Why Consider Home Dialysis? Empower the patient!

Transcription

1 Why Consider Home Dialysis? Empower the patient! Michael Kraus, MD FACP Professor of Clinical Medicine Indiana University School of Medicine

2 Arguments against increased frequency home dialysis 1. Too small of studies not enough evidence 2. Studies only cherry picked patients 3. Too much burden of therapy 4. Costs are not justified

3 Case 1 37 y.o. mother of 3 with ESRD from IgA nephropathy. On HD for 5 years, likes to travel but cannot find a transient unit. Feels bad for 5 hours post dialysis and cannot keep up with her kids can we do better?

4 Case 2 52 y.o. male with ESRD from GN. Now with ESRD for 6 years. Had been working until three years ago, when he retired due to fatigue and decreased physical and cognitive function. Wants to travel with his wife and return to work. Not a transplant candidate.

5 Case 3 68 yo male with a bad heart. On dialysis for three years. Blood pressure high before dialysis and very low after dialysis. Feels terrible after dialysis. No longer able to walk any distance. His nephrologists say he is doing as well as can be expected. On exam, not ambulatory, cheyne-stokes respirations, tardive dyskinesia

6 Reasons to return to Home Dialysis Why go home? To have the chance to: Improve Outcomes Increase Quantity Increase Quality Improve Satisfaction Improve Economics Now and the future. Populations and Individuals

7 Fix the problem Improvements in dialysis Bicarbonate-based dialysis Ultrafiltration control Biocompatible membranes Your Best is NOT Anemia management Good enough Bone health management Low-calcium dialysate Water quality Vascular access management Newer phosphorus binders Better antihypertensive agents

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9 Adjusted mortality rates, by vintage Figure 6.9 (Volume 2) Period prevalent dialysis patients; adjusted for age, gender, race, & primary diagnosis. Dialysis patients, 2005, used as reference cohort. 67% Mortality at 5 years with both HD and PD.

10 Cardiovascular Disease Sarnak MJ, et al, Am J Kidney Dis 2000;35(4 Suppl 1) S:

11 Increased cardiac deaths after weekends Deaths on HD n = 326,728 Deaths % of Total * * * * Bleyer, et al Kidney Int 1999, 55

12 Cardiovascular Risks with ESRD Based on Our Experience: Increased UF associated with increased risk of death. Increased LVH associated with increased risk of cardiac death in ESRD.

13 Hypertension Diabetes Smoking Hyperlipidemia Genetic Factors LVH Htn Anemia Chronic Fluid Overload Chronic Inflammation Cardiovascular risks Many Factors May Be Modifiable with Increased Frequency Dialysis Phosphorous and Calcium x Phosphorous Product Vitamin D Dialysis off Days

14 Quality of Life In-center Dialysis Inflexible Schedule Hypertension and Drugs Travel To dialysis, Vacation Challenging to work or continue working Post dialysis fatigue Cognitive function/sense of well-being

15 ESRD spending, by payor Figure 11.4 (Volume 2) Medicare costs obtained from claims files, & include all Medicare as primary payor claims as well as amounts paid by Medicare as secondary payor (MSP). Medicare patient obligations estimated as the difference between the Medicare payment & the Medicare allowable cost, HMO costs estimated as the number of HMO months times the Medicare AAPCC rate, & organ acquisition costs estimated as $25,000 per transplant. Non-Medicare estimate includes all non- Medicare patients (using AAPCC), the primary payor estimate for MSP patients, & estimated patient obligations.

16 Review Expensive therapy VERY expensive Poor quality 24% mortality

17 What can we do? Today - Novel approaches to Home Dialysis and increasing frequency SDHD, Nocturnal 1 Tomorrow Smaller devices, Wearable devices, Implantable devices, biologic devices, continuous devices 1 There are currently no systems with a specific nocturnal indication. NxStage is currently nearing completion of an FDA approved IDE Clinical Study for this specific indication.

18 What we Do -USRDS 2008 data Modality # of patients % of patients In- center HD 325, % CAPD 10, % CCPD 15, % Home HD 2, %

19 Options for home therapy Peritoneal Dialysis Traditional Hemodialysis Thrice weekly, 3 5 hours Short Daily Hemodialysis 4-7 days per week, 2-3 hours per session Nocturnal Dialysis 1 Extended dialysis 3 6 days per week, 6-8 hours per session Devices Conventional devices Low dialysate flow devices 1 There are currently no systems with a specific nocturnal indication. NxStage is currently nearing completion of an FDA approved IDE Clinical Study for this specific indication.

