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Endovaskuläre Therapie von Aortenklappenpathologien

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Presentation on theme: "Endovaskuläre Therapie von Aortenklappenpathologien"— Presentation transcript:

1 Endovaskuläre Therapie von Aortenklappenpathologien
TAVI Kurt Huber, Wilhelminenspital, Wien

2 Historical background
2000 Bonhoeffer et al. – Pulmonary valve 2002 Cribier et al. – Aortic valve 2007 Approval for CoreValveTM and SapienTM (Europe) 2010 Partner trial 2013 over cases worldwide

3 Therapeutic opportunities
SAVR: Surgical aortic valve replacement First line therapy TAVI: in case of high risk or inoperability (EURO Score >20% or STS >10%) (Iung B, et al.; Eur Heart J Dec;26(24): )

4 Devices Medtronic CoreValve Edwards Sapien (XT) Jenavalve
St. Jude Portico Symetis Acurate Direct Flow Medical

5 Devices Medtronic CoreValveTM Edwards SapienTM

6 Specifications Medtronic CoreValveTM Edwards SapienTM 26mm, 29mm, 31mm
18 French delivery catheter Self expanding Nitinol Porcine pericardium Edwards SapienTM 23mm, 26mm, 29mm 18 French delivery catheter Balloon expandable Cobalt chromium Bovine pericardium

7 Approach Percutaneous: -Transfemoral Surgical: -Transapical
-Transjugular -Transcarotid Surgical: -Transapical -Transaortal

8 Requirements TTE/TEE Carotid artery sonography CT-Angiography
MMSE/Frailty Score/Quality of Life Heart team assessment

9 Medial upper arm perforators
Procedure Medtronic CoreValveTM Dieses Slide hat eine Verlinkung zu einem Youtube Video von Medtronic.

10 Complications - VARC Procedure failure Myocardial Infarction Stroke Bleeding Vascular Access site complication Akute kidney injury Conduction disturbances

11 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

12 Rationale GARY • 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.

13 Design GARY • 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.

14 TAVI Valve Type GARY transvascular transapical n = 1.181 n = 2.695
Others Others n = 2.695 n = 1.181

15 Baseline Characteristics
GARY Baseline Characteristics AVR without CABG with Transvasc. TAVI Transapical 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 all p<0.001

16 Baseline Characteristics
GARY Baseline Characteristics n=6517 n=3458 n=2689 n=1177 100% Patients > 75 years 44,9% 33,3% 86,3% 80% 60% 40% 20% 0% 84,0% without CABG with CABG transvascular transapical Surgical AVR TAVI

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

18 Baseline Characteristics
GARY Baseline Characteristics Heart failure (NYHA III/IV) n=6523 62 % n=3462 69 % n=2694 86 % n=1181 86 % 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% without CABG with CABG transvascular transapical Surgical AVR TAVI

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

20 Results – Procedure GARY New Pacemaker 23,7% 9,9% 4,6% 3,9% 25% 20%
15% 10% 9,9% 4,6% 3,9% 5% 0% without CABG with CABG transvascular transapical Surgical AVR TAVI

21 GARY Euro-Score in-hospital mortality without CABG with CABG
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% expected 4,7% 13,7% 24,3% 45,3% 2,6% 4,8% 8,5% 17,7% 5,3% 14,0% 24,1% 45,0% 3,9% 3,5% 4,7% 7,7% 7,3% 14,5% 24,5% 48,4% 3,6% 5,5% 6,5% 13,6% 7,4% 14,6% 24,2% 47,4%

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

23 The Wilhelminenspital TAVI Registry
- providing an international comparison Florian Egger, Matthias Freynhofer, Gerhard Unger, Kurt Huber

24 Medial upper arm perforators
Aortic stenosis 3. Med Braunwald et al. Textbook of Cardiov. Med 2004

25 Medial upper arm perforators
TAVI - Bioprothesis Medtronic CoreValveTM Edwards SapienTM

26 WSP TAVI Registry - Patients
Patients with severe inoperable AS* (n=87) Conservative management (n=39) Patient refused procedure (n=16) Patients assigned to conservative therapy (n=23) TAVI-intention to treat (n=48) Deaths before procedure (n=2) TAVI-on treatment (n=46) *Characteristics: -Transvalvular gradient > 40mmHg or -Aortic valve area < 1cm2 Operability assessed by heart team

27 WSP TAVI Registry - Outcome
NYHA class before and after TAVI Mean/peak transvalvular gradient

28 WSP TAVI Registry - Outcome
1 year survival (Kaplan Meier) Endpoints (30 Days)

29 International comparison
Clinical Trials: PARTNER B (179 Pat., transfemoral, RCT, Edwards) Registries: SOURCE (463 Pat., transfemoral/-apical, Edwards) FRANCE 2 (2293 Pat., transfemoral/-apical, Edwards/Medtronic) Limitations: -Self reporting (Registries) -Selected patient population (Clinical trials) -incomparable results due to inconsistent endpoint reporting (VARC)

30 International comparison - Patients

31 International Comparison - Outcome
Himbert D, et al.; Am J Cardiol Jul. 21; 54(4):303-11 Gurvitch R, et al.; Catheter Cardiovasc Interv 2011;78:977–984.

32 International Comparison - Outcome

33 Medial upper arm perforators
Conclusion & Outlook HEART TEAM Approach Gefäßchirurgie-WSP, Anästhesie (WSP), Herzchirurgie + Kardiotechniker (Hietzing) Optimal equipment (Heart-Lung-Machine) Higher caseload desirable to guarantee safety and high quality Pacemaker sub-study

34 • Expansion of patient access • Further improvement of ease of use
CoreValve Innovation Focused Efforts on: • Expansion of patient access • Further improvement of ease of use • Continue to advance patient and procedural outcome Anti- Mineralization Tissue Treatment *Delivery System Improvements Alternative Access Technology 18 FR 16 FR Profile Reduction *Greater Annulus Coverage

35 New TAVI valves are coming to the
market in a few year’s time Today Tomorrow Next Gen. Medtronic CoreValve Boston Sci. Lotus™ HLT Edwards Sapien XT Saint Jude Portico™ Direct Flow Medtronic CoreValve Medtronic Engager Edwards Sapien JenaValve Edwards Sapien XT Symetis ACCURATE

36 Medial upper arm perforators
Conclusion & Outlook HEART TEAM Approach Gefäßchirurgie-WSP, Anästhesie (WSP), Herzchirurgie + Kardiotechniker (Hietzing) Optimal equipment (Heart-Lung-Machine) Higher caseload desirable to guarantee safety and high quality Pacemaker sub-study

37 Thank you for your attention !

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