Health economic evaluation of left atrial appendage closure in patients with atrial fibrillation and at high risk for stroke and bleeding: a study protocol.

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).