Background Comprehensive assessments of the frequency and associated doses from radiologic and nuclear medicine procedures are rarely conducted. The use of these procedures and the population-based radiation dose increased remarkably from 1980 to 2006. Purpose To determine the change in per capita radiation exposure in the United States from 2006 to 2016. Materials and Methods The U.S. National Council on Radiation Protection and Measurements conducted a retrospective assessment for 2016 and compared the results to previously published data for the year 2006. Effective dose values for procedures were obtained from the literature, and frequency data were obtained from commercial, governmental, and professional society data. Results In the United States in 2006, an estimated 377 million diagnostic and interventional radiologic examinations were performed. This value remained essentially the same for 2016 even though the U.S. population had increased by about 24 million people. The number of CT scans performed increased from 67 million to 84 million, but the number of other procedures (eg, diagnostic fluoroscopy) and nuclear medicine procedures decreased from 17 million to 13.5 million. The number of dental radiographic and dental CT examinations performed was estimated to be about 320 million in 2016. Using the tissue-weighting factors from Publication 60 of the International Commission on Radiological Protection, the U.S. annual individual (per capita) effective dose from diagnostic and interventional medical procedures was estimated to have been 2.9 mSv in 2006 and 2.3 mSv in 2016, with the collective doses being 885 000 and 755 000 person-sievert, respectively. Conclusion The trend from 1980 to 2006 of increasing dose from medical radiation has reversed. Estimated 2016 total collective effective dose and radiation dose per capita dose are lower than in 2006. © RSNA, 2020 See also the editorial by Einstein in this issue.

Catheterization and Cardiovascular InterventionsVolume 95, Issue 7 p. 1327-1333 CORE CURRICULUMFree Access SCAI multi-society position statement on occupational health hazards of the catheterization laboratory: Shifting the paradigm for Healthcare Workers' Protection Lloyd W. Klein MD, FACC, MSCAI, Corresponding Author lloydklein@comcast.net orcid.org/0000-0003-0156-3094 University of California, San Francisco, San Francisco, California Correspondence Lloyd W. Klein, University of California, San Francisco, San Francisco, CA. Email: lloydklein@comcast.netSearch for more papers by this authorJames A. Goldstein MD, FACC, FSCAI, William Beaumont School of Medicine, Royal Oak, MichiganSearch for more papers by this authorDavid Haines MD, FACC, FHRS, William Beaumont School of Medicine, Royal Oak, MichiganSearch for more papers by this authorCharles Chambers MD, FACC, MSCAI, Penn State College of Medicine, Hershey, PennsylvaniaSearch for more papers by this authorRoxana Mehran MD, FACC, MSCAI, Mount Sinai School of Medicine, New York, New YorkSearch for more papers by this authorSmadar Kort MD, FACC, FASE, Stony Brook University, Stony Brook, New YorkSearch for more papers by this authorC. Michael Valentine MD, MACC, FSCAI, Stroobants Cardiovascular Group, Lynchburg, VirginiaSearch for more papers by this authorDavid Cox MD, MSCAI, FACC, Brookwood Baptist Health, Birmingham, AlabamaSearch for more papers by this author Lloyd W. Klein MD, FACC, MSCAI, Corresponding Author lloydklein@comcast.net orcid.org/0000-0003-0156-3094 University of California, San Francisco, San Francisco, California Correspondence Lloyd W. Klein, University of California, San Francisco, San Francisco, CA. Email: lloydklein@comcast.netSearch for more papers by this authorJames A. Goldstein MD, FACC, FSCAI, William Beaumont School of Medicine, Royal Oak, MichiganSearch for more papers by this authorDavid Haines MD, FACC, FHRS, William Beaumont School of Medicine, Royal Oak, MichiganSearch for more papers by this authorCharles Chambers MD, FACC, MSCAI, Penn State College of Medicine, Hershey, PennsylvaniaSearch for more papers by this authorRoxana Mehran MD, FACC, MSCAI, Mount Sinai School of Medicine, New York, New YorkSearch for more papers by this authorSmadar Kort MD, FACC, FASE, Stony Brook University, Stony Brook, New YorkSearch for more papers by this authorC. Michael Valentine MD, MACC, FSCAI, Stroobants Cardiovascular Group, Lynchburg, VirginiaSearch for more papers by this authorDavid Cox MD, MSCAI, FACC, Brookwood Baptist Health, Birmingham, AlabamaSearch for more papers by this author First published: 11 February 2020 https://doi.org/10.1002/ccd.28579Citations: 2 Dedicated to the memory of Dr. Chambers for his unrelenting work in this area to safeguard all health care professionals against occupational hazards of the fluoroscopy laboratory. Author disclosure information is available in Supplemental Table 3. This document should be cited as follows: Klein LW, Goldsteing AJ, Haines D, Chambers C, Mehran R, Kort S, Valentine CM, Cox D, SCAI Multi-society Position Statement on Occupational Health Hazards of the Catheterization Laboratory: Shifting the Paradigm for Healthcare Workers' Protection, Catheterization and Cardiovascular Interventions (DOI:10.1002/ccd.28579) Reprints and Permissions: This document is available on the World Wide Web site of Catheterization and Cardiovascular Interventions (https://onlinelibrary.wiley.com/journal/1522726x). For reprints of this document, please contact corporatesalesusa@wiley.com. For permissions, requests may be completed online via at https://onlinelibrary.wiley.com/page/journal/1522726x/homepage/permissions.html. AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinked InRedditWechat 1 INTRODUCTION Renewed attention has focused on the occupational health hazards posed by working in the fluoroscopic laboratory.1-6 Accumulated occupational radiation exposure is associated with health risks to physicians, nurses, and technologists working in this environment. Health care workers are subject to insidious health effects of radiation exposure over many years. Adverse effects include the established predilection to posterior subcapsular cataracts, as well as worrisome signals of lifetime risks of cancer induction, particularly in the unprotected brain.7-12 A further consequence is the extensively documented incidence of orthopedic illnesses reported in physicians as well as nurses and technologists and injuries linked to the cumulative burden of bearing the weight of only partly protective lead aprons mandatory to reduce radiation risk.13-16 The increased volume and complexity of procedures, together with the physical stresses inherent in procedural performance, have exacerbated the prevalence and magnitude of such orthopedic injuries.17 The high prevalence of orthopedic afflictions not only affects individual health but also could be potential career ending, with workforce implications for both the profession as well as for society.15 1.1 Limited progress to improve fluoroscopic laboratory occupational health Advances in interventional imaging techniques and treatments over the last three decades have achieved significant success with clear benefits to our patients18; yet protective measures for workers have unfortunately lagged the pace, magnitude, and