KODEX-EPD for cardiac imaging during ablation of arrhythmias

Level of innovation

All experts agreed that the KODEX‑EPD system is a minor variation compared with existing systems but has novel aspects. Innovative aspects include dielectric tissue imaging and characterisation. Experts said it also has the potential to enhance the safety of the procedure, shorten procedure times, allow for non‑contact 3D anatomical maps, and provide data on lesion quality and tissue thickness. Three experts were aware of competing technologies in the NHS including the CARTO, Rhythmia, Precision and NavX system. Most of these systems use contact mapping and can only use specific catheters.

Potential patient impact

The main patient benefit mentioned by the experts is reduced radiation exposure from ablation procedures. Two experts identified 2 groups of people who would particularly benefit from KODEX‑EPD. These are people who are allergic to contrast when cryoballoon ablation is needed and people who need pulmonary‑vein isolation procedures for atrial fibrillation. One expert said that it could benefit when used as first line treatment for atrial fibrillation ablation and other 'simple' ablation procedures. If this were the case, another expert said that it could be used in several thousand cases per year.

Potential system impact

The experts noted several system impacts including that a wider choice of catheters, potentially faster procedures and improved radiofrequency ablation may lead to reduced risk of damage to extra‑cardiac structures. One expert said that it can enhance access because the technology can be used in catheter labs not fully equipped for electrophysiology procedures, to deliver simple ablation procedures. All experts agreed that no changes were needed to clinical facilities.

Three experts noted that currently the KODEX‑EPD system is used in addition to current standard care and is therefore likely to cost more. Two experts said that the technology costs more. One expert said that if it is used as an alternative to current standard care it is likely to cost the same or even less. Two experts noted that the staff costs, procedure duration and setting are likely to be the same.

Two experts agreed that specific training is needed on how to use the technology. Two experts said that it is relatively easy to use, with 1 expert stating that it should only be used by cardiologists with electrophysiology expertise and an electrophysiology‑trained catheter laboratory team. None of the experts were aware of any safety concerns around this technology. However, 2 experts said that the technology is still in development and has not yet been tested in large‑scale clinical trials.

General comments

All experts agreed that the KODEX‑EPD system could replace standard care. However, the experts also agreed that the technology needs further clinical development and advances first. One expert said that this technology probably does have the potential to change or replace the current pathway, stating that it may only improve atrial fibrillation ablation outcomes marginally.

Three experts said that the cost could prevent this technology from being adopted in their organisation or across the NHS. One expert raised that the system is likely to undergo further improvement and refinement because it is currently still under development.

All experts agreed that further research is needed. One expert said that the data is limited, with small patient numbers. Another expert said that superior efficacy over existing technologies remains to be shown. Research should include randomised controlled trials to address efficacy for both cryo- and radiofrequency ablation compared with standard care.