TAVI Future Marin Leon TCT 2010

Martin B. Leon, MDMartin B. Leon, MDColumbia University Medical CenterColumbia University Medical Center

Cardiovascular Research FoundationCardiovascular Research FoundationNew York CityNew York City

Predicting the Future for Predicting the Future for TranscatheterTranscatheter Valve Therapies: Valve Therapies:

New Devices and Expanded New Devices and Expanded Clinical IndicationsClinical Indications

Presenter Disclosure Information forPresenter Disclosure Information forTCTAP 2010TCTAP 2010; April ; April 2727--30, 30, 20102010

Martin B. Leon, M.D.Martin B. Leon, M.D.

NONNON--PAID Consultant: PAID Consultant: Edwards Edwards LifesciencesLifesciences, Medtronic, Medtronic

NONNON--PAID Consultant: PAID Consultant: Edwards Edwards LifesciencesLifesciences, Medtronic, Medtronic

Rules of EngagementRules of EngagementRules of EngagementRules of Engagement

TAVI in 2005TAVI in 2005

SurgerySurgery

TAVITAVI

Predicting the FuturePredicting the FuturePredicting the FuturePredicting the Future

Transcatheter AVI (TAVI) Transcatheter AVI (TAVI)

TAVI: TAVI: The FutureThe Future

Expanded Clinical Expanded Clinical IndicationsIndications


New DevicesNew DevicesNew DevicesNew Devices





Early CatheterEarly Catheter--Based AV DesignsBased AV Designs

The Davis valve (1965)

The Andersen valve (1992)

Edwards Lifesciences Medtronic CoreValve

Current Generation DevicesCurrent Generation Devices

TAVI TechnologiesTAVI Technologies

TAVI TechnologiesTAVI TechnologiesCurrent Generation DevicesCurrent Generation Devices

•• Edwards Aortic Edwards Aortic BioprosthesisBioprosthesis¡¡ Balloon expandable stainless steel Balloon expandable stainless steel bioprosthesisbioprosthesis¡¡ Equine Equine Bovine Bovine pericardial valvepericardial valve¡¡ Sheathed (Sheathed (RetroFlexRetroFlex) with tip deflection) with tip deflection¡¡ AntegradeAntegrade, retrograde, or trans, retrograde, or trans--apical approachapical approach

•• CoreValveCoreValve RevalvingRevalvingTMTM SystemSystem¡¡ SelfSelf--expanding expanding nitinolnitinol cage cage bioprosthesisbioprosthesis¡¡ Porcine pericardial valvePorcine pericardial valve¡¡ Sheathed system (low profile = Sheathed system (low profile = 18 18 Fr)Fr)¡¡ Retrograde (femoral + Retrograde (femoral + subclaviansubclavian) approach) approach

The Current GenerationThe Current GenerationEdwards Edwards –– SAPIEN THVSAPIEN THV

Current Skirt Height

Untreated EquineTissue

[]

Edwards-SAPIEN THV

New Skirt Height

Bovine TissueThermaFix TreatmentPericardial MappingLeaflet DeflectionProprietary Processing

Cribier-Edwards THV

Edwards Edwards Flex CathFlex CathDelivery System EvolutionDelivery System Evolution

Retroflex Delivery CatheterRetroflex Delivery Catheter

Retroflex Retroflex 22Retroflex 3Retroflex 3

Edwards Sapien XT THVEdwards Sapien XT THV

Cobolt Frame & New Leaflet Geometry Tissue Attachment

.0109 .0217 .0187 .0210 .0196 .0177 .0156 .0189 .0171 .0182 .0121

.0193 .0136 .0189 .0173 .0118 .0189 .0261 .0247 .0212 .0231 .0235 .0205 .0208 .0177 .0166 .0149 .0153 .0170 .0155

.0111 .0138 .0187 .0204 .0144 .0141 .0250 .0244 .0189 .0187 .0214 .0204 .0208 .0187 .0135 .0140 .0150 .0150 .0134

.0113 .0115 .0162 .0218 .0184 .0139 .0256 .0292 .0194 .0164 .0186 .0211 .0217 .0169 .0144 .0115 .0118 .0135 .0117

