Dialysis Initiation and Optimal Vascular Access: Outcomes and Mortality

Dialysis Initiation and Optimal Vascular Access: Outcomes and Mortality Shannon H. Norris, BSN, RN June 6, 2018

Dialysis Initiation and Optimal Vascular Access: Outcomes and Mortality DISCUSSION: End Stage Renal Disease (ESRD) Medicare End Stage Renal Disease Program Hemodialysis: Incidence - Prevalence Hemodialysis: Vascular Access Dialysis Initiation: Catheter vs Arteriovenous Fistula (AVF) Outcomes: Catheter vs Arteriovenous Fistula (AVF) Mortality: Catheter vs. Arteriovenous Fistula (AVF)

Dialysis Initiation and Optimal Vascular Access: Outcomes and Mortality Erythropoietin: stimulates the bones to make red blood cells Renin: regulates blood pressure Vitamin D Active form: helps maintain calcium for bones and normal chemical balance in the body

The Five Stages of Chronic Kidney Disease (CKD) Stage 1: Kidney damage with normal kidney function (estimated GFR 90 ml/min per 1.73 m 2 ) and persistent ( 3 months) proteinuria. Stage 2: Kidney damage with mild loss of kidney function (estimated GFR 60-89 ml/min per 1.73 m 2 ) and persistent ( 3 months) proteinuria. Stage 3: Mild-to-severe loss of kidney function (estimated GFR 30-59 ml/min per 1.73 m 2 ). Stage 4: Severe loss of kidney function (estimated GFR 15-29 ml/min per 1.73 m 2 ). Stage 5: Kidney failure requiring dialysis or transplant for survival. Also known as ESRD (estimated GFR <15 ml/min per 1.73 m 2 ).

Dialysis and Chronic Renal Failure in the United States

2017 ANNUAL DATA REPORT VOLUME 2: END-STAGE RENAL DISEASE Chapter 1: Incidence, Prevalence, Patient Characteristics, and Treatment Modalities 2017 Annual Data Report Volume 2 ESRD, Chapter 1

Trends in annual number of ESRD incident cases 1980-2015 Year No. cases Incident Count % Change from previous year 1980 17,903 n/a 1981 20,039 11.9 1982 22,567 12.6 1983 25,774 14.2 Year No. Cases % Change from Previous yr 1984 27,325 6.0 2000 94,702 3.6 1985 30,214 10.6 2001 97,966 3.4 1986 33,109 9.6 2002 100,177 2.3 1987 36,604 10.6 2003 102,599 2.4 1988 40,994 12.0 2004 104,465 1.8 1989 46,304 13.0 2005 106,623 2.1 1990 50,826 9.8 2006 110,327 3.5 1991 55,388 9.0 2007 110,316 0.0 1992 60,891 9.9 2008 111,843 1.4 1993 64,488 5.9 2009 115,497 3.3 1994 69,958 8.5 2010 115,829 0.3 1995 72,199 3.2 2011 113,735-1.8 1996 77,000 6.6 2012 115,437 1.5 1997 82,120 6.6 2013 118,160 2.4 1998 87,330 6.3 2014 121,033 2.4 1999 91,409 4.7 2015 124,114 2.5 Trends in annual number of ESRD prevalent cases 1980-2015 Year No. of cases Prevalent Count % change from previous year 1980 56,434 n/a 1981 64,252 13.9 1982 72,491 12.8 1983 85,570 18.0 Year No. Cases % Change from Previous yr 1984 95,887 12.1 2000 390,561 5.7 1985 105,423 9.9 2001 410,502 5.1 1986 116,109 10.1 2002 429,876 4.7 1987 127,468 9.8 2003 448,514 4.3 1988 143,523 12.6 2004 467,038 4.1 1989 162,662 13.3 2005 485,905 4.0 1990 180,474 11.0 2006 506,633 4.3 1991 199,548 10.6 2007 526,709 4.0 1992 220,348 10.4 2008 547,750 4.0 1993 240,557 9.2 2009 570,416 4.1 1994 262,626 9.2 2010 592,656 3.9 1995 281,557 7.2 2011 612,417 3.3 1996 304,413 8.1 2012 633,912 3.5 1997 326,185 7.2 2013 656,856 3.6 1998 348,762 6.9 2014 680,320 3.6 1999 369,623 6.0 2015 703,243 3.4 2017 Annual Data Report Volume 2, Chapter 3