impact of this therapeutic progress. The purpose of this position statement is to review the data documenting occupational health injuries, summarize current equipment and processes that can be widely applied to optimize protection, emphasize the importance of investment by hospitals and health systems in protective equipment established to enhance workplace safety, examine barriers that need to be overcome to spur advances to enhance the occupational safety of the fluoroscopic laboratory environment, and propose enhanced advocacy for innovation. Future processes and proposals to improve the fluoroscopic laboratory environment should be based on the following precepts: (a) there is ample clinical data documenting the prevalence of serious occupational health risks engendered by the fluoroscopic laboratory environment; (b) sufficient attention to these occupational health issues has been drawn in annual meetings and published clinical scientific studies; (c) despite these data and advocacy efforts, advances to improve worker safety in the fluoroscopic laboratory remain inadequate; and (d) a concerted effort by all stakeholders (physicians, catheterization laboratory nurses, and technologists, sonographers, hospitals, professional societies, and industry) in the fluoroscopic laboratory is necessary to further advance occupational safety and health. 1.2 Radiation exposure: Risks and injuries Radiation exposure is inherent to procedural performance in the fluoroscopic laboratory. Exposure to ionizing radiation imposes health risks to both patients and operators, resulting in an increased likelihood of numerous illnesses and diseases.1-8 The association with posterior subcapsular cataracts is well documented.11, 12 There are growing concerns for cancer induction,7, 8 with recent reports of a cluster of predominantly left-sided brain cancers in interventionists,9, 10 as well as a signal for increased breast19-22 and skin cancers.23-26 Radiation exposure generally, not necessarily as part of occupational exposure, is associated with leukemia/lymphoma, myeloma, numerous gastrointestinal and bone cancers, and thyroid and parathyroid adenomas. These disquieting signals fuel the increasing anxiety regarding radiation exposure-related oncogenesis, though no mortality impact has been proven.27 Recent studies have also suggested that occupational radiation exposure is associated with hypertension, hypercholesterolemia, and possibly atherosclerosis.28-30 Evidence of lengthening sarcomere length and early vascular aging in epidemiologic studies suggests that workers who are occupationally exposed to radiation during interventional procedures may be at increased risk to develop these same illnesses.30, 31 1.3 Orthopedic injuries: Collateral damage of working in the fluoroscopic laboratory There is now overwhelming evidence demonstrating that working in the interventional laboratory is associated with an increased incidence of orthopedic illnesses, particularly those related to the cervical and lumbar spine. These orthopedic injuries have been linked to the cumulative effects of bearing the weight of leaded aprons.5, 15, 16 Additionally, the design of the catheterization laboratory environment promotes awkward orthopedic ergonomic postures (e.g., monitors placed out of the line of natural working sight views). As procedures become increasingly complex and prolonged, and their volume increase in number, it should not be surprising that interventional practice is attended by a high rate (40–50%) of occupational-induced orthopedic injuries.15-17 Over a career's duration, the likelihood of suffering such illnesses are 2–7 times27, 28 higher than other medical occupations. Studies report substantial differences in orthopedic injuries between those wearing lead aprons working in the fluoroscopic laboratory compared to colleagues working in the same department not working in the fluoroscopic laboratory and thus not bearing the burden of wearing lead aprons.27-29 These occupational-related injuries not uncommonly result in missed days of work, surgery, and, in some cases, curtailed careers. This issue has significant implications for the interventional workforce, particularly in view of the aging of the population and anticipated increased procedural demand concomitant with aging of the operators who pioneered these advances.17, 27-29 1.4 The scope of health care personnel at risk These occupational health concerns potentially affect several medical specialties, including cardiologists, radiologists, and surgeons working with fluoroscopy, as well as pain management specialists performing nonvascular fluoroscopic procedures. Importantly, all such issues also pertain to the other personnel who are essential members of the "interventional team" (e.g., nurses and technologists, interventional imagers, and cardiac anesthesiologists) who are exposed to the harmful effects of scattered ionizing radiation.30-33 Electrophysiologists and their team are also exposed to radiologic risks and orthopedic injury34 and perhaps even more so, given the duration of their procedures and lack of upper torso shielding during device cases (e.g., implantable defibrillators and cardiac resynchronization therapy). These issues also have particular importance to women; although radiation effects on the fetus have not been demonstrated, women report concerns for adverse effects during reproduction as an obstacle to choice of an interventional career. These radiation exposure concerns have sometimes been considered a reason for disproportionately low representation of women in the field.35 As noninvasive cardiologists specialized in imaging are now required to guide interventions in the catheterization and electrophysiology laboratories, pursuing career in imaging is no longer radiation free and a safer choice for women. This may result in shifts in gender distribution in various cardiology subspecialties, further impacting strategies to improve diversity and inclusion in out profession. 1.5 Imperative to shift the paradigm for health care personnel protection The past three decades have witnessed astounding progress in interventional equipment, technique, therapeutics, and the clinical research that catalyzed these advances. Progress in interventional laboratory protection and safety has comparatively lagged, despite the growing mounting data emphasizing occupational health concerns. A paradigm shift to dramatically improve the occupational safety for all stakeholders in the fluoroscopic laboratory (members of the interventional team, professional societies, hospitals, and industry) is required. In particular, there is an opportunity and obligation for industry and hospitals, who clearly benefit from the workers' commitment to their profession, to play a leadership role in correcting these deficiencies. A template exists based on the collaboration established by recent FDA-led efforts aimed to reduce patient exposure.36 Leveraging the concept and practice of the "Image Wisely" and "Image Gently" campaigns codified by Radiological Society of North America37 and Pediatric Cardiology community38 to minimize radiation exposure to patients, in 2010, the FDA Center for Devices and Radiological Health launched an Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. As