Is a Fistula Less Expensive Than aGraft?

Gary A. Gelbfish, MD, FACS

Advanced Vascular Care, Brooklyn, NYAssistant clinical professor, Mt. Sinai, NY, NY

USRDS 2008

• Fistulas used for hemodialysis require lessintervention than grafts to maintain long termpatency.

• Fistulas used for hemodialysis typically lastlonger than grafts

Fistula

Graft

For every complex question, there is ananswer that is clear, simple and wrongH.L.Mencken 1880-1956

• Early thrombosis and ultimate non-maturation occur much moreoften with fistulas as compared to graft.

• BAM are more often performed on fistulas than grafts therebyincreasing early costs.

• Once mature, “crummy” fistulas require more frequentintervention over the long term

• Prolonged catheter use is an inevitable result and a significantcost when fistula maturation is prolonged in patients already ondialysis.

Why/when wouldn’t a fistula be better?

“Cumulative patency did not differ between fistulas and grafts;however, grafts necessitated more interventions to maintain functionalpatency.” …………..However, when primary failures were excluded,cumulative patency became significantly longer for fistulas than forgrafts for both first and subsequent accesses (61.9 versus 23.8 months[HR, 0.56; 95% CI, 0.43−0.74; P<0.001]

CJASN 2013

In conclusion, as compared with grafts, subsequent upper armfistulas are associated with a higher primary failure rate, moreinterventions to achieve maturation, longer catheter dependence, andmore frequent catheter-related bacteremia. However, once the accessis usable for dialysis, fistulas have superior cumulative patency thando grafts and require fewer interventions to maintain patency. J AmSoc Nephrol 18: 1936–1941, 2007. doi: 10.1681/ASN.2006101119

How successful are we in the US atestablishing a functional fistula?

13

AV

fistulaAV graft Catheter

All 62.5 18.4 19.2

Age

0-21 47.0 6.8 46.1

22-44 64.8 15.7 19.6

45-64 64.2 17.7 18.1

65-74 61.9 19.3 18.8

75+ 58.7 20.4 20.9

Sex

Male 68.7 14.2 17.1

Female 54.5 23.7 21.8

Race

White 64.3 13.6 22.1

Black/African American 56.9 25.4 17.7

Native American 73.3 12.1 14.6

Asian 67.2 16.7 16.1

Ethnicity

Hispanic 67.5 15.4 17.1

Primary Cause of ESRD

Diabetes 62.7 18.2 19.1

Hypertension 61.9 19.3 18.8

Glomerulonephritis 64.8 18.1 17.2

Cystic Kidney 69.5 16.9 13.7

Other Urologic 61.9 17.6 20.4

Other Cause 57.5 17.2 25.3

Unknown/Missing 61.4 17.6 21.0

Vol 2, ESRD, Ch 4

Table 4.2 Distribution of type of vascular access in use amongprevalent hemodialysis patients in 2013, from CROWNWeb data, December

2013

Data Source: Special analyses, USRDS ESRD Database. CROWNWeb data catheter=anycatheter use; fistula and graft use shown are without the use of a catheter. Abbreviations:AV, arteriovenous; ESRD, end-stage renal disease.

14

Vol 2, ESRD, Ch 4

Figure 4.6 Trends in vascular access type use among ESRD prevalent patients,2003-2014

Data Source: Special analyses, USRDS ESRD Database, and Fistula First data. FistulaFirst data reported from July 2003 through April 2012, CROWNWeb data are reported fromJune 2012 through December 2013. Abbreviations: AV, arteriovenous; ESRD, end-stagerenal disease.

2015 CMS report (2013 data)

Dopps

What prevents higher fistula rates?

Enrollment was stopped after 877 participants were randomized basedon a stopping rule for intervention efficacy. Fistula thrombosisoccurred in 53 (12.2%) participants assigned to clopidogrel comparedwith 84 (19.5%) participants assigned to placebo (relative risk, 0.63;95% confidence interval, 0.46-0.97; P = .018). Failure to attainsuitability for dialysis did not differ between the clopidogrel andplacebo groups (61.8% vs 59.5%, respectively; relative risk, 1.05;95% confidence interval, 0.94-1.17; P = .40).

gg1

Slide 18

gg1 gary gelbfish, 2/16/2016

1. Venous and arterial anatomy and quality ofvessels (size, thickening, calcification, lesions)

2. OBESITY (much longer maturation interval andadditional procedures)

3. Surgical judgement and talent

4. Interventional talent for maturation

Limitations of fistula success.

