Establishing the European diagnostic reference levels for interventional cardiology

Interventional cardiac procedures may be associated with high patient doses and therefore require special attention to protect the patients from radiation injuries such as skin erythema, cardiovascular tissue reactions or radiation-induced cancer. In this study, patient exposure data is collected from 13 countries (37 clinics and nearly 50 interventional rooms) and for 10 different procedures. Dose data was collected from a total of 14,922 interventional cardiology procedures. Based on these data European diagnostic reference levels (DRL) for air kerma-area product are suggested for coronary angiography (CA, DRL = 35 Gy cm²), percutaneous coronary intervention (PCI, 85 Gy cm²), transcatheter aortic valve implantation (TAVI, 130 Gy cm²), electrophysiological procedures (12 Gy cm²) and pacemaker implantations. Pacemaker implantations were further divided into single-chamber (2.5 Gy cm²) and dual chamber (3.5 Gy cm²) procedures and implantations of cardiac resynchronization therapy pacemaker (18 Gy cm²). Results show that relatively new techniques such as TAVI and treatment of chronic total occlusion (CTO) often produce relatively high doses, and thus emphasises the need for use of an optimization tool such as DRL to assist in reducing patient exposure. The generic DRL presented here facilitate comparison of patient exposure in interventional cardiology.     

Local diagnostic reference levels for paediatric non-cardiac interventional radiology procedures

PurposeTo establish local diagnostic reference levels (DRLs) for non-cardiac interventional procedures in paediatrics.MethodsThe type of procedure, the patient’s weight and age and dose-related data from 279 interventions was recorded in a database completed by interventional radiologists, radiographers and technicians of the Medical Physics department. These procedures were classified into 14 categories and 6 weight ranges. Local DRLs were proposed for those ranges in which a sample of at least 15 patients could be gathered and were calculated as the third quartile (Q3) of the air kerma-area product (P_KA) values. The Q3 of the fluoroscopy time (FT) and number of digital subtraction angiography (DSA) images were also obtained. Finally, the correlation between P_KA and weight was analysed.ResultsLocal DRLs are proposed for three types of procedures: hepatic/biliary interventions (5–15 kg, 1304 cGy·cm²; 15–30 kg, 2121 cGy·cm²), sclerotherapy procedures (15–30 kg, 704 cGy·cm²; 30–50 kg, 4049 cGy·cm²; 50–80 kg, 3734 cGy·cm²) and central venous catheter (CVC) procedures (5–15 kg, 84 cGy·cm²). Hepatic/biliary interventions showed a moderate correlation (r = 0.61), while sclerotherapy procedures presented a poor correlation (r = 0.34) between P_KA and weight, possibly due to the P_KA dependence on the complexity level. Regarding CVC procedures, a clearly higher correlation was found when the fluoroscopy P_KA value was normalised to the FT (r = 0.85 vs r = 0.35).ConclusionsThe results support the feasibility of establishing DRLs for the most common procedures (sclerotherapy, hepatic/biliary and CVC interventions) despite the small number of paediatric interventions.     

Preliminary diagnostic reference levels for endoscopic retrograde cholangio-pancreatography in Greece