20 Limited options Note: Only NxStage is FDA cleared for home hemodialysis with a trained partner. No devices are cleared for nocturnal dialysis.

21 Low flow dialysate device New therapy with less experience Growing use for home and CRRT Designed for use in the home Standard grounded 110 v required Swap device for PM or repair (24 hour turnaround) Portable 75 pounds Flexible system FDA cleared in 2005 for home hemodialysis

22 Dialysate Bags with NxStage Lactate based therapy in home setting. Prepackaged Bags Sterile Storage and delivery requirements 5 liters = 11 pounds liters daily use= typical Portable 1 or 2K, 40 or 45 Lactate, 3 calcium

23 Dialysate Generation with Lactate based therapy in home setting Self-contained, disposable DI system Generates AAMI- quality dialysate Decreased Storage and delivery requirements No lifting bags Generates 60 L dialysate in 7 hours - good for three days Not portable Simple plumbing and standard electricity NxStage

24 Purification Pack details Purification Pack Sediment Filter UV Light Carbon Resin Dual-bed Resin X3 Mixed-bed DI Resin Ultrafilter X2 0.2 micron filter Water Dialysate Sack Sensor 1 Sensor 2 Ultrapure Water For further details see NxStage APM151 Dialysate Preparation Primer

25 Traditional Comparison of Hemodialysis Devices Low Dialysate Flow (NxStage) Comfort with device and Rx. Qb 400, Qd 800 Dedicated Electric Complicated Water Treatment Not portable Supplies, Daily set-up Not cleared for home use Novel device, Rx and dosing Qb 400, Qd cc/min Standard Electric Simple water or bagged fluids Portable 75 pounds Supplies, Daily set-up Only device cleared for home dialysis

26 Roadblocks to Patient Access Can t get clearance with low flow dialysate dialysis devices

27 Prescription writing with Low Dialysate Flow Dialysis

28 Optimizing dialysis Per treatment single pool Kt/V GUS Calculate Kt/V using Daugirdas II formula Minimal target 0.45 give std Kt/V of I like minimum of 0.5 Cost for patient/partner -Time and Frequency Can be adjusted for most, 3 hours for larger (6/wk) Kt rather than Kt/V may be important for smaller Efficacy Listen to the patient Quality = Benefit/Cost

29 Prescribing Therapy StdKt/V (Gotch, KI 2000)

30 New way to dialyze Fluid efficiency illustrated 600 Urea Clearance (ml/min) Low Dialysate Flow 3:1 or greater Qb:Qd >95% fluid efficiency 1l fluid: 1l clearance liters dialysate liters dialysate Conventional Therapy 50% fluid efficiency 80-90% R.O. rejection 10-20l fluid: 1l clearance Dialysate Flow Rate (ml/min) Qb=300 Qb=400 Qb=500 Qb=600 Source: Data was calculated using "Membranes and Filters for Hemodialysis Database 2001 by Ronco et al.

31 Typical Prescription Do NOT prescribe time as a variable 20 liter dialysate, 1 K and 45 lactate Blood Flow 450 cc/min, FF 33%, 3,000 units heparin bolus, EDW 98 kg

32 Time vs. Weight (4/09) /-23 Min Weight (Kg) 84+/-24 Kg

33 Std Kt/v vs. Weight (4/09) /-0.33 Std Kt/V Weight (kg)

34 Control of Dialysis quantity With Low dialysate flow dialysis clearance and time are dependent on: Volume of dialysis Amount of ultrafiltration Blood flow FLOW FRACTION

35 Flow Fraction Flow fraction is the dialysate flow divided by blood flow expressed as a percent Range 25 35% USUALLY Dialysate flow is effluent dialysate Effluent dialysate =Dialysate inflow plus ultrafiltration Therefore this determines time and clearance

36 Increasing Kt/V Increase time Decrease blood flow, Decrease Qd/Qb Increase Clearance Increase dialysate Increase UF Increase frequency

37 Why go Home? Control of Hypertension and Extracellular Volume

38 Hypertension Control Based on our experience: 85% of patients on a daily therapy will discontinue their blood pressure medications Most patients dry-weight will be lowered 2-5 kg during daily dialysis training

39 Blood Pressure with Low Dialysate SDHD N = 25 Retro In-Center (10 wks) SBP 150 ± ± 20.5 < Home (20 wks) 127 ± 21.2 < DBP 81.8± ± 12.9 p= ± 10.2 p=0.010 Pulse Pressure 68.2 ± ± 15.8 < ± 19.1 p= p values are change from retrospective period Kraus et al, Hemodialysis International 2007;11.

