Advertisement

Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI)

Joint Consensus Document of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V. (ALKK) and cooperating Cardiac Surgery Departments
  • Wolfgang von ScheidtEmail author
  • A. Welz
  • M. Pauschinger
  • T. Fischlein
  • V. Schächinger
  • H. Treede
  • R. Zahn
  • M. Hennersdorf
  • J. M. Albes
  • R. Bekeredjian
  • M. Beyer
  • J. Brachmann
  • C. Butter
  • L. Bruch
  • H. Dörge
  • W. Eichinger
  • U. F. W. Franke
  • N. Friedel
  • T. Giesler
  • R. Gradaus
  • R. Hambrecht
  • M. Haude
  • H. Hausmann
  • M. P. Heintzen
  • W. Jung
  • S. Kerber
  • H. Mudra
  • T. Nordt
  • L. Pizzulli
  • F.-U. Sack
  • S. Sack
  • B. Schumacher
  • G. Schymik
  • U. Sechtem
  • C. Stellbrink
  • C. Stumpf
  • H. M. Hoffmeister
Critical Perspective
  • 50 Downloads

Abstract

Indications for TF-TAVI (transfemoral transcatheter aortic valve implantation) are rapidly changing according to increasing evidence from randomized controlled trials. Present trials document the non-inferiority or even superiority of TF-TAVI in intermediate-risk patients (STS-Score 4–8%) as well as in low-risk patients (STS-Score < 4%). However, risk scores exhibit limitations and, as a single criterion, are unable to establish an appropriate indication of TF-TAVI vs transapical TAVI vs SAVR (surgical aortic valve replacement). The ESC (European Society of Cardiology)/EACTS (European Association for Cardio-Thoracic Surgery) guidelines 2017 and the German DGK (Deutsche Gesellschaft für Kardiologie)/DGTHG (Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie) commentary 2018 offer a framework for the selection of the best therapeutic method, but the individual decision is left to the discretion of the heart teams. An interdisciplinary TAVI consensus group of interventional cardiologists of the ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V.) and cardiac surgeons has developed a detailed consensus on the indications for TF-TAVI to provide an up-to-date, evidence-based, comprehensive decision matrix for daily practice. The matrix of indication criteria includes age, risk scores, contraindications against SAVR (e.g., porcelain aorta), cardiovascular criteria pro TAVI, additional criteria pro TAVI (e.g., frailty, comorbidities, organ dysfunction), contraindications against TAVI (e.g., endocarditis) and cardiovascular criteria pro SAVR (e.g., bicuspid valve anatomy). This interdisciplinary consensus may provide orientation to heart teams for individual TAVI-indication decisions. Future adaptations according to evolving medical evidence are to be expected.

Graphic abstract

Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI).

Keywords

TAVI TAVR SAVR Indication Consensus Low risk 

Notes

Acknowledgements

Interdisciplinary Working Group members: W. von Scheidt, A. Welz, M. Pauschinger, T. Fischlein, V. Schächinger, H. Treede, R. Zahn, M. Hennersdorf; TAVI-Consensus-Group members: J. M. Albes, R. Bekeredjian, M. Beyer, J. Brachmann, C. Butter, L. Bruch, H. Dörge, W. Eichinger, U. F. W. Franke, N. Friedel, T. Giesler, R. Gradaus, R. Hambrecht, M. Haude, H. Hausmann, M. P. Heintzen, W. Jung, S. Kerber, H. Mudra, T. Nordt, L. Pizzulli, F.-U. Sack, S. Sack, B. Schumacher, G. Schymik, U. Sechtem, C. Stellbrink, C. Stumpf, H. M. Hoffmeister. Members of the ALHK (Arbeitsgemeinschaft Leitende Herzchirurgische Krankenhausärzte e.V.): T. Fischlein, W. Eichinger, U. F. W. Franke, H. Hausmann, F.-U. Sack.

