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Endovaskuläre Therapie von Aortenklappenpathologien
TAVI
Kurt Huber, Wilhelminenspital, Wien
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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
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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
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Devices
Medtronic CoreValveTM
Edwards SapienTM
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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
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Approach
Percutaneous: -Transfemoral-Transjugular-Transcarotid
Surgical: -Transapical -Transaortal
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Requirements
TTE/TEE
Carotid artery sonography
CT-Angiography
MMSE/Frailty Score/Quality of Life
Heart team assessment
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Complications - VARC
Procedure failure
Myocardial Infarction
Stroke
Bleeding
Vascular Access site complication
Akute kidney injury
Conduction disturbances
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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
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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.
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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.
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GARY TAVI Valve Type
n = 1.181
transvascular
Others
transapical
Others
n = 2.695
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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
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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%
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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
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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
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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%
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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
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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
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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
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The Wilhelminenspital TAVI Registry
- providing an international comparison
Florian Egger, Matthias Freynhofer, Gerhard Unger, Kurt Huber
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Aortic stenosis
3. Med
Braunwald et al. Textbook of Cardiov. Med 2004
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TAVI - Bioprothesis
Medtronic CoreValveTM Edwards SapienTM
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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
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WSP TAVI Registry - Outcome
NYHA class before and after TAVI Mean/peak transvalvular gradient
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WSP TAVI Registry - Outcome
1 year survival (Kaplan Meier) Endpoints (30 Days)
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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)
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International comparison - Patients
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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.
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International Comparison - Outcome
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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
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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
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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
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Thank you for your attention !