Is a Fistula Less Expensive Than a Graft? Gary A. Gelbfish, MD, FACS

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1 Is a Fistula Less Expensive Than a Graft? Gary A. Gelbfish, MD, FACS Advanced Vascular Care, Brooklyn, NY Assistant clinical professor, Mt. Sinai, NY, NY

2 USRDS 2008

3 Fistulas used for hemodialysis require less intervention than grafts to maintain long term patency. Fistulas used for hemodialysis typically last longer than grafts

4 Fistula Graft

5 For every complex question, there is an answer that is clear, simple and wrong H.L.Mencken

6 Why/when wouldn t a fistula be better? Early thrombosis and ultimate non-maturation occur much more often with fistulas as compared to graft. BAM are more often performed on fistulas than grafts thereby increasing early costs. Once mature, crummy fistulas require more frequent intervention over the long term Prolonged catheter use is an inevitable result and a significant cost when fistula maturation is prolonged in patients already on dialysis.

7 Cumulative patency did not differ between fistulas and grafts; however, grafts necessitated more interventions to maintain functional patency...however, when primary failures were excluded, cumulative patency became significantly longer for fistulas than for grafts for both first and subsequent accesses (61.9 versus 23.8 months [HR, 0.56; 95% CI, ; P<0.001] CJASN 2013

8 In conclusion, as compared with grafts, subsequent upper arm fistulas are associated with a higher primary failure rate, more interventions to achieve maturation, longer catheter dependence, and more frequent catheter-related bacteremia. However, once the access is usable for dialysis, fistulas have superior cumulative patency than do grafts and require fewer interventions to maintain patency. J Am Soc Nephrol 18: , doi: /ASN

12 How successful are we in the US at establishing a functional fistula?

13 Table 4.2 Distribution of type of vascular access in use among prevalent hemodialysis patients in 2013, from CROWNWeb data, December 2013 AV fistula AV graft Catheter All Age Sex Race Male Female White Black/African American Native American Asian Ethnicity Hispanic Primary Cause of ESRD Diabetes Hypertension Glomerulonephritis Cystic Kidney Other Urologic Other Cause Unknown/Missing Data Source: Special analyses, USRDS ESRD Database. CROWNWeb data catheter=any catheter use; fistula and graft use shown are without the use of a catheter. Abbreviations: AV, arteriovenous; ESRD, end-stage renal disease. Vol 2, ESRD, Ch 4 13

14 Figure 4.6 Trends in vascular access type use among ESRD prevalent patients, Data Source: Special analyses, USRDS ESRD Database, and Fistula First data. Fistula First data reported from July 2003 through April 2012, CROWNWeb data are reported from June 2012 through December Abbreviations: AV, arteriovenous; ESRD, end-stage renal disease. Vol 2, ESRD, Ch 4 14

15 2015 CMS report (2013 data)

16 Dopps

17 What prevents higher fistula rates?

gg1 Enrollment was stopped after 877 participants were randomized based on a stopping rule for intervention efficacy. Fistula thrombosis occurred in 53 (12.

18 gg1 Enrollment was stopped after 877 participants were randomized based on a stopping rule for intervention efficacy. Fistula thrombosis occurred in 53 (12.2%) participants assigned to clopidogrel compared with 84 (19.5%) participants assigned to placebo (relative risk, 0.63; 95% confidence interval, ; P =.018). Failure to attain suitability for dialysis did not differ between the clopidogrel and placebo groups (61.8% vs 59.5%, respectively; relative risk, 1.05; 95% confidence interval, ; P =.40).

19 Slide 18 gg1 gary gelbfish, 2/16/2016

20 Limitations of fistula success. 1. Venous and arterial anatomy and quality of vessels (size, thickening, calcification, lesions) 2. OBESITY (much longer maturation interval and additional procedures) 3. Surgical judgement and talent 4. Interventional talent for maturation

22 Average number of procedures/doctor 6 AV access CPT codes <1% perform >170 procedures/year Adapted from 2012 CMS Data

23 Not all patients are the same regarding suitability and success of a fistula placement (obesity is a huge factor) Not all surgeons have similar experience (and talent) in vascular access.

24 The average established fistula is better/cheaper than a graft in the long term It does NOT follow that we should TRY to implant a fistula 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

25 Highest economical fistula rate is not accomplished by putting fistulas in all patients. Instead: 1. Pick the right patients 2. Pick the right type of fistula 3. Use a surgeon with judgement to chose and technical talent to execute the right operation 4. Same with interventional talent to BAM 5. Avoid procedures that are destined to fail