part of this initiative, the FDA held a public meeting on ways to improve devices to reduce unnecessary radiation exposure to help the agency decide on any new, targeted requirements for manufacturers of computed tomographic and fluoroscopic devices. This effort resulted in an industry-driven enhanced awareness, with mandates to recognize both the needs for and market potential of innovations focused on minimizing patient radiation exposure. These initiatives rapidly resulted in dramatic changes to improve the X-ray systems. Examples of these improvements include minimizing radiation exposure through lower emission X-ray systems as well as monitoring, recording of each procedure's patient exposure, and standardization in laboratory reports and patient charts. These efforts have also stimulated industry to develop X-ray systems that provide high-quality imaging at low-radiation exposure dose levels. Hospitals should be encouraged to invest in adopting such platforms that have potential to mitigate occupational risk. 1.6 The goal: A comprehensive "Culture of Safety" in the fluoroscopic laboratory Physicians working with our professional societies should strive to establish a culture of safety encompassing both patients and catheterization laboratory personnel (Table 1). The pathway forward should be focused to assure: (1) consistent application and adherence to established and procedural processes; (2) widespread adoption and utilization of novel commercially available protection systems; and (3) encouragement and support to further develop even more effective equipment and processes that facilitate enhanced safety and protection in the workspace. Table 1. Professional society "Best Practices" Professional societies should assist its members to Understand the evidence demonstrating the risks of occupational radiation exposure, including both possible direct (cataracts, cancer risk, cardiovascular) and indirect (orthopedic injury) hazards; Champion use of protective measures including proper use of shielding and minimize unnecessary radiation usage in the laboratory; Ensure consistent application and adherence to established training and procedural processes; Insist on accurate monitoring of operator and laboratory personnel exposure; Encourage widespread adoption and utilization of new technologies for the reduction of occupational hazards; Acknowledge that current advocacy efforts have been inadequate and participate in more robust effective advocacy initiatives on behalf of the members; Undertake further efforts with industry, including encouragement and support to further develop effective equipment that fosters/facilitates enhanced safety and protection in the workspace, including fluoroless laboratories; Support individual physicians and practices to work with hospital administration to ensure worker safety; Initiate formal training programs to minimize the hazards of radiation exposure that should become mandatory for laboratory's certification; Commit to playing a leadership role in correcting these deficiencies and establishing a culture of safety; Assist hospitals and health systems to establish comprehensive programs for clinician health in the catheterization and electrophysiology laboratories which are consistent with recommended wellness programs; Use this issue as an opportunity to share and collaborate with international colleagues. Our professional societies must support individual physicians, teams, and practices, especially those that are hospital owned. It is critical that clinician leaders speak authoritatively to hospital administration and industry partners regarding these concerns without fear of reprisal; societal support could be influential in these situations. The following specific steps should be endorsed by our professional societies to enhance hospital and physician compliance: 1.6.1 Optimal procedural practice: Processes and training to minimize injury Whether or not to comply with appropriate shielding and other safety measures should not be at the discretion of the operator. The imaging team (physician, sonographer, radiologic technologist, physicist, and other medical personnel) should be responsible for developing optimized protocols, implementing regular equipment quality control tests, and monitoring radiation doses to patients and members of the team. This group and their products should be recognized as an essential part of the quality assurance program, present in all laboratories, for emphasizing radiation management. Operator dose is directly proportional to patient dose; thus, reducing the dose to the patient will benefit the operator. Knowledge of radiation and methods to reduce risk should be stressed to all operators who perform fluoroscopically guided interventions, practiced routinely, and all staff educated in these measures and assuring they are adhered. These methods and concepts have been well described previously.1-7 Recently, publications from the Society of Cardiovascular Angiography and Interventions, The Heart Rhythm Society, and the American College of Cardiology/multi-society consensus document18 articulate detailed procedural systems and processes, as well as practical approaches, to assist cardiac catheterization laboratories in establishing optimal radiation safety program. The components of a radiation safety program include essential personnel, radiation monitoring, protective shielding (at minimum strict adherence to protective aprons and leaded glasses), imaging equipment, and training/education.39-41 1.6.2 Novel equipment to enhance protection Fundamental principles of radiation safety teach the tenet that radiation exposure should be "as low as reasonably achievable (ALARA)", with monitoring to assure individuals do not exceed annual or lifetime "safe limits." Unfortunately, the term "reasonably achievable" is ambiguous and not actionable, and may unintentionally inhibit innovative strides to improve safety both for patients who require medically necessary procedures and for workers in radiation-exposed environments. The phrase might incorrectly imply that as long as one's exposure is "minimized," then that is all that need to be accomplished. Rather, the ultimate goal of innovation efforts should strive to achieve a completely safe environment wherein the ultimate definition of ALARA translates to as close to a zero radiation exposure work environment as possible. 