German Aortic Valve RegistrY

Transcription

1 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 i l 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 id complete survey of patients t with aortic valve disease undergoing invasive procedures: surgical (AVR), replacement/reconstruction 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 t undergoing an invasive i therapy for acquired aortic valve disease consecutively included; 88 active centers/ 7 inactive The only exclusion criterion: no informed consent. Follow-up: in-hospital, 1, 3, 5 years

5 Data Management and Sponsorship Data management: BQS Institut für Qualität & Patientensicherheit. Sponsorship: p Investigator initiated study with unrestricted grant from: Edwards, Medtronic, Jena Valve, Symetis, St Jude, Sorin Support: German Cardiac Society (DGK) German Society for Thoracic and Cardiovascular Surgery German Heart Foundation

6 Patients with Written Consent 2010 until 02/ Patients with Written Consent Number End Dec 2010 End Dec 2011 End Dec 2012 Jan 2013 Feb 2013 Month BQS-Institut - Database:

7 Patients (360 Ross and David excluded ) 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

8 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

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

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

11 Results Outcome 9,0% 8,0% 7,0% n=6517 n=3458 n=2689 n=1177 Mortality (in-hospital) 7,7% 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

12 Results Procedure New Pacemaker 25% 20% n=6517 n=3458 n=2689 n= ,7% 15% 10% 9,9% 9% 5% 4,6% 3,9% 0% without CABG with CABG transvascular transapical Surgical AVR

13 1 year follow-up: patients 2011: patients included Follow-up: patients 98,1 % direct follow-up: 89,5 % indirect follow-up: 8,6 % (National population register) Unknown: 1,9% 13

14 Kaplan-Meier mortality-rate by procedure Death log-rank test AVR AVR+ AVR+CTV TV TA TA CABG ABG p-values (GH: <0.001) Hospital 2.1% 4.5% 5.1% 7.7% AVR < < < Days 2.4% 4.5% 5.6% 9.0% 180 AVR+CABG Days 5.2% 9.2% 14.7% < % < TV Days 6.7% 11.0% 20.7% 28.0% <

15 Kaplan-Meier mortality-rate by procedure Age: < 75 years; >= 75 years Age: < 75 years Age: >= 75 years Death No. Day AVR Day AVR+C Day 180 TV Day TA Risk 0 30 ABG 365 AVR AVR Days 2.0% 3.9% 4.6% 11.2% +CABG Days 4.0% 7.7% 14.2% 22.7% TV TA Days % % % % Death No. Day AVR Day AVR+C Risk 0 30 ABG Day 180 TV TA Day 365 AVR Days 3.4% 5.3% 5.8% 8.6% AVR +CABG Days 7.7% 11.1% 14.8% 19.9% TV TA Days 989.7% % % % 15

16 Kaplan-Meier mortality by procedure EuroSCORE 16

17 Kaplan-Meier mortality by procedure EuroSCORE log-rank test p-values (GH: <0.001) AVR+C ABG TV TA AVR < < < AVR+CABG < < TV log-rank test AVR+ TV TA p-values (GH: =0.001) CABG AVR < AVR+CABG TV log-rank test p-values (GH: <0.001) AVR+ CABG TV TA AVR < < AVR+CABG < TV log-rank test AVR+ TV TA p-values (GH: <0.001) CABG AVR < AVR+CABG TV <

18 German Aortic Valve Disease Score AKL-Score 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)

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

20 Kaplan-Meier mortality by procedure German AV-Score (AKL-Score) 20

21 Kaplan-Meier mortality by procedure German AV-Score (AKL-Score) log-rank test AVR+ TV TA log-rank test AVR+ TV TA p-values (GH: <0.001) CABG p-values (GH: <0.001) CABG AVR < < < AVR+CABG < < TV AVR < AVR+CABG TV log-rank test p-values (GH: <0.001) AVR+ CABG TV TA AVR < AVR+CABG TV log-rank test AVR+ TV TA p-values (GH: =0.003) CABG AVR AVR+CABG TV <

22 1-year follow-up: interviewed patients Stroke 5% 4% 1-year follow-up: interviewed patients Stroke n = 5421 n = 2718 n = 1782 n = 715 Minor Stroke Major Stroke 2,1% 2,8% 3% 1,3% 1,8% 2% 1,7% 2,3% 2,0% 1,8% 1% 0% without CABG with CABG transvascular transapical Surgical AVR 22

