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14-04-19
1
S3 MonitorforHomeHaemodialysisTechnical Overview
(potentiële)belangenverstrengeling Geen/Ziehieronder
Voorbijeenkomstmogelijkrelevanterelatiesmetbedrijven Eucept Homecare
• Sponsoringofonderzoeksgeld• Honorariumofandere(financiële)
vergoeding• Aandeelhouder• Andererelatie,namelijk…
• Geen• Employee
• Geen• Geen
Disclosurebelangenspreker
What is Physidia?
314/04/2019
Physidia founded,Angers(FR),11/2010
CEMark,2013
Medical InnovationAward,2016
InternationalDevelopment &Clinical Evidence,
2017
1st patienttreated,Clinical study,
2013
…acontinuous evolution
Ourvalues
• TherapeuticInnovation• AtrueServiceCulture• Expertise
Clinicalbenefitsofdailyhaemodialysis
Clinicalbenefits:ureareduction
5
• Ureareductionbyhaemodialysis cannotreplicatenormalkidneyfunction[1]
• BUT
• Increasingdialysisfrequencyreducesintradialyticchangesandlowerstheaverageconcentration[2]
ComparisonofestimatedGFRvaluesforHDwithnormalkidneyfunction[1]
Clinicalbenefits:cardiacprotection
• Fluid over-load leadstoincreased left ventricular mass(LVM)&is associated withmortality &cardivascularmorbidity [3]
• TheFrequent Hemodialysis Trial(FHT)daily trialdemonstrated a13.1%reduction inLVM
• Thegreatest reduction occuredinthose who already had leftventricular hypertrophy
6
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Clinicalbenefits:weightandbloodpressurecontrol
• Reductions inintradialytic weight gainandbloodpressurewere also evident inthose ondailydialysis [3]AdjustedMeanChangesinNetVolumeRemoval,BloodPressureandPre-dialysisPhosphorusover12months
7
Dailyhaemodialysis – Clinical benefits – Summary
Cardio-vascularsystem
Hypertension[4,5]
Antihypertensivetreatment[4]
Leftventricularhypertrophy[6,7]
Phospho-calcicmetabolism
Phosphorus[8,9]
Phosphatebindersdose[8]
PTH[8]
Nutritionalstatus
Nutrientandmineralintake[11]
Predialysis serumalbumin[12,13]
Qualityoflife
Qualityoflife(SF36)[10]
Recoverytimeafterdialysissession[10]
Generalhealth[10]
8
Clinicalbenefitsofconvectivetherapies
Convectivetherapies
On-linehaemodiafiltration:
Variousstudieshavereportedthefollowing:
• Betterhaemodynamic stabilityduringdialysis• Betterphosphateclearance• Bettermiddlemoleculeclearance• Decreasedinflammatorymarkers• IncreasedEPOresponsiveness
ComparedwithconventionalHD
10
Improvedclearanceofmiddleandhighmolecularweight
11
T.Cornelisstudy[15]– AdaptedschemaRandomizedstudyon13patientsinHDorpost-dilutionHDF(15l)withFx80dialyzer(Fresenius)showingthesignificantimpactofconvectiononeliminationoflargemolecularweightmolecules
Meert study[16]Crossoverstudyon14patientsinHDandHDFmodes(postdilutionat31lofconvection)withtwodialyzertypes(DiaPES HF800– whitebarsandElisio 170H– greybars)showingimprovedeliminationwithconvectivemodes,dependingonmembranechoice.
Cystatin C(13,3kDa) Myoglobin (17,6kDa)
10
30
50
70
90
Urée(60Da) Créatinine(113Da)
β2microglobuline(11,8kDa)
FGF23(32kDa)
Redu
ctionrate%
Reductionrate%
HD HDF
Convectivedialysis(HDF)improvesclearanceofuremictoxinswithincreasedeffectonmiddleorhighmolecularmassmolecules
Simplicity- Security- Sterility
12
S3 MonitorforHomeHaemodialysis
Designed fordaily dialysisDesigned forconvectivetherapy
Designed foreasy patientuse
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S3 Innovations• Patenteddisposabledialysatecircuitfor
accurateUFcontrol• Steriledialysisfluid• IRmeasurementofdialysatetemperature• Patentedlinearbloodpumpforeasylining• ConvectivetherapyusingSeCoHD system• Tabletbaseduserinterface• Patientprescriptioncard• Treatmentdataemailedbacktoclinicusing
Wifi• BluetoothconnectedBPcuffwithnohose• Controlofpatientleakagecurrentusing
dedicatedisolationtransformer• Easilyportableduetosmallfootprint,
weightandnorequirementformainswater
13
S3 monitor– Patientcard
• Individualizedpatientcardwiththemedicalprescription
• Securedprescription:Thepatientcardholdsallprescriptiondata:Thepatientcanonlychange:– Fluidremoval(withinlimits)– Bloodpump speed(withinlimits)– Dialysatetemperature(withinlimits).
