{"id":6683,"date":"2024-08-01T14:31:01","date_gmt":"2024-08-01T19:31:01","guid":{"rendered":"https:\/\/staging.advancedrenaleducation.com\/wparep\/?post_type=article&p=6683"},"modified":"2025-05-09T13:45:46","modified_gmt":"2025-05-09T18:45:46","slug":"effect-of-high-volume-online-hemodiafiltration-ol-hdf-on-mortality","status":"publish","type":"article","link":"https:\/\/staging.advancedrenaleducation.com\/wparep\/article\/effect-of-high-volume-online-hemodiafiltration-ol-hdf-on-mortality\/","title":{"rendered":"Effect of High Volume Online-Hemodiafiltration (OL-HDF) on Mortality"},"content":{"rendered":"

Data from four randomized controlled trials assessing mortality rates with OL-HDF (the CONTRAST, ESHOL, Turkish, and Frenchie HDF studies (1-4)) are conflicting. The ESHOL study found a 30% lower risk of death (HR: 0.70; 95% CI: 0.53-0.92; P = 0.01) in the OL-HDF group, while the other studies showed no significant overall effect on mortality. However, when analyses of the effect of convection volume were performed, the CONTRAST (post-hoc), Turkish (post-hoc), and ESHOL studies report improved survival with convection volumes >20 – 23 L (Table 1 below). A re-analysis of the ESHOL data, considering the competing risks and time-dependent co-variates showed similar results (5).<\/p>\n

Table 1. Mortality rates in randomized controlled trials and observational studies stratified and arranged by convection volumes, on-treatment analyses.<\/strong><\/span><\/p>\n

\"\"<\/sup><\/span><\/p>\n

a<\/sup>Sum of the intradialytic weight loss and the amount of substitution fluid. b<\/sup>The amount of fluid infused into the bloodstream to compensate for water and solute movement from the blood to the dialysate. c<\/sup>In ESHOL and CONTRAST, survival risks were reported by tertiles of convection volume (CV).d<\/sup>In the Turkish HDF study and Imamovic\u00a0et al.<\/em>, survival risks were reported for patients above and below the median SV (17.6 L).e<\/sup>In RISCAVID, \u2018Relative Risks\u2019 (and not HRs) are reported for offline HDF treatment (mean SV 14 L) and online HDF (mean SV 23 L). CI, confidence interval; CONTRAST, CONvective TRAnsport STudy; CV, convection volume (SV + net ultrafiltration); DOPPS, Dialysis Outcomes and Practice Patterns Study; ESHOL, Estudio de Supervivencia de Haemodiafiltration On-Line; HDF, Hemodiafiltration; HR, hazard ratio; IDWL, interdialytic weight loss; RISCAVID, RISchio CArdiovascolare nei pazienti afferenti all\u2019 Area Vasta In Dialisi; EUCLID, European CLInical Database; SV, substitution volume.<\/span><\/p>\n

The fact that 50%\u201366% of patients enrolled in the CONTRAST study did not achieve the targeted convection volume could be considered a weakness of that study (2). Subsequently, the CONTRAST Study investigators reported that, after implementation of a targeted policy and nurse training, 80% of patients could achieve the threshold convection volume of 22 L per treatment (13,14), suggesting that failure to achieve the target convection volume was not inherent to HDF but was related to its clinical implementation. However, the Frenchie study showed no overall effect of convection volume in elderly patients, but there were fewer episodes of intradialytic hypotension (but higher rate of arrhythmias) in the OL-HDF group (Figure 1). Notably, the study was underpowered and mortality in their ESRD population was low (15).\u00a0 Discordance among these RCTs may also stem from study design confounders, including use of low-flux HD membranes, no predefined specification for delivered convection volume, potential selection bias, and dropping of patients who did not reach prescribed replacement volume.<\/p>\n

\"\"<\/strong><\/span><\/p>\n

Figure 1. Significantly lower occurrence of IDH in OL-HDF vs. HFHD (3).<\/strong><\/span><\/p>\n

