GARY Deutsches Aortenklappenregister German Aortic Valve RegistrY 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 Christian W. Hamm Kerckhoff Heart and Thorax Center Bad Nauheim and Medical Clinic I, University of Giessen, Germany
Disclosures UNIVERSITÄTSKLINIKUM GIESSEN KERCKHOFF HERZ- UND THORAXZENTRUM Speaker’s name: Christian W. Hamm I have the following potential conflicts of interest to report: 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
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 Inclusion from 01/01/2011 to 31/12/2011 53 cardiac surgery units 69 cardiology units 13.860 patients 6.523 surgical AVR 3.462 surgical 2.694 transvascular 1.181 transapical without CABG AVR with CABG TAVI TAVI
GARY Baseline Characteristics AVR AVR Transvasc. Transapical without with TAVI TAVI CABG CABG CAD 18.6 97.1 53.6 56.1 LV-EF 3.1 5.1 9.3 7.5 <30% 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 all p<0.001
GARY TAVI Valve Type transvascular transapical Others Others n = 1.181 n = 2.695
GARY Baseline Characteristics n=6517 n=3458 n=2689 n=1177 100% Patients > 75 years 80% 86,3% 84,0% 60% 40% 44,9% 33,3% 20% 0% without CABG with CABG transvascular transapical Surgical AVR TAVI
GARY Baseline Characteristics n=6517 n=3458 n=2689 n=1177 70% Female gender 60% 58,8% 50% 49,8% 40% 39,0% 30% 28,4% 20% 10% 0% without CABG with CABG transvascular transapical Surgical AVR TAVI
GARY Baseline Characteristics Heart failure (NYHA III/IV) n=6523 n=3462 n=2694 n=1181 90% 86 % 80% 86 % 70% 69 % 60% 62 % 50% 40% 30% 20% 10% 0% without CABG with CABG transvascular transapical Surgical AVR TAVI
GARY Results – Outcome n=6517 n=3458 n=2689 n=1177 9,0% Mortality (in-hospital) 8,0% 7,7% 7,0% 6,0% 5,0% 5,1% 4,0% 4,5% 3,0% 2,0% 2,1% 1,0% 0,0% without CABG with CABG transvascular transapical Surgical AVR TAVI
GARY Risk-adjusted In-Hospital Mortality Reference: AVR without CABG TAVI transvascular < 75 years TAVI transapical TAVI transvascular ≥ 75 years TAVI transapical 0,0 1,0 2,0 3,0 4,0 5,0 6,0 7,0
GARY Results – Outcome Cerebrovascular Events 4,0% n=6517 n=3458 n=2689 n=1177 3,5% 3,7% 3,6% 3,5% 3,0% 2,5% 2,0% 2,2% 1,5% 1,0% 0,5% 0,0% without CABG with CABG transvascular transapical Surgical AVR TAVI
GARY Results – Procedure Vascular complications 14% n=6517 n=3458 n=2689 n=1177 12% 11,9% 10% 8% 6% 4% 2,5% 1,6% 2% 1,0% 0% without CABG with CABG transvascular transapical Surgical AVR TAVI
GARY Results – Procedure New Pacemaker n=6517 n=3458 n=2689 n=1177 25% 23,7% 20% 15% 9,9% 10% 4,6% 3,9% 5% 0% without CABG with CABG transvascular transapical Surgical AVR TAVI
GARY Results – Risk Score EuroSCORE 50 log. EuroSCORE (%) 40 // // 30 20 10 0 without CABG with CABG transvascular transapical Surgical AVR TAVI
GARY Results – Euro Score Euro-Score in-hospital mortality Surgical AVR TAVI 60% without CABG with CABG transvascular transapical 50% 40% 30% 20% 10% 0% < 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%
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 Chronic obstructive lung disease three weeks (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 Surgical AVR TAVI Without CABG transvascular With CABG transapical
GARY Results – AKL Risk Score AKL-Score in-hospital mortality 50% Surgical AVR TAVI 40% without CABG with CABG transvascular transapical 30% 20% 10% 0% < ≥ < ≥ < ≥ < ≥ < 3% < 6% < 3% < 6% < 3% < 6% < 3% < 6% 10% 10% 10% 10% 10% 10% 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%
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!
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