martin b. leon, mdthe 1st tct - 1988 purpose • explore a new eraof interventional device therapies...

Keynote Lecture

Martin B. Leon, MDMartin B. Leon, MDColumbia University Medical CenterColumbia University Medical Center -- NYPresbyterianNYPresbyterian HospitalHospital

Cardiovascular Research FoundationCardiovascular Research FoundationNew York CityNew York City 40 mins

DisclosureS tatem entofFinancialInterestDisclosureS tatem entofFinancialInterestCAT CD 2018;Beverly Hills,CA;N ovem ber15CAT CD 2018;Beverly Hills,CA;N ovem ber15--16,201816,2018

M artinB.L eon,M DM artinB.L eon,M DWithin the past 12 months, I or my spouse/partner have had a financialinterest/arrangement or affiliation with the organization(s) listed below.

Affiliation / Financial Relationship Company

• Grant / Research Support Abbott, Boston Scientific, EdwardsLifescience, Medtronic, Sinomed

• Consulting Fees / Honoraria Boston Scientific, Gore, Medtronic,Meril Lifesciences

• Shareholder / Equity Cathworks, Elixir, GDS, Medinol,Valve Medical, Triventures

Affiliation / Financial Relationship Company

• T ocapturethepioneeringspiritofinterventionalcardiologyandtoacknow ledgecontributionstothem oderneraofP CI

Modern Era of PCI - 2018GoalsofthisL ectureGoalsofthisL ecture

40 YearsofP CI40 YearsofP CI40 YearsofP CI40 YearsofP CI

« Don’tDon’t gogo therethere!! » « Just stop me!Just stop me! »

The 1st TCT - 1988

PURPOSEPURPOSE

• Explore a new eraofinterventional device therapies -innovation!

• Re-introduce the live casedemonstration format

• Explore a new eraofinterventional device therapies -innovation!

• Re-introduce the live casedemonstration formatdemonstration format- education

• Apply rigorous methods toevaluate devices and clinicaloutcomes - evidence-based

• Create an international networkof multi-disciplinary scientists -GL O BA L !

demonstration format- education

• Apply rigorous methods toevaluate devices and clinicaloutcomes - evidence-based

• Create an international networkof multi-disciplinary scientists -GL O BA L !


• T oaccurately representtheevolutionofinterventionalcardiology from the“ early P T CA days” toitscurrentroleasa


cardiology from the“ early P T CA days” toitscurrentroleasafundam entalcom ponentofcardiovasculartherapeutics

15 min P os t15 min P os t--TA VITA VI

15YearsofT AVI15YearsofT AVI15YearsofT AVI15YearsofT AVI

April 16, 2002; FIM-TAVI, Trans-septal

•• 11,542 attendees;57% U S ;>90 countries;1,432 faculty11,542 attendees;57% U S ;>90 countries;1,432 faculty•• >1400 lectures;1,127abstracts;957challengingcases>1400 lectures;1,127abstracts;957challengingcases•• >1400 lectures;1,127abstracts;957challengingcases>1400 lectures;1,127abstracts;957challengingcases•• 15L BCT ;12 L B science;37key interventionalstudies15L BCT ;12 L B science;37key interventionalstudies•• 14 livecasesites;33 livecases14 livecasesites;33 livecases•• 8trainingpavilions;102 trainingsessions8trainingpavilions;102 trainingsessions


• T oaccurately representtheevolutionofinterventionalcardiology from the“ early P T CA days” toitscurrentroleasa


cardiology from the“ early P T CA days” toitscurrentroleasafundam entalcom ponentofcardiovasculartherapeutics

• T oreflectonthenecessity toharnesstheexplosionofnewinterventionaltechnologiesby applyingjudicioususeprinciples;ahealthy respectfor“ w hennottotreat” and“ w hentotreatw ithless,notm ore”

Modern Era of PCI - 2018T heInterventionalP aradoxT heInterventionalP aradox

in·ter·venecome between or act so as to alter a result or course of events

par·a·doxa seemingly self-contradictory statement or proposition thatwhen investigated or explained may prove to be well founded ortrue

• Artificialintelligence,neuralnetw orks,anddeepm achinelearning

• “ Big” data(esp.onthecloud)• Digitalhealthandintegrateddigitalservices

Modern Era of PCI - 2018T opicsN otintheS copeofthisL ectureT opicsN otintheS copeofthisL ecture