vol 2 Figure 1.1 Trends in the (a) unadjusted and standardized incidence rates of ESRD, and (b) the annual percentage change in the standardized incidence rate of ESRD in the U.S. population, 1980-2015 (a) Incidence rate per million/year Data Source: Reference Table A.2(2) and special analyses, USRDS ESRD Database. Standardized for age, sex, and race. The standard population was the U.S. population in 2011. Abbreviation: ESRD, end-stage renal disease. 2017 Annual Data Report Volume 2, Chapter 3 9

USRDS Incident counts of reported ESRD, 2015 Q1-2017 Q3 2015^ 2016^ 2017^ Qtr1 Qtr2 Qtr3 Qtr4 Qtr1 Qtr2 Qtr3 Qtr4 Qtr1 Qtr2 Qtr3 0-19 267 300 271 268 286 271 268 261 258 246 259 20-44 3,780 3,635 3,444 3,504 3,744 3,545 3,293 3,463 3,617 3,504 3,138 45-64 12,839 12,126 11,459 11,906 12,773 11,994 11,231 11,678 12,584 11,695 10,928 65-74 8,450 8,134 7,703 8,113 8,997 8,587 7,977 8,263 8,787 8,507 7,907 75 + 7,585 7,346 6,871 7,120 7,730 7,154 6,667 6,975 7,581 7,260 6,495 Male 19,249 18,377 17,129 18,006 19,556 18,145 16,962 17,794 19,189 18,094 16,707 Female 13,672 13,164 12,619 12,905 13,974 13,406 12,474 12,846 13,638 13,118 12,020 Diabetes 15,044 14,199 13,491 14,610 15,857 14,730 13,699 14,462 15,494 14,407 13,207 Hypertension 9,573 9,152 8,450 8,387 9,303 8,813 8,360 8,712 9,321 8,921 8,203 Glomerulonephritis 2,383 2,423 2,252 2,345 2,521 2,287 2,173 2,201 2,400 2,200 1,947 Cystic kidney 667 694 701 836 922 935 864 836 883 854 828 Other urologic 368 347 334 456 450 452 396 426 444 460 372 Other cause 2,977 2,923 2,903 3,199 3,315 3,284 2,967 3,017 3,090 3,101 2,669 Unknown cause 801 741 635 124 144 112 99 102 115 114 93 Missing cause 1,108 1,062 982 954 1,018 938 878 884 1,080 1,155 1,408 All 32,921 31,541 29,748 30,911 33,530 31,551 29,436 30,640 32,827 31,212 28,727 ^ Data as of December 31, 2017 * Suppressed due to inadequate sample size.. Zero values in this cell.

vol 2 Table 1.7 Distribution of the reported duration of pre-esrd nephrology care, by (a) demographic and (b) clinical characteristics, among incident ESRD cases in the U.S. population, 2015 (b) Clinical characteristics (% within row) No. of cases Duration of pre-esrd nephrology care Data Source: Special analyses, USRDS ESRD Database. Population only includes incident cases with CMS form 2728. *Count 10. egfr calculated using the CKD-EPI equation (CKD-EPI egfr (ml/min/1.73 m 2 ) for those aged 18 years and the Schwartz equation for those aged <18 years. Abbreviations: AV, arteriovenous; CKD-EPI, chronic kidney disease epidemiology calculation; CV, central venous; egfr, estimated glomerular filtration rate; ESA, erythropoiesisstimulating agents; ESRD, end-stage renal disease; RRT, renal replacement therapy. >12 mo. 6-12 mo. 0-6 mo. None Unknown Dietary care No 110,306 29.1 18.9 12.7 24.2 15.2 Yes 9,274 53.2 24.6 20.9 0.7 0.7 ESA use No 103,238 27.4 18.4 12.7 25.4 16.1 Yes 16,342 53.6 24.8 17.3 3.3 0.9 egfr at RRT start <5 16,846 26.2 16.4 11.6 32.1 13.7 5-<10 56,028 33.2 20.1 13.4 20.3 13.0 10-<15 32,624 32.0 20.2 14.0 19.8 14.0 >=15 14,008 25.4 17.7 14.1 24.8 17.9 Vascular Access AV fistula 17,897 54.3 24.8 9.8 3.6 7.4 AV graft 3,147 42.5 26.3 13.6 8.5 9.0 CV catheter with maturing fistula/graft 19,078 32.8 21.7 14.4 18.2 12.8 CV catheter only 65,153 19.5 15.7 14.1 32.7 18.1 Other/Unknown 14,305 49.0 24.3 12.8 7.6 6.3 2017 Annual Data Report Volume 2, Chapter 3 11

