冠心病介入治疗及应用课件

冠心病介入治疗的现状与展望冠心病介入治疗的现状与展望CharlesT.DotterM.D.(1920-1985)InterventionalRadiologistPioneerintheFieldofMinimallyInvasiveProcedures(Catheterization)DevelopedContinuousX-RayAngio-CardiographyPerformedFirstAngioplasty(PTCA)Procedurein1964.CharlesT.DotterM.D.(1920-1MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology19771984198819891997199920002002200320042005200616MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology1977MauriceBuchbinder,MDHistory七十年代PCI适应证和禁忌证PCI初期

单纯球囊扩张（PTCA）年代适应证局限七十年代PCI适应证和禁忌证PCI初期MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology19771984MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineDirectionalCoronaryAtherectomy(DCA)

JohnSimpsonMauriceBuchbinder,MDDirecti八十年代PCI适应证病变适应证：简单病变→各类型复杂病变

—远端、长节段（＞10mm）、偏心、钙化、

—分叉病变（bifurcation）

—一支多处病变（tandem）

—位于血管转弯处

—成角病变（angularlesion＞45°）

—完全闭塞病变（totalocclusionlesion）

＜3个月，新近阻塞；＞3个月，慢性阻塞

—冠脉口病变（ostiallesion）

—溃疡或血栓病变八十年代PCI适应证病变适应证：简单病变→各类型复杂MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology197719841988MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineRotationalAtherectomy(PTCRA)

DavidAuthMauriceBuchbinder,MDRotatioMauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology1977198419881989MauriceBuchbinder,MDHistoryTheX-SizerThrombectomyCatheterSystemTheX-SizerThrombectomyCathe远端保护装置Angioguard远端保护装置AngioguardBare

Metal

Stents….the

good,

the

bad,

and

the

ugly!BareMetalStents….thegood,t九十年代PCI适应证和禁忌证PCI成熟期

—以支架术为主要技术的年代九十年代PCI适应证和禁忌证PCI成熟期急性下壁心肌梗死

直接支架植入冯某，男，32岁病例演示一急性下壁心肌梗死

直接支架植入冯某，男，32岁病例演示一MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology1977198419881997MauriceBuchbinder,MDHistory-AngiosculptCuttingballoonFlextome-AngiosculptCuttingballoonFl冠心病介入治疗及应用课件0.0155inch

(0.39mm)ElementScoring

Balloon

PCI

for

Severe

Calcified

Lesions

120°

CrackingCrack

Formation(Intentional

Dissection)

InflationCompared

to

Rotablator

less

invasive

easier

to

use0.0155inchElementScoringBallo

Semi-compliantballoon,dualwiresexertfocusedinflationforceFacilitatecontrolledplaquefractures-creationoffocusedforceinalocalizedregionoftheplaqueScoreflexSemi-compliantballoon,dualRS球囊1977支架1983旋切1985旋磨1988DES2000切割球囊1997RS球囊1977支架1983旋切1985旋磨1988DES2再狭窄:新内膜过度增生所致治疗方案放射治疗药物治疗再狭窄:新内膜过度增生所致治疗方案放射治疗药物治疗MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology19771984198819891997199920002000MauriceBuchbinder,MDHistory冠脉介入治疗最新亮点药物支架DrugElutingStent冠脉介入治疗最新亮点药物支架MauriceBuchbinder,MDFoundationforCardiovascularMedicineDrugElutingStentsMauriceBuchbinder,MDStentBasecoat

Basecoat=聚合物+雷帕霉素

+Topcoat=弥散屏障控制释放雷帕霉素的聚合物Topcoat(TC)StentBasecoatBasecoat=聚合物TAXUSCypherFirst

Generation

DESPolyolefin

derivative

PolymerPEVA

+

PBMA

blendPaclitaxel

DrugSirolimus

Express2

StentBX

VelocityTAXUSCypherFirstGenerationDEIntervention

2006Just

DEStent

It!Intervention2006JustDEStentDESinFIM术前术后FU

1年FU

4年

DESinFIM术前术后FU1年DES支架内预防再狭窄率3.235.401020304050In-stent%P<0.00191%CYPHER组对照组再狭窄率(%)DES支架内预防再狭窄率3.235.401020304050高危情况的多支血管病高龄患者—Stent左心功能受损—Stent肾功能不全—Stent糖尿病—DES高危情况的多支血管病高龄患者—Stent病例演示二男，47岁急性非ST段抬高性心肌梗死病例演示二男，47岁冠心病介入治疗及应用课件冠心病介入治疗及应用课件DES….the

good,

the

bad,

and

the

ugly!48

months40

mosBMSDESIncomplete

appositionLate

stentthrombosis-10-15-20

0-510

5252015Distal

Ref.Abn

VasomotionSirolimusControl

*P<0.001*

vs.

controlProx.