1.6.3 Shielding systems to reduce operator radiation exposure Meticulous application of established prudent radiation techniques is obvious and essential. Standard shielding combines laboratory based (e.g., movable ceiling suspended and fixed table-side shielding). Personal protective aprons and eyewear should be properly fitted and maintained, and hospitals should finance these protective devices for all of their employees, including trainees. Newer personal protective choices, including two-piece aprons that are much lighter, may be beneficial; accessory sleeves for arm protection are also available. Despite these advances, the orthopedic burden of only partially protective leaded apparel continues. Institutions and operators must partner to develop a program specific for their laboratory that will result in the adoption of appropriate recent innovations to reduce radiation exposure. Strategies should also include usage of adjunctive devices for which there is substantial data documenting their capability to reduce exposure. Specifically, there is now compelling data demonstrating reductions in exposure with accessory drapes42 (Supplementary Tables); such disposable radiation shielding pads should NOT be refused by hospitals due to their expense. The use of leaded caps has been proposed with mixed results regarding reduction in exposure.43, 44 Simple accessory mobile shields afford significant protection to both nurses and technologists45 as well as to the interventional imaging team.30 More expansive and encompassing lead shielding systems are commercially available,46 and there is a need for more clinical research data supporting their capabilities to reduce exposure. Robotic systems developed to enhance procedural performance also provide protection from radiation exposure to the physician and reduce leaded apron orthopedic burden.47 Thus far, robotics has had limited adoption, due mostly to cost considerations but also fear from the loss of a "hands-on" sensibility. In electrophysiology, intracardiac navigation systems48 have shown efficacy to navigate catheters for ablation procedures with lesser exposure. Simultaneously, industry and physicians must partner to expedite development of a fluoroless catheterization laboratory, using echocardiography, magnetic resonance imaging, 3D mapping, or other technologies. Removing the necessity of lead aprons should be the ultimate goal. Although the proximate cause of many orthopedic complications may be wearing lead, there are other important factors, such as screen height and position, and other ergonometric considerations, which may account for much cervical spine pathology.49 This growing portfolio of enhanced/innovative protective technology will continue to yield a growing pipeline of solutions providing optimism for a healthier work environment. 1.7 Shifting the paradigm: Responsibility, innovation, and implementation Table 1 summarizes the responsibilities of professional societies going forward. A direct role is a necessity to coordinate the policy matters raised in this document. Table 2 lists the specific future directions recommended for all stakeholders to achieve. Table 2. Future policy directions Operators should receive consultation by an ergonomics specialist to optimize posture, positioning, and equipment that might reduce orthopedic impact; Each laboratory should create and enforce policies and processes to assure continued operator education on best practices for radiation reduction and protection. Hospitals (and other facilities) should upgrade imaging equipment (hardware and software) and radiation-producing equipment to take advantage of the newer technologies that may significantly reduce radiation exposure, including investment in enhanced shielding. Clinicians and professional societies should support research, education, and advocacy efforts to advance the field of occupational safety and health. Hospitals should purchase their employees, including fellows, nurses, techs and physicians, protective goggles/eyeglasses (including prescriptions and bifocals where needed), personalized lead aprons (with shoulder shields when requested), and lead caps (if requested). Other protective equipment such as disposable radiation shielding pads should NOT be refused by hospitals due to their expense. Catheterization laboratories should implement evidence-based strategies/tools to reduce radiation exposure and decrease orthopedic burden. We should continue to acquire high-quality data to validate occupational hazards and the benefits of devices designed to mitigate them. 1.7.1 The role of the physician and professional societies It is essential to emphasize that the operator has the responsibility to understand how to use protective equipment optimally to minimize exposure to both patients and personnel.50 Education in this area is already part of cardiology trainee education and is tested in certification exams. Nevertheless, formal training for those who are planning to be interventional operators and imagers should be considered, and compliance monitored on site. Real-time radiation dose monitoring should become standard. Further, physicians must accept the challenge to adopt new technologies for the reduction of occupational hazards. Expense is one reason that new innovations are often not adopted, as it is difficult to advocate for expensive nonrevenue-enhancing equipment in the current fiscal environment. Other obstacles to overcome include potential discomfort with the design modifications and the resistance to making changes in familiar techniques even if there are improvements. The question always arises as to "proof" as to whether the changes are really beneficial, which sometimes become a justification to maintain an unsatisfactory status quo. Therefore, it is incumbent on our profession to continue to produce high-quality clinical research that documents the capabilities of novel imaging equipment, protective devices, and processes designed to improve workplace safety and health. As previously discussed, structural heart interventions depend on procedural image guidance/interventional echocardiography using transthoracic (TTE) or transesophageal echocardiography (TEE) in addition to fluoroscopy. Interventional imagers who operate the TTE or TEE probe and echo console are highly exposed to the harmful effects of scattered ionizing radiation. Protection for these workers also needs to be incorporated and mandated.30, 45, 46 Professional societies should develop programs to assist hospitals and health systems to address occupational safety. It is in everyone's interest to assure the health of medical caregivers.17 The establishment of new, and coordination with existing, comprehensive programs for clinician health in the catheterization and electrophysiology laboratories consistent with recommended wellness programs are an opportunity to highlight this problem. This may include an on-site physical or massage therapist, programs for core strengthening and stretching, and improved posture techniques to prevent orthopedic injury.34 Moreover, this issue can be an opportunity for societies to share and collaborate with international colleagues, who face similar problems. 1.7.2 The role of industry Since the inception of radiologic imaging, the biomedical industry has taken primary responsibility for development and refinement of catheterization laboratory equipment with associated financial benefits. As this equipment engenders intrinsic radiation exposure hazards, industry should assume a level of fiduciary responsibility to optimize the safety of the equipment they design and sell. It is our role to communicate the cardiology community's widespread support for innovations and catheterization laboratory design reformation. Though definite progress has occurred in the past two decades, particularly the advent of high-quality X-ray systems that produce high-quality imaging at lower radiation dose, further innovations are needed to achieve maximal operator radiation protection. The goal is a laboratory design that achieves a completely radiation-safe environment that eliminates the need for personal protective apparel and thereby mitigates the orthopedic consequences. Remarkable progress has been made by the FDA directives to industry and medical institutions to improve equipment and processes designed to achieve reduced radiation exposure to patients. We are optimistic that analogous efforts can be marshaled to enhance operator safety by providing a collaborative template by which this may be achieved. Industrial innovation will be evident once convinced that market forces are favorable to such changes. 