The CONVINCE trial*, a pragmatic, open-label 1:1 randomized controlled trial that included 1360 adult HD patients from 61 European dialysis centers (12), compared the clinical outcomes in OL-HDF vs. HFHD, when delivering high dose convection volume (>23 \u00b1 1 L). A mean convection volume of 25.3 L\/session was achieved during the study period. The primary outcome of all-cause mortality was significantly lower in the HDF group compared to the HFHD group (HR=0.77; 95% CI: 0.65-0.93; p<0.05), equating to a 23% reduction in relative risk of all-cause mortality in the HDF group compared to the HD group (Figure 2). There were no significant differences between groups for cardiovascular (HR=0.81; 95% CI: 0.49-1.33) or non-COVID-19 infection-related deaths (HR=0.68; 95% CI: 0.42-1.10). Similarly, there were no significant differences in fatal or non-fatal cardiovascular outcomes (HR=1.07; 95% CI: 0.86-1.33), kidney transplants (HR=1.01; 95% CI: 0.71-1.44), or recurrent hospitalizations (for any non-fatal cause: HR=1.11, 95% CI: 0.98-1.25; infection-related including COVID-19: HR=1.06, 95% CI: 0.86-1.30; infection-related excluding COVID-19: HR=0.97, 95% CI: 0.74-1.26) between groups. Moreover, death from COVID-19 and death from cardiovascular causes could not be distinguished in patients with COVID-19, suggesting that these cause-specific results should be interpreted with caution. The trial was limited due to lower sample size than anticipated (due to COVID-19), lower overall risk of death than expected, potential selection bias for patients with good vascular access and those able to complete outcome assessments.<\/p>\n

\"\"<\/strong><\/span><\/p>\n

Figure 2. 23 % Lower rate of all-cause mortality in HDF vs. HD (12).<\/strong><\/span><\/p>\n

Independent pooled and meta-analyses also suggest that when delivered at high doses (>20-23L convective volume), OL-HDF can provide a reduction in mortality risk when compared to conventional HD (16,17). In their pooled analysis, Peters et al. reported 14% decreased mortality risk with OL-HDF; when they analyzed by convection volume, there found 22% reduction in all-cause mortality in patients prescribed convections volumes >23L (95% CI: 0.62; 0.98) (Figure 3). Davenport and colleagues pooled the 2793 patients from four randomized trials (CONTRAST, Turkish, Frenchie, ESHOL) and assessed all-cause mortality with high convective doses unstandardized or standardized to body surface area and total body water (18).\u00a0 They reported lower mortality in patients on HDF, with hazard ratios (95% confidence intervals) of 0.65 (0.51\u20130.82; unstandardized), 0.74 (0.58\u20130.93; standardized to BSA), and 0.71 (0.56\u20130.93; standardized to TBW) for those receiving convective doses between 24.4-27.4 L. The EUDIAL group assessed three RCTs designed to study mortality rates in HD and HDF (19). They reported a RR of 0.81; (random effects model; 95% CI 0.66\u20130.99) with OL-HDF. Cumulative mortality was also significantly lower with HDF. Wang et al. and Nistor et al. independently reported that convective therapies\u2014both HDF and HF\u2014showed nonsignificant trends to improved mortality in randomized trials (12-13% reduced risk) (20,21).<\/p>\n

\"\"<\/p>\n

Figure 3. All-cause mortality decreases in tertile receiving highest, BSA-standardized convection volume (17) (p.981).<\/strong><\/span><\/p>\n

In addition to the ESHOL and CONVINCE RCTs, which demonstrated that high-efficiency postdilution online HDF reduces all-cause mortality compared to high-flux HD, several other studies also suggest that high-volume online HDF offers a survival benefit over conventional HD (Table 1).<\/p>\n

A 2006 study from the DOPPS group that compared patients on HDF with convective volumes of 15-24.9 L found a 35% reduced relative risk of mortality (RR =0.65) compared to high- (RR = 1.03) or low-flux HD (reference RR -= 1.00) (22). In contrast, a recent multi-country, real-world data analysis from DOPPS (2009-2015, N=8567) did not find any added benefit with OL-HDF compared to HD [adjusted mortality HR: 1.14 (95% CI: 1.00\u20131.29); HR: 1.08 (0.92\u20131.28) for HDF >20 L replacement fluid volume] (23). However, only 6% of clinics prescribed HDF to all patients; and when adjusted for study era and country, convection volume > 20L showed a 10% reduction in all-cause mortality. Age, sex, vintage and certain comorbidities did not have an impact. Adjusting for vascular access, blood flow rate, BMI, Hgb, and albumin appeared to negatively impact mortality with HDF. Discrepancies between the two DOPPS data may be attributed to actual achieved convection volumes, study design confounders, center effects, actual numbers of patients prescribed HDF, and sampled populations. It is important to note that, replacement volume in this DOPPS study refers to the prescribed replacement fluid volume.<\/p>\n