Ref.

Prox.

Stent*

DistalDelayed

Healing!Angioscopy

BMSDESLate

loss

=

0Giant

cellsIVUS

EosInflammationDES….thegood,thebad,48montThe

ESC

Firestorm

(August

’06)TheESCFirestorm(August’06)MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology19771984198819891997199920002002200320042005MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineTreatingBifurcationLesions

LimitationsofCurrentDESStentsaretubularstructuresnotintendedforY-shapedanatomySidebranchjailingLimitedostialcoverage(“Gaps”)TechnicallydemandingMultiplelayersofmetalIncreasingriskofthrombosisMyriadofTechniquesGapMultipleLayersMauriceBuchbinder,MDTreatinMauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology197719841988198919971999200020022003200420052006MauriceBuchbinder,MDHistoryIN.PACTDRUGELUTINGBALLOONFreepacSeparatesPaclitaxelmoleculesBalanceshydrophilicandlipophilicpropertiesFacilitatesPaclitaxelelutionintothevesselwallIN.PACT:

Medtronic-InvatecDEBballoonlineFreepac:Proprietaryhydrophilicdrugcoatingformulation

Drug:Paclitaxel(3g/mm2balloonsurface)Paclitaxel+HydrophilicSpacer:Urea(100%naturalcomponent)DEB:shorttermelutionforlongtermeffectIN.PACTDRUGELUTINGBALLOONFDrug-Eluting

Balloons

(and

beyond)

In.Pact

InvatecElutax®

-

Aachen

Resonance

SeQuent®

PleasePaccocath®

Technology

–

B.

Braun

DIOR®

-

EuroCorClearWay™

Atrium

Genie™AcrostakCricket™MercatorDrug-ElutingBalloons(andbeyMauriceBuchbinder,MDFoundationforCardiovascularMedicineWhyDegradableStents?NolateadverseeventsLatethrombosisHypersensitivityreactions(chronicinflammation)StentfracturesDoesnotrestrictarterialremodelingPermitsnon-invasiveimagingofarteryPermitsbypasssurgeryinfutureDegradableStentsMauriceBuchbinder,MDWhyDegMauriceBuchbinder,MDFoundationforCardiovascularMedicineBioabsorbableStentDesign.Core:PolymerAUndercoat:PolymerBTopcoat:PolymerBDrugLayer:PolymerB+SirolimusCoatingLayersMauriceBuchbinder,MDBioabsoFully

Bioresorbable

Stents

(Scaffolds)Igaki-Tamai

BVS

REVA

ELIXIR

Biotronik

PLA

PLLA

(with

everolimus)Iodinated

tyrosine-polycarbonate

(withsirolimus)

PLLA

(with

novolimus)

Magnesium

(with

sirolimus)FullyBioresorbableStents(Sc1Initial

Clinical

ExperiencePerforming

Robotic

PercutaneousCoronary

Intervention

from

theRadial

ApproachJ.D.

Sheets,

MS-IVMichigan

State

UniversityCollege

of

Human

MedicineFrederik

Meijer

Heart

&

Vascular

Institute1InitialClinicalExperiencePeFrederik

Meijer

Heart

&

Vascular

Institute•

BMW

wire

intodiagonal

branch•

3.0

x

26

mmResolute

DESdeployed

inLADFrederikMeijerHeart&VasculFrederik

Meijer

Heart

&

Vascular

InstituteFrederikMeijerHeart&VasculMauriceBuchbinder,MDFoundationforCardiovascularMedicine介入心脏病学新进展Percutaneous“Mitral”ValveRepairMauriceBuchbinder,MD介入心脏病学新Catheter-Based