References

  1. 1.
    Deutscher Herzbericht (2018) Deutsche Herzstiftung e.V., Frankfurt am Main. https://www.herzstiftung.de/herzbericht. Accessed 2 June 2019
  2. 2.
    IQTIG Qualitätsreport (2017) https://iqtig.org/berichte/qualitaetsreport/. Accessed 2 June 2019
  3. 3.
    Leon MB, Smith CR, Mack M et al (2010) Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363:1597–1607CrossRefGoogle Scholar
  4. 4.
    Kapadia SR, Leon MB, Makkar RR et al (2015) 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1B): a randomized controlled trial. Lancet 385:2485–2491CrossRefGoogle Scholar
  5. 5.
    Kodali SK, Williams MR, Smith CR et al (2012) Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 366:1686–1695CrossRefGoogle Scholar
  6. 6.
    Mack MJ, Leon MB, Smith CR et al (2015) 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1A): a randomized controlled trial. Lancet 385:2477–2484CrossRefGoogle Scholar
  7. 7.
    Adams DH, Popma JJ, Reardon MJ et al (2014) Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 370:1790–1798CrossRefGoogle Scholar
  8. 8.
    Deeb GM, Reardon MJ, Chetcuti S et al (2016) 3-year outcomes in high-risk patients who underwent surgical or transcatheter aortic valve replacement. J Am Coll Cardiol 67:2565–2574CrossRefGoogle Scholar
  9. 9.
    Leon MB, Smith CR, Mack MJ et al (2016) Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 374:1609–1620CrossRefGoogle Scholar
  10. 10.
    Thourani VH, Kodali S, Makkar RR et al (2016) Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet 387:2218–2225CrossRefGoogle Scholar
  11. 11.
    Reardon MJ, Van Mieghem NM, Popma JJ et al (2017) Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 376:1321–1331CrossRefGoogle Scholar
  12. 12.
    Mack MJ, Leon MB, Thourani VH et al (2019) Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 380:1695–1705CrossRefGoogle Scholar
  13. 13.
    Popma JJ, Deeb GM, Yakubov SJ et al (2019) Transcatheter aortic valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 380:1706–1715CrossRefGoogle Scholar
  14. 14.
    Baumgartner H, Falk V, Bax JJ et al (2017) 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 38:2739–2791CrossRefGoogle Scholar
  15. 15.
    Nishimura RA, Otto CM, Bonow RO et al (2017) 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 135:e1159–e1195CrossRefGoogle Scholar
  16. 16.
    Kötting J, Schiller W, Beckmann A, Schäfer E, Döbler K, Hamm C, Veit C, Welz A (2013) German Aortic Valve Score: a new scoring system for prediction of mortality related to aortic valve procedures in adults. Eur J Cardiothorac Surg 43:971–977CrossRefGoogle Scholar
  17. 17.
    Kuck KH, Eggebrecht H, Elsässer A et al (2016) Qualitätskriterien zur Durchführung der kathetergestützten Aortenklappenimplantation (TAVI). Kardiologe 10:282–300CrossRefGoogle Scholar
  18. 18.
    Rosenhek R, Iung B, Tornos P et al (2012) ESC Working Group on Valvular Heart Disease Position Paper: assessing the risk of interventions in patients with valvular heart disease. Eur Heart J 33:822–828CrossRefGoogle Scholar
  19. 19.
    Vahanian A, Alfieri O, Andreotti F et al (2012) Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 33:2451–2496CrossRefGoogle Scholar
  20. 20.
    EuroSCORE II Calculator. http://www.euroscore.org/calc.html. Accessed 2 June 2019
  21. 21.
    Logistic EuroSCORE I Calculator. http://www.euroscore.org/calcge.html. Accessed 2 June 2019
  22. 22.
    STS Score Calculator. http://riskcalc.sts.org/stswebriskcalc/#/calculate. Accessed 2 June 2019
  23. 23.
    Otto CM, Kumbhani D, Alexander KP et al (2017) 2017 ACC expert consensus decision pathway for transcatheter aortic valve replacement in the management of adults with aortic stenosis. J Am Coll Cardiol 69:1313–1346CrossRefGoogle Scholar
  24. 24.