.0130 .0111 .0133 .0198 .0225 .0167 .0259 .0343 .0268 .0179 .0195 .0181 .0253 .0163 .0144 .0118 .0112 .0115 .0050

.0136 .0104 .0124 .0154 .0243 .0178 .0237 .0372 .0337 .0231 .0180 .0138 .0200 .0145 .0127 .0132 .0116 .0109 .0104

.0119 .0208 .0369 .0330 .0272 .0210 .0108 .0302 .0134 .0115 .0133 .0119 .0135 .0110

.0122 .0100 .0110 .0128 .0113 .0136 .0110

.0113 .0110 .0084 .0117

Leaflet Matching & ThermaFix

Finite ElementAnalysis

Partially Closed Design Sapien XTSapien XT

Sapien XT + NovaFlex Delivery SystemSapien XT + NovaFlex Delivery System

18 Fr profile18 Fr profile

TransfemoralTransfemoral TransapicalTransapical

Transcatheter AVITranscatheter AVITransapical Access RouteTransapical Access Route

CoreValve SelfCoreValve Self--Expanding Expanding BioprosthesisBioprosthesis

A porcine pericardial tissue A porcine pericardial tissue valvevalvefixed to the frame with PTFE suturesfixed to the frame with PTFE sutures

•• HIGHER PART:HIGHER PART: low radial low radial force area axes the system force area axes the system and increases quality of and increases quality of anchoringanchoring

•• MIDDLE PART:MIDDLE PART: functional functional valve area with three leaflets valve area with three leaflets and constrained to avoid and constrained to avoid coronaries (convexocoronaries (convexo--concave) concave) –– avoids need for avoids need for rotational positioningrotational positioning

•• LOWER PART:LOWER PART: high radial high radial force of the frame pushes force of the frame pushes aside the native calcified aside the native calcified leaflets for secure anchoring leaflets for secure anchoring and avoids recoil and paraand avoids recoil and para--valvular leaksvalvular leaks

GEN1GEN18mm8mm

GEN2GEN27mm7mm

GEN3GEN36mm6mm

(18 Fr)(18 Fr)

CoreValve CoreValve ReValvingReValving SystemSystemDelivery Catheter EvolutionDelivery Catheter Evolution

12 Fr shaft12 Fr shaft

Over-the-wire 0.035 compatible

12F Shaft

18F Capsule

Loading/Release Handle

CoreValve ReValvingCoreValve ReValvingTMTM SystemSystem18 Fr Delivery System18 Fr Delivery System

TAVI TechnologiesTAVI TechnologiesAccess PossibilitiesAccess Possibilities

•• Edwards Aortic BioprosthesisEdwards Aortic Bioprosthesis¡¡ TransTrans--Arterial: femoral (percutaneous),Arterial: femoral (percutaneous),

iliac (surgical), abdominal Ao (surgical), iliac (surgical), abdominal Ao (surgical), subclaviansubclavian--axillary (surgical), thoracic Ao axillary (surgical), thoracic Ao (surgical)(surgical)

¡¡ TransTrans--Apical (surgical)Apical (surgical)•• CoreValve RevalvingCoreValve RevalvingTMTM SystemSystem

¡¡ TransTrans--Arterial: femoral (percutaneous), Arterial: femoral (percutaneous), subclaviansubclavian--axillary (surgical),axillary (surgical), thoracic Ao thoracic Ao (surgical)(surgical)

TransTrans--axillaryaxillary ((subclaviansubclavian) ) TAVI TAVI ((CoreValveCoreValve))

Surgical exposureSurgical exposure

1818Fr sheath (Fr sheath (±± graft)graft)

•• Lower profile devicesLower profile devices¡¡ ≤≤ 18 Fr (ultimately 1418 Fr (ultimately 14--16 Fr)16 Fr)

•• Expanded range of valve sizesExpanded range of valve sizes¡¡ accommodate annulus diameters from 17accommodate annulus diameters from 17--29 mm29 mm

