Radiation Safety in Cath Labs: A Systematic Review of Past and Current Practices By Florence Chike-Okeke A thesis submitted to the School of Radiologic Sciences in collaboration with a research agenda team In partial fulfillment of the requirements for the degree of MASTER OF SCIENCE IN RADIOLOGIC SCIENCES (MSRS) WEBER STATE UNIVERSITY Ogden, Utah August 14, 2024 THE WEBER STATE UNIVERSITY GRADUATE SCHOOL SUPERVISORY COMMITTEE APPROVAL of a thesis submitted by Florence Chike-Okeke This thesis has been read by each member of the following supervisory committee and by majority vote found to be satisfactory. ______________________________ Dr. Tanya Nolan, EdD Chair, School of Radiologic Sciences ______________________________ Dr. Robert Walker, PhD Director of MSRS Innovation & Improvement 2 THE WEBER STATE UNIVERSITY GRADUATE SCHOOL RESEARCH AGENDA STUDENT APPROVAL of a thesis submitted by Florence Chike-Okeke This thesis has been read by each member of the student research agenda committee and by majority vote found to be satisfactory. Date August 14, 2024 ____________________________________ Florence Chike-Okeke 3 Table of Contents Title Page 1 Table of Contents 4-6 Abstract 7 Acknowledgment 8 Chapter One • 1.0 Introduction 9 • 1.1 Problem Statement 10 • 1.2 Justification 11 • 1.3 Study Objectives 12 Chapter Two • 2.0 Literature Review 13 • 2.1 Historical Perspective 13 • 2.2 Current Practices 15 • 2.3 Effectiveness of Radiation Safety Protocols 17 and Dose Optimization Strategies • 2.4 Emerging Technologies and Innovative Approaches 18 for Enhancing Radiation Safety in Cath Labs • 2.5 Importance of Multidisciplinary Collaboration in Promoting 21 Radiation Safety in Cath Labs • 2.6 Future Directions and Recommendations 23 • 2.7 Established Best Practices in Personal Protective Equipment (PPE) 25 Chapter Three • 3.0 REVIEW METHODOLOGY 41 • 3.1 Search Strategy 41 4 Table of Content Cont’d • 3.2 Search Strategy 41 • 3.3 Inclusion and Exclusion Criteria 42 • 3.4 Screening Process 43 • 3.5 Data Synthesis 44 • 3.6 Data Collection Process 44 • 3.7 Data Analysis 45 • 3.8 Quality Assurance 46 • 3.9 Ethical Considerations 46 Chapter Four • 4.0 Results 47 • 4.1 Flow of the Systemic Review 47 • 4.2 Description of Included Study 47 • 4.3 Historical Evaluation of Safety Practice in Catheterization Laboratory 49 • 4.4 Current Status of Radiation Exposure in Catheterization Laboratory 50 • 4.5 Occupational Hazard in Catheterization Laboratory 54 • 4.6 Evaluation of the effectiveness of radiation safety protocol and dose 54optimization strategies in minimizing radiation exposure for healthcare and patients • 54 4.7 Identify Challenges and Barriers to Implementing Radiation Safety Measures in Catheterization Laboratory 54 Chapter Five • 5.0 Discussion and Conclusion 59 5 Table of Content Cont’d • 5.1 Discussion 59 • 5.2 Conclusion 60 • 5.3 Implication of the Study in Radiology Practice 60 References 62 6 Abstract Radiation exposure in catheterization laboratories (Cath labs) during interventional cardiology procedures poses significant occupational hazards to healthcare professionals and patients alike. This systematic review provides a comprehensive analysis of past and current practices surrounding radiation safety in Cath labs, focusing on radiation safety measures and policies, dose monitoring techniques, and strategies for dose optimization. Through synthesizing evidence from studies conducted over the years, this review offers insights into the historical progression and status of radiation protection practices in Cath labs that involve human, technological, and managerial aspects. Key challenges and opportunities for minimizing radiation risks for healthcare workers and patients are identified and underscore the importance of ongoing innovation, education, and collaboration to optimize radiation dose management in Cath labs and ensure the safe delivery of interventional cardiovascular procedures. Keywords: Radiation exposure, Cath labs, Radiation safety, Dose optimization, Fluoroscopy, Ionizing radiation, Occupational hazards, 7 Acknowledgments I would like to express my deepest gratitude to my advisor, Dr Tanya Nolan for her immense support, guidance, patience, and encouragement that gave me the strength to push through. My special recognition goes to Dr. Mrs. Ihuoma Ubosi, Dr. Gideon Okoroiwu, and Dr Emmanuel Obeagu for their invaluable contributions. My sincere appreciation goes to Cathy Wells of the School of Radiology Dept for your diligence throughout this period. I would also like to express my gratitude to my family for their love, encouragement, patience, and understanding, and to my colleagues at work for their support and understanding during this journey. And lastly to Weber State University for an opportunity for this work. 8 CHAPTER ONE 1.0 INTRODUCTION Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide, necessitating the widespread use of catheterization laboratories (Cath labs) for the diagnosis and treatment of various cardiac conditions. 1 Cath labs facilitate minimally invasive procedures such as angiography, angioplasty, and stent placement, offering significant benefits in terms of reduced patient morbidity, shorter recovery times, and improved clinical outcomes. 2 However, the use of ionizing radiation in these procedures poses inherent risks to both healthcare workers and patients, necessitating stringent radiation safety measures to minimize potential hazards.3 Over the years, technological advancements in imaging modalities and interventional techniques have revolutionized the field of interventional cardiology, enabling precise visualization of coronary anatomy and targeted treatment of obstructive lesions. 4 Fluoroscopy, a cornerstone of Cath lab procedures, provides real-time imaging guidance during interventions but is associated with prolonged radiation exposure, particularly for healthcare professionals who work close to the radiation source. 5,6 The historical evolution of Cath labs is marked by a gradual recognition of the risks associated with radiation exposure and the implementation of measures to mitigate these risks. 7 Early Cath lab procedures, dating back to the mid-20th century, were characterized by limited imaging capabilities and inadequate radiation protection measures, resulting in significant radiation exposure for both patients and operators.8 The advent of lead shielding, protective garments, and radiation monitoring devices represented important milestones in radiation safety, laying the foundation for subsequent advancements in the field. 9,10 Despite these advancements, concerns about radiation-induced health effects persisted, prompting ongoing efforts to refine radiation safety protocols and optimize dose management practices in Cath labs.11,12 In recent 9 decades, the increasing complexity of interventional procedures, coupled with the growing prevalence of chronic cardiovascular conditions, has underscored the importance of comprehensive radiation safety strategies correlated with the well-being of both patients and healthcare professionals.13 1.1 Problem Statement Radiation exposure in catheterization laboratories poses a significant occupational hazard to healthcare workers, including interventional cardiologists, nurses, and technicians. The prolonged and repeated exposure to ionizing radiation during fluoroscopically guided procedures increases the risk of radiation-induced health effects, such as cataracts, skin injuries, and malignancies, among medical staff. 14,15 Additionally, patients undergoing cardiac interventions are also susceptible to radiation-related complications, including skin injuries and stochastic effects such as cancer16,17. Despite advancements in radiation safety protocols and equipment, radiation exposure remains a concern due to the complex nature of interventional procedures and the need for prolonged fluoroscopy time and high-dose imaging techniques18,19. The lack of standardized radiation protection practices, inadequate training, and inconsistent adherence to safety guidelines further exacerbate the problem20,21. Moreover, the cumulative effects of radiation exposure throughout a healthcare worker's career raise long-term health concerns and underscore the need for continuous monitoring, optimization of radiation protection measures, and implementation of dose-reduction strategies in catheterization laboratories22,23. Therefore, the problem statement revolves around the urgent need to address radiation exposure in catheterization laboratories to safeguard the health and well-being of both healthcare workers and patients, emphasizing the importance of implementing effective radiation safety 10 measures and promoting a culture of radiation safety awareness in interventional cardiology practice. 1.2 Justification The current landscape of radiation exposure in catheterization laboratories is characterized by a delicate balance between the benefits of advanced imaging technologies and the potential risks of radiation-induced harm.11,24 While modern imaging modalities such as digital subtraction angiography (DSA) and flat-panel detectors have enabled dose reduction and improved image quality, concerns about cumulative radiation exposure and long-term health effects persist. Moreover, variations in radiation safety practices among healthcare facilities and operators highlight the need for standardized guidelines and best practices to ensure consistent adherence to radiation safety protocols. 22 The advent of real-time dose monitoring systems and dose optimization algorithms offers promising avenues for enhancing radiation safety in Cath labs by enabling operators to monitor radiation exposure in real-time and adjust procedural parameters to minimize dose. 25 However, it does not address occupational behaviors or risks for injury in an ever-demanding healthcare environment. In addition to occupational hazards, patients undergoing interventional procedures in Cath labs are also at risk of radiation exposure, particularly during complex interventions requiring prolonged fluoroscopic guidance.26–28 While the benefits of interventional cardiology procedures often outweigh the risks, efforts to minimize radiation exposure to patients through dose optimization techniques and radiation dose tracking are paramount. 29 Furthermore, the potential long-term health consequences of radiation exposure, including radiation-induced malignancies and cataracts, underscore the importance of vigilant radiation safety practices and continuous monitoring of radiation dose levels in Cath labs. 11,30 As such, there is a growing recognition of the need for multidisciplinary collaboration among healthcare providers, 11 radiation safety experts, regulatory agencies, and industry stakeholders to develop and implement evidence-based radiation safety guidelines and promote a culture of radiation safety in Cath labs worldwide.22,31 Radiation exposure in Cath labs remains a significant concern, necessitating ongoing efforts to optimize radiation safety protocols and minimize risks for both healthcare workers and patients.27,32,33, Through a comprehensive understanding of the historical evolution and current landscape of radiation safety practices in Cath labs, this systematic review aims to provide insights into key challenges and opportunities for enhancing radiation safety and ensuring the safe and effective delivery of interventional cardiovascular procedures. 