    Bonow RO, Brown AS, Gillam LD, Kapadia SR, Kavinsky CJ et al (2017) ACC/AATS/AHA/ASE/EACTS/HVS/SCA/SCAI/SCCT/SCMR/STS 2017 appropriate use criteria for the treatment of patients with severe aortic stenosis. J Am Coll Cardiol 70:2566–2598CrossRefGoogle Scholar
  25. 25.
    Baumgartner H, Eggebrecht H, Hamm C, Haude M, Ince H, Kuck K-H, im Auftrag des Vorstands der DGK, Cremer J, Diegeler A, Welz A, Beyersdorf F, Walther T, Falk V, im Auftrag des Vorstands der DGTHG (2018) Kommentar zur ESC/EACTS-Leitlinie von 2017 zum Management von Herzklappenfehlern. Kardiologe 12:184–193CrossRefGoogle Scholar
  26. 26.
    Grover FL, Vemulapalli S, Carroll JD et al (2017) 2016 annual report of the Society of Thoracic Surgeons/American College of Cardiology transcatheter valve therapy registry. J Am Coll Cardiol 69:1215–1230CrossRefGoogle Scholar
  27. 27.
    Hamm CW, Möllmann H, Holzhey D, Beckmann A, Veit C, Figulla HR, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler G, Walther T, Beyersdorf F, Böhm M, Heusch G, Funkat AK, Meinertz T, Neumann T, Papoutsis K, Schneider S, Welz A, Mohr FW, GARY-Executive Board (2014) The German Aortic Valve Registry (GARY): in-hospital outcome. Eur Heart J 35:1588–1598CrossRefGoogle Scholar
  28. 28.
    Walther T, Hamm CW, Schuler G, Berkowitsch A et al (2015) Perioperative results and complications in 15.964 transcatheter aortic valve replacements: prospective data from the GARY registry. J Am Coll Cardiol 65:2173–2180CrossRefGoogle Scholar
  29. 29.
    Gaede L, Blumenstein J, Liebetrau C et al (2017) Outcome after transvalvular transcatheter aortic valve implantation in 2016. Eur Heart J.  https://doi.org/10.1093/eurheartj/ehx688 Google Scholar
  30. 30.
    Thyregod HGH, Ihlemann N, Jorgensen TH et al (2019) Five-year clinical and echocardiographic outcomes from the Nordic Aortic Valve Intervention (NOTION) randomized clinical trial in lower surgical risk patients. Circulation.  https://doi.org/10.1161/circulationaha.118.036606 Google Scholar
  31. 31.
    Waksman R, Rogers T, Torguson R et al (2018) Transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis. J Am Coll Cardiol 72:2095–2105CrossRefGoogle Scholar
  32. 32.
    Waksman R, Corso PJ, Torguson R et al (2019) Transcatheter aortic valve replacement in low-risk patients: one-year results from the LRT trial. JACC Cardiovasc Interv 72:2095.  https://doi.org/10.1016/j.jcin.2019.03.002 Google Scholar
  33. 33.
    Otto CM (2019) Informed shared decisions for patients with aortic stenosis. N Engl J Med 380:1769–1770CrossRefGoogle Scholar
  34. 34.
    Siontis GCM, Overtchouk P, Cahill TJ et al (2019) Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis. Eur Heart J 37:3503.  https://doi.org/10.1093/eurheartj/ehz275 CrossRefGoogle Scholar
  35. 35.
    Capodanno D, Petronio AS, Prendergast B et al (2017) Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 38:3382–3390CrossRefGoogle Scholar
  36. 36.
    Lancelotti P, Martinez C, Radermecker M (2019) The long quest for the holy grail in transcatheter aortic bioprosthesis. J Am Coll Cardiol 73:554–558CrossRefGoogle Scholar
  37. 37.
    Barbanti M, Petronio AS, Ettori F et al (2015) 5-Year outcomes after transcatheter aortic valve implantation with CoreValve prosthesis. J Am Coll Cardiol Interv 8:1084–1091CrossRefGoogle Scholar
  38. 38.
    Eltchaninoff H, Durand E, Avinée G, Tron C et al (2018) Assessment of structural valve deterioration of transcatheter aortic bioprosthetic balloon-expandable valves using the new European consensus definition. EuroIntervention.  https://doi.org/10.4244/eij-d-18-00015 Google Scholar
  39. 39.
    Blackman DJ, Saraf S, MacCarthy PA et al (2019) Long-term durability of transcatheter aortic valve prostheses. J Am Coll Cardiol 73:537–545CrossRefGoogle Scholar
  40. 40.