40 Changes in Antihypertensive Medication Usage # of patients taking Antihypertensives 20 # of drugs taken Retrospective (20 patients) In-Center Home (13 patients) Mean number of drugs taken (per patient) Retrospective In-Center Home Total number of drugs dose increased 2 Total number of drugs dose decreased 12 Total number of drugs dose unchanged 5 Kraus et al, Hemodialysis International 2007;11.

41 Control of Phosphorus

42 Phosphate Binder Usage 6 6 N=40 Tabs of Phosphate Binders Pre 1 YR 2 YR 3 YR 4YR 5YR Amount of Time on Daily Nocturnal Hemodialysis Lockridge, et al, Hemodialysis International :61.

43 Improved Phosphorous Control Short Daily Hemodialysis 17% to 31% reduction in phosphorous levels 15% reduction in Ca x P product 24% to 75% reduction in phosphate binders ASAIO J 2001;47: , Kidney Int 2003;64: , Am J Kidney Dis 2001;37:S95-98., Nephrol Dial Transplant 1998;13: , Sem Dial 2004;17: , J Am Soc Nephrol 2001;12:262A.

44 Quality of Life

45 Adjusted admissions & days, by modality Figure 6.3 (Volume 2) Period prevalent ESRD patients; rates adjusted for age, gender, race, & primary diagnosis. ESRD patients, 2005, used as reference cohort.

46 Hospitalizations SDHD with NxStage System One Number of events Retrospective In-Center Home Total number of hospitalizations Number of follow-up days Rate of hospitalization/#follow-up days Kraus et al, Hemodialysis International

47 The FREEDOM Study RECOVERY TIME *Home daily therapies are not for everyone. They require a patient and partner who are committed to being trained on and following the guidelines for proper system operation, as well as their dialysis prescription, which may require treatments up to six days per week. The NxStage System One is a prescription device, and, like all medical devices, involves some risks. Patients should consult with their doctor to understand the risks and responsibilities of home and/or daily hemodialysis using the NxStage System One. The experiences reported here may not necessarily be experienced by another patient. All patients differ, and their experiences will vary.

48 The FREEDOM Study DEPRESSIVE SYMPTOMS

49 The FREEDOM Study Quality of Life Scores

50 ADC 2010 Medical Outcomes Studies Sleep Survey and International Study Group Rating Scale RLS and sleep disorders improved at 4 months. Overall Sleep Quality improved (p < 0.001) Reported adequacy, daytime somnolence, initiation and maintenance, and respiratory disturbances all improved Reduction in reports of RLS 36% of patients with RLS reported resolution.

51 ASN 2009 Daily Hemodialysis (DHD) Reduces the Need for Anti-Hypertensive Medications Baseline Month-4 Month-12 Global P value Number of prescribed A-H medications * * < % not prescribed A-H medications 12 (21%) 22 (39%) 27 (47%) < Jaber et al ASN 2009

52 ASN 2009 Daily Hemodialysis (DHD) is Associated with Lower than Expected Mortality SMR = 0.39 (95% CI = ) 190 pts, 332 days, 12 deaths in 2072 months. Miller B et al ASN 2009

53 SMR for HHD p=0.03 P<0.005 P<0.05 P<0.001 P< KI 1996 Hemo Int 2006 JASN 2007 NDT 2008 On File 2008 Therapy HHD SDHD Nocturnal SDHD SDHD Patients # Centers NR >300 Locations US US Australia US, Eur US

54 Practical Experience Retention is essential for success Give patients what they expect. Realistic expectations Know your results and work to improve.

