03

Vol 2esrd

5

Ch 3pg 241

Although the painter’s eye sees but the surface of things it must in rendering the surface discern and interpret the organic structure that lies beneath.

LEONARDO DA VINCI

Chapter ThreePatient characteristics

5Ch 3

pg 242

Using data from the Medical Evidence form (2728), the USRDS tracks patient information at the initiation of end-stage renal disease (ESRD) treatment, assessing changing demographic characteristics and access to care. A revised form was introduced in 2005, with new informa-tion on vascular access use at the first outpatient dialysis treatment as well as on care received prior to ESRD from nephrologists and nutritional counselors. ¶ The high

first-year mortality rates reported in recent ADRs have raised questions about risk factors that may contribute to elevated morbidity and mortality. Last year we began reporting on the vascular access used at the first outpatient dialysis, noting the high percentage of patients using a catheter. New data for 2007 show that more than 80 percent of patients use a catheter at initiation; 20 percent have a catheter along with a maturing internal vascular access. Findings differ, however, based on primary diagnosis. In patients whose ESRD is caused by some form of cystic kidney disease, the rate of catheter use at initiation is just 61 percent. This same population also has the lowest percentage of patients receiving no nephrologist care prior to ESRD, and the greatest percentage receiving such care for more than a year. These data suggest that early nephrologist care is associated with better planning for vascular access placement, leading to lower use of catheters and, potentially, to lower infectious complication rates as well. ¶ The level of anemia correction after the initiation of dialysis has slowed, with the rise in hemoglobin levels now similar to that seen in 2004 — a notable change from the increasing levels presented in past ADRs. There also appears to be a shift in the pre-ESRD use of erythropoiesis stimulating agents (ESAs), with a continued decline since 2004. This shift may, however, simply reflect a change in the ESA question on the new Medical Evidence form. The previous form asked if an ESA was used before dialysis began, which could be misinterpreted to mean before a single dialysis treat-ment rather than before the ESRD first service date, as intended. The form now asks specifically if ESA therapy was begun before ESRD. ¶ Across all age and race groups, creatinine levels at the initiation of ESRD therapy continue to decline, and are lowest in patients age 75 and older. There has been concern that the lower serum creatinines at initiation may indicate that physicians are choosing to start therapy earlier in the course of disease. Other possible explanations could center on the increasing survival of CKD patients, with more now considered for dialysis than in prior years. The large increase in the number of patients from the baby boomer generation (age 45–64) appears to be driving the continued growth of the ESRD population, with declining rates of cardiovascular mortality meaning that more patients survive to reach nephrologist care and ESRD treatment. These possible causes underlying the initiation of ESRD patients with lower serum creatinines and higher estimated glomerular filtration rates (eGFRs) will require additional investigation to determine if the changes are related to physician practices or to changes in CKD patient survival, leading to greater early referral to nephrologists. ¶ The recently revised Medi-

Contents244 • Patient care prior to initiation; anemia & treatment

246 • Laboratory values at initiation

248 • Summary

Vol 2esrd

5

Ch 3pg 243

2009 USRDS Annual D

ata Report 4

PATIENT CH

ARACTERISTICS

cal Evidence form includes new questions on laboratory data prior to ESRD initiation. Among patients beginning ESRD therapy in 2007, the average cholesterol and triglyceride levels were 157 mg/dl and 154 mg/dl, respectively, and levels were highest in children. Average glycemic control appears to be at a glycosylated hemoglobin (A1c) level of 7.3 percent. This suggests that one in two diabetic patients has less than optimal glycemic control, based on guidelines from the American Diabetes Association which target an A1c level of less than 7 percent. Patients with a primary diagnosis of glomerulonephritis or cystic kidney disease, and those with diabetes as a secondary comorbidity, have an average A1c of 6.3–7.1 percent. This may reflect severity of disease, as those with secondary diabetes may have had the disease for a shorter period of time and therefore have fewer complications. ¶ In conclusion, the incident population age 45–64 is expanding. The population appears to carry more comorbidity, and is starting ESRD therapy with higher eGFRs — a reflection of both increasing disease burden and, in those with low body mass indices, of malnutrition as well. The use of anemia treatment before dialysis appears to have declined, but some of these changes may reflect a change in wording on the newest Medical Evidence form. Correction of anemia after the initiation of dialysis is now similar to that noted in 2004, a finding that may reflect practice changes secondary to safety concerns regarding higher hemoglobin levels noted in recent clinical trails, changes in FDA labeling for ESAs, and CMS pay-ment policies for hemoglobin levels over 13 g/dl. Lipid abnormalities are present at the start of dialysis, and are more pronounced in younger patients. And glycemic control appears to be an issue in the population starting dialysis with diabetes as a primary or complicating condition. Younger patients, who typically have Type 1 diabetes, have less control than older patients, who typically have Type 2.

