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Minimal-invasiver perkutaner Aortenklappenersatz: eine systematische Übersichtsarbeit

Percutaneous aortic valve stenosis

  • Gesundheitspolitik
  • Published:
Der Kardiologe Aims and scope

Zusammenfassung

Hintergrund

In Österreich wurde der minimal-invasive perkutane Aortenklappenersatz zur Aufnahme in den Leistungskatalog der Spitäler beantragt. Entscheidungen zur Aufnahme neuer medizinischer Leistungen in Entgeltkataloge werden zunehmend aber erst auf Basis von evidenzbasierten Übersichtsarbeiten klinischer Studien und deren patientenrelevanten Ergebnissen gefällt.

Material und Methoden

Eine systematische Literatursuche in 4 Datenbanken identifizierte 10 unkontrollierte Vorher-Nachher-Studien. Diese wurden qualitätsbeurteilt, die Ergebnisse extrahiert und in einer Übersichtsarbeit zusammengefasst.

Ergebnisse

Das Verfahren Aortenklappenersatz ohne offenen chirurgischen Eingriff ist erst seit wenigen Jahren, seit 2004, in klinischer Erprobung. Die klinischen Studien mit insgesamt 254 PatientInnen zeigen, dass die vorliegende Evidenz sehr niedrig ist, eine Tendenz der Linderung der Symptome (etwa 1 NYHA-Klasse) bei gleichzeitig sehr hoher Mortalität abgeleitet werden kann.

Schlussfolgerung

Da es sich um ein noch experimentelles Verfahren handelt, wird derzeit von einer Aufnahme in den Leistungskatalog abgeraten.

Abstract

Background

In Austria, an application was submitted for percutaneous aortic valve replacement (PAVR) to be included in the Diagnostic Related Fields (DRG) benefit catalogue. Decisions on the inclusion of new medical interventions in benefit catalogues are increasingly based on systematic reviews of clinical studies and their patient-relevant results.

Material and Methods

A systematic literature search in four databases identified ten uncontrolled clinical trials (CTs). A systematic analysis of the evidence was carried out based on the critical appraisal of the CTs.

Results

All uncontrolled before-after CTs on PAVR with a total of 254 patients show that the intervention is still in the early stages of application for humans (since 2004). To date, low-level evidence indicates a tendency of palliative effects (improvement of 1 NYHA class), but concomitantly very high mortality.

Conclusion

Available clinical data suggest that PAVR therapy should still be considered an experimental intervention. Inclusion in the benefit catalogue is not recommended.

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Authors and Affiliations

  1. Ludwig Boltzmann Institut für Health Technology Assessment, Garnisongasse 7/20, 1090, Wien, Österreich

    C. Wild, T. Langley, B. Guba & G. Gartlehner

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  1. C. Wild
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  2. T. Langley
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  3. B. Guba
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  4. G. Gartlehner
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Correspondence to C. Wild.

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Wild, C., Langley, T., Guba, B. et al. Minimal-invasiver perkutaner Aortenklappenersatz: eine systematische Übersichtsarbeit. Kardiologe 3, 164–170 (2009). https://doi.org/10.1007/s12181-008-0148-z

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  • DOI: https://doi.org/10.1007/s12181-008-0148-z

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