• Digitalhealthandintegrateddigitalservices• Cybersecurity• N ano-fabricationand3D/4D bioprinting• S ensors– internalandexternal(w earables)• Virtualoraugm entedreality• A nythingthattw eets…

65yom alew ithseverechestpain,after“ stuttering”chestpainforthreedays

• N oknow nP M H,form ersm oker,Jehovah’sw itness(refusesallbloodproducts)

Modern Era of PCI - 2018CaseHistory (01/15/18)CaseHistory (01/15/18)

(refusesallbloodproducts)

• VS :HR 88,BP 150/77,diaphoresis

• ECG:acuteinfero-lateralM I

• Cath: L VEDP 22m m Hg;L V -severeM R ,severeanterolateralhypokinesia,EF~40% ;CAs– 3VD w ithacuteocclusionoflargedistalR CA

Modern Era of PCI - 2018Coronary AngiogramCoronary Angiogram --L CAL CA

Modern Era of PCI - 2018Coronary AngiogramCoronary Angiogram --R CAR CA

Modern Era of PCI - 2018ClinicalCourse(1)ClinicalCourse(1)

• R apidclinicaldecom pensationduringcasew ithseverecardiogenicshock

• Im pellaCP inserted

• T ransientarrestrequiringvasopressors,continuedseverehypoxem iaandshock

• IntubatedandVA ECM O instituted

• R P L andO M 1 recanalizationandDES placem ent

Modern Era of PCI - 2018R P L InterventionR P L Intervention

S ynergy DES ;3.5m m x 16m m @ 12 atm

Modern Era of PCI - 2018O M 1 InterventionO M 1 Intervention

S ynergy DES ;3.0m m x 20m m ;2.5 m m balloon(branch)


• R HC:R A 13,R V 28/11,P A 25/20,P CW 17w ithlargevw aves,P A sat57% ,CO /CI= 3.2/1.6

• Adm ittedtoCCU onlow doseinotropesandpressors

• T EE:rupturedpapillary m uscleandflailedleaflet,severe• T EE:rupturedpapillary m uscleandflailedleaflet,severeacuteM R

• Heartteam discussion(w fam ily andCT surgery)–surgeryw obloodrefused,decision= acutem itraclipplacem ent

Modern Era of PCI - 2018T ransesophagealEchoT ransesophagealEcho

Modern Era of PCI - 2018T ransesophagealEchoT ransesophagealEcho--3D3D

Modern Era of PCI - 2018Deploym entof1Deploym entof1stst M itraclipM itraclip

Modern Era of PCI - 2018Deploym entof2Deploym entof2ndnd M itraclipM itraclip

Modern Era of PCI - 2018FinalFinalM itraClipM itraClipR esultR esult

• ECM O decannulatedpost-procedureday 1

• Extubatedpost-procedureday 2

• N ofurthercom plications

• P re-dischargeecho:M R 1-2+ andEF45%


• P re-dischargeecho:M R 1-2+ andEF45%

• Dischargedpost-procedureday 10,fully am bulatoryandw osym ptom s

• Firstclinicvisit:w ocom plicationsorsym ptom s

• L AD revascularizationsuccessful6 w eekslater

Modern Era of PCI - 2018EssentialCom ponentsEssentialCom ponents

• T houghtfulandreasonableclinicalindicationsforP CItherapy(clinicianvs.proceduralist)


DevicesDevices

“Early” Days Modern Era

TherapiesTherapies

ProceduralistProceduralist ClinicianClinician


• T houghtfulandreasonableclinicalindicationsforP CItherapy(clinicianvs.proceduralist)

• Com m andofadvancedP CIskills(training,caseexperiences,em braceglobalcollectivew isdom )em braceglobalcollectivew isdom )

• Applicationofadjunctivepharm acotherapy tosupportP CIproceduresandclinicalsyndrom es(before,during,andafter)

• Judicioususeofnon-invasiveandintravascularim agingandphysiologiclesionassessm ent


• Appropriateuseoftheinterventionaldevice“ toolbox” ,includingm echanicalcirculatory support

• Com m itm enttoevidence-basedvalidationofnew devicesandtherapy approachestherapy approaches

• Com plexcardiovasculardiseasem anagem entrequiresa“ heartteam ” approach,including… cardiologists,interventionalists,surgeons,im agingspecialists,heartfailureandheartrhythmexperts,andarobustsupportcastofhealthcareprofessionals!

