Jos h u a Ch u n g , MD

As s ocia te Surg eon

Dep artm en t of Card ioth oracic Su rg ery

SESSION VCONTROVERIES IN ADVANCED HEART DISEASE

Th e New UNOS Don or Heart Alloca t ionProp osal is NOT Fair!

What are th e g oa ls of th e p rop osa l?

• Red uce wait ing lis t m orta lity ra t es– Active h eart t ran s p lan t can d id ates have d ou b led s in ce

2 0 0 6

– 5 4 8 % in creas e of Sta tu s 1 A can d ida tes

– Sta tu s 1 A can d id a tes a re 3 x m ore like ly to d ie on th ewait in g lis t

• Morta lity ris ks are vas t ly d is p ara te

• Red uce the use o f excep t ions to q ualify fo r a s t a tus

What are th e g oa ls of th e p rop osa l?

• Accom m od ate increased use of m echan ica lcircu la to ry sup p ort d evice s

• Im p rove overa ll access to t ransp lan tat ion b ym od ifying g eog rap h ica l d is t rib u t ion– OPTN Fin a l Ru le : Org an a lloca t ion p olicies “[s ]h a ll n ot b e

b as ed on th e can d id a te ’s p lace of res id en ce or p lace oflis t in g…”

Prop osed New Sta tuses

Current St at us Proposed Stat us

1 A

1

2

3

1 B 4

25

6

Prop osed Sta tuses

Status Cr i t er ia

1 ECMO (1 4 d ays )Non-d is charg eab le (s u rg ica lly im p lan ted ) VADMCS with life -th rea ten ing ven t ricu la r a rrhythm ia

2 IABPVen tricu la r tachycard ia / ven tricu la r fib rilla t ion , m ech an ica ls upp ort n ot re qu iredTota l a rt ificia l he artDis charg eab le BiVAD , RVAD, or s in g le ve n t ricle pa t ie n ts withLVADPe rcu taneous end ovas cu la r m echan ica l circu la to ry d evice sMCS with d evice m alfunct ion / m echan ica l fa ilu re

3 Dis charg eab le LVAD for up to 30 d aysMult ip le in ot rop es or s in g le h igh d ose in o trop es withcon t inuous h em odynam ic m on ito ringMCS with d evice re la te d com p lica t ions

Prop osed Sta tuses

Status Cr i t er ia

4 Stab le LVADIn otropes withou t Hem odynam ic Monito ringDiagn os is excep t ions : Con ge n ita l heart d is eas e , Am ylo id os is ,Hype rt rop h ic card iom yop ath y, Re s t rict ive card iom yopa thyRe-t rans p lan t

5 Com b ine d org an t rans p lants

6 All rem ain in g act ive can d ida te s

ECMO as Brid g e to Tran sp lan t

De Pa s q ua le , EC e t a l., The Jo urna l o f He a rt a nd Lung Tra nsp la nta t io n Ap ril 2 0 1 3 ; Vo l 3 2 , Is s ue 4

ECMO as Brid g e to MCS

Ch en g R, e t a l. Device Stra teg ies for Patien ts in INTERMACS Profiles 1 an d 2 Card ioge n ic Sh ock: Dou ble Br id ge with Extracorp o rea l Mem b ran e Oxygen at ion an d In it ia l Im plan t of More Du rab le DevicesAr t if ical Or gans 20 16

ECMO

• Salvag e therap y

• ECMO p at ien ts are h ig h ris k and usually p ortendwors e survival– Scarcity of d on or h earts

• 1 4 d ays m ay b e too la t e to e ffect ive ly t rans it ionp at ien t s t o ano ther sup p ort

“Gam in g ”

• In cen t iviz es u s age of ECMO

• In cen t iviz es us ag e of IABP

• In cen t iviz es u s age of tem p orary m echan ical s u p p ort in s teadof d u rab le d evices

Curren t Alloca t ion Policy

Geographic Al locat ioLocal: Sta tus 1 A, Sta tus 1 BZone A: Sta tus 1 A, Sta tusLoca l: Sta tu s 2Zone B: Sta tus 1 A, Sta tusZone A: Sta tus 2Zone B: Sta tu s 2

OPO Don at ion Service Areas

1 2

58 OPO Donat ion Service Areas in the U.S.

OPO DataPop ula t ion Bases ran g ed from 1 .2 Million to 1 8 .9 Million

Deceas ed Don ors Recovered ran g ed from 3 2 to 4 3 9 Don orsDon ors p er m illion (d p m ) ran g ed from 1 7 to 4 4 DPM: 2 6 .5 m ean

Prop osed Broad e r Sh aring Seq uen ce

Candidat e Status Locat ion

Sta tus 1 Ad ult + Sta tus 1 A Ped ia t ric Lo ca l + Zo ne A

Sta tus 2 Ad ult Loca l + Zo ne A

Sta tus 3 Ad ult + Sta tus 1 B Ped ia t ric Lo ca l

Sta tus 1 Ad ult + Sta tus 1 A Ped ia t ric Zo ne B

Sta tus 2 Ad ult Zo ne B

Sta tus 4 Ad ult Loca l

Sta tus 3 Ad ult + Sta tus 1 B Ped ia t ric Zo ne A

Sta tus 5 Ad ult + Sta tus 2 Ped ia t ric Loca l

Sta tus 3 Ad ult + Sta tus 1 B Ped ia t ric Zo ne B

Sta tus 6 Ad ult + Sta tus 2 Ped ia t ric Loca l

Sta tus 1 Ad ult + Sta tus 1 A Ped ia t ric Zo ne C

Sta tus 2 Ad ult Zo ne C

Sta tus 3 Ad ult + Sta tus 1 B p ed ia t ric Zo ne C

Sta tus 4 Ad ult Zo ne A

Broad e r Sh aring

• Increased t rave l t im e increases long er ischem ict im es which can worsen outcom es– Com p ou nd s ris k factor with h ig h ris k recip ien ts

• Increased cos t s– Tran s p orta t ion

– Benefit s la rge t ran s p lan t cen te rs

• Benefit / Hurt coas t a l reg ion p rog ram s and thosewho d o not share a cen t ra l loca t ion

• Zones d o not accoun t fo r p op ula t ion d ens ity

• The wait lis t in larg e r p rog ram s can p o tent ia llyincrease

• Back up cen t e rs m ay b e necessary

Con clus ion

• Th e new UNOS heart a llocat ion p rop osal will…

– d ecreas e wait lis t m orta lity vs in creas e p os t t ran s p lan tm orb id ity and m orta lity

– Broader s h aring will b en efit s icker p at ien ts h owever m aycom p rom is e ou tcom es d u e to in creas ed is ch em ic t im e

– Ben efit s m all t ran s p lan t cen ters / OPO DSA vs b enefit la rg et rans p lan t cen te rs