28 What is the true cost of a fistula or graft?

29 Graft Cost Cost of implantation + cost of failed attempts (5%) + cost of ultimate maintenance/thrombectomy procedures

30 Fistula 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 and subsequent intervention

31 Figure i.8 Vascular access use during the first year of hemodialysis by time since initiation of ESRD treatment, among patients new to hemodialysis in 2013, from the ESRD Medical Evidence form (CMS 2728) and CROWNWeb data, Data Source: Special analyses, USRDS ESRD Database. Medical Evidence form (CMS 2728) at initiation and CROWNWeb for subsequent time periods. Abbreviations: CMS, Centers for Medicare & Medicaid; ESRD, end-stage renal disease. This graphic is also presented as Figure 4.7. Vol 2, ESRD, Intro 30

32 2015 CMS report (2013 data)

33 Fistula Cost of creation Cost of failed creation attempts Cost of Balloon assisted maturation Cost of ultimate access maintenance/thrombectomy +++ Cost of prolonged catheter use ++ Impact from physician experience ++ Impact from patient population factors ++ Longevity Graft +

34 USRDS 2008

35 Current status: fistula vs. graft Good data exists regarding the performance of a given access type once established Patient specific parameters are important but seem to get lost in recommendations of decision making. Some patients are clearly more difficult (Obesity, bad vessels/anatomy) Surgical judgment and skill is important, and can help avoid wasted fistula effort (Logic) Financial data regarding overall cost is exceedingly poor

36 Road forward Better definition of all relevant parameters More financial and other data, in cooperation with Crownweb and CMS More experience in access placement for individuals surgeons More studies Individualize therapy to patient

37 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 Dec 22: Farber A, Imrey PB, Huber TS, Kaufman JM, Kraiss LW, Larive B, Li L, Feldman HI; HFM Study Group. Multiple preoperative and intraoperative factors predict early fistula thrombosis in the Hemodialysis Fistula Maturation Study. J Vasc Surg Jan;63(1): e6. doi: /j.jvs

38 When is it not in our power to determine what is true, we aught to act in accordance with what is most probable. Descartes Use a patient centric and local reality approach with emphasis on decreasing catheter interval and cost. CONSIDER using a fistula in all. Implant graft in few/some/many?

39 Summary: The essence of maximizing the inherent benefit of a fistula vs. a graft, is to avoid early postop thrombosis and to minimize maturation procedures and prolonged catheter dialysis The lack of accurate cost data and the variability of patient populations and surgical/interventional talent make this goal difficult to define and execute.

40 Challenge To identify those patients or circumstances where trying for a fistula is not indicated. To maximize intrinsic fistula benefit without wasting effort on fistulas that will fail or cannot be matured in a reasonable way. To decrease catheter use interval.

41 Data types Please enter

42 Road forward Limited value of retrospective data, especially in a technologically evolving discipline. Useful to tell us that things are a mess! Limited value of randomized studies especially with wide variations in patient populations, acess to care and of surgical and interventional ability Expansion of CrownWeb type data AND END USER ACCESS, to assist in the analysis of comparative quality parameters

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

45 Quality measures Crownweb 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 permcath removal Cost of access care including hospitalizations Number of open procedures per patient Number of interventional procedures per patient

46 Quality measures Crownweb Would need opening of medical database for research and comparison purpose Individual patient or practice statistics are inadequate to describe outcomes that occur over years with multiple practitioners. No incentive to really innovate without this Current setup is ripe for scamming.

47 Where are we and why are we here? Dopps Fistula first Failure rates of fistulae Current fistula rates Maintenance costs Future directions

48 A wise man s question contains half the answer Solomon Ibn Gabirol

49 In which cases are the up-front investments worth the ultimate payback? We can only review concepts and trends. Exact recommendation are not possible considering: Inter-patient variability that has not been quantified. Methodological limitations, leading to lack of good data regarding outcomes and cost. Significant differences in skill levels amongst surgeons and interventionalists. Prompt access to care and scheduling challenges Access creation and maintenance is still an art!

50 Recommendations 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 your surgical actions 6. Decide early whether an access is likely to mature. 1-2 weeks is usually sufficient to know. 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 from others! 9. Learn from you experience and hone your judgement by diligent long-term patient follow up and meticulous records! 10. Learn how to examine the patient. There is no substitute to the physical exam

51 An established fistula is better than a graft An established graft is better than a fistula that never matures. 1. How hard should one try to place a fistula? Are we trying too hard and making wrong choices? 2. What parameters should be used to abandon a fistula? 3. What are the cost implications? Which financial category do maturation and other wasted procedures go into? 4. What patient or physician factors should influence access choice?

52 Why do we need crownweb Dopps is a voluntary sample that ostensible describes a larger group. It confidence level is unknown. It has a documentred propensity to under or overestimate certain parameters (68% vs 62.5%) much quicker use of a dialysis fistula than crownweb. Crownweb is real data on every patient Crownweb can access reimbursement data and to consolidate procedures performed in multiple institutions

53 miscelaneous Tremendous hole of knowledge in the middle of whento do graft vs fistula Improvement in fistula rates Early referral, education of newer techniques tanspostions and elevations Number of procedures and cost of access per patient Specializaion of surgeons. Availabailty and competitition amongst provodrs with accurate cost and other milestone

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