Francesco Locatelli MD, FRCPC, FNKF, FERA, Dr H.C.

Department of Nephrology and Dialysis

Ospedale“Alessandro Manzoni” – Lecco - Italy

Valencia ERA - EDTNA Congress , September17-20,2016

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Biosimilari: aspetti clinici e

medico-legali

Ethical Issues in renal care

Ethic dilemma in renal aging

medico-legali

Kidney Int 2006; 69: 2118-2120

Death is far more common than

ESRD in CKD patients

Peralta CA et al. J Am Soc Nephrol 2006; 17: 2892-2899

39,550 patients with CKD stage 3-4 (SCr 1.32±0.35)

Mean follow-up 3.83 years (range 0.003-7.0)

0

2

4

6

8

10

12

ESRD Any CV event Death from any cause

0,67

10,94

5,25

1,22

10,31

4,08 White

Hispanic

Ag

e-a

dju

ste

d r

ate

(per

100 p

ers

on

-years

)

In response to this need for greater education and awareness, the American Society of Nephrology has initiated a program of educational activities in geriatric nephrology. The priority being given to geriatric nephrology is a hopeful sign that issues such as treatment options, the efficacy of treatments, and their effect on quality of life for the elderly patient with kidney disease will be improved in the coming years.

Elderly population (over 65) Elderly population (over 65)

Young elderly: 65-74 years

Old elderly: 75-84 years

Very old elderly: >85 years

ELDERLY ?

Kurella M et al. Ann Intern Med (2007) 146: 177-183

The rapid growth in the number of

patients of advanced age starting dialysis

Incidence of dialysis initiation from 1993 to 2003 by age group

(per 100 000 persons in US population), adjusted for sex and age

Data from USRDS

65 – 69 y 70 – 74 y 75 – 79 y 80 – 84 y 85 y

Age Group

1996 - 1997 1998 - 1999 2000 - 2001 2002- 2003

75

100

125

150

175

Incid

en

ce o

f D

ialisys I

nit

iati

on

( p

er

100 P

ers

on

s )

Survival by age cohorts, ambulatory state

and number of comorbidities

Percent change in life expectancy by different

age classes in normal and dialytic population (USRDS 2008)

0

10

20

30

40

50

60

70

80

90

100

30-35 40-45 50-55 60-65 70-75 80-85 85+ overall

76,6 78,2 78,4 78,1 76,1 72,0

56,8

77,1

% reduction N D

Murtagh FE et al. Nephrol Dial Transplant, April 2007

Patients over 75 years with CKD stage 5:

Dialysis or not? A retrospective analysis of 129 pts with estimated

GFR<15ml/min

Log rank statistic= 13.63 p<0.001

0

20

40

60

80

100

0 500 1000 1500 2000

Days after eGFR fell below 15 ml/min

Cu

mu

lati

ve s

urv

ival

Dialysis ( n – 52 )

Conservative ( n – 77 )

P < 0.001

Murtagh FE et al. Nephrol Dial Transplant, April 2007

Patients over 75 years with CKD stage 5:

Dialysis or not? A retrospective analysis of 129 pts with estimated GFR<15ml/min

Log rank statistic p=0.27 Log rank statistic p<0.0001

Pts with ischaemic heart

disease

Pts without ischaemic heart

disease

0 500 1000 1250 750 250 0

20

40

60

80

100

( A )

Dialysis ( n – 17 )

Conservative ( n – 30 ) C

um

ula

tive s

urv

ival

Days after eGFR fell below 15 ml/min

0 500 1000 1250 750 250 0

20

40

60

80

100 Dialysis ( n – 35 )

Conservative ( n – 30 )

Days after eGFR fell below 15 ml/min

( C )

Cu

mu

lati

ve s

urv

ival

Comorbidity:

•Cardiac disease; vascular disease; cerebrovascular disease; respiratory disease

graduati =0 (assente) – 4 (avanzata)

•Cancer (1-4) su base attività e sopravvivenza medio termine

•Cirrhosis: 4

Score >4: high

Advance Access published November 22, 2010

Modello Cox

Chandna SM et al. Nephrol Dial Transplant 2010

Nephrol Dial Transplant

(2006) 21: 2543-2548

Design, Setting, and Patients Prospective cohort study of 267 consecutively recruited outpatients with CKD (stages 2-5 and who were not receiving dialysis) between May 2005 and November 2006 and followed up for 1 year (age, y 65.4 +11.8 non-depressed and 60.6 +11.9 depressed, p= .007). An Major Depressive Episode (MDE) was diagnosed by blinded personnel using the Diagnostic and Statistical Manual of Mental Disorders criteria.