    Søndergaard L, Ihlemann N, Capodanno D et al (2019) Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk. J Am Coll Cardiol 73:546–553CrossRefGoogle Scholar
  41. 41.
    Puri R, Iung B, Cohen DJ et al (2016) TAVI or no TAVI: identifying patients unlikely to benefit from transcatheter aortic valve implantation. Eur Heart J 37:2217–2225CrossRefGoogle Scholar
  42. 42.
    Thourani VH, Borger MA, Holmes D et al (2017) Transatlantic commentary on transcatheter aortic valve replacement. J Thorac Cardiovasc Surg 154:7–21CrossRefGoogle Scholar
  43. 43.
    GBA-Richtlinie zu minimalinvasiven Herzklappeninterventionen BAnz AT 24.07.2015 B6Google Scholar
  44. 44.
    Chambers JB, Prendergast B, Iung B, Rosenhek R, Zamorano JL et al (2017) Standards defining a “Heart Valve Centre”: ESC working group on valvular heart disease and European Association for cardiothoracic surgery viewpoint. Eur Heart J 38:2177–2183CrossRefGoogle Scholar
  45. 45.
    Carabello BA (2017) Valve-in-valve TAVR. J Am Coll Cardiol 69:2263–2265CrossRefGoogle Scholar
  46. 46.
    Deeb GM, Chetcuti SJ, Reardon MJ et al (2017) 1-Year results in patients undergoing transcatheter aortic valve replacement with failed surgical bioprostheses. J Am Coll Cardiol Interv 10:1034–1044CrossRefGoogle Scholar
  47. 47.
    Vahl TP, Kodali SK, Leon MB (2016) Transcatheter aortic valve replacement 2016. J Am Coll Cardiol 67:1472–1487CrossRefGoogle Scholar
  48. 48.
    Webb JG, Mack MJ, White JM et al (2017) Transcatheter aortic valve implantation within degenerated aortic surgical bioprostheses. J Am Coll Cardiol 69:2253–2262CrossRefGoogle Scholar
  49. 49.
    Neumann FJ, Sousa-Uva M, Ahlsson A et al (2018) 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 40:87.  https://doi.org/10.1093/eurheratj/ehy394 CrossRefGoogle Scholar
  50. 50.
    Colombo A, Latib A (2014) Bicuspid aortic valve: any room for TAVR? J Am Coll Cardiol 64:2340–2342CrossRefGoogle Scholar
  51. 51.
    Frangieh AH, Kasel AM (2017) TAVI in bicuspid aortic valves “made easy”. Eur Heart J 38:1177–1181CrossRefGoogle Scholar
  52. 52.
    Guyton RA, Padala M (2016) Transcatheter aortic valve replacement in bicuspid aortic stenosis. Early success, but concerning red flags. J Am Coll Cardiol Interv 9:825–827CrossRefGoogle Scholar
  53. 53.
    Mylotte D, Lefevre T, Søndergaard L et al (2014) Transcatheter aortic valve replacement in bicuspid aortic valve disease. J Am Coll Cardiol 64:2330–2339CrossRefGoogle Scholar
  54. 54.
    Perlman GY, Blanke P, Dvir D et al (2016) Bicuspid aortic valve stenosis: favorable early outcomes with a next-generation transcatheter heart valve in a multicenter study. J Am Coll Cardiol Interv 9:817–824CrossRefGoogle Scholar
  55. 55.
    Afilalo J, Lauck S, Kim DH, Lefèvre T, Piazza N, Lachapelle K et al (2017) Frailty in older adults undergoing aortic valve replacement: the FRAILTY-AVR study. J Am Coll Cardiol 70:689–700CrossRefGoogle Scholar
  56. 56.
    Prados-Torres A, Calderón-Larranaga A, Hancco-Saavedra J et al (2014) Multimorbidity patterns: a systematic review. J Clin Epidemiol 67:254–266CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Wolfgang von Scheidt
    • 1
    Email author
  • A. Welz
    • 2
  • M. Pauschinger
    • 3
  • T. Fischlein
    • 4
  • V. Schächinger
    • 5
  • H. Treede
    • 2
  • R. Zahn
    • 6
  • M. Hennersdorf
    • 7
  • J. M. Albes
    • 8
  • R. Bekeredjian
    • 9
  • M. Beyer
    • 10
  • J. Brachmann
    • 11
  • C. Butter
    • 12
  • L. Bruch
    • 13
  • H. Dörge
    • 14
  • W. Eichinger
    • 15
  • U. F. W. Franke
    • 16
  • N. Friedel
    • 17
  • T. Giesler
    • 18
  • R. Gradaus
    • 19
  • R. Hambrecht
    • 20
  • M. Haude
    • 21
  • H. Hausmann
    • 22
  • M. P. Heintzen
    • 23
  • W. Jung
    • 24
