Proven Radiation Reduction in Interventional Labs

Reducing the risk of radiation exposure without compromising image quality or procedural workflow should be the goal of every interventionalist using X-ray imaging systems. It should also be the goal of every manufacturer of X-ray systems. ROI technology is known. The results in radiation reduction using ROI technology are proven. However, not all manufacturers use the best available ROI technology and, surprisingly, many physicians don’t demand that they do so.

In an article in RSNA Imaging & Therapeutic Technology, Stephen Rudin, Ph.D. et al., touted the benefits of using region of interest (ROI) technology to substantially reduce radiation dose outside of the ROI while maintaining – or improving – the image quality within the ROI. This was in 1996 and ROI technology still is not standard or even expected with newer X-ray systems. It should be demanded.

ROI technology is proven to significantly reduce radiation exposure. Still, this technology has been adopted by a only few manufacturers. Interventional cases are often done using a full field of view (FOV) instead of the physician’s actual ROI. This exposes the patient to unnecessary radiation and the physician and staff to additional scatter radiation.

Radiation exposure is a real threat in the interventional lab – for physicians, staff, and patients. The risks of ionizing radiation exposure are well documented. Physicians and their staff are at risk due to the number of cases (procedures) they perform each year – over a career. The risks to staff should not be taken lightly, but what about patients? There are risks to them due to the complexity of their cases and the reality that many will endure several procedures in their treatment.

Hospitals follow the principles of ALARA – as low as reasonably achievable – which assumes that no dose of radiation is safe and every precaution possible should be taken to prevent radiation exposure to patients and the medical team that treats them.

Efforts such as ALARA are important steps in providing radiation safety, but are they enough? Should the goal of radiation protection really be what’s “reasonably” achievable?

Like pulsed fluoro and cine technology before, the adoption of ROI technology has been slow. If every interventionalist demanded the use of ROI technology in their interventional X-ray systems, the result would be a tremendous leap forward in radiation reduction and radiation safety during the ever-growing number of interventional cases.

The radiation reduction using ROI technology is undeniable. In an objective study first presented at TCT 2021 and then again at HRS 2022, the REDEFINE trial evaluated whether technology could reduce radiation exposure to operators and patients during diagnostic and interventional cardiac catheterization procedures. This study was based on technology from ControlRad® that relied on manual control of the ROI and filtered radiation rather than blocking it with collimation.

The REDEFINE trial sponsored by Boston Scientific showed a 57% radiation dose reduction to the primary operator across all procedures and 71% for interventions. The results also showed a 49% DAP reduction to the secondary operator and a 38% reduction to the circulating nurse. The patient received a 35% reduction in radiation dose. The results can be seen in this one-page summary or viewed in this one-minute video.

ROI Technology Study

A system that requires manual control of the ROI creates an interruption in the established workflow. Better technology is a system that automatically detects and maintains the ROI. An AI system follows the movements of devices and anatomy during a procedure and eliminates the manual input requirements and distractions inherent in manual ROI systems. The process is completely automatic and hands-free – allowing the physician to focus on their patient and not on manually controlling an ROI.

In a comparative study, Omega Medical Imaging proved a significant dose reduction is achieved when using an AI image-guided ROI system compared to a non-AI system. Radiation is reduced in all modes of acquisition (fluoro and cine) at varying frame rates. The results are consistent and repeatable with no change in the existing workflow.

The objective of this study was to access the efficacy of an AI image-guided ROI system versus a conventional, non-AI system in reducing radiation dose. The conclusions were clear – the AI system from Omega significantly reduced radiation exposure. Radiation reduction in cine mode was up to ~75% for staff and ~71 for patients. In fluoro mode, radiation reduction was ~61% for staff and ~51% for patients.

Radiation Reduction

Omega’s AI image-guided interventional systems are proven to reduce radiation exposure. This reduction is in addition to any current ALARA best practices for radiation safety and significantly better than any conventional non-AI system. Omega’s AI-enabled systems go beyond merely managing radiation risk to providing an actual reduction in radiation dose. The result is a groundbreaking solution that provides safer healthcare for both patients and staff. Omega allows physicians and hospitals to provide the best care and the best radiation reduction and safety to their staff and patients – improving the radiation safety of everyone in the room.

Omega represents a new standard of care as the only FDA-cleared interventional system using ROI/AI technology. Omega is the only manufacturer in the world to offer this technology. No other OEM has anything like it – despite any claims or allusions that they do. Omega provides something totally new, something unique. By reducing the total radiation dose, Omega has established a new modality of radiation protection and image quality.

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