Disclosures

•Consultant/A dvisory Board:W L Gore,M edtronic,BardP eripheralVascular,CookM edical,A kebia,T VA

•FounderandChiefS cientificO fficer:Inovasc

•Grant/R esearchS upport:N IH,VA ,U niversity ofA rizona,N S F

•ClinicalT rialS upport:N IH,Bayer,A kebia,A bbvie,Baxter,VascularT herapies,P roteon,Corm edix

T heFutureofDialysisVascularA ccess

Prabir Roy-Chaudhury, MD, PhD, FACP, FRCP (Edin)University of Arizona and SAVAHCS

Artery

Vein

GP /P CP %%Early%referral%to%%

nephrologist%

Vein%preserva7on%(GFR %=%30)%R efer%for%m apping%and%

surgery%(GFR %=%20)%

S urgeon%decision%

on%type%of%A VF%

P lacem ent%of%A VF%in%the%O R %

A VF%follow %up%at%4I6%

w eeks%

R eferral%for%angioplasty/surgery%

as%needed%

?%R eady%to%use;%Expert%cannulator%

S uccessful%A VF%

+ +

+++

+ +

T heFutureofDialysisVascularA ccess:of value, quality and outcomes

Prabir Roy-Chaudhury, MD, PhD, FACP, FRCP (Edin)University of Arizona and SAVAHCS

Artery

Vein

GP /P CP %%Early%referral%to%%

nephrologist%

Vein%preserva7on%(GFR %=%30)%R efer%for%m apping%and%

surgery%(GFR %=%20)%

S urgeon%decision%

on%type%of%A VF%

P lacem ent%of%A VF%in%the%O R %

A VF%follow %up%at%4I6%

w eeks%

R eferral%for%angioplasty/surgery%

as%needed%

?%R eady%to%use;%Expert%cannulator%

S uccessful%A VF%

+ +

+++

+ +

HealthCareisChanging

Volum e Value

Individual P opulation

FFS Global

ValueinHealthCare

Value

O utcom es

Cost

P oorValueinvascularaccesscare

P oorValue

BadO utcom es

Cost

How do we improve VALUE invascular access care = INNOVATION

T echnology innovation

P rocessofcareinnovation

T echnology Innovation

EverL inqHum acyte

Vein

A rtery

Vonapanitase L utonix

Lutonix drug eluting balloon for AVF stenosisimproves patency at 8 months (p=0.04)

P resentedby S cottT rerotolaatL IN C

N odifferenceat6m onths

p=0.04

P rocessofcareinnovation(70% ofVA dysfunctionisduetoprocessofcareissues)

S urgeondecision

ontypeofAVF

P lacem entofAVFintheO R

AVFfollowupat4-6

w eeks

R eferralforangioplasty/surgery

asneeded

? R eady touse;Expertcannulator

S uccessfulAVF

Veinpreservation(GFR = 30)R eferform appingand

surgery (GFR = 20)

GP /P CPEarly referralto

nephrologist

Conventionalapproach

Value

O utcom es

Cost

Precision medicine approach topopulation health

•N ew technology thatw orks

•U seitoneveryone

Very effective in 30%

Somewhat effective or have no effect in 60%

Have a negative effect in 10%

•Ifyou w anttoincreasevalueyou havetouseitonly inthosepatientslikely torespond

P recisionm edicineapproach

Value

O utcom es

CostP redictthenaturalhistory ofvascularaccess

successorfailure

Real world evidence generation forvascular access

•Com ingtogetheroftheclinicalcareandclinicalresearchenterprises

•S tandardofcareclinicaldatathatisgeneratedevery day isusedforclinicalresearchandprocessofcareim provem ent(learninghealthsystem )

Real world evidence generation could beparticularly suited to vascular access

HealthcareP rovider

O rganization(HP O )

L argeDialysisO rganizations

(HDU )

VascularA ccess

Centers(VAC)

• M ostdialysisvascularaccesseventsoccurintheHP O ,HDU ortheVAC

• Hightech.settingsw ithphysicians,nurses,dieticians,technicians,highquality EHRsystem sw ithinnationalchains

P atients(subjects)areseenrepeatedly

O verallVisionandGoal

•Createatripartitepartnershipbetw eenHP O ’s,L DO ’sandVAC’s

• L everagetheirintrinsicEM R andsam plesizestrengthstocollectstandardizedvascularaccessdatafieldsacrosstheentirespectrum ofvascularaccesscare(creation/m aintenance/abandonm ent)

•Developuniform datastandardsonclinical,dem ographic,biologicalandprocessofcareparam eters

Benefitsofdevelopingsuchacom prehensiveR EA L T IM Edataset

• Identify clinicaland biologicalpredictorsofdialysisaccesssuccessandfailure(stratify patientsintohighandlow riskgroups)

• Incentivize processofcareinnovationinvascularaccess

• Facilitate pragm aticclinicaltrialsforvascularaccess(interventionw ithacoordinatorinoneunitbutnottheother:clusterrandom ization)

• R ealw orld realtim edatabasetocollectoutcom edataw ithm inim aladditionalcost

Innovation+ P recisionM edicine= Im provedVA L U E

T echnology

P rocessofCare

VA L U EP recisionM edicineA pproach

Innovation

Biodegradable Stent

Lutonix DEB RCT in AVF (downstream)

0 30 60 90 120 150 180 210 240

0.0

0.2

0.4

0.6

0.8

1.0

Surv

ival

Pro

bab

ility

T im etoEvent(days)

P T A = 49.4% )

DEB = 61.6%

P ostinterventionprim ary patency at8

m onths

P resentedby S cottT rerotolaatL IN C