Mitral

Valve

Repair（一）MitraClip®

SystemCatheter-BasedMitralValveRePARTNER

THV

Evolution

PII

-

2010Edwards

SAPIENXT

™

THV

23

mm,

26

mm,

and

29mm

PI

-

2007Edwards

SAPIEN™THV

23

mm

and

26

mm

PII

S3

-

2013

Edwards

SAPIEN3™

THV20

mm,

23

mm,

26

mm,

and

29mmPARTNER

enrolled

8,494

patients

in

FDA

studies

(including

4

RCTs)

with

3

generations

of

TAVR

systems

in

~

7

years!PARTNERTHVEvolution PII-2MauriceBuchbinder,MDFoundationforCardiovascularMedicineSelf-expandingNitinolmulti-levelframePorcinepericardiumTissueValveDisposableLoadingSystemDeliveryCatheter18French12FrbodyTheCoreValveRevalving™System

Self-ExpandingSupportFrameMauriceBuchbinder,MDSelf-exNo.

at

RiskTranscatheterSurgical391

378359

34335430433428221919114.1%Δ

=

4.8All-Cause

MortalityMonths

Post-Procedure4018.9%

22.2%

ACC

2015Δ

=

6.5

28.6%Log-rank

P=0.04No.atRiskTranscatheter391TAVR

Development

in

China•

In

2010,

with

the

technical

help

of

proctors

fromEurope•

We

in

China

cooperate

with

Medtronic

Co.•

In

starting

the

first

TAVR

case

in

Zhong-ShangHospital

Shanghai

on

Oct.

3

with

CorValve•

And

the

2nd

and

3rd

TAVR

cases

in

Fu-WaiHospital

Beijing

on

Dec.

9

also

withCorValve•

Thereafter,

more

sites

such

as

west

China

Univ.Hospital

etc.

started

the

TAVR

ProgameTAVRDevelopmentinChina•IThe

Site

List

of

TAVR

Program

in

China•

>200

TAVR

cases

have

been

done

in

11

CVcenters

in

7

cities

in

mainland

China

including:•

Beijing:

Fu-Wai

Hosp.,

301

Hosp.•

Shanghai:

Zhongshan

Hosp.,

Ruijin

Hosp.,Changhai

Hosp.•

Chengdu:

West

China

Univ.

Hosp.•

Hangzhou:

Zhejiang

Univ.

2nd

Hosp.•

Nanjing:

Nanjing

Med

Univ.

Hosp.,

South

middleChina

Univ.

Hosp.•

Xiamen:

Xiamen

Heart

Center•

Guizhou:

Guizhou

Provincial

Hosp.TheSiteListofTAVRProgram

Valves•

InternationalCorValve

(n=118)

(

self-expanding,

Medtronic)Sapien

XT

(n=16)

(

balloon-expandable,

Edwards)•

Domestic

(self-expanding)Venus-A:

(Venus

Med-Tech,

Hangzhou)

•

The

registry

(n=81)

finished

&

in

follow-upJena.ValveTM

:

(Transapical,

Suzhou)

•

The

registry

(n=114)

finished

and

in

follow-upMicroPort

:

(MicroPort

Co.,

Shanghai)

•

FIM

(n=10)

finished

&

in

follow-upTaurus

(Peijia

Co.,

Suzhou)

•

FIM

(n=10)

in

preparation ValvesCorValve(n=118)(sel.

HuaxiN=22

苏Zhejiang

N=10

Jiangsu

N=6Shanghai

N=2

TotalN=81Enrolling

Study

Sites

2012-9-7

Start

2014-6-3

finish

Fuwai

Hospital

41. Huaxi 苏 Jiangsu TotalEnrolCase

1.

TCT2014

Live

Demonstration

Case

Female,

77yrs,

Risk

Scores:

STS

8.24%Case1.TCT2014LiveDemonstraMauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology1977198419881989199719992000200220032004MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineAtrialfibrillationisamajorsourceofcardiogenicembolism-relatedstroke（三）Source:Neurology,1978;Stroke,1985;EuropeanHeartJournal,1987;Lancet,1987500,000strokesperyearAHAestimatesthat15–20%ofstrokes/yeararerelatedtoAFMauriceBuchbinder,MDAtrialMauriceBuchbinder,MDFoundationforCardiovascularMedicineWATCHMAN®DeviceFrame:Nitinol(shapememory)ContourshapeaccommodatesmostLAAanatomyBarbsengagetheLAAtissueFabricCap:Polyethylterephthalate(PET)FabricPreventsharmfulembolifromexitingduringthehealingprocessBarbs160µPETfabricDeviceavailableinvarioussizes:21,24,27,30and33mm(diameter)DevicediameterismeasuredacrossfaceofdeviceDeviceLength=DeviceDiameterMauriceBuchbinder,MDWATCHMALAA