•• Dedicated delivery systemsDedicated delivery systems¡¡ useruser--friendly, sheathfriendly, sheath--based with soft tapered based with soft tapered

nosecone, ? tip deflectionnosecone, ? tip deflection•• Improved circumferential annulus fixationImproved circumferential annulus fixation

¡¡ reduced parareduced para--valvular AR valvular AR

What is Needed… What is Needed… What is Needed… What is Needed…


•• LongLong--term durability of valve and platformterm durability of valve and platform¡¡ 1010--15 year valve and sustained mechanical 15 year valve and sustained mechanical

integrity of platformintegrity of platform•• Optimal positioning before/during deployment Optimal positioning before/during deployment

(improved placement position)(improved placement position)¡¡ advanced imagingadvanced imaging¡¡ localization and stabilizing featureslocalization and stabilizing features¡¡ ? retrievable and repositionable? retrievable and repositionable

•• Embolic protection devicesEmbolic protection devices¡¡ prevent embolic strokesprevent embolic strokes



•• Dedicated accessory devicesDedicated accessory devices¡¡ specialized sheaths, guidewires, valvuloplasty specialized sheaths, guidewires, valvuloplasty

balloons, indeflators, etc.balloons, indeflators, etc.•• Improved vascular closure methodologiesImproved vascular closure methodologies

¡¡ “large hole” closure devices“large hole” closure devices



New TAVI TechnologiesNew TAVI Technologies¡¡ Direct FlowDirect Flow¡¡ SadraSadra¡¡ AorTxAorTx¡¡ Jena ValveJena Valve¡¡ HLTHLT¡¡ ABPS ABPS PercValvePercValve¡¡ EndoTechEndoTech¡¡ VentorVentor EmbracerEmbracer¡¡ SymetisSymetis

Sadra LotusSadra Lotus™™ Valve SystemValve System

•• SelfSelf--expanding nitinol platformexpanding nitinol platform•• External polyurethane conformingExternal polyurethane conformingmembranemembrane

Adaptive SealAdaptive Seal

Can be fully retractedCan be fully retractedand repositionedand repositioned

SadraSadra LotusLotus™™ Valve SystemValve System

Simplified AttachmentSimplified Attachment

Current 15 finger design New 3 finger design

SadraSadra LotusLotus™™ Valve SystemValve System

Multilumen

Slightly Tapered, ConformablePolyester Fabric Cuff

Tri-leaflet Valve constructed of

Bovine Pericardium

Position Fill Lumens (PFLs)-Used to position/reposition valve-Complete Inflation Media Exchange

Aortic and Ventricular Rings- Inflate independently so device

can be repositioned- Deflatable so that device can

be fully retrieved

Non-metallic PercutaneousDirect Flow Aortic Valve

22F Design 18F Design

Improved Coronary Clearance and Opening ForceImproved Coronary Clearance and Opening Force3 3 sizes matching sizes matching

valvuloplasty balloonsvalvuloplasty balloons

Direct Flow MedicalDirect Flow MedicalNew 18F DesignNew 18F Design

Paieon THV Imaging SystemPaieon THV Imaging System

Device on target

Ventor Embracer TransapicalVentor Embracer TransapicalAortic ValveAortic Valve

Diverging OutletDiverging Outlet•• Prevents turbulencePrevents turbulence•• Pressure recoveryPressure recovery•• Optimal hemodynamicsOptimal hemodynamics

Subvalvular InletSubvalvular Inlet•• Physiologic flow entryPhysiologic flow entry•• Seals off subSeals off sub--annular zone (limits PVL)annular zone (limits PVL)

Throat at native orificeThroat at native orifice•• No aggressive No aggressive

predilatation requiredpredilatation required•• Avoids pushing the Avoids pushing the

native leaflets against native leaflets against the coronary ostiathe coronary ostia

Need for embolic protection… Need for embolic protection… Need for embolic protection… Need for embolic protection…


•• 32 pts with TAVI; Diffusion32 pts with TAVI; Diffusion--Weighted MRI at baseline, postWeighted MRI at baseline, post--procedure, and @ 3 mosprocedure, and @ 3 mos¡¡ 22 balloon22 balloon--expandable and 10 selfexpandable and 10 self--expanding THV devicesexpanding THV devices

