superDimension Navigation System to help diagnostic sampling of peripheral lung lesions

Level of innovation

Specialists agreed that the technology is an innovative development for bronchoscopy. Although it has been used internationally for many years, the technology has not gained substantial uptake in the NHS, most likely because of the cost and a perceived lack of widespread need. One specialist emphasised that this is a completely novel approach, moving from the percutaneous, radiation-based technique of CT-guided biopsy to one that is endoscopic, does not need skin or pleural puncture but makes use of the natural, pre-existing conduits to the lesion through the airway. This specialist added that the next generation superDimension Navigation System uses a short sweep of C-arm fluoroscopy to refine the accuracy of the procedure. Whilst this uses ionising radiation, the risks associated are still considerably lower than CT-guided biopsy, and potentially increases the diagnostic yield for the electromagnetic navigation bronchoscopy procedure.

Potential patient impact

All 4 specialists agreed that the patient groups most likely to benefit from the technology include those who cannot have surgical biopsies or those for whom CT-guided trans-bronchial needle biopsy is too high risk because of the position of the lesion or comorbidities such as severe chronic obstructive pulmonary disorder and poor lung function. In patients with suspected cancer, a tissue diagnosis could inform potential treatment with targeted therapies and thereby improve clinical outcomes.

Particular sub-groups who may benefit from the technology include patients with multiple, especially bilateral, lung lesions and patients with only 1 lung (after pneumonectomy). Individuals having linear endobronchial ultrasound staging of the mediastinum, where diagnosis from the peripheral lesion is also needed, can benefit by avoiding further biopsy for confirmatory diagnosis later.

Two specialists agreed that the technology allows more patients, with more distal disease, to have endobronchial biopsy for diagnostic tissue sampling. Another specialist further considered that the technology should be used instead of percutaneous biopsy to reduce risk from pleural puncture (pneumothorax, pain, haemothorax), even in patients for whom the procedure is low risk. The fourth specialist considered that the main benefit to patients would be through placing fiducials to guide surgeons or clinical oncologists (for novel radiotherapy techniques), or with therapeutic procedures such as cryotherapy. Minimising radiation exposure for patients was a further benefit mentioned by 2 specialists.

However, given the low negative predictive value seen in the evidence base, 1 specialist expressed concern that individuals having a negative biopsy with this technology should be considered for another mode of biopsy, to confirm.

Potential system impact

Specialists generally agreed that the technology would shorten the current pathway by allowing tissue diagnosis and mediastinal staging in 1 biopsy, so that, where needed, the correct treatment can be started within a few days. If done as a day case, the procedure uses fewer hospital resources than an inpatient stay and takes less time than an invasive surgical biopsy. It can also free up radiology resources for other patient workloads. The quoted average cost per procedure may be reduced in a scenario with just sedation and normal bronchoscopy staff in a bronchoscopy suite.

However, 1 specialist considered that the technology will have limited system impact, being a very niche indication at a high cost. It has been available for over 10 years, but has not gained much traction, compared with the widespread uptake of endobronchial ultrasound in the NHS. Another specialist expressed concern about upgrade costs. Because there have been 7 software/firmware upgrades of superDimension Navigation System, this could potentially mean high maintenance costs and should be included if appropriate in the cost effectiveness.

General comments

As with most new technologies, the studies in the evidence base are done by expert users. Diagnostic yields are likely to be lower for newly trained users.

The latest unpublished efficacy data from conferences suggest that electromagnetic navigation bronchoscopy should be used with radial endobronchial ultrasound, or fluoroscopy. Hence the cost of setting up a diagnostic service should include all additional technology costs.

Also, it will be interesting to see the full results of NAVIGATE study, but so far it looks very promising and this trial is probably most relevant to the current version of the technology.

Most of the systems bought in the UK recently are for thoracic surgery departments who use the technology for both diagnosis and intraoperative localisation (to help find small, difficult-to-feel lesions). The latter is an unmet need and current solutions are high risk, inaccurate, costly and disruptive to both the radiology department and operating theatres. The technology may be best limited to adoption in specialist bronchoscopy centres, with procedures subject to registry data collection, audit and adherence to a quality standard.