quale trattamento sostitutivo per l’anziano? michele giannattasio struttura complessa di...
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Quale trattamento sostitutivo per l’anziano?
Michele GiannattasioStruttura Complessa di Nefrologia e Dialisi
Ospedale San Paolo - Bari
The IDEAL Study: a RCT with a large population
Cooper BA et al. N Engl J Med 2010;363:609-19Multicenter, randomized, controlled trial
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
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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.
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 %
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
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
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
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
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