•• New foci of restricted perfusion in 27/32 pts (84%)New foci of restricted perfusion in 27/32 pts (84%)¡¡ Lesions usually multiple and both hemispheres (embolic)Lesions usually multiple and both hemispheres (embolic)

•• No impairment of neuroNo impairment of neuro--cognitive function nor clinical cognitive function nor clinical neurologic events assoc with MRI defectsneurologic events assoc with MRI defects¡¡ 80% of MRI defects resolved at 3 mos imaging study80% of MRI defects resolved at 3 mos imaging study

SMTSMT EmbrellaEmbrella ClaretClaret

TAVI TAVI in Evolutionin EvolutionCerebral Embolic ProtectionCerebral Embolic Protection

Deflectors and FiltersDeflectors and Filters

EmbrellaEmbrella: Embolic Protection: Embolic Protection(intra(intra--cardiac and valve procedures)cardiac and valve procedures)

Cerebral Cerebral Embolic Embolic ProtectionProtectionClaretClaret

Filter in Filter in InnominateInnominate

Filter in Filter in Left Left CarotidCarotid

PercutaneousPercutaneous ClosureClosure10 Fr 10 Fr ProstarProstar devicedevice

CoreValve 2005CoreValve 2005

-- 24 F 1st Gen CoreValve 24 F 1st Gen CoreValve -- Surgical Surgical access and closureaccess and closure-- Cardiopulmonary bypassCardiopulmonary bypass-- General anesthesiaGeneral anesthesia

CoreValve CoreValve 20102010

-- 18 F 3rd Gen CoreValve 18 F 3rd Gen CoreValve -- Percutaneous access and closurePercutaneous access and closure-- No hemodynamic supportNo hemodynamic support-- Conscious sedationConscious sedation

PCI PCI –– like Procedure!like Procedure!





TAVI TAVI in 2010in 2010Expanded Clinical indicationsExpanded Clinical indications

•• Untreated Severe AS (+ symptoms)Untreated Severe AS (+ symptoms)•• Asymptomatic Severe ASAsymptomatic Severe AS•• Low Flow Low Flow –– Low Gradient ASLow Gradient AS•• AS + CADAS + CAD•• “Medium” (normal) Risk AS“Medium” (normal) Risk AS•• BioprostheticBioprosthetic Valve FailureValve Failure

TAVI TAVI in in 20102010Expanded Clinical indicationsExpanded Clinical indications


At Least 30% of Patients with Severe At Least 30% of Patients with Severe Symptomatic AS are “Untreated”!Symptomatic AS are “Untreated”!

5968 70

4052

6955

41 32 30

6048

3145

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Bouma1999

Iung* 2004

Pellikka2005

Charlson2006

Bach Spokane(prelim)

Vannan(Pub.

Pending)

Severe Symptomatic Aortic StenosisPercent of Cardiology Patients Treated

1. Bouma B J et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999;82:143-1482. Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal

2003;24:1231-1243 (*includes both Aortic Stenosis and Mitral Regurgitation patients)3. Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation 20054. Charlson E et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis2006;15:312-321

AVRNo AVR

Under-treatment especially

prevalent among patients

managed by Primary Care physicians

Same age and predicted riskOne passes the “eyeball test” – one does not

Same age and predicted riskOne passes the “eyeball test” – one does not

FrailtyFrailty is being studied systematically as part ofis being studied systematically as part ofthe PARTNER U.S. IDE studythe PARTNER U.S. IDE study

Patient A Patient Bvs.

Photos courtesy of Michael J. Mack, MDMedical City Dallas

TAVI TAVI PatientPatient SelectionSelectionIncludes Careful Frailty AssessmentIncludes Careful Frailty Assessment

Bach DS, et al. Circ Bach DS, et al. Circ CardiovascCardiovasc QualQual Outcomes. 2009;2:533Outcomes. 2009;2:533--539539

Severe AS without AVRSevere AS without AVR

Severe AS without AVRSevere AS without AVR

Perc

ent (

%)

