the risk for HD with a CVC. The of an AVF a CVC has been in for mo is low and the risk for in the first year with CVC use is Care the is to CVC and graft placement and to initiate dialysis with a functioning The K/DOQI guidelines 6 to mo and fistula placement 1 to mo of dialysis it has recently been to fistula placement 6 mo before dialysis start The FFI fistula 6 to mo of HD start This is a and important by the FFI because and fistula are The from to creation and from to 1 mo to mo to are required to determine whether a fistula is to mature and is required to the appropriate intervention, have it may take and for to 6 to determine whether the fistula will mo have now and fistula is there is not for a new fistula to be created and before the first dialysis (31). The is when patients are to because they need to be by the first before This not even the patient and or need to that or will need and the of Indeed, even when patients are mo before only dialysis with a permanent access study the impact of care on VA placement and use at dialysis and found that only of patients who were before dialysis initiated dialysis with a functioning and initiated with a CVC. a of the for dialysis with a CVC when in is the should and support greater of primary care for the need for of patients their (1) disease, (2) need for and appropriate and (3) and of access and of and the for This will the creation and of fistulas that they can mature and for the first Care Although an AVF should be for all access and risk factors for AVF failure should be into For example, in a who an dialysis who has on and for the most success for an AVF is in the the that a graft may be to an AVF the graft can be made to achieve a cumulative patency, it may improve the rates to the and improve the of a successful This AVF may for many it has the by 3 of access and the risk of a CVC. an AVF were created not and was to a it may only have a cumulative of 3 and the patient would have the of a access The would be a this the need for care and early to a fistula at dialysis to PDSA and The FFI should be for its significant and achieving the goal of increasing AVF in many the AVF rate was previously FFI provided a and for clinical to However, is change an The impact of FFI also be by the on AVF, with higher rates of AVF primary failure and increased costs of and AVF creation and the in and the increase in CVC with their on patient quality of and should the be and reevaluation should appropriate and a new plan (Figure 1). It is on the FFI Workgroup to complete the PDSA cycle and study the impact of FFI before its targets. Although it is to in such CQI it is equally to new in the form of basic or clinical research to the research are in the following determine to or treat failure of AVF to an evaluation of using a to determine to reduce cannulation analysis of AVF grafts from creation to failure include the costs and complications of CVC patient for access and when grafts are used as a The and patients would from the that FFI has demonstrated to increase AVF in the plan and phases. Now, this should be to CVC. FFI is an systemwide CQI project that has resulted in a higher of incident AVF It has provided materials, and such as cannulation to improve access the it has also increased the need for and a high of AVF failures and subsequent procedures to AVF, and increased CVC use and its These all to increased costs to the health and to the health care patients who have AVF failures will to and for a permanent may a in patients with AVF or who are with the of for AVF and the need for CVC and their associated of these factors has the K/DOQI VA 2006 to that grafts can be used as a to an AVF and grafts can be to AVF This the need to patient it planning with appropriate and to and and should the from care to the when the access and intervention or a new changes and quality require continual critical evaluation to determine whether the change is an overall be an appropriate reevaluation of the change should The a need to from a seemingly on to a of and with grafts used as Plan–Do–Study–Act to continuous quality of hemodialysis (HD) patients and who dialysis with an arteriovenous fistula (AVF) as their vascular access on their last HD session during October through December compared with study 2005 ESRD CPM from with access for all HD patients on their last HD session during the study 2005 ESRD CPM from with in access use in a of a Kidney Disease Outcomes Quality Initiative AVF as the permanent access with complications. from with and of fistulas grafts when primary failure is from of programs with a increase in AVF following K/DOQI guidelines or Fistula to and for their and review of this

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