The Old Paradigm (The full cup)

The Old Paradigm(The full cup)

• Fistula First• Utilize Kt/V for “adequate” dialysis

3 – 4 hours, thrice weekly

• Manage ASCVD• “Optimize” treatment: anemia (EPO and Iron),

divalent ions (phosphate binders), PTH (Vitamin D), lipids, BP control, estimate “dry weight”

• Restrictive diets• Early Start

The State of Renal Care in the U.S. Challenges and Changes

“We can do better”

Dallas, Texas

June, 2010

The Boston Steering Committee Conclusions

• The model of dialytic care since the 1970s is insufficient:– the nephrology community likely used incomplete - perhaps even

flawed – science, at least as we know the science now– the providers and payers supported the model– for 35 years.

• The problem is propagated by how we measure ourselves:– Clinical Performance Measures; (CPMs; CPGs; i.e., HGB, Kt/V, Ca,

P, …) • Though enormously helpful, current CPMs do not provide the

power to predict the outcomes that we had hoped for, either for the patient or the facility.

• Current CPMs account for only about 14% of the measurable differences in facility outcomes (SMRs).

• Consequentially, too many patients are dying, hospitalizations are too high, and cost is enormous.

• The Boston meeting concluded that now we have the information to change this

To accomplish:

• The REASONS for the Boston Meeting– Mortality trends – Hospitalization trends – Costs

• SUMMARY of Boston Meeting data, conclusions and recommendations

• ACTIONS to implement change, since the meeting

Mortality

USRDS 2009 ADR

Adjusted mortality rates in period prevalent patients, by vintage & modalityFigure p.18 (Volume 2)

Period prevalent dialysis patients; adjusted for age, gender, race, & primary diagnosis. Dialysis patients, 2005, used as reference cohort.

Dallas M and M Conference

USRDS 2009 ADR

Adjusted all-cause mortality in the first year of hemodialysis, by month & ageFigure 1.2 (Volume 2)

Incident hemodialysis patients age 20 and older; followed from the day of onset of ESRD; adjusted for gender, race, & primary diagnosis. Incident hemodialysis patients, 2005, used as reference.

The Boston meeting concluded that – now – we can do better than this.

Hospitalizations

USRDS 2009 ADR

Adjusted admissions & days, by modalityFigure 6.3 (Volume 2)

Period prevalent ESRD patients; rates adjusted for age, gender, race, & primary diagnosis. ESRD patients, 2005, used as reference cohort.

USRDS 2009 ADR

Adjusted cardiovascular admissions in the first year of hemodialysis, by month & ageFigure 1.7 (Volume 2)

Incident hemodialysis patients age 20 and older; followed from the day of onset of ESRD; adjusted for gender, race, & primary diagnosis. Incident hemodialysis patients alive at day 90 after initiation, 2005, used as reference.

The Boston meeting concluded that we can do something about this.

USRDS 2009 ADR

Adjusted admissions for infection in the first year of hemodialysis, by month & ageFigure 1.8 (Volume 2)

Incident hemodialysis patients age 20 and older; followed from the day of onset of ESRD; adjusted for gender, race, & primary diagnosis. Incident hemodialysis patients alive at day 90 after initiation, 2005, used as reference.

Once again, it was concluded that we can do something about this.

USRDS 2009 ADR

Total ESRD expenditures Figure p.22 (Volume 2)

Period prevalent ESRD patients. Includes payments for MSP patients, but no estimate for HMO costs or organ acquisition.

$34B if other payors included

USRDS 2009 ADR

Per person per year totalMedicare ESRD expenditures Figure p.23 (Volume 2)

Period prevalent ESRD patients with Medicare as primary payor & not enrolled in Medicare Advantage.

Our Current Milieu of Care• 20% of facility patients die each year; 70% deceased in 5

years; Up to 40% mortality in the first year• A program that costs $34+,000,000,000/year• With a cost of $60 – 80,000 PPPY with the difference

based on AV access alone• $20,000 PPPY in hospitalizations, mostly due to

cardiovascular disease and infection• Less than 20% rehabilitation

• 110,996 new ESRD patients – 2007– 101,688 In Center HD– 6506 PD (6875 in 2005)– 2665 Pre-emptive transplant (2424 in 2005)

Therapies and OutcomesResults from an informal survey at 2008 ASN

• Possible Therapies– CAPD– CCPD– Conventional In Center– Nocturnal In Center– Conventional HHD– Nocturnal HHD– Short Daily HHD– Transplant

• Living• Cadaveric

– Palliative

• Therapies Stratified by Nephrologists’ Choice– Transplantation– Nocturnal HHD– Nocturnal In-center and

Short Daily HHD– Conventional HHD– CAPD and CCPD– Conventional In Center– Palliative

98% would choose alternatives to conventional care.