1.3 Study Objectives This systematic review aims to evaluate past and current practices regarding radiation exposure in catheterization laboratories (Cath labs), focusing on technical, organizational, and human factors affecting safety practices spanning from the 1900s to the advent of lead contact shielding to the present day. The specific objectives of this present study are to: ⮚ review the historical evolution of radiation safety practices in Cath labs, including the development of protective measures and dose monitoring techniques over time. ⮚ assess the current radiation exposure status in Cath labs, including the prevalence of occupational hazards and patient risks associated with interventional procedures. ⮚ evaluate the effectiveness of radiation safety protocols and dose optimization strategies in minimizing radiation exposure for healthcare workers and patients in Cath labs. ⮚ identify challenges and barriers to implementing radiation safety measures in Cath labs, including variations in practice, resource constraints, and technological limitations 12 CHAPTER TWO 2.0 LITERATURE REVIEW Radiation is energy that comes from a source and travels through space at the speed of light, this energy has an electrical field and a magnetic field associated with it and has wave-like properties also called electromagnetic wave34. Exposure to ionizing radiation may cause skin and blood damage, cataracts, infertility, birth defects, and cancer. The probability of radiation adverse health effects is proportional to the dose received, but no level of radiation exposure is completely safe.35 Ionizing radiation has a deterministic or stochastic effect on exposed human tissues. These deterministic effects are dose-related and include both tissue reactions, such as skin necrosis, and increased risk for stochastic events, such as radiation-induced cancer. The development and refinement of advanced invasive cardiovascular procedures over the past 2 decades have led to increased exposure to both patients and medical personnel at the population level, between 1987 and 2006, exposure to medical radiation increased from 0.6 millisieverts (mSv) per year to 4 mSv.36 This exposure now exceeds that because of background radiation (average 3 mSv per year). 2.1 Historical Perspective Radiation control has always involved three important stakeholders whose contributions are the foundation of the practice of radiation safety historically and presently. They are the technical, organizational, and human aspects of radiation control practices in the Cath labs. The historical evolution of radiation safety practices in catheterization laboratories reflects a progressive recognition of the risks associated with ionizing radiation and the implementation of measures to mitigate these risks. 22,37 The early years of Cath lab procedures, dating back to 13 the mid-20th century, were marked by limited awareness of radiation hazards, inadequate protective measures, equipment that delivered radiation twice as much, and lack of regulations leading to significant radiation exposure for healthcare workers and patients. 8 During this period, fluoroscopy emerged as a pivotal imaging modality in interventional cardiology, enabling real-time visualization of cardiac anatomy and guidance during procedures. 38,39 However, fluoroscopy was associated with prolonged radiation exposure, particularly for healthcare professionals who operated the equipment and performed interventions close to the radiation source.40,41 In the absence of standardized radiation safety protocols, Cath lab personnel were often exposed to high levels of radiation without adequate protection. Lead shielding, such as aprons, thyroid shields, and protective eyewear, was gradually introduced to mitigate radiation exposure to healthcare workers.42,43 Additionally, radiation monitoring devices, such as dosimeters, were implemented to measure and track individual radiation doses, providing valuable data for assessing occupational radiation risks. 44,45 Despite these early advancements, concerns about radiation-induced health effects persisted, prompting the development of more stringent radiation safety guidelines and dose monitoring techniques. 42,46 Regulatory agencies and professional organizations began issuing recommendations and standards for radiation protection in Cath labs, emphasizing the importance of minimizing radiation exposure through dose optimization strategies and adherence to ALARA (As Low As Reasonably Achievable) principles.47,48 Technological innovations also played a significant role in improving radiation safety in Cath labs. The introduction of digital fluoroscopy systems and flat-panel detectors enabled dose reduction while maintaining image quality, allowing for more precise visualization of cardiac structures and reduced radiation exposure for patients and operators alike.49–51 Furthermore, advancements in radiation shielding materials and the ergonomic design of protective 14 equipment have enhanced comfort and compliance among healthcare workers, reducing the risk of musculoskeletal injuries associated with prolonged use of lead aprons. 52–54 In recent years, the integration of real-time dose monitoring systems and dose optimization algorithms has further improved radiation safety in Cath labs. 5,6 These systems provide operators with immediate feedback on radiation dose levels, allowing for adjustments in procedural parameters to minimize radiation exposure without compromising procedural success. 12,55 2.2 Current Practices and Challenges In contemporary catheterization laboratories, radiation safety remains a paramount concern, necessitating ongoing efforts to optimize practices and mitigate risks associated with ionizing radiation exposure. Despite significant advancements in technology and awareness of radiation safety principles, several challenges persist, impacting current practices in Cath labs. 1. Technological Advancements: Modern Cath labs are equipped with advanced imaging modalities, which offer superior image quality and dose reduction capabilities, such as digital subtraction angiography (DSA) and flat-panel detectors compared to conventional fluoroscopy systems. However, the rapid pace of technological innovation poses challenges in ensuring adequate training and proficiency among healthcare professionals in utilizing these complex systems effectively. 2. Occupational Hazards: Healthcare workers in Cath labs continue to face occupational hazards related to radiation exposure, including increased risk of radiation-induced malignancies, cataracts, and musculoskeletal injuries. Despite the use of lead shielding and protective equipment, prolonged and repeated exposure to ionizing radiation remains a significant concern, necessitating diligent adherence to radiation safety protocols and dose monitoring practices, also, musculoskeletal injuries due to long- 15 term use of heavy lead aprons leave the staff in chronic pain even after the end of their career in Cath labs. 3. Patient Safety: While the benefits of interventional procedures in Cath labs are wellestablished, patients undergoing these procedures are also at risk of radiation exposure. Complex interventions requiring prolonged fluoroscopic guidance may result in higher radiation doses to patients, increasing the risk of radiation-induced skin injuries and long-term health effects. Strategies for optimizing radiation dose to patients while maintaining procedural success are essential for ensuring patient safety in Cath labs. 4. Procedural Complexity: The increasing complexity of interventional procedures in Cath labs, such as chronic total occlusion (CTO) interventions and structural heart interventions, poses challenges in minimizing radiation exposure while achieving optimal procedural outcomes. Operators may face difficulty in balancing the need for adequate imaging guidance and the goal of reducing radiation dose to patients and staff, particularly during lengthy and technically demanding procedures. 5. Radiation Safety Culture: Establishing a strong radiation safety culture in Cath labs is essential for promoting awareness, accountability, and compliance with radiation safety practices among healthcare professionals. However, maintaining a culture of safety requires ongoing education, training, and reinforcement of best practices, as well as organizational support and leadership commitment to prioritizing radiation safety initiatives. 6. Resource Constraints: Limited resources, including staffing shortages, budget constraints, and competing priorities, may present challenges in implementing comprehensive radiation safety programs in Cath labs. Adequate staffing levels, access to training and continuing education opportunities, and investment in radiation safety 16 infrastructure are essential for overcoming resource constraints and ensuring safe working environments for healthcare professionals. 7. Regulatory Compliance: Compliance with regulatory requirements and accreditation standards for radiation safety in Cath labs is essential for maintaining quality and safety in patient care. However, navigating complex regulatory frameworks and ensuring adherence to evolving guidelines and recommendations may pose challenges for healthcare organizations, particularly in resource-limited settings. 8. Data Collection and Monitoring: Effective data collection and monitoring systems are essential for evaluating radiation exposure levels, identifying areas for improvement, and implementing targeted interventions to optimize radiation safety practices in Cath labs. However, the challenges of data collection, integration, and analysis may hinder efforts to track radiation doses, monitor compliance with safety protocols, and assess long-term health outcomes. 2.3 Effectiveness of Radiation Safety Protocols and Dose Optimization Strategies Radiation safety protocols and dose optimization strategies are critical components of radiation protection efforts in catheterization laboratories. These measures aim to minimize radiation exposure to both healthcare workers and patients while maintaining optimal image quality and procedural success. Evaluating the effectiveness of these protocols and strategies involves assessing their impact on reducing radiation dose levels, mitigating occupational hazards, and ensuring patient safety. 1. Radiation safety protocols: The use of lead shielding, protective equipment, and positioning aid, have been shown to effectively reduce radiation dose levels for healthcare workers in Cath labs. Studies have demonstrated significant reductions in radiation dose exposure with the implementation of lead aprons, thyroid shields, and 17 ceiling-suspended radiation shields, particularly for personnel working near the radiation source. 