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Endovaskuläre Therapie von Aortenklappenpathologien. TAVI Kurt Huber, Wilhelminenspital , Wien. Historical background. 2000 Bonhoeffer et al. – Pulmonary valve 2002 Cribier et al. – Aortic valve 2007 Approval for CoreValve TM and Sapien TM (Europe) 2010 Partner trial

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endovaskul re therapie von aortenklappenpathologien

EndovaskuläreTherapie von Aortenklappenpathologien

TAVI

Kurt Huber, Wilhelminenspital, Wien

historical background
Historicalbackground

2000 Bonhoeffer et al. – Pulmonary valve

2002 Cribier et al. – Aortic valve

2007 Approval for CoreValveTM and SapienTM (Europe)

2010 Partner trial

2013 over 50000 cases worldwide

therapeutic opportunities
Therapeutic opportunities

SAVR: Surgicalaorticvalvereplacement

Firstlinetherapy

TAVI: in case of high risk or inoperability (EURO Score >20%

or STS >10%)

(Iung B, et al.; EurHeart J. 2005 Dec;26(24):2714-20.)

devices
Devices

MedtronicCoreValveTM

Edwards SapienTM

specifications
Specifications

Medtronic CoreValveTM

  • 26mm, 29mm, 31mm
  • 18 French delivery catheter
  • Self expanding
  • Nitinol
  • Porcine pericardium

Edwards SapienTM

  • 23mm, 26mm, 29mm
  • 18 French delivery catheter
  • Balloon expandable
  • Cobalt chromium
  • Bovine pericardium
approach
Approach

Percutaneous:-Transfemoral

-Transjugular

-Transcarotid

Surgical: -Transapical

-Transaortal

requirements
Requirements

TTE/TEE

Carotid artery sonography

CT-Angiography

MMSE/Frailty Score/Quality of Life

Heart team assessment

complications varc
Complications - VARC

Procedurefailure

MyocardialInfarction

Stroke

Bleeding

Vascular Access sitecomplication

Akute kidneyinjury

Conductiondisturbances

slide9

GARYDeutschesAortenklappenregister

GermanAorticValveRegistrY

C.W.Hamm,F.W.Mohr,H.Möllmann,D.Holzhey,

A.Beckmann,H.-R.Figulla,J.Cremer,K.-H.Kuck,R.Lange,

R.Zahn,S.Sack,G.Schuler,T.Walther,F.Beyersdorf,

M.Böhm,G.Heusch,A.-K.Funkat,T.Meinertz,T.Neumann,

K.Papoutsis,S.Schneider,A.WelzfortheGARY-Executive

Board

ChristianW.Hamm

KerckhoffHeartandThoraxCenterBadNauheimand

MedicalClinicI,UniversityofGiessen,Germany

slide10

GARY

Rationale

• Nationwidecompletesurveyofpatientswithaortic

valvestenosisundergoinginvasiveprocedures:

• 

• 

• 

• 

surgical(AVR),

catheter-based(TAVI)transfemoral,

catheter-based(TAVI)transapical,

valvuloplasty.

• Toevaluatecatheter-basedproceduresin

comparisontosurgicalaorticvalvereplacement.

• Developcriteriaforanadequatepatientselectionof

besttreatmentmodality.

slide11

GARY

Design

• Prospective,controlled,multicenterregistry.

• Allpatientsundergoinganinvasivetherapyfor

acquiredaorticvalvediseaseconsecutively

included.

• Theonlyexclusioncriterion:noinformedconsent.

• Follow-up:in-hospital,30days,1,3,5years.

slide12

GARY

TAVIValveType

transvascular

transapical

Others

Others

n=1.181

n=2.695

slide13

GARY

BaselineCharacteristics

allp<0.001

slide14

GARY

BaselineCharacteristics

n=6517

n=3458

n=2689

n=1177

100%

Patients>75years

44,9%

33,3%

86,3%

84,0%

80%

60%

40%

20%

0%

withoutCABG

withCABG

transvascular

transapical

SurgicalAVR

TAVI

slide15

GARY

BaselineCharacteristics

n=2689

n=1177

n=6517n=3458

Femalegender

70%

60%

58,8%

50%

49,8%

40%

30%

39,0%

28,4%

20%

10%

0%

withoutCABG

withCABG

transvascular

transapical

SurgicalAVR

TAVI

slide16

GARY

BaselineCharacteristics

Heartfailure(NYHAIII/IV)

n=2694

86%

n=1181

86%

n=6523

62%

n=3462

69%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

withoutCABG

withCABG

transvascular

transapical

SurgicalAVR

TAVI

slide17

GARY

Results–Outcome

n=1177

7,7%

n=2689

5,1%

n=6517n=3458

Mortality(in-hospital)