Data from the EUCLID study also reported reduced mortality (38%) with high volume HDF (Table 1) (24). The RISCAVID study reported that OL-HDF had higher cumulative survival than standard HD even after adjusting age, gender, diabetes, dialytic vintage, albumin levels, hemoglobin levels, use of epoetin, blood pressure, use of antihypertensive medications, and dialytic efficiency (RR 0.78, P =0.01) (Figure 4) (25). Impressive mortality reduction (71%) vs. high-flux HD was also demonstrated in an observational trial in incident patients by Imamovic et al. using OL-HDF with substitution volumes \u226520.4 L (9). Although not as large of a reduction in mortality, Maduell et al. reported a 24% reduction in all-cause mortality in a propensity-score matched cohort of incident patients (26).\u00a0 Siriopol et al. also suggest a significant benefit of HDF in incident patients (8). In subgroup analyses, Canaud et al. further supported potential survival benefit with higher convection volumes for some subgroups compared to the complete cohort (i.e., patients aged between 65 and 74, females, obese patients, non-diabetics and patients with high blood pressure) (27). These studies suggest that outcomes may depend on various patient and treatment parameters.<\/p>\n

\"\"<\/p>\n

Figure 4. Cumulative survival of patients on standard bicarbonate HD (BHD), LV-HDF, and OL-HDF (25) (pp. 2341-2342).<\/strong><\/span><\/p>\n

Data published in 2018 from the ANZDATA registry also suggest a benefit of HDF (N=4110) vs. HD (N=22,851) (28). The mortality rate was 8.87 deaths per 100 patient-years with HDF vs. 14.95 deaths per 100 patient-years for standard HD. There were 2447 (60%) patients who permanently remained on hemodiafiltration after starting or switching, and of the 1663 (40%) patients who did switch off hemodiafiltration, 465 (28%) eventually returned. On multivariate analysis, the HRs were 0.79 in the Australian (N=3302; 95% CI 0.72\u20130.87, P < 0.001) and 0.88 New Zealand (N=808; 95% CI 0.78\u20131.00, P = 0.05) cohorts [adjusted for: age, sex, race, body mass index, year of hemodialysis start, chronic lung disease, coronary artery disease, cerebrovascular disease, peripheral vascular disease, diabetes, smoking status, vascular access type, previous transplant, initial treatment with hemodialysis, blood flow rate, weekly treatment time and dialysis setting] (Figure 5). They did not examine the convective volume or state specific use of OL-HDF in patients. Other limitations include possible population bias, criteria for HDF use, high modality switch after 12 months, first year mortality was not assessed, and center effects were not different.<\/p>\n

\"\"<\/p>\n

Figure 5. Mortality risk in HD vs. HDF (28) (p. 333).<\/strong><\/span><\/p>\n

Study\u00a0 from the Japanese Society for Dialysis Therapy Renal Data Registry, used propensity-matched cohort of 5,000 pairs of patients treated with conventional high-flux HD or predilution HDF; one-year follow-up was performed (11) . All-cause and cardiovascular mortality were compared between the two groups. HDF was associated with improved overall survival compared to HD (HR all cause-mortality 0.83), with a trend towards improved cardiovascular survival (Figure 6). Among patients treated with predilution on-line hemodiafiltration, those treated with high substitution volumes (\u226540.0 L\/ses) had improved all-cause and cardiovascular survival compared to those treated with low substitution volumes (<40.0 L\/ses) or those on hemodialysis. The optimal predilution substitution volume associated with improved overall survival was estimated to be 50.5 L\/session. This observational study suggests that HDF, especially with high substitution volumes, is associated with a reduction in all-cause and cardiovascular mortality.<\/p>\n

\"\"\"\"<\/p>\n

Figure 6. All-cause and cardiovascular survival in HD vs. predilution OL-HDF (11) (p. 934).<\/strong><\/span><\/p>\n

Based on the presented information, there is a clear trend towards improved mortality in ESKD patients with high-volume OL-HDF, with a delivered dose >23 L of convection volume (12, 29).<\/p>\n