23 1-year follow-up: interviewed patients NYHA-classification 72 to 85 %innyhaior II 1-year follow-up: interviewed patients Heart failure - NYHA I - NYHA IV Surgical AVR 0,9% 0,4% 13,7% 48,6% 36,4% NYHA I NYHA II NYHA III NYHA IV N/A 34,4% 34% 3,4% 10% 1,0% 23,2% 38,0% without CABG transvascular 1,1% 0,3% 2,1% 1,4% 14,9% 36,6% 47,2% 22,8% 39,3% 34,4% 23 with CABG transapical

24 1-year follow-up: interviewed patients Current state of health vs. state of health before procedure ~ 60 % better than before 1-year follow up: interviewed i patients t Current state of health in comparison to state of health before procedure Surgical AVR 0,4% 12,1% better same 0,4% 14,8% 26,6% 60,9% worse N/A 23,0% 61,8% without CABG transvascular 0,4% 0,3% 13,4% 18,2% 24,2% 61,9% 23,8% 57,8% 24 with CABG transapical

25 1-year follow-up: interviewed patients Patient satisfaction s ac 1 year after intervention e 93 1-year 96 % follow-up: satisfied interviewed with patients procedure Patient satisfaction 1 year after intervention Surgical AVR 33% 3,3% 08% 0,8% 8,0% very good good satisfactory 55,2% 32,6% unsatisfactory N/A 36,5% 2,9% 1,3% 9,0% 50,2% without CABG transvascular 0,8% 3,9% 0,6% 6,3% 9,1% 35,9% 50,5% 13,8% 35,9% 43,1% with CABG transapical 25

26 Summary First large scale registry on comparing surgical & catheter based procedures with 1 year follow-up. Continuous increase in mortality after hospital discharge, predominately in high risk groups. In low and intermediate risk groups, surgical AVR (no CABG) group has better outcome than. TV- and conventional surgery have equal outcome in patients EURO Score > 20%, AKL Score > 6%. Good one year clinical outcome (QoL) and high patient satisfaction across all groups. 26

27 Conclusion Score > 20% or AKL Score > 6% and age > 75 yrs good cut-offs Mortality equal (TA-) or better (TV-) than PARTNER A. Limitations: Voluntary participation of centers The AV risk score is derived predominately from patients with surgery, a separate risk score for is under development 27

28 Grazie! Danke! 28

29 Kaplan-Meier mortality : residual aortic insufficiency Death none / trace mild / severe 30 Days 6.1% 8.8% 180 Days 15.5% 23.6% 365 Days 22.3% 26.9% log-rank test p-value

30 Kaplan-Meier mortality : residual aortic insufficiency Death none trace mild severe 30 Days 6.0% 6.2% 6.7% 37.5% 180 Days 14.7% 16.3% 21.7% 50.0% 365 Days 21.2% 23.3% 25.3% 50.0% 30

31 1-year follow-up: interviewed patients Myocardial Infarction 5% 1-year follow-up: interviewed patients Myocardial Infarction n = 5421 n = 2718 n = 1782 n = 715 4% 3% 2% 1% 0% 0,4% 0,7% 0,6% 0,7% without CABG with CABG transvascular transapical Surgical AVR 31

32 1-year follow-up: interviewed patients Stroke 5% 4% 1-year follow-up: interviewed patients Stroke n = 5421 n = 2718 n = 1782 n = 715 4,5% 4,8% 3% 3,0% 3,6% 2% 1% 0% without CABG with CABG transvascular transapical Surgical AVR 32

33 1-year follow-up: interviewed patients CABG after discharge from hospital 5% 1-year follow-up: interviewed patients CABG after discharge from hospital n = 5421 n = 2718 n = 1782 n = 715 4% 3% 2% 1% 0% 0,3% 0,4% 0,1% 0,4% without CABG with CABG transvascular transapical Surgical AVR 33

34 1-year follow-up: interviewed patients PCI after discharge from hospital 1-year follow-up: interviewed patients PCI after discharge from hospital 5% n = 5421 n = 2718 n = 1782 n = 715 4% 3% 2% 1% 1,1% 1,9% 1,5% 0% 0,5% without CABG with CABG transvascular transapical Surgical AVR 34

35 1-year follow-up: interviewed patients Patients with hospital stays after procedure because of: complications of procedure; cardiovascular problems 50% 40% 30% 1-year follow-up: interviewed i patients t Patients with hospital stays after the procedure 29,6% 34,4% 4% 40,2% 45,5% AVR without CABG AVR with CABG - transvascular - transapical 20% 10% 83% 8,3% 6,5% 6,5% 4,4% 16,9% 15,4% 11,3% 12,3% 0% Hospital stays Hospital stays for complications of the procedure Hospital stays for cardiovascular problems 35