4,5%

2,1%

9,0%

8,0%

7,0%

6,0%

5,0%

4,0%

3,0%

2,0%

1,0%

0,0%

withoutCABG

withCABG

transvascular

transapical

SurgicalAVR

TAVI

slide18

GARY

Results–Procedure

NewPacemaker

n=6517

n=3458

n=2689

n=1177

25%

23,7%

20%

15%

10%

9,9%

4,6%

3,9%

5%

0%

withoutCABG

withCABG

transvascular

transapical

SurgicalAVR

TAVI

slide19

GARY

Results–EuroScore

Euro-Scorein-hospitalmortality

SurgicalAVR

TAVI

60%

withoutCABG

withCABG

transvascular

transapical

50%

40%

30%

20%

10%

0%

<10%<20%<30%≥30%

<10%<20%<30%≥30%

<10%<20%<30%≥30%

<10%<20%<30%≥30%

observed1,3%3,3%3,8%7,8%

expected4,7%13,7%24,3%45,3%

2,6%4,8%8,5%17,7%

5,3%14,0%24,1%45,0%

3,9%3,5%4,7%7,7%

7,3%14,5%24,5%48,4%

3,6%5,5%6,5%13,6%

7,4%14,6%24,2%47,4%

slide20

GARY

Risk-adjustedIn-HospitalMortality

Reference:AVRwithoutCABG

TAVI

transvascular

TAVI

transapical

TAVI

transvascular

TAVI

transapical

<75years

≥75years

0,0

1,0

2,0

3,0

4,0

5,0

6,0

7,0

the wilhelminenspital tavi registry

The Wilhelminenspital TAVI Registry

- providing an international comparison

Florian Egger, Matthias Freynhofer, Gerhard Unger, Kurt Huber

aortic stenosis
Aorticstenosis

3. Med

Braunwald et al. Textbook of Cardiov. Med 2004

tavi bioprothesis
TAVI - Bioprothesis

MedtronicCoreValveTM Edwards SapienTM

wsp tavi registry patients
WSP TAVI Registry - Patients
  • *Characteristics:
  • -Transvalvular gradient > 40mmHg or
  • -Aortic valve area < 1cm2
  • Operability assessed by heart team
wsp tavi registry outcome
WSP TAVI Registry - Outcome

NYHA classbefore and after TAVI Mean/peaktransvalvulargradient

wsp tavi registry outcome1
WSP TAVI Registry - Outcome

1 yearsurvival (Kaplan Meier) Endpoints (30 Days)

international comparison
International comparison

Clinical Trials: PARTNER B (179 Pat., transfemoral, RCT, Edwards)

Registries: SOURCE (463 Pat., transfemoral/-apical, Edwards)

FRANCE 2 (2293 Pat., transfemoral/-apical, Edwards/Medtronic)

Limitations: -Self reporting (Registries)

-Selected patient population (Clinical trials)

-incomparable results due to inconsistent endpoint

reporting (VARC)

international comparison outcome
International Comparison - Outcome

Himbert D, et al.; Am J Cardiol. 2009 Jul. 21; 54(4):303-11

Gurvitch R, et al.; CatheterCardiovascInterv 2011;78:977–984.

conclusion outlook
Conclusion & Outlook

HEART TEAM Approach

Gefäßchirurgie-WSP, Anästhesie (WSP), Herzchirurgie + Kardiotechniker (Hietzing)

Optimal equipment (Heart-Lung-Machine)

Higher caseload desirable to guarantee safety and high quality

Pacemaker sub-study

slide32

CoreValveInnovation

FocusedEffortson:

•Expansionofpatientaccess

•Furtherimprovementofeaseofuse

•Continuetoadvancepatientandproceduraloutcome

Anti-

Mineralization

TissueTreatment

*Delivery

System

Improvements

Alternative

Access

Technology

16FR

18FR

Profile

Reduction

*GreaterAnnulus

Coverage

slide33

NewTAVIvalvesarecomingtothe

marketinafewyear’stime

Today

Tomorrow

BostonSci.

Lotus™

NextGen.

Medtronic

CoreValve

HLT

Edwards

SapienXT

SaintJude

Portico™

DirectFlow

Medtronic

CoreValve

Medtronic

Engager

Edwards

Sapien

JenaValve

Symetis

ACCURATE

Edwards

SapienXT