Closurefor

Stroke

Prevention

in

AF•

Difficulties

with

Warfarin

use–

Frequent

Monitoring–

Difficulty

in

Compliance

(TTR

48-63%)–

Drug

/

Diet

Interactions–

Bleeding

Risk

(ICH)–

Risks

in

Elderly

(falls,

poly-pharmacy)•

Autopsy

&

TEE

data

implicate

LAA•

LAA

Closure

DevicesBarbs

EngageLAA

Wall160

µ

PETfabricLAAClosureforStrokePreventi

Percutaneous

Ventricular

Restoration（四）Treatment

GoalImprove

hemodynamics

by:Partition

ScarLV

Volumes

ReductionLVED

Pressure

ReductionRestoring

LV

Conical

ShapeNot

preventing

TorsionalContractionNot

causing

arrhythmiasProcedural

aspects

similar

to

a

standard

PCI(Duration

–

80

min

/

Flouroscopy

time

–

20

min) PercutaneousVentricularRestAPATIENTWITHRESISTANTHYPERTENSION（五）APATIENTWITHRESISTANTHYPERHyperactivityoftherenalsympatheticnervesplaysakeyroleinhypertensionSymplicityHTN-2Investigators,LancetPublishedonlineNovember17,2010DOI:10.1016/S0140-6736(10)62039-9ConceptDescriptionCatheter-basedprocedureusingstandardinterventionaltechniquesRFenergydeliveredthroughtherenalarterywalltodenervatetherenalnerves

RESISTANTHYPERTENSION

CATHETERBASEDTECHNOLOGIESRESULTSSYMPLICITYHTN2**TrialperformedwithSYMPLICITYCATHETERSYSTEMAdevicedevelopedbyArdianThetrasactionissubjecttocustomaryclosingconditions,includingU.S.andforeignregulatoryclearancesHyperactivityoftherenalsymEUCE

mark

in

2008No

RCT

evidenceSymplicity

Registry

in

5000

pts

Renal

Denervation

forResistant

Hypertension

Symplicity

HTN-3:

(NEJM

2014)

No

evidence

of

efficacyUSANo

FDA

approvalEU RenalDenervationforUSAANATOMICALLOCATIONOFRENALSYMPATHETICNERVESArisefromT10-L1FollowtherenalarterytothekidneyPrimarilyliewithintheadventitiaTheJournalofClinicalHypertension.14,pages799–801,2012Circulation.2002;106:1974–1979ANATOMICALLOCATIONOFRENALSIABPAbruptinflationafterAVclosure-increasesAorticRootdiastolicpressureAbruptdeflationuponAVopeningdecreasesimpedancetoejection(ie-afterload)IABPAbruptinflationafterAVIntra-AorticBalloonPump（六）↑diastolicpressure↓systolicpressure↓afterload↑cardiacoutput↓fillingpressures↑coronaryarteryperfusionIntra-AorticBalloonPump（六）↑ECMO-extracorporealmembraneoxygenationvenous-=RAarterial=FACombinesmembraneoxygenatorwithpumpPostcardiacarrestRVfailurehourstodaysmembraneactivesharmfulcytokinesECMO-extracorporealmembraneoExtraCorporealMembraneOxygenation(ECMO)（七）ExtraCorporealMembraneOxygenTandemHeart

Centrifugalflow,lubricatedmechanicalbearingDisposablepumpheadshort-termuse(upto7-10days)CanbeimplantedpercutaneouslyasanLVAD,RVAD,BiVAD(incathlab)LVADCannulation:Inflowisplacedinleftatriumthroughseptalpuncture.OutflowisplacedinfemoralarteryPumpgeneratesflowof1to5LPM,withRPMsfrom1,000to7,500,dependingoncannulasizesTandemHeart