1.7.3 The role of hospitals Prioritization of worker health to increase worker longevity is both the ethical thing to do, and a stable workforce (physicians, nurses, and technologists) makes "good business sense."17, 33 Hospitals and health care systems should recognize that foregoing protective equipment and wellness processes to save expenditures at the expense of the long-term health of their workers is ultimately more costly, since it encourages increased turnover, more labor downtime, and increased training expenditures. Hospitals have the legal responsibility to monitor and assure worker safety and optimal occupational radiation exposure. Each institution's radiation physicists provide training and monitoring of personnel and equipment. It therefore follows that hospitals have a "fiduciary type" responsibility for those working in their facilities and therefore an implicit responsibility not only to maintain and calibrate present imaging systems but also to equip catheterization laboratories with the most modern equipment (imaging and protective) established to offer benefits to the safety and welfare of their workforce. Calibration of the X-ray system, modernization with updated features, replacement of outdated imaging systems, and equipment maintenance are the responsibilities of the hospital. Only time will tell if governmental authorities (e.g., Occupational Health and Safety Agency) might weigh in on these occupational safety issues and issue standards that require a pl

Radiation exposure can cause lens opacities. We examined the relationship between occupational exposure to ionizing radiation and the prevalence of lens changes in interventional cardiologists (ICs) and catheterization laboratory (“cath-lab”) staff. A cross-sectional study at an interventional

Introduction Patients with end-stage renal disease (ESRD) have a higher incidence of coronary artery disease (CAD). Hence, it is crucial to evaluate CAD before renal transplantation. This study compares the utility of pharmacologic single-photon emission computed-tomography (SPECT) imaging directly to coronary angiography for diagnosis of CAD with correlation to cardiovascular risk factors. Method Retrospective review of asymptomatic renal failure patients who underwent both SPECT and coronary angiography to identify obstructive CAD between the years 2008-2016. Ninety-four ESRD subjects were evaluated. Results Myocardial perfusion SPECT study found, when compared to coronary angiography demonstrated for CAD, the sensitivity of 93.3% with a specificity of 73.4%. Importantly, the negative predictive value for coronary artery disease was 96%. With seven or more cardiac risk factors, 66.7% of patients had obstructive coronary artery disease. Among all the risk factors examined, patients with a previous history of coronary artery disease had a 68% risk of obstructive coronary artery disease. Conclusion Comparing myocardial perfusion imaging SPECT findings with coronary angiography in patients with ESRD, a sensitivity of 93.3% and a specificity of 73% were observed. Of all the risk factors examined, patient with the previous history of CAD was the single most significant risk factor for CAD in 68% of cases.

Introduction: Hyperoxia has been shown to increases vascular resistance and hence decrease flow in healthy coronary arteries through various compensatory mechanisms including nitric oxide pathways....

This article illustrates the effectiveness of targeted radioprotective strategies for the interventional echocardiographer. The reader should recognize the importance of engagement of all team members in the multifaceted process of radiation exposure mitigation. Future efforts/studies should focus on the impact of team oriented training, lab design, and development of novel supplies and equipment to mitigate radiation exposure of all personnel in the cardiac catheterization lab, particularly during more complex interventional procedures.

Real time radiation dose monitoring in the cath lab may provide immediate feedback for potential dose reduction during PCI. Radiation dose monitoring to predict potential tissue injury utilizes equipment measured air Kerma at the interventional reference point (IRP) with then calculated specific tissue peak skin dose. The role of the cath lab Quality Committee is not only to assess individual high dose radiation cases but also to create processes and assess new technologies to assure radiation dose is best utilized in all cases.

This review, which details 2 DAPT risk scoring systems and includes a treatment guide, can help ensure that you deliver the right treatment to the right patients.

The stimulus to create this document was the recognition that ionizing radiation-guided cardiovascular procedures are being performed with increasing frequency, leading to greater patient radiation exposure and, potentially, to greater exposure to clinical personnel. While the clinical benefit of these procedures is substantial, there is concern about the implications of medical radiation exposure. ACC leadership concluded that it is important to provide practitioners with an educational resource that assembles and interprets the current radiation knowledge base relevant to cardiovascular procedures. By applying this knowledge base, cardiovascular practitioners will be able to select procedures optimally, and minimize radiation exposure to patients and to clinical personnel. "Optimal Use of Ionizing Radiation in Cardiovascular Imaging - Best Practices for Safety and Effectiveness" is a comprehensive overview of ionizing radiation use in cardiovascular procedures and is published online. To provide the most value to our members, we divided the print version of this document into 2 focused parts. "Part I: Radiation Physics and Radiation Biology" addresses radiation physics, dosimetry and detrimental biologic effects. "Part II: Radiologic Equipment Operation, Dose-Sparing Methodologies, Patient and Medical Personnel Protection" covers the basics of operation and radiation delivery for the 3 cardiovascular imaging modalities (x-ray fluoroscopy, x-ray computed tomography, and nuclear scintigraphy). For each modality, it includes the determinants of radiation exposure and techniques to minimize exposure to both patients and to medical personnel.

This article illustrates the positive impact of fluoroscopic imaging equipment on radiation dose reduction in CTO PCI. The reader should recognize the importance of purchasing and maintaining the best equipment, understanding procedure/patient complexity, and assuring operator training in radiation dose reduction. Future efforts/studies should focus upon all three areas of dose reduction for best results.

