Navigational bronchoscopy

Lung cancer remains the primary cause of cancer-related mortality in the United Kingdom, accounting for 21% of all cancer deaths. Despite the successful implementation of a national lung cancer screening programme in 2023, a significant challenge persists in the diagnosis and treatment of early-stage lung cancers. Currently, pulmonary nodules measuring less than 10mm in diameter present a diagnostic dilemma, as they cannot be accurately risk-stratified or biopsied using conventional methods. This limitation often results in delayed treatment initiation and potential disease progression. 

The ability to detect and diagnose these small nodules at an earlier stage could potentially lead to substantial improvements in treatment outcomes and patient quality of life, while simultaneously offering considerable cost savings to the NHS. Navigational bronchoscopy has emerged as a promising solution to address this diagnostic challenge, offering a minimally invasive approach for accessing and sampling peripheral lung lesions.

The less invasive nature of the procedure also means that it can be used in cases where other diagnostic options might be contraindicated due to comorbidities, as well as presenting a lower risk of complications in general compared to other diagnostic tests currently more widely used.

These advanced bronchoscopic techniques utilise electromagnetic navigation, which creates a three-dimensional map of the lungs. Clinicians are able to navigate to and biopsy lesions in areas of the lungs that are typically inaccessible using conventional bronchoscopy. By integrating navigational bronchoscopy into the diagnostic pathway, healthcare providers can potentially establish a more efficient and less invasive process for the early diagnosis of lung cancer (particularly for small or previously inaccessible lesions). 

These resources are designed to help cancer professional understand the safety and effectiveness of navigational bronchoscopy as a procedure, as well as practical insights to support the implementation of navigational bronchoscopy within NHS lung cancer pathways.

Safety profile 

Navigational bronchoscopy demonstrates a superior safety profile compared to traditional diagnostic methods for peripheral pulmonary lesions. The NAVIGATE study, a large prospective multicentre trial involving 1,215 patients, reported a pneumothorax rate of 4.3% with navigation bronchoscopy, with only 2.9% requiring intervention or hospitalisation. This is substantially lower than the rates associated with CT-guided Transthoracic Needle Aspiration (TTNA), which has reported pneumothorax rates of 25.3% for core biopsies and 18.8% for fine-needle aspiration. 

The risk of significant haemorrhage with navigation bronchoscopy is also relatively low, reported at 1-3% in transbronchial biopsies. This favourable safety profile is particularly beneficial for patients with comorbidities or those at higher risk for complications from procedures like CT-guided biopsy. 

Diagnostic accuracy and early cancer detection 

Navigational bronchoscopy has demonstrated high diagnostic yields, particularly for small peripheral lesions that are challenging to access with conventional methods. Studies have reported diagnostic yields ranging from 62.5% to 100% for nodules less than 10mm in diameter. Importantly, the diagnostic yield does not significantly decrease for nodules smaller than 10mm, highlighting its potential in early lung cancer detection. 

This capability aligns with NHS England's objective of diagnosing 75% of cancers at stage I or II by 2028. By enabling the accurate sampling of nodules as small as 6mm, navigation bronchoscopy can potentially detect lung cancers at their earliest, most treatable stages.  

Implications for the cancer pathway 

The integration of navigational bronchoscopy into the diagnostic pathway can significantly expedite the cancer care journey. Real-world experiences demonstrate its potential to reduce time-to-diagnosis and treatment initiation substantially. 

For instance, patients with nodules in challenging locations, unsuitable for CT-guided or endobronchial ultrasound (EBUS) biopsy, can undergo navigation bronchoscopy within days of referral, rather than waiting for interval CT scans. When combined with on-site pathology, this approach can provide a definitive diagnosis rapidly, allowing for prompt treatment planning. 

