We demonstrated that a protocol assessing several cycler readout parameters might be a feasible, easy-to-perform tool to adequately screen APD patients for catheter dysfunction.
Patients with a malfunctioning catheter may clinically present with slow drainage of PD fluid, prolonged drain times, poor net UF [6, 7] or constant alarms during cycler treatment [10], resulting in impairment of quality of life. Early diagnosis prevents the possibility of volume overload and complications associated with increased intraperitoneal volume that subsequently may lead to technique failure [11].
Recent ISPD guidelines recommend that mechanical problems should be excluded prior to membrane function testing in patients with insufficient UF capacity. However, there exists no standard protocol on how to diagnose catheter dysfunction [5].
One of the requirements for good catheter performance is an adequate position of the PD catheter tip. The ISPD guidelines on PD access recommend using the upper border of the pubic symphysis as a reference point for the ideal location of the catheter tip deep in the pelvic area [7]. During or after catheter implantation, the position of the catheter tip might be confirmed with a plain abdominal radiological examination, but this is not routinely performed [17].
Single diagnostic tests performed in yearly intervals (e.g. ultrafiltration capacity during the PET) may not be suitable for diagnosing mechanical problems. Net ultrafiltration is more variable than peritoneal small solute transport. Availability of daily treatment data extracted from the APD cycler card software allows a better clinical evaluation of mechanical drainage problems in routine practice.
In this proof-of-concept study, we confirmed the clinically observed impression that the parameters under investigation serve as predictors for diagnosis of catheter dysfunction. This is the first controlled analysis evaluating parameters obtained from the APD cycler software for the diagnosis of catheter dysfunction in two well-defined patient groups. The selected cases and controls represent typical APD patients with radiological confirmation of PD catheter position and clinical assessment of catheter performance.
In the stepwise logistic regression analysis, only number of alarms/week was a statistically significant predictor of catheter dislocation. As the Pearson and Spearman correlation coefficients between number of total alarms and the other metric variables revealed values above 0.5 (indicating moderate to strong correlations), none of the other variables could contribute anything in addition. However, considering the limited patient number this analysis does not refute the importance of other parameters for diagnosing mechanical drainage problems.
A combination of at least two of three parameters which had significant ROC curves and an AUC of > 0.75 (number of alarms, drain time, net ultrafiltration of last fill) could identify a similar number of patients with catheter dislocation compared to using the number of alarms alone (85.7%). However, when using a combination of parameters, the percentage of false positive control decreased (Table 3a).
The results of this study are strengthened by the accordance of the cut-off values derived from the ROC curves with conclusions of other authors in the recent literature. We determined that a cut-off value of > 7 alarms/week is a good predictor of catheter dysfunction. According to Neri et al [9], the use of tidal PD optimized catheter flow function, resulting in the presence of < 1 alarm per day (corresponding to < 7 alarms per week). Accordingly, other authors suggest that outflow failure prompts alarms in APD patients treated with HomeChoicePro™ [10]. Moreover, the cut-off value for mean drain time of > 22 minutes for predicting catheter dysfunction found in our study is similar to the conclusion of other authors who suggested that a drainage time of less than 20 minutes is a marker of good catheter performance [3, 18]. A sub-optimal catheter position results in poor hydraulic function that may cause outflow failure and can prolong drain time at the end of the cycler session [17, 19]. We demonstrated that low or negative UF of last fill during the daytime dwell was evident in patients with catheter dislocation. Our selected cut-off value of UF for predicting catheter dysfunction of 150 mL is consistent with data reported by Plum et al [20] who found an ultrafiltration volume of last fill of 278 ± 43 mL/day in APD patients treated with icodextrin during the long dwell.
Our study has certain limitations. We acknowledge that we are reporting a retrospective, single-center study of patients on APD, which may limit statistical power and generalizability of our results. For example, albeit not statistically significant, assessing the number of treatment days with negative UF of last fill may be more practicable than analyzing cut-off values of ultrafiltration with icodextrin. Although we included all APD patients treated in our center between 2015 and 2021 who were suitable for inclusion in either groups, the sample size is still small and may have limited the validity of the multiple logistic regression analysis and the representativeness of the results. Larger, prospective studies are required to confirm our clinical observations.
In conclusion, a timely intervention in patients with catheter dysfunction may prevent adverse events with potential negative impact on technique survival [11]. In this context, the use of total number of alarms/week as well as a combination of parameters derived from the APD cycler card management software with the selected cut-off values are good predictors for assessing catheter function. Our findings may be especially interesting because these parameters are also available in new APD cyclers with devices connected to remote monitoring platforms, which are rapidly gaining importance and availability [11, 12].