2. Dose Optimization Algorithms: Dose optimization algorithms use advanced image processing techniques to enhance image quality while reducing radiation dose exposure. By optimizing imaging parameters, such as pulse rate, pulse width, and dose rate modulation, these algorithms can achieve dose reductions of up to 50% without compromising diagnostic accuracy or procedural outcomes. Studies have shown that dose optimization algorithms can significantly reduce radiation dose levels for both patients and operators during interventional procedures. 3. Staff Education and Training: Comprehensive education and training programs are essential for ensuring healthcare workers are proficient in radiation safety protocols and dose optimization strategies. Training initiatives should cover topics such as radiation physics, radiation biology, dose monitoring techniques, and best practices for minimizing radiation exposure. Studies have demonstrated that targeted education and training programs can improve radiation safety knowledge, compliance with safety protocols, and overall radiation safety culture in Cath labs. 4. Quality Assurance Programs: Quality assurance programs play a crucial role in ensuring the effectiveness of radiation safety protocols and dose optimization strategies. These programs involve regular monitoring of radiation dose levels, equipment performance, and compliance with safety guidelines to identify areas for improvement and implement corrective actions. By establishing robust quality assurance programs, healthcare organizations can maintain high standards of radiation safety and ensure continuous optimization of dose management practices. 2.4 Emerging Technologies and Innovative Approaches for Enhancing Radiation Safety in Cath Labs: 18 As the demand for interventional cardiovascular procedures continues to rise, there is a pressing need for innovative approaches and emerging technologies to enhance radiation safety in catheterization laboratories. These advancements aim to reduce radiation exposure for both healthcare workers and patients while maintaining optimal procedural outcomes. Several promising technologies and strategies are being developed and implemented to address this critical issue: 1. Real-Time Dose Monitoring Systems: Real-time dose monitoring systems provide immediate feedback on radiation dose levels during procedures, enabling operators to adjust imaging parameters and procedural techniques to minimize radiation exposure. These systems utilize advanced sensors and software algorithms to track radiation dose rates, cumulative dose levels, and dose distribution patterns in real-time, facilitating proactive dose management and optimization. 2. Dose Tracking Software: Dose tracking software enables healthcare organizations to monitor radiation dose levels over time, identify trends, and implement targeted interventions to optimize radiation safety practices. These software platforms integrate with existing electronic health record systems and imaging equipment to collect and analyze dose data, generate dose reports, and facilitate compliance with regulatory requirements and quality assurance initiatives. 3. Artificial Intelligence (AI) Algorithms: AI-driven algorithms are being developed to optimize imaging parameters and reduce radiation dose exposure during procedures. These algorithms analyze procedural data, patient characteristics, and imaging requirements to generate personalized dose optimization strategies, such as dose rate modulation, pulse rate adjustment, and image noise reduction, tailored to individual patient needs and procedural complexity. 19 4. 3D Image Reconstruction: Three-dimensional (3D) image reconstruction techniques enable operators to visualize cardiac anatomy and guide interventions with higher precision and lower radiation dose exposure. Advanced reconstruction algorithms, such as iterative reconstruction and model-based iterative reconstruction, improve image quality while reducing noise and artifacts, allowing for more accurate diagnosis and treatment planning with reduced radiation dose. 5. Low-Dose Imaging Modalities: Low-dose imaging modalities, such as low-dose fluoroscopy and low-dose computed tomography (CT), offer alternatives to conventional imaging techniques for reducing radiation dose exposure in Cath labs. These modalities utilize optimized acquisition protocols, dose reduction filters, and noise reduction algorithms to achieve diagnostic image quality with lower radiation dose levels, particularly for routine diagnostic imaging and follow-up studies. 6. Radiation Shielding Materials: Advancements in radiation shielding materials, such as lead-free aprons, lightweight lead glasses, and radiation-blocking drapes, improve comfort and compliance among healthcare workers while maintaining effective radiation protection. These materials offer equivalent or superior radiation attenuation properties compared to traditional lead-based shielding, reducing the risk of musculoskeletal injuries and promoting long-term adherence to radiation safety protocols. 7. Remote Monitoring and Telemetry: Remote monitoring and telemetry systems enable real-time monitoring of radiation dose levels and equipment performance from a centralized control room, reducing the need for direct operator exposure in the Cath lab. These systems utilize wireless communication technology and cloud-based platforms to transmit dose data, alarm notifications, and equipment status updates to 20 remote monitoring stations, enhancing situational awareness and enabling timely intervention in response to radiation safety events. 8. Educational and Training Initiatives: Comprehensive education and training initiatives are essential for ensuring healthcare professionals are proficient in radiation safety practices and aware of emerging technologies and innovative approaches for enhancing radiation safety in Cath labs. Simulation-based training programs, handson workshops, and online educational resources provide opportunities for healthcare workers to learn and practice radiation safety techniques in a controlled environment, fostering a culture of safety and continuous improvement in Cath lab practice. 2.5 Importance of Multidisciplinary Collaboration in Promoting Radiation Safety in Cath Labs: Multidisciplinary collaboration among healthcare providers, radiation safety experts, regulatory agencies, and industry stakeholders is essential for promoting a culture of radiation safety and implementing evidence-based guidelines in catheterization laboratories (Cath labs). This collaborative approach brings together diverse perspectives, expertise, and resources to address complex challenges and ensure the highest standards of radiation safety for both healthcare workers and patients. Several key reasons highlight the importance of such collaboration: 1. Comprehensive Expertise: Multidisciplinary collaboration enables the pooling of expertise from various fields, including cardiology, radiology, radiation physics, occupational health, and regulatory compliance. Each stakeholder brings unique insights and knowledge to the table, contributing to a holistic understanding of radiation safety issues and facilitating the development of comprehensive solutions. 2. Risk Assessment and Mitigation: Collaborative efforts allow for comprehensive risk assessment and mitigation strategies to be developed and implemented in Cath labs. 21 Radiation safety experts can conduct thorough evaluations of radiation hazards, assess potential risks to healthcare workers and patients, and recommend appropriate protective measures and dose optimization strategies. Regulatory agencies provide oversight and guidance to ensure compliance with safety standards and regulations, while industry stakeholders contribute technological innovations and best practices to enhance radiation safety. 3. Standardization of Practices: Multidisciplinary collaboration fosters the development of standardized practices and guidelines for radiation safety in Cath labs. By bringing together stakeholders from diverse backgrounds, consensus can be reached on best practices, protocols, and quality assurance measures. Standardization promotes consistency in radiation safety practices across healthcare facilities, enhances clarity and accountability, and facilitates benchmarking and continuous quality improvement initiatives. 4. Education and Training: Collaborative efforts support the development and implementation of comprehensive education and training programs for healthcare workers in Cath labs. Radiation safety experts can design curricula, deliver training sessions, and provide ongoing support to ensure that healthcare professionals are proficient in radiation safety practices and aware of emerging technologies and guidelines. Regulatory agencies can mandate training requirements and provide accreditation for educational programs, while industry stakeholders can offer resources and support for training initiatives. 5. Research and Innovation: Multidisciplinary collaboration fosters research and innovation in the field of radiation safety, driving advancements in technology, practices, and policies. Collaborative research projects enable the evaluation of new technologies, dose optimization techniques, and interventions aimed at reducing 22 radiation exposure and improving outcomes for patients and healthcare workers. Industry stakeholders play a crucial role in funding research, developing new technologies, and translating research findings into clinical practice. 6. Continuous Improvement: Collaboration among stakeholders facilitates continuous improvement in radiation safety practices and outcomes in Cath labs. Regular communication, feedback, and knowledge sharing enable healthcare providers to identify areas for improvement, implement changes, and monitor the effectiveness of interventions over time. By fostering a culture of continuous learning and improvement, multidisciplinary collaboration ensures that Cath labs remain at the forefront of radiation safety excellence. 2.6 Future Directions and Recommendations The future of radiation safety in catheterization laboratories (Cath labs) hinges on continued innovation, collaboration, and adherence to evidence-based practices. As technology evolves and interventional procedures become increasingly complex, it is essential to proactively address emerging challenges and opportunities to optimize radiation safety. The following recommendations outline future directions for advancing radiation safety in Cath labs: 1. Integration of Artificial Intelligence (AI): Explore the potential of artificial intelligence (AI) algorithms to optimize radiation dose management in Cath labs. Develop AI-driven software tools capable of analyzing procedural data, predicting radiation dose levels, and providing real-time feedback to operators to facilitate personalized dose optimization strategies. 