Endovaskuläre Therapie von Aortenklappenpathologien TAVI Kurt Huber, Wilhelminenspital, Wien

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 50000 cases worldwide

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. 2005 Dec;26(24):2714-20.)

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

Devices Medtronic CoreValveTM Edwards SapienTM

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

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

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

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

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

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

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.

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.

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

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

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

Baseline Characteristics GARY Baseline Characteristics n=6517 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

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

Results – Outcome GARY Mortality (in-hospital) 4,5% 2,1% 5,1% 7,7% n=6517 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

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

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%

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

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

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

Medial upper arm perforators TAVI - Bioprothesis Medtronic CoreValveTM Edwards SapienTM

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

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

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

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)

International comparison - Patients

International Comparison - Outcome Himbert D, et al.; Am J Cardiol. 2009 Jul. 21; 54(4):303-11 Gurvitch R, et al.; Catheter Cardiovasc Interv 2011;78:977–984.

International Comparison - Outcome

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

• 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

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

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

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