royal brompton & harefield - promedica international · • o n a pril4, 1969, dr. denton a . c...

Royal Brompton & HarefieldNHS Foundation Trust A . S imon

•C ons u ltant:•C ons u ltant:

–Trans med ic s

–ReliantH eart–ReliantH eart

–H eartware/M ed tronic

• Younger: Und er60 , u nd er50 oru nd er40 ?• Younger: Und er60 , u nd er50 oru nd er40 ?

• Artificial Heart : L V A D , RVA D , B iVA D , TA H ?• Artificial Heart : L V A D , RVA D , B iVA D , TA H ?

• Realistic Solution : W hatis the reality ou t• Realistic Solution : W hatis the reality ou tthere, whatare the res u lts etc … .

• Developments : W hatc an we expec t?

D es tination Therapy

A s horts tory…

3rd c entru ry B C3rd c entru ry B C

A reportfrom 3rd c entru ry B C C hinaA reportfrom 3rd c entru ry B C C hinas tates how the phs ic ian and s u rgeonP ien C h'iao exc hanged the heartsbetween two s old iers (Ku ng H e u ndC h’ I Ying), who s u ffered fromC h’ I Ying), who s u ffered from“d ys balanc e”.H e ad minis tered s ed ative med ic ation,opened theirc hes ts and c ontinu ed toexc hange theirhearts .The patients awoke three d ays afterThe patients awoke three d ays afters u rgery. They had to take s trongmed ic ation, d erived from mou ntainherbs and were d is c harged homehealthy.healthy.

1967 A D1967 A D

197 2 A D197 2 A D

Heart Transplantation(US)(US)

• N u mberofP atients on W L H Tx: 40 22

• Trans plants 20 16: 3191

• Inc reas e in H Tx (US )20 10 -15: 37 %

• % trans plants ofW L H Tx: 7 9%

• M ed ian s u rvival: 1 0 . 7 yrs .• M ed ian s u rvival: 1 0 . 7 yrs .

• D eaths on H Tx W L (20 16, ac tive P ts . ): 1 2 8

• % ofd eaths ofP ts . O n H Tx W L (ac tive): 3%

• O ne in 9 d eaths has H F mentioned on the d eathc ertific ate (N C H S ,N H L B I). 21

• In 20 13, H F any-mention mortality was 30 0 , 1 2 2 (140 126 males and159 996 females ). H F was the u nd erlyingc au s e in 65 120 ofthos ed eaths in 20 13. 21 Table 20 -1 s hows the nu mbers ofthes e d eathsthatwere c od ed forH F as the u nd erlyingc au s e.

• The nu mberofany-mention d eaths attribu table to H F wasapproximately as highin 1995 (2 8 7 0 0 0 )as itwas in 20 13 (30 0 0 0 0 ;N C H S , N H L B I). 21

• S u rvivalafterH F d iagnos is has improved between 197 9 and 20 0 0 ,as s hown by d ata from the O lms ted C ou nty S tu d y. H owever, theas s hown by d ata from the O lms ted C ou nty S tu d y. 22 H owever, thed eathrate remains high: ≈50 % of people d iagnos ed with H F will d ie within 5 years . 22 , 23

Dariush Mozaffarian et al. Circulation. 2016;133:e38-e360

The Impact of Heart Transplantation(US)(US)

• 20 13 : 30 0 , 1 2 2 d eaths

• S u rvivalrate: 50 % at5 years

• H Tx: n=2614• H Tx: n=2614

• S u rvivalrate 50 % at11 years

• Impac t1%• Impac t1%

The Impact of Heart Transplantation(UK)(UK)

• US popu lation (20 13): c a. 31 8 , 0 0 0 , 0 0 0

• UK pu pu ation (20 13): c a. 64, 0 0 0 , 0 0 0

• H Tx (US ): n=2614• H Tx (US ): n=2614

• H Tx (UK): n=164

• Ratio popu lation US /UK: c a. 5/1• Ratio popu lation US /UK: c a. 5/1

• Ratio H Tx US /UK: c a. 16/1

• Impac t: N O N E

US vs . UK

Adult and Pediatric Heart TransplantsMedian Donor Age by LocationMedian Donor Age by Location

