update on peritoneal dialysis: new positioning of an older ... · catheter type and exit-site •...

Update on Peritoneal Dialysis: New Positioning of an Older TherapySteven Guest, MDDirector, Medical Consulting ServicesBaxter Healthcare CorporationDeerfield, Illinois, USA

49.4%

33.2%

15.8%

20.0%

17.1%

7.4%

0%

10%

20%

30%

40%

50%

60%

Jalisco (Mexico)New Zealand Netherlands Denmark Canada United States

% P

revale

nt

Pati

en

ts o

n P

DUnderutilization of Peritoneal Dialysis

2

U.S. Renal Data System. USRDS 2013 Annual Data Report.

Peritoneal Clearance

3Image courtesy of Steve Guest, MD

Incidence of ESRD

U.S. Renal Data System. USRDS 2013 Annual Data Report. 4

Incident ESRD patients.

Adj: gender/race; ref: 2010 ESRD patients.

Similar Outcomes- PD and HD

5

Mehrotra R, Chiu Y, Kalantar-Zadeh K, et al. Similar outcomes with hemodialysis and peritoneal dialysis in

patients with end-stage renal disease. Arch Intern Med 2011;171(2):110.

Perl J, Wald R, McFarlane P, et al. Hemodialysis vascular access modifies the associated between

dialysis modality and survival. J Am Soc Nephrol 2011;22:1113-1121.

6

Adapted from:

Perl J, Wald R, McFarlane P, et al. Hemodialysis vascular access

modifies the associated between dialysis modality and survival.

J Am Soc Nephrol 2011;22:1113-1121.

HD-CVC

HD-CVC

Unadjusted

Adjusted

PD, HD-

AVF, AVG

HD- AVF, AVG

PD

7

Catheter Use at First Outpatient HD

8

9

Medicare Spending Per Patient Year by Type of Renal Replacement Therapy

U.S. Renal Data System. USRDS 2013 Annual Data Report.

.

Costs of Caring for Patients with ESRD

10

U.S. Renal Data System. USRDS 2013 Annual Data Report.

Changes in Dialysis Reimbursement to Providers in the USA

11

Golper TA, Guest S, Glickman JD, Turk J, Pulliam JP. Home Dialysis in the New USA Bundled

Payment Plan: Implications and Impact. Perit Dia Int. 2011;31;12-16 .

The “Bundle”

12

49.4%

33.2%

15.8%

20.0%

17.1%

7.4%

0%

10%

20%

30%

40%

50%

60%

Jalisco (Mexico)New Zealand Netherlands Denmark Canada United States

% P

revale

nt

Pati

en

ts o

n P

DUnderutilization of Peritoneal Dialysis

13

U.S. Renal Data System. USRDS 2013 Annual Data Report.

Most Patients Are Medically Eligible for PD

1. Jager KJ, Korevaar JC, Dekker FW et al. The effect of contraindications and patient preference

on dialysis modality selection in ESRD patients in the Netherlands. Am J Kidney Dis. 2004;43:891-899.

2. Mehrotra R, Marsh D, Vonesh E, et al. Patient education and access of ESRD patients to renal replacement

therapies beyond in-center hemodialysis.. Kidney Int. 2005;68:378-390.

>1000 ESRD Patients Starting Dialysis

The prevalence of medical contraindications to PD

(23% to 24%) is similar to the 17% to 21% reported …

from other parts of the world.2

% Medically Eligible for PD

Netherlands1 83%

U.S.2 76%

Surveys of Nephrologists

1. Troidle L, Kliger A, Finkelstein F. Barriers to utilization of chronic peritoneal dialysis in network #1, New England. Perit Dial Int.

2006;26:452-457.

2. Mendelssohn DC, Mullaney SR, Jung B, et al. What do American nephrologists think about dialysis modality selection? Am J Kidney

Dis. 2001;37:22-29.

3. Jung B, Blake PG, Mehta RL, Mendelssohn DC. Attitudes of Canadian nephrologists toward dialylsis modality selection. Perit Dial

Int. 1999;19:263-268.

