Quale trattamento sostitutivo per l’anziano? Michele Giannattasio Struttura Complessa di...

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Quale trattamento sostitutivo per l’anziano? Michele Giannattasio Struttura Complessa di Nefrologia e Dialisi Ospedale San Paolo - Bari

Transcript of Quale trattamento sostitutivo per l’anziano? Michele Giannattasio Struttura Complessa di...

Quale trattamento sostitutivo per l’anziano?

Michele GiannattasioStruttura Complessa di Nefrologia e Dialisi

Ospedale San Paolo - Bari

Planning

• When to start RRT

• HD vs PD

• Tx vs Dialysis

The IDEAL Study: a RCT with a large population

Cooper BA et al. N Engl J Med 2010;363:609-19Multicenter, randomized, controlled trial

Kaplan–Meier Curves for Time to Death

Cooper BA et al. N Engl J Med 2010;363:609-19

Primary Outcome

Lessons learnt from the IDEAL study

It is possible to safely reduce economic burden due to earlier

dialysis

Data from 24 hour urine collection (urea, sodium) are mandatory

Importance of nutritional status assessment

Pay more attention to patient symptoms than to eGFR

Importance of close clinical follow up in non-dialysis CKD stage

5 patients

Conservative therapy is possible also till GFR <10 ml/min

(corresponding to 6 months dialysis delay)

No benefit from “early-dialysis”

Locatelli F et al. Contrib Nephrol 2011

Copyright © 2012 American Medical Association. All rights reserved.

From: Early Start of Hemodialysis May Be HarmfulRosansky SJ et al: Arch Intern Med. 2011;171(5):396-403. doi:10.1001/archinternmed.2010.415

Tools Available in the RPA Guideline for Shared Decision Making for dialysis initiation

• Depression Assessment• Cognitive Capacity Assessment• Decision Making Capacity Assessment• Quality of Life and Functional Status Assessment• Prognosis Assessment• National Kidney Foundation Initiation and Withdrawal Checklists• Pain and Symptom Assessment and Management• Communication Skills• Glossary of Terms

RPA Clinical Practice Guideline in the Appropriate Initiation and Withdrawal from Dialysis, 2nd Edition, 2010.

Planning

• When to start RRT

• HD vs PD

• Tx vs Dialysis

Peritoneal DialysisUnited States Renal Data System 2012 Annual Data Report

Incident & prevalent patient counts (USRDS), by modality

USRDS 2010 ADR

Incident counts & adjusted rates of ESRD at initiation & at day 90, by modality, age, gender, race, ethnicity, & primary diagnosis, 2008Table 4.a (Volume 2)

Incident ESRD patients; unknowns dropped. Rates by age adjusted for gender & race, rates by gender adjusted for age & race, rates by race & ethnicity adjusted for age & gender, & rates by primary diagnosis adjusted for age, gender, & race. *Values for cells with ten or fewer patients are suppressed.

6 % 3,9 %

Seminars in Dialysis—Vol 25, No 6 (November–December) 2012 pp. 668–674

The ultimate test for any therapy is a randomized, prospective (double blinded) trial.

To show a mortality difference of 20%, the enrollment would require at least 1000 patients.

It will probably be impossible to design an adequately powered randomized trial comparing PD and HD with mortality as an endpoint.

Mallappallil M et al Sem Dial 2012; 25, 6 671

Due to the low inclusion rate, the trial was prematurely stopped after which 38 patients had been randomized: 18 patients to HD and 20 to PD.

The vast majority, some 735 patients, refused participation because of a preference for one of the modalities; 52% of the patients preferred to start with HD, 48% chose to start with PD.

Similar Outcomes With Hemodialysis and Peritoneal Dialysis in Patients With End-Stage Renal Disease

Mehrotra et al.: Arch Intern Med. 2011;171(2):110-118. doi:10.1001/archinternmed.2010.352

It appears that any mortality benefit attributed to PD compared with HD is more evident in younger, nondiabetic and healthier patients; this may be influenced by patient selection rather than by any superiority of the modality.

Types of Dialysis: Advantages

HD PD-No family burden -Carried at home

-No input from patient -Easy access

-Social encounter (?) -No need for transport to hospital

-Anemia less severe

-Safe for patients with CV disease

Cassidy MJ, Sims RJ: Dialysis in the elderly. New possibilities, new problems. Minerva Urol Nephrol 2004; 56: 305-17

HD PDCV instability Access

Access difficulties Peritoneal infections

Sepsis

Intradialytic problems Difficult for patients with impaired mobility *

Repeat visits to hospital Reduced dexterity *

Hospital transport Huge burden to family *

Lengthy waits * For APD

Types of Dialysis: Disadvantages

Cassidy MJ, Sims RJ: Dialysis in the elderly. New possibilities, new problems. Minerva Urol Nephrol 2004; 56: 305-17

The disability in self-care is common among older HD-patients

Of the 162 mostly male participants averaging 75 years old, eight (5% ) were fully independent and reported no functional impairment in any activity, 69 had only instrumental dependence, and 85 had combined disability.