Europe North America Other

2016JHLT. 2016 Oct; 35(10): 1149-1205

Adult and Pediatric Heart TransplantsDonor Age Distribution by Location

0-9 10-17 18-39 40-59 60-69 70+

Donor Age Distribution by Location(Transplants: January 2009 – June 2015)

Europe North America OtherEurope North America Other

Donor age (years): mean/median2016

JHLT. 2016 Oct; 35(10): 1149-1205

Europe = 40/43; North America = 28/27; Other = 32/29

Deceased donors &transplantstransplants

Predicted based onactivity to 1 Feb

Age of deceased donorsAge of deceased donorsBased on activity

to 1 Feb

donors

•US•UKPatient Status Status US Status UK

TA H 1a N ormal(=2) •US•UK

•N ormal(=2)

TA H 1a N ormal(=2)

EC M O /IA B P 1a S u perUrgent(1a)

H ighd os e inotroped epend ent

1a (revalid ation 7 d ) Urgent(1b)

(=2)d epend ent

M ec hanic alVentilation 1a (revalid ation 14d ) Unlikely to be lis ted forlong

VA D (notin hos pital) 1a (30 d ays ) N ormal(2)VA D (notin hos pital) 1a (30 d ays ) N ormal(2)

M ec hanic alVentilationM C S c . s ignific antc omplic ation

1a (revalid ation 14d ) Urgent(1b)

c omplic ation

VA D 1b N ormal(2)

Inotrope infu s ion 1b N ormal(2)(leveld epend ent)

d epend ent)

Number of adult heart transplants in the UK, 1 April 2005 to 31 March2015, by financial year and urgency status

20 07 5%

u rgent8 3%

u rgent

P red ic tedbas ed onac tivity to

35 126

u rgent

68 %u rgent57 %

u rgent

37 5161 8 0

11 8159

2 0 0 5

2 0 0 6

2 0 0 7

2 0 0 8

2 0 0 9

2 0 1 0

2 0 1 1

2 0 1 2

2 0 1 3

2 0 1 4

2 0 1 5

40 8 1 8 8

59 52 48 40 46 38 4125

0 0 5/2 0 0 6

0 0 6/2 0 0 7

0 0 7 /2 0 0 8

0 0 8 /2 0 0 9

0 0 9/2 0 1 0

0 1 0 /2 0 1 1

0 1 1/2 0 1 2

0 1 2/2 0 1 3

0 13/2 0 1 4

0 1 4/2 0 1 5

0 1 5/2 0 1 6

Financ ialyear

TotalP red ic tedUrgentNon-u rgent

•O n an ind ivid u allevel, H Tx is highly•O n an ind ivid u allevel, H Tx is highlys u c c es s fu l

•O n epid emiologic allevel, H Tx is irrelevant

•H Tx is a very expens ive orphan therapy•H Tx is a very expens ive orphan therapy

•In the UK, itis almos tc ompletely irrelevantRoyal Brompton & Harefield

NHS Foundation Trust A . S imon

•In the UK, itis almos tc ompletely irrelevant

•M aximize O rgan Utilization•M aximize O rgan Utilization

•Explore alternatives•Explore alternatives

M oore’ s law applied ?

O rthotopic C ard iac P ros thes is forTwo-S tagedC ard iac Replac ement(1969)C ard iac Replac ement(1969)V24 (1969), American Journal of Cardiology (pp. 7 23-7 30 ).

• O n A pril4, 1969, D r. D enton A .C ooley performed the firs ttotalartific ialheartimplantin the world .The d evic e, d eveloped by D r.D omingo L iotta, was implanted in aD omingo L iotta, was implanted in a47 -year-old patientwiths evereheartfailu re. The L iotta hearts u pported the patientfornearlythree d ays , atwhic htime a d onorthree d ays , atwhic htime a d onorheartwas fou nd for trans plantation.This experienc e s howed d oc torsthatpatients c ou ld be "brid ged " totrans plantation, meaningthatmec hanic alc irc u latory s u pportmec hanic alc irc u latory s u pports ys tems c ou ld be u s ed to keepapatientalive u ntila d onorheartisfou nd .

