Advice

Clinical and technical evidence

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Six studies are summarised in this briefing, including a total of 132 people.

The included studies are 4 comparative observational studies, 1 case series and 1 single‑arm study. There are further studies that are not summarised here.

The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

The evidence is of low‑to‑moderate methodological quality, and all studies are small in terms of patient numbers. Three studies were reported in conference abstracts only. Only 1 study was done in the UK. The evidence suggests that KODEX‑EPD can create 3D real‑time and high‑resolution images to enable catheter navigation, without the need for additional imaging such as fluoroscopy. Further evidence comparing the KODEX‑EPD system with standard care is needed, with a large sample size.

Maurer et al. (2019)

Intervention and comparator

The KODEX‑EPD system and the CARTO 3 system.

Key outcomes

Using the KODEX‑EPD system, the left atrial imaging was completed within a median of 9.7 (7.5 to 12.8) minutes. The median procedure time was 97.5 (90 to 112.5) minutes, and median total fluoroscopy time was 8.2 (5.7 to 10.6) minutes, of which a median of 1.4 (1.1 to 2.3) minutes was used to create the left atrial map. Both the KODEX‑EPD system and CARTO 3 measurements correlated well with fluoroscopy measurements, as reflected by Pearson's correlation coefficients (r) of 0.91 and 0.95, respectively. Bland‑Altman plots revealed that, on average, KODEX‑EPD measurements underestimated fluoroscopy measurements by 0.04 mm (95% limits of agreement of ‑5.72 mm and 5.64 mm). CARTO 3 measurements underestimated fluoroscopy measurements by 0.02 mm (95% limits of agreement of ‑3.61 mm and 3.57 mm). There were no procedural complications.

Strengths and limitations

The novel wide‑band dielectric KODEX mapping system has the potential to create 3D real‑time and high‑resolution images of left atrial anatomy in CT‑like quality without the need for additional imaging. This study is an early experience of high‑resolution cardiac imaging using KODEX‑EPD, so there is no data available for a standalone approach for left atrial mapping. The study sample size was small and may be underpowered to detect quantitative differences in the navigational accuracy between the different imaging modes. One author has received research grants and is a consultant to EPD Solutions and Philips.

Romanov et al. (2019)

Intervention and comparator

The KODEX‑EPD system.

Key outcomes

KODEX‑EPD showed all major anatomical landmarks relevant to intracardiac catheter placement and navigation. The right atrium showed the inferior vena cava and right atrium junction, superior vena cava and right atrium junction, coronary sinus, fossa ovalis, Thebesian valve, and tricuspid valve. The left atrium showed each transseptal site, all pulmonary vein ostia, left atrium appendage orifice and mitral valve. A right accessory top pulmonary vein, a rare but clinically important anatomical pulmonary vein drainage variation, was also clearly identified. A CT image confirmed the presence of this variation.

Strengths and limitations

This study suggests that KODEX‑EPD can accurately enable catheter navigation and enable real‑time mapping of atrial anatomy with a high level of anatomical detail. The authors suggested that next steps include validating the system's ability to integrate cardiac electrical activity within the high‑definition image.

Abeln et al. (2020)

Intervention and comparator

The KODEX‑EPD system.

Key outcomes

Ablations were done for atrial fibrillation in 13 people (50.0%): atrial flutter in 10 (38.5%), atrial tachycardia in 1 (3.8%), atrioventricular‑nodal re‑entrant tachycardia in 1 (3.8%), atrioventricular re‑entrant tachycardia in 2 (7.7%) and ventricular extrasystole in 2 (7.7%). The median procedure time was 99.5 (68.8 to 112.3) minutes, and median fluoroscopy time was 14.4 (10.0 to 16.9) minutes. All procedures were successful. There were no adverse events during follow up.

Strengths and limitations

This study suggests that KODEX‑EPD is a novel system for cardiac mapping and anatomical imaging and can be used safely and effectively for a variety of cardiac arrhythmia ablations. The study is reported in conference‑abstract form only and so is limited in detail.

Taylor et al. (2020)

Intervention and comparator

The KODEX‑EPD system compared with contrast venograms.

Key outcomes

There were 58 pulmonary vein occlusions verified with both contrast venography and the KODEX‑EPD system. Of the 52 pulmonary veins indicated as occluded on the KODEX‑EPD system pulmonary‑vein‑occlusion tool, 37 were satisfactorily occluded on contrast venography. Of the 6 pulmonary veins displayed as not occluded on the pulmonary‑vein‑occlusion tool, 3 were satisfactorily occluded on contrast venography. The sensitivity and specificity of the KODEX‑EPD system occlusion tool for pulmonary vein occlusion, as defined by contrast venography, were 92.5% and 16.7%, respectively. The positive and negative predictive values of the occlusion tool were 71.2% and 50%, respectively. There were 4 pulmonary veins that had grade 4 occlusion on contrast venography, and all were identified as occluded with the occlusion tool.

Strengths and limitations

This study suggests that the KODEX‑EPD system could substantially reduce fluoroscopy exposure. However, the current software version may not currently have sufficient diagnostic accuracy to replace contrast venography. This study is reported in conference‑abstract form only and so is limited in detail.

Cauti et al. (2021)

Intervention and comparator

The KODEX‑EPD system compared with angiogram.

Key outcomes

A total of 105 pulmonary vein cryoballoon occlusions were tested. The new occlusion tool software module showed 91% sensitivity and 76% specificity in assessing a complete pulmonary vein occlusion, verified with contrast medium injection. The positive predictive value was 80%, and the negative predictive value was 88.6%. Mean procedure time was 81, plus or minus 17 minutes. Mean fluoroscopy time was 6, plus or minus 2 minutes. No 30‑day complications were observed.

Strengths and limitations

The authors state that this is the first study to assess the safety, feasibility, and efficacy of the use of a new tool. This study suggests that KODEX‑EPD was able to assess the degree of pulmonary vein occlusion during a cryoballoon ablation with good sensitivity and specificity.

Schillaci et al. (2020)

Intervention and comparator

The KODEX‑EPD system compared with no KODEX‑EPD system (fluoroscopy).

Key outcomes

There were 20 patients who had the procedure under fluoroscopy guidance before the new system introduction, while 20 patients had the procedure under fluoroscopy and KODEX‑EPD guidance with its occlusion tool software. The total time of the procedure was comparable between the 2 groups (90.15 minutes, plus or minus 28.67 compared with 80.77 minutes plus or minus 17.17 using the dielectric imaging system, p=0.34). Fluoroscopy time was significantly lower in the group using KODEX‑EPD (16.92 minutes plus or minus 8.96 compared with 5.54 minutes plus or minus 2.06, p<0.01). Acute isolation was achieved in all pulmonary veins. No 30‑day complications were observed.

Strengths and limitations

The authors state that this is the first study to show the feasibility of a reduced fluoroscopy workflow using KODEX‑EPD. This study is reported in conference‑abstract form only and so is limited in detail.

Sustainability

The company provided no details about sustainability.

Recent and ongoing studies