(ADL, basic activities of daily living);

W L Cook, and S V Jassal Kidney Intern (2008) 73, 1289–1295

IADL, instrumental activities of daily living.

Covic A, Bammens B, Lobbedez T, Segall L, Heimbürger O, van Biesen W, Fouque D, Vanholder R : Educating end-stage renal disease patients on dialysis modality selection: Clinical advice from the European Renal Best Practice (ERBP) Advisory Board. Nephrol Dial Transplant 25: 1757–1759, 2010

Assisted PD

PD performed at the patients’ home with the

assistance of:

•a health care technician,

•a community nurse,

•a family member, or

•a partner

CONTRIBUTO ECONOMICO ALLADIALISI DOMICILIARE

REGIONE SICILIA - 12/05/2011

OBIETTIVO DELLA LEGGE (sperimentale 2 anni)Promozione e sviluppo dei programmi di dialisi domiciliare

IL PAIDD: Piano Assistenziale Individuale Dialisi Domiciliare

Intensità assistenziale BASSA MEDIA ALTA

APD – HHD 200 350 450

CAPD 200 300 400

myocardial stunning: asymptomatic regional wall motion abnormalities

Age is a significant predictor of Myocardial Stunning (MS) during HD

Independent determinants associated with MS:

• advancing age (P = 0.03);

• higher intradialytic UF volumes (P = 0.01);

• the presence of DM (P = 0.002);

• lower albumin levels (P = 0.02);

• elevated cTnT concentration (P = 0.001).

Burton JO et al: CJASN 2009 4 914-920

AVF outcomes in the era of the elderly dialysis population

Lok CE et al: Kidney International (2005) 67, 2462–2469; doi:10.1111/j.1523-1755.2005.00355.x

< 65 years old> 65 years old

Fistula failure is more common

in the elderly

Lazarides et: J VASC SURGERY Volume 45(2),420-426,2007

at 12 months (odds ratio [OR], 1.525; P<0.001)

at 24 months (OR, 1.357, P<0.019).

Survival curves for HD-CVC (short-dashed line), HD-AVF/AVG (long-dashed line), and PD (solid line) patients

Perl J et al. JASN 2011;22:1113-1121

©2011 by American Society of Nephrology

(A) Unadjusted

PD

HD-AVF/AVG

HD-CVC

Perl J et al. JASN 2011;22:1113-1121

©2011 by American Society of Nephrology

(B) Adjusted

Survival curves for HD-CVC (short-dashed line), HD-AVF/AVG (long-dashed line), and PD (solid line) patients

(B) Adjusted for age, race, gender, era of dialysis initiation, ESRD, comorbidity index, primary renal diagnosis, serum albumin, eGFR, province of treatment, and late referral

PD

HD-AVF/AVG

HD-CVC

The higher peritonitis rate observed in elderly patients may represent an era effect

Nassim SJ et al: CJASN January 2009 vol. 4 no. 1 135-141

In a negative binomial model, older age was independently associated with a higher peritonitis rate (rate ratio [RR] 1.06 per decade increase; 95% CI 1.01 to 1.10; P = 0.008).

Impact of ESRD on life expectancy

Jassal S V et al. CMAJ 2007;177:1033-1038

©2007 by Canadian Medical Association

Planning

• When to start RRT

• HD vs PD

• Tx vs Dialysis

1. Better quality of life

2. Release from the tedium of dialysis

3. Longer survival

In the younger patient, renal Tx has potential advantages when compared with dialysis

Additional aspects of renal Tx that may differ in the older patient

• Ethics of transplantation, including issues surrounding the allocation of organs

• Pretransplant evaluation

• Mechanisms of graft loss and death

• Degree and type of immunosuppressive therapy

Renal Transplantation:Is age a contraindication?

Recipient age alone should no longer be considered a contraindication to transplantation, since the age limit for being a transplant recipient has steadily increased

Ismail N, Hakim RM, Helderman JH. Renal replacement therapies in the elderly: Part II. Renal transplantation. Am J Kidney Dis 1994; 23:1.

The 2008 SRTR report on the state of transplantation. Accessed February, 2010. www.ustransplant.org/annual_reports

Renal Transplantation:Is age a contraindication?

Any patients over the age of 60, and selected patients over 70, have been transplanted safely and with an acceptable rate of long-term graft function

The 2008 SRTR report on the state of transplantation. Accessed February, 2010. www.ustransplant.org/annual_reports.

Vivas CA, Hickey DP, Jordan ML, et al. Renal transplantation in patients 65 years old or older. J Urol 1992; 147:990.

Tapson JS, Rodger RS, Mansy H, et al. Renal replacement therapy in patients aged over 60 years. Postgrad Med J 1987; 63:1071.

