La Dialisis Peritoneal como puente a la Hemodialisis José Divino MD, PhD VP Medical Affairs Baxter Renal Division Latin America Congreso de la Sociedad

La Dialisis Peritoneal como puente a la

Hemodialisis

José Divino MD, PhD

VP Medical Affairs

Baxter Renal Division Latin America

Congreso de la Sociedad Española de Nefrologia

Cadiz

29 Septiembre 2007

The incidence of infection associated with PD is no greater than that associated with HD.

Data from the USRDS demonstrate that modality-related infections

(i.e., peritonitis and vascular access infection) are lower in PD than in HD patients

What infections do dialysis patients get?

Infections directly related to the therapy:– Hemodialysis

• Vascular access (catheters, grafts, fistulas)

– Peritoneal Dialysis• Peritonitis, exit site infections

Other infections – Pneumonia– Skin infections (esp with poor circulation)– Dental, ENT (ear, nose, throat)

Bacteremia/Septicemia

Bacteremia is when a bacterial infection is found in the blood. This is documented by a blood culture growing out the organism. Patients may be mild to severely ill.

Septicemia is when a patient has bacteremia and is clinically ill. In the USRDS, it means the patient is admitted to hospital.

Local infections, e.g. skin infection, can cause bacteremia/septicemia, but not usually unless the local infection is severe.

USRDS 2003 Annual Report

Mortality from Infection: PD & HD

Reason for Admission: PD & HD


Bacteremia associated with PD is significantly less common

than with HD, and bacteremia associated with peritonitis is rare

Incident dialysis patients with 90-day rule; adjusted rates adjusted for age, gender, race, & primary diagnosis. Patients with Medicare as a secondary payor or enrolled in an HMO on day 90 are excluded, as are patients with septicemia claims overlapping the start date of the followup period.

Figure 6.38

Overall first-year hospital admission rates for septicemia, by modality: adjusted rates

Organisms in Sepsis: HD &PD


Foley et al JASN 2004;15:1038-1045

Foley et al JASN 2004;15:1038-1045

Incident dialysis patients, 1996–2000, with 90-day rule & with Medicare as primary payor; adjusted rates adjusted for age, gender, race, primary diagnosis, & vintage. Patients without sepsis in the first year + 90 days after initiation are used as the reference cohort.

Mortality after first bacteremia/septicemia event: adjusted mortality rates

Figure 6.39

Fig. 1. Cumulative incidence of bacteremia or septicemia over time inthe Wave 2 population.

The incidence of peritonitis associated with PD has dramatically decreased over the last decade

Why has peritonitis improved?

Advances in the systems– “Flush before fill”– Fewer connections

Better appreciation of surgical issues– Immobilization

Not related to catheter type ISPD guidelines target 1 episode in every 18

patient months, but many programs do better and we should aim for better.

“Flush before fill”

Simplifying the TherapyUltraBag™ Integrated Disconnect System

Unique product design: Asymmetrical Y-junction with straight drain path

• Clinically validated for: – Reduced potential of re-circulation1

– Reduced potential of re-infusion ofbacteria into peritoneum1

– Easy for patients to use– Reduced training time

An optimal PD Delivery System needs to incorporate both contamination protection AND flush efficiency

1 Kubey,W., Straka, P., Holmes, C.J. (1998, January 27,) Importance of Product Design on Effective Bacterial Removal by Fluid Convection in Y Set and Tiwnbag Systems. Blood Purification, 16, 154-161.

R e g is t r o D P A n d a lu c ía A ñ o 2 0 0 5

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E P I S O D I O S / P A C I E N T E S / A Ñ O

E v o lu tio n o f perito n itis d a ta :E v o lu tio n o f perito n itis d a ta :

Remón et al. Nefrología 26 Nº1: 45-55, 2006

Technique success with PD has shown continuing improvement over time

Improved PD

Reduced infection rates and easier to use systems have improved technique success with PD

Drop rates remain high, ranging from 10-50% per year in different parts of the world

Programs with greater experience have better outcomes

Conclusions

There are advantages of PD in managing common clinical issues seen in dialysis patients, and improvements are being made in managing clinical issues specifically related to PD

Why Start on PD ?

Better preservation of RRF.