The main objective of this study was to determine the preliminary Diagnostic Reference Levels (DRLs) in terms of Kerma Area Product (KAP) and fluoroscopy time (Tf) during Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. Additionally, an investigation was conducted to explore the statistical relation between KAP and Tf.Data from a set of 200 randomly selected patients treated in 4 large hospitals in Greece (50 patients per hospital) were analyzed in order to obtain preliminary DRLs for KAP and Tf during therapeutic ERCP procedures. Non-parametric statistic tests were performed in order to determine a statistically significant relation between KAP and Tf.The resulting third quartiles for KAP and Tf for hospitals (A, B, C and D) were found as followed: KAP_A = 10.7 Gy cm², Tf_A = 4.9 min; KAP_B = 7.5 Gy cm², Tf_B = 5.0 min; KAP_C = 19.0 Gy cm², Tf_C = 7.3 min; KAP_D = 52.4 Gy cm², Tf_D = 15.8 min. The third quartiles, calculated for the total 200 cases sample, are: KAP = 18.8 Gy cm² and Tf = 8.2 min. For 3 out of 4 hospitals and for the total sample, p-values of statistical indices (correlation of KAP and Tf) are less than 0.001, while for the Hospital A p-values are ranging from 0.07 to 0.08. Using curve fitting, we finally determine that the relation of Tf and KAP is deriving from a power equation (KAP = Tf^1.282) with R² = 0.85.The suggested Preliminary DRLs (deriving from the third quartiles of the total sample) for Greece are: KAP = 19 Gy cm² and Tf = 8 min, while the relation between KAP and Tf is efficiently described by a power equation.     

Towards the definition of Institutional diagnostic reference levels in paediatric interventional cardiology procedures in Greece

This study aimed to evaluate paediatric radiation doses in a dedicated cardiology hospital, with the objective of characterising patterns in dose variation. The ultimate purpose was to define Local (Institutional) Diagnostic Reference Levels (LDRLs) for different types of paediatric cardiac interventional procedures (IC), according to patient age. From a total of 710 cases performed during three consecutive years, by operators with more than 15 years of experience, the age was noted in only 477 IC procedures. The median values obtained for Fluoroscopy Time (FT), Number of Frames (N) and Kerma Area Product (P_KA) by age range were 5.8 min, 1322 and 2.0 Gy.cm² for <1 y; 6.5 min, 1403 and 3.0 Gy.cm² for 1 to <5 y; 5.9 min, 950 and 7.0 Gy.cm² for 5 to <10 y; 5.7 min, 940 and 14.0 Gy.cm² for 10 to <16 y, respectively. A large range of patient dose data is observed, depending greatly on procedure type and patient age. In all age groups the range of median FT, N and P_KA values was 3.1–15.8 min, 579–1779 and 1.0–20.8 Gy.cm² respectively. Consequently, the definition of LDRLs presents challenges mainly due to the multiple clinical and technical factors affecting the outcome. On the other hand the lack of paediatric IC DRLs makes the identification of good practices more difficult. A consensus is needed on IC procedures nomenclature and grouping in order to allow a common assessment and comparison of doses.     

Review of skin dose calculation software in interventional cardiology

PurposeIn interventional cardiology, patients may be exposed to high doses to the skin resulting in skin burns following single or multiple procedures. Reviewing and analysing available software (online or offline) may help medical physicists assessing the maximum skin dose to the patient together with the dose distribution during (or after) these procedures.Method and resultsCapabilities and accuracy of available software were analysed through an extensive bibliography search and contacts with both vendor and authors. Their markedly differed among developers.In total, 22 software were identified and reviewed according to their algorithms and their capabilities. Special attention was dedicated to their main features and limitations of interest for the intended clinical use.While the accuracy of the 12 software products validated with measurements on phantoms was acceptable (within ± 25%), the agreement was poor for the two products validated on patients (within ± 43% and ± 76%, respectively). In addition, no software has been validated on angiographic units from all manufacturers, though several software developers claimed vendor-independent transportability. Only one software allows for multiple procedures dose calculation.ConclusionLarge differences among vendors made it clear that work remains to be done before an accurate and reliable skin dose mapping is available for all patients.     

Establishment of national diagnostic reference levels (DRLs) for radiotherapy localisation computer tomography of the head and neck

Aim

The aim of this research is to establish if variation exists in the dose delivered for head and neck (HN) localisation computed tomography (CT) imaging in radiation therapy (RT); to propose a national diagnostic reference levels (DRLs) for this procedure and to make a comparison between the national DRL and a DRL of a European sample.