United States Organ TransplantationSRTR & OPTN Annual Data Report, 2011

Adult kidney transplants

The number of transplants performed

annually among patients age 65 or

older has tripled between 1998 and

2011

Among older adults with ESRD, it remains unclear whether the possible benefits with renal Tx are sufficiently great to advocate Tx over dialysis.

August 2004

Patient and graft survival in elderly

• Graft loss in older adults is related primarily to patient death.

• The two main causes of morbidity and mortality following transplantation are CVD and infection. A majority of infections occur in the first six months post-Tx.

• Acute rejection may occur less commonly

..… but there is an increased risk of chronic allograft nephropathy among older adult patients, which is enhanced if the allograft is from an older donor.

J Am Geriatr Soc 50: 14-17, 2002

The pharmacokinetics and effects of drugs are altered in older adults

Mangoni AA, Jackson SH : Br J Clin Pharmacol, 2004

Reduced gastric motility

Reduced secretion of acid/enzymes

Change in numbers of hepatocytes

Reduced production of albumin

Reduced number of functioning glomeruli

Reduced blood flow

Alterations in neurochemical transmission

Reduced cognitive capacity and ability

5667 waiting-list patients older than 70 years of age

Results from Scientific Registry of Transplant Recipients

Elderly transplant recipients had a 41% lower overall risk of death compared with wait-listed candidates (RR=0.59; P<0.0001).

Recipients of nonstandard, that is, expanded criteria donor, kidneys also had a significantly lower mortality risk (RR=0.75; P<0.0001).

Elderly patients with DM and those with hypertension, as a cause of ESRD, also experienced a large benefit.

Renal Tx offers a significant reduction in mortality compared with dialysis in the wait-listed elderly population with ESRD

Rao PS et al: Transplantation 2007 Vol 83, 8 pp 1069-1074

Projected remaining years of life

among patients aged 60 to 74 years of age

Rao PS et al: Transplantation 2007 Vol 83, 8 pp 1069-1074

Patient and graft survival in the older adult transplant recipient are excellent

Patient survival (%) 1 year 3 year 5 year

Living donor renal Tx 95 88 77

Deceased donor non-ECD kidneys 93 81 65

Deceased donor ECD kidneys 86 76 55

Allograft survival (%) 1 year 3 year 5 year

Living donor renal Tx 93 84 70

Deceased donor non-ECD kidneys 89 75 60

Deceased donor ECD kidneys 80 66 46

The 2010 SRTR report on the state of transplantation. www.ustransplant.org/annual_reports.

• Less wait time,

• diabetic,

• no living donor,

• an anticipated long wait

The main benefit of ECD kidneys for older patients

Marion RM et al: JAMA 2005, 294: 2726

RRT Decision-making in the Elderly Patient with ESRD requires consideration of factors more common in this population to help guide the clinical thought process:

• functional impairment• cognitive impairment • the severity of comorbid conditions

Berger J R , Hedayati S S CJASN 2012;7:1039-1046

Approach to the Elderly Patient with ESRD

Berger J R , Hedayati S S CJASN 2012;7:1039-1046

Approach to the Elderly Patient with ESRD

Berger J R , Hedayati S S CJASN 2012;7:1039-1046

Approach to the Elderly Patient with ESRD

Berger J R , Hedayati S S CJASN 2012;7:1039-1046

Approach to the Elderly Patient with ESRD

Berger J R , Hedayati S S CJASN 2012;7:1039-1046

Approach to the Elderly Patient with ESRD

Berger J R , Hedayati S S CJASN 2012;7:1039-1046

Approach to the Elderly Patient with ESRD

Fine

USRDS 2012 ADR

Incident-Prevalent counts & adjusted rates of ESRD, by age

Incident ESRD patients. Adj: gender/race; ref: 2005 ESRD patients.

Renal Tx vs Dialysis

A paucity of data exists concerning:

• Patients survival;

• QOL (quality of life).

Knoll G A CJASN 2009;4:2040-2044

RR of mortality for Tx recipients versus dialysis patients on the waitlist at ≥70 yr

Relative Risks (PD:HD)Patient Group As-Treated ITT All Patients 0.73 (0.69-0.77)** 0.93 (0.87-0.99)**

Non-DM, <65 yrs 0.53 (0.46-0.60)** 0.84 (0.73-0.96)**

Non-DM, 65 yrs 0.75 (0.65-0.86)** 0.95 (0.86-1.05)NS

DM, <65 yrs 0.76 (0.65-0.83)** 0.90 (0.82-1.10)NS

DM, 65 yrs 0.88 (0.75-1.04)NS 1.04 (0.87-1.24)NS

NS=Not Signififcant, ** p<0.05

Schaubel, et al, Perit Dial Int, 1998; 18:478-484

Anuric patients usually die in 8-12 days

With residual function, some may survive several

months

JAMA 2003; 289, 2113