If we are going to choose conventional therapy for patients, then we need to do it better. Let’s

at least get it right.

To Accomplish This Morning

• The REASONS for the Boston Meeting– Mortality– Hospitalization trends and causes– Costs

• A SUMMARY of Boston Meeting data, conclusions and recommendations

• ACTION since the meeting

Primary Issues Identified(4 days, >1700 PPT Slides)

• Infection and AV Access

• Cardiovascular Disease

• Inflammation

• The Dialysis Dose

• The First Year

USRDS 2008 ADRUSRDS 2008 ADR

Preventive care for infectious complications

• The variation is vaccination rates for influenza and pneumococcal pneumonia are considerable and unexplained.

• These vaccinations are very inexpensive compared to the cost of a single hospitalization for pneumonia yet universal adoption is lacking.

• In fact, there has been no progress in influenza vaccination rates for the last 5 years!

• Pneumococcal pneumonia vaccinations have increase to a greater degree in some providers!

• Providers need to be held accountable for the lack of performance is this area.

USRDS 2009 ADR

Vascular access use at initiation, by gender, 2007Figure p.10 (Volume 2)

Incident hemodialysis patients, 2007, with new (revised edition) Medical Evidence forms.

82%

USRDS 2009 ADR

Access use at first outpatient dialysis, by primary diagnosis, 2007Figure 3.1 (Volume 2)

Incident hemodialysis patients, 2007.

USRDS 2009 ADR

Catheter events & complicationsFigure 5.20 (Volume 2)

Prevalent hemodialysis patients age 20 & older, ESRD CPM data; only includes patients who are also in the USRDS database. Year represents the prevalent year & the year the CPM data were collected. Access is that listed as “current” on the CPM data collection form.

Catheter Events and Hospitalizations

Fistula events and complication are .2 to .4 as prevalent

Consequences of Catheters

• 22% infectious complications, with septic arthritis, endocarditis and osteomyelitis

• 43% higher cardiovascular related death rate than fistulas in some studies

• AVF after 90 days with 29% reduction in all-cause mortality compared to catheters

• Greater all cause and infection related hospitalizations

• Reduced dialysis adequacy, poorer quality of life and greater costs


Trends in CVD and Infectious Hospitalization rates in the first monthAdjusted for age, gender, race and cause of ESRD

300

350

400

450

500

550

600

650

700

750

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

All CV 0<1

All Infect 0<1

All CV 1<2

All Infect 1<2

Rat

e p

er 1

,000

Pt

Yrs

Incident Cohort Year

Infectious hospitalizations now approach CVD for the 1st time!

1.45

1.311.24

1

1.07

1.14

1.38

1.26

11.14

0.5

0.75

1

1.25

1.5

0 20 40 60 80

Fac. Catheter Use(R2=0.95)

Fac. Graft Use(R2=0.966)

RR of death

% Adjusted Facility Access Use

Mortality Risk in Facilities that have Greater Use of Catheters or AV Grafts versus low use

Quintiles for Graft and Catheter Use

Infection Trends

• Infection hospitalizations substantially increasing over past 10 years, largely due to catheters

• Infection hospitalizations increasing at a rate greater than cardiovascular hospitalizations

• Much higher costs in patients with catheters• There is even likely a linkage between one

access infection and associated ongoing risk of death

• Higher mortality in catheter patients and facilities with more catheters (and grafts)

Boston Meeting Recommendations #1:Infection and Access

• Acknowledge: The catheter problem is IATROGENIC• Hospitals, health plans, nephrologists, providers and

vascular surgeons (currently, 50% primary failure rate) must be accountable for reducing catheter placement

• CMS might consider moving catheters, as a CPM, to the very highest level of scrutiny and surveys and place less emphasis on CPMs that make little difference in outcomes – They just concluded a TEP to make just such

recommendations, which are now being considered• Vaccination, as a CPM, needs to be an important

aspect of facility practice and accountability

Primary Issues



• Inflammation


• The First Year

ASCVD is apparently not the leading cause of CV death, and all of these years we’ve concentrated on hemoglobin, calcium,

phosphorus, lipids and the like – to fix the cardiovascular problem.

We’ve simply been looking at the wrong outcomes measures to improve mortality,

hospitalizations and cost associated with CV disease.

