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Qualitätskriterien zur Durchführung der transvaskulären Aortenklappenimplantation (TAVI)

Positionspapier der Deutschen Gesellschaft für Kardiologie

Quality criteria on the implementation of transcatheter aortic valve implantation (TAVI)

Position paper of the German Society of Cardiology

  • Positionspapier
  • Published:
Der Kardiologe Aims and scope

Zusammenfassung

Transvaskuläre Aortenklappenimplantation (TAVI): effektives, sicheres Behandlungsverfahren für Patienten mit symptomatischer, hochgradiger Aortenklappenstenose

  • Inoperable Patienten: TAVI hochsignifikant der Standardtherapie überlegen (PARTNER-B-Studie)

  • Hochrisikopatienten: TAVI mindestens gleichwertig zur OP (PARTNER A, CoreValve High-Risk)

  • Schwerwiegende Komplikationen selten; herzchirurgische Konversion ca. 1 %.

Indikationsstellung:

  • Scores (EuroScore, STS etc.) unzureichend für individualisierte Risikoabschätzung

  • Gemeinsame Einschätzung des individuellen Morbiditäts-/Mortalitätsrisikos im kardiologischen/herzchirurgischen Herzteam (Herzteam-Sprechstunde)

  • Primär AKE: < 75 Jahre mit niedrigem OP-Risiko

  • Primär TAVI: ≥ 75 Jahre mit hohem OP-Risiko bzw. ≥ 85 Jahre auch ohne erhöhtes OP-Risiko bzw. degenerierte chirurgische Bioprothese/Zustand nach Herz-OP

  • Wunsch des Patienten (nach Aufklärung und Beratung) wesentlich

  • Prognose < 1 Jahr: Valvuloplastie

TAVI-Zentren:

  • ≥ 2 interventionelle Kardiologen (langjährige Erfahrung in PCI; zudem > 25 supervidierte TAVI-Prozeduren)

  • ≥ 2 Herzchirurgen mit TAVI-Erfahrung (Fachabteilung im Haus oder vertraglich geregelte Kooperation mit Herzchirurgie, zur Sicherstellung der herzchirurgischen Versorgung vor Ort)

  • Externe Operateure: vertragliche Regelung der Indikationsstellung, prozeduralen/postprozeduralen Betreuung und Zuständigkeiten mit den Kardiologen und Herzchirurgen des TAVI-Zentrums; Rückverlegung zum Standort der externen Operateure innerhalb 48 h nicht möglich

  • ≥ 2 Anästhesisten mit Erfahrung in Kardioanästhesie/TAVI

  • Sicherstellung interventionelle/chirurgische Versorgung von Gefäßkomplikationen

  • Bildgebung (CT/MRT/TEE) im Haus

  • ≥ 50 TAVIs/Jahr zur Sicherstellung der Expertise

Durchführung TAVI:

  • Optimale Bildgebung analog Herzkatheterlabor; C-Bogen unzureichend

  • Ausreichend Platz für HLM/ECMO, TEE, Vorbereitungstische etc.

  • Optimal: Hybridkatheterlabor; alternativ: Herzkatheterlabor mit OP in räumlicher Nähe

  • Möglichkeit zur Notfall-OP im Herzkatheterlabor muss gegeben sein (Instrumente, Geräte etc.)

  • Entsprechende Hygienestandards, Raumluftklasse Ib

  • Herzchirurg/Kardiotechniker frei verfügbar, in räumlicher Nähe; zeitgleiche Einteilung im OP nicht möglich

  • Festlegung der Standard Operating Procedures (SOPs) für die häufigsten Komplikationen

Nach TAVI:

  • Überwachung auf Intensivstation/IMC (24-h-Arztpräsenz, Facharzthintergrund) im Haus für ≥ 24 h

  • Danach Normalstation mit telemetrischer EKG-Überwachung für ≥ 72 h

  • Standardisierung der Betreuung durch Festlegung von SOPs

  • Im Falle von Komplikationen:

    • Kardiologischer Interventionsdienst: Rufdienst, Anfahrt < 30 min

    • Herzchirurgisches OP-Team: Rufdienst, Anfahrt < 30 min

    • CT/TEE < 30 min

    • Gefäßchirurgie/Neurologie/Radiologie/Allgemeinchirurgie: Rufdienst

Zertifizierung:

  • Teilnahme an überregionalem, unabhängigem Qualitätsregister

  • Strukturelle Veränderungen bzw. Veränderungen im Herz-Team: aktive Meldung durch das TAVI-Zentrum < 12 Wochen

  • Rezertifizierung nach 3 Jahren

Abstract

TAVI: an effective and safe treatment modality for patients with symptomatic high-grade aortic valve stenosis

