Journal Article Epublish
PubMed: 42459774 DOI: 10.3389/frhs.2026.1771683
Health economic evaluation of left atrial appendage closure in patients with atrial fibrillation and at high risk for stroke and bleeding: a study protocol.
Front Health Serv 6:1771683
Authors: Franziska Claus, Marco Müller, Eric Faß, Joanna Diesing, Carsten Skurk, Claudio Seppelt, Denitsa Meteva, Andi Rroku, Ingo Eitel, Leif-Hendrik Boldt, Ulf Landmesser, Eberhard Wille, Ines Weinhold
Affiliations
- Scientific Institute for Health Economics and Health System Research, Leipzig, Germany.
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Charité-University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany.
- German Center for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany.
- German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Lübeck, Germany.
- University Heart Center Lübeck, Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine), Lübeck, Germany.
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Charité-University Medicine Berlin, Campus Virchow, Berlin, Germany.
- Department of Economics, University of Mannheim, Mannheim, Germany.
Abstract
BACKGROUND
Atrial fibrillation (AF) is the most common cardiac arrhythmia. The associated risk of stroke can be effectively reduced by oral anticoagulation; however, these increase bleeding risk or can even be contraindicated. Clinical studies indicate that percutaneous catheter-based left atrial appendage closure (LAAC) may represent an effective alternative for stroke prevention in this high-risk patient group. While the clinical and economic benefits of LAAC have been compared with standard drug therapy indirectly, direct comparisons are lacking, especially for patients with AF at high risk of stroke and bleeding. EvaClosure, a substudy of the CLOSURE-AF-DZHK16 trial, was designed to describe current therapy paths of patients with AF and high risk of stroke and bleeding, while quantifying resource utilization and healthcare costs. Moreover, this study aims to evaluate the health economic impact of LAAC in patients with high risk of stroke and bleeding, compared with the best physician-directed medical therapy (including direct oral anticoagulants when eligible).
METHODS
Data gathered in CLOSURE-AF address the effect of different treatment options on health-related quality of life; analyses of resource utilization and healthcare costs are based on claims data from a German statutory health insurance (SHI) provider. Economic information derived from SHI data is complemented by a validated resource use measurement instrument capturing non-medical and indirect costs. The cost-utility analysis uses a Markov model, for which parameters are quantified from statistically matched SHI claims and CLOSURE-AF clinical study data, supplemented by data from the literature.
DISCUSSION
The combination of these databases allows a comprehensive, valid, and policy-relevant assessment of costs and benefits related to LAAC. Moreover, the advantages of the different databases are used for health economic evaluation. The results of this study are expected to generate robust evidence to inform health economic evaluations and provide valuable insights for SHI providers and policymakers on the societal and economic impact of LAAC.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, Identifier NCT03463317. The clinical study CLOSURE-AF-DZHK16, including the substudy EvaClosure, was registered at ClinicalTrials.gov PRS (Identifier: NCT03463317, Posted: March 13, 2018, Update: July 30, 2021).
MeSH
Quality Of Life, Health Care Costs, Atrial Appendage, Hemorrhage, Stroke, Arrhythmias, Cardiac, Atrial Fibrillation, Therapeutics