Safety in fluoroscopy guided interventional procedures

» IAEA project on strengthening radiation safety in image guided interventional procedures
» First project phase (2022-2023): International study of patient doses and tissue reactions from fluoroscopy guided interventional procedures
» Study methodology
» What are the benefits for the participating facilities?
» How can my facility participate?

IAEA project on strengthening radiation safety in image guided interventional procedures

In recent years, minimally invasive medical interventions performed under fluoroscopy and other types of imaging guidance have been extensively replacing the open surgery for many medical interventions. Further, the number of image-guided interventional procedures performed by physicians of different specialities has also dramatically increased. The growth in the variety, frequency and complexity of these sometimes relatively higher radiation dose procedures and the involvement of staff who may have insufficient radiation protection training, pose challenges for patient dose management and occupational safety. Patients may be at risk of tissue reactions, and both patients and staff may be at increased risk of a stochastic effect.  

Published reports demonstrate the need for more data to understand the prevalence of tissue reactions in patients and their relationship with dose metrics and other factors related to procedure and patient characteristics. More research is needed to understand how often percutaneous interventions are needed, and the proper management of repeated interventions to reduce the risk of tissue reactions and stochastic effects. The correlation between staff and patient exposure in different applications and the factors that influence these exposures also require further investigation and proper implementation of optimization approached in the clinical practice.

With the goal of bridging the data gap for skin injuries from radiation exposure, the IAEA established the voluntary reporting system Safety in Radiological Procedures (SAFRAD) to collect data for patients whose exposure or dose parameters from a fluoroscopically guided interventional (FGI) procedure exceeded some defined trigger level.

In response to the concern of higher doses to staff in interventional procedures, and especially those performed in cardiology, the IAEA established a module on interventional cardiology (IC) in the Information System on Occupational Exposure in Medicine, Industry and Research (ISEMIR-IC). Since the establishment of SAFRAD and ISEMIR, technologies have developed rapidly, including better standardization of patient dose reporting with the Radiation Dose Structured Report (RDSR), improved assessment of patient skin doses, including software tools for real time or post-procedure skin dose maps, and developments in staff dosimetry through active and passive dosemeters and software tools.

Automatic radiation exposure monitoring systems have become available in many clinics around the world, including local or national automatic dose index registries. These and other ongoing developments have significantly improved access to a large volume of data. This improved access provides more opportunities for using this information on a global level to improve radiation protection. It also highlights the need to upgrade the IAEA reporting systems.

The overall objective of this project is to make the best use of the international collaboration coordinated by the IAEA, to collect and analyse information on patient and staff dose and exposure metrics in FGI procedures for various practices and settings worldwide. The project will be implemented in phases.

First project phase (2022-2023): International study of patient doses and tissue reactions from fluoroscopy guided interventional procedures

The IAEA will be launching an International Study of Patient Doses and Tissue Reactions from Fluoroscopy Guided Interventional Procedures in 2022, with the following objectives:

• Improve the information about the frequency of occurrence of tissue reactions in patients from different type of FGI procedures (cardiac, neuro, and body) performed in different parts of the world.
• Study the relationship between the tissue reactions and the radiation exposure metrics, procedure factors and patient related factors.
• Use the results of the study to update trigger level values for patient follow up for skin reactions.
• Update recommendations for improving radiation protection of patients.
• Provide feedback for the needed development of the IAEA reporting and learning system SAFRAD.

The duration of this phase is one calendar year.

Who can participate?

Participation in the project is voluntary, and withdrawal is permitted at any stage of the project.

Medical facilities performing FGI procedures from all IAEA Member States can participate. There is no limitation on the number of facilities that can participate.

Different departments/ functional units of the same hospital may register independently or may provide a coordinated response. The same applies to facilities from a region or a country – coordinated data submission from the existing local, national or regional registries is also welcome.

A participating medical facility should perform complex FGI procedures of at least one of the following groups/ types of procedures on a regular basis:

• Cardiac interventions, such as: percutaneous coronary intervention (PCI); and especially chronic total occlusion (CTO); transcatheter valve implantations; cardiac ablation; percutaneous repair of septal defects.
• Neurovascular interventions, such as: intracranial or spinal embolization; intracranial and extracranial angioplasty, stenting and stent-assisted coiling; endovascular treatment of stroke; vertebroplasty/ kyphoplasty and vertebral augmentation with an implant; radiofrequency spine tumor ablation.
• Abdominal and thoracic interventions, such as: endovascular aneurysm repair (EVAR); transjugular intrahepatic portosystemic shunt (TIPS); transcatheteral embolisation in the abdomen and pelvis; hepatic chemo/radio-embolization (TACE and SIRT); treatment of arterial stenoses or occlusive disease in the abdomen or pelvis; percutaneous transhepatic biliary drainage (PTCD) and stenting; bronchial artery embolization; endovascular central venous reconstruction.