5248

62

51

34 34 33 35

22 24

1015

0

10

20

30

40

50

60

70

Total University VA Private

Unoperated

Unoperatedsymptomatic

Unoperatedsymptomaticrisk<AVR median

NonNon--operative Patients with Severe AS by Siteoperative Patients with Severe AS by Site

SOURCE RegistrySOURCE RegistryEuroSCORE as Predictor of EuroSCORE as Predictor of

3030--day Mortalityday Mortality

C statistic:C statistic:TF = TF = 00..6464TA = TA = 00..6161

ROC Curves

0

0.2

0.4

0.6

0.8

1

0 0.2 0.4 0.6 0.8 1

1 - Specificity

Sens

itivi

ty

TA ROCTF ROC

EuroSCORE = 35

EuroSCORE = 30

EuroSCORE = 25

EuroSCORE = 20

Courtersy of Martyn ThomasCourtersy of Martyn Thomas

Logistic EuroSCORE (%)

STS

Scor

e (%

)

* Data from patients enrolled in REVIVAL II and PARTNER EU studies

R2 = 0.1427

Correlation Between STS and Logistic Correlation Between STS and Logistic EuroSCORE in High Risk AS PatientsEuroSCORE in High Risk AS Patients

0 10 20 30 40 50 60 70 80 90 1000

5

10

15

20

25

30

35

40

45



68

33

32

67

Genuinely Genuinely AsymptomaticAsymptomatic

Tested Tested SymptomaticSymptomatic

Amato 2001

Das 2005

Many Presumed “Asymptomatic” Many Presumed “Asymptomatic” Patients May Not BePatients May Not Be

Amato MCM et al. Amato MCM et al. HeartHeart 2001;86:3812001;86:381--386; 386; Das P et al. Das P et al. European Heart JournalEuropean Heart Journal 2005;26:13092005;26:1309--1313.1313.

Percent of Asymptomatic PatientsPercent of Asymptomatic Patientswith Positive Exercise Testwith Positive Exercise Test

TAVI TAVI in 2010in 2010Asymptomatic Severe ASAsymptomatic Severe AS

RosenheckRosenheck R, et al. Circulation 2010;121:151R, et al. Circulation 2010;121:151--66



Low gradients and AS severityLow gradients and AS severity

10092

67

020406080

100

% patients with AVG < 40 mmHgAVA > 1.5 AVA 1.0-1.5 AVA < 1.0

Aortic Aortic StenosisStenosis in the Communityin the Community

Sarano et al; TCT09Sarano et al; TCT09

Two Distinct Entities! Two Distinct Entities! Two Distinct Entities! Two Distinct Entities!

1.1. Low EFLow EF -- may be “pseudo” severe may be “pseudo” severe AS or true anatomic severe ASAS or true anatomic severe AS

2.2. Normal EFNormal EF –– paradoxical low flow paradoxical low flow 22ryry valvulovalvulo--arterial impedance arterial impedance mismatchmismatch

Low Flow/Low Gradient ASLow Flow/Low Gradient AS

Both syndromes require further diagnosticBoth syndromes require further diagnosticassessment and both have importantassessment and both have important

prognostic and therapeutic implications prognostic and therapeutic implications

•• 544 544 consecutive pts with at least mod AS (jetconsecutive pts with at least mod AS (jetvelocity velocity ≥ ≥ 22..5 5 m/s) and no symptoms at baselinem/s) and no symptoms at baseline

•• primary endpoint = overall mortality regardless ofprimary endpoint = overall mortality regardless oftherapy (incl AVR); therapy (incl AVR); 44--year actuarial FUyear actuarial FU

•• 44--yr survival significantly (p < yr survival significantly (p < 00..001001) lower in) lower inpatients with baseline Zpatients with baseline Zvava ≥ ≥ 44..5 5 mm Hg.mlmm Hg.ml--11.m.m22

Hachichi Z, Dumesnil JG, Pibarot P. Hachichi Z, Dumesnil JG, Pibarot P. J Am Coll Cardiol 2009;54:1003J Am Coll Cardiol 2009;54:1003--10111011



Number of Aortic Valve ProceduresNumber of Aortic Valve ProceduresSTS DatabaseSTS Database