It’s LVH and Cardiomyopathy

glassock

%LVH

THEME:

Alterations in LV Mass in CKD/ESRD are an Example of

What is WRONG with Conventional Regimens of

Treatment

The Core Issues: LV Disease

• LV mass disease progresses as CKD progresses (not inevitably)

• Increased LV Mass is very prevalent in the incident ESRD patient (70%), with only minimal to modest improvement with conventional in-center HD (A bit better with PD)

• Non regressors have a very poor prognosis

Glassock

Three of every four deaths and hospitalizations in dialysis patients can be linked to

sudden death or CHF

Glassock

Left Ventricular in Origin

Myocardial changes in patientswith renal failure

normal morphology morphology of the myocardium of a patientwith chronic renal failure

Ritz

Cardiac fibrosis –most powerful predictor of survival in HD patients

(endomyocardial biopsies)

Aoki, Kidn.Internat.(2005) 67:333

dilatedcardiomyopathy

idiopathic

hemodialysis

< 30%

> 30%

fibrosisarea

RitzRitz

Leading Causes of LV Muscle and Fibrotic Disease

• Hypervolemia– “dry weight” is an “evil doer”– Whatever happened to euvolemia or

normalized extracellular volume?

• Hypertension

• Inflammation (likely caused by hypervolemia)

• Cardiac stunning during overly aggressive ultrafiltration because of shortened dialysis

Volume Overload and LVH

• In experimental spontaneous hypertension, LV Mass increase is linked to volume expansion and salt intake, not to blood pressure

• Salt-loading may increase LV mass through local effects (augmentation of A-II effects and TGFβ)

(Varagic J. et al Am J Physiol Heart Circ Physiol 290:Hi503, 2006; Wu HCM,

et al Circulation 98:2621, 1998))

Consequences of LVH and cardiac fibrosis

• CHF– Difficulty attaining euvolemia with short Rx time– Because of ongoing hypervolemia, it is the leading cause of

hospitalizations and death, especially in the first year, but ongoing.

– High cause of re-hospitalization

• Arrhythmias– Fibrous tissue encircling myocytes with high electrical

resistance; local delay of the spreading front of the action potential

• Favors “re-entry” type of atrial and ventricular ARRYTHMIAS with high hospitalization and death

LVH and Dialysis mode and Prescription

• Conventional 3x/wk dialysis corrects less than 40% of LVH

• Observational (cross-sectional) studies show a lower prevalence of LVH in PD compared to conventional HD patients

• Emerging data: More frequent/longer HD sessions: strongly associated with a much lower prevalence, even reversal of LVH compared to conventional HD (Awaiting FHN studies)

• It is very difficult to attain euvolemia with the current model of care

What has not worked so farin conventional hemodialysis to resolve cardiovascular disease?

• Statins have not been effective– 4D and Aurora

• ESA treatment of anemia has not had a salutary effect on mortality

• Attempting to attain euvolemia with conventional HD• Traditional outcome assessments oriented towards

ASCVD• Sodium modeling and control

LVH in ESRD:Effect of EPO therapy

• Seven (7) RCT have been conducted that examine the effect of EPO therapy on LVH in CKD/ESRD

• All but one have failed to show any beneficial effect on LVH of EPO therapy and correction of hemoglobin to normal or near normal levels

Harmful Effect of Dialysis(after McIntyre CW, et al CJASN, 4:914,2009)

• Myocardial “Stunning” (transient regional wall motion abnormality) develops frequently (65%) during hemodialysis, especially in presence of underlying CHD and/or Diabetes

• High UF volumes increase risk

• Repeated episodes compromise cardiac function, lead to LV fibrosis and enhance mortality risk

Sodium• Known effects on blood pressure and

hypervolemia (inter-dialytic weight gains)• Blood pressure independent target organ damage

– Vasculature changes

– Minor increases of sodium in CSF or serum increases pressor mechanisms and increases cardiotonic steroids – sodium modeling

• And we load our patients with sodium– Hypertonic Saline bolus for hypotension– Saline bolus in the rinse back (hypertonic) and priming– Sodium modeling– Dialysate sodium (hypertonic to usual serum sodium)

A New Paradigm

Adding control of LVH to Clinical Performance Guidelines will achieve

salutary effects on morbidity and mortality in ESRD therapy

Cardiovascular Disease in ESRD:Boston Conclusions

• This is a problem of the left ventricle, not ASCVD• It is a problem of hypervolemia• The new paradigm of ESRD therapy must include

modification of LVH as a high priority• Current “conventional” HD regimen is insufficient to fully

correct or substantially modify LVH by lowering extracellular volume, BP and correcting fibrosis (despite “adequate” Kt/V), in the majority of patients

• Longer/more frequent HD regimens with shorter inter-dialytic intervals very likely improve LVH (and thereby reduce hospitalizations and mortality due to CHF and arrhythmias) - FHN will provide the definitive answer

Boston Meeting Recommendations #2:Cardiovascular (LV) Disease

• Forego misapplication of the formulaic (Kt/V) approach to “adequate” dialysis

• Greater emphasis on LV disease with Td tied to attainment of normalized ECV (not “dry weight). Td and volume become the new CPMs.