¶ Figure 3 .1; see page 366 for ana-lytical methods. Incident hemodi-alysis patients, 2007, with a valid Medical Evidence form; access type & primary diagnosis obtained from the Medical Evidence form.

DM HTN GN CK Other/unk All

Perc

ent

of p

atie

nts

0

20

40

60

80

100

Arteriovenous fistulaArteriovenous graftCatheter with maturing fistula Catheter with maturing graft Catheter

31ii Access use at first outpatient hemodialysis,by primary diagnosis, 2007

DM HTN GN CK

Perc

ent

of p

atie

nts

0

20

40

60

80

100

No nephrologist care

Neph care, >12 months

Neph care, 0-12 months

Cath Cath/maturing AVF/AVG

AVF AVG

Perc

ent

of p

atie

nts

0

20

40

60

80

100

No nephrologist care

Neph care, >12 months

Neph care, 0-12 months

DM HTN GN CK

Perc

ent

of p

atie

nts

0

20

40

60

80

100

Catheter AV fistula AV graft Other/unknown

5Ch 3

pg 244

32 ii Pre-initiation nephrologist care, by primary diagnosis, 2007

33 ii Pre-initiation nephrologist care, by access at initiation, 2007

34ii First access in patients with >12 mos. of nephrologist care, by diagnosis, 2007

The number of new ESRD pa-tients who receive no care from a nephrologist prior to

beginning therapy varies by primary di-agnosis, from just 18.5 percent of those with cystic kidney disease to more than 46 percent of those whose ESRD is caused by hypertension. ¶ Figure 3 .2; see page 366 for analytical methods. Incident ESRD patients, 2007.

Among hemodialysis patients starting ESRD therapy in 2007, 57 percent of those

with a catheter had received no nephrol-ogist care prior to initiation, compared to 10 percent of those with an arterio-venous fistula, and 21 percent of those with an arteriovenous graft. ¶ Figure 3 .3; see page 366 for analytical methods. In-cident hemodialysis patients, 2007.

This figure looks at new pa-tients who received more than 12 months of nephrolo-

gist care prior to starting ESRD therapy in 2007. Fourteen percent of those with a primary diagnosis of diabetes or hy-pertension began treatment with an arteriovenous fistula, compared to 33 percent of those with ESRD caused by cystic kidney disease. ¶ Figure 3 .4; see page 366 for analytical methods. Inci-dent hemodialysis patients, 2007.

3aii Pre-ESRD nephrologistcare (column percent), 2007 A

mong patients beginning ESRD therapy in 2007, nearly 43 percent had not seen a ne-

phrologist prior to initiation. Of those with no pre-ESRD nephrologist care, 91 percent had a catheter as their inital ac-cess, while only 2.9 and 1.7 percent had a fistula or graft. Eleven percent had a catheter with a maturing fistula, and 2.3 percent had a maturing graft. Twenty-four percent of patients with more than twelve months of nephrologist care, in contrast, used a fistula at initiation. Use of erythropoiesis stimulating agents (ESAs) and dietary care are more com-mon in patients with nephrology care. In those seeing a nephrologist for more than one year, for example, 54.4 percent were on an ESA pre-ESRD and 18 percent saw a dietitian, compared to 3.4 and 0.2 percent, respectively, of those with no pre-ESRD nephrologist care. ¶ Table 3 .a; see page 366 for analytical methods. Incident ESRD patients, 2007.