In conclusion, the presence of a current MDE was associated with progression to maintenance dialysis, hospitalization, or death in CKD patients, independent of comorbidities and kidney disease severity.

N Engl J Med. 2009; 361:1539-47

In conclusion, nursing home residents who are starting to

undergo dialysis have a substantial and sustained decline in

functional status in addition to very high mortality.

Comparative Survival among Older Adults with

Advanced Kidney Disease Managed

Conservatively Versus with Dialysis

• No statistically significant survival advantage

among patients ages ≥80 years old choosing

RRT over conservative management (CM)

• Comorbidity was associated with a lower

survival advantage

• This provides important information for decision

making in older patients with ESRD

• CM could be a reasonable alternative to RRT in

selected patients

W. R. Verberne et al. JASN 2016

Functional and Cognitive Impairment, Frailty, and

Adverse Health Outcomes in Older Patients

Reaching ESRD—A Systematic Review

• Functional and cognitive impairment and frailty in

patients reaching ESRD are highly prevalent and

strongly and independently associated with

adverse health outcomes, and they may,

therefore, be useful for risk stratification

• More research into their prognostic value is

needed

M H. Kallenberg et al.JASN 2016

Age is no longer seen as a contraindication to dialysis

Quality-of-life data suggest that older dialysis patients have

similar levels of social functioning and mental health as

younger dialysis patients but usually poorer physical function

Consequently, the survival of elderly patients depends mainly

on the severity of comorbid conditions

The rationing of dialysis on the basis of age alone is not

justified

Medical professionals must understand that medicine is not

capable of defining QoL on its own, but it can (and MUST)

provide all the means to allow patients to gain the health

status that permits them to enjoy life in their own way.

The Evolving Ethics of Dialysis in the United States:

A Principlist Bioethics Approach

• Greater recognition that health care financial

resources are limited makes fair allocation more

pressing, highlighting the importance of

distributive justice.

• However we should be aware of the great

risk that with the advent of accountable

care and bundled payment previous

incentives to offer hemodialysis to as many

patients as possible are being replaced with

a disincentive to dialyze high-risk patients

C. R. Butler et al. JASN 2016

• While we should avoid the harm of overtreatment

for elderly patients with comorbidities, there are

concerns that we could return to rationing

hemodialysis.

• The importance of patient preferences and

personal values should be of paramount in medical

decisions, reflecting a focus on the principle of

patient autonomy

C. R. Butler et al. JASN 2016

The Evolving Ethics of Dialysis in the United States:

A Principlist Bioethics Approach

The Ethics of Chronic Dialysis for the Older Patient:

Time to Reevaluate the Norms

Nephrologists are called on to help patients make a decision,

for which the patient's goals of care guide determination of

potential benefit from hemodialysis.

• Concerns about present overtreatment and future risk of

undertreatment of older adults with ESRD.

• Providers can ethically approach the question of initiation

of hemodialysis in the elderly patient by including patient-

specific estimates of prognosis, shared decision-making,

and the use of specialist palliative care clinicians or ethics

consultants for complex cases

B.Thorsteinsdottir et al. JASN 2016

Supportive Care: Economic Considerations in

Advanced Kidney Disease

• Kidney supportive care is an essential component

of quality care throughout the illness trajectory

• The dominant evaluative framework of a cost per

quality–adjusted life year may not be suitable for

evaluations in this context

• Relevant outcomes may include broader measures

of patient wellbeing, having care aligned with

treatment preferences, and family satisfaction with

the end of life care experience

(R.Morton,CJASN 2016)

• Longitudinal collection of quality of life and

functional status should be added to existing

cohort or kidney registry studies

• Interventions that improve health outcomes for

people with advanced CKD, such as kidney

supportive care, not only have the potential to

improve quality of life, but also may reduce the

high costs associated with unwanted

hospitalization and intensive medical treatments.

(R.Morton,CJASN 2016)

Supportive Care: Economic Considerations in

Advanced Kidney Disease

Patients care more about how they will live

instead of how long

• Nephrologists and nurses are called on to help

patients make their decision

• They should ensure that the patient is correctly

informed about the potential benefits and

burdens of hemodialysis, including age and all

the comorbidities potentially affecting the

balance between benefits and burdens

Older age by itself is not a good reason for denying

dialysis treatment

The survival and quality of life of many older patients on

dialysis is reasonable and they often fare better than

expected

However, dialysis withdrawal should be considered at

least in the presence of severe dementia, permanent

unconsciousness, or severe cachexia (which represent a

prolongation of death rather than life)

It is important to take into account the social context

in which dialysis treatment is delivered. It is well

known that family and social support greatly affects

the quality of life of patients

In this context, the difficult decision about whether to

prolong life become easier if it is shared between

attending physicians and families

Thank you for listening