4. Jassal SV, Krishna G, Mallick NP, Mendelssohn DC. Attitudes of British Isles nephrologists toward dialysis modality selection: a

questionnaire study. Nephrol Dial Transplant. 2002;17:474-477.

Country Year% of ESRD patients

nephrologists feel should be

on PD N

USA1 2006 29% 59

USA2 2001 33% 240

Canada3 1999 37% 192

British

Isles4 2002 38% 108

Home based

Avoids needles

With cycler machines- exchanges done at night time

Travel, portability

Flexible scheduling, day to day to allow for dialysis to revolve

around the life schedule, not life revolving around HD

schedule

Challenges

• Storage of product

• Fear of doing medical procedure at home

Lifestyle Considerations of PD

16

Driving analogy

Patient Response - “I could never do that”

The Importance of Patient Education

Golper T. Patients education: can it maximize the success of therapy? Nephrol Dial

Transplant. 2001;16(suppl 7):20-24.

The National Pre-ESRD Education Initiative Survey

After Pre-ESRD Education, 45% Chose PD

and 33% Actually Started PD

PD

HD

N = 2400100

80

60

40

20

0

Choice of Modality Actual Modality Started US Incidence

Pe

rce

nta

ge

of P

atie

nts

Rioux J, Cheema H, Bargman JM, et al. Effect of an in-hospital chronic

kidney disease education program among patients with unplanned

urgent-start dialysis. Clin J Am Soc Nephrol 2011;6:799.

19

228 Acute Start Between 2005-2009228 Acute Start Between 2005-2009

Education program before dischargeEducation program before discharge

132In-center HD

132In-center HD

71Home 71

Home

49 PD49 PD 22 HHD22 HHD

25Died

(before discharge)

25Died

(before discharge)

Patients’ flow through the study

20

Adapted from:

Rioux J, Cheema H, Bargman JM, et al. Effect of an in-hospital chronic kidney disease education

program among patients with unplanned urgent-start dialysis. Clin J Am Soc Nephrol 2011;6:799.

Physician Preference For Modality

21

Merighi JR, Schatell DR, Bragg-Gresham JL, et al. Insights into nephrologist training, clinical

practice, and dialysis choice. Hemodial Int 2012;16:242-251.

N=629

Distribution of nephrologists’ modality choice for themselves

Adapted from: Merighi JR, Schatell DR, Bragg-Gresham JL, et al.

Insights into nephrologist training, clinical practice, and dialysis choice.

Hemodial Int 2012;16:242-251.

Select practice advances

Infectious complications

Surgical approaches

PD in the late-referred patient

Integrated care approach

What is current status of PD in USA?

23

Tenckhoff Modifications to Boen Technique

24

McBride P. Fred T.S. Boen, M.D. (1927……). Perit Dial Int 1982;2:50–53.

Boen’s Portable Cycler—U Washington

Home

Peritoneal

Dialysis

Baxter Museum, Largo Florida

Older Cyclers- PAX Extra

Current Cycler Machines

Rx Only. For Safe and proper use of these devices refer to respective operator’s manual.

Dialysis Completed at Night

28 Rx Only: For safe and proper use of these devices refer to respective operator’s manual

Univ. of Pittsburgh-Infection Rates Reduced In PDAs Innovations and Protocols Are Introduced

Bender FH, Bernardini J, Piraino B. Prevention of infectious complications in peritoneal dialysis:

best demonstrated practices. Kidney Int, 2006;70:S44-S54.29

ESI prophylaxis

Spike assist device

Double bag system introduced

Mupirocin Prophylaxis

30

Approaches to Reduce Exit-Site Infections

1

2

*Risk of exit-site infection, mupirocin : without mupirocin.

†P < 0.001 vs. placebo or no treatment.

Tacconelli E, Carmeli Y, Aizer A, et al.Mupirocin prophylaxis to prevent Staphlococcus aureus infection

in patients udergoing dialysis: a meta-analysis. Clin Infect Dis. 2003;37:1629-1638.