None 0–12 mo. >12 mo.All 42.8 33.3 23.8Mean age 62.2 63.1 63.6Female 43.7 44.3 43.9Race White 64.0 66.6 70.2 African American 30.6 27.5 24.6 Native American 1.0 1.0 1.0 Asian 4.0 4.4 3.8Hispanic 16.0 13.2 10.0Access at initiation Catheter 91.0 69.2 55.1 Fistula 2.9 15.8 24.4 Graft 1.7 4.2 5.1 Maturing fistula 11.0 17.7 17.5 Maturing graft 2.3 2.9 2.6ESA use 3.4 43.7 54.4Dietary care 0.2 16.3 18.0eGFR (ml/min/1.73 m2) <5 11.0 6.0 5.9 5-<10 39.2 40.1 41.3 10-<15 29.0 34.7 35.6 ≥15 18.1 17.6 16.0DM (comorbidity) 49.1 55.4 53.3Primary diagnosis Diabetes 39.6 49.0 46.7 Hypertension 29.9 27.0 25.3 Glomerulonephritis 5.4 6.9 9.5 Cystic kidney 1.0 2.4 4.8

Anemia & treatment

1 2 3 49

10

11

12

131998200120042007

Year

Hem

og

lob

in (g

/dl)

Months after initiation

1 2 3 4 1 2 3 4

ecaRredneG

White: 1998Af Am: 1998 Other: 1998

White: 2007Af Am: 2007Other: 2007

Male: 1998Female: 1998

Male: 2007Female: 2007

96 97 98 99 00 01 02 03 04 05 06 07 08

Hem

oglo

bin

(g/d

l)

9.0

9.4

9.8

10.2

10.6

Perc

ent r

ecei

ving

ESA

20

24

28

32

36

Hgb:with ESA

Hgb: without ESA

Hgb: Overall

% receiving ESA

2009 USRDS Annual D

ata Report

Vol 2esrd

5

Ch 3pg 245

4 PATIEN

T CHARACTERISTICS

Patient care prior to initiation; anemia &

treatment

35 ii Hemoglobin after initiation, by year, gender, & race

36 ii Mean hemoglobin at initiation,by pre-ESRD ESA treatment

37 ii Geographic variations in the percentage of patients receiving ESAs at initiation, by HSA, 2006–2007

In 2007, hemoglobin levels following initiation in incident dialysis patients were unchanged from those found in 2004. Levels increased from 10.5

to 12.4 g/dl over the first four months of dialysis — 1.2 and 0.4 g/dl higher, respectively, than levels achieved in 1998 and 2001, and slightly higher than the recommended target he-moglobin level of 11–12 g/dl. In 2004 and 2007, the rapid rise in hemoglobin levels following initiation indicates a willing-ness on the part of renal practitioners to aggressively manage anemia early in the dialytic process. With recent clinical trials (CHOIR and CREATE) showing evidence of potential harm in high hemoglobin levels, and KDOQI guidelines indicating no benefit related to morbidity or mortality with a hemoglobin above 13 g/dl, anemia management protocols must incorpo-rate safeguards against overuse of erythropoiesis stimulating agents (ESAs) and IV iron so that that patients do not remain at high hemoglobin levels for an extended period of time.

In males and females, 2007 hemoglobin levels four months post-initiation were 1.1 and 1.2 g/dl higher, respec-

tively, than 1998 levels, while levels in whites, African Amer-icans, and patients of other races rose 1.1, 1.3, and 1.1 g/dl, respectively.

In the incident ESRD population, the mean hemoglobin level at initiation of therapy peaked in 2006 at 10.2 g/dl, and has since fallen to approximately 10.0 in May, 2008 — mean-ing that half of new patients begin therapy with a hemoglo-bin lower than 10 g/dl. This coincides with a decline in the proportion of patients receiving pre-ESRD ESAs, from a high of 33–34 percent in 2002–2004 to 26–27 percent in the first part of 2008.