• Truemobility
14/04/2019 14
Dialysatecircuit• Theflowisgeneratedbyapplyingairpressureandvacuumtopairsoffluid
filledpouches(notbalancechamber)• Thepouchessitinsealedchambers• Thefillingandemptyingcanbeadjustedindependently• Thisallowsforconvectionthroughthedialysermembrane,SeCoHD
15
Disposable dialysate circuit
Uf control
Dialysate flowgenerator(150to200ml/min)
Finalheating
S3 monitor– Dialysate module
17
• Flowiscontrolledbymeasuringpressuredropacrosscapillarytubes• Pressureisproportionaltoflow
Inletflowrate
Outletflowrate
Dialysatebags
Drain
Steriledialysisfluid• Providedin5litrebags• BicarbonateorLactate• Bicarbonatesuppliedon2compartmentbag• S3monitorensuressealhasbeenbrokenbetweencompartments
18
Advantages:• Nocostlyinstallations• Noneedtoconnecttomainswater• Noneedtomonitorqualityofwateror
dialysisfluid• SeCoHD reinfusionfluidissterile• Nodialysateinducedinflammation• RemovesuncertaintyofROwaterquality
allowingconvectivetherapiesathome• Alwaysthesamequality,evenwhen
travelling
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1914/04/2019
Technical presentation - Tray Dialyzers
• FreechoiceofanyHighFluxdialyseraccordingtopatientclinicalneedsandprecripstionreducingtheriskofanaphylacticreaction.
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Linearbloodpump
• ThelinearbloodpumpisanuniquemodedevelopedbyPhysidia• Simplicityofinstallationofthebloodline• Maximumefficiency• Occlusioncontrolofthebloodlinepumpsegment
21
Bloodcircuit
• Anydialysercanbeused• Allpressureportsarehousedinone
module
22
Convectivetreatment,SeCoHD• The1st HHDmachinedesignedforconvectivetherapy• SeCoHD:SelfConvectiveHD• Usesthe‘push-pull’technique[17]• Alternatephasesofpushingsteriledialysateintotheblood(backfiltration)• Thenultrafiltrating theexcessfluid• Backfiltrationreducesblindingofthedialyserpores,maintainingclearance
[17]
23
Clampclosed,fluidentersblood
Clampisopen,excessfluidleavesblood
S3 monitor– Ultrafiltrationcontrol
• ControlofultrafiltrationwiththepatentedPhysidiamodule– Highprecisioncontrolofdialysateflowrates
• TechnicalinnovationallowsperformingSeCoHDtherapy
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5
0 2,5s 5s 7,5s 10s
5s 5s
OPEN
ReinfusionSeCoHD ofPhysidiaS3monitor
• Valvetimingandflowcanbeadjustedtoachieveoptimumconvectiveresults
• Convectivevolumesof0to9litrespersession
26
Retrospective datawith PhysidiaS3using reinfusion SeCoHD
• 134 patients – 215 sessions (during training period)• Sex: male 74%
0
5
10
15
20
25
30
≤30 30-40 40-50 50-60 60-70 70-80 80-90
%patients
age (years)
Agedistribution
0
5
10
15
20
25
<40 40-50 50-60 60-70 70-80 80-90 90-100 100-110
110-120 >120
poidskg
Weight distribution%
Residual kidney function
- 43%
+ 57%
Datatobepublishedbyend2019
27
Treatment dataPhysidiaS3
average min max
Frequency(x/week) 5,9 5 6
Sessionduration(min) 124 120 180
Bloodflowrate(ml/min) 285 250 350
Dialysatflowrate(ml/min) 181 180 200
Convectionvolume 3040 1400 6000
Datatobepublishedbyend201928
Performancesregarding urea removal – Kt/V
28
00,51
1,52
2,53
3,54
4,5
0 50 100 150 200 250
SdtK
t/V
Sdt Kt/V(N=215)
0102030405060708090100
<1,8 >1,8 & <2,0 >2,0
%
SdtKt/V
Sdt Kt/Vdistribution(N=215)
Sd Kt/V:2,6+/- 0,5
Sdt Kt/V=168x(1−exp[−eKt/V])/t/[(1−exp[−eKt/V])/(eKt/V)+168/(Nxt)−1],PredictingTreatmentDoseforNovelTherapiesUsingUreaStandardKt/V,J.KLeypoldtetal,SeminarsinDialysis,Vol17,No2(March–April)2004;pp.142–145KDOQI2015,Guideline3,Measurementofdialysis;ureakinetics,p58
Datatobepublishedbyend2019
29
Ultrafiltration rate
0
10
20
30
40
50
60
<10 >10 & <13 >13
%
Average ultrafiltrationml/kg/h
UFrate- distribution(N=215)
Average UFrate:8,5ml/kg/h
Datatobepublishedbyend2019
References
1. Consequences of Frequent Hemodialysis: Comparison to Conventional Hemodialysis and Transplantation. John B. Stokes, Trans Am Clin ClimatolAssoc. 2011; 122: 124-136 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116337/
2. Principesetmodalitésd’applicationdel’hémodialyseautraitementdel’insuffisancerénalechronique,B.Canaud,Néphrologie&Thérapeutique;2009;5,218—238
3. DeterminantsofLeftVentricularMassinPatientsonHemodialysis:theFrequentHemodialysis Network(FHN)Trials,ChristopherTChadetal,CircCardiovascImaging.2012March1;5(2):251–261.doi:10.1161/CIRCIMAGING.111.969923.https://www.ncbi.nlm.nih.gov/pubmed/22360996
4. Volumecontrolandbloodpressuremanagementinpatientsundergoingquotidianhemodialysis.G.Nesrallah etal,Am.J.KidneyDis. 2003,Jul;42(1Suppl):13-7.