A participating medical facility should nominate a Facility coordinator who will coordinate data collection within the facility and be responsible for submission of deidentified data to the IAEA. Facility coordinators will receive detailed instructions and online support from the IAEA coordinator. They will also be invited to attend trainings and meetings organized by the IAEA. As the trainings and data submission will be in English, coordinators should have sufficient proficiency in this specific language.

The medical facility is responsible for adhering to the local rules and obtaining needed ethical approval for participation in this study.

Study methodology

Participating medical facilities should establish their internal procedure for follow-up of patients with a potential for developing tissue reactions. The guidance from the SAFRAD page can be used and training will be provided by the IAEA. All patients who exceeded one or more of the trigger levels should be effectively followed-up by the concerned health staff and the details need to be documented locally, including any clinically observed tissue effect. Photos of the observed tissue reaction should be added to the patient file. De-identified data for those patients who developed tissue effects should be submitted to the IAEA by following the specific instructions that will be provided to the facility coordinators.

Facilities should also keep records of procedures and patient exposure data for each fluoroscope separately, preferably using an automatic exposure monitoring system, or by using spreadsheets (a template will be provided by the IAEA) or other form of data collection. At least the following parameters should be available for all FGI procedures performed in the department during the study period:

• patient data (age, gender, patient weight);
• procedure type;
• dose and exposure parameters: total fluoroscopy time; total kerma-area product; total cumulative reference air kerma; peak skin dose (if provided by the equipment).

The individual patient records should be kept locally and not be submitted to the IAEA, but they will be needed for submitting two summary reports as detailed in the next section.

Data submission will be organized through a dedicated online data submission platform provided by the IAEA. The following data should be submitted using standard templates:

• During the first month of the study: Information about the facility and fluoroscopy equipment.
• Mid-term summary report based on the data collected during the first 6-months of the study.
• Annual summary report based on the data collected during one calendar year (12 months).

The mid-term and the annual reports will include:

• Description of any observed tissue reaction accompanied with the de-identified data of the individual patients, who developed such a reaction as a result of a FGI procedure during the study period.
• The summary information about the total number of FGI procedures performed in the facility and the number of patients for the reporting period who exceeded the pre-defined trigger levels. 

The study will not collect any personal data, except the name and email address of the Facility coordinator, which will be treated confidentially by the IAEA. Only de-identified data of patients who developed tissue reaction will be collected by the IAEA. All facility data submitted to the IAEA will be stored in a secure and confidential electronic format.

The IAEA will maintain confidentiality of each facility’s data at every step of this study, by ensuring that each user can only see the information pertaining to his/her facility, and the IAEA will not identify any practices, good or suboptimal, at any specific participating site.

No site-specific information will be provided from the IAEA to any national regulatory agency or other external or third party. However, the IAEA will provide summary information from the analyses of overall data, to serve as a benchmarking tool for individual facilities and for learning purposes. The first mid-term report, based on the six-months data collection, will be provided to the project participants, along with recommendations for improving data collection.

The final report after completion of the study will be made public, and feedback will be provided to the participating facilities. The results of this phase will inform the update/ upgrade of the SAFRAD database, the need to create additional training resources and aid in planning the second phase of the project.

The IAEA will maintain close contact with the facilities’ coordinators during the project through regular virtual meetings and training and will provide online expert support, reminders and feedback.

What are the benefits for the participating facilities?

Participating facilities will learn how to establish a follow-up programme for patients at risk for skin injuries that will help them improve management of patient overexposures and reduce unnecessary tissue reactions and adverse effects for patients from high dose FGI procedures.

Participating facilities will be acknowledged in the published reports. They will receive feedback and recommendations from international experts for optimizing FGI procedures and improving radiation protection in their departments.

At the international level, participating facilities will contribute to improving knowledge about tissue reactions and their correlation with the procedure and exposure factors.

How can my facility participate?

Individual medical facilities can express interest for participation by completing this online feedback form.

Existing local, national or regional registries that are interested to submit data should contact the IAEA by sending an email.