Gentamicin Prophylaxis

*P < 0.01 vs. mupirocin

Bernardini J, Bender F, Florio T, et al. Randomized, double-blind trial of antibiotic exit site cream for

Prevention of exit site infection in peritoneal dialysis patients. J Am Soc Nephrol 16: 539-545, 2005.31

Rates of Exit-Site Infection (ESI) in PD

*

*

cream

Peritonitis Outcomes

Percent (%) of All Episodes (N = 666)

Adapted from:

Bunke CM, Brier ME, Golper TA. Outcomes of single organism peritonitis in peritoneal dialysis:

gram negatives versus gram positives in the Network 9 Peritonitis Study. Kidney Int. 1997;52:524-529.

CoagNS=coagulase-negative staphylococci; nP-GNR=non-pseudomonal gram negative

Resolved Hospital Catheter

Removed

Transfer Death0

10

20

30

40

50

60

70

80

90

Pe

rce

nt o

f A

ll E

pis

od

es

CoagNS S aureus nP-GNR

• Adequate training time

• Protocols (Hand washing, masks)

• Flush before fill

• Exit site topical antibiotics

• Exit site location

• Alcohol based hand washes or dilute bleach solutions

Reduce Infections

33

Probability of Remaining Free of Mechanical Flow Obstruction

At 24 Months Significantly Increased by Newer Techniques

P < 0.0001 vs. open or basic technique

Crabtree JH et al. Am Surg. 2005;71:135-143.34

Rectus sheath tunneling before entering the peritoneal cavity

Adjunctive Laparoscopic Procedures

35

Rectus Sheath Tunneling

Permission from John Crabtree, MD36

Permission from John Crabtree, MD37

Pelvis

Redundant

Omentum

Omental Wrap

Redundant Omentum

Courtesy of John Crabtree MD38

Omentopexy

Guest S. Handbook of Peritoneal Dialysis, 2011, pg 65.39

Minimally Invasive Surgery

Effective use of laparoscopy for long-term peritoneal dialysis access

Crabtree JH, Burchette RJ. Effective Use of Laparoscopy for Long-term

Peritoneal Dialysis Access. Am J Surg 2009;198,135-141.40

John H. Crabtree, M.D.a,*, Raoul J. Burchette, M.S.b

Laparoscopy Permits Diagnosis of Unsuspected Hernias

Courtesy of John Crabtree MD41

• Body habitus

• Occupations or responsibilities

that require bending at the

waist

• Factors affecting infection risk:

stoma, fecal incontinence

Exit Site Location to Suit Special Needs

42Crabtree JH. Kidney Int Suppl. 2006;70:S27-S37.

Crabtree JH. Kidney Int Suppl. 2006;70:S27-S37.

Chronic Infection - Poor Exit-Site Location

43 Courtesy of John Crabtree MD

A. Missouri catheter is

standard with kit

B. Presternal extension tube

C. Substituted Tenckhoff

catheter

D. Titanium connector

Extended Dialysis Catheter System

44 Courtesy of John Crabtree MD

Catheters cut to appropriate length

Courtesy of John Crabtree MD45

Joined with titanium connector and 2-0

polypropylene suture.

Obese Abdomen with Exit-Site Out of Sight and Under Belt Line

46

Preoperative Postoperative

Courtesy of John Crabtree MD

Presternal Exit-Site is Easily Visualized and Remote from Urostomy

47

Urostomy

Obesity

Presternal Exit-Site

Permission from John Crabtree, MD48

Advanced Planning

49

Courtesy of Steve Guest MD

Instructional DVD, 2nd Edition

51

John Crabtree MD

Kaiser Permanente Bellflower, CA

Funded and Distributed by Baxter Healthcare Corporation

Didactic Instruction:

• Introduction for surgeons to

concepts, issues and economics

of PD

• Preoperative assessment,

planning, and preparation

• Implantation techniques

• Salvage procedures for infectious

and mechanical complications

Surgical Laboratory:

• Preoperative mapping for

catheter type and exit-site

• Laparoscopic simulator for

rectus sheath tunneling

• Laparoscopic simulator for

omentopexy

• Simulator for extended

catheter placement

• Simulator for embedding

catheters

52

Peritoneal Dialysis University for Surgeons

www.pdusurgeons.com

Laparoscopic Simulator

Reusable

laparoscopic port

sites (to accept 5

mm ports).

