Advice

The technology

The technology

The superDimension Navigation System (Medtronic) is used to guide endoscopic tools or catheters during biopsy of mediastinal and peripheral lung lesions. It allows access to peripheral lesions that would not otherwise be reached using conventional bronchoscopes. The superDimension Navigation System consists of computer software, which creates a 3D-reconstruction from CT data of the airway. Conventional bronchoscopes can only reach areas of the lung that are close to the main airways, but the superDimension Navigation System may allow access to more distant regions of the lung when needed, for example for biopsies.

Additional image guidance, such as X-ray fluoroscopy, radial endobronchial ultrasound (rEBUS) or cone beam CT are not compulsory, but are recommended by the company to confirm the intended position of biopsy tools, before sampling, to increase diagnostic yield.

Innovations

The innovative aspect of the superDimension Navigation System is that it allows localisation, access and biopsy of smaller and more peripheral lung lesions, without the risks of pleural puncture. This allows sampling of distal endobronchial disease, beyond the limits of direct vision with a conventional bronchoscope. Avoiding pleural puncture minimises the risk of pneumothorax, pain and haemothorax for patients.

It offers an alternative technique for patients for whom percutaneous approaches to biopsy (such as CT-guided trans-thoracic needle biopsy, or surgical excision) are thought to be too high risk.

Current care pathway

People with suspected endobronchial disease may have lesions that have been identified using standard imaging techniques. However, they may need to have a biopsy to diagnose what is causing the lesion(s). Current standard of care in the NHS for sampling solitary lesions is CT-guided trans-thoracic needle biopsy by an experienced radiologist. If there is mediastinal lymph node involvement, endobronchial ultrasound guidance is used for diagnostic sampling.

If CT-guided trans-thoracic needle biopsy is not suitable, electromagnetic navigation bronchoscopy, radial endobronchial ultrasound and fluoroscopy-guided biopsy may be used, but these have a lower diagnostic sensitivity.

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

Population, setting and intended user

The superDimension Navigation System is intended for use in people with lesions that are further into the lungs than conventional bronchoscopes may be able to reach. It allows clinicians to navigate to the lesions through the bronchial tree, to diagnose or treat them. Once the lesion is reached, the clinician can do a biopsy, insert fiducial markers to guide radiotherapy or brachytherapy catheters, or do lung marking with methylene blue to help surgical resection of small nodules. Only the application of biopsy for diagnostic sampling is in scope of this briefing.

Specific patient populations for the electromagnetic navigation bronchoscopy biopsy procedure include:

  • individuals for whom CT-guided trans-thoracic needle biopsy is thought to be high risk, including those with multiple and bilateral lesions or previous pneumonectomy

  • individuals in whom CT-guided trans-thoracic needle biopsy is technically not possible.

The safety of the procedure has been shown in high-risk patients with severe chronic obstructive pulmonary disorder (COPD; Towe et al. 2017). The system is used in secondary and tertiary care in the NHS. Operators may include pulmonologists and thoracic surgeons trained in bronchoscopy and after training in use of the superDimension Navigation System.

Costs

Technology costs

The total average cost of using the technology is estimated to be £1,942 (if done outside of an operating theatre) or £2,331 (in an operating theatre) per procedure, based on costs from an unpublished study done in the NHS. This average cost assumes that 79.7% of procedures are done using a general anaesthetic and represents a staff skills mix including consultant, anaesthetist, operating department practitioner, band 5/6 scrub nurse and band 5 recovery nurse.

Table 1 superDimension navigation system costs

Description

Cost

Additional information

superDimension system

superDimension Navigation System*

£110,000 to £130,000

All prices are for financial year 2018 to 2019

superDimension V6.x to V7.1 Upgrade*

£32,000

This can be bought to upgrade a version 6 superDimension technology to the latest version (7.1)

EDGE Kits and Catheters

EDGE Firm Tip Procedure Kit – 180°, 90° or 45° Curve

£773

–

EDGE locatable guide

£730

–

EDGE 180°, 90°, 45° Firm Tip or straight extended working channel

£405

–

Bronchoscope Adaptors

EDGE Bronchoscope adaptor – Olympus 180, Pentax, Fujinon or Olympus 190 Scopes

£86

Also available as a box of 10 for £859

Biopsy Tools

superDimension Cytology Brush

£189

Box of 10

ArcPoint Pulmonary Needle – 21G

£848

Box of 5

ArcPoint Pulmonary Needle – 18G

£970

Box of 5

superDimension Triple Needle Cytology Brush – 10 mm or 15 mm

£773

Box of 10

superDimension Needle-tipped Cytology Brush

£412

Box of 10

GenCut™ Core Biopsy System

£250

–

CrossCountry Trans-bronchial Access Tool

£250

–

Markers and Patches

superLock Fiducial Marker

£764

Box of 5

superDimension Marker Delivery Kit

£361

Box of 5

superDimension Patient Sensor Patches*

£189

Box of 60

Items in multiple box units are individually packaged and sterile.

Items marked with an asterisk (*) are not sterile.
Costs of standard care

CT-guided trans-thoracic needle biopsy is the main alternative in the NHS and, where a CT scanner is already installed, there will be no need for additional capital costs (however, this is likely to be over £1 million). Biopsy needles range in price from £8.00 to £27.50 (inc. VAT) on the NHS Supply Chain catalogue. The tariff cost for standard care is £1,357, which captures the costs of image-guided biopsy and full pulmonary function testing.

Resource consequences

In April 2019, 10 NHS trusts have either bought the superDimension Navigation system, have business cases for funding in process, or have the system under clinical evaluation or trial. Sixteen clinicians are experienced in its use.

Resources needed include costs of the system and training to develop staff skills needed for the electromagnetic navigation bronchoscopy procedure. Training takes place over 2 days and there is on-site support from the company for the operator and team during their first series of patients.

The main barrier to adoption is the capital cost of the system and potential changes to staffing. No changes in facilities or infrastructure are needed because the procedure can be done under sedation (as in conventional bronchoscopy and endobronchial ultrasound in the bronchoscopy suite done by respiratory physicians) or under general anaesthetic (as in the operating theatre if the procedure is being done by thoracic surgeons).

There may be cost savings from fewer surgical biopsies and a shorter inpatient stay. However, there are examples of best practice of standard care in the NHS, using CT-guided trans-thoracic needle biopsy, where the diagnostic yield is high and risk is low, with pneumothoraces managed in an outpatient setting in most cases. The time needed to complete a CT-guided trans-thoracic needle biopsy procedure is short and it is done under local anaesthetic. There may be some patients for whom CT-guided biopsy is too high risk, because of comorbidities. If used in people who are at less risk, then there could be fewer CT-guided biopsies, which would free up radiology resources for other biopsy demand. It should be noted that the procedure kit (catheter and locatable guide) costs more than a CT-guided biopsy needle.

Centres with the infrastructure to provide the recommended additional fluoroscopy and radial endobronchial ultrasound for optimal diagnostic yield will be best placed to adopt this technology.