Centrifugalflow,ComponentsandPropertiesMinimalinvasiveCompactsizeandlightweightContinuousflowandveryquietUpto4-5LPMPrimingvolumeofonly60mlNovellubricationandanticoagulationsystemControllerPumpComponentsandPropertiesMinimImpella（八）DirectlyunloadtheleftventricleReducemyocardialworkloadandoxygenconsumptionIncreasecardiacoutputandcoronaryandend-organperfusionImpella（八）DirectlyunloadthImpellaTMDeviceImpellaTMDevice冠心病介入治疗的现状与展望冠心病介入治疗的现状与展望CharlesT.DotterM.D.(1920-1985)InterventionalRadiologistPioneerintheFieldofMinimallyInvasiveProcedures(Catheterization)DevelopedContinuousX-RayAngio-CardiographyPerformedFirstAngioplasty(PTCA)Procedurein1964.CharlesT.DotterM.D.(1920-1MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology19771984198819891997199920002002200320042005200616MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology1977MauriceBuchbinder,MDHistory七十年代PCI适应证和禁忌证PCI初期

单纯球囊扩张（PTCA）年代适应证局限七十年代PCI适应证和禁忌证PCI初期MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology19771984MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineDirectionalCoronaryAtherectomy(DCA)

JohnSimpsonMauriceBuchbinder,MDDirecti八十年代PCI适应证病变适应证：简单病变→各类型复杂病变

—远端、长节段（＞10mm）、偏心、钙化、

—分叉病变（bifurcation）

—一支多处病变（tandem）

—位于血管转弯处

—成角病变（angularlesion＞45°）

—完全闭塞病变（totalocclusionlesion）

＜3个月，新近阻塞；＞3个月，慢性阻塞

—冠脉口病变（ostiallesion）

—溃疡或血栓病变八十年代PCI适应证病变适应证：简单病变→各类型复杂MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology197719841988MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineRotationalAtherectomy(PTCRA)

DavidAuthMauriceBuchbinder,MDRotatioMauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology1977198419881989MauriceBuchbinder,MDHistoryTheX-SizerThrombectomyCatheterSystemTheX-SizerThrombectomyCathe远端保护装置Angioguard远端保护装置AngioguardBare

Metal

Stents….the

good,

the

bad,

and

the

ugly!BareMetalStents….thegood,t九十年代PCI适应证和禁忌证PCI成熟期

—以支架术为主要技术的年代九十年代PCI适应证和禁忌证PCI成熟期急性下壁心肌梗死

直接支架植入冯某，男，32岁病例演示一急性下壁心肌梗死

直接支架植入冯某，男，32岁病例演示一MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology1977198419881997MauriceBuchbinder,MDHistory-AngiosculptCuttingballoonFlextome-AngiosculptCuttingballoonFl冠心病介入治疗及应用课件0.0155inch

(0.39mm)ElementScoring

Balloon

PCI

for

Severe

Calcified

Lesions

120°

CrackingCrack

Formation(Intentional

Dissection)

InflationCompared

to

Rotablator

less

invasive

easier

to

use0.0155inchElementScoringBallo

Semi-compliantballoon,dualwiresexertfocusedinflationforceFacilitatecontrolledplaquefractures-creationoffocusedforceinalocalizedregionoftheplaqueScoreflexSemi-compliantballoon,dualRS球囊1977支架1983旋切1985旋磨1988DES2000切割球囊1997RS球囊1977支架1983旋切1985旋磨1988DES2再狭窄:新内膜过度增生所致治疗方案放射治疗药物治疗再狭窄:新内膜过度增生所致治疗方案放射治疗药物治疗MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology19771984198819891997199920002000MauriceBuchbinder,MDHistory冠脉介入治疗最新亮点药物支架DrugElutingStent冠脉介入治疗最新亮点药物支架MauriceBuchbinder,MDFoundationforCardiovascularMedicineDrugElutingStentsMauriceBuchbinder,MDStentBasecoat