  • S. Kerber
    • 25
  • H. Mudra
    • 26
  • T. Nordt
    • 27
  • L. Pizzulli
    • 28
  • F.-U. Sack
    • 29
  • S. Sack
    • 30
  • B. Schumacher
    • 31
  • G. Schymik
    • 32
  • U. Sechtem
    • 33
  • C. Stellbrink
    • 34
  • C. Stumpf
    • 35
  • H. M. Hoffmeister
    • 36
  1. 1.I.Medizinische KlinikUniversitätsklinikum Augsburg, Herzzentrum Augsburg-SchwabenAugsburgGermany
  2. 2.Klinik und Poliklinik für HerzchirurgieRheinische-Friedrich-Wilhelms-Universität BonnBonnGermany
  3. 3.Medizinische Klinik 8Universitätsklinik der Paracelsus Medizinischen PrivatuniversitätNurembergGermany
  4. 4.Klinik für HerzchirurgieUniversitätsklinik der Paracelsus Medizinischen PrivatuniversitätNurembergGermany
  5. 5.Medizinische Klinik IKlinikum Fulda, Herz-Thorax-Zentrum FuldaFuldaGermany
  6. 6.Medizinische Klinik BHerzzentrum Ludwigshafen, Klinikum LudwigshafenLudwigshafen am RheinGermany
  7. 7.Medizinische Klinik ISLK-Kliniken HeilbronnHeilbronnGermany
  8. 8.Abteilung HerzchirurgieImmanuel Klinikum Bernau, Herzzentrum BrandenburgBrandenburgGermany
  9. 9.Abteilung für KardiologieRobert-Bosch-Krankenhaus StuttgartStuttgartGermany
  10. 10.Klinik für Herz- und ThoraxchirurgieUniversitätsklinikum Augsburg, Herzzentrum Augsburg-SchwabenAugsburgGermany
  11. 11.II.Medizinische Klinik Kardiologie, Angiologie, Pneumologie, Regiomed-KlinikenKlinikum CoburgCoburgGermany
  12. 12.Abteilung KardiologieImmanuel Klinikum Bernau, Herzzentrum BrandenburgBrandenburgGermany
  13. 13.Innere Medizin/KardiologieUnfallkrankenhaus BerlinBerlinGermany
  14. 14.Klinik für Herz- und ThoraxchirurgieKlinikum Fulda, Herz-Thorax-Zentrum FuldaFuldaGermany
  15. 15.Klinik für HerzchirurgieKlinikum München, München-BogenhausenMunichGermany
  16. 16.Abteilung für Herz- und GefäßchirurgieRobert-Bosch-KrankenhausStuttgartGermany
  17. 17.Klinik für Herz- und ThoraxchirurgieKlinikum BayreuthBayreuthGermany
  18. 18.Klinik für Kardiologie und AngiologieMediClin Herzzentrum CoswigCoswigGermany
  19. 19.Klinik für Herz- und KreislauferkrankungenKlinikum KasselKasselGermany
  20. 20.Klinik für Kardiologie und AngiologieKlinikum Links der WeserBremenGermany
  21. 21.Medizinische Klinik IStädtische Kliniken Neuss, LukaskrankenhausNeussGermany
  22. 22.Klinik für Herz- und GefäßchirurgieMediClin Herzzentrum CoswigCoswigGermany
  23. 23.Medizinische Klinik IIKlinik für Herz- und Gefäßerkrankungen, Klinikum BraunschweigBrunswickGermany
  24. 24.Klinik für Innere Medizin III, Kardiologie und IntensivmedizinSchwarzwald-Baar KlinikumVillingen-SchwenningenGermany
  25. 25.Klinik für Kardiologie IHerz- und Gefäßklinik Bad NeustadtBad Neustadt an der SaaleGermany
  26. 26.Klinik für Kardiologie, Pneumologie und Internistische IntensivmedizinKlinikum Neuperlach, Städtisches Klinikum MünchenMunichGermany
  27. 27.Klinik für Herz- und GefäßkrankheitenKlinikum StuttgartStuttgartGermany
  28. 28.KardiologieGemeinschaftskrankenhaus BonnBonnGermany
  29. 29.Klinik für HerzchirurgieHerzzentrum Ludwigshafen, Klinikum LudwigshafenLudwigshafen am RheinGermany
  30. 30.Klinik für Kardiologie, Pneumologie und Internistische IntensivmedizinKlinikum Schwabing, Städtisches Klinikum MünchenMunichGermany
  31. 31.Klinik für Innere Medizin 2Westpfalz Klinikum KaiserslauternKaiserslauternGermany
  32. 32.Medizinische Klinik IVStädtisches Klinikum KarlsruheKarlsruheGermany
  33. 33.Abteilung für KardiologieRobert-Bosch-KrankenhausStuttgartGermany
  34. 34.Klinik für Kardiologie und Internistische IntensivmedizinKlinikum BielefeldBielefeldGermany
  35. 35.Klinik für Kardiologie, Angiologie und Internistische IntensivmedizinKlinikum BayreuthBayreuthGermany
  36. 36.Klinik für Kardiologie und Allgemeine Innere MedizinStädtisches Klinikum SolingenSolingenGermany

Personalised recommendations