Modern Era of PCI - 2018

CoronaryModern Era PCI =Modern Era PCI =

Vascular S tructuralS tructural

Modern Era PCI =Modern Era PCI =PercutaneousPercutaneous CardiovascularCardiovascular

Intervention!Intervention!


ClinicalIm peratives

N ewT echnology

EvidenceEvidence--basedbased

ValidationValidation

Modern Era of PCI - 2018IncorrectClinicalHypothesesIncorrectClinicalHypotheses

R otationalatherectom y O rbitalatherectom yO rbitalatherectom y

ECLIPSE Trial DesignO rbitalAherectom y vs.ConventionalAngioplasty P riortoDES Im plantationinS everely CalcifiedCoronary L esions

≈2000 pts with severely calcified lesions; ≈100 US sites

Orbital Atherectomy StrategyConventional Angioplasty Strategy

Randomize 1:1

Orbital Atherectomy Strategy(1.25m m Crow nfollow edby non-com pliantballoonoptim ization)

Conventional Angioplasty Strategy(conventionaland/orspecialty balloonsperoperatordiscretion)

Primary Endpoints

2nd generation DES implantation and optimization

Post-PCI minimal stent area by OCT (N≈500) 1-yearT VF(allpatients)

Principal investigators: Philippe Généreux, Ajay Kirtane; Study chairman: Gregg W. StoneSponsor: Cardiovascular Systems, Inc.

Modern Era of PCI - 2018IncorrectClinicalHypothesesIncorrectClinicalHypotheses

Thromboaspiration for STEMIT AS T EandT O T ALT AS T EandT O T AL

TASTE, N= 7,244 TOTAL, N=10,732CV death,recurrentM I,cardiogenicshock,orheartfailurew ithin180 days

N Engl J Med 2013; 369:1587-97 N Engl J Med 2015; 372:1389-98

The Efficacy – Invasiveness Relationship

WORSEWORSE

CurrentCurrent

SOCSOC

Unmet Need?Unmet Need?Pt. willing to accept risk orPt. willing to accept risk orinvasiveness for increased benefitinvasiveness for increased benefit

A ccounting forU nm etN eedandP atientP referenceBenefit-Risk Determinations

More BeneficialMore Beneficial

More Risk orMore Risk orInvasivenessInvasiveness

LessLess MoreMore

FDA PMA Approval – Clinical Decisions

Worse Better

--------Statistical Test Limits (e.g. 95% CI)

------ Benefit–Risk Threshold

Benefit/RiskDetermination

Greater Utility orGreater Utility orNew Standard of Care (SOC)New Standard of Care (SOC)Less Risk orLess Risk or

InvasivenessInvasiveness

SOCSOCOutcomesOutcomesAcceptableAcceptableAlternativesAlternatives

Pt. willing to tradePt. willing to tradebenefit for lower risks,benefit for lower risks,less invasivenessless invasiveness

More BeneficialMore BeneficialAlternativesAlternatives

SaferSaferAlternativesAlternatives

LessLessBenefitBenefit

MoreMoreBenefitBenefit

Courtesy of John Laschinger, MD (FDA)

The Interventional ParadoxW henM oreisM oreW henM oreisM ore

T heP alm az-S chatzbarem etalstent

A S im pleS olution!

When More is MoreCoronary S tentsCoronary S tents

S tentFrenzy…

45%

25% 19% 17% 13% 8%

80%

100%

120% Stents Balloon Angioplasty Atherectomy

49%

70% 76% 80% 84% 90%

45%

0%

20%

40%

60%

1997 1998 1999 2000 2001 2002

T hegood,thebad,andtheU GL Y!

TA

XU

STA

XU

S


FirstGenerationDES

Polyolefin derivativePolyolefin derivativePaclitaxelPaclitaxel ExpressExpress22

DrugDrug PolymerPolymer StentStent

Cyp

he

rC

yp

he

r

PEVA + PBMAPEVA + PBMASirolimusSirolimus BX VelocityBX Velocity

Courtesy ofEduardoS ousa

10 years


McFadden EP et al. Lancet 2004; 364:1519–21 T hegood,thebad,andtheU GL Y!


