Advice

The technology

The technology

The KODEX-EPD system (Philips Medical Systems Nederland BV) is a non‑fluoroscopic 3D cardiac imaging and navigation (mapping) system. It is an open-platform catheter-based cardiac electrophysiology system that works with any validated electrophysiology catheter and uses a novel dielectric energy source. This allows electrophysiologists to electrically image unique characteristics of the heart and detail the heart wall and other structures. The sensor can be contact or non‑contact on the heart wall, giving a before and after view, and provides detailed images of structures. Dielectric imaging creates real‑time, high‑definition 3D images of a patient's cardiac structures, without using ionising radiation or contrast media or touching the endocardium. The system can guide physicians during ablation treatment of cardiac arrhythmias and reduces the need for X‑ray imaging. The company states that the system can provide this imaging in as little as 3 minutes.

The system consists of 2 units:

  • a KODEX‑EPD processing unit that connects multiple components including 7 dielectric sensors, a diagnostic catheter pin box, a recording pin box and a foot pedal

  • a KODEX‑EPD workstation.

The KODEX‑EPD system also needs a key that unlocks software modules specific to whether the treatment is cryo- (freezing) or radiofrequency- (heating) based.

Innovations

The KODEX‑EPD system could give real‑time information of heart muscle characteristics and an indication of ablation quality once the lesion has been applied. The company claims that using KODEX imaging would reduce exposure of radiation to both patients and healthcare professionals during ablation procedures. This claim is specifically for cryoballoon procedures because assessment of pulmonary vein occlusion can be done without the need for fluoro- or contrast injection. The company also claims that KODEX‑EPD visualises patient‑specific anatomical details to allow personalised therapy planning and delivery.

Current care pathway

Cardiac arrhythmias can be treated with catheter ablation if medication has not been effective or tolerated. During the ablation procedure, continuous X‑ray (fluoroscopy) and a 3D mapping system (such as KODEX‑EPD) are used to visualise the catheters and find the source of abnormal electrical activity, respectively. Continuous X‑ray (fluoroscopy) may not be needed for all techniques but must be used with cryoballoon ablation. In the procedure, catheters are guided through the veins into the heart, where electrical activity is recorded. Once the source of abnormal electrical activity is found, an energy source is spread through the catheter to destroy the diseased area and interrupt the abnormal electrical circuits. The most common methods are radiofrequency ablation using heat, or cryoablation using freezing. Laser energy and ultrasound energy are less commonly used in the NHS. The procedure usually takes 2 to 3 hours and may be done under sedation or general anaesthesia.

The following publications have been identified as relevant to this care pathway:

Population, setting and intended user

The KODEX‑EPD system is indicated for catheter‑based atrial and ventricular mapping in people for whom electrophysiology studies are indicated. This includes people with atrial fibrillation, atrial flutter, supraventricular tachycardias and ventricular tachycardias.

KODEX‑EPD is exclusively used by cardiac electrophysiology specialists who are fluent in cardiac catheterisation and ablation procedures. The technology is used in standard electrophysiology procedure environments (catheter labs).

The company states that instructions for use are provided as part of the device labelling and that training is needed and provided during system handover. The training is included in the costs of the device.

Costs

Technology costs

The KODEX‑EPD visualisation and mapping system costs £300,000 with a price reduction for NHS use. The company states that the maintenance contract is in line with other 3D mapping systems, priced at about £12,000 per year. The KODEX‑EPD system lifespan is 7 years.

The company states that the cost for treatment with KODEX‑EPD depends on the type of arrhythmia and the consumables selected. Cost for treatment with KODEX‑EPD could range from about £1,000 in a cryo- procedure to about £2,000 for less complex procedure disposable packs for radiofrequency, up to about £3,000 for complete atrial fibrillation disposable packs. These packs include a key, sensors and catheters.

For cryoablation, the catheters are not provided by the company and need to be sourced from other vendors. KODEX‑EPD disposables for cryo- procedures are the cryo- sensor and key kit, which costs £1,000.

For radiofrequency ablation, the company provides the following packs:

  • The radiofrequency atrial fibrillation kit costs £2,600. It includes a contact‑force‑enabled ablation catheter, a 20‑pole pulmonary vein catheter, a coronary sinus decapolar catheter and a radiofrequency sensor and key.

  • The radiofrequency flutter kit costs £2,100. It includes a contact‑force‑enabled ablation catheter, a coronary sinus decapolar catheter and a radiofrequency sensor and key.

Costs of standard care

  • Standard-irrigated radiofrequency ablation catheter: £700.

  • Complete-irrigation radiofrequency ablation catheters for atrial fibrillation (including pulmonary vein and coronary sinus catheters combined): £1,550. This excludes 3D mapping.

  • Specialist contact‑force‑enabled catheter to be used with other mapping systems: £1,250.

  • Cryoablation catheter: about £2,000.

  • 3D mapping atrial fibrillation procedure with contact‑force‑enabled catheter: over £2,500.

Resource consequences

The company states that the KODEX‑EPD system is currently used in 3 NHS trusts and that they are engaging with other trusts.

It states that the technology costs more than current standard care but has greater benefits. The company claims that KODEX‑EPD maintains the speed of cryoballoon ablation but reduces exposure to radiation for both patient and healthcare professional. With cryoballoon ablation, a second procedure with a radiofrequency catheter may be necessary. Both procedures can be done with the KODEX‑EPD system, saving the need for, and cost of, additional imaging technologies.

The company claims that KODEX‑EPD is designed for integration into catheter labs and can be mobile for use in multiple labs, with no changes needed to the existing infrastructure.