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APD

Automated peritoneal dialysis withĢýsڱ harmonyand SILENCIA

Why automated peritoneal dialysis (APD)?

APD uses a programmable machine, or cycler,that controls the volume, filling, dwell time and drainage of the solution. Thanks toautomated dialysis, patients can be dialyzed at home, even when sleeping.

As APD is offering more free daytime, it is the PD technique with obvious advantages for patientĢýs lifestyle. Patients may pursue a job and have more time for personal and family activities.1

Finally, APD cyclers offer a variety of individualization options for the treatment, allowing you to even better consider the needs of your patient, supporting you to improve patient care.

In APD both our cyclers,Ģýsڱharmonyand SILENCIA, offer advanced features, all aimed at improving patient care.

    • Increased treatment flexibilitywith FlexPoint technology3
    • Integrated on-screen animationsgive guidance and facilitate setup3
    • As proposed by Fischbach et al., potentiallyimproved ultrafiltration and clearancewith individually adapted APD (aAPD)2

    Getting started with education in APD Ģý The difficult part was making it easier

    FMC created training solutions that focus on conveying the information that really matter and offers support in preparing and setting up the treatment.

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    Preparation

    Train

    • Spot-ontraining videosfor caregivers and patients to support training
    • Start with supportive extra training material for ourAPD devices
    • Set ofpatient information materialsto support you in training the patient

    Start

    • Support inplanning and preparingthe therapeutic home environment

    Our products - Key features of the sleep·safe harmony

    sleep·safe harmony offers features aimed at improving patient care. It also provides training support by guiding on-screen animations directly on the device.

    • Create prescriptions directly on the device
    • On-screen keyboard
    • Improved fluid usage Ģý no extra volume for priming

    • Permitted patient volume Ģý the maximum individual fill volume
    • Permitted residual volume Ģý the maximum individual volume that may remain in the patientĢýs peritoneal cavity
    • The goal is to:
      • Reduce potential outflow alarms for a more quiet and restful sleep
      • Maintain the prescribed treatment time
      • Improve treatment effectiveness
      • Provide more flexibility in treatment execution within defined individual limits to improve patientsĢý well-being and safety

    • Automatic connection and barcode recognition of bags
    • Integrated handles
    • PatientCardpluscapable of storing up to nine different prescriptions and more than 12 months of treatment data
    • Automatic inline flow heating of the dialysis solution to body temperature directly during the inflow phase - no need to preheat the solution bag upfront/in advance of the treatment
    • Automatic draining feature Ģý the solution bags and the line set are drained automatically, no manual handling needed

    • Plug & use Ģý no transformer needed due to double installation

    • Guiding animations directly on the device
    • Large touch screen

    • Ģýsڱ harmonysystem daily disposables are made of PVC-free and plasticizer-free materials such as Biofine (Except APD drainage options)

    Our products - Key features of SILENCIA

      SILENCIAis delivering individual APD therapy in a reliable and convenient way, providing the following benefits :

      • Improved sleep quality due to silent operation and soft alarms4,5
      • Simple design enables easy setup and short training time6
      • APD individualization as supported by the latest ISPD guidelines7
      • Developed for home use even with limited space
      • High patient satisfaction with the handling of the SILENCIA cycler
      • Increased treatment flexibility with FlexPoint technology3

      Adapted APD (aAPD) is one way to personalize treatments

      Ģýsڱharmonyand SILENCIAoffermultiple options to individualize prescriptions according to patients' needs. Usingour APD cyclers,the prescription can be individualized on several levels:

      • Infusion volume
      • Dwell time
      • Glucose profile
      • Calcium profile
      • FlexPoint

      Different PD solutions per cycle within the same treatment can be used withĢýsڱ harmony.

      Because every patient is different: aAPD Ģý Fischbach et al.2suggests potential better results using the same time and resources2

      Your patients have a chronic disease in common, but differ in many ways: age, height, weight, stage of illness, residual kidney function etc. These differences have a decision impact on the PD treatment required.
      PatientsĢý needs are different:

      Age is an important factor influencing the choice of dialysis modality. Patients with good dexterity and motivation are good candidates for PD. With increasing age, the associated comorbidities of dialysis patients might deteriorate and with it their frailty.

      Management of weight is an important success factor in PD patients. Changes in weight due to lifestyle, calorie intake, disease and hydration status need constant monitoring and adaptation of PD therapy.

      Dialysate to plasma ratio is a common measure used to evaluate peritoneal transport characteristic in PD patients. Patients can be into high (fast), high average and low (slow) transporters based depending upon the status of their peritoneal membrane.Ģý Peritoneal membrane transport characteristics change with time on PD. Therefore, regular monitoring of D/P creatinine and subsequent adjustment of PD prescriptions is recommended.