Cumulative Over Last 10 YearsCumulative Over Last 10 Years

AV Replace AV Replace+ CAB

AV Replace+ MV Replace

1997 2006 1997 2006 1997 20060

10,00020,00030,00040,00050,00060,00070,00080,00090,000

100,000110,000120,000

Cum

ulat

ive

Cou

nt

Unadjusted Aortic Valve Operative MortalityUnadjusted Aortic Valve Operative MortalitySTS DatabaseSTS Database

Yearly Over Last 10 YearsYearly Over Last 10 Years

AV Replace AV Replace+ CAB

AV Replace+ MV Replace

1997 2006 1997 2006 1997 20060%1%2%3%4%5%6%7%8%9%

10%11%12%

Perc

ent o

f Pat

ient

s

Ann Thorac Surg 2009; 88: 23Ann Thorac Surg 2009; 88: 23--42, 4342, 43--6262

MortMort CVACVA RFRF VentVent DSWIDSWI ReopReop CompComp

Isolated AVRIsolated AVR 3.23.2 1.51.5 4.14.1 10.910.9 0.30.3 8.08.0 17.417.4

AVR + CABGAVR + CABG 5.65.6 2.72.7 7.67.6 17.617.6 0.60.6 10.710.7 26.326.3

AverageAverage 4.44.4 2.12.1 5.95.9 14.314.3 0.450.45 9.49.4 21.921.9

Ann Thorac Surg 2009; 88: 23Ann Thorac Surg 2009; 88: 23--42, 4342, 43--6262

Complications of AVR Pts Complications of AVR Pts STS Database (STS Database (20022002--66))

3.8

5.5

8.5

0123456789

10

AVR Isolated AVR + CABG AVR After CABG

Mor

talit

y (%

)

Dallas Cardiac Surgery DatabaseDallas Cardiac Surgery DatabaseAortic Valve Surgery 1986Aortic Valve Surgery 1986--20072007

Source: Courtesy of Michael Mack

N = 41,023 total cardiac surgery cases

18.0

14.0

11.3

02468

101214161820

STS St. Lukes TX Mayo

Mor

talit

y (%

)

Operative Mortality of AVROperative Mortality of AVRAfter CABGAfter CABG

age > 75yrsage > 75yrs

n=2,416n=2,416

? CABG + AVR for CAD + mild/mod AS? CABG + AVR for CAD + mild/mod AS

Integrating “modern” PCI Integrating “modern” PCI (hybrid approaches) (hybrid approaches)

Integrating “modern” PCI Integrating “modern” PCI (hybrid approaches) (hybrid approaches)

•• In In high surgical risk or “inoperable” pts, high surgical risk or “inoperable” pts, prepre--treatment treatment with PCI may defer AVR with PCI may defer AVR ((esp. in mod AS pts) or reduce subsequent esp. in mod AS pts) or reduce subsequent risk of surgical risk of surgical AVRAVR

•• In pts with AS + CAD…In pts with AS + CAD…ØØprepre--treatment with PCI may reduce risk of treatment with PCI may reduce risk of

AVR + CABGAVR + CABGØØPCI + TAVI (? staged) may reduce risk of PCI + TAVI (? staged) may reduce risk of

AVR + CABG AVR + CABG

Combined CAD and Combined CAD and AS AS



•• Currently, treating highest risk Currently, treating highest risk deciledecile (top 10% risk (top 10% risk strata) strata) –– next target should be top next target should be top 33% 33% risk strata.risk strata.ØØ Still older pts Still older pts –– estimated mean age estimated mean age ~80 ~80 yrsyrsØØ Disproportionate % pts with concomitant CAD Disproportionate % pts with concomitant CAD ––

both requiring CAD treatment and after previous both requiring CAD treatment and after previous CABG (? TAVI + PCI strategies)CABG (? TAVI + PCI strategies)

ØØ Approximate STS Approximate STS ≥ 5≥ 5•• For the time being, should avoid …For the time being, should avoid …

ØØ Younger pts, esp. with bicuspid valve disease + Younger pts, esp. with bicuspid valve disease + dilated dilated AoAo

