Conduction System Pacing vs Biventricular Pacing in Chronic Heart Failure: Protocol for the Economic Analysis of the
Sérgio R R Decker1,2,3,4, Ana Paula Beck da S Etges5,6,7, André Zimerman3,4,8,9
1Serviço de Clínica Médica do Hospital Moinhos de Vento, Porto Alegre, RS - Brasil.
Insights
Conduction system pacing (CSP) offers a cost-effective alternative to biventricular pacing (BVP) for cardiac resynchronization therapy (CRT) in heart failure patients. This trial evaluates the economic benefits of CSP, potentially improving access to CRT.
Area of Science:
- Cardiology
- Health Economics
- Clinical Trials
Background:
- Conduction system pacing (CSP) is an emerging alternative to biventricular pacing (BVP) for cardiac resynchronization therapy (CRT).
- CSP presents potential clinical advantages and cost reductions compared to BVP.
- The PhysioSync-HF trial is a multicenter, randomized study assessing CSP versus BVP in heart failure with reduced ejection fraction (HFrEF).
Purpose of the Study:
- To outline the rationale and design of the economic evaluation integrated within the PhysioSync-HF trial.
- To compare the economic impact of CSP versus BVP for CRT in HFrEF patients.
- To assess the potential for cost savings and improved access to CRT.
Main Methods:
- The PhysioSync-HF trial included 179 patients with a 1-year follow-up period.
- Time-driven activity-based costing and resource-based accounting methods were used to collect procedural and follow-up costs.
- Statistical analyses addressed missing data and skewed cost distributions.
Main Results:
- The primary economic endpoint is the difference in total direct medical costs per patient over 1 year between CSP and BVP groups.
- Secondary outcomes include detailed cost component breakdowns and a budget impact analysis for Brazil's healthcare system.
- The economic evaluation aims to identify cost-saving opportunities associated with CSP.
Conclusions:
- This economic evaluation within the PhysioSync-HF trial provides crucial data on the cost-effectiveness of CSP versus BVP.
- Findings aim to support expanded equitable access to CRT for HFrEF patients in Brazil.
- The study offers insights relevant to healthcare settings globally regarding CRT cost optimization.
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.
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