Two reusable holes

through this port site

for laparoscope or

omentopexy needle

(one hole to accept

5 mm port and 2nd to

accept omentopexy

needle.

Reusable rectus

sheath tunneling

port site (to

accept 7-8 mm

port).

Umbilicus

53

Probability of Remaining Free of Mechanical Flow Obstruction

At 24 Months Significantly Increased by Newer Techniques

P < 0.0001 vs. open or basic technique

Crabtree JH et al. Am Surg. 2005;71:135-143.54

Ultrasound / Fluoroscopic Placement

Ivan Maya MD55

Peel-away Sheath In Place

Courtesy of Ivan Maya MD56

Tunnel Creation

57 Courtesy of Ivan Maya MD

Final View

Courtesy of Ivan Maya MD58

Urgent Start PD Program

59

BUN 120

Cr 14

Femoral Catheter

IJ temporary or tunneled catheter

Urgent HD

Urgent Start PD

60

BUN 120

Cr 14

Femoral Catheter

IJ temporary or tunneled catheter

Urgent HD

Urgent PD catheter placement

Urgent-Start PD

61Ghaffari A. Am J Kidney Dis 2012;59:400-408.

62

“…at our center, the interventional radiology group is the main

group placing urgent tunneled HD catheters and therefore was

the ideal service for placing urgent PD catheters, essentially

substituting one procedure for another…”

Ghaffari A. Urgent-Start Peritoneal Dialysis: A Quality

Improvement Report. Am J Kidney Disease 2012;59: 402.

Urgent Start PD Program

63

BUN 120

Cr 14

Femoral Catheter

IJ temporary or tunneled catheter

Urgent HD

Urgent interventional

or surgical PD catheter

?

Urgent Start PD

64

BUN 120

Cr 14

Femoral Catheter

IJ temporary or tunneled catheter

Urgent HD

Urgent interventional

or surgical PD catheter

Hospitalized- low volume, recumbent PD

Outpatient- low volume, recumbent PD

Urgent Start PD Program

65

BUN 120

Cr 14

Femoral Catheter

IJ temporary or tunneled catheter

Urgent HD

Urgent interventional

or surgical PD catheter

Hospitalized- low volume, recumbent PD

Outpatient- low volume, recumbent PD

Chronic IPD M-W-F for 2 weeks

Then

Train for Home

The Influence of Dialysis Treatment Modality on Remaining RRF

Adapted from:

Lysaght MJ, Vonesh EF, Gotch F, et al. The influence of dialysis treatment modality on the decline of

remaining renal function. Trans Am Soc Artif Intern Organs. 1991;37:598-604.66

N = 57

N = 58

The difference persists after adjustment for age,

sex, hypertensive status and the use of ACEI

• Fluid removal

• Sodium removal

• Phosphate removal

• Middle molecule clearance

• Vitamin D production

• Erythropoietin production

• Reduced Left ventricular hypertrophy

• Survival benefit

Benefits of Residual Kidney Function

67

5 L/wk per 1.73 m2 GFR

• 12% decrease in relative risk (RR) of death

250 mL increment in urine volume

• 36% decrease in the RR of death

RRF & Survival Re-analysis of CANUSA

Bargman JM, Thorpe KE, Churchill DN. Relative contribution of residual renal function and peritoneal

clearance to adequacy of dialysis: a reanalysis of the CANUSA study. J Am Soc Nephrol 2001;12:2158-

2162.