2. Enhanced Training and Education: Prioritize radiation safety training and education for healthcare professionals working in Cath labs. Develop comprehensive educational programs covering radiation physics, safety protocols, dose monitoring techniques, and best practices for minimizing radiation exposure. Implement simulation-based 23 training modules and ongoing competency assessments to ensure proficiency among staff. 3. Standardization of Dose Metrics: Establish standardized metrics for assessing radiation dose exposure in Cath labs. Develop consensus guidelines for measuring and reporting radiation dose levels, including air Kerma, Kerma-area product (KAP), fluoroscopy time, and cumulative dose indices. Standardization facilitates data comparability, quality assurance, and benchmarking across healthcare facilities. 4. Advancements in Imaging Technology: Invest in research and development initiatives to advance imaging technology and dose reduction techniques in Cath labs. Explore novel imaging modalities, such as low-dose fluoroscopy, spectral imaging, and iterative reconstruction algorithms, to achieve diagnostic image quality with lower radiation dose exposure for patients and healthcare workers. 5. Personalized Dose Optimization: Embrace personalized dose optimization strategies tailored to individual patient characteristics and procedural requirements. Develop algorithms capable of predicting patient-specific radiation dose levels based on demographic factors, anatomy, and procedural complexity. Implement real-time dose monitoring systems to adjust imaging parameters and procedural techniques to minimize radiation exposure while maintaining optimal image quality. 6. Multi-Modal Imaging Integration: Integrate multi-modal imaging techniques, such as ultrasound, magnetic resonance imaging (MRI), and nuclear imaging, with fluoroscopy in Cath labs. Utilize complementary imaging modalities to reduce reliance on fluoroscopy, minimize radiation dose exposure, and enhance procedural guidance and diagnostic accuracy. 7. Collaborative Research Initiatives: Foster collaborative research initiatives involving academia, healthcare institutions, industry partners, and regulatory agencies 24 to address key challenges and opportunities in radiation safety. Prioritize research areas such as dose optimization strategies, long-term health outcomes, radiationinduced malignancies, and the effectiveness of radiation shielding materials and protective equipment. 8. Global Harmonization of Standards: Advocate for global harmonization of radiation safety standards and guidelines in Cath labs. Collaborate with international organizations, regulatory bodies, and professional societies to develop consensus guidelines, share best practices, and promote knowledge exchange across geographic regions. Facilitate international collaborations and initiatives to address regional disparities in radiation safety practices and outcomes. 9. Patient-Centered Care: Prioritize patient-centered care in radiation safety initiatives in Cath labs. Engage patients in shared decision-making regarding radiation exposure risks, informed consent, and alternative imaging options. Implement strategies to minimize radiation dose exposure for vulnerable patient populations, such as pediatric patients, pregnant women, and individuals with pre-existing conditions. 10. Continuous Quality Improvement: Implement robust quality assurance programs to monitor and optimize radiation safety practices in Cath labs. Establish performance metrics, conduct regular audits, and review adverse events to identify areas for improvement and implement corrective actions. Foster a culture of continuous learning, feedback, and improvement among healthcare providers and staff. 2.7 Established Best Practices in Personal Protective Equipment (PPE). The current practice requires all members of the CCL team to wear personal protective equipment with at least lead body aprons and thyroid shields. Some operators also use leaded skull covering, leaded eyeglasses, and arm shields. Conventional lead aprons are now being 25 replaced with newer aprons made of lighter materials that include aluminum, antimony, barium, bismuth, tungsten, tin, and titanium. Some of these materials may reduce personal protective apron weight by 20% to 40%.56 Yet, these composite aprons may still pose a significant cumulative orthopedic burden to the members of the CCL team. Moreover, many composite garments did not meet manufacturer-stated lead equivalence when attenuation was tested under scattered radiation57. A protective apron lead thickness standard of 0.5 mm should stop 95% of scatter radiation, and protective integrity should be checked regularly58. Every CCL should have a ceiling-mounted, movable upper-body shield and lower-body shield mounted on the side of the patient table57. A ceiling-suspended screen and a curtain shield under the table reduce scatter radiation by approximately 80% to 90%.59,60 The protective shielding should form a continuous “curtain” between the operator and the radiation source. Portable lead acrylic mobile shields can be used to further protect the nursing and ancillary staff. These shields can be placed in proximity to the patient to increase protection during prolonged fluoroscopy procedures such as electrophysiology (EP) procedures, and structural heart or CTO coronary interventions. Healthcare Workers with the Highest Radiation Exposure Risk In the era of structural heart disease and complex EP or coronary interventional procedures, personnel at risk include not only the patient and primary operators but also radiology technologists, nursing staff, ancillary physicians such as anesthesiologists and echocardiographers as well as device representatives61. The positions of these team members around the X-ray table often determine the exposure risk. An interventional cardiologist’s radiation exposure varies with the length and complexity of the procedure, patient characteristics, and radiation protection equipment available 62. When compared to staff interventional cardiologists, fellows-in-training are at higher risk of radiation 26 exposure63. When adjusting for complexity, a prospective trial found that fellows-in-training were exposed to 34% more radiation than staff interventionalists. This finding is likely attributable to fellows’ eagerness to learn and to place patient safety over their own, failure to optimize collimation settings, and acquisition of more fluoroscopy recordings than necessary63. Studies have shown anesthesiologists to be at high risk of radiation exposure, which is likely attributable to ineffective shielding during procedures. 64 Despite being near equal distances to the C-arm, scrub nurses and radiation technicians received 1/15th the amount of radiation compared to anesthesiologists due to adequate shielding and positioning behind the primary operator. 64 Special Population at Risk A special population at risk is pregnant women. Radiation exposure can have deleterious effects on the fetus including delayed mental development, intrauterine growth retardation, and organ malformation65. There is no difference in fetal outcomes in women exposed to a cumulative radiation dose <50 mGy during their pregnancy when compared to the general population. Consequently, the National Council on Radiation Protection and Measurements has limited cumulative exposure to 0.5 mSV per month or to a total of 5 mSV during the span of the pregnancy65. During most PCIs, the patient may receive a total of 8 to 10 mSv of radiation. However, more complex procedures and increased patient body mass index may increase cumulative radiation exposure65. Electrophysiological (EP) procedures may give patients an effective dose of 6.6 to 59.7 mSV for atrial fibrillation ablation and up to 95 mSV for cardiac resynchronization therapy implantations. This compares up to 16 mSv for diagnostic coronary angiograms and 57 mSv for PCI and structural procedures 64. Electrophysiologists are also at increased risk of radiation exposure compared to other interventionists, particularly during implantation of cardiac pacing and other similar devices 66. 27 In these cases, factors that contribute to increased exposure include positioning of the operator on the left side of the patient with a lack of proper shielding to accommodate these procedures, longer fluoroscopy time with cardiac resynchronization device implants, and unprotected scatter from the patient. Cath Lab staff should be routinely re-educated about radiation safety, including considerations for pregnant patients and staff. Staff should be encouraged to advocate for appropriate protective equipment or implement systems changes to meet safety standards. Best practices in the Cath Lab are provided below along with advanced practices and enhancements in each of these categories. Table 1: Best practices in the cardiac catheterization laboratory with associated advanced practices and enhancements. Current practices Advanced practices Benefits of novel technology Accessory Personal Dosimeter badges protective equipment (PPE) - RaySafe i2 system Real-time dose detection Thyroid shield: standard nominal thickness of 0.25 to 0.5 mm of lead, with effective shielding area ∼300 cm2- Tight fit of thyroid collar around neck Reduce risk of thyroid cancers Leaded glasses: optimal thickness of 0.35 mm to 0.5 mm of lead - Proper fit and facial contour.- Reduce gap between lens and frameMaximize front, lateral, and angular protection Reduce rates of cataracts Reduced fluoroscopy intensity or time - Decreasing frame rate - Fluoro-save Minimize cine usage Collimation - Automatic dose rate control (ADRC) - ControlRad Precise collimation of area of interest Avoid magnification - Live Zoom Decrease magnification which increases radiation Operator techniques -Bismuth masking reagent 28 Environmental radiation protection Distance to table Tubing extensions on contrast injectors Allows operator to stay further away during imaging Ceiling-mounted upperbody radiation shields and movable tablemounted curtain shields -RADIATION - Patient Pelvic shielding - RADPAD - EggNest-XR system - Steradian vertical radiation shield Greatly reduce scatter to the operator and the rest of the team from both above the table and under the table. Lead aprons and portable - Zero-Gravity system radiation shields - Rampart M1128 Reduces radiation drastically with large Radiation Monitoring All CCL staff should have their radiation exposure monitored with a dosimeter. Radiation safety officers are responsible for reviewing dosimeter data so staff may receive feedback on proper dosimeter placement and methods to reduce radiation exposures67. However, standard dosimeters are limited by the lack of real-time updates on cumulative high-grade exposure, and generally, staff may not be notified for weeks to months until their dosimeter is due for review. The development of a real-time radiation level display allows staff to actively react and use radiation reduction strategies to limit exposure. The novel RaySafe i2 system68 (RaySafe) offers real-time x-ray radiation dose monitoring for CCL staff, where the detector badges relay live dose data to a display monitor in the laboratory69. Teams