Basecoat=聚合物+雷帕霉素

+Topcoat=弥散屏障控制释放雷帕霉素的聚合物Topcoat(TC)StentBasecoatBasecoat=聚合物TAXUSCypherFirst

Generation

DESPolyolefin

derivative

PolymerPEVA

+

PBMA

blendPaclitaxel

DrugSirolimus

Express2

StentBX

VelocityTAXUSCypherFirstGenerationDEIntervention

2006Just

DEStent

It!Intervention2006JustDEStentDESinFIM术前术后FU

1年FU

4年

DESinFIM术前术后FU1年DES支架内预防再狭窄率3.235.401020304050In-stent%P<0.00191%CYPHER组对照组再狭窄率(%)DES支架内预防再狭窄率3.235.401020304050高危情况的多支血管病高龄患者—Stent左心功能受损—Stent肾功能不全—Stent糖尿病—DES高危情况的多支血管病高龄患者—Stent病例演示二男，47岁急性非ST段抬高性心肌梗死病例演示二男，47岁冠心病介入治疗及应用课件冠心病介入治疗及应用课件DES….the

good,

the

bad,

and

the

ugly!48

months40

mosBMSDESIncomplete

appositionLate

stentthrombosis-10-15-20

0-510

5252015Distal

Ref.Abn

VasomotionSirolimusControl

*P<0.001*

vs.

controlProx.

Ref.

Prox.

Stent*

DistalDelayed

Healing!Angioscopy

BMSDESLate

loss

=

0Giant

cellsIVUS

EosInflammationDES….thegood,thebad,48montThe

ESC

Firestorm

(August

’06)TheESCFirestorm(August’06)MauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology19771984198819891997199920002002200320042005MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineTreatingBifurcationLesions

LimitationsofCurrentDESStentsaretubularstructuresnotintendedforY-shapedanatomySidebranchjailingLimitedostialcoverage(“Gaps”)TechnicallydemandingMultiplelayersofmetalIncreasingriskofthrombosisMyriadofTechniquesGapMultipleLayersMauriceBuchbinder,MDTreatinMauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology197719841988198919971999200020022003200420052006MauriceBuchbinder,MDHistoryIN.PACTDRUGELUTINGBALLOONFreepacSeparatesPaclitaxelmoleculesBalanceshydrophilicandlipophilicpropertiesFacilitatesPaclitaxelelutionintothevesselwallIN.PACT:

Medtronic-InvatecDEBballoonlineFreepac:Proprietaryhydrophilicdrugcoatingformulation

Drug:Paclitaxel(3g/mm2balloonsurface)Paclitaxel+HydrophilicSpacer:Urea(100%naturalcomponent)DEB:shorttermelutionforlongtermeffectIN.PACTDRUGELUTINGBALLOONFDrug-Eluting

Balloons

(and

beyond)

In.Pact

InvatecElutax®

-

Aachen

Resonance

SeQuent®

PleasePaccocath®

Technology

–

B.

Braun

DIOR®

-

EuroCorClearWay™

Atrium

Genie™AcrostakCricket™MercatorDrug-ElutingBalloons(andbeyMauriceBuchbinder,MDFoundationforCardiovascularMedicineWhyDegradableStents?NolateadverseeventsLatethrombosisHypersensitivityreactions(chronicinflammation)StentfracturesDoesnotrestrictarterialremodelingPermitsnon-invasiveimagingofarteryPermitsbypasssurgeryinfutureDegradableStentsMauriceBuchbinder,MDWhyDegMauriceBuchbinder,MDFoundationforCardiovascularMedicineBioabsorbableStentDesign.Core:PolymerAUndercoat:PolymerBTopcoat:PolymerBDrugLayer:PolymerB+SirolimusCoatingLayersMauriceBuchbinder,MDBioabsoFully

Bioresorbable

Stents

(Scaffolds)Igaki-Tamai

BVS

REVA

ELIXIR

Biotronik

PLA

PLLA

(with

everolimus)Iodinated

tyrosine-polycarbonate

(withsirolimus)

PLLA

(with

novolimus)

Magnesium

(with

sirolimus)FullyBioresorbableStents(Sc1Initial

Clinical

ExperiencePerforming

Robotic

PercutaneousCoronary

Intervention

from

theRadial

ApproachJ.D.

