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Endovaskuläre Therapie von Aortenklappenpathologien

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 CoreValve TM and Sapien TM (Europe) 2010 Partner trial

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Endovaskuläre Therapie von Aortenklappenpathologien

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  1. EndovaskuläreTherapie von Aortenklappenpathologien TAVI Kurt Huber, Wilhelminenspital, Wien

  2. Historicalbackground 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

  3. Therapeutic opportunities SAVR: Surgicalaorticvalvereplacement Firstlinetherapy TAVI: in case of high risk or inoperability (EURO Score >20% or STS >10%) (Iung B, et al.; EurHeart J. 2005 Dec;26(24):2714-20.)

  4. Devices MedtronicCoreValveTM Edwards SapienTM

  5. Specifications Medtronic CoreValveTM • 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

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

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

  8. Complications - VARC Procedurefailure MyocardialInfarction Stroke Bleeding Vascular Access sitecomplication Akute kidneyinjury Conductiondisturbances

  9. GARYDeutschesAortenklappenregister GermanAorticValveRegistrY 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.WelzfortheGARY-Executive Board ChristianW.Hamm KerckhoffHeartandThoraxCenterBadNauheimand MedicalClinicI,UniversityofGiessen,Germany

  10. GARY Rationale • Nationwidecompletesurveyofpatientswithaortic valvestenosisundergoinginvasiveprocedures: •  •  •  •  surgical(AVR), catheter-based(TAVI)transfemoral, catheter-based(TAVI)transapical, valvuloplasty. • Toevaluatecatheter-basedproceduresin comparisontosurgicalaorticvalvereplacement. • Developcriteriaforanadequatepatientselectionof besttreatmentmodality.

  11. GARY Design • Prospective,controlled,multicenterregistry. • Allpatientsundergoinganinvasivetherapyfor acquiredaorticvalvediseaseconsecutively included. • Theonlyexclusioncriterion:noinformedconsent. • Follow-up:in-hospital,30days,1,3,5years.

  12. GARY TAVIValveType transvascular transapical Others Others n=1.181 n=2.695

  13. GARY BaselineCharacteristics allp<0.001

  14. GARY BaselineCharacteristics n=6517 n=3458 n=2689 n=1177 100% Patients>75years 44,9% 33,3% 86,3% 84,0% 80% 60% 40% 20% 0% withoutCABG withCABG transvascular transapical SurgicalAVR TAVI

  15. GARY BaselineCharacteristics n=2689 n=1177 n=6517n=3458 Femalegender 70% 60% 58,8% 50% 49,8% 40% 30% 39,0% 28,4% 20% 10% 0% withoutCABG withCABG transvascular transapical SurgicalAVR TAVI

  16. GARY BaselineCharacteristics Heartfailure(NYHAIII/IV) n=2694 86% n=1181 86% n=6523 62% n=3462 69% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% withoutCABG withCABG transvascular transapical SurgicalAVR TAVI

  17. GARY Results–Outcome n=1177 7,7% n=2689 5,1% n=6517n=3458 Mortality(in-hospital) 4,5% 2,1% 9,0% 8,0% 7,0% 6,0% 5,0% 4,0% 3,0% 2,0% 1,0% 0,0% withoutCABG withCABG transvascular transapical SurgicalAVR TAVI

  18. GARY Results–Procedure NewPacemaker n=6517 n=3458 n=2689 n=1177 25% 23,7% 20% 15% 10% 9,9% 4,6% 3,9% 5% 0% withoutCABG withCABG transvascular transapical SurgicalAVR TAVI

  19. GARY Results–EuroScore Euro-Scorein-hospitalmortality SurgicalAVR TAVI 60% withoutCABG withCABG transvascular transapical 50% 40% 30% 20% 10% 0% <10%<20%<30%≥30% <10%<20%<30%≥30% <10%<20%<30%≥30% <10%<20%<30%≥30% observed1,3%3,3%3,8%7,8% expected4,7%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%

  20. GARY Risk-adjustedIn-HospitalMortality Reference:AVRwithoutCABG TAVI transvascular TAVI transapical TAVI transvascular TAVI transapical <75years ≥75years 0,0 1,0 2,0 3,0 4,0 5,0 6,0 7,0

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

  22. Aorticstenosis 3. Med Braunwald et al. Textbook of Cardiov. Med 2004

  23. TAVI - Bioprothesis MedtronicCoreValveTM Edwards SapienTM

  24. WSP TAVI Registry - Patients • *Characteristics: • -Transvalvular gradient > 40mmHg or • -Aortic valve area < 1cm2 • Operability assessed by heart team

  25. WSP TAVI Registry - Outcome NYHA classbefore and after TAVI Mean/peaktransvalvulargradient

  26. WSP TAVI Registry - Outcome 1 yearsurvival (Kaplan Meier) Endpoints (30 Days)

  27. 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)

  28. International comparison - Patients

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

  30. International Comparison - Outcome

  31. 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

  32. CoreValveInnovation FocusedEffortson: •Expansionofpatientaccess •Furtherimprovementofeaseofuse •Continuetoadvancepatientandproceduraloutcome Anti- Mineralization TissueTreatment *Delivery System Improvements Alternative Access Technology 16FR 18FR Profile Reduction *GreaterAnnulus Coverage

  33. NewTAVIvalvesarecomingtothe marketinafewyear’stime Today Tomorrow BostonSci. Lotus™ NextGen. Medtronic CoreValve HLT Edwards SapienXT SaintJude Portico™ DirectFlow Medtronic CoreValve Medtronic Engager Edwards Sapien JenaValve Symetis ACCURATE Edwards SapienXT

  34. Thankyouforyourattention !

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