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GARY
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
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
GARY 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.
GARY 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.
GARY 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
GARY 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
GARY
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
GARY TAVI Valve Type
transapical
n = 1.181
transvascular
Others
Others
n = 2.695
GARY 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
GARY 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
GARY 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
GARY 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
GARY 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
GARY
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
GARY
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
GARY
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
GARY
0
10
20
30
40
50
without CABG with CABG transvascular transapical
log.
Eur
oSC
OR
E (%
)
EuroSCORE
Results – Risk Score
TAVI Surgical AVR
// //
GARY Results – Euro Score
< 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% 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
GARY 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
GARY AKL Score Distribution
TAVI Surgical AVR
Without CABG
With CABG
transvascular
transapical
GARY 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% observed 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
GARY 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.
GARY
Thank you!