can all see their personal radiation exposure on an overhead screen in the laboratory and adjust positions or make other changes to lower their exposure. Laboratory Equipment Modifications to Reduce Exposure Newer-generation angiography systems utilize low-dose imaging technologies. Hardware advancements include improved X-ray tubes, flat panel detectors, spectral beam shaping filters, and pulsed fluoroscopy. Advancements in software have improved image quality, reduced 29 noise at lower radiation dose settings, and avoided unnecessary use of cine angiography 22,70,71. The generation of x-radiation is reviewed elsewhere and is beyond the scope of this paper. To summarize, energy conversion takes place within the x-ray tube. The quantity (exposure) and quality (spectrum) of the x-radiation produced automatically adjust the electrical quantities (kVp, mA) and exposure time applied to the tube. 27,72 The different X-ray machines on the market have built-in functions to automatically reduce or increase radiation delivery to obtain optimal angiographic images. Furthermore, default protocols for patients of low weight or pediatric age or those undergoing an EP procedure have a tailored approach that utilizes low energy while maintaining high image quality. Operators can choose from patient-specific protocols to optimize image acquisition while limiting radiation exposure.33,73 Operator Techniques Recent updates to best practices in radiation safety in the CCL have reiterated important concepts and advances in the technical generation and recording of X-ray imaging. The primary mechanism for radiation exposure to the operator and staff is radiation scatter coming from the patient. Therefore, reducing patient radiation directly reduces scatter radiation to everyone else in the room. The guiding principle of radiation safety is “ALARA,” which stands for “as low as reasonably achievable.” Radiation exposure is dependent on time, distance, and shielding 38. Operators and staff must maintain good working habits and constant radiation situational awareness to minimize radiation exposure. Techniques that should be implemented include the following: i. Reduce fluoroscopy time. Activation of the fluoroscopy unit should be minimized by avoiding pressing the fluoroscopy pedal when not looking at the image. 30 ii. Minimize fluoroscopy and cine frame rates. A reduction of the fluoroscopic rate from 15 frames/s to 7.5 frames/s with a low-dose fluoroscopy mode reduces radiation exposure by 67%6. This is especially important for prolonged interventions, such as CTO PCI and some EP cases. The radiation dose of cine angiography image acquisition is also about 6 to 10 times higher than during fluoroscopy74. Therefore, one should minimize the use of cine when possible. Most CCLs now have a “store last fluoroscopy image” (i.e., “fluoro-save”) function that can reduce the need for cine and document the different steps of the procedure75 . Optimize magnification and collimation. Increasing magnification results in increased radiation and should be minimized. Some modern systems allow for magnification without additional radiation (i.e., “Live Zoom” feature). This enlarges the image on the field of view without the added radiation. Using collimators and focusing only on the field of interest helps reduce radiation to the patient and thus reduce radiation scatter. In a room with a large flat panel detector, collimation should be used to focus on the anatomy of interest and avoid other body areas of no interest. 22,71. Many systems have integrated dose rate control functions that automatically select exposure parameters for different field exposures by utilizing the shutters. Devices developed to reduce radiation also include the recent Food and Drug Administrationapproved Control Rad by Boston Scientific which precisely collimates the area of interest and reduces the dose significantly to peripheral areas in the image76 31 Figure 1: Employ best techniques for distance, angulation, and table position Diagrammatic Representation of an X-Ray Fluoroscopy System to Illustrate X-Ray Exposure Modality. (A) The primary beam, collimated to a rectangular cross-section, enters the patient, typically through the patient’s back. The magnitude of beam exposure can be reduced by minimizing the use of magnification, using collimators, decreasing frame rate, and minimizing the use of cine. (B) The beam attenuates upon passing through the patient and is scattered within the imaging field. The scattered radiation exposes personnel to radiation. Scatter can be reduced by increasing the distance of the operator from the radiation source, keeping the image detector close to the patient, and increasing table height to maximal elevation to increase the distance from the X-ray generator to the patient. (C) Radiation exposure can also be reduced using proper shielding techniques and by (D) avoiding steep angulation to reduce scatter. Adapted from Hirshfeld et al (2018) with permission from Elsevier. 32 Increasing the distance from the operator to the radiation source can significantly reduce radiation exposure. The inverse square law for radiation means that doubling the distance between the primary beam and the operator reduces radiation by 4-fold. It is a good practice to use trigger extensions on contrast injectors to allow operators to stand further away from the radiation beam during image acquisition. Minimizing the use of steep angles of the x-ray beam can have a significant decrease in radiation scatter.30 Steep angles, such as steep cranial or caudal views, increase the path beam length within the patient resulting in higher radiation scatter and up to a 3-fold increase in radiation dose. The left anterior oblique (LAO) cranial angulation has the highest degree of scatter exposure to the operator on the right side of the patient (Diagram below). 33 Figure 2: Steep Angles of the X-ray Beam Radiation dose to the operator. Calculated dose lines in a three-dimensional graph of the operator’s mean personal dose per time (Sv/h), as a function of tube angulation. LAO; left anterior oblique; PA, posteroanterior; RAO, right anterior oblique. Adapted from Kuon et al 30 with permission from Elsevier. Another precaution to specifically decrease exposure to the operator is to optimize the table height, i.e. the distance of the image detector to the patient, and the operator position. Methods to reduce exposure to radiation scatter include minimizing the distance between the image detector and the patient (low subject–image distance) and maximizing the table height from the x-ray tube while still maintaining operator comfort (Diagram below). 34 Figure 3: Diagrammatic Representation of the Effect of System Positioning on Patient and Operator Radiation Exposure During X-ray Fluoroscopy. Note that in the “table too low” circumstance, the entrance port dose delivered to the patient is increased compared with optimal positioning. In the “table too low, detector too high” circumstance, the entrance port dose to the patient is further increased. In addition, in the “table too low” circumstance, the scattered dose to the operator increases because less of the scattered dose is intercepted by the detector. Adapted from Hirshfeld et al (2018) with permission from Elsevier. Procedural Access (Radial Versus Femoral) Coronary angiography and PCI via radial access have continued to grow in use worldwide. Although data has been mixed, some publications suggest that trans-radial access may be associated with higher radiation77–79. Interestingly, data from the French multicenter RAY'ACT-1 study showed that radial access was associated with lower radiation than femoral access in high-volume center 80. Several variables influence radiation exposure with radial access, with the most notable being institutional and operator familiarity and volume, patient characteristics and comorbidities, laterality (e.g., right vs left radial access), and equipment or catheter selection 79,81. A meta-analysis of randomized controlled trials reporting primary outcomes of fluoroscopy time and dose-area product between trans-radial and transfemoral approaches between the years 2014 and 2021 showed that although the radial approach was associated with increased radiation exposure, the gap has decreased from year to year with crossover around the year 201979. As radial access operators’ competency increases, the decision to perform radial or femoral access will not be made based on radiation exposure but rather on patient and procedural needs. Choosing one access approach over another likely does 35 not mitigate radiation dose exposure. Nonetheless, this emphasizes the overall importance of reducing radiation exposure for all cases in the CCL. Removing the Operators from the Source: Robotic-Assisted Interventions The Corindus CorPath (Siemens Medical Solutions USA, Inc) is a Food and Drug Administration-approved technology designed to relocate the operator from bedside to a remote console permitting the operators to perform procedures from a distance—dramatically reducing exposure and ergonomic hazards (DIAGRAM BELOW). Using a robotic system allows operators to shed their lead aprons and sit in a lead-lined booth away from the radiation field to remotely control catheters82. 36 Figure 4: The Corindus Corpath Uses A Robotic System That Relocates The Operator From Bedside To A Remote Console To Perform Procedures From A Distance. Corpath GRX robotic system for use during percutaneous coronary interventions. Reprinted with permission from Siemens Medical Solutions Inc. The large-scale multicenter PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) study of the Corindus CorPath robotic PCI system showed 98.8% technical success rate without device-related complications and 97.6% clinical procedural success with 2.4% having periprocedural non–Q-wave myocardial infarctions. Although radiation exposure was not a clinical endpoint, there was a median reduction of radiation exposure of 95.2% as well as the benefit of spending a significant portion of the procedure sitting in the console 83. Without the need for lead aprons, this minimizes the risk of orthopedic or musculoskeletal injury. As procedural complexity in coronary intervention grows, robotic-assisted percutaneous intervention becomes increasingly valuable for its ability to reduce operator occupational exposure. CORA-PCI (Complex Robotically Assisted Percutaneous Coronary Intervention) demonstrated the technical success rate of robotic PCI to be comparable to manual PCI (P = 1.00) for more complex cases, excluding atherectomy, planned 2-stent bifurcation lesions or CTO where a hybrid robotic-manual approach is required. CORA-PCI showed a significant reduction in the dose-area product (cGy∗cm2) in the robotic versus manual PCI groups (P = 0.045), although overall fluoroscopy time was not significantly different (P = 0.39) 46. The Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease study demonstrated the feasibility of robotic peripheral vascular interventions. The small single-arm study enrolled 20 subjects and evaluated device technical success (defined as successful cannulation of the target vessel using the CorPath 200 system), device safety (defined as an absence of device- 37 related serious adverse events), and clinical procedural success (< 50% residual stenosis without unplanned manual conversion or assistance or periprocedural device-related adverse events). RAPID demonstrated similar fluoroscopy time (7.1 ± 3.2 min) and contrast use 73.3 ± 9.2 mL) to manually perform peripheral cases in similar patient cohorts 83. Although roboticassisted intervention is a promising approach to reducing radiation exposure for operators, it does not confer immediate protection for the rest of the CCL team. The potential benefits of robotics and automation of other CCL staff roles should be further explored. Current Methods for Radiation Protection Several technologies are now available that can markedly reduce scatter radiation, and even remove the operator from the radiation field altogether. These approaches may allow CCLs to achieve the goal of removing lead aprons altogether. The diagram below provides an overview of potential areas to reduce radiation84. 