Initial survival advantage relative to HD.

Better results after renal transplantation.

Preservation of vascular access

Access outcome

Oliver et al: KI 2000; 58: 2543

3.8 - 9.7 bacteremias per 1000 catheter days

Incidence of bacteremiafrom temporary CVC’s

Internal Jugular 5.4% after 3 weeks

Femoral 10.7% after 1 week

Hospitalization in the first year of RRT for ESRD

Prospective study of 526 incident patients starting RRT. 1 year follow up. Univariate analysis:

The most common single reason for admission was creation of & complications to vascular access for HD.

The use of temporary vascular access for HD were associated with prolonged hospitalization & repeated admissions.

Patients initially treated with HD rather than PD spent longer time in hospital & were more likely to be admitted.

Metcalfe et al. Q J Med 2003; 96: 899

The more than 10-fold increase in mortality in ESRD patients is mainly due to CVD and infections

USRDS analysis stratified by gender, race, and age

0,001

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25-34 35-44 45-54 55-64 65-74 75-84 85+

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Foley et al. Am J Kidney Dis 1998,32:S112-S119

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Sarnak et al. Kidney Int 2000 Oct;58(4):1758-64

CVD Sepsis

ESRD ESRD

GP GP

Pecoits-Filho & Lindholm 2003

Central venous catheter (CVC) and its risks

Development of (long-term) access-failure is correlated with both use of central venous catheter, and premature puncture of access system at start of dialysis. ( Vanholder 2001)

They are exposed to risks of venous dialysis catheter insertion, and catheter-related infection and thrombosis.

Complications of catheter usage

Limited ability to provide adequate dialysis

Related to size of CVC:- Diameter- Length

Recirculation

Placement problemsComplicationsTip location

ThrombosisExtrinsicIntrinsic

Infection•Exit site•Tunnel•Catheter related bacteremia

Peritoneal Dialysis as a bridge in chronic hemodialysis patients

Juan Fernández Cean

HD

RT

PD

Three treatment options for

End Stage Renal Disease:

Vascular access in chronic HD patients :

Arteriovenous fistulae (AVF)

Arteriovenous grafts (AVG)

Vascular access in chronic HD patients :



Venous Catheter (VC) is used as a bridge in CHD patients

The outcome of HD patients depends on the vascular access:



Venous Catheter (VC)

1 1.05

1.761.95

0

0.5

1

1.5

2

2.5

3

AVF AVG Catheter(T)

Catheter(P)

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Septicemia, access and cardiovascular disease in dialysis patients: The USRDS Wave 2 Study.

Ishani A, Collins A, Herzog C and Foley R. Kidney International (2005) 68, 311-318

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Septicemia, access and cardiovascular disease in dialysis patients: The USRDS Wave 2 Study. Ishani A, Collins A, Herzog C and Foley R. Kidney International (2005) 68, 311-318

11.7

14.2

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0

2

4

6

8

10

12

14

16

18

AVF AVG VC

An

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Annual mortality rate according to the vascular accessType of vascular access and survival among incident HD patients: the Choices for healthy outcomes in caring for ESRD (CHOICE) study. Astor B et al. JASN, March 2005

11.7

14.2

16.1

0

2

4

6

8

10

12

14

16

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AVF AVG Catheter

Mortality (%)

Type of vascular access and survival among incident HD patients: the Choices for healthy outcomes in caring for ESRD (CHOICE) study. Astor B et al. JASN, March 2005

PD

11.7

14.2

16.1

0

2

4

6

8

10

12

14

16

18

AVF AVG Catheter

Mortality (%)

Type of vascular access and survival among incident HD patients: the Choices for healthy outcomes in caring for ESRD (CHOICE) study. Astor B et al. JASN, March 2005

PD

Fig. 2. Vascular access use among new ESRD (incident) patients in Canada, Europe and the USA in DOPPS II, 2002–2004 (n = 2025). Analysis included incident patients who entered DOPPS within 5 days of their first ever chronic HD treatment.