A n air-d riven extrac orporealpu mp. The d es ign provid ess u pportforeitherthe leftorrights u pportforeitherthe leftorrightventric le, orboth.The pu mpc ons is tts oftwopolyu rethane c hambers : an atrialc hamberthatfills withbloodc hamberthatfills withbloodthrou ghgravitationalforc e and aventric u larc hamber thatpu mpsblood by air-d riven power. Theatrialc hamberis vented ou ts id eatrialc hamberis vented ou ts id ethe patient. The ventric u larc hamberis c onnec ted to thepowerc ons ole by pneu matic airline. Two trileafletvalves s eparateline. Two trileafletvalves s eparatethe atrialand ventric u larc hambers . The pu mpc anprod u c e blood flow ofu pto 5liters perminu te.

liters perminu te.

TotalA rtific ialH eart(198 2)

Tec hnic ald etails :Tec hnic ald etails :

• A xialflow pu mp

• N on-pu ls atile

• S peed : 9, 0 0 0 -13, 0 0 0 rpm

• Flow: 3 -10 l/min

• B S A : >1 . 2m²• B S A : >1 . 2m²

• S inc e 20 0 4• S inc e 20 0 4

Heart Assist5 AVADHeart Assist5 AVAD

Tec hnic ald etails :Tec hnic ald etails :

• C entrifu galpu mp

• S peed : 2 , 0 0 0 -3, 0 0 0 rpm• S peed : 2 , 0 0 0 -3, 0 0 0 rpm

• Flow: 3-10 l/min

Inflow Cannula: Tipvis ible on P A (profile)and lateral(head on)views andC annu la exits thorax at2 nd interc os tals pac e

Micro-pump : P os ition over2 nd interc os tals pac e and parallels c lavic le

Royal Brompton & HarefieldNHS Foundation Trust A . S imon 2 0 /10 /20 0 9

Thoratec

MVAD® PumpFu ll-s u pport

CircuLiteP artial-as s is t

d evic e;Fu ll-s u pportd evic e;

B TT/D T patient

d evic e;C las s IIIpatients ,H FpEF patients

LonghornFu ll-s u pport; eld erly and high-

ris kpatients

C A UTIO N : Inves tigationalD evic e. L imited byUnited S tates law to inves tigationalu s e.

ris kpatients

HVAD®HVAD®

MVAD®

PumpPump

Advances HTWR into Class IIIpatient populationpatient population

•Targetingpatients who failC RTtherapy

•L arge u nmetneed

P u mpin s u bc u taneou s pac emakerpoc ket

Rights id ed mini-thorac otomy

O ff-pu mpproc ed u re

Extu bation in O R pos s ible

C A UTIO N –Inves tigationalD evic e. L imited by United S tates law to inves tigationalu s e.Exc lu s ively forC linic alInves tigations .

• Intracardiac device with no arterialanastomosis required

• O u tflow c annu la ac ros s aortic valve• O u tflow c annu la ac ros s aortic valve

• Designed for:

• S mall, s ingle inc is ion, minimally invas ive implant• S mall, s ingle inc is ion, minimally invas ive implant(s imilarto Trans apic alTA VR)

• ‘ O ffpu mp’ implantproc ed u re

• Potential benefits:• Potential benefits:

• Eliminate C P B

• Red u c e L O S

• Red u c e blood u tilization• Red u c e blood u tilization

• Expand treatmentpopu lation

• Eld erly/H ighRis k

In d evelopment. N otapproved forc linic alu s e.

