Abstract

Abstract Background and Aims Intradialytic hypotension (IDH) is the most common complication of hemodialysis (HD), which is often related to ultrafiltration. Due to the high prevalence of cardiovascular disease (CVD), compensatory mechanisms often fail. In clinical practice, BP is measured 2x/hour, while additional readings are only performed when symptoms arise. However, since IDH defined by a nadir systolic BP (SBP)<90 mmHg or <100 mmHg (depending on pre-dialysis SBP), regardless of symptoms, is most strongly associated with mortality, current BP measurement frequency may severely underestimate the true incidence of IDH. Continuous BP-monitoring may offer a solution to this issue. The Clearsight device (CSD) is a non-invasive continuous BP-monitoring system that measures arterial pressure and waveforms through a finger cuff by photoplethysmography. Yet, a compromised peripheral circulation may hamper its reliability in HD patients. This study aims to assess the agreement between intradialytic CSD-monitoring and standard oscillometric brachial arterial pressure (oBAP) assessment. Methods 40 Chronic HD patients were cross-over randomized to 4 modalities, each for 2 weeks: [standard HD (S-HD), cool HD (C-HD), low volume hemodiafiltration (LV-HDF) and high-volume HDF (HV-HDF)]. During one session of each second week, BP and heart rate (HR) were continuously recorded with the CSD (BMEYE/Edwards Lifesciences) and every 15 minutes with a brachial arterial cuff (contralateral of the fistula or graft, if applicable). Simultaneous measurements of SBP, diastolic BP (DBP) and HR were compared with descriptive statistics (mean difference [bias, BAP minus CSD], standard deviation (SD) and range) and Bland-Altman analysis. Bias was defined as the mean difference between oBAP and CSD, and 95% limits of agreement (LA) as the mean difference ±1.96 SD. Post-hoc, patients were stratified into tertiles of unexplained missing CSD-readings, to explore whether specific patient characteristics explain failed readings. Results 75% of patients was male, with a mean age 69.7 (±13.5 years) and median dialysis vintage 3.0 years (IQR 1.0-5.8). Diabetes mellitus and CVD were present in 48% and 73%, resp. Of the 2720 paired BP-measurements, 42% CSD and 6% of oBAP-readings were missing, leaving 36% of absent CSD-readings unexplained. Bland-Altman analysis, comparing oBAP and CSD-measurements, revealed a mean bias ± LA of 13.3 ± 44.5 mmHg for SBP, a mean bias ± LA of 13.3 ± 25.5 for DBP, and a mean bias ± LA of −0.03 ± 22.9 for HR. Surprisingly, the group with a high (>38%) proportion of unexplained missing CSD-values was significantly younger compared to the low (<21%) and intermediate group (21-38%) (p = 0.015), whereas no significant differences were observed with respect to dialysis vintage, diabetes mellitus or CVD. Conclusions 1) Compared to the oBAP method, finger cuff-monitoring shows poor precision and accuracy in BP-measurements, but good accuracy and poor precision in HR-readings; 2) 1/3 of readings failed for unknown reasons. Thus, CSD-monitoring is unsuitable for intradialytic hemodynamic monitoring in chronic HD patients.

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