Th e New UNOS Don or Heart Allocation Prop osal is NOT Fair!

Transcription

1 SESSION V CONTROVERIES IN ADVANCED HEART DISEASE Th e New UNOS Don or Heart Allocation Prop osal is NOT Fair! Jos h u a Ch u n g, MD As s ociate Surg eon Dep artm en t of Cardioth oracic Su rg ery

2 What are th e g oals of th e p rop osal? Reduce waiting list m ortality rates Active h eart tran s p lant can d id ates have d ou b led s in ce % in creas e of Statu s 1 A can d idates Statu s 1 A can d id ates are 3 x m ore likely to d ie on th e waitin g lis t Mortality ris ks are vas tly d is p arate Reduce the use of exceptions to q ualify fo r a status

3 What are th e g oals of th e p rop osal? Accom m od ate increased use of m echan ical circulatory sup p ort d evices Im p rove overall access to transplan tation b y m odifying g eograp hical d istrib ution OPTN Fin al Ru le: Org an allocation p olicies [s ]h all n ot b e b as ed on th e can d id ate s p lace of res id en ce or p lace of lis tin g

4 Prop osed New Statuses Current St at us Proposed Stat us 1 1 A B

5 Prop osed Statuses Status Criteria 1 ECMO (1 4 d ays ) Non-d is charg eable (s urgically im p lanted) VAD MCS with life -threatening ventricular arrhythm ia 2 IABP Ventricular tachycard ia/ ventricular fib rillation, m ech an ical s upport n ot re quired Total artificial heart Dis charg eab le BiVAD, RVAD, or s in gle ve ntricle patie nts with LVAD Pe rcutaneous endovas cular m echanical circulatory d evice s MCS with d evice m alfunction/ m echanical failu re 3 Dis charg eab le LVAD for up to 30 d ays Multip le in otrop es or s in gle high d ose in otrop es with continuous h em odynam ic m onitoring MCS with d evice relate d com p lications

6 Prop osed Statuses Status Criteria 4 Stable LVAD In otropes without Hem odynam ic Monitoring Diagnos is exceptions: Con genital heart d is eas e, Am yloid os is, Hypertrop hic card iom yop ath y, Re strictive cardiom yopathy Re-transplant 5 Com b ined org an transplants 6 All rem ain in g active can didates

7 ECMO as Brid g e to Tran sp lan t DePasquale, EC et al., The Journal of Heart and Lung Transplantation April 2013 ; Vol 32, Issue 4

8 ECMO as Brid g e to MCS Cheng R, et al. Device Strategies for Patients in INTERMACS Profiles 1 and 2 Cardiogenic Shock: Double Bridge with Extracorporeal Membrane Oxygenation and Initial Implant of More Durable Devices Ar tifical Or gans 20 16

9 ECMO Salvag e therap y ECMO p atients are hig h ris k and usually p ortend wors e survival Scarcity of d on or h earts 1 4 d ays m ay b e too late to effectively transition p atients to another sup p ort

10 Gam in g In cen tiviz es u s age of ECMO In cen tiviz es usag e of IABP In cen tiviz es u s age of tem p orary m echan ical s u p p ort in s tead of d u rab le d evices

11 Current Allocation Policy Geographic Allocatio Local: Status 1 A, Status 1 B Zone A: Status 1 A, Status Local: Status 2 Zone B: Status 1 A, Status Zone A: Status 2 Zone B: Status 2

12 OPO Don ation Service Areas 58 OPO Donation Service Areas in the U.S. OPO Data Pop ulation Bases ran g ed from 1.2 Million to Million Deceas ed Don ors Recovered ran g ed from 3 2 to Don ors Don ors p er m illion (d p m ) ran g ed from 1 7 to 4 4 DPM: m ean 1 2

13 Prop osed Broad er Sh aring Sequence Candidat e Status Status 1 Ad ult + Status 1 A Pediatric Status 2 Ad ult Status 3 Ad ult + Status 1 B Ped iatric Status 1 Ad ult + Sta tus 1 A Pediatric Status 2 Ad ult Status 4 Ad ult Status 3 Ad ult + Status 1 B Pediatric Status 5 Ad ult + Status 2 Pediatric Status 3 Ad ult + Status 1 B Ped iatric Status 6 Ad ult + Status 2 Pediatric Status 1 Ad ult + Status 1 A Pediatric Status 2 Ad ult Status 3 Ad ult + Status 1 B p ed iatric Status 4 Ad ult Location Lo cal + Zo ne A Local + Zo ne A Lo cal Zo ne B Zo ne B Local Zo ne A Local Zo ne B Local Zo ne C Zo ne C Zo ne C Zo ne A

14 Broad er Sh aring Increased travel tim e increases longer ischem ic tim es which can worsen outcom es Com p ou nds ris k factor with h ig h ris k recipien ts Increased costs Tran s p ortation Benefits large tran s p lant cen ters Benefit/ Hurt coastal region p rogram s and those who d o not share a central location Zones d o not account for p opulation d ensity The waitlist in larg er p rogram s can p otentially increase Back up centers m ay b e necessary

15 Con clusion Th e new UNOS heart allocation p roposal will d ecreas e wait lis t m ortality vs in creas e p os t tran s p lant m orb id ity and m ortality Broader s h aring will b en efit s icker p atients h owever m ay com p rom is e ou tcom es d u e to in creas ed is ch em ic tim e Ben efit s m all tran s p lant cen ters / OPO DSA vs b enefit larg e transplan t centers