38 Figure 5: Diagram Above Shows The Current Best Practices To Minimize Radiation Exposure To The Patient And Operator In The Cardiac Catheterization Laboratory. Thyroid Shielding The association between radiation exposure and risks of thyroid cancer has been well established. The risk is proportional to cumulative dose exposure and age at exposure, with greater risk at younger ages, particularly less than 20 years of age 85. Limited studies have compared thyroid shield designs and radiation exposure. One study showed that a properly fitted thyroid collar with a bismuth masking reagent compared to a collar that was too tight or too loose on the neck resulted in the lowest radiation exposure in μSv/min during C-arm fluoroscopy86. Eye Protection Protective eyewear provides maximal shielding from front, lateral, and angular radiation while maintaining good vision and reducing eye fatigue. Studies comparing radioprotective eyewear have demonstrated that the optimal thickness for lead glass is 0.35 mm to 0.5 mm. The gap between the lens and frame of the radioprotective eyewear and the length of the front radioprotective glass contribute significantly to angular protective shielding. 88 Materials used in eyewear include Kynetium, Grilamid, titanium, and carbon fiber with clear lead protective lenses. Anti-reflective coatings and anti-fog coatings are also featured on some designs. The proper fit and facial contour are important for reducing penetrating radiation exposure. Special considerations for individuals with certain facial features brought new designs considering the diverse facial formations – high nose bridges and flatter ones. 39 Patient Applied Radiation Shields A simple lead apron applied on the patient is a feasible, practical, and inexpensive shielding method. Pelvic lead shielding of the patient has been reported to reduce radiation exposure significantly for the operator, during cardiac catheterization in both femoral and radial approaches. Disposable radiation shielding pads such as the RADPAD (Worldwide Innovations & Technologies, Inc) are sterile, disposable, lead-free shields placed on the patient between the image intensifier and the operator, and that have been shown to reduce radiation exposure to the operator in multiple trials89. In conclusion, A successful catheterization Laboratory radiation safety program must manage patient and staff safety by reducing exposure to ionizing radiation to a level that is as low as reasonably achievable (ALARA) whenever ionizing radiation is required for invasive cardiology procedures, radiation protection will continue to evolve. Novel innovations in personnel protection and patient-centered room shielding will significantly reduce exposure. It is a common goal to apply best practices to reduce radiation exposure and embrace proven technologies leading to a more efficient, safer, and comfortable lead-free working environment. 40 CHAPTER THREE 3.0 REVIEW METHODOLOGY 3.1 Study Design Retrospective cohort studies were adopted to assess historical data on radiation exposure in the Cath Lab. These studies provided insights into long-term trends, cumulative doses, and associated health outcomes among Cath Lab personnel and patients. They were chosen for their ability to analyze large data sets and identify potential risk factors for excessive radiation exposure. 3.2 Search Strategy The search strategy for this review involved comprehensive literature searches across electronic databases, including PubMed, Scopus, Web of Science, and Google Scholar. The search terms used were "radiation exposure," "catheterization laboratory," "interventional cardiology," "radiation safety," and "dose optimization." Boolean operators (AND, OR) were used to combine search terms and broaden the scope of the search. The search was limited to articles published in English-language journals. Table 1:Complete Search Strategy S/N Concept Search Terms 1 Radiation “Radiation exposure*” OR “Radiation occurrence” OR “Radiation safety*” 2 Exposure “Exposure protection*” OR “Exposure safety” OR “Exposure mechanism” 41 3 Catheterization Laboratory “Catheterization laboratory*” OR “Catheterization procedure” OR “Catheterization Laboratory techniques” 4 Safety Practices “Safety Practices*” OR “Safety procedures” OR “Safety protocols” OR “Occupational Hazard*” “Prevalence of occupational hazards” OR “Barriers*” 3.3 Inclusion and Exclusion Criteria 3.3.1 Inclusion Criteria 1. Relevance: Studies focusing on radiation exposure in catheterization laboratories, particularly in the context of interventional cardiology procedures. 2. Study Type: Original research articles, review articles, systematic reviews, metaanalyses, and guidelines. 3. Scope: Articles addressing radiation safety measures, dose monitoring techniques, dose optimization strategies, technological advancements, educational initiatives, and regulatory guidelines. 4. Publication Date: Articles published from 2010 to 2024 to capture recent advancements and developments in the field. 5. Peer-Reviewed: Articles published in peer-reviewed journals to ensure the quality and reliability of information. 3.3.2 Exclusion Criteria 1. Irrelevant Studies: Studies not related to radiation exposure in catheterization laboratories or interventional cardiology procedures. 2. Duplicate Publications: Duplicate articles or redundant data published in multiple sources. 42 3. Non-English Language: Articles published in languages other than English due to language barriers. 4. Conference Abstracts: Abstracts, posters, conference proceedings, and non-peerreviewed sources lacking detailed methodology and results. 5. Animal Studies: Studies conducted on animal models rather than human subjects. 3.4 Screening process Screening involved Reviewing titles and abstracts to identify potentially relevant articles based on the inclusion and exclusion criteria. Full-text articles were assessed for eligibility and relevant studies were selected for inclusion in the review. Data extraction was performed to extract relevant information, including study design, objectives, methods, results, and conclusion. Quality assessment was conducted to evaluate the rigor and validity of included studies with a focus on study design, sample size, methodology, and potential biases. In searching these articles, three domains were attributed to safety practices in the Cath lab. Of the 30 articles reviewed for technical factors, 3.5 Data Synthesis Data from included studies were synthesized to identify key themes, trends, and findings related to radiation exposure in catheterization laboratories. A narrative synthesis approach was used to summarize and interpret the findings, highlighting significant developments, challenges, and future directions in the field of radiation safety. Relevant tables, figures, and visual aids are used to present key data and illustrate important concepts. 3.6 Data Collection Process 43 ⮚ Identification of Relevant Studies: Literature search conducted using specified databases and keywords. ⮚ Screening of Titles and Abstracts: Initial screening of search results to identify potentially relevant studies. ⮚ Full-Text Review: Evaluation of full-text articles to determine eligibility for inclusion in the systematic review. ⮚ Data Extraction: Relevant data extracted from included studies, including study characteristics, methodology, outcomes, and key findings. ⮚ Quality Assessment: Assessment of the methodological quality and risk of bias of included studies using appropriate tools (e.g., Newcastle-Ottawa Scale for cohort studies). ⮚ Synthesis of Findings: Collation and synthesis of data from included studies to address research questions and objectives. 3.6.1 Systemic Review Flow ➢ Records identified from the database (n=180) ➢ Records removed before the screening: ➢ Duplicate records removed (n=75） ➢ Title and abstract of articles screened (n-105) ➢ Records excluded (n=80） ➢ Full-text articles assessed for eligibility (n=25） ➢ Full-text articles excluded with reasons (n=12) 44 ➢ (Wrong outcome = 10 Articles in another language with no English translation=2) ➢ Included ➢ Studies included in review (n=13) 3.7 Data Analysis ⮚ Statistical Methods: Statistical techniques such as effect size calculation, subgroup analysis, or sensitivity analysis are used to analyze pooled data. ⮚ Qualitative Analysis: Thematic analysis is employed for qualitative data extracted from interviews, focus groups, or surveys. ⮚ Coding: Coding of qualitative data to identify recurring themes, patterns, and insights related to radiation safety practices in Cath labs. ⮚ Interpretation: Interpretation of findings from both quantitative and qualitative analyses to draw conclusions and implications for practice. 3.8 Quality Assurance Quality assurance measures will be implemented throughout the review process to ensure the reliability and validity of findings. This includes rigorous screening of articles based on predefined inclusion and exclusion criteria, critical appraisal of study methodology, and transparent reporting of methods and results. Any discrepancies or disagreements are to be resolved through consensus among the review team members. 45 3.9 Ethical Considerations This review adheres to ethical guidelines and standards for conducting systematic reviews and meta-analyses. All included studies were cited appropriately, and proper attribution was given to the authors. The confidentiality and privacy of study participants were maintained, and ethical approval was not required as this review did not involve human subjects or primary data collection. 46 CHAPTER FOUR 4.0 RESULTS 4.1 Flow of the Systemic Review As seen from (3.6.1) 180 records were identified relating to the topic in question of which 75 of the records were screened out due to duplications, leaving the researcher with 105 titles and abstracts of articles to be screened, 80 records were excluded because they were abstracts leaving the researcher with just 25 full-text articles to be further assessed for eligibility. Twelve (12) full-text articles were removed, of which 10 had wrong outcomes and 2 were articles not in the English Language. Thus, 13 studies were included in this study. 