Haemodialysis vascular access problems in Canada: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS II)

David C. Mendelssohn1, Jean Ethier2, Stacey J. Elder3, Rajiv Saran4,5, Friedrich K. Port3 and Ronald L. Pisoni3 NDT- March 2006; 21: 721 - 728. 2006

70 %46 % 66 %

Fig. 1. Vascular access use among prevalent HD patients in Canada, Europe and the USA in DOPPS II, 2002–2003 (n = 6460). From data collected on a prevalent cross-section of HD patients at 252 dialysis units participating in DOPPS during 2002–2003 from Canada, Europe (France, Germany, Italy, Spain, Sweden and the UK) and the

USA. Sample weights were employed to account for the differing proportions of patients sampled in each facility.

Haemodialysis vascular access problems in Canada: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS II)

David C. Mendelssohn1, Jean Ethier2, Stacey J. Elder3, Rajiv Saran4,5, Friedrich K. Port3 and Ronald L. Pisoni3 NDT- March 2006; 21: 721 - 728. 2006

33 % 25 %18 %

Colonia de bacterias dentro de la capa de biofilm, sobre la superficie de un catéter vascular

Raad I. Intravascular catheter related infections. Lancet 1998; 351:893-898

Thromboses, infection

Venous Catheter AVF or AVGAVF or AVG

Venous catheters are a necessary bridge to perform HD when there is an AVF-AVG complication or at the initiation of HD

Initiation of HD

Venous Catheter AVF or AVG

HD

RT

PD

Three treatment options for


HDavf

RT

PDHDcat

treatment options for


Three or four ?

69

31

0

10

20

30

40

50

60

70

Catheter AVF

%

%

%

ASN 37th Annual Meeting.2004

ESRD patients arriving in an emergency situation for the first dialysis treatment

Juan Fernández-Cean

Patients with venous catheter at the initiation of HD

ESRDPatients

PDPenetration

PDPatients

Argentina 24,740 4.9% 1,186Puerto Rico & Caribbean 9,020 7.1% 566Colombia 18,526 35.2% 5,711Brazil 77,250 10.4% 7,713Central America 6,576 51.2% 3,346Chile 13,110 5.4% 632Ecuador 3,019 10.7% 262Mexico 48,489 76.5% 35,811Peru 5,560 16.7% 928Venezuela 9,569 22.2% 2,018

Total LA 215,859 28.4% 58,173

LA DIALYSIS OVERVIEW: ESRD AND PD Patients

Infective endocarditis in chronic haemodialysis: two treatment strategies

Juan Fernández-Cean, Asunción Alvarez, Sergio Burguez, Graciela Baldovinos, Patricia Larre-Borges and Mercedes Cha

Nephrol Dial Transplant (2002) 17: 2226-2230

Infective Endocarditis, incidence in

general population and in chronic dialysis (1996)

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5

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20

25

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45

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11 Abbott K et al. Hospitalization for Bacterial Endocarditis after initiation of Chronic Dialysis in the United States.

Nephron 2002;91:203-209

Infective Endocarditis in chronic HDIn-hospital mortality

USA 1990 - 1997 30% Robinson,AJKD 30:521-4, 1997

Uruguay 1995 - 2000 29%Fernández,NDT 17:2226-30, 2002

Country Year Mortality

HD General

Francia 1992 - 1994 43% 17%HanslikNDT, 12:1301-2,1997

population

IE HD with a new venous catheter (as a bridge)

HD Removal of the infected vascular access AVF, AVG or

Venous catheter

Infective Endocarditis and vascular access

PD (as a bridge)

IE

PD (n: 12)

HD (n: 21)

HD (n: 9)


Juan Fernández-Cean, Asunción Alvarez, Sergio Burguez, Graciela Baldovinos, Patricia Larre-Borges and Mercedes Cha Nephrol Dial Transplant (2002) 17: 2226-2230

Period: 1995 - 2000

Vascular access removal

HD (9) PD (12) P All

Age 65 + 12 58 +16 NS 61 + 14

SEX m/f 4/5 7/5 NS 11/10

Diabetes 2 0 NS 2

Cancer 2 1 NS 3

Valv. disease 4 4 NS 8

Prosthetic valve

1 2 NS 3

Time in HD (months)

