Cost-Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in German Severe Aortic Stenosis Patients at Low Surgical Mortality Risk.


Journal

Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864

Informations de publication

Date de publication:
03 2023
Historique:
received: 17 10 2022
accepted: 28 11 2022
pubmed: 10 1 2023
medline: 9 3 2023
entrez: 9 1 2023
Statut: ppublish

Résumé

In the randomized PARTNER 3 trial, transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device significantly reduced a composite of all-cause death, stroke, and rehospitalization, compared with surgical aortic valve replacement (SAVR), in patients with severe symptomatic aortic stenosis and low risk of surgical mortality. Furthermore, TAVI has been shown to be cost-effective in low-risk patients, compared with SAVR, in a number of countries. This study aimed to determine the cost-effectiveness of TAVI with SAPIEN 3 versus SAVR in Germany. A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER 3 trial was adapted for the German context using the German Statutory Health Insurance perspective. The model had a lifetime horizon. The cost-utility analysis estimated changes in direct healthcare costs as well as survival and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. TAVI with SAPIEN 3 increased quality-adjusted life years (QALYs) by + 0.72 at an increased cost of €8664 per patient. The incremental cost-effectiveness/QALY ratio was €12,037, which fell below that of other cardiovascular interventions in use in Germany. The cost-effectiveness of TAVI over SAVR remained robust across multiple challenging scenarios and was driven by lower longer-term management costs compared with SAVR. TAVI with SAPIEN 3 appears to be a clinically meaningful, cost-effective treatment option over SAVR for patients with severe symptomatic aortic stenosis and low risk for surgical mortality in Germany. www. gov identifier: NCT02675114.

Identifiants

pubmed: 36622552
doi: 10.1007/s12325-022-02392-y
pii: 10.1007/s12325-022-02392-y
pmc: PMC9988804
doi:

Banques de données

ClinicalTrials.gov
['NCT02675114']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Pagination

1031-1046

Informations de copyright

© 2023. The Author(s).

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Auteurs

Karl H Kuck (KH)

Department of Cardiology, University Heart Center, Lübeck, Germany.
LANS Cardio, Hamburg, Germany.

Reiner Leidl (R)

Institute of Health Economics and Health Care Management, Helmholtz Zentrum München, Neuherberg, Germany.
Munich School of Management, Ludwig-Maximilians-Universität, Munich, Germany.

Lutz Frankenstein (L)

Department of Cardiology, Angiology, and Pulmonology, University Hospital Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.

Thorsten Wahlers (T)

Department of Cardiothoracic Surgery, University Hospital of Cologne, Cologne, Germany.

Archita Sarmah (A)

Edwards Lifesciences SA, Nyon, Switzerland. archita_sarmah@edwards.com.

Pascal Candolfi (P)

Edwards Lifesciences SA, Nyon, Switzerland.

Judith Shore (J)

York Health Economics Consortium, University of York, York, UK.

Michelle Green (M)

York Health Economics Consortium, University of York, York, UK.

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