4.2 Description of Included Study Twelve (13) studies were included in this review: ten qualitative studies as seen in Table 2. Articles were published between 2004 and 2023. The study populations included patients, cardiologists, interventional radiologists, technologists, interventional physicians, and catheterization laboratory personnel. The total number of reported participants in all the studies was 830. The study design includes experimental, cohort, exhaustive, cross-sectional, and systemic reviews. Sampling techniques and procedures adopted include purposive sampling, simple random sampling, and reviews based on set criteria. The reported age range varies from 39-78 years. 47 Table 2:Description and Characteristics of the Included Studies Author & Year Country research was underta ken Study Design Study Populatio n Sample size Gender Male Gender Female Samplin g Age Range (Years) Weight Range (kg) Height Range (m) BMI Range (kg/m2 ) Lickfett et al, 2004 USA Experime ntal Patients 25 17 8 Purposiv e clinical recruitm ent 39-78 61-132 1.5-2.0 21-42 Charles et al.,2011 USA Policy General guideline for interventio nal cardiology Not applica ble Not applica ble Not applica ble Not applicab le Not applica ble Not applica ble Not applica ble Not applica ble Roguin et al., 2013 Global Cohot Interventio nal physician 31 Not reporte d Not reporte d Based on cases received globally 49-67 Not reporte d Not reporte d Not reporte d Maria Grazia Andreassi et al., 2016 Italy Exhaustiv e Cardiologi sts & paramedic al staff 746 460 286 Simple Random 44±9 Not reporte d Not reporte d 24.1±1. 8 Reza Fazel et al., 2014 USA Scientific Statement for AHA AHA Cardiologi st Not applica ble Not applica ble Not applica ble Not applicab le Not applica ble Not applica ble Not applica ble Not applica ble Efstathopoul oset al., 2011 Greece Experime ntal Patients 25 Not reporte d Not reporte d Purposiv e Not reporte d Not reporte d Not reporte d Not reporte d Chang Lienard A et al, 2017 Finland Systemic review Patients Not applica ble Not applica ble Not applica ble Not applicab le Not applica ble Not applica ble Not applica ble Not applica ble 48 Table 2 cont’d:Description and Characteristics of the Included Studies Author & Year Country research was undertak en Study Design Study Population Sample size Gender Male Gender Female Sampli ng Age Range (Years) Weight Range (kg) Height Range (m) BMI Range (kg/m2 ) Asgari et al.,2020 Iran Cross section al Health workers 3 Not reported Not reported Purposi ve Not reported Not reported Not reported Not reported Kim et al., 2012 Global System ic review Physicians Not applicab le Not reported Not reported Based on set criteria Not reported Not reported Not reported Not reported Sylvia Marie R. Biso and Mladen I. Vidovic h, 2020 Global System ic review Cardiac catheterizati on laboratory staff Not applicab le Not applicab le Not applicab le Based on set criteria Not applicab le Not applicab le Not applicab le Not applicab le Ariel Roguin et al., 2023 Global System ic review Cardiac catheterizati on laboratory staff Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Nathanie l R. Smilowit z, 2013 Global System ic review Intervention al cardiologists Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Not applicab le Alejandr o Gutierre zBarrios et al.,2022 System ic review Catheterizati on laboratory personnel 4.3 Historical Evaluation of safety practices in the Catheterization laboratory Results relating to the historical evaluation of safety practices in catheterization laboratories including the development of protective measures and dose monitoring techniques over time are evident from studies. Studies show a significant reduction in dose comparisons over past years to the present signifying radiation protection practices over the years as effective and progressing90, however, no radiation is safe radiation though not currently achievable, therefore, continuous effort towards minimal radiation is relentless. It was reported that current practice requires catheterization laboratory (CCL) staff to put on personal protective equipment with at least lead body aprons and thyroid shields. Other personnel also use leaded 49 skull covering to protect the brain, leaded eyeglasses for the eyes, and arm shields. Some of these conventional lead aprons are now being replaced with newer aprons made of lighter materials such as aluminum, antimony, barium, bismuth, tungsten, tin, titanium and thus reduce personal protective apron weight by 20% to 40%. Yet, these composite aprons may still pose significant cumulative orthopedic issues to members of the CCL team despite the weight reduction33 It was also reported that a tutorial on the physics of X-ray imaging, essential to the safe practice of radiation dose management, has been published in the ACCF/AHA/HRS/SCAI Clinical Competence Statement on Physician Knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures58. Passive and active processes were not left out in safety practices employed in some of the catheterization laboratories28. The passive component consists of the protective equipment in the laboratory, while the active component is based on the use of the equipment. Active protection strategies include routine and appropriate use of lead apparel, proper staff training on radiation exposure, routine radiation dose monitoring, and techniques for reducing radiation use on patients and operators. Others reported on education, justification, and optimization as the best options for safety practices for radiation exposures in the catheterization laboratory91, 92. Studies reported lead aprons as the most common safety practices adopted in catheterization laboratory. The use of real-time radiation devices, radiation-blocking hats, gloves, and disposable radioprotective drapes were also reported as adopted safety measures by some catheterization laboratories while another researcher reported ceiling-mouthed movable shields for operators 33,93 . 4.4 Current Status of Radiation Exposure in Catheterization Laboratory According to the report, all modern X-ray systems use pulsed fluoroscopy allowing the operators to change the pulse rate for a given procedure. Other standard dose-saving features 50 include virtual collimation, last image hold, and store of X-ray fluoroscopy (when cine image quality, as in documenting balloon inflation, is not required). Real-time display of total air kerma at the reference point (Ka,r, Gy) and air kerma area product (PKA, Gy cm2) all assist the operator in radiation dose management during the procedure 58. A 3D-electroanatomic mapping and multimodal imaging have enabled operators to reduce fluoroscopy use resulting in less radiation exposure. More so, Intravascular ultrasound (IVUS) provides detailed coronary arterial wall architecture and lesion morphology. Robotic remotecontrol angiography where cardiologists work from a shielded workstation away from the radiation source has also been shown to reduce radiation dose by as much as 96% in recent times28. Intravascular ultrasound (IVUS), robotic remote-control angioplasty, and real-time radiation dose monitoring have also been reported as some of the current advanced practices in reducing radiation exposures in the catheterization laboratory7. Suspended radiation protection systems such as Zero Gravity, mobile radiation protection cabins: CathPax, disposable radioprotective drapes, robotic percutaneous systems, radiation hats, gloves, and radiation blocking cream are all recent advanced practices used in catheterization laboratories in reducing radiation exposures of staff and patients 93. RaySafe i2 system (Real-time dose detection); Tight fit of thyroid collar around neck (Reduce risk of thyroid cancers); Proper fit and facial contour (Reduce gap between lens and frame, Maximize front, lateral, and angular protection, Reduce rates of cataracts,); Automatic dose rate control (ADRC)- ControlRad (Precise collimation of area of interest); Live Zoom (Decrease magnification which increases radiation); Tubing extensions on contrast injectors (Allows operator to stay further away during imaging); RADIACTION- Patient Pelvic shielding- RADPAD- EggNest-XR system- Steradian vertical radiation shield (Greatly reduce scatter to the operator and the rest of the team from both above the table and under the table); Zero-Gravity system (BIOTRONIK)- Rampart M1128- Protego Radiation Protection 51 System-Corindus CorPath robotic system (Reduces radiation drastically with large barrier device, allowing operators and/or most of the CCL team to work “lead-free”) are all buttressed as the recent developments in catheterization laboratory in curtaining radiation exposure 33. Table 3:Detailed Summary on Catheterization Laboratory Radiation Exposure Author & Year Anteropost erior Thickness (cm) Later Thickn ess (cm) Proced ure Param eter Peak Voltag e (kVp) 76±15 Radiation dose distribution measurement Radiati on Dosage Receive d in RAO and LAO projecti ons Effecti ve Dose Estima ted Organ Doses (mSv) for women Estimat ed Organ Doses (mSv) for men Health worker designation Thermolumin escent dosemeter (TLD) 1.00±0. 5& 1.48±0. 37 Peak skin dosage (Gy) 27.25±8 .93 for men & 18.74±4 .75 for women Breast 10.14; Risk 71%.B one Marro w 12.02; Risk 96%. Lungs 81.79; Risk 1227%. Stomac h 6.35; Risk 184%. Personal dose monitor (dosemeter) 3.1-3.0 0.0230.2 Not reporte d Not reported Not applicable Not reporte d Not reporte d Not reported Interventional cardiologist & radiologist, electrophysiol ogists Breast NA; Risk NA. Bone Marrow 16.97; Risk 187%.Lu ngs 122.45; Risk 2326%. Stomach 10.71; Risk 182%. Lickfett et al,, 2004 16-30 25-39 RAO &LAO Charles et al.,2011 Not applicable Not applica ble Not applica ble Not applica ble Ariel Roguin et al., 2013 Not reported Not reporte d Not reporte d Not reporte d Not reported Not reported Maria Grazia Andreassi et al., 2016 Not reported Not reporte d Not reporte d Not reporte d Not reported Not reported Not reporte d Not reporte d Not reported Reza Fazel et al., 2014 Not applicable Not applica ble Not applica ble Not applica ble Not applicable Not applicab le Not applica ble Not applica ble Not applicabl e Not applicable Efstathopo ulos et al., 2011 Not reported Not reporte d Not reporte d Not reporte d Thermolumin escent dosemeter (TLD) Not reported Not reporte d Not reporte d Not reported Not reported Personnel staff 52 Table 3 cont’d:Detailed Summary on Catheterization Laboratory Radiation Exposure Author & Year Anteroposte rior Thickness (cm) Later Thickn ess (cm) Asgari et al.,2020 Not reported Not reporte d Kim et al.,2012 Not reported Not reporte d Sylvia Marie R. Biso and Mladen I. Vidovic h, 2020 Ariel Roguin et al., 2023 Not reported Not reporte d Not reported Not reporte d Nathani el R. Smilow itz, 2013 Not reported Alejand ro Gutierre zBarrios et al.,2022 Not reported