DES vs.BM S M eta-Analysis L essonsL earned

• Im portance(“ pow er” )ofclinicalevidence(EBM )

Kirtane AJ et al. Circulation 2009;119: 3198-3206

clinicalevidence(EBM )• R elianceonappropriate

adjunctpharm acotherapy(prolongdDAP T )

• N eedfor2nd generationDES (e.g.X ience,R esolute,andS ynergy)

When More is MoreIm aging andP hysiologyIm aging andP hysiology

Study Year # OR IVUS MACE Angio MACE

IVUS-XLP 2015 1400 0.49 19/700 39/700

CTO-IVUS 2015 402 0.37 5/201 14/201

AIR-CTO 2015 230 0.82 25/115 29/115

..

..

Meta-analysis of 8 RCTs of IVUS vs Angio-Guided DES ImplantationEvent IVUS

eventsAngioevents

OR 95% CI P-value

MACE 6.5% 10.3% 0.59 0.46-0.76 <0.0001

AIR-CTO 2015 230 0.82 25/115 29/115

Tan-LM 2015 123 0.42 8/61 17/62

MOZART 2014 83 0.41 2/41 5/42

RESET 2013 543 0.60 12/269 20/274

AVIO 2013 284 0.67 24/142 33/142

Home-DES 2010 210 0.91 11/105 12/105

OVERALL 3275 0.59 106/1634 169/1641

IVUSbetter

Angiobetter 6.5% 10.3%

.

...

.

CVmortality

0.5% 1.2% 0.46 0.21-1.00 0.05

MI 0.9% 1.6% 0.58 0.30-1.11 0.10

TLR 4.1% 6.6% 0.60 0.43-0.84 0.003

TVR 5.5% 8.7% 0.61 0.41-0.91 0.02

ST 0.6% 1.3% 0.49 0.24-0.99 0.04

Elgendy IY et al. Circ Cardiovasc Interv 2016 Apr;9(4):e003700


FAME: 1ry Endpoint (1005 pts w MVD)

Tonino PAL et al. NEJM 2009;360:213–24


iFR was non-inferior to FFR (MACE at 12 mos)

ACC 2017


Non-invasive FFRCT from Coronary CT Scans


CATHWORKS: ”Wireless” Angiography FFR

When More is MoreCom plex/HighCom plex/High--R iskP CIR iskP CI

41,310 ptsfrom 316high-volum ehospitalsinACT IO N -GW T G

NSTEMI with LMCA/3VD: Role for Medical Rx?

Harskamp et al, AHJ 2014


Are We Up to the Challenge of TreatingComplex and Higher-Risk Patients?

CHIP =

Com plex Higher-R isk

(andIndicated)P atients

T hissuggeststhatT hissuggeststhatinterventionalistsinterventionalistsaresystem atically undertreatingaresystem atically undertreating

im portantpatientcohortsw ithP CIim portantpatientcohortsw ithP CIduetoriskduetorisk–– avoidancebehavior!avoidancebehavior!

P atient

Com orbidities


Defining the CHIPPopulation

AnatomicConsiderations…

• CT O s• L M disease

Anatom icAnatom ic

ConsiderationsConsiderations

LV Function&LV Function&

Hem odynam icsHem odynam ics

• L M disease• DiffuseM V disease• Com plexanatom ies

(Ca++ ,ostialandbifurcationlesions)


“ T heCHIP O peratorsCredo”

The indications

M andatefortheFuture

• Extensive operator andThe indicationsfor the case donot change just

because thelesion is “harder

to treat”

• Extensive operator andteam training to masteradvanced skills

• Designated operators andcenters (tiered approach)to manage CHIP patients

The Interventional ParadoxW henL essisM oreW henL essisM ore

ExperimentalExperimentalAngioplasty

Program

NIH - 1988

When Less is MoreL aserCoronary AngioplastyL aserCoronary Angioplasty

T he“ S m art” L aser

T heillT heill--fateduseofadvancedtechnology;fateduseofadvancedtechnology;T heillT heill--fateduseofadvancedtechnology;fateduseofadvancedtechnology;addingcom plexity andcost,w ithoutaddingcom plexity andcost,w ithout

increm entalclinicalvalue!increm entalclinicalvalue!