Sheets,

MS-IVMichigan

State

UniversityCollege

of

Human

MedicineFrederik

Meijer

Heart

&

Vascular

Institute1InitialClinicalExperiencePeFrederik

Meijer

Heart

&

Vascular

Institute•

BMW

wire

intodiagonal

branch•

3.0

x

26

mmResolute

DESdeployed

inLADFrederikMeijerHeart&VasculFrederik

Meijer

Heart

&

Vascular

InstituteFrederikMeijerHeart&VasculMauriceBuchbinder,MDFoundationforCardiovascularMedicine介入心脏病学新进展Percutaneous“Mitral”ValveRepairMauriceBuchbinder,MD介入心脏病学新Catheter-Based

Mitral

Valve

Repair（一）MitraClip®

SystemCatheter-BasedMitralValveRePARTNER

THV

Evolution

PII

-

2010Edwards

SAPIENXT

™

THV

23

mm,

26

mm,

and

29mm

PI

-

2007Edwards

SAPIEN™THV

23

mm

and

26

mm

PII

S3

-

2013

Edwards

SAPIEN3™

THV20

mm,

23

mm,

26

mm,

and

29mmPARTNER

enrolled

8,494

patients

in

FDA

studies

(including

4

RCTs)

with

3

generations

of

TAVR

systems

in

~

7

years!PARTNERTHVEvolution PII-2MauriceBuchbinder,MDFoundationforCardiovascularMedicineSelf-expandingNitinolmulti-levelframePorcinepericardiumTissueValveDisposableLoadingSystemDeliveryCatheter18French12FrbodyTheCoreValveRevalving™System

Self-ExpandingSupportFrameMauriceBuchbinder,MDSelf-exNo.

at

RiskTranscatheterSurgical391

378359

34335430433428221919114.1%Δ

=

4.8All-Cause

MortalityMonths

Post-Procedure4018.9%

22.2%

ACC

2015Δ

=

6.5

28.6%Log-rank

P=0.04No.atRiskTranscatheter391TAVR

Development

in

China•

In

2010,

with

the

technical

help

of

proctors

fromEurope•

We

in

China

cooperate

with

Medtronic

Co.•

In

starting

the

first

TAVR

case

in

Zhong-ShangHospital

Shanghai

on

Oct.

3

with

CorValve•

And

the

2nd

and

3rd

TAVR

cases

in

Fu-WaiHospital

Beijing

on

Dec.

9

also

withCorValve•

Thereafter,

more

sites

such

as

west

China

Univ.Hospital

etc.

started

the

TAVR

ProgameTAVRDevelopmentinChina•IThe

Site

List

of

TAVR

Program

in

China•

>200

TAVR

cases

have

been

done

in

11

CVcenters

in

7

cities

in

mainland

China

including:•

Beijing:

Fu-Wai

Hosp.,

301

Hosp.•

Shanghai:

Zhongshan

Hosp.,

Ruijin

Hosp.,Changhai

Hosp.•

Chengdu:

West

China

Univ.

Hosp.•

Hangzhou:

Zhejiang

Univ.

2nd

Hosp.•

Nanjing:

Nanjing

Med

Univ.

Hosp.,

South

middleChina

Univ.

Hosp.•

Xiamen:

Xiamen

Heart

Center•

Guizhou:

Guizhou

Provincial

Hosp.TheSiteListofTAVRProgram

Valves•

InternationalCorValve

(n=118)

(

self-expanding,

Medtronic)Sapien

XT

(n=16)

(

balloon-expandable,

Edwards)•

Domestic

(self-expanding)Venus-A:

(Venus

Med-Tech,

Hangzhou)

•

The

registry

(n=81)

finished

&

in

follow-upJena.ValveTM

:

(Transapical,

Suzhou)

•

The

registry

(n=114)

finished

and

in

follow-upMicroPort

:

(MicroPort

Co.,

Shanghai)

•

FIM

(n=10)

finished

&

in

follow-upTaurus

(Peijia

Co.,

Suzhou)

•

FIM

(n=10)

in

preparation ValvesCorValve(n=118)(sel.

HuaxiN=22

苏Zhejiang

N=10

Jiangsu

N=6Shanghai

N=2

TotalN=81Enrolling

Study

Sites

2012-9-7

Start

2014-6-3

finish

Fuwai

Hospital

41. Huaxi 苏 Jiangsu TotalEnrolCase

1.

TCT2014

Live

Demonstration

Case

Female,

77yrs,

Risk

Scores:

STS

8.24%Case1.TCT2014LiveDemonstraMauriceBuchbinder,MDFoundationforCardiovascularMedicineHistoryof

InterventionalCardiology1977198419881989199719992000200220032004MauriceBuchbinder,MDHistoryMauriceBuchbinder,MDFoundationforCardiovascularMedicineAtrialf