Free • B as ed on Trans c u taneou s Energy Trans fer(“TET”)tec hnology

Advanced Technology

Mobile

tec hnology

• P eriod ic ally rec harged u s ingind u c tive c ou plingac ros sthe s kin

• Fu lly-implantable c ontroller& battery optimized forlong-term s u pportand patientmobility

Mobile

Tethered

term s u pportand patientmobility

• W ireles s monitoringand managementofVA Dparameters

Tethered

• Designed for both HVAD® Pump and MVAD® Pump

No exit site care or risk of trauma to exit site

Patient Benefits

• No exit site care or risk of trauma to exit site

• Patient physical freedom from externalcomponents

• Discreet physical appearance

C A UTIO N : In d evelopmentand notavailable forc linic alu s e.

HTx VAD

B rid ge to Rec overy

D es tination Therapy D es tination Therapy

B rid ge to D ec is ion

B rid ge to Trans plantation

• L arges ttrans plant/M C S program inthe UKthe UK

• C u rrently, 7 5 long-term M C S patients

• 20 14/15 we implanted 48 longtermd evic esd evic es

• L onges ton-goingVA D patient10years on s u pport

• In 20 16, >10 0 pts . on EC L S

• 20 14/15, 25 hearttrans plants• 20 14/15, 25 hearttrans plants

• 1 7 ofthes e trans plants were onpatients s u pported by M C S

S u c c es s was d efined as s u rvivalto trans plant, s u c c es s fu lrec overy withd evic eexplant, oron c ontinu ed H eartW are S ys tem s u pport.

explant, oron c ontinu ed H eartW are S ys tem s u pport.

L ong-term follow-u pin a pos t-C E markC ommerc ialRegis try (ReVO L VE)

d emons trated improved tlong-term s u rvival; withlow ad vers e eventrates

(59% at5 years ).

* S c hmitto, J. L ongTerm S u pportofP atients Rec eivingan L VA D forA d vanc ed H eartFailu re: A Follow-u pA nalys is ofthe Regis try to Evalu ate the H eartW are L eftVentric u larA s s is tS ys tem (The ReVO L VE Regis try), P res entation atIS H L T,

the Regis try to Evalu ate the H eartW are L eftVentric u larA s s is tS ys tem (The ReVO L VE Regis try), P res entation atIS H L T,A pril16, 2 0 15, N ic e Franc e

Fig1HeartWare Left Ventricular Assist Device Implantation

Through Bilateral Anterior ThoracotomyAron Frederik Popov, MD, Morteza Tavakkoli Hosseini, MD, Bartlomiej Zych, MD, Andre Ruediger Simon, MD,Aron Frederik Popov, MD, Morteza Tavakkoli Hosseini, MD, Bartlomiej Zych, MD, Andre Ruediger Simon, MD,

PhD, Toufan Bahrami, MD,The Annals of Thoracic Surgery Volume 93, Issue 2, Pages 674-676 (February 2012

(A )Implantation ofthe s ewing ring. (B )Es tablis hmentofc ard iopu lmonary bypas s . (C )Tu nnelingofthe ou tflow grafttowardthe rightthorac otomy inc is ion. (D )P os toperative res u lt.

The Annals of Thoracic Surgery 20 12 93, 67 4-67 6D O I: (10 . 1 0 16/j. athorac s u r. 2 0 11 . 0 9. 0 55)

• Primary Anatomy1

• Failed Fontan’ s

• S ys temic RV/trans pos ition ofgreatves s els• S ys temic RV/trans pos ition ofgreatves s els

• CMO associated with MuscularDystrophy:Dystrophy:

• D u c henne M D

• It’ s the mos tc ommon lethalgenetic d is eas e inc hild ren world wid e

• 8 0 % d ie from ad vanc ed heartfailu re

The firs tfemale withD u c henne M u s c u larD ys trophy is implanted withan L VA D atC inc innatiC hild ren's H os pital

1S hahetal, 2 0 13, JH L T

Left Ventricular Assist Device Implantation With Dor Procedure viaBilateral Limited Thoracotomy.Bilateral Limited Thoracotomy.

A rtifO rgans . 2 0 15 Ju l; 39(7 ): 641-2 .P atilN P , P opov A F, S imon A R.