48 + 45 63 + 47 NS 56 + 46

Characteristics of patients

Two treatment strategies in infective Endocarditis in HDC (n= 21) - Mortality

All 21 6 28.6 %

Patients Number Mortality of deaths

HD 9 5 55.5 %

PD 12 1 8.3 %

P: 0.03

Nephrol Dial Transplant (2002) 17: 2226-2230

EI

PD (12)

HD (21)

HD (9)


Juan Fernández-Cean, Asunción Alvarez, Sergio Burguez, Graciela Baldovinos, Patricia Larre-Borges and Mercedes Cha Nephrol Dial Transplant (2002) 17: 2226-2230

5

1

3

8

4

Venous Catheter AVF or AVGAVF or AVG

Initiation of HD

Venous Catheter AVF or AVG

PD

PD

PD could also be used as a bridge when there is an AVF complication or at the initiation of HD

Thromboses, infection

These results suggest that if PD is utilized as a bridge to HD, the hospitalization and mortality associated with infectious endocarditis in chronic HD patients may be significantly reduced.

In those case where the use of a central venous catheter is being considered, PD can be applied as a safer transitory solution, “a bridge”, while the patient receives an AV fistula and it matures

La colocación del catéter peritoneal asocia menos complicaciones

DP puede iniciarse inmediatamente luego de colocado el catéter

La frecuencia de complicaciones infecciosas es menor durante su utilización

Se puede planificar un acceso vascular definitivo para HD

Considerar el uso de DP como un “puente”

Perspectives in renal medicine

Hemodialysis access failure: a call to action.

R Hakim and J Himmelfarb. Kidney Int, Vol 54 (1998), pp 1029-1040

Se debe considerar el uso de DP como un “puente” en los pacientes que presentan uremia avanzada y no son candidatos ideales para tratamiento prolongado con DP.

El inicio de tratamiento sustitutivo con DP, en tanto permite que madure la FAV o prótesis, puede mejorar la sobrevida de los accesos vasculares y del paciente.

J. Fernández-Cean*1, G. Baldovinos1, A. Stein2, A. Varela1, V. Matonte3, N. Orihuela4, M. Garau1, I. Olaizola1, C. González1, R. López1, M. Mautone5, M. Pereyra1, Z. Lydia1, A. Petraglia1, R. Lombardi2, S. Orihuela4, T. Gómez4, A. Altuna1, C. Tenca1, E. Carbonell2

1HD, SARI, 2HD, INU, Montevideo, 3HD, CAMEDUR, Durazno, 4PD, Uruguayana, 5PD, Americano, Montevideo, Uruguay

Access related morbidity in hemodialysis and peritoneal dialysis patients

Fernandez-Cean J et al, WCN 2007

Introduction:

Venous catheters (VC) are used as an unavoidable bridge in ESRD patients in HD, at the initiation or when there are complications of the arteriovenous access (AVA). Many publications stress that morbidity and mortality are higher in HD patients treated with VC.


Introduction:

Venous catheters (VC) are used as an unavoidable bridge in ESRD patients in HD, at the initiation or when there are complications of the arteriovenous access (AVA). Many publications stress that morbidity and mortality are higher in HD patients treated with VC.

In this study we analyze the different vascular access (VA) used in a population of chronic HD patients and the related morbidity. The results are compared with those of PD patients.


Introduction:

Venous catheters (VC) are used as an unavoidable bridge in ESRD patients in HD, at the initiation or when there are complications of the arteriovenous access (AVA). Many publications stress that morbidity and mortality are higher in HD patients treated with VC

In this study we analyze the different vascular access (VA) used in a population of chronic HD patients and the related morbidity. The results are compared with those of PD patients.

Our hypothesis is that PD could be safer than VC as a bridge in patients without a usable AVA.

All HD and PD patients treated in 5 dialysis centers (3 HD centers and 2 PD Centers) from January 1, 2004 to November 30, 2006 were included

Variables recorded in the observation period

Demographics: age, sex, diabetes

HD or PD access: type (AVA, VC, PD catheter) date of creation and date of last use Hospitalization days (Hosp-s)

Date of death, Transplantation or lost of follow-up.

