KODEX-EPD for cardiac imaging during ablation of arrhythmias

The technology described in this briefing is the KODEX-EPD system. It is used for cardiac imaging and navigation during ablation of cardiac arrhythmias.

The innovative aspects are that the KODEX‑EPD system offers real‑time, high‑definition imaging that visualises 3D cardiac anatomy during electrophysiology procedures and allows for an indication of ablation quality once the ablation has been done. It can also reduce radiation exposure during procedures that need fluoroscopy, such as cryoablation.

The intended place in therapy would be as an alternative to existing 3D mapping systems in people with cardiac arrhythmias who are having treatment with an ablative technology.

The main points from the evidence summarised in this briefing are from 6 studies (4 observational studies, 1 case series and 1 single‑arm study) including a total of 132 people. They show that the KODEX‑EPD system can create 3D real‑time and high‑resolution images without additional imaging such as fluoroscopy.

Key uncertainties around the evidence or technology are that half of the studies were reported in conference abstracts only, and only 1 small case series was done in the UK.

The cost of the KODEX‑EPD system is £300,000 per unit, and about £1,000 to £3,000 for consumables, depending on case type (cryo- or radiofrequency ablation, excluding VAT). The company states that the maintenance contract is in line with other 3D mapping systems, priced at about £12,000 per year. Standard care is existing 3D mapping systems and costs about £700 to £3,000 for consumables.