martin b. leon, mdthe 1st tct - 1988 purpose • explore a new eraof interventional device therapies...
TRANSCRIPT
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 ocapturethepioneeringspiritofinterventionalcardiologyandtoacknow ledgecontributionstothem oderneraofP CI
• T oaccurately representtheevolutionofinterventionalcardiology from the“ early P T CA days” toitscurrentroleasa
Modern Era of PCI - 2018GoalsofthisL ectureGoalsofthisL ecture
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 ocapturethepioneeringspiritofinterventionalcardiologyandtoacknow ledgecontributionstothem oderneraofP CI
• T oaccurately representtheevolutionofinterventionalcardiology from the“ early P T CA days” toitscurrentroleasa
Modern Era of PCI - 2018GoalsofthisL ectureGoalsofthisL ecture
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)
Modern Era of PCI - 2018ClinicalCourse(2)ClinicalCourse(2)
• 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%
Modern Era of PCI - 2018ClinicalCourse(3)ClinicalCourse(3)
• 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)
Modern Era of PCI - 2018EssentialCom ponentsEssentialCom ponents
DevicesDevices
“Early” Days Modern Era
TherapiesTherapies
ProceduralistProceduralist ClinicianClinician
Modern Era of PCI - 2018EssentialCom ponentsEssentialCom ponents
• 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
Modern Era of PCI - 2018EssentialCom ponentsEssentialCom ponents
• 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!
Modern Era of PCI - 2018
Modern Era of PCI - 2018
ClinicalIm peratives
N ewT echnology
EvidenceEvidence--basedbased
ValidationValidation
Modern Era of PCI - 2018
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
Modern Era of PCI - 2018
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)
Modern Era of PCI - 2018
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
When More is MoreCoronary S tentsCoronary S tents
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
When More is MoreCoronary S tentsCoronary S tents
McFadden EP et al. Lancet 2004; 364:1519–21 T hegood,thebad,andtheU GL Y!
When More is MoreCoronary S tentsCoronary S tents
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)
The Interventional ParadoxW henM oreisM oreW henM oreisM ore
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
When More is MoreIm aging andP hysiologyIm aging andP hysiology
FAME: 1ry Endpoint (1005 pts w MVD)
Tonino PAL et al. NEJM 2009;360:213–24
When More is MoreIm aging andP hysiologyIm aging andP hysiology
iFR was non-inferior to FFR (MACE at 12 mos)
ACC 2017
When More is MoreIm aging andP hysiologyIm aging andP hysiology
Non-invasive FFRCT from Coronary CT Scans
When More is MoreIm aging andP hysiologyIm aging andP hysiology
CATHWORKS: ”Wireless” Angiography FFR
The Interventional ParadoxW henM oreisM oreW henM oreisM ore
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
When More is MoreCom plex/HighCom plex/High--R iskP CIR iskP CI
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
When More is MoreCom plex/HighCom plex/High--R iskP CIR iskP CI
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)
When More is MoreCom plex/HighCom plex/High--R iskP CIR iskP CI
When More is MoreCom plex/HighCom plex/High--R iskP CIR iskP CI
“ 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
When Less is MoreDedicatedBifurcationS tentsDedicatedBifurcationS tents
BifurcationR CT sFavorP rovisionalS tenting(N O R DIC,BBC O N E,CACT U S )
When Less is MoreDedicatedBifurcationS tentsDedicatedBifurcationS tents
T heT R YT O N BifurcationS tentR CT
When Less is MoreDedicatedBifurcationS tentsDedicatedBifurcationS tents
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
When Less is MoreBioresorbableS caffolds(BR S )BioresorbableS caffolds(BR S )
Ali Z et al. Lancet May, 2017
When Less is MoreBioresorbableS caffolds(BR S )BioresorbableS caffolds(BR S )
Expectationsvs.R eality
Courtesy of D. Capodanno
ClinicalIm peratives
When Less is MoreBioresorbableS caffolds(BR S )BioresorbableS caffolds(BR S )
N otconvincing
Difficulttouse
N ewT echnology
EvidenceEvidence--basedbased
ValidationValidation
S afetyconcerns
touse
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
GoodCandidatesforGoodCandidatesforM itraClipM itraClipGoodCandidatesforGoodCandidatesforM itraClipM itraClipandand
ExperiencedO perators!ExperiencedO perators!
When Less is More & More is MoreM itraClipM itraClipforFM RforFM R
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
Modern Era of PCI - 2018
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
The Next Big BreakthroughInterventionalHeartFailureInterventionalHeartFailure
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!!!