Modern Era of PCI - 2018W henL essisM oreW henL essisM ore

Bifurcations are still a challenge…• Cost,resourceconsum ption• P eri-proceduralM isandstent

throm bosis• S uboptim alproceduralresults,leading

toincreasedrestenosis(esp.sidebranch)

When Less is MoreDedicatedBifurcationS tentsDedicatedBifurcationS tents

MMMMain prox. first

AAMain AAccross side first

DDDDistal first

SSSSide branch first

PMstenting

MB stentingaccross SB

DMstenting

ProvisionalSKS

SB ostial stenting

After

1st stent

Intention

Final

MMMMain prox. first

AAMain AAccross side first

DDDDistal first

SSSSide branch first

PMstenting

MB stentingaccross SB

DMstenting

ProvisionalSKS

SB ostial stenting

After

1st stent

Intention

Final

Abbott SBAbbott SB ABSABS

Extended V

Skirt MB stenting+ kissing

MB stenting+ SB balloon

ElectiveT stenting

Internalcrush

Culotte TAP Vstenting

SKS

Trouser legsand seat

SBminicrush

SB crush

Syst. TStenting

Minicrush Crush

Afterballoon

2 stents

3 stents

Skirt+ DM

Skirt+ SB

Extended V

Skirt MB stenting+ kissing

MB stenting+ SB balloon

ElectiveT stenting

Internalcrush

Culotte TAP Vstenting

SKS

Trouser legsand seat

SBminicrush

SB crush

Syst. TStenting

Minicrush Crush

Afterballoon

2 stents

3 stents

Skirt+ DM

Skirt+ SB

AxxessAxxessAbbott SBAbbott SBBIOSSBIOSSBSC PetalBSC PetalMinvasysMinvasys NilePaxNilePaxStentYsStentYsTriRemeTriRemeTwinTwin--RailRailYY--medmed

MDTMDT“Y” stent“Y” stent

ABSABSCappellaCappellaTrytonTryton

Courtesy of Yves Louvard


BifurcationR CT sFavorP rovisionalS tenting(N O R DIC,BBC O N E,CACT U S )


T heT R YT O N BifurcationS tentR CT

Modern Era of PCI - 2018W henL essisM oreW henL essisM ore

T heFirstBR S :T heFirstBR S :IgakiIgaki--T am aiT am ai

stentatstentat10 years!10 years!

Onuma Y et al. EuroInt 2009

When Less is MoreBioresorbableS caffolds(BR S )BioresorbableS caffolds(BR S )

A virtualavalancheofcreativebioresorbable

scaffoldshavebeenscaffoldshavebeendeveloped,ledby the

pioneeringeffortsoftheABS O R B clinicaltrials!

Iqbal J et al. EHJ. 2014;35,:765-76


Ali Z et al. Lancet May, 2017


Expectationsvs.R eality

Courtesy of D. Capodanno

ClinicalIm peratives


N otconvincing

Difficulttouse

N ewT echnology

EvidenceEvidence--basedbased

ValidationValidation

S afetyconcerns

touse

When Less is More & More is MoreM itraClipM itraClipforFM RforFM R


GoodCandidatesforGoodCandidatesforM itraClipM itraClipGoodCandidatesforGoodCandidatesforM itraClipM itraClipandand

ExperiencedO perators!ExperiencedO perators!

Mortality Benefit of Therapies for HFrEF

Courtesy: J. Lindenfeld; TCT 2018

The Interventional ParadoxJustR ight= T AVRJustR ight= T AVR

Itlookslikeastent

It’sballoon-expandable

Itbehaveslikeasurgicalbioprosthsis

It’seasy toim plant

Just Right = T AVRT AVR

Estim atedU .S .T AVR Grow th(2018– 2025)

U S T AVR M arketw illIncrease2.5X In2025,>75% ofallAVR inU S w illbeT AVR

Current (2018) Market Projections (multiple sources)

Just Right = T AVRT AVR

Since 2007, in the U.S.,Since 2007, in the U.S.,> 15,000 patients have been> 15,000 patients have been> 15,000 patients have been> 15,000 patients have been

enrolled in FDA studies (includingenrolled in FDA studies (including10 RCTs) with multiple generations10 RCTs) with multiple generations

of four different TAVR systems!of four different TAVR systems!

Capodanno D, Leon MB. EuroIntervention 2016

Just Right = T AVRT AVRT heL ow R iskR CT sT heL ow R iskR CT s

Modern Era of PCI - 2018T AVR istheCatalystfortheS tructuralR evolution!T AVR istheCatalystfortheS tructuralR evolution!

• S tructuralHeartDiseaseisaW A S T EBA S KET m eanttoincludeallnon-vascularproceduresutilizingcatheter-basedtechnologies!

