Sérgio R. R. Decker et al. Ana Paula Beck da S Etges André Zimerman Fernanda D. Alves … Caique M. Ternes Juliana S. Santos Leandro Zimerman Luis Eduardo Rohde Alexander Dal Forno André d’Avila Dhruv S. Kazi Eduardo G. Bertoldi Carisi A. Polanczyk
Abstract
Background
Conduction system pacing (CSP) has emerged as an alternative to biventricular pacing (BVP) for cardiac resynchronization therapy (CRT), with potential clinical benefits and lower costs. PhysioSync-HF is a multicenter, randomized trial comparing these strategies from both clinical and economic perspectives in patients with heart failure with reduced ejection fraction (HFrEF).
Objective
To describe the rationale and design of the trial-based economic evaluation embedded within the PhysioSync-HF trial.
Methods
The PhysioSync-HF trial enrolled 179 patients with 1-year follow-up. Procedural cost data will be collected using a time-driven activity-based costing approach. Costs associated with the device, adverse clinical events, and ambulatory care during follow-up will be estimated using resource-based accounting methods. Appropriate methods will address missing data, and statistical analyses will account for the skewed distribution of cost variables.
Results
The primary economic outcome is the between-group difference in total direct medical costs per patient over the 1-year follow-up (CSP vs BVP). Secondary outcomes include component-level cost breakdowns of direct medical expenses and a budget impact analysis estimating the annual effect on Brazil’s health care system if all eligible patients received CSP instead of BVP.
Conclusion
By leveraging a multicenter cardiovascular trial to measure costs of CSP versus BVP, this economic evaluation aims to identify cost-saving opportunities that could expand equitable access to CRT for individuals with HFrEF in Brazil, while providing insights relevant to other health care settings worldwide.
Trial Registration
NCT05572736.