2017 ANNUAL DATA REPORT VOLUME 2: END-STAGE RENAL DISEASE Chapter 3: Vascular Access 2017 Annual Data Report Volume 2 ESRD, Chapter 3

Eighty percent of patients still use catheters as the main vascular access at initiation of hemodialysis. This must change, as catheters predispose to serious infections and higher mortality. Seventeen percent of patients used an arteriovenous fistula exclusively at dialysis initiation. This increased to 65 percent by the end of one year on hemodialysis, and to 72 percent at the end of two years. 2017 Annual Data Report Volume 2 ESRD, Chapter 3

vol 2 Figure 3.1 Vascular access use at hemodialysis initiation, from the ESRD Medical Evidence form (CMS 2728), 2005-2015 Data Source: Special analyses, USRDS ESRD Database. ESRD patients initiating hemodialysis in 2005-2015. Abbreviations: AV, arteriovenous; CMS, Centers for Medicare & Medicaid; ESRD, end-stage renal disease. 2017 Annual Data Report Volume 2, Chapter 3 14

vol 2 Table 3.2 Distribution of type of vascular access in use among prevalent hemodialysis patients in 2016, from CROWNWeb data, May 2016 AV fistula AV graft Catheter All 62.9 17.7 19.4 Age 0-21 45.6 5.7 48.6 22-44 64.5 14.8 20.7 45-64 64.9 16.8 18.4 65-74 62.3 18.5 19.1 75+ 59.2 20.3 20.5 Primary Cause of ESRD Diabetes 63.4 17.4 19.3 Hypertension 63.0 18.7 18.3 Glomerulonephritis 64.9 17.7 17.4 Cystic Kidney 68.9 15.6 15.6 Other Urologic 60.7 16.8 22.4 Other Cause 56.5 16.6 26.9 Unknown/Missing 58.8 17.1 24.2 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; CROWNWeb, Consolidated Renal Operations in a Web-enabled Network; CROWNWeb, Consolidated Renal Operations in a Webenabled Network; ESRD, end-stage renal disease. 2017 Annual Data Report Volume 2, Chapter 3 15

vol 2 Figure 3.6 Trends in vascular access type use among ESRD prevalent patients, 2003-2016 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 May 2016. Abbreviations: AV, arteriovenous; CROWNWeb, Consolidated Renal Operations in a Web-enabled Network; ESRD, end-stage renal disease. 2017 Annual Data Report Volume 2, Chapter 3 16

vol 2 Figure 3.7 Change in type of vascular access during the first year of dialysis among patients starting ESRD via hemodialysis in 2013 quarterly: (a) type of vascular access in use (cross-sectional), and (b) longitudinal changes in vascular access use and other outcomes, ESRD Medical Evidence form (CMS 2728) and CROWNWeb, 2013-2016 (a) Type of vascular access in use (cross-sectional) Data Source: Special analyses, USRDS ESRD Database. Data from January 1, 2013 to May 30, 2016: (a) Medical Evidence form (CMS 2728) at initiation and CROWNWeb for subsequent time periods. (b) ESRD patients initiating hemodialysis (N =101,453). Patients with a maturing AV fistula / AV graft with a catheter in place were classified as having a catheter. Abbreviations: AV, arteriovenous; CMS, Centers for Medicare & Medicaid; CROWNWeb, Consolidated Renal Operations in a Web-enabled Network; ESRD, end-stage renal disease; HD, hemodialysis; PD, peritoneal dialysis. 2017 Annual Data Report Volume 2, Chapter 3 17