BACKGROUND:There is great variability in radiation safety practices in cardiac catheterization laboratories around the world. METHODS:We performed an international online survey on radiation safety including interventional cardiologists, electrophysiologists, interventional radiologists, and vascular surgeons. RESULTS:A total of 570 responses were received from various geographic locations, including the United States (77.9%), Asia (7.9%), Europe (6.8%), Canada (2.8%), and Mexico and Central America (2.1%). Most respondents (73%) were interventional cardiologists and 23% were electrophysiologists, with 14.4 ± 10.2 years in practice. Most respondents (75%) were not aware of their radiation dose during the past year and 21.2% had never attended a radiation safety course; 58.9% are "somewhat worried" and 31.5% are "very worried" about chronic radiation exposure. Back pain due to lead use was reported by 43.0% and radiation-related health complications including cataracts and malignancies were reported by 6.3%. Only 37.5% of respondents had an established radiation dose threshold for initiating patient follow-up. When comparing United States operators with the other respondents, the former were more likely to attend radiation safety courses (P<.001), wear dosimeters (P<.001), know their annual personal radiation exposure (P<.001), and have an established patient radiation dose threshold (P<.001). They were also more likely to use the fluoro store function, under-table shields, leaded glasses, ceiling lead glass, and disposable radiation shields, and were more concerned about the adverse effects of radiation. CONCLUSIONS:Radiation safety is of concern to catheterization laboratory personnel, yet there is significant variability in radiation protection practices, highlighting several opportunities for standardization and improvement.

Background: Rapid activation of the cardiac catheterization laboratory for primary percutaneous coronary intervention (PCI) improves outcomes for ST-segment elevation myocardial infarction (STEMI), but selected emphasis on minimizing time to reperfusion may lead to an increased frequency of false -positive STEMI activations (FPSA). While delays in reperfusion therapy are associated with worse outcomes, inaccurate diagnosis also has potential clinical as well as cost related repercussions. According to prior reports, FPSA rates vary between 15-52 percent. Method: We analyzed consecutive patients referred for primary PCI for a possible STEMI at a single center from November 2013 to February 2017. False-positive STEMI activation was defined as lack of electrocardiographic criteria consistent with American College of Cardiology/American Heart Association guidelines for diagnosis of STEMI, and clinical assessments. Overall differences amongst various STEMI activators were evaluated using Chi-square test. Differences between working-hours (0700-1600) versus off-hours (1601-0659) were evaluated using Cochran-Mantel-Haenszel test. Results: Of 355 STEMI activations, 194 (55%) were called by emergency physicians (ED), 81 (23%) by emergency medical services (EMS) and 80 (22%) by other (inpatient services & out of hospital transfers). A total of 120 (34%) cases occurred during working-hours and 235 (66%) cases occurred during off-hours. The average age of the study population was 62 (13) years, with 245(68%) males and average BMI of 30 (6) kg/m2. The prevalence of FPSA initiated by the ED, EMS, and others was 32 (16.5%), 9 (11%), and 14 (18%), respectively (p=0.06). Of FSPA, 40% were anterior, 25% inferior, 21% lateral, and 14% inferolateral wall infarctions. Out of 55 total FPSA, 37 (67%) occurred during the off-hours. Comparing activators based on hours, the prevalence of FPSA during off-hours initiated by the ED, EMS, and others were 69%, 66%, and 66%, respectively (p=0.6). Conclusion: In this study, approximately 1 out of 6.5 STEMI activations was a false-positive. This trend is the same during working as well as off-hours and does not differ between various STEMI activators. Improved and structured communication between cardiology, emergency medicine, and paramedic teams may promote lower false positive rates and positively impact overall delivery of care.

HomeCirculation: Cardiovascular Quality and OutcomesVol. 10, No. 8Morbidity and Mortality and Beyond Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBMorbidity and Mortality and BeyondAssuring Quality in Cardiac Catheterization Laboratory Quality Programs Charles E. Chambers, MD Charles E. ChambersCharles E. Chambers From the Hershey Medical Center, PA. Originally published10 Aug 2017https://doi.org/10.1161/CIRCOUTCOMES.117.004001Circulation: Cardiovascular Quality and Outcomes. 2017;10:e004001Quality assurance (QA) is an essential component of invasive cardiology with guideline recommendations for all percutaneous coronary interventions facilities to have a QA Committee.1 Although the concept of quality has been embraced, the implementation of such programs has potential inappropriate variability. For examples, some facilities have cath laboratory QA as a component of a hospital-wide program and not as an independent entity that is needed; physician participation is not consistently required but is necessary to be effective; administrative support may be insufficient to provide for adequate data collection and entry. In addition, barriers for standardization may occur based on the local laboratory characteristics. Open physician staffs require quality assessment to be performed by competing individuals/groups. These multispecialty cath laboratories create challenges in leadership definition and program delineation. With no requirements for how to do quality and limited methods available for the assessment of an individual catheterization laboratory QA program, assuring quality in one's cath laboratory QA program can be challenging.See Article by Doll et alThe morbidity and mortality (M&M) conference is a traditional key component to the cath laboratory quality process, as adverse events are frequently the emphasis of QA. This should be identified as such to address potential legal concerns and attendance threshold established for maintenance of privileges. Most academic programs have well-developed M&M conferences. These not only assess quality but also provide memorable educational opportunities for general and interventional cardiology fellows, per Accreditation Council for Graduate Medical Education requirements, as well as all faculty, both young and old. Despite the ubiquity and importance of M&M, the literature has been lacking in specifics on how to do an M&M conference. These specifics can help to prevent inappropriate or punitive case selection and a lack of impartiality in scoring/assessing performance. The systematic review of prespecified triggered events in patients with poor outcomes could help to standardize the approach