68

Probability of Anuria

Adapted from:

Li PK, Chow KM, Wong TY, et al. Effects of an angiotensin-converting enzyme inhibitor on residual renal

function in patients receiving peritoneal dialysis. A randomized, controlled study.

Ann Intern Med. 2003;39:105-112.69

ARBs Preserve RRF

Suzuki H, Kanno Y, Sugahara S, et al. Effects of an angiotensin II receptor blocker, valsartan, on residual

renal function in patients on CAPD. Am J Kidney Dis. 2004;43:1056-1064. 70

Diuretics in Peritoneal Dialysis Patients

Medcalf JF, Harris KPG, Walls J. Role of diuretics in the preservation of residual kidney function in

patients on continuous ambulatory peritoneal dialysis. Kidney Int. 2001;59:1128-1133.

71

Possible Membrane PreservationMesothelial RAS System

72

Effect of Valsartan Versus Lisinopril on Peritoneal Sclerosis in RatsS. Duman, S. Sen, C. Duman, D.G. Oreopoulos

73

A. Normal

B. PD Solution

C. Valsartan

D. Lisinopril

Duman S, et al. Int J Artif Organs. 2005;28:156-163. 74

RAS System and the Peritoneum

75

Nessim SJ, Perl J, Bargman JM. The renin-angiotensin-aldosterone system in peritoneal dialysis: what

is good for the kidney also good for the peritoneam? Kidney Int 2010;78:23-28.

Integrated Care Concept

Davies SJ, Van Biesen W, Nicholas J, Lamiere N. Integrated care.

Perit Dial Int 2001;21:[Suppl 3]:S269-S274.

ESRD Life Plan

CKD

Nurse Educator

ESRD: Initial

Renal DietitianSocial Worker

PeritonealDialysis

Hemodialysis

Transplant

“Transition Points”

Death/Treatment Withdrawal

Late

Monthly VisitAcute Visits

Post HospitalizationAcute Transition Points

Continuing Care

Home HD

MD

Design a SEQUENCE

To Maximize Survival

ESRD Life Plan

CKD

Nurse Educator

ESRD: Initial

Renal DietitianSocial Worker

PeritonealDialysis

Death/Treatment Withdrawal

Late

Monthly VisitAcute Visits

Post HospitalizationAcute Transition Points

Continuing Care

Home based

Initial survival advantage

Preserve RRF

Preserve arms

MD

PD Is Not Just a Viable RRT Option

CKD

Nurse Educator

ESRD: Initial

Renal DietitianSocial Worker

PeritonealDialysis

Death/Treatment Withdrawal

Late

Monthly VisitAcute Visits

Post HospitalizationAcute Transition Points

Continuing Care

Home HDHome based

Initial survival adv.

Preserve RRF

Preserve arms

MD

PD Is Not Just a Viable RRT Option

CKD

Nurse Educator

ESRD: Initial

Renal DietitianSocial Worker

PeritonealDialysis

Transplant

Death/Treatment Withdrawal

Late

Monthly VisitAcute Visits

Post HospitalizationAcute Transition Points

Continuing Care

Home HDHome based

Initial survival adv.

Preserve RRF

Preserve arms

MD

ESRD Life Plan

CKD

Nurse Educator

ESRD: Initial

Renal DietitianSocial Worker

PeritonealDialysis

In CenterHemodialysis

Transplant

Death/Treatment Withdrawal

Late

Monthly VisitAcute Visits

Post HospitalizationAcute Transition Points

Continuing Care

Home HDHome based

Initial survival adv.

Preserve RRF

Preserve arms

MD

• The ESRD population continues to rise

• Financial constraints dictate that we consider cost effective

therapies

• Patient education on the home option is critical

• Survival studies indicate similar long term survival HD vs PD

• Peritonitis rates have decreased

• Novel surgical approaches have improved long-term catheter

function

• PD offers many lifestyle benefits for the appropriate patient

population

• “Life Plan” approach for integrated care

Conclusion

82

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Steven_guest@baxter.com