      Patients are classified into high (fast), high average and low (slow) transporters based on the function of their peritoneal membrane. With time and increasing duration of stay on PD, patients tend to become fast transporters. PD prescriptions need to be adapted according to patients'transport status for an optimal patient outcome.

      RKF has an impact on patient survival and quality of life of PD dialysis patients. Its longer preservation is a major advantage. Thus, interventions to preserve RKF, like prescription of biocompatible PD fluids, are important.

      Due to compromised kidney function, bodies' own capacity to remove excess fluid also diminishes and patients need dialysis to generate UF. The amount of UF needed varies depending upon many factors, like lifestyle, disease progression and other comorbid conditions. An adequate UF is therefore critical for successful PD.

      Kt/V urea is urea clearance normalized to total body water. It is an important parameter to check PD adequacy. A total Kt/V urea of at least 1.7 per week is recommended for PD patients.8

      Fischbach study supports aAPD2

        Fischbach M. et al. conducted a randomized, prospective, cross-over, multicenter study. Nineteen patients were included in the final analysis.

        According to Fischbach et al., aAPD offers better results using the same time and resources2

        • aAPD is possible without extra fluids or a longer amount of time
        • Efficiently uses existing treatment resources: better ultrafiltration and clearance with same, low glucose concentration, fluid volume and treatment time compared to conventional APD (cAPD)

        Attaining adequacy targets

        The aAPD approach was proposed by Fischbach M. et al.2By combining sequences of short dwells and small fill volumes with long dwells and large fill volumes, aAPD aims to promote UF and clearance within one PD session. The blood purification and UF achieved for every gram of glucose absorbed was higher in aAPD in comparison to cAPD.

        The challenges of PD Ģý Reaching adequacy targets

        Reaching adequacy targets in PD for both UF and clearance is challenging. Fischbach et al. propose that shorter dwell times and smaller fill volumes promote the process of UF, while longer dwell times and large fill volumes increase solute clearance.2The proposed strategy may have the potential to improve the two targets within one PD session.

        cAPD

        aAPD

        Figure 1: Modified cAPD graphic following Fischbach M. et al.

          aAPD

          Figure 2: Modified aAPD graphic following Fischbach M. et al.

            Adapted APD is possible without extra fluids or a longer amount of time, with the same glucose concentration.

            The study results suggest that, compared with cAPD, targeting UF vs. clearance separately, by varying dwell times and fill volumes may improve dialysis adequacy with a reduction in metabolic burden.2

            Comparison after 45 days1

            Figure 3: Figure created based on study data from Fischbach, M. et al., comparing mean daily UF and sodium removal after 45 days, showing better UF (+100 mL/session) and sodium removal (+14 mmol/session) for aAPD

              Figure 4:Figure created based on study data from Fischbach, M. et al,. Higher clearance with aAPD over glucose absorbed

                Summary of potential patient benefits as reported by Fischbach et al2

                Patient benefits

                • Improves ultrafiltration
                • Better sodium removal
                • Lower blood pressure
                • Promotes clearance: urea, creatinine, phosphate
                • Reduced metabolic load

                Clinical value

                • Improved use of existing treatment resources: better ultrafiltration and clearance with same, low glucose concentration, fluid volume and treatment time compared to cAPD

                APD monitoring and support

                Smart digital tools offer convenience for patients and caregivers in the comfort of the patientsĢý homes.

                3

                Treatment

                Support

                  • A simple ordering process in combination with personal phone support ensures that patients can order materials anytime and anywhere
                  • Thedelivery serviceensures that PD solutions and disposables are delivered straight to your patientĢýs doorstep
                  • ThePD travel serviceenables patients to continue travelling as the required goods are directly sent to the patientĢýs holiday destination*

                  Monitor

                      • Streamlined PD therapy management through easy accessibility to therapy information via ourPatientOnLinetool

                      * The service is not available in all countries. The availability of the service and products must be clarified before planning or booking a vacation.

                      Related content

                      1Roumeliotis A et al. Int Urol Nephrol 2021; 53(6):1149-1160

                      2Fischbach M et al. Peritoneal Dial Int 2011; 31(4):450-458

                      3Punzalan S et al. Journ of Kidn Care 2017; 2(5):262-267

                      4Morales R et al. 2021 ISPD Congress, PO-40 (abstract, article submitted)

                      5Unpublished data on file at Ģý DeutschlandGmbH; with operation noise of LAeq 12-14 dB classification as Ģýsilently operatingĢý according to Berglund, Birgitta, Lindvall, Thomas, Schwela, Dietrich H & World Health Organization. Occupational and Environmental Health Team. (1999). Guidelines for community noise. World Health Organization, page 10, available as download undersite was accessed the last time 31/07/2023; 16:35 CET

                      6Unpublished data on file at Ģý Deutschland GmbH (short training times)

                      7Brown EA et al. Perit Dial Int. 2020;40(3):244-253.

                      8Tzamaloukas AH et al. Semin Dial 2008; 21(3):250-257