Typical values for pediatric interventional cardiology catheterizations: A standardized approach towards Diagnostic Reference Level establishment

PurposeTo define weight-stratified Diagnostic Reference Levels (DRL) typical values for pediatric interventional cardiology (IC) procedures adopting standardized methodologies proposed by ICRP135 and RP185.MethodsProcedures performed at the pediatric catheterization room of the University-Hospital of Padua were analysed. Patients were stratified into body weight (BW) classes and DRL quantities were analysed for the most performed procedures. Typical values are defined as median P_KA and K_a,r. For database consistency, sampling and exclusion methods were precisely defined. The DRL-curve methodology by means of quantile regression median curves was investigated to assess the relationship between P_KA and weight. A like-to-like comparison with literature was made.Results385 procedures were analysed. A large P_KA variability was observed in each weight group. P_KA differences across BW groups were not always statistically significant. When stratifying by procedure, P_KA variability decreased while correlations of P_KA and P_KA/FT with weight increased. The established typical values are generally lower than DRLs published data, whatever stratification method adopted. The highest P_KA median values were observed for Angioplasty (4.9 and 11.6 Gycm² for 5-<15 kg and 15-<30 kg, respectively). The DRL-curve approach shows promising results for Valvuloplasty and Angioplasty.ConclusionsTypical values for pediatric IC DRL quantities were determined according to ICRP135 and RP185 methodologies. Stratification by BW classification does not reduce the variability of the P_KA values, unlike what happens when stratifying by procedure type. Results seem to corroborate that variability and exposure are more affected by procedure type and complexity than by patient weight. DRL-curve is a feasible approach.     

Institutional Diagnostic Reference Levels and Peak Skin Doses in selected diagnostic and therapeutic interventional radiology procedures

PurposeInstitutional (local) Diagnostic Reference Levels for Cerebral Angiography (CA), Percutaneous Transhepatic Cholangiography (PTC), Transarterial Chemoembolization (TACE) and Percutaneous Transhepatic Biliary Drainage (PTBD) are reported in this study.Materials and methodsData for air kerma-area product (P_KA), air kerma at the patient entrance reference point (K_a,r), fluoroscopy time (FT) and number of images (NI) as well as estimates of Peak Skin Dose (PSD) were collected for 142 patients. Therapeutic procedure complexity was also evaluated, in an attempt to incorporate it into the DRL analysis.ResultsLocal P_KA DRL values were 70, 34, 189 and 54 Gy.cm² for CA, PTC, TACE and PTBD respectively. The corresponding DRL values for K_a,r were 494, 194, 1186 and 400 mGy, for FT they were 9.2, 14.2, 27.5 and 22.9 min, for the NI they were 844, 32, 602 and 13 and for PSD they were 254, 256, 1598 and 540 mGy respectively. P_KA for medium complexity PTBD procedures was 2.5 times higher than for simple procedures. For TACE, the corresponding ratio was 1.6. PSD was estimated to be roughly 50% of recorded K_a,r for procedures in the head/neck region and 10% higher than recorded K_a,r for procedures in the body region. In only 5 cases the 2 Gy dose alarm threshold for skin deterministic effects was exceeded.ConclusionProcedure complexity can differentiate DRLs in Interventional Radiology procedures. PSD could be deduced with reasonable accuracy from values of K_a,r that are reported in every angiography system.     

Establishing national diagnostic reference levels (DRLs) for computed tomography in Egypt

