Indocyanine Green Angiography & Spy Imaging
Health Technology Assessment Committee Recommendations
- Indocyanine Green Angiography (ICGA) for colorectal surgery is safe and expected to provide substantial patient and health system benefits and, therefore, should be publicly provided under the following conditions:
- The manufacturer follows up to ensure the Spy Elite is licensed in Canada for use in providing ICGA in open colorectal surgeries
- ICGA in open and laparoscopic colorectal surgeries is first adopted in select hospitals under a controlled trial or monitored environment to confirm the cost-effectiveness parameters modelled in the evidence review ICGA and Novadaq Spy Imaging System in Colorectal Surgeries in British Columbia Health Technology Assessment Report prior to broad implementation.
Health Technology Assessment Committee Findings
- Based on four non-randomized comparative studies that had a total of 1,224 patients enrolled, clinical evidence shows ICGA significantly reduces the risk of anastomotic leak when compared to clinical judgement alone. The pooled estimate of risk ratio was RR = 0.55, the absolute risk reduction was four percent and the number needed to treat was 25. The effect on anastomotic leak was statistically significant.
- The clinical evidence assumes a class effect across similar ICGA devices. There were no studies that compared the performance of different ICGA devices; however, there is no evidence to suggest the Spy Elite (for open surgeries) or the Pinpoint (for laparoscopic surgeries) is superior or inferior to other ICGA devices.
- The use of ICGA in colorectal surgeries is expected to be cost-effective and associated with positive gains in QALYs and cost savings due to fewer resources spent on addressing complications:
- For every 1,000 patients, ICGA compared to no ICGA was expected to prevent 50 complications, five deaths, 15 permanent stomas and be associated with a gain of 50 QALYs
- ICGA was associated with an average cost saving of $905/patient
- A budget impact analysis suggests that ICGA would likely result in overall cost savings (avoided costs) of between $245 million (ICGA performed in high volume hospitals; 78% of colorectal surgeries) and $280 million (ICGA performed in 100% of colorectal surgeries) over 20 years due to spending fewer resources on complications:
- Capital costs are estimated to be $21.6 million in order to provide ICGA province-wide based on an assumption that 42 Spy Elite and 38 Pinpoint devices would be needed. Under this scenario, there would be a net incremental cost in acquisition years (e.g. $9.1 million in the first year) but this would be offset overall by cost savings in other years
- The capital costs and average cost per surgery would be much less if ICGA was provided only in high volume hospitals. Under this scenario, cost savings would be immediate with no net incremental cost in acquisition years
- ICGA potentially avoids over 6,000 complications (major and minor leaks) over 20 years from colorectal surgery resulting in substantial patient benefits:
- A reduction in the number of major leaks, including an estimated 42% decrease in deaths and 30% decrease in the number of permanent stomas
- A reduction in local cancer recurrence
- Reduced negative impacts on quality of life, including social and mental health, particularly with respect to living with a permanent stoma, and fear of cancer recurrence
- An important consideration is that no randomized controlled trials were found. As a result, selection bias and lack of blinding could significantly affect estimates. These risks are common in surgical observation studies; however, adoption under controlled trial circumstances or a monitored environment can confirm the real life benefits of the technology and confirm the assumptions on cost-effectiveness.
- There are moderate risks and challenges associated with the implementation of ICGA, primarily capital costs and logistics, including ensuring adequate infrastructure in operating rooms (physical space, staff) and adequate supply and administration of the ICG dye. Establishing an adequate supply of ICG dye prior to purchasing the ICGA technology is advised to help avoid potential shortages in the future.
- The Spy Elite includes a software toolkit that clinicians note can support better training of surgeons.
- The Spy Elite system is licensed in Canada for open surgeries by Health Canada. In the US it is approved by the FDA for cardiovascular surgery, plastic surgery, organ transplants and gastrointestinal surgery, but for Canada these are not listed under the current license.