Haemodiafiltration - the case against. Prof Peter G Kerr Professor/Director of Nephrology Monash Health
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1 Haemodiafiltration - the case against Prof Peter G Kerr Professor/Director of Nephrology Monash Health
2 Know your opposition..
3
4 Haemodiafiltration NB: pre or post-dilution
5 What is HDF how is it different to High-Flux? High Flux porous membrane, allows passage of middle molecules. High Kuf allows passage of large volumes of ultrafiltrate convective clearance Potential backfiltration HDF (very) porous membrane Allows very large ultrafiltration volume (and therefore convective clearance) Need for large volume replacement fluid
6 HDF what does it achieve? Added convection improved clearance of middle molecules. Minimal difference in small molecules (NB: Phos) Cardiovascular stability Improved thermal balance (infused dialysate) How is this different to High-Flux? Larger UF volume NB: internal HDF in High-Flux.
7 Internal Filtration During High Flux HD Canaud et al, Nephrol Dial Transplant 2000
8 HD (solid) vs Post-dilutional HDF (dotted) vs Pre-dilutional HDF (dashed)
9 Why Should Mortality be Improved? Removal of extra toxins? B2m, other unmeasured toxins. Removal of cytokines? Better tolerance of dialysis less cardiovascular stress? RISK: Infusion of potentially dirty dialysate Poor fluid/electrolyte balance.
10 Grooteman MPC et al, JASN, 2012 CONTRAST study; 714 patients, low-flux vs HDF, 2 year follow-up. At ASN: no difference in LV mass either
11 Contrast Study Grooteman, JASN Not a pre-specified analysis statistically naughty!
12 Ok E et al, 782 patients randomised 1:1 high-flux vs HDF, follow-up 2 years, mean UF volume 17.2 litres; no difference in B2m clearances.
13 Overall (A) and cardiovascular survival (B) among the treatment groups. Ercan Ok et al. Nephrol. Dial. Transplant. 2013;28: Not a pre-specified analysis statistically naughty! The Author Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please journals.permissions@oup.com
14 What s the problem with the stats? The determination of substitution volume was not randomised Unwell patients don t tolerate high substitution volumes Not so good fistulae cannot deliver high flows for high substitution volumes (= not so good patients) So there is a clinical bias favouring high substitution volumes
15
16 ESHOL KM curves for 36-month survival in the intention-to-treat population (P=0.01 by the log-rank test). F Maduell et al. JASN 2013;24: by American Society of Nephrology
17
18 Was ESHOL well randomised? Pre-screening: need to be able to tolerate the high convection volume (prespecified) Again = better patients on HDF
19 Cochrane Review 20/5/2015
20 DOPPS new HDF analysis (ASN) N=8567 patients from 7 European countries in DOPPS phases 4-5 ( ) with vintage >90 days N=2012 (23%) patients were on HDF, about half had replacement fluid volume >20L Adjusted Cox regression was used to estimate the association between HDF (both overall and high-volume) and mortality (vs. HD) All-cause, CV, and infection-related mortality Also examined whether facility practice of treating more patients with HDF was associated with survival
21 Association between HDF (vs. HD) and all-cause mortality, by level of adjustment Adjustment variables HDF better HDF worse Model 1: unadjusted* HR=1.00 ( ) Model 2: + age, sex, vintage HR=1.07 ( ) Model 3: + 13 comorbidities HR=1.08 ( ) Model 4: + catheter, blood flow rate HR=1.13 ( ) Model 5: + BMI, albumin, Hgb HR=1.13 ( ) HR (95% CI) of mortality for HDF (any volume) vs. HD *Unadjusted Cox model stratified by DOPPS phase and country and accounted for facility clustering