55 Defining Outcomes Required data Quality Indicators Water Quality Home visits Quality Indicators Usual Novel Goal is to optimize therapy for the individual and for the center

56 Clarian 2008 SDHD 32 started, 26 left Fistula 46%, PC 34% - 1 infection/8.9 months 79% Hgb >10.5, 10% < hospitalizations/yr 1 death every 119 patient months

57 New Markers of QOL Stay on therapy Perception of well-being Quality of therapy for patient and spouse Normal life Work Travel Pregnancy

58 Raw Technique Survival CAPD 1/2002 5/2007 SDHD 3/2004 5/2007 SDHD CAPD Data on file, Indiana University Medical Center/Clarian Health Partners

59 Censored Technique Survival Censored for transplant, death, and renal recovery SDHD CAPD Data on file, Indiana University Medical Center/Clarian Health Partners

60 Many patients quit working in the first 90 days of ESRD care All Patients Ages at 90 Days, May 1995-June ,000 44, % 41% No longer working At 90 days post initiation 40,000 30,000 26, % 28% no longer working At 90 days post initiation 20,000 10,000 10, % 7, % 4,301 3, % 48.8% 0 Hemo PD Transplant N=127,518 N=22,180 N=7,036 6 Mo Prior At Initiation Witten et al ASN presentation 2004

61 Employment Statistics 22/80 patients working at time of training All 22 either continue to work or did so until off of therapy (18 on SDHD presently) 3 patients have returned to the workforce 3 patients went back to school (college or tech) Kraus et al, 18: A

62 Percent working - Prevalent IU SDHD Program and Network 9/10 Working Age Hemodialysis Population Incident USRDS 2007 Overall Clarian/IU SDHD May 2007 Prevalent State of Indiana HD 2005 Prevalent Network9/ Prevalent USRDS 2007 Overall Incident 0 Kraus ASN 2007, The Renal Network 2005 annual report, USRDS 2007

63 Planes, Trains and Automobiles 35% of all patients have traveled 42% of prevalent patients have traveled > 40 trips > 35 states > 6 plane 2 Cruises 3 RV 1 bus 1 train (Idaho) multiple Automobile Kraus et al, 18: A.

64 Pregnancy! Toronto Nocturnal Program ( ) 5 women, 7 pregnancies 6 live births Maternal Age Gestational age 37 weeks and wt 2.6 kg Normalized pre HD BUN Increased from 36 to 48 hours per week 15% of child bearing age females over 6 year period Barua et al Clin J Am Soc Nephrol 3: , 2008

65 Clarian Experience The sickest patients frequently experience the greatest benefit. SDHD does not: Cure Cancer Improve severe COPD Correct other end stage diseases.. SDHD might: Change the primary diagnosis with death Only 1/3 of patients die of cardiac disease (MI, Sudden death, Cardiac other)

66 Roadblocks to Care Of course home dialysis patients do better, they are cherry picked and the healthiest patients Program only takes healthy patients.

67 Case 3 68 yo male with a bad heart. On dialysis for three years. Blood pressure high before dialysis and very low after dialysis. Feels terrible after dialysis. No longer able to walk any distance. His nephrologists say he is doing as well as can be expected. On exam, not ambulatory, cheyne-stokes respirations, tardive dyskinesia

68 Characteristics active patients 66% Male, 66% Caucasian Age Weight kg Cause of ESRD 24%DM, 16%FSGS, 12% vasculitis (half are active), 8% BMtx/MM, 12%htn Co-morbid diseases Myeloma, BMTx, AIDS, CHF, s/p Amputation Visually impaired, cachexia, liver transplant 1 paraplegic, 1 quadraplegic

69 Only 35% of patient respondents currently active on HHD with NxStage first learned about HHD through their physicians. 89% of current HHD patients had another treatment modality other than HHD recommended to them NxStage data on file

70 Power of a Comprehensive Program PD and HHD are frequently complimentary Nurses are Caregivers and Teachers. May be used at different stages of ESRD HHD Txp Patient PD Incenter

71 Offer all Modalities The Patient MUST be Empowered by knowledge. ESRD educate on all modalities Transplant Home Dialysis Home dialysis In-Center Peritoneal Dialysis Home Hemo Home hemodialysis Short Daily 3/wk NxStage Cleared

72 Conclusions Outcomes for in-center HD are inadequate and not what nephrologists promised to Medicare in the 1970s Daily home hemodialysis shows signs of improving: Quality-of-life Cardiovascular parameters Depression scores Time to recovery Economics

73 Courage Heart Knowledge There s no place like home! - Dorothy 1939 The ability to know you can do it

74 Monitoring Economics Know payment parameters 3 or 6 per week. Know your unit charges (to insured) Consider the ethics Range is huge - <$400/day to >$2,000 per day Impacts overall healthcare costs, insurance costs, economy ESRD is an entitlement, No true free market forces even in the insured. Insurance is handcuffed Monopolies in area and US as a whole