vol 2 Table 3.3 Cross-sectional distributions of vascular access use, quarterly during the first two years of hemodialysis, among patients new to hemodialysis in 2013, by age group, from the ESRD Medical Evidence form (CMS 2728) and CROWNWeb, 2013-2016 Age 0-21 22-44 45-64 65-74 75+ Access type At initiation Time 3 months 6 months 9 months 1 year 18 months 2 years AV fistula 7.7 12.9 31.7 45.4 50.4 59.9 58.5 AV graft 0.6 0.8 2.5 3.3 3.5 3.5 4.9 Catheter 91.7 86.4 65.8 51.3 46.0 36.6 36.6 AV fistula 13.5 22.5 44.6 59.6 67.2 73.0 74.6 AV graft 1.8 4.3 7.5 9.5 10.8 12.3 13.0 Catheter 84.7 73.2 47.9 31.0 22.0 14.7 12.4 AV fistula 17.3 25.3 46.1 60.1 67.1 72.6 74.1 AV graft 2.6 5.5 9.2 11.7 13.2 14.4 15.0 Catheter 80.1 69.2 44.7 28.2 19.7 13.0 10.9 AV fistula 18.6 27.1 46.6 59.1 65.5 70.7 72.0 AV graft 3.1 6.9 11.0 13.5 15.0 16.2 16.8 Catheter 78.3 66.1 42.4 27.4 19.4 13.1 11.2 AV fistula 17.3 24.9 43.6 56.1 61.6 66.0 67.5 AV graft 3.5 8.5 14.0 16.9 18.5 19.6 19.8 Catheter 79.2 66.6 42.4 27.0 20.0 14.5 12.6 Data Source: Special analyses, USRDS ESRD Database. Medical Evidence form (CMS 2728) at initiation and CROWNWeb for subsequent time periods. Abbreviations: AV, arteriovenous; CMS, Centers for Medicare & Medicaid; CROWNWeb, Consolidated Renal Operations in a Web-enabled Network; ESRD, endstage renal disease. 2017 Annual Data Report Volume 2, Chapter 3 18

vol 2 Table 3.5 Cross-sectional distributions of vascular access use, quarterly during the first two years of hemodialysis among patients new to hemodialysis in 2013, by sex, from the ESRD Medical Evidence form (CMS 2728) and CROWNWeb, 2013-2016 Sex Access type Time At initiation 3 months 6 months 9 months 1 year 18 months 2 years AV fistula 18.7 28.5 50.9 65.0 71.4 76.3 77.7 Male AV graft 2.1 4.9 8.0 9.9 11.0 11.9 12.3 Catheter 79.2 66.7 41.1 25.2 17.6 11.8 10.0 AV fistula 14.9 20.6 37.6 49.9 56.7 62.3 64.0 Female AV graft 3.8 8.5 14.1 17.5 19.4 21.1 21.9 Catheter 81.3 70.9 48.4 32.7 23.9 16.6 14.2 Data Source: Special analyses, USRDS ESRD Database. Medical Evidence form (CMS 2728) at initiation and CROWNWeb for subsequent time periods. Abbreviations: AV, arteriovenous; CMS, Centers for Medicare & Medicaid; CROWNWeb, Consolidated Renal Operations in a Web-enabled Network; ESRD, end-stage renal disease. 2017 Annual Data Report Volume 2, Chapter 3 19

Vascular Access Types Central Venous Catheter (CVC) Arteriovenous Fistula (AVF) Arteriovenous Graft (AVG)

ARTERIOVENOUS FISTULA (AVF) Gold Standard

ARTERIOVENOUS FISTULA (AVF)

ARTERIOVENOUS FISTULA (AVF)

DIALYSIS SHUNT In the beginning..