* <\/em>Disclaimer: The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability. The opinions expressed in the document are of the authors only and in no way reflect the European Comission\u2018s opinions.<\/em><\/span><\/p>\n

\"\" <\/strong><\/span>\u00a0<\/strong>Funded by the European Union<\/em><\/span><\/p>\n

The CONVINCE study was exclusively supported by the European Comission Research & Innovation, Horizon 2020, Call H2020-SC1-2016-2017 under the topic SC1-PM-10-2017: Comparing the effectiveness of existing healthcare interventions in the adult population (grant no 754803).<\/em><\/span><\/p>\n

\u00a0<\/strong>References<\/strong><\/p>\n

    \n
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  8. Siriopol D, Canaud B, Stuard S, Mircescu G, Nistor I, Covic A. New insights into the effect of haemodiafiltration on mortality: the Romanian experience. Nephrol Dial Transplant<\/em>. 2015;30(2):294-301. Available from: https:\/\/academic.oup.com\/ndt\/article-lookup\/doi\/10.1093\/ndt\/gfu347.<\/li>\n
  9. Imamovi\u0107 G, Hrva\u010devi\u0107 R, Kapun S, et al. Survival of incident patients on high-volume online hemodiafiltration compared to low-volume online hemodiafiltration and high-flux hemodialysis. Int Urol Nephrol<\/em>. 2014;46(6):1191-1200. Available from: http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/24057682.<\/li>\n
  10. See EJ, Hedley J, Agar JWM, et al. Patient survival on haemodiafiltration and haemodialysis: a cohort study using the Australia and New Zealand Dialysis and Transplant Registry. Nephrol Dial Transplant<\/em>. 2019;34(2):326-338. Available from: https:\/\/doi.org\/10.1093\/ndt\/gfy209.<\/li>\n
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  12. Blankestijn PJ, Vernooij RWM, Hockham C, et al. Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure.\u00a0N Engl J Med. 2023;389(8):700-709<\/li>\n
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  15. Morena M, Jaussent A, Chalabi L, et al. Treatment tolerance and patient-reported outcomes favor online hemodiafiltration compared to\u00a0high-flux\u00a0hemodialysis in the elderly. Kidney Int<\/em>. 2017;91(6):1495-1509. Available from: https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0085253817300406.<\/li>\n
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  22. Canaud B, Bragg-Gresham JL, Marshall MR, et al. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int<\/em>. 2006;69(11):2087-2093. Available from: http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16641921.<\/li>\n
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  25. Panichi V, Rizza GM, Paoletti S, et al. Chronic inflammation and mortality in haemodialysis: effect of different renal replacement therapies. Results from the RISCAVID study. Nephrol Dial Transplant<\/em>. 2008;23(7):2337-2343. Available from: https:\/\/academic.oup.com\/ndt\/article-lookup\/doi\/10.1093\/ndt\/gfm951.<\/li>\n
  26. Maduell F, Varas J, Ramos R, et al. Hemodiafiltration Reduces All-Cause and Cardiovascular Mortality in Incident Hemodialysis Patients: A Propensity-Matched Cohort Study. Am J Nephrol<\/em>. 2017;46(4):288-297. Available from: https:\/\/www.karger.com\/Article\/FullText\/481669.<\/li>\n
  27. Canaud B, Bayh I, Marcelli D, et al. Improved survival of incident patients with high-volume haemodiafiltration: a propensity-matched cohort study with inverse probability of censoring weighting. Nephron<\/em>. 2015;129(3):179-188. Available from: https:\/\/www.karger.com\/Article\/FullText\/371446.<\/li>\n
  28. See EJ, Hedley J, Agar JWM, et al. Patient survival on haemodiafiltration and haemodialysis: a cohort study using the Australia and New Zealand Dialysis and Transplant Registry. Nephrol Dial Transplant<\/em>. Published online August 13, 2018. Available from: https:\/\/academic.oup.com\/ndt\/advance-article\/doi\/10.1093\/ndt\/gfy209\/5071933.<\/li>\n
  29. Basile C, Davenport A, Blankestijn PJ. Why choose high volume online post-dilution hemodiafiltration? J Nephrol<\/em>. 2017;30(2):181-186. Available from: http:\/\/link.springer.com\/10.1007\/s40620-016-0343-0.<\/li>\n<\/ol>\n

     <\/p>\n

    GMO-000121 \u00a0Rev B \u00a005\/2024<\/p>\n

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