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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
Switch da ESA Originators a
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