Conduction system pacing using electro-anatomical mapping-guided system vs. fluoroscopy: a systematic review,...

Area of Science:

• Cardiology
• Medical Imaging
• Health Economics

Background:

• Conduction system pacing (CSP) is crucial for managing severe bradyarrhythmia.
• Fluoroscopy is the traditional imaging modality for CSP, but involves ionizing radiation.
• Electro-anatomical mapping (EAM) systems present a potential alternative to fluoroscopy for CSP.

Purpose of the Study:

• To systematically review the safety, effectiveness, and cost-effectiveness of EAM versus fluoroscopy for CSP in severe bradyarrhythmia.
• To conduct an economic evaluation comparing the costs of EAM and fluoroscopy from the Spanish National Health System perspective.
• To perform a five-year budget impact analysis for the implementation of EAM systems.

Main Methods:

• A systematic review of seven comparative observational studies (N=231) comparing EAM and fluoroscopy for CSP.
• Statistical analysis of fluoroscopy time, radiation dose, procedure success rates, and safety outcomes.
• Partial economic evaluation and budget impact analysis from the Spanish National Health System's viewpoint.

Main Results:

• EAM significantly reduced total fluoroscopy time (-9.87 min) and His-lead fluoroscopic time (-8.08 min) compared to fluoroscopy.
• EAM also led to a significant reduction in His-lead radiation dose (-17.21 mGy).
• No significant differences were found in total fluoroscopy dose, procedure success, or safety. EAM increased costs by EUR 1397.81 per patient, with a net budget impact of EUR 1.63 million over five years.

Conclusions:

• EAM is a safe and effective alternative to fluoroscopy for CSP, particularly for patients needing to avoid ionizing radiation.
• Despite comparable safety and effectiveness, EAM systems represent a significant cost increase for the Spanish National Health System.
• The widespread adoption of EAM for CSP requires careful consideration of its economic implications.