Average number of procedures/doctor6 AV access CPT codes

<1% perform >170 procedures/year

Adapted from 2012 CMS Data

Not all patients are the same regardingsuitability and success of a fistula placement(obesity is a huge factor)

Not all surgeons have similar experience (andtalent) in vascular access.

• The average established fistula is better/cheaper thana graft in the long term

• It does NOT follow that we should TRY to implant afistula in every patient.

• A fistula that never matures (or takes prolonged &heroic measures to mature) should not be implanted.

• Fistula should be CONSIDERED in patients

1. Pick the right patients

2. Pick the right type of fistula

3. Use a surgeon with judgement to chose andtechnical talent to execute the right operation

4. Same with interventional talent to BAM

5. Avoid procedures that are destined to fail

Highest economical fistula rate is notaccomplished by putting fistulas in allpatients. Instead:

What is the true cost of a fistula or graft?

Cost of implantation

+ cost of failed attempts (5%)

+ cost of ultimate maintenance/thrombectomy procedures

Graft Cost

Cost of creation (intention to treat)

+ cost of failed attempts (20%-60%)

+ cost of balloon assisted maturation (successful and failed)

+ cost of ultimate maintenance/thrombectomy procedures

+ cost of prolonged catheter use

– (CRBSI)

– damage to central venous system andsubsequent intervention

Fistula Cost

30Vol 2, ESRD, Intro

Figure i.8 Vascular access use during the first year of hemodialysis by timesince initiation of ESRD treatment, among patients new to hemodialysis in

2013, from the ESRD Medical Evidence form (CMS 2728) and CROWNWebdata, 2013-2014

Data Source: Special analyses, USRDS ESRD Database. Medical Evidence form (CMS 2728)at initiation and CROWNWeb for subsequent time periods. Abbreviations: CMS, Centers forMedicare & Medicaid; ESRD, end-stage renal disease. This graphic is also presented asFigure 4.7.

2015 CMS report (2013 data)

Fistula Graft

Cost of creation +Cost of failed creation attempts ++Cost of Balloon assisted maturation ++

Cost of ultimate accessmaintenance/thrombectomy

+++

Cost of prolonged catheter use ++

Impact from physician experience ++

Impact from patient population factors ++

Longevity +

USRDS 2008

• Good data exists regarding the performance ofa given access type once established

• Patient specific parameters are important butseem to get lost in recommendations ofdecision making. Some patients are clearlymore difficult (Obesity, bad vessels/anatomy)

• Surgical judgment and skill is important, andcan help avoid wasted fistula effort (Logic)

• Financial data regarding overall cost isexceedingly poor

Current status: fistula vs. graft

Road forward

• Better definition of all relevant parameters

• More financial and other data, in cooperationwith Crownweb and CMS

• More experience in access placement forindividuals surgeons

• More studies

• Individualize therapy to patient

Robbin ML, Greene T, Cheung AK, Allon M, Berceli SA, Kaufman JS, Allen M, Imrey PB, Radeva MK, Shiu YT,Umphrey HR, Young CJ, Group FT. Arteriovenous Fistula Development in the First 6 Weeks after Creation. Radiology.2015 Dec 22:150385.Farber A, Imrey PB, Huber TS, Kaufman JM, Kraiss LW, Larive B, Li L, Feldman HI; HFM Study Group. Multiplepreoperative and intraoperative factors predict early fistula thrombosis in the Hemodialysis Fistula Maturation Study. JVasc Surg. 2016Jan;63(1):163-170.e6. doi: 10.1016/j.jvs.2015.07.086.

• When is it not in our power todetermine what is true, we aught toact in accordance with what is mostprobable…. Descartes 1596-1650

• Use a “patient centric and local reality” approach withemphasis on decreasing catheter interval and cost.