22 HDF replacement fluid volume and mortality HR (95% CI) of mortality Unadjusted Adjusted* (Refs) HD HDF 4-15L HDF 15-20L HDF >20L HDF replacement fluid volume Both Cox models stratified by DOPPS phase and country and accounted for facility clustering *Adjusted for age, sex, vintage, 13 comorbidities, vascular access, blood flow rate, BMI, albumin, hemoglobin
23 HR (95% CI) of mortality Facility % HDF and mortality HR (95% CI) of mortality (Ref.) (Ref.) 0.9 None 1-14% 15-49% 50% Facility % HDF (any) 0.9 None 1-24% 25% Facility % high-volume HDF (>20 L) Cox models stratified by DOPPS phase and country, accounted for facility clustering, and adjusted for age, sex, vintage, 13 comorbidities, vascular access, blood flow rate, BMI, albumin, hemoglobin, and 5 facility-level covariates: % catheter use, % Kt/V < 1.2, % albumin < 3.5 g/dl, % phosphorus > 5.5 mg/dl, mean hemoglobin
24 Subject selection flow diagram Patients treated by conventional HD or pre-dilution online HDF in 2012 (n=272,316) Exclusion criteria; Age < 18 yrs. (n=41) Dialysis vintage < 3 mo. (n=5,786) Dialysis session >< 3/w. (n=7,946) Incomplete data set (n=21,043) Age > 18yrs., Dialysis vintage >= 3mo, 3/w-session (n=238,756) Exclusion criteria; Incomplete data set for Propensity Score (n=148,548) With full data set for Propensity Score (n= 90,208) Masakane I et al, courtesy of JSDT
25 Propensity Score (PS) Matching 1. Age 2. Sex 3. Dialysis vintage 4. Primary cause of dialysis 5. Past myocardial infarction 6. Past cerebral hemorrhage 7. Past cerebral infarction 8. Past amputation of limb 9. Antihypertensive agent 10. BMI 11. Serum albumin 12. Serum C-reactive protein 13. Serum calcium 14. Serum phosphate 15. Systolic blood pressure 16. Diastolic blood pressure 17. Hemoglobin 18. Kt/V 19. Dialysis time 20. Blood flow rate 21. Serum urea 22. Serum creatinine 23. Serum ferritin Subjects 90,208 Conventional HD 85,202 Pre-OL HDF 5,006 PS matched pair 5,000 Conventional HD 5,000 Pre-OL HDF 5,000 Statistical analysis Kaplan-Meier survival analysis Log-Rank test Sub-analysis for substitution volume High dose group: >= 40L/session Low dose group: < 40L/session Masakane I et al, courtesy of JSDT
26 Comparison of All Cause Mortality between HD and Pre-OL HDF All cause death HD (n=5,000) Pre-OL HDF (n=5,000) Cumulative survival rate Time (mo.) Masakane I et al, courtesy of JSDT
27 Mion M.Kerr PG et al, NDT, 1992.
28
29 Definitive cardiac assessment
30 Comprehensive CV assessment Global function Segmental function Coronary flow Right coronar y artery Myocardial fibrosis Myocardial perfusion Stroke volume (ml) Cardiac Output (L/min) Ejection Fraction (%) Short axis cine Buchanon C..McIntyre CW. J Am Soc Nephrol 2016
31 IVC Stroke Volume (ml) Cardiac Output (L/min) HD vs. HDF comparison- Hemodynamics Systolic BP HD HDF BP mmhg Time Mins min POST min post Buchanon C McIntyre CW. J Am Soc Nephrol 2016
32 Coronary artery flow and perfusion Right coronary artery How is blood flow and perfusion of the heart tissue altered? Myocardial perfusion: (using arterial spin labelling) Blood Blood Label Image Tissue Control Image Tissue Buchanon C McIntyre CW. J Am Soc Nephrol 2016
33 Nadir MAP (mmhg) Number of stunned sections Number of stunned segments Circulatory stress and cardiac effects LA HD 2 LA HDF post r = Number of stunned segments r = UF rate (L/hour) Buchanon C McIntyre CW. J Am Soc Nephrol 2016
34
35 Some things change.. Including our opinions
36 It doesn t need to be: HDF may just be a complicated form of HD without much benefit!
37 No clear mortality benefit. - Maybe not as benign as once thought - Infusate quality? - No improvement in symptoms More complicated dialysis - Hidden costs water testing, tubing, concentrate It s a CON.
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