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 CoreValveTM and SapienTM (Europe)

2010 Partner trial

2013 over 50000 cases worldwide

Therapeutic opportunities

TAVI: in case of high risk or inoperability (EURO Score >20% or STS >10%)

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

SAVR: Surgical aortic valve replacementFirst line therapy

Devices

Medtronic CoreValveTM

Edwards SapienTM

Specifications

Medtronic CoreValveTM

o 26mm, 29mm, 31mm

o 18 French delivery catheter

o Self expanding

o Nitinol

o Porcine pericardium

Edwards SapienTM

o 23mm, 26mm, 29mm

o 18 French delivery catheter

o Balloon expandable

o Cobalt chromium

o Bovine pericardium

Approach

Percutaneous: -Transfemoral-Transjugular-Transcarotid

Surgical: -Transapical -Transaortal

Requirements

TTE/TEE

Carotid artery sonography

CT-Angiography

MMSE/Frailty Score/Quality of Life

Heart team assessment

Complications - VARC

Procedure failure

Myocardial Infarction

Stroke

Bleeding

Vascular Access site complication

Akute kidney injury

Conduction disturbances

Christian W. HammKerckhoff Heart and Thorax Center Bad Nauheim and

Medical Clinic I, University of Giessen, Germany

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. Welz for the GARY-Executive

Board

GARY Deutsches AortenklappenregisterGerman Aortic Valve RegistrY

GARY Rationale

•  Nationwide complete survey of patients with aorticvalve stenosis undergoing invasive procedures:

• • • • 

surgical (AVR),catheter-based (TAVI) transfemoral ,catheter-based (TAVI) transapical,valvuloplasty.

•  To evaluate catheter-based procedures incomparison to surgical aortic valve replacement.

•  Develop criteria for an adequate patient selection ofbest treatment modality.

GARY Design

•  Prospective, controlled, multicenter registry.

•  All patients undergoing an invasive therapy foracquired aortic valve disease consecutivelyincluded.

•  The only exclusion criterion: no informed consent.•  Follow-up: in-hospital, 30 days, 1,3, 5 years.

GARY TAVI Valve Type

n = 1.181

transvascular

Others

transapical

Others

n = 2.695

AVRwithoutCABG

AVRwithCABG

Transvasc.TAVI

TransapicalTAVI

CAD 18.6 97.1 53.6 56.1

LV-EF<30%

3.1 5.1 9.3 7.5

A.fib. 15.9 15.0 28.9 29.5

Art.HT 79.5 86.1 86.4 90.0

Pulm.HT 10.8 11.1 39.8 23.4

COPD 10.0 12.2 19.8 20.5

IDDM 8.2 12.9 13.3 17.5

GARY Baseline Characteristics

all p<0.001

GARY Baseline Characteristics

86,3% 84,0%80%

60%

40%

20%

0%

100%

without CABG with CABG transvascular transapical

n=6517 n=3458 n=2689 n=1177

Surgical AVR TAVI

Patients > 75 years

44,9%

33,3%

GARY Baseline Characteristics

39,0%

28,4%

58,8%

49,8%

0%

20%

10%

40%

30%

50%

70%

60%

without CABG with CABG transvascular transapical

Surgical AVR TAVI

n=6517 n=3458

Female gendern=2689 n=1177

GARY

50%

40%

30%

20%

10%

0%

90%

80%

70%

60%

without CABG with CABG transvascular transapical

n=6523

62 %

n=3462

69 %

n=2694

86 %

n=1181

86 %

Baseline Characteristics

Heart failure (NYHA III/IV)

Surgical AVR TAVI

GARY Results – Outcome

0,0%

9,0%

8,0%

7,0%

6,0%

5,0%

4,0%

3,0%

2,0%

1,0%

without CABG with CABG transvascular transapical

Surgical AVR TAVI

n=6517 n=3458

Mortality (in-hospital)

4,5%

2,1%

n=2689

5,1%

n=1177

7,7%

GARY

4,6% 3,9%

23,7%

9,9%

5%

0%

20%

15%

10%

25%

without CABG with CABG transvascular transapical

Surgical AVR TAVI

Results – Procedure

New Pacemakern=6517 n=3458 n=2689 n=1177

GARY

< 10% < 20% < 30% ≥ 30% < 10% < 20% < 30% ≥ 30% < 10% < 20% < 30% ≥ 30% < 10% < 20% < 30% ≥ 30%

observed 1,3% 3,3% 3,8% 7,8%

expected 4,7% 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%

0%

40%

30%

20%

10%

50%

60%Surgical AVR TAVI

without CABG transapicaltransvascularwith CABG

Results – Euro Score

Euro-Score in-hospital mortality

GARY

0,0 1,0 2,0 3,0 4,0 5,0 6,0 7,0

TAVItransvascular

TAVItransapical

TAVItransvascular

TAVItransapical

< 75 years

≥ 75 years

Risk-adjusted In-Hospital Mortality

Reference: AVR without CABG

The Wilhelminenspital TAVI Registry

- providing an international comparison

Florian Egger, Matthias Freynhofer, Gerhard Unger, Kurt Huber

Aortic stenosis

3. Med

Braunwald et al. Textbook of Cardiov. Med 2004

TAVI - Bioprothesis

Medtronic CoreValveTM Edwards SapienTM

WSP TAVI Registry - PatientsPatients with

severe inoperable AS*

(n=87)

Conservative management

(n=39)

Patient refused procedure

(n=16)

Patients assigned to conservative

therapy (n=23)

TAVI-intention to treat (n=48)

Deaths before procedure (n=2)

TAVI-on treatment (n=46)

*Characteristics: -Transvalvular gradient > 40mmHg or -Aortic valve area < 1cm2

Operability assessed by heart team

WSP TAVI Registry - Outcome

NYHA class before and after TAVI Mean/peak transvalvular gradient

WSP TAVI Registry - Outcome

1 year survival (Kaplan Meier) Endpoints (30 Days)

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 - Patients

International Comparison - Outcome

Himbert D, et al.; Am J Cardiol. 2009 Jul. 21; 54(4):303-11 Gurvitch R, et al.; Catheter Cardiovasc Interv 2011;78:977–984.

International Comparison - Outcome

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

CoreValve InnovationFocused Efforts on:• Expansion of patient access• Further improvement of ease of use• Continue to advance patient and procedural outcome

*DeliverySystem

Improvements

*Greater AnnulusCoverage

AlternativeAccess

Technology

Anti-Mineralization

Tissue Treatment

18 FR 16 FR

ProfileReduction

New TAVI valves are coming to themarket in a few year’s time

Boston Sci.Lotus™ HLT

Direct FlowSaint JudePortico™

SymetisACCURATE

JenaValve

MedtronicEngager

EdwardsSapien

MedtronicCoreValve

Next Gen.MedtronicCoreValve

EdwardsSapien XT

EdwardsSapien XT

Today Tomorrow

Thank you for your attention !