Patients and Methods:


HD PD ALL

Patients 198 121 319

Diabetic (%) 22 26 24

Older than 65 (%) 36 25 32


319 patients

HD PD ALL


Diabetic (%) 22 26 24

Older than 65 (%) 36 25 32


319 patients

Access changes 231 14 245 (changes per person-year) (0.50) (0.07) (0.38)

HD PD ALL


Diabetic (%) 22 26 24

Older than 65 (%) 36 25 32

Hosp-days per 754 1072 365 668 1000 person-month

AVA VC


319 patients

Access changes 231 14 245 (changes per person-year) (0.50) (0.07) (0.38)

Conclusion:

These HD patients had a higher rate of change in dialysis access than the PD patients.

In this investigation, morbidity, measured by Hosp-d, is lower in PD than in HD patients with a venous catheter and the difference is statistically significant.

This result fits with our hypothesis and could be a reason to consider PD as a bridge in HD patients without a usable AVA.


Limitations:

Restrospective

Limitations:

Restrospective Prevalent and incident patients

Limitations:

Restrospective Prevalent and incident patients Mortality was not analyzed

VASCULAR ACCESS SITE RELATED INFECTION IN DIALYSIS (V.A.R.I.): a multicenter, prospective, Italian

study. The A.St.R.I.D. project

Rio de Janeiro, 23 April 2007

Aim of the study

1.To assess the V.A.R.I. rates

2.To identify variables associated with them

Participating centres

11 dialysis units: 10-50

technical beds

Study population

Patients: 940 - age: 65±15 years- male 57 %

# vascular accesses: 1221

Total follow-up: 10991 pt-months

Median patient f.u.: 11.2 months

Total access f.u.: 334,306 days

# dialysis sessions: 142,883 treatments

Patient characteristics

# of patients % Housing: alone 72 7,6

nursing home 39 4,1 family 829 88,2

Malnourished: 279 29,7

Diabetics: 189 20,1

HBsAg positive: 41 4,4HCVAb positive: 147 15,6HIV positive: 13 1,4

Karnofsky (median): 86 (IQR: 60-90)

Reported events

V.A.R.I. 18%

Infection not access related

41%

Not infectious event41%

883 events, requiring hospitalization or antibiotic therapy

Distribution of pathogens

Pathogen n %

S. aureus 41 26.1%

S. epidermidis 29 18.5%

Other Coagulase negative Staphylococci 39 24.8%

E. coli 25 15.9%

Klebsiella 1 0.6%

Enterobacter spp. 3 1.9%

P. aeruginosa 5 3.2%

S. malthophilia 5 3.2%

Candida albicans 1 0.6%

Other 8 5.1%

69.4

Factors associated to VARI-1*

Variable Category HR p

Sex F vs M 1.61 0.004

Type of vascular access

(vs AVF) Graft 6.43 <0.001

p CVC 22.47 <0.001

t CVC 28.58 <0.001

HCV yes vs no 1.34 NS

HBV yes vs no 1.65 NS

HIV yes vs no 1.49 NS

* Univariate Cox regression analysis

Factors associated to VARI-2*

Variable Category HR p

Number of dialysissession per week 2.16 NS

Housing (vs. nursing home) living with family 0.49 0.02

living alone 0.89 NS

Karnofsky per 10 points increase 0.82<0.001

Diabetes yes vs no 1.27 NS

Malnutrition yes vs no 1.38 NS

Impaired immune syst. drug related 0.15 0.04disease related 2.12 0.01

* Univariate Cox regression analysis

Multivariate analysis

Only the type of access retained

statistical significance

Infection rates

Infection risk per patient:

1.19 per 100 patient-month

Infection risk per access:

0.38 per 1000 access-days

0.26 per 1000 dialysis sessions

Infection-free survival

0

0.25

0.50

0.75

1

0 200 400 600 800 Access-days

fistula graft permanent CVC temporary CVC

AVF

Graft

pCVC

tCVC

Kaplan Meier analysis

365 730

Conclusion

The incidence of VARI is elevated in dialysis population

The pathogen responsible of infection is mainly Staph Aureus

CVC, either permanent or temporary, have a very high incidence of VARI

AVF remains the “preferred” vascular access and any effort for reducing the use of CVC must be done

Documents

La Dialisis Peritoneal como puente a la Hemodialisis José Divino MD, PhD VP Medical Affairs Baxter Renal Division Latin America Congreso de la Sociedad