ObjectivesTo establish national diagnostic reference levels (DRLs) in Egypt for computed tomography (CT) examinations of adults and identify the potential for optimization.MethodsData from 3762 individual patient’s undergoing CT scans of head, chest (high resolution), abdomen, abdomen-pelvis, chest-abdomen-pelvis and CT angiography (aorta and both lower limbs) examinations in 50 CT facilities were collected. This represents 20% of facilities in the country and all of the 27 Governorates. Results were compared with DRLs of UK, USA, Canada, Japan, Australia and France.ResultsThe Egyptian DRLs for CTDI_vol in mGy are for head: 30, chest (high resolution): 22, abdomen (liver metastasis): 31, abdomen-pelvis: 31, chest-abdomen–pelvis: 33 and CT angiography (aorta and lower limbs): 37. The corresponding DRLs for DLP in mGy.cm are 1360, 420, 1425, 1325, 1320 and 1320. For head CT, the Egyptian DRL for CTDI_vol is 2–3 times lower than the DRLs from other countries. However, the DRL in terms of DLP is in the same range or higher as compared to others. The Egyptian DRL for chest CT (high resolution) is similar to others for DLP but higher for CTDI_vol. For abdomen and abdomen-pelvis DRLs for CTDI_vol are higher than others. For DLP, the DRLs for abdomen are higher than DRL in UK and lower than those in Japan, while for abdomen-pelvis they are higher than other countries.ConclusionDespite lower DRLs for CTDI_vol, an important consistent problem appears to be higher scan range as DRLs for DLP are higher.     

Diagnostic reference levels during fluoroscopically guided interventions using mobile C-arms in operating rooms: A national multicentric survey

PurposeTo establish diagnostic reference levels (DRLs) and achievable levels (ALs) for the most common fluoroscopically guided interventions (FGIs) performed in operating rooms using mobile C-arm equipment.MethodsA national survey was performed in 57 centers in France. Anonymous data from 6817 patients undergoing FGIs were prospectively collected over a period of 7 months. DRLs (third quartile of the distribution) and ALs (median of the distribution) were determined for each type of intervention in terms of kerma area product (KAP) and fluoroscopy time (FT).ResultsDRLs and ALs were proposed for 31 procedure types related to seven surgical specialties: orthopedics (n = 9), urology (n = 3), vascular (n = 6), cardiology (n = 5), neurosurgery (n = 3), gastrointestinal (n = 3), and multi-specialty (n = 2). DRLs in terms of KAP ranged from 0.1 Gy·cm² for hallux valgus to 78 Gy·cm² for abdominal aortic aneurysm endovascular repair. A factor of 155 was obtained between the FTs for a herniated lumbar disk (0.2 min) and an abdominal aortic aneurysm endovascular repair (31 min). The highest variations were obtained within orthopedic procedures in terms of KAP (ratio 122) and within gastrointestinal procedures in terms of FT (ratio 9). Overall, the FGIs associated with the highest radiation exposure (KAP > 10 Gy·cm²) were found in the cardiology, vascular, and gastrointestinal specialties.ConclusionsDRLs and ALs are suggested for a wide range of FGIs performed in operating rooms using a mobile C-arm. We aim at providing a practical optimization tool for medical physicists and surgeons.     

Patient exposure data and operator dose in coronary interventional procedures: Impact of body-mass index and procedure complexity

PurposeThe aim of this study was to assess patient exposure data and operator dose in coronary interventional procedures, when considering patient body-mass index and procedure complexity.MethodsTotal air kerma area product (P_KA), Air-Kerma (AK), Fluoroscopy time (FT), operator dose and patient body-mass index (BMI) from 97 patients’ procedures (62 coronary angiography (CA) and 35 Percutaneous Coronary Intervention (PCI) were collected for one year. For PCI procedures, also the complexity index-CI was collected. Continuous variables for each of the 2 groups procedures (CA and PCI) were compared as medians with interquartile range and using Mann-Whitney U test. Multiple group data were compared using Kruskal-Wallis test (significance: p < 0.05).ResultsMedian P_KA was 63 and 125 Gy cm² for CA and PCI respectively (p < 0.001); FT was 3 and 14 min, respectively (p < 0.001). P_KA and FT significantly increased (p < 0.05) with BMI class for CA procedures. P_KA and FT also increased in function of CI class for PCI, thought significantly only for FT (p < 0.001), possibly because of the low number of PCI procedures included; cine mode contributed most to P_KA. Significant dose variability was observed among cardiologists for CA procedures (p < 0.001).ConclusionsDose references levels for P_KA and FT in interventional cardiology should be defined - on a sufficient number of procedures- in function of CI and BMI classes. These could provide an additional tool for refining a facility’s quality assurance and optimization processes. Dose variability associated with cardiologists underlines the importance of continuous training.     