Left ventricular assist device implantation with concomitant leftventricular reconstruction without patchplastyventricular reconstruction without patchplasty

JA rtifO rgans . 2 0 14 D ec ; 1 7 (4): 37 0 -2 .Fatu llayev J1 , B u tters T, S abas hnikov A , Garc ia S aez D , M ohite P N , E d ward s G,

H oegerle B , W ahlers T, P opov A F, S imon A R.H oegerle B , W ahlers T, P opov A F, S imon A R.

Figu re 1

Tunneling of ventricular assist device outflow graft rostral to superior vena cavaPrashant N. Mohite, MCh, Aron F. Popov, MD, Tarun K. Mittal, MD, Andre R. Simon, MD

The Journal of Thoracic and Cardiovascular Surgery 20 12 144, 1519-1520 D O I: (10 . 1 0 16/j. jtc vs . 2 0 12 . 0 7 . 0 2 7 )

Prashant N. Mohite, MCh, Aron F. Popov, MD, Tarun K. Mittal, MD, Andre R. Simon, MDThe Journal of Thoracic and Cardiovascular Surgery, Volu me 144, Is s u e 6, P ages 1519-1520 (D ec ember20 12)

Tunneling of ventricular assist device outflow graft rostral tosuperior vena cava

Prashant N. Mohite, MCh, Aron F. Popov, MD, Tarun K. Mittal, MD, Andre R. Simon, MDPrashant N. Mohite, MCh, Aron F. Popov, MD, Tarun K. Mittal, MD, Andre R. Simon, MDThe Journal of Thoracic and Cardiovascular Surgery

Volu me 144, Is s u e 6, P ages 1519-1520 (D ec ember20 12)

Royal Brompton & HarefieldNHS Foundation Trust A . S imonC opyright© 20 12 The A meric an A s s oc iation forThorac ic S u rgery Terms and C ond itions

Minimally invasive HeartWare LVAD implantation through singleleft thoracotomy

JA rtifO rgans . 2 0 15 Ju n; 1 8 (2): 1 7 0 -2 . .JA rtifO rgans . 2 0 15 Ju n; 1 8 (2): 1 7 0 -2 . .P opov A F1 , M ohite P N , S abas hnikov A , W eymann A , P atilN P , S áez D G, S imon A R.

• 3 years u rvivalc omparable orbetterwhen c ompared to• 3 years u rvivalc omparable orbetterwhen c ompared toH Tx in s elec tgrou ps (7 5% H H ongoing)

• 5 years u rvival59% in non s elec ted patients (H Tx: 69% )• 5 years u rvival59% in non s elec ted patients (H Tx: 69% )

• Exc ellentQ oL• Exc ellentQ oL

• Us ed as d es tination orc hronic s u pport(ou ts id e UK)• Us ed as d es tination orc hronic s u pport(ou ts id e UK)therapy rou tinely

• H earttrans plantation d oes notpres enta feas ible• H earttrans plantation d oes notpres enta feas ibletherapeu tic alc onc eptin reallife.

• M ed iu m term VA D res u lts are VA D res u lts areac c eptable, longterm res u lts ac c eptable in s elec tedac c eptable, longterm res u lts ac c eptable in s elec tedgrou ps and res u lts c ontinu e to improve rapid ly.

• A s s u gges ted by N IC E , d es tination/c hronic s u pport• A s s u gges ted by N IC E , d es tination/c hronic s u pports hou ld be fu nd ed .

• VA D therapy s hou ld bec ome the s tand ard longtermtherapy forpatients withend s tage heartfailu retherapy forpatients withend s tage heartfailu re

• H Tx s hou ld be res tric ted to a highly s elec ted patientpopu lation

popu lation

2 0 /10 /20 0 9

A rtific ialH earts have bec ome a Realis tic S olu tion forYou ngerP atients withC irc u latory Failu reYou ngerP atients withC irc u latory Failu re

S potthe VA D ?S potthe VA D ?

1659 Days on Support

royal brompton & harefield - promedica international · • o n a pril4, 1969, dr. denton a . c...

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