• Caution about sodium modeling until safety studies affirm benefit

• (Did not recommend more frequent or hugely longer therapies. Though tying therapy to volume removal will likely result in somewhat longer therapies.)

• CMS to work with nephrology community in development of objective measures for assessment of volume status that would result in decreased hospitalization costs induced by volume/CHF/LVH/arrhythmias– They just concluded a TEP to do just that

Primary Issues



• Inflammation


• The First Year

Reversing “Inflammation-Induced” Malnutrition

• Dietary counseling, in the traditional manner, has minimal effect

• Dietary supplements have mixed effect

• IDPN does not have sustainable effect

• More frequent and/or longer therapy has the greatest effect in reversing the problem

Boston Meeting Recommendations #3:Inflammation

• No infection from catheters• Abandon the “renal diet” as a universal approach to

nutritional counseling, except Na• Attain normovolemia• Feed patients, even nutritional supplements, and

then give them more than conventional dialysis to remove K, P, etc. (The “renal diet” seems to have served the renal community, rather than the patient, by allowing the patient to look biochemically intact, while we give inadequate dialysis.)

• So, no catheters, more food and more dialysis • (Note the emerging same story)

Primary Issues



• Inflammation


• The First Year

The Dialysis Dose

• The history and methodologies about our current dosing are flawed and not supported by current science

• It was a model developed over 30 years ago, propagated by nephrologists, the payment system and dialysis providers

• And no longer sustainable• Too many patients are going into the hospital,

are dying, with the associated high costs• The misapplication of Kt/V is highly detrimental

012345678910 H

azard

Ratio

25

35

45

55

65

75

1.2

1.3

1.4

1.5

1.6

1.7

1.8

1.9

2.0

2.1

2.2

Kt (l/Rx)BSA (M2)

16

.6 x

De

teri

ora

tio

nHazard Ratios by Kt & BSA With InteractionHazard Ratios by Kt & BSA With Interaction

BSA

CurveLinear, 0 Intercept

0 1 2 3 40

10

20

30

40

50

60

70

80

Kt

Incorrect to AssumeKt = 0 + {Kt/V} x V

LowrieLowrie

And this totally ignores volume removal

Effect of Other TherapiesTd and Interval

Alan Kliger

Daily (Suri et al) Outcomes # of Studies

SBP or MAP Decrease 10 of 11

P or Binder Dose No Change 6 of 8

Anemia Improvement 7 of 11

Albumin Increase 5 of 10

QOL Improvement 5 of 10

Nocturnal (Walch)

LV Mass Improvement Culleton

SBP or MAP Decrease 4 of 4

HBP Medications Decrease 4 of 4

Anemia Improvement 3 of 3

QOL Improvement Variable

The Four Major Problems with Kt/V

• In and of itself, it may not be “bad”. It is simply not enough

• Does not acknowledge the differences in therapies required for size of the individual

• Does not acknowledge the disproportionate value of TD (duration of treatment time per week)

• Does not account for the fact that most dialysis patients, using conventional Kt/V, are not euvolemic, but indeed are volume overloaded

Boston Meeting Recommendations #4:Dialysis Prescription

• Kt/V is not the “Holy Grail” and has enormous shortcomings

• Time on dialysis needs to become a CPM, tied to:– LV disease– Euvolemia, not “dry weight”– blood pressure– inter-dialytic weight gain

• Work with CMS to develop CPMs acknowledging this with the goal to fix CV disease– They have just concluded a TEP to address this very

issue

Primary Issues



• Inflammation


• The First Year


All-cause & cause-specific mortality in the first months of ESRDFigure 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.


Percent change in hospital admissions from day 1: 1993 to 2005Incident hemodialysis patients age 65 and older

-10

10

30

50

70

90

110

130

150

170

190

210

230

0-<1 1-<2 2-<3 3-<6 6-<9 9-<12

months after dialysis initiation

pe

rce

nt

ch

an

ge

in a

dm

iss

ion

ra

tes

fro

m

19

93

to

20

05

all-cause

cardiovascular

infection

vascular access infection

*Model based adjustment for age, sex, race, cause of ESRD: Interval Poisson regression (ASN 2008 poster)

Survival Curve, 1st 365 DaysAdjusted Cox-proportional hazards regression model

4003002001000

risk_days_365

1.00

0.95

0.90

0.85

0.80

Cu

m S

urv

ival

RightStart

Controlgroup_number

Survival Function for patterns 1 - 2

P<0.001 by Cox Log-rank, Breslow, and Tarone-Ware testsat 90, 180, and 365 day exposure levels.

