Deutsches Aortenklappenregister German Aortic Valve RegistrY

Transcription

1 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

2 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

3 Rationale Nationwide complete survey of patients with aortic valve stenosis undergoing invasive procedures: surgical (AVR), catheter-based () transfemoral, catheter-based () 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.

4 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.

5 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

6 Patients Inclusion from 01/01/2011 to 31/12/ cardiac surgery units 69 cardiology units patients surgical AVR surgical transvascular transapical without CABG AVR with CABG

7 Baseline Characteristics AVR without CABG AVR with CABG Transvasc. Transapical CAD LV-EF <30% A. fib Art. HT Pulm. HT COPD IDDM all p<0.001

8 Valve Type transvascular transapical Others Others n = n = 1.181

9 Baseline Characteristics 100% n=6517 n=3458 n=2689 n= % Patients > 75 years 86,3% 84,0% 60% 40% 20% 33,3% 44,9% 0% without CABG with CABG transvascular transapical Surgical AVR

10 Baseline Characteristics 70% 60% 50% n=6517 n=3458 n=2689 n=1177 Female gender 58,8% 49,8% 40% 30% 20% 39,0% 28,4% 0% without CABG with CABG transvascular transapical Surgical AVR

11 Baseline Characteristics Heart failure (NYHA III/IV) 90% 80% 70% 60% 50% 40% 30% 20% 0% n=6523 n=3462 n=2694 n= % 86 % 69 % 62 % without CABG with CABG transvascular transapical Surgical AVR

12 Results Outcome 9,0% 8,0% 7,0% n=6517 n=3458 n=2689 n=1177 Mortality (in-hospital) 7,7% 6,0% 5,0% 4,0% 3,0% 4,5% 5,1% 2,0% 1,0% 0,0% 2,1% without CABG with CABG transvascular transapical Surgical AVR

13 Risk-adjusted In-Hospital Mortality Reference: AVR without CABG < 75 years transvascular transapical 75 years transvascular transapical 0,0 1,0 2,0 3,0 4,0 5,0 6,0 7,0

14 Results Outcome 4,0% Cerebrovascular Events n=6517 n=3458 n=2689 n=1177 3,5% 3,0% 3,6% 3,7% 3,5% 2,5% 2,0% 2,2% 1,5% 1,0% 0,5% 0,0% without CABG with CABG transvascular transapical Surgical AVR

15 Results Procedure 14% 12% Vascular complications n=6517 n=3458 n=2689 n= ,9% 8% 6% 4% 2% 1,0% 1,6% 2,5% 0% without CABG with CABG transvascular transapical Surgical AVR

16 Results Procedure New Pacemaker 25% 20% n=6517 n=3458 n=2689 n= ,7% 15% 9,9% 5% 4,6% 3,9% 0% without CABG with CABG transvascular transapical Surgical AVR

17 Results Risk Score 50 EuroSCORE log. EuroSCORE (%) // // 0 without CABG with CABG transvascular transapical Surgical AVR

18 Results Euro Score Euro-Score in-hospital mortality 60% 50% without CABG Surgical AVR with CABG transvascular transapical 40% 30% 20% 0% < < 20% < 30% 30% < < 20% < 30% 30% < < 20% < 30% 30% < < 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%

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

20 AKL Score Distribution Surgical AVR Without CABG transvascular With CABG transapical

21 Results AKL Risk Score AKL-Score in-hospital mortality 50% 40% Surgical AVR 30% without CABG with CABG transvascular transapical 20% 0% < 3% < 6% < < 3% < 6% < < 3% < 6% < < 3% < 6% 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% <

22 Conclusions First large scale registry on surgical & catheter based procedures. 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 at least as good as with surgical AVR.

23 Thank you!