The percentage of patients receiving ESAs prior to initia-tion is highest for those residing in the northern tier of states, the New England area, and portions of the southwest, the Ohio Valley, and Texas, averaging 43.1 percent in the upper quintile. ¶ Figures 3 .5–7; see page 366 for analytical methods. Incident dialysis patients (3.5); incident ESRD patients (3.6–7).

43.1

37.5

32.0

27.9

23.8

19.2

Serum creatinine

96 98 00 02 04 06 08

Seru

m c

reat

inin

e (m

g/d

l)

4

6

8

10

120-19 20-44 45-64

65-74 75+ All

96 98 00 02 04 06 08

Seru

m c

reat

inin

e (m

g/d

l)

4

6

8

10

12

White African American Native American

AsianHispanicAll

All

Perc

ent

of p

atie

nts

0

20

40

60

80

100

0-19 20-44 45-64 65-74 75+ M F White Af Am N Am Asian Hisp.

Age Gender Race/ethnicity

<4

4-<6

6-<8

8-<10

10+ mg/dl

5Ch 3

pg 246

38 ii Serum creatinine atinitiation, by age

39 ii Serum creatinine at initiation,by race & ethnicity

310 ii Patient distribution at initiation, by serum creatinine level, age, gender, race, & ethnicity, 2007

Serum creatinine levels at the start of ESRD treatment have fallen 2.4 mg/dl since 1995,

from 8.7 to 6.3, perhaps indicating a tendency to initiate ESRD therapy earli-er in the course of a patient’s treatment, or suggesting that patients are starting treatment with greater disease burdens. In 2007, levels ranged from 5.2 mg/dl among patients age 75 and older to 8.4 in those age 20–44. By race and eth-nicity, the initial mean creatinine level ranges from 5.8 mg/dl among whites to 7.4 among African Americans.

One in five patients beginning ESRD therapy in 2007 did so with a serum creatinine of less than 4 mg/dl, while nearly six in ten had a level of 4.0–7.9. The percentage of patients initiating with a level less than 4 mg/dl rises by age in adults, from 8.8 in those age 20–44 to 29.4 in those age 75 and older, and is 25.8 in women compared to 14.6 in men. ¶ Figures 3 .8–10; see page 366 for analytical methods. Incident ESRD patients.

Cholesterol values at the start of ESRD therapy vary by race, from a mean of 147 mg/dl in

Native American patients to 167 among African Americans. The range is even greater by age, from 144 mg/dl in the oldest patients to 192 in the pediatric population. Initial glycosylated hemo-globin (A1c) values suggest that blood glucose levels are best controlled in the Native American population and in patients with glomerulonephritis and cystic kidney disease. ¶ Table 3 .b; see page 366 for analytical methods. Incident ESRD patients, 2007. *A1c data include only patients with diabetes as their pri-mary diagnosis or as a comorbidity.

3bii Mean laboratory valuesat initiation, 2007

eGFR Creatinine Hemoglobin Cholesterol Triglycerides A1c* (ml/min/1.73 m2) (mg/dl) (g/dl) (mg/dl) (mg/dl) (%)

0-19 12.1 7.8 9.9 192.3 202.9 7.020-44 9.4 8.4 9.8 176.5 176.6 7.445-64 10.4 6.8 10.0 162.5 162.0 7.465-74 11.2 5.8 10.1 149.0 147.9 7.475+ 11.9 5.3 10.3 143.6 130.6 7.1Male 11.3 6.9 10.2 149.7 149.0 7.3Female 10.4 5.8 10.0 167.5 160.5 7.3White 11.1 5.9 10.2 153.1 159.5 7.2African American 10.6 7.4 9.8 166.5 138.5 7.6Native American 10.0 6.6 10.1 146.8 156.9 6.8Asian 9.6 6.9 10.1 162.9 163.0 7.5Hispanic 10.1 6.7 9.9 160.7 164.2 7.3Diabetes 11.4 5.9 10.1 155.8 154.3 7.6Hypertension 10.7 6.6 10.1 155.0 140.7 7.1Glomerulonephritis 9.4 7.7 10.2 175.0 174.5 6.4Cystic kidney 9.6 6.9 10.8 163.7 167.9 6.3All 10.9 6.4 10.1 157.2 153.9 7.3

All

Perc

ent

of p

atie

nts

0

20

40

60

80

100

0-19 20-44 45-64 65-74 75+ M F White Af Am N Am Asian Hisp.