ValveValve NonNon--ValveValveValveValve

TAVR/BAVMitraClip/TMVRTricupsidPVL

NonNon--ValveValve

Adult CongenitalLAACHF therapiesOther

Modern Era of PCI - 2018T AVR istheCatalystfortheS tructuralR evolution!T AVR istheCatalystfortheS tructuralR evolution!

• S tructuralHeartDiseaseisaW A S T EBA S KET m eanttoincludeallnon-vascularproceduresutilizingcatheter-basedtechnologies!

• Em phasizestheconfluenceoftw ofully evolved concepts–• Em phasizestheconfluenceoftw ofully evolved concepts–non-vascularim age-guidedtherapy (usingechoandM S CT )andm ulti-disciplinary heartteam strategies(w ithpre-procedureplanning).

• R equiressignificantadjustm entsintrainingofinterventionaloperatorsandtreatm entm ilieus(e.g.hybridcathlabsandO R s).

Modern Era of PCI - 2018W orldw ide$ InterventionalCardiology M arketT rendsW orldw ide$ InterventionalCardiology M arketT rends

• New market segments may exceed PCI market size by 2020

• OUS markets will lead and exceed the size of US markets

M ultipleIndustry S ources


Global InterventionalStructural Procedure Volume

M ultipleIndustry S ources

Modern Era of PCI - 2018EvolutiontoM ainstream T herapiesEvolutiontoM ainstream T herapies

• T heless-invasive(non-surgical)useofcatheter-basedtherapiestorem otely treatdistantdiseasetargetshastransform edm edicine!

N euro-radiology andneuro-surgery N euro-radiology andneuro-surgery

M inim ally invasiveendoscopicsurgery

Gastroenterology

O rthopedics

O ncology

P ulm onology (andEN T )

U rology andgynecology

Modern Era of PCI - 2018EvolutiontoM ainstream T herapiesEvolutiontoM ainstream T herapies

• T heless-invasive(non-surgical)useofcatheter-basedtherapiestorem otely treatdistantdiseasetargetshastransform edm edicine!

• A m ajorcurrenteffortistoredirectintra-vascularinterventional• A m ajorcurrenteffortistoredirectintra-vascularinterventionaltherapiestoaddressm ainstream cardiovascularandnon-cardiovasculardiseases(e.g.VHD,HT N ,HF,AF,DM ,obesity)

• T hisrequiresthattheinterventionalistbecom esam em berofnew ly form edm ulti-disciplinary team sAN D learnsnewcognitiveskills;thetransform ationfrom anisolatedproceduralisttoathoughtfulandengagedtherapist!

The Next Big BreakthroughInterventionalHeartFailureInterventionalHeartFailure

• T ranscatheterM echanicalcirculatory support

• S ensorstom onitorHFtherapy

• LV rem odelingdevices• LV rem odelingdevices

• Contractility m odulation

• M icro-VADs(interventional)

• Inter-atrialshuntim plants

• S tem celltherapies

The Next Big BreakthroughInterventionalHeartFailureInterventionalHeartFailure

What Would Andreas Think?O fw hat’sbecom eofinterventionalcardiology…O fw hat’sbecom eofinterventionalcardiology…

Ithinkhew ouldbe…Ithinkhew ouldbe…• A pproving of the mandate to generate and utilize evidence-based

medicine in clinical decision-making

• Ecstaticandoverw helm edwith the technology explosion that hasovercome many of the limitations of PTCAovercome many of the limitations of PTCA

• Enthralledwith the extension of catheter-based treatment to non-vascular disease states (e.g. structural/valvular)

• A ppalledwith the sometimes inappropriate use of devices, andconcerned about operators who don’t practice with the higheststandards of quality and ethics

• Distressedby the myriad external social, economic and politicalforces that are interfering with the practice of medicine

Modern Era of PCI - 2018T heHeartT eam 3.0T heHeartT eam 3.0

W ho’sM issing?W ho’sM issing?S haredS haredDecisionDecision--M akingM aking

P atientP atientP referencesP references

Remember,Remember,your patients areyour patients are

It’s All About the Patients!

First Cypher Stent First TAVR

your patients areyour patients arethe pointthe point--ofof--care!!!care!!!

martin b. leon, mdthe 1st tct - 1988 purpose • explore a new eraof interventional device therapies...

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