Procedure Parameter Peak Volta ge (kVp) Radiation dose distribution measurement Not reported Not report ed Thermolumine scent dosemeter (TLD) Not reported 6.4 ± 6.4 (range: 2.6-24.7) Not reported Not reporte d Cardiolo gist Fluoroscopica lly-guided (FG) procedures’ Not report ed Not reported Not reported 0.1-2.5 KSv Not reported Not reporte d Not reported Organ malformat ion threshold dose of 250 mGy; Intrauteri ne growth retardatio n, 200 mGy; delayed mental developm ent 100 mGy. 0.5 mSv per month or a total of 5 mSv during the span of pregnanc y. Not reporte d Not reported 6.6-59.7 mSV for atrial fibrillatio n ablation 0.5 mSV per month or to a total of 5 mSv during the span of the pregnanc y Not reporte d Not reported Fluoroscopyg uided catheter-based cardiology procedures Not report ed Not reported Radiati on Dosage Receive d in RAO and LAO projecti ons Not reported Effective Dose Estimate d Organ Doses (mSv) for women Estima ted Organ Doses (mSv) for men Health worker designat ion Not reported Not report ed Not reported Not reported Not reporte d Not reported Not report ed Not reported Not reported Not reported Not reported Not reporte d Not reported Not reporte d Not reported Not report ed Not reported Not reported 20-500 mSv/year Not reported Not reporte d Not reported 53 4.5 Occupational Hazard in Catheterization Laboratory Stochastic, or probabilistic are real concerns in radiation practices. Skin lesions, cataracts, thyroid disease, cancer, Brain & neck cancer, Transient erythema, skin, chest, wrist, leg, and neck Occupational orthopedic problems were all reported as hazards incurred during work by the catheterization laboratory personnel by several authors reports58,94–97 . 4.6 Evaluation of the effectiveness of radiation safety protocol and dose optimization strategies in minimizing radiation exposure for healthcare and patients Studies suggest that fines be put in place for those who violate safety policy, stating protective shields and garments should be worn as well as training & education, these might go a long way in effecting the safety protocol 58. Innovations in shielding systems will permit the cardiac catheterization laboratory team to work in a personal “lead-free” environment. i.e. BIOTRONIK33. 4.7 Identify Challenges and Barriers to Implementing Radiation Safety Measures in Catheterization Laboratory Some barriers and challenges to implementing radiation safety measures in catheterization laboratories were observed by several authors such as pregnancy (the most common one), radiation scattering, infants and children scanning, and skeletal issues due to heavy lead apron7,28,58,93. 54 Table 4:Current Status of Radiation Exposure in Catheterization Laboratory Author & Year Patients (Subject) diagnosis Lickfett et ,al, 2004 Patients undergoing Catheter ablation of AVNRT & atrial flutter Charles et al.,2011 Not reported Ariel Roguinet al., 2013 Glioblastoma multiforme, astrocytomas,mening iomas Maria Grazia Andreassi et al., 2016 Reza Fazel et al., 2014 Efstathopoul oset al., 2011 Histori cal evoluti on Advanced practice Safety practice Not reporte d Not reported Not reported Not reporte d Modern Xray systems use pulsed fluoroscopy. And other standard dose-saving features. Real-time display of total air kerma at the reference point A tutorial on the physics of X-ray imaging, essential to the safe practice of radiation dose managem ent. Not reporte d Not reported Not reported Not reporte d 3Delectroanato mic mapping and multimodal imaging. Robotic remotecontrol angioplasty. IVUS. Passive and active processes Not applicable Not reporte d Not reported Education , justificati on & optimizati on Not reported Not reporte d Not reported Not reported Not reported Radiati on exposu re subject Radiati on exposu re body part Radiati on Induce d Injury Not reporte d Back skin Not reporte d Not reporte d Skin Brain & neck Radiation safety protocol Dose optimizat ion Challen ges and barriers None Not reported Not reported Not reported Transie nt erythem a; Stochas tic Fines in place for those who violate safety policy. Protective shield garment should be worn.Train ing & Education Procedure dose managem ent system Pregnan cy Not reported Physicia n head not covered leads to brain cancer Brain &neck cancer Not reported Staff & patients Not reporte d Skin lession, cataract , thyroid disease, cancer Not reported Not reported Scattere d radiation , pregnan cy Not reporte d Not reporte d Not reporte d Not reported Not reported Not reported Not reporte d Apron, collar, glasses, gloves, table curtain, ceiling shield, floor shield. Not reported Not reported Not reporte d Not reporte d 55 Table 4 cont’d:Current Status of Radiation Exposure in Catheterization Laboratory Author & Year Patients (Subject) diagnosis Historical evolution Advanced practice Safety practice Asgari et al.,2020 Angiogra phy Not reported Not reported Kim et al.,2012 Not reported Not reported Not reported Ariel Roguin et al., 2023 Nathani el R. Smilowi tz, 2013 Sylvia Marie R. Biso and Mladen I. Vidovic h, 2020 Alejandr o Gutierre zBarrios et al.,2022 Chang Lienar d A et al, 2017 Radiati on exposu re subject Radiati on exposur e body part Radiation Induced Injury Radiatio n safety protocol Dose optimizat ion Challeng es and barriers Not reported Not reported Skin,che st, wrist, leg,neck Not reported Not reported Not reported Not reported Not reported Lead aprons Operato r Head, eyes, neck Not reported Not reported Not reported Not reported Not reported Intravascular ultrasound (IVUS). Robotic remote-control angioplasty. Realtime radiation dose monitoring. Not reported Not reported Not reported Not reported Passive and active process Not reported Pregnant women and children Not reported Cardiac catheterizat ion laboratory (CCL) team wear personal protective equipment with at least lead body aprons & thyroid shields RaySafe i2 system (Real-time dose detection); utomatic dose rate control (ADRC)ControlRadetc Ceiling mouthed movable shield for operators Patients & staff Not reported Not reported Innovati ons in shielding systems Not reported High BMI, Heavy lead apron etc Not reported Not reported Robotic catheterbased systems Not reported Not reported Not reported Stochastic , or probabilist ic Lead apron Not reported Occupatio nal orthopedi c problems Not reported Suspended radiation protection system: Zero Gravity.Mobile radiation protection cabins: CathPax, robotic percutaneousesyst ems, radiation blocking cream Use of real time radiation device.Radia tion blocking hats, gloves, Disposable radioprotecti ve drapes, Tradition al lead personal protectiv e equipme nt, Surgical caps etc. Not reported Not reported Patients Lead , thyroid shield Fluoro Radiograph, CT, Lead Apron, thyroid shield Not reported Not reported Not reported Patient s Thyroid Stochasti c Probabili stic Cancer Lead Shield Not applicabl e Pregnant women and childre 56 CHAPTER FIVE 5.0 DISCUSSION AND CONCLUSION 5.1 Discussion Healthcare workers in catheterization laboratories- cardiologists, nurses, and radiologic technologists, - are at significant risk of radiation exposure. Studies show that interventional cardiologists receive the highest doses of radiation among all medical professionals 92. Chronic exposure can lead to cataracts, skin injuries, and an increased risk of malignancies as seen in this present review 94. Patients undergoing interventional procedures are also exposed to high radiation doses, which can lead to deterministic effects like skin injuries and stochastic effects, such as cancer97. The complexity and duration of procedures directly correlate with increased radiation doses 64,98. The implementation of radiation safety protocols has significantly improved over the past decades. Standard protocols include the use of lead aprons, thyroid shields, lead glasses, and radiation monitoring badges. However, compliance varies across catheterization laboratories and institutions99. Advancements in imaging technology, such as real-time dose monitoring, low-dose fluoroscopy, and digital subtraction angiography, have been effective in reducing radiation exposure. The use of collimation, optimal positioning – tube/patient/intensifier distancing,- and minimizing fluoroscopy time are crucial strategies to arrest this issue 100 . Continuous education and training on radiation safety are paramount. Simulation-based training programs have been shown to enhance the knowledge and skills of healthcare workers in minimizing radiation exposure101. There is significant variation in radiation safety practices across different institutions. Factors such as institutional policies, availability of safety equipment, and individual practitioner habits influence radiation safety102. Resource constraints, including financial limitations, impede the 57 widespread adoption of advanced radiation safety technologies and comprehensive training programs. Smaller or rural hospitals may lack access to the latest protective equipment and dose-monitoring systems103. Despite technological advancements, challenges remain in fully optimizing radiation dose reduction. Issues such as equipment malfunctions, lack of interoperability between systems, and the need for frequent updates can hinder effective radiation management 104. 5.2 Conclusion Radiation exposure in catheterization laboratories presents significant occupational hazards and patient risks. It is important to possess updated equipment in the laboratories, however, it is not enough without proper use, therefore collaboration among the three major players in radiation safety is essential. While radiation safety protocols and dose optimization strategies have demonstrated effectiveness in reducing exposure, challenges such as practice variations, resource constraints, and technological limitations remain. Addressing these barriers through standardized practices, enhanced training, and investment in advanced technologies is critical for ensuring the safety of both healthcare workers and patients. 5.3 Implication of the Study in Radiology Practices ➢ This review has established several radiation exposure issues of matter arising in catheterization laboratories. Thus, there is a need to properly address radiation exposure in catheterization laboratories to safeguard the health and well-being of healthcare workers and patients. ➢ Healthcare workers in catheterization laboratories and patients are at high risk of developing cancer due to accumulated exposure to radiation. 58 ➢ This review established that the use of heavy lead apron to protect against radiation can lead to musculoskeletal problems, including back and neck pain. ➢ Long-term exposure in catheterization laboratories can lead to cataracts in healthcare/operators. ➢ Pregnant women and young children's exposure to radiation is still a huge challenge and barrier that requires a proactive approach to solve. 59 REFERENCES: 1. Mühlberger V, Kaltenbach L, Bates K, Ulmer H, Austrian National Cardiac Catheterization Laboratory Registry (ANCALAR), Österreichische Kardiologische Gesellschaft (ÖKG). 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