ØØ Asymptomatic ASAsymptomatic ASØØ Low flow Low flow –– low gradient AS low gradient AS

Target Population … Target Population … Target Population … Target Population …

TAVI TAVI –– “Medium” “Medium” Risk Risk ASAS

•• Achieve 30Achieve 30--day mortality with TAVI ~ 4day mortality with TAVI ~ 4--5%, in these 5%, in these more standard risk AS pts.more standard risk AS pts.ØØ Requires intense training effort and commitment to Requires intense training effort and commitment to

a multia multi--disciplinary valve therapy center conceptdisciplinary valve therapy center conceptØØ Restrict access to no more than 25% of currently Restrict access to no more than 25% of currently

practicing practicing interventionalistsinterventionalists•• Reduce current TAVI Reduce current TAVI –– related complications.related complications.

ØØ Improve precision and consistency of THV Improve precision and consistency of THV positioning (adjunctive imaging)positioning (adjunctive imaging)

ØØ Reduce Reduce parapara--valvularvalvular leak (THV sizing, technique, leak (THV sizing, technique, and other device adjustments)and other device adjustments)

TAVI Goals … TAVI Goals … TAVI Goals … TAVI Goals …


ØØ Reduce Reduce periperi--procedural strokes (e.g. embolic procedural strokes (e.g. embolic protection devices)protection devices)

ØØ Reduce vascular complications (case selection and Reduce vascular complications (case selection and lower profile lower profile -- < 20 Fr < 20 Fr –– TAVI systems)TAVI systems)

ØØ Other Other –– pacemaker requirements, chronic kidney pacemaker requirements, chronic kidney injury, CA access and obstructioninjury, CA access and obstruction

•• Stress lesserStress lesser--invasive procedural considerations.invasive procedural considerations.ØØ Conscious sedation (whenever possible)Conscious sedation (whenever possible)ØØ Access closure (totally Access closure (totally percutaneouspercutaneous procedure)procedure)ØØ Reduced LOS and ICU time, reduced Reduced LOS and ICU time, reduced ventilatoryventilatory

requirements, rapid ambulation and return to daily requirements, rapid ambulation and return to daily activities activities



•• Insist on adequate valve/support structure Insist on adequate valve/support structure DURABILITY (DURABILITY (≥ ≥ 10 10 years for these standard risk years for these standard risk pts)pts)ØØ Careful annual echo followCareful annual echo follow--upupØØ ValveValve--inin--valve may be mitigating factorvalve may be mitigating factor

•• Demand rigorous clinical trial methodologiesDemand rigorous clinical trial methodologiesØØ Standard endpoint definitions (VARC)Standard endpoint definitions (VARC)ØØ Randomized trials for most important subsets Randomized trials for most important subsets

(incl. standard risk pts vs. surgical AVR) (incl. standard risk pts vs. surgical AVR)





TranscatheterTranscatheter AVIAVIEndless Possibilities!Endless Possibilities!

TransTrans--apicalapicalAVRAVR

Courtesy of Dr. John WebbCourtesy of Dr. John Webb

TransTrans--apicalapicalMVRMVR

(valve(valve--inin--valve)valve)

EdwardsEdwards--SapienSapien

TAVI TAVI in 2010in 2010BioprostheticBioprosthetic Valve FailureValve Failure

Webb JG, et al. Circulation 2010;121:151Webb JG, et al. Circulation 2010;121:151--66

Aortic (n=10), mitral (n=7), pulmonary (n=6), and tricuspid (n=1)Aortic (n=10), mitral (n=7), pulmonary (n=6), and tricuspid (n=1)

TranscatheterTranscatheter AVIAVIMy My RoseyRosey ProphecyProphecy

Surgery – The PAST

TAVR – The Future

In the next In the next 55--10 10 years, most patients with years, most patients with severe AS requiring AVR will be treated severe AS requiring AVR will be treated

using transcatheter lesserusing transcatheter lesser--invasiveinvasivemodalities!modalities!

Rules of EngagementRules of EngagementRules of EngagementRules of Engagement

TAVI in 2010TAVI in 2010

TAVITAVI

surgerysurgery

Documents

TAVI Future Marin Leon TCT 2010