5. EffectofFrequentorExtendedHemodialysis onCardiovascularParameters:AMeta-analysisP.Susantitaphong etal,JKidneyDis.2012,May;59(5):689–699https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3395217/pdf/nihms361205.pdf
6. In-Center Hemodialysis SixTimesperWeekversusThreeTimesperWeek,G.M.Chertow etal,NEngl JMed2010;363:2287-300https://www.nejm.org/doi/pdf/10.1056/NEJMoa1001593
7. DeterminantsofLeftVentricularMassinPatientsonHemodialysis:theFrequentHemodialysis Network(FHN)Trials,C.T.Chanetal,Circ CardiovascImaging.2012,March1;5(2):251–261https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3328963/pdf/nihms366195.pdf
8. Theroleofdailydialysisinthecontrolofhyperphosphatemia,G.Stevenetal,KidneyInternational,2005,Vol.67,Supplement95,pp.S28–S32https://www.kidney-international.org/article/S0085-2538(15)50804-1/pdf
9. Shortdailyhemodialysis isassociatedwithlowerplasmaFGF23levelswhencomparedwithconventionalhemodialysis,J.Zaritsky etal,Nephrol DialTransplant.2014,29:437–441https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3910340/pdf/gft382.pdf
10. Patientsreceivingfrequenthemodialysis havebetterhealth-relatedqualityoflifecomparedtopatientsreceivingconventionalhemodialysis,A.X.Garg etal,KidneyInt.2017,91,746–754https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5333984/pdf/nihms844166.pdf
11. Shortdailyhemodialysis rapidlyimprovesnutritionalstatusinhemodialysis patients,R.Galland etal,KidneyInternational,Vol.60(2001),pp.1555–1560https://www.kidney-international.org/article/S0085-2538(15)48026-3/pdf
12. Clinicalandbiochemicalcorrelatesofstarting“daily”hemodialysis,J.D.Woodsetaal,KidneyInternational,Vol.55(1999),pp.2467–2476https://www.kidney-international.org/article/S0085-2538(15)46210-6/pdf
13. Lowfluxdialysatedailyhomehemodialysis:Aresultforthe62firstFrenchandBelgianpatients,A.Benabed etal,Néphrologie &Thérapeutique,13,(2017),18-25http://www.theradial.com/wp-content/uploads/2017/02/011_Benabed-A-Hemodialyse-quotidienne-a-bas-debit-de-dialysat-a-domicile-Nephrol-Ther-2016.pdf
14. Mortalityandcardiovasculareventsinonlinehaemodiafiltration (OL-HDF)comparedwithhigh-fluxdialysis:resultsfromtheTurkishOL-HDFStudy,Erkac Oketal,NDT,Volume28,Issue1,1st January2013,Pages192-202http://ndt.oxfordjournals.org/content/28/1/192.long
15. Engineeringperspectiveontheevolution ofpush/pull-based dialysis treatments,K.Lee,ExpertRev.Med.Devices ,2013;10(5),611–62016. Whithergoest Kt/V?FRANKA.GOTCHetal,KidneyInternational,2000,Vol.58,Suppl.76,pp.S-3–S-18https://www.kidney-
international.org/article/S0085-2538(15)47396-X/pdf17. AcuteHemodynamicResponseandUremicToxinRemovalinConventionalandExtendedHemodialysis andHemodiafiltration:ARandomized
CrossoverStudy,T.Cornelisetal,AmJKidneyDis.2014;64(2):247-25618. Comparisonofremovalcapacityoftwoconsecutivegenerationsofhigh-fluxdialyzersduringdifferenttreatmentmodalities,N,Meert,Nephrol Dial
Transplant,2011;26:2624–2630https://academic.oup.com/ndt/article/26/8/2624/1916177
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