RightStart®

Control

Adjusted by age, race, gender, diabetes

HakimHakim

Hospital Days per Patient Yr at Risk

14.513.3

13.4

18.3 18.5

17

0

5

10

15

20

Mo 1-3 Mo 1-6 Mo 1-12

Ho

spit

al

Da

ys/

Pt

Yr

at

Ris

kRightStart Control

14.513.3

13.4

18.3 18.5

17

0

5

10

15

20

Mo 1-3 Mo 1-6 Mo 1-12

Ho

spit

al

Da

ys/

Pt

Yr

at

Ris

kRightStart Control

HakimHakim

Boston Meeting Recommendations #5: Incident Patients

• They need more intensive care, by the nephrologist and dialysis provider, and directed at those co-morbid processes that cause the greatest mortality, hospitalizations, re-hospitalizations and costs: catheters and infection, volume overload, wound care, malnutrition...

Primary Issues



• Inflammation


• The First Year

Dialysis: The Old Paradigms

• Fistula First

• Optimize kT/V

• Manage Coronary Heart Disease

• “Optimal” treatment: anemia (EPO and Iron), divalent ions (phosphate binders), PTH (Vitamin D), lipids, BP medications, albumin

• Restrictive diets

• Early Start

Dialysis: The New Paradigm

• Catheter last• Volume control first, minding the

left ventricle• More dialysis with emphasis on time• Emphasis on the incident patient• Eat, eat, eat (but not salt)

Conclusions for this Network 14 Meeting

After 1711 slides and 4 days in Boston

• The Boston Meeting is not suggesting that we discard existing CPMs. CPMs and CPGs are a rigorous and thoughtful process.

• The emphasis on traditional CPMs needs to be changed and new CPMs need to be added.

• And that we be held more accountable for better outcomes

Specific Conclusions for this RPA Meeting:

After 1711 slides and 4 days in Boston• Cease to spend so much time on weaker clinical

outcomes measurements that may only account for 14% of the morbidity and mortality difference. Change the CPMs

• Save the left ventricle and gain optimal control of volume. Change the CPMs

• Do not tolerate catheters or those who place them. Change the CPMs

• Intensify the care of the incident patients. Do not be satisfied with a formulaic approach to conventional dialysis. Change the CPMs

• (Partially treat inflammation with more protein and caloric intake and time on dialysis)

I’m asking that, when you leave here today, that you:

• Challenge your prior perceptions of adequate dialysis, time on dialysis and euvolemia and implement change.– Patients should attain normal ECV the first of the week. If

not, schedule more time or an extra treatment that week.

• Abandon all catheters > 90 days in incident patients• Intensify care of incident patients• Feed your patients more protein, then give them

sufficient dialysis

To accomplish:

• An very brief overview of current ESRD data– Mortality– Hospitalization trends and causes– Costs

• A SUMMARY of Boston Meeting data, conclusions and recommendations

• ACTION since the meeting and in the future

Action Since Boston Meeting

• Letter to CMS and White House• Meeting with CMS, November – 2009 and follow-up calls• CJASN Supplement, December – 2009• Articles in NNI and RenalWeb• ASN 2009 – 2 hour session• RPA 2010• ANNA 2010• Numerous Medical Schools and other venues• ASN 2010• Recent CMS Technical Expert Panel Mtg: March 10-11• Upcoming studies

CMS and Volume

• Held a meeting in Baltimore, 3-2010, a Technical Expert Panel to address the volume component of adequacy of dialysis

• Recommendations– All patients start at 4 hours– Greater sodium control

• No sodium modeling• Lower dialysate sodium concentration

– Required clinical assessment of volume– Home BP monitoring– Pending: objective measurement

Recent CMS Regulation and Reporting Change

• New data reporting for adequacy, infection and vascular access beginning July 1, 2010– Purpose: To develop “quality incentive payment

for dialysis providers” by January 1, 2012

• Indicators– Kt/V– Access infection– Type of access

The world is changing.

The old ways will not do. It’s time…

John Kennedy

The Old Paradigm (The full cup)

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Transcript of The Old Paradigm (The full cup)