SP489MID-TERM EVALUATION OF THE NEW MEDIUM CUT-OFF FILTER (THERANOVA) ON REMOVAL EFFICIENCY AND QUALITY OF LIFE

Abstract

INTRODUCTION AND AIMS: H-F dialysers in standard HD offer numerous benefits for patients (pts), such as the purification of a broad spectrum of uremic toxins. In fact, the retention of medium molecules (MMs) has been related to higher mortality in pts with ESRD. However, the diffusive HD techniques currently available are able to remove mainly low molecular weight solutes, unlike convective therapies, such as HDF, which also remove larger solutes inducing a substantial improvement of uremic toxicity, as well as morbidity and mortality, when exchange volumes> 15 L per session are obtained. The new mediumcut-off filter (MCO), TheranovaVR , is designed to expand the purification spectrum of MMs (PM> 15 kDa) compared to conventional H-F membranes, 'beyond standard HD'. The purpose of this study was to evaluate the midterm performances on removal and quality of life in ESRD patients. METHODS: 14 stable HD pts with a vascular access flow of less than or equal to 300 ml/min were enrolled in a 2 month (m) observational case-control study. Each patient was evaluated in his common treatment and then treated in eXpanded HemoDialysis (HDx) with the TheranovaVR 400 filter (PAES/PVP membrane of 1.7 m2, Baxter). They were monthly assessed: Baseline (b-l), 30 days, 60 days, using the following pre and post-HD parameters: Urea, Phosphate, Beta2-m, Myoglobin, free light chains Kappa and Lambda (FLC-k and FLC-k), CRP, Haemoglobin (Hb) and Albumin. Furthermore, Kt/V, ERI and SF-36 questionnaire were evaluated at the beginning and end of the observation. We treat the HD pts according to the KDIGO Guideline for Anemia in CKD. The values have been reported as mean6SD. RESULTS: All pts completed the study (Age 71.569.0 y, vintage HD 6.165.5 y, Qb= 275641 ml/m' and treatment time=215621 m'). The Kt/V showed a trend of improvement (b-l: 1.360.2, 2nd m: 1.560.4, p=0,102) such as CRP (b-l: 11.5+/-13, 2nd m: 9.6+/-7, p=0,746) and the reduction of MMs was noticeable despite the low blood flow: Urea RR=69%69%, Phosphate RR=54%611%, Beta2-m RR=63%69% and Myo RR=55%68%. The pre-HD values of the uremic toxins evaluated during the follow-up (tab.1) did not show any change, probably due to a short period of observation. Pre-HD Hb value did not change in these period (tab.1), despite the EPO dose reduction from 714368439 to 546264892 UI. According to this the values of ERI was reduced but non significantly (b-l: 11.4+/-18.0, 2nd m: 7.267.2, p=0,347). The results of the SF-36 showed a tendency to increase in the Physical Health indexes (b-l: 26.869.9, 2nd m: 28.4+/-12.8, p=0,341) while those relating to Mental Health remained unchanged (b-l: 43.9+/-13.6, 2nd m: 43.4+/-12.9, p=0,908). CONCLUSIONS: This pilot study showed that TheranovaVR filter can provide high removal of a wide spectrum of uremic toxins, from small to MMs up to 45 kDa, even with blood flow below 300 ml/min, without changing serum albumin. The pre-HD values of MMs observed did not change, but a tendency to improve quality of life, inflammation and anemia management seems to be promising. Long-term studies are needed to evaluate the clinical impact of these findings especially in those pts who cannot benefit from convective techniques as a result of the flow of vascular access or intolerance to high volumes of exchange (Table presented).