to the M&M conference.Doll et al2 describe their 10-year experience with processes that use clinical data systems to systematically identify high-complexity percutaneous coronary interventions cases for peer review. In this study, 9 specific events/triggers were assessed through an information technology program to identify cases for review. Many procedural issues were also addressed. Attendance was required, protocols for case presentation were outlined, and case discussion was encouraged/essential. Finally, a peer review score was calculated on which decisions on corrective action were based. The additional strengths of this approach include clear administrative/personnel support for conference organization, an excellent database with little missing data, and a detailed approach for potential corrective action as determined by the M&M score.The authors noted that this basic M&M program would allow certain components to be modified by the individual laboratory based on their local practice environment. Conference attendance may be expanded to other colleagues to accommodate the heart and vascular institute concept or physician extender involvement in their practices. Confidential distribution of cases for discussion before the M&M conference may be beneficial. Case presentations should only occur with the primary operator present and deferred if not. Case discussion, although key, may require appropriate time limits, as prolonged repetitive discussions may become more detrimental than productive. Although the infrastructure for M&M is well outlined, local adaptation should be driven by the cath laboratory QA Committee to address specific needs of the individual laboratory. This may include modification of the specific triggers to be tracked and when to perform random case reviews. Assurance of quality requires random case reviews be performed, and 5% to 10% of case volume is considered necessary for such an assessment. A peer review setting is required for the assessment of professional performance with the primary goal being to improve patient care through professional interactions.3The M&M conference is 1 part to cath laboratory QA, but the potential benefits for standardization should apply to the entire cath laboratory QA effort. Without uniformity, it is challenging to assess the effectiveness of an individual laboratory's quality program. An independent cath laboratory quality program, designed to address issues specific to the laboratory, is required and not just incorporated as part of a hospital quality effort. Assessing quality requires the 3 standard measures or indicators of quality be addressed: structure, process, and outcomes. The structural indicators are the objective criteria for a functioning laboratory, including physician privileging or staff credentialing/recredentialing. Process indicators reflect how the patient was managed, covering a broad spectrum of both patient- and procedure-specific issues, including appropriateness and adherence to guidelines and system-driven variables such as door-to-balloon time.4 Because these are less objective and potentially amenable to observer bias than objective clinical outcomes, they are more difficult to measure. Outcomes identify what happened to the patient and reflect how the patient was managed; these include procedure death, cerebral vascular accident, vascular complications, and periprocedural myocardial infarction. This is often the focus of QA because of an implied association with physician and hospital performance.Local variation in healthcare delivery presents challenges for a standardized percutaneous coronary interventions quality improvement process to be constructive and impartial. Issues, such as open versus closed cath laboratories with various physician groups, or hospital versus nonhospital employees, present potential obstacles. In this era of an expanding electronic medical record, there is a need to embrace information technology in this quality effort. A standardized cath report assures a uniform and complete data entry to populate the required databases5 and identify specific triggers for M&M conferences. National uniformity would allow all programs to request similar administrative support and strive for uniform goals. Publications on this standardized approach to establishing a quality program are available.4,6 In 2011, the Society of Cardiovascular Angiography and Intervention created the Quality Improvement Tool Kit to help cath laboratories with the process.7 Using these tools and publications as templates would assist in the standardized assessment of quality in the cath laboratory potentially mitigating the many local challenging variables.Although standards for cath laboratory quality programs are available, it is difficult to know how these have been incorporated into an individual laboratory's QA program and what impact local variations in healthcare delivery has on this process. This ability to assess an individual laboratories quality program will be difficult until a method for external review is used/required to provide a means to compare laboratories to a national standard. Cath laboratory accreditation, as a means to assess the quality of an individual laboratories quality program, has been available for >5 years. However, at this time, this is infrequently sought as there is no current mandate for external review/accreditation. Cost is often noted as a concern despite its potential value.8 Although all cath laboratories strive to achieve a high-quality program, how to assure this will likely require standardized practices with external oversight to assure appropriate application. As the potential benefits are recognized, more widespread accreditation may be the key to assuring quality in one's quality program.The busy interventionalist is assessing critically ill patients and mastering new technologies. QA is essential to this process with assuring the quality of one's quality program similarly essential. QA has improved over the years with certain standard practices established. Doll et al2 strengthen these standardization efforts with an excellent overview of the M&M conference. This offers a peek under the hood at the engine that drives invasive cardiac care. Local challenges in healthcare delivery dictate some variability in individual QA programs. However, it is important to assure that the basic program requirements are met by recognizing the potential benefits of external oversight and accreditation. With the implementation of a uniform quality improvement process and a method to assess the quality of one's own quality program, physician and laboratory performance will be assessed uniformly against national standards, and quality patient care will be assured to the best of our abilities.DisclosuresDr Chambers is a board member, Accreditation for Cardiovascular Excellence (ACE).FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to Charles E. Chambers, MD, Pennsylvania State University College of Medicine, Hershey Medical Center, 500 University Dr, Hershey, PA 17033. E-mail [email protected]References1. Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions.Circulation. 2011; 124:e574–e651. doi: 10.1161/CIR.0b013e31823ba622.LinkGoogle Scholar2. Doll JA, Overton R, Patel MR, Rao SV, Sketch MH, Harrison JK, Tcheng JE. Morbidity and mortality conference for percutaneous coronary intervention.Circ Cardiovasc Qual Outcomes. 2017; 10:e003538. doi: 10.1161/CIRCOUTCOMES.116.003538.LinkGoogle Scholar3. Heupler FA, Chambers CE, Dear WE, Angello DA, Heisler M. Guidelines for internal peer review in the cardiac catheterization laboratory. Laboratory Performance Standards Committee, Society for Cardiac Angiography and Interventions.Cathet Cardiovasc Diagn. 1997; 40:21–32.CrossrefMedlineGoogle Scholar4. Bashore TM, Balter S, Barac A, Byrne JG, Cavendish JJ, Chambers CE, Hermiller JB, Kinlay S, Landzberg JS, Laskey WK, McKay CR, Miller JM, Moliterno DJ, Moore JW, Oliver-McNeil SM, Popma JJ, Tommaso CL; ACCF Task Force Members. 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions expert consensus document on cardiac catheterization laboratory standards update: A report of the American College of Cardiology Foundation Task Force on Expert Consensus documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine.J Am Coll Cardiol. 2012; 59:2221–2305. doi: 10.1016/j.jacc.2012.02.010.CrossrefMedlineGoogle Scholar5. Sanborn TA, Tcheng JE, Anderson HV, Chambers CE, Cheatham SL, DeCaro MV, Durack JC, Everett AD, Gordon JB, Hammond WE, Hijazi ZM, Kashyap VS, Knudtson M, Landzberg MJ, Martinez-Rios MA, Riggs LA, Sim KH, Slotwiner DJ, Solomon H, Szeto WY, Weiner BH, Weintraub WS, Windle JR. ACC/AHA/SCAI 2014 health policy statement on structured reporting for the cardiac catheterization laboratory: a report of the American College of Cardiology Clinical Quality Committee.Circulation. 2014; 129:2578–2609. doi: 10.1161/CIR.0000000000000043.LinkGoogle Scholar6. Klein LW, Uretsky BF, Chambers C, Anderson HV, Hillegass WB, Singh M, Ho KK, Rao SV, Reilly J, Weiner BH, Kern M, Bailey S; Society of Cardiovascular Angiography and Interventions. Quality assessment and improvement in interventional cardiology: a position statement of the Society of Cardiovascular Angiography and Interventions, part 1: standards for quality assessment and improvement in interventional cardiology.Catheter Cardiovasc Interv. 2011; 77:927–935. doi: 10.1002/ccd.22982.CrossrefMedlineGoogle Scholar7. Society for Cardiovascular Angiography and Interventions. SCAI Quality Improvement Tool Kit (QIT).www.scai-qit.org. Accessed August 1, 2017.Google Scholar8. Weiner B, Dehmer G, Brindis R, et al. The value of catheterization laboratory accreditation.Paper presented at: 2015 Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions; May 6–9, 2015; San Diego, CA. Abstract 13833.Google Scholar Previous Back to top Next FiguresReferencesRelatedDetails August 2017Vol 10, Issue 8 Advertisement Article InformationMetrics © 2017 American Heart Association, Inc.https://doi.org/10.1161/CIRCOUTCOMES.117.004001PMID: 28798018 Originally publishedAugust 10, 2017 Keywordspeer reviewgoalsleadershipcatheterizationpatient careEditorialsPDF download Advertisement SubjectsPercutaneous Coronary InterventionQuality and Outcomes

Objectives To evaluate radiation reduction by reducing fluoroscopy pulse rate in diagnostic cardiac catheterizations and percutaneous coronary interventions (PCI) as well as outcomes at 30 days and six months. Background Radiation exposure to the public at large has increased dramatically over the past three decades, and the cardiac catheterization laboratory is a large contributor. Fluoroscopy pulse rate is one way to decrease radiation exposure. Methods Fluoroscopy pulse rate was reduced from 10 pulses/sec (p/s) to 7.5 p/s as part of an internal quality improvement project. A retrospective analysis of all cardiac catheterizations was performed, evaluating Air KERMA at the interventional reference point (Ka, r), Air KERMA area product (PKA), procedural complications and major adverse cardiac events at 30 days and 6 months. Results In diagnostic catheterization median PKA (µGy·m2) and Ka,r (mGy) were significantly reduced (PKA – 5,613.3 vs. 4,400, P < 0.001; Ka,r – 703.0 vs. 621.0, P = 0.041). In PCI, median PKA and Ka,r were further reduced (PKA – 13,481.6 vs. 10,648.0, P < 0.001; Ka,r – 1787.0 vs. 1,459.0, P = 0.002). There was no difference in complications, fluoroscopy time or number of stents placed. There was no difference in MACE after adjustment for number of STEMIs. Conclusions Reducing fluoroscopy pulse rates to 7.5 from 10 is an effective way to reduce patient radiation exposure across meaningful dose indices. A pulse rate of 7.5 p/s is safe, with no difference in complications or outcomes. A fluoroscopy pulse rate of 7.5 p/s should be given strong consideration for a new standard. © 2016 Wiley Periodicals, Inc.

Quality assurance (QA) is an essential component of invasive cardiology with guideline recommendations for all percutaneous coronary interventions facilities to have a QA Committee.1 Although the concept of quality has been embraced, the implementation of such programs has potential inappropriate variability. For examples, some facilities have cath laboratory QA as a component of a hospital-wide program and not as an independent entity that is needed; physician participation is not consistently required but is necessary to be effective; administrative support may be insufficient to provide for adequate data collection and entry. In addition, barriers for standardization may occur based on the local laboratory characteristics. Open physician staffs require quality assessment to be performed by competing individuals/groups. These multispecialty cath laboratories create challenges in leadership definition and program delineation. With no requirements for how to do quality and limited methods available for the assessment of an individual catheterization laboratory QA program, assuring quality in one’s cath laboratory QA program can be challenging.See Article by Doll et al The morbidity and mortality (M&M) conference is a traditional key component to the cath laboratory quality process, as adverse events are frequently the emphasis of QA. This should be identified as such to address potential legal concerns and attendance threshold established for maintenance of privileges. Most academic programs have well-developed M&M conferences. These not only assess quality but also provide memorable educational opportunities for general and interventional cardiology fellows, per Accreditation Council for Graduate Medical Education requirements, as well as all faculty, both young and old. Despite the ubiquity and importance of M&M, the literature has been lacking …