• CONSIDER using a fistula in all.

• Implant graft in few/some/many?

Summary:

• The essence of maximizing the inherentbenefit of a fistula vs. a graft, is to avoid earlypostop thrombosis and to minimizematuration procedures and prolonged catheterdialysis

• The lack of accurate cost data and thevariability of patient populations andsurgical/interventional talent make this goaldifficult to define and execute.

• To identify those patients or circumstanceswhere trying for a fistula is not indicated.

• To maximize intrinsic fistula benefit withoutwasting effort on fistulas that will fail or cannotbe matured in a reasonable way.

• To decrease catheter use interval.

Challenge

Data types• Please enter

Road forward

• Limited value of retrospective data, especiallyin a technologically evolving discipline. Usefulto tell us that things are a mess!

• Limited value of randomized studies especiallywith wide variations in patient populations,acess to care and of surgical and interventionalability

• Expansion of CrownWeb type data AND ENDUSER ACCESS, to assist in the analysis ofcomparative quality parameters

• Second year was more expensive than first year• Transposed basilic vein fistula is least expensive• Only analyzed established fistulas

• Current measures

Percent fistula/graft/catheter

Percent catheter over 90 days

• Future measures on query-able groups of patients

Onset of dialysis to first access use or to permcathremoval

Cost of access care including hospitalizations

Number of open procedures per patient

Number of interventional procedures per patient

Quality measures “Crownweb”

• Would need opening of medical database for researchand comparison purpose

• Individual patient or practice statistics are inadequateto describe outcomes that occur over years withmultiple practitioners.

• No incentive to really innovate without this

• Current setup is ripe for scamming.

Quality measures Crownweb

Where are we and why are we here?

• Dopps

• Fistula first

• Failure rates of fistulae

• Current fistula rates

• Maintenance costs

• Future directions

• A wise man’s question contains halfthe answer Solomon Ibn Gabirol 1021-1058

We can only review concepts and trends. Exactrecommendation are not possible considering:

• Inter-patient variability that has not been quantified.

• Methodological limitations, leading to lack of gooddata regarding outcomes and cost.

• Significant differences in skill levels amongstsurgeons and interventionalists.

• Prompt access to care and scheduling challenges

Access creation and maintenance is still an art!

In which cases are the up-frontinvestments worth the ultimate payback?

1. Stay within your technical competence level and grow over time

2. Have a sonogram machine in the OR and use it for your surgical decision making

3. Don’t be afraid to put in a graft as needed. Resist coercion.

4. Match the operation to the patient and their access history and future needs

5. Gauge your available interventional talents for maturation and then match yoursurgical actions

6. Decide early whether an access is likely to mature. 1-2 weeks is usually sufficient toknow.

7. Plan intervention early when needed (4-6 weeks after fistula creation)

8. Access creation and maintenance is still very much an art. Practice and learn fromothers!

9. Learn from you experience and hone your judgement by diligent long-term patientfollow up and meticulous records!

10. Learn how to examine the patient. There is no substitute to the physical exam

Recommendations

1. How hard should one try to place a fistula? Are wetrying too hard and making wrong choices?

2. What parameters should be used to abandon a fistula?

3. What are the cost implications? Which financialcategory do maturation and other wasted procedures gointo?

4. What patient or physician factors should influenceaccess choice?

• An established fistula is better than a graft• An established graft is better than a fistula that

never matures.

Why do we need crownweb• Dopps is a voluntary sample that ostensible

describes a larger group. It confidence level isunknown. It has a documentred propensity tounder or overestimate certain parameters (68%vs 62.5%) much quicker use of a dialysis fistulathan crownweb.

• Crownweb is real data on every patient

• Crownweb can access reimbursement data andto consolidate procedures performed inmultiple institutions

miscelaneous• Tremendous hole of knowledge in the middle

of whento do graft vs fistula

• Improvement in fistula rates

• Early referral, education of newer techniquestanspostions and elevations

• Number of procedures and cost of access perpatient

• Specializaion of surgeons.

• Availabailty and competitition amongstprovodrs with accurate cost and other milestonedata. Otherwise, low priority.