ARTERIOVENOUS GRAFT (AVG)

Arteriovenous Graft (AVG)

Arteriovenous Graft (AVG)

CENTRAL VENOUS CATHETER (CVC)

Vascular access use at hemodialysis initiation, from the ESRD Medical Evidence form (CMS 2728), 2005-2015

vol 2 Figure 3.7 Change in type of vascular access during the first year of dialysis among patients starting ESRD via hemodialysis in 2013 quarterly: (a) type of vascular access in use (cross-sectional), and (b) longitudinal changes in vascular access use and other outcomes, ESRD Medical Evidence form (CMS 2728) and CROWNWeb, 2013-2016 (a) Type of vascular access in use (cross-sectional) Data Source: Special analyses, USRDS ESRD Database. Data from January 1, 2013 to May 30, 2016: (a) Medical Evidence form (CMS 2728) at initiation and CROWNWeb for subsequent time periods. (b) ESRD patients initiating hemodialysis (N =101,453). Patients with a maturing AV fistula / AV graft with a catheter in place were classified as having a catheter. Abbreviations: AV, arteriovenous; CMS, Centers for Medicare & Medicaid; CROWNWeb, Consolidated Renal Operations in a Web-enabled Network; ESRD, end-stage renal disease; HD, hemodialysis; PD, peritoneal dialysis. 2017 Annual Data Report Volume 2, Chapter 3 30

vol 2 Figure 3.7 Change in type of vascular access during the first year of dialysis among patients starting ESRD via hemodialysis in 2013 quarterly: (a) type of vascular access in use (cross-sectional), and (b) longitudinal changes in vascular access use and other outcomes, ESRD Medical Evidence form (CMS 2728) and CROWNWeb, 2013-2016 (b) Longitudinal changes in vascular access use and other outcomes Data Source: Special analyses, USRDS ESRD Database. Data from January 1, 2013 to May 30, 2016: (a) Medical Evidence form (CMS 2728) at initiation and CROWNWeb for subsequent time periods. (b) ESRD patients initiating hemodialysis (N =101,453). Patients with a maturing AV fistula / AV graft with a catheter in place were classified as having a catheter. Abbreviations: AV, arteriovenous; CMS, Centers for Medicare & Medicaid; CROWNWeb, Consolidated Renal Operations in a Web-enabled Network; ESRD, end-stage renal disease; HD, hemodialysis; PD, peritoneal dialysis. 2017 Annual Data Report Volume 2, Chapter 3 31

Predictors of AV Fistula Use at Hemodialysis Initiation Odds ratios and 95% confidence intervals from logistic regression models of (a) AV fistula use at hemodialysis initiation, and (b) AV fistula or graft use at hemodialysis initiation, from the ESRD Medical Evidence form (CMS 2728), 2015

2017 ANNUAL DATA REPORT VOLUME 2: END-STAGE RENAL DISEASE Chapter 5: Mortality 2017 Annual Data Report Volume 2 ESRD, Chapter 5

All-cause & cause-specific mortality in the first months of ESRD Figure 1.1 (Volume 2) incident dialysis patients, 1993 1998 & 1999 2005 combined, adjusted for age, gender, race, & primary diagnosis. Incident dialysis patients, 2005, used as reference.

Distribution of number of days between AV fistula placement and first successful use*, overall and by patient characteristics, for new AV fistulas created in 2015

2017 Annual Data Report Volume 2 ESRD, Chapter 5

REFERENCES United States Renal Data System. 2017 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2017. Publications based on USRDS data reported in the Annual Data Report or on the USRDS web site or supplied upon request must include the above citation and the following notice: The data reported here have been supplied by the United States Renal Data System (USRDS). The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy or interpretation of the U.S. government. US Department of Health and Human Services: NIH National Institute of Diabetes and Digestive and Kidney Diseases: https://www.niddk.nih.gov/health-information/health-statistics/kidneydisease Am J Kidney Dis. 2007 Mar;49(3):482-96: The Early History of Dialysis for Chronic Renal Failure in the United States: A View From Seattle