GARY Deutsches Aortenklappenregister German Aortic Valve RegistrY - - PowerPoint PPT Presentation

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Apr 05, 2024 7 likes •240 views

GARY Deutsches Aortenklappenregister German Aortic Valve RegistrY C. W. Hamm, F.W. Mohr, H. Mllmann, 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. Bhm,

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Christian W. Hamm

Kerckhoff 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

Deutsches Aortenklappenregister

German Aortic Valve RegistrY

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KERCKHOFF HERZ- UND THORAXZENTRUM UNIVERSITÄTSKLINIKUM GIESSEN

Affiliation/Financial Relationship Company 1. Honoraria for lectures Medtronic, Edwards 2. Honoraria for advisory board activities Medtronic 3. Participation in clinical trials Medtronic, Edwards, Symetis, Jena Valve 4. Financial shares and options: no

Speaker’s name: Christian W. Hamm I have the following potential conflicts of interest to report:

Disclosures

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Rationale

Nationwide complete survey of patients with aortic

valve stenosis undergoing invasive procedures:

surgical (AVR),
catheter-based (TAVI) transfemoral ,
catheter-based (TAVI) transapical,
valvuloplasty.
To evaluate catheter-based procedures in

comparison to surgical aortic valve replacement.

Develop criteria for an adequate patient selection of

best treatment modality.

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Design

Prospective, controlled, multicenter registry.
All patients undergoing an invasive therapy for

acquired aortic valve disease consecutively included.

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

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Data Management and Sponsorship

Data management:

BQS – Institut für Qualität & Patientensicherheit.

Sponsorship:

Investigator initiated study with unrestricted grant from: Edwards, Medtronic, Symetis, Jena Valve, St Jude, Sorin

Support:

German Cardiac Society (DGK) German Society for Thoracic and Cardiovascular Surgery

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Patients

53 cardiac surgery units 69 cardiology units

13.860 patients

6.523 surgical AVR without CABG 3.462 surgical AVR with CABG 2.694 transvascular TAVI 1.181 transapical TAVI

Inclusion from 01/01/2011 to 31/12/2011

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AVR without CABG AVR with CABG Transvasc. TAVI Transapical TAVI

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

Baseline Characteristics

all p<0.001

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TAVI Valve Type

transapical n = 1.181 transvascular

Others Others

n = 2.695

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Baseline Characteristics

33,3% 44,9% 86,3% 84,0%

0% 20% 40% 60% 80% 100% without CABG with CABG transvascular transapical

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

Surgical AVR TAVI

Patients > 75 years

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Baseline Characteristics

39,0% 28,4%

58,8%

49,8%

0% 10% 20% 30% 40% 50% 60% 70%

without CABG with CABG transvascular transapical

Female gender

Surgical AVR TAVI

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

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Baseline Characteristics

62 % 69 % 86 % 86 %

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

without CABG with CABG transvascular transapical

n=6523 n=3462 n=2694 n=1181

Heart failure (NYHA III/IV)

Surgical AVR TAVI

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Results – Outcome

2,1% 4,5% 5,1% 7,7%

0,0% 1,0% 2,0% 3,0% 4,0% 5,0% 6,0% 7,0% 8,0% 9,0%

without CABG with CABG transvascular transapical Surgical AVR TAVI

Mortality (in-hospital)

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

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Risk-adjusted In-Hospital Mortality

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

TAVI transvascular TAVI transvascular TAVI transapical TAVI transapical

≥ 75 years < 75 years

Reference: AVR without CABG

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2,2% 3,6% 3,7% 3,5%

0,0% 0,5% 1,0% 1,5% 2,0% 2,5% 3,0% 3,5% 4,0%

without CABG with CABG transvascular transapical Surgical AVR TAVI

Cerebrovascular Events

Results – Outcome

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

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1,0% 1,6% 11,9% 2,5% 0% 2% 4% 6% 8% 10% 12% 14%

without CABG with CABG transvascular transapical Surgical AVR TAVI

Vascular complications

Results – Procedure

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

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4,6% 3,9% 23,7% 9,9% 0% 5% 10% 15% 20% 25%

without CABG with CABG transvascular transapical

Results – Procedure

Surgical AVR TAVI

New Pacemaker

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

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10 20 30 40 50

without CABG with CABG transvascular transapical

log. EuroSCORE (%)

EuroSCORE

Results – Risk Score

TAVI Surgical AVR

// //

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Results – Euro Score

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

bserved 1,3% 3,3% 3,8% 7,8%

2,6% 4,8% 8,5% 17,7% 3,9% 3,5% 4,7% 7,7% 3,6% 5,5% 6,5% 13,6% expected 4,7% 13,7% 24,3% 45,3% 5,3% 14,0% 24,1% 45,0% 7,3% 14,5% 24,5% 48,4% 7,4% 14,6% 24,2% 47,4%

0% 10% 20% 30% 40% 50% 60%

Surgical AVR TAVI

without CABG transapical transvascular with CABG

Euro-Score in-hospital mortality

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German Aortic Valve Disease Score „AKL-Score“

Age (5 risk classes) LV-EF (2 risk classes) Gender (female) Redo-procedure Body mass index (2 risk classes) Infection (endocarditis) Heart failure (NYHA) Peripheral arterial disease Myocardial infarction within last three weeks Chronic obstructive lung disease (2 risk classes) Critical preoperative status Renal failure Pulmonary hypertension Emergency Rhythm (no sinus rhythm)

http://www.bqs-outcome.de/2008/ergebnisse/leistungsbereiche/hch

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AKL Score Distribution

TAVI Surgical AVR

Without CABG With CABG transvascular transapical

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Results – AKL Risk Score

Surgical AVR TAVI

AKL-Score in-hospital mortality

< 3% < 6% < 10% ≥ 10% < 3% < 6% < 10% ≥ 10% < 3% < 6% < 10% ≥ 10% < 3% < 6% < 10% ≥ 10%

bserved 1,3% 3,5% 6,6% 9,0%

2,7% 7,1% 8,2% 16,9% 2,8% 3,9% 5,0% 8,1% 5,0% 4,9% 5,1% 16,9% expected 1,3% 4,1% 7,5% 17,0% 1,5% 4,2% 7,6% 19,7% 2,1% 4,4% 7,7% 19,0% 2,1% 4,4% 7,7% 18,9%

0% 10% 20% 30% 40% 50%

without CABG transapical transvascular with CABG

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Conclusions

First large scale registry on surgical & catheter

based procedures.

TAVI performed predominantly in high risk patients.
AKL score better reflects outcome than EuroScore.
In-hospital mortality and complications comparable

to randomized controlled studies.

In high risk patients in-hospital mortality with TAVI

at least as good as with surgical AVR.

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