• Current pathway: a patient with a suspicious nodule might undergo multiple imaging studies, followed by a conventional bronchoscopy, CT-guided biopsy and EBUS biopsy, with potential delays between each step.
• Integrated pathway: navigational bronchoscopy can be performed earlier in the diagnostic process, potentially combining multiple diagnostic processes into a single procedure, thus reducing the overall time to diagnosis. 

This proposed redesign of the diagnostic pathway maximises existing NHS resources by streamlining care into a single, coordinated clinic visit. By consolidating blood tests, lung function assessments, and imaging into one visit, followed by a single accurate diagnostic test, the need for additional resources and the burden on the patient is minimised.

Cost/benefit analysis of navigational bronchoscopy implementation 

Navigational bronchoscopy offers significant potential for cost savings and improved resource utilisation. When compared to current diagnostic and treatment pathways, the following areas of cost reduction and efficiency gains can be identified: 

• Direct cost savings: lower rates of pneumothorax, bleeding, and other procedure-related complications translate to reduced costs for managing these adverse events. 

• Indirect savings: fewer complications lead to shorter hospital stays and decreased need for additional interventions, further reducing overall healthcare expenditure. 

• Fewer A&E attendances: early and accurate diagnosis can prevent emergency presentations due to undiagnosed or progressive disease, significantly reducing the high costs associated with emergency care. 

• Reduced need for repeat biopsies: navigational bronchoscopy’s higher diagnostic yield (especially for small or difficult-to-access nodules) significantly lowers the need for repeat biopsies or additional diagnostic tests. By achieving a more accurate diagnosis in the first instance, the overall costs associated with repeated interventions, imaging, and pathology assessments are reduced, leading to lower overall healthcare expenditure and faster treatment initiation.

Funding for navigational bronchoscopy: opportunities for NHS trusts

Hospital trusts in the UK can explore various funding avenues to support the capital expenditure associated with adopting navigational bronchoscopy systems. Here are some potential options: 

Considerations for implementation

1. Procurement of equipment and consumables: trusts need to collaborate with suppliers to procure the navigational bronchoscopy system and its associated consumables. With a range of options and pricing available, it's essential to evaluate institutional factors such as existing supplier relationships, the clinical team’s familiarity with each technology, and the diagnostic yield offered by each system. When considering options, weigh the benefits of electromagnetic versus robotic bronchoscopy as well as radiology options, including fluoroscopy, radial ultrasound, and CT guidance. Leasing options or phased procurement strategies can also help manage capital expenses effectively.

2. Clinical governance and regulatory compliance: ensure the technology is CE marked. Both Medtronic and Intuitive navigational bronchoscopy stacks are CE marked. Establish clear protocols for use, maintenance, and quality assurance. 

3. Phased implementation: begin with a small cohort of patients to allow for system optimisation and workflow adjustments. This allows time for the work force to adapt and troubleshoot for any potential unintended consequences. Gradually increase utilisation as team proficiency improves. 

4. Workforce development and training: radiologists, radiographers, respiratory physicians, anaesthetists, theatre nurses, operating department practitioners, pathologists and other relevant professionals may require specialised training. A comprehensive training programme, regular staff and stakeholder engagement and practice are essential. Establish ongoing support and regular refresher training to maintain skills and ensure quality. 

5. Access to general anaesthesia: negotiate dedicated anaesthesia support for navigation bronchoscopy procedures. In some NHS trusts this has been achieved by adding a navigational bronchoscopy case at the beginning or end of existing theatre lists. It is possible to perform the procedure under sedation and programmes have been set up outside of the UK in bronchoscopy suites with good results.  

6. Workflow adjustments: redesign care pathways to incorporate navigation bronchoscopy at the appropriate stage. Develop new multidisciplinary team (MDT) workflows to expedite referrals for navigational bronchoscopy to avoid diagnostic delays. 

The integration of navigational bronchoscopy into the lung cancer pathway requires careful planning and significant changes to existing workflows. Successful implementation will depend on effective training, clear communication across all involved specialties, and a phased approach to allow for learning and optimisation.