Age Gender Race/ethnicity

<5

5-<10

10-<15

15+ ml/min/1.73 m2

All

Perc

ent

of p

atie

nts

0

20

40

60

80

100

0-19 20-44 45-64 65-74 75+ M F White Af Am N Am Asian Hisp.

Age Gender Race/ethnicity

<10 10-<12 12+ g/dl

All

Perc

ent

of p

atie

nts

0

20

40

60

80

100

0-19 20-44 45-64 65-74 75+ M F White Af Am N Am Asian Hisp.

Age Gender Race/ethnicity

<6 6-<7

7-<8 8-<9 9+ %

2009 USRDS Annual D

ata Report

Vol 2esrd

5

Ch 3pg 247

4 PATIEN

T CHARACTERISTICS

Laboratory values at initiation

311 ii Patient distribution at initiation, by estimated glomerular filtration rate, age, gender, race, & ethnicity, 2007

312 ii Patient distribution at initiation, by hemoglobin level, age, gender, race, & ethnicity, 2007

313 ii Patient distribution at initiation, by glycosylated hemoglobin (A1c) level, age, gender, race, & ethnicity, 2007

The percentage of new adult patients with an estimated glomerular filtration rate less

than 5 ml/min/1.73 m2 declines with age, from 16.6 among those age 20–44 to just 4.5 among the oldest patients; this coincides with the rise in serum creatinine levels by age noted in Fig-ure 3.10. Nearly 18 percent of patients initiate with an eGFR of 25 or greater. ¶ Figure 3 .11; see page 366 for analytical methods. Incident ESRD patients, 2007.

Patients initiating ESRD ther-apy continue to begin with less than optimal hemoglobin

levels. In 2007, one-half of new patients had a hemoglobin less than 10 g/dl; only 12.5 percent began therapy with a hemoglobin of 12 or above. This in part reflects the low number of patients re-ceiving an erythropoiesis stimulating agent prior to initiation — just 27 per-cent, as shown in Figure 3.6. ¶ Figure 3 .12; see page 366 for analytical methods. Incident ESRD patients, 2007.

Glycosylated hemoglobin (A1c) levels above 7 percent indi-cate poorly controlled diabe-

tes. Nearly four in ten diabetic patients starting ESRD therapy in 2007 had an A1c level of 7 percent or above. This varies little by gender, but by age rang-es from 27 percent of those age 75 and older to 55 percent of those age 20–44. ¶ Figure 3 .13; see page 366 for analytical methods. Incident ESRD patients with diabetes as their primary diagnosis or as a comorbidity, 2007.

Of patients whose ESRD is caused by hy�p�eRtension, 46% receive no care from a nephrologist prior to the start of ESRD therapy. • 3.2

Among new hemodialysis patients using a catheteR, 57% receive no nep�hRologist caRe prior to initiation. • 3.3

One in nine patients with no pre-ESRD nephrologist care begins therapy with an estimated gfR <5 ml/min/1.73 m2. • 3.a

Just 19% of patients with a primary diagnosis of cystic kidney disease have visited a nephrologist prior to ESRD. • 3.a

Between 2006 & 2008, mean hemoglobin levels at initiation fell from 10.2 to 10.0 g/dl. • 3.6

Nine percent of new ESRD patients age 20–44, compared to 29% of those age 75 & older, initiate with a serum cReatinine less than 4 mg/dl. • 3.10

Nearly 17% of new patients age 20–44 have an estimated gfR of less than 5 ml/min/1.73 m2 at initiation. • 3.11

one in two new ESRD patients begins therapy with a hemoglobin less than 10 g/dl. • 3.12

Nearly fouR in ten new diabetic ESRD patients in 2007 had a hemoglobin a1c of 7% or greater. • 3.13

5Ch 3

pg 248

chapter summary

summary