  • Inoperable patients: TAVI significantly superior to standard therapy (PARTNER B trial)

  • High-risk patients: TAVI at least equivalent to surgery (PARTNER A, CoreValve High-Risk)

  • Major complications rare; surgical conversion rate 1 %

Indication:

  • Scores (EuroSCORE, STS, etc.) insufficient for individualised risk assessment

  • Assessment of individual morbidity/mortality risk by consensus of heart team of cardiologists and surgeons (heart-team consultation)

  • Surgical aortic valve replacement as primary therapeutic approach: patients < 75 years with low surgical risk

  • TAVI as primary therapeutic approach: patients ≥ 75 years with high surgical risk or patients ≥ 85 years even without increased surgical risk or with degenerated surgical bioprosthesis or after cardiac surgery

  • Patient wish (following education and counsel) essential

  • Life expectancy < 1 year: valvuloplasty

TAVI centres:

  • ≥ 2 interventional cardiologists (long-standing PCI experience; in addition > 25 supervised TAVI procedures

  • ≥ 2 cardiac surgeons with TAVI experience (specialty department in-house or contractually arranged cooperation with cardiac surgery to ensure on-site cardio-surgical patient care)

  • External operators: contractual arrangement of indication, intra- and postprocedural patient care, and responsibilities with cardiologist and surgeons of the TAVI centre; back transfer of patient to the external operators’ facility not possible within 48 h

  • ≥ 2 anaesthesiologists with experience in cardio-anaesthesia/TAVI

  • Capability for interventional/surgical management of vascular complications

  • Imaging (CT/MRI/TEE) in-house

  • ≥ 50 TAVIs per year to maintain expertise

TAVI performance:

  • Optimal imaging commensurate with cardiac catheter laboratory; C-arm insufficient

  • Adequate space for heart-lung machine/ECMO, TEE, preparation tables, etc.

  • Optimal: Hybrid operating theatre; alternative: cardiac catheter laboratory with operating theatre in close vicinity

  • Facilities for emergent surgery in cardiac catheter laboratory must be available (instruments, devices, etc.)

  • Corresponding standards of hygiene; room air class IB

  • Cardiac surgeons/perfusionists on short call; simultaneous allocation to operating theatre not possible

  • Regulation of standard operating procedures (SOPs) for most frequent complications

After TAVI:

  • In-house monitoring on intensive care unit/IMC (24-h physician presence; medical specialist on call) for ≥ 24 h

  • Afterwards patient ward with telemetric ECG monitoring for ≥ 72 h

  • Standardised patient care by regulation of SOPs

  • In case of complications:

    • Interventional cardiologist on-call service < 30 min

    • Cardiac surgeon on-call service < 30 min

    • CT/TEE < 30 min

    • Vascular surgery/neurology/radiology/general surgery: on-call service

Certification:

  • Participation in nationwide independent registry

  • Structural changes or changes within the heart team: active announcement by TAVI centre < 12 weeks

  • Re-certification after 3 years

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Authors and Affiliations

  1. Abteilung für Kardiologie, Herz-, Gefäß- und Diabeteszentrum, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099, Hamburg, Deutschland

    K.-H. Kuck

  2. Cardioangiologisches Centrum Bethanien, Frankfurt, Deutschland

    H. Eggebrecht

  3. Klinik für Innere Medizin I (Kardiologie, Angiologie, Pneumologie, Internistische Intensivmedizin), Universitätsklinikum Jena, Jena, Deutschland

    H.R. Figulla

  4. Medizinische Klinik I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Deutschland

    M. Haude

  5. Klinik für Kardiologie, Angiologie und Pneumologie, Medizinische Universitätsklinik Heidelberg, Heidelberg, Deutschland

    H. Katus

  6. Abteilung Kardiologie, Herz-, Thorax- und Rheumazentrum, Kerkhoff-Klinik GmbH, Bad Nauheim, Deutschland

    H. Möllmann

  7. Contilia Herz- und Gefäßzentrum, Elisabeth-Krankenhaus, Essen, Deutschland

    C.K. Naber

  8. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, München, Deutschland

    H. Schunkert

  9. Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin) - Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein, Lübeck, Deutschland

    H. Thiele

  10. Medizinische Klinik I – Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg, Gießen, Deutschland

    C. Hamm

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  1. K.-H. Kuck
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  2. H. Eggebrecht
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  3. H.R. Figulla
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  4. M. Haude
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  5. H. Katus
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  10. C. Hamm
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Correspondence to K.-H. Kuck.

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Kuck, KH., Eggebrecht, H., Figulla, H. et al. Qualitätskriterien zur Durchführung der transvaskulären Aortenklappenimplantation (TAVI). Kardiologe 9, 11–26 (2015). https://doi.org/10.1007/s12181-014-0622-8

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