National survey to set diagnostic reference levels in nuclear medicine single photon emission imaging in Croatia

PurposeIn order to introduce the concept of diagnostic reference levels (DRLs) in the national nuclear medicine practice a survey was proposed and completed through all nuclear medicine departments in Croatia. An additional aim was to increase the awareness of importance and full implementation of a comprehensive quality program that includes devices used in the nuclear medicine chain.MethodsData were collected for more than 30 nuclear medicine single photon emission procedures. National DRLs (NDRLs) as administered activity and also as administered activity per unit mass were calculated in accordance to International Commission on Radiological Protection (ICRP) recommendations. Additionally, effective doses were estimated using conversion factors published by the ICRP.ResultsNDRLs for nuclear medicine single photon emission procedures were proposed. For procedures performed in only one department typical values were presented as reference. Effective doses related to applied radiopharmaceuticals were calculated to estimate radiation risk related to respective nuclear medicine procedure in more detail.ConclusionThis work presents results of the first national survey on DRLs of nuclear medicine single photon emission procedures and proposes reliable NDRLs that represent an actual status of nuclear medicine practice in Croatia. Results have motivated departments to introduce and set their own typical values to be used, as one of the tools, for further optimization process. One of the drawbacks of the DRL concept in nuclear medicine is the lack of the image quality parameters involved. For this reason, a quantity that considers both radiation protection and image quality should be introduced.     

Local diagnostic reference levels for intraoral dental radiography in the public hospitals of Cyprus

PurposeThe purpose of this study was to determine local DRLs for children and adults undergoing intraoral dental examinations at the intraoral radiology units of the public hospitals in Cyprus.MethodsMeasurements were made on all the twenty intraoral X-ray units of the public hospitals in Cyprus with the intention to establish the local DRLs for all the possible intraoral X-ray examinations for children and adults. All units are film based. The measurements were made by a Dose Area Product (DAP) meter (GAMMEX RMI 841-RD) placed at the surface of the dental unit’s X-ray shaping cone (FSD 20 cm). A diagnostic radiology dosimeter (Dosimax Plus A) was also placed at an FSD of 100 cm to compare the dose reading between the two dosimeters.ResultsDRLs were established at the 3rd quartile for 7 exposure settings corresponding to 12 types of teeth (Adult and children mandibular and maxillary incisor, premolar and molar) with values of 197, 163, 128, 102, 81, 65 and 49 mGycm⁻² and 7.23, 5.94, 4.75, 3.68, 3.10, 2.41 and 1.88 mGy for benchmark nominal exposure times of 1000, 800, 640, 500, 400, 320 and 250 ms respectively, at a nominal exposure voltage of 70 kVp.ConclusionsThe local DRLs of the present study compare well with other similar published DRLs.     

Web-based platform for patient dose surveys in diagnostic and interventional radiology in Bulgaria: Functionality testing and optimisation

In the period 2013–2016 the National Centre of Radiobiology and Radiation Protection (NCRRP) at the Ministry of Health of Bulgaria has developed a web based platform for performing national patient dose surveys and establishing Diagnostic Reference Levels (DRLs). It is accessible via internet browser, allowing the users to submit data remotely. Electronic questionnaires, specific for radiography, fluoroscopy, image guided interventional procedures, mammography and CT, were provided. Short and clear manuals were added to guide users and minimise human errors. The web-based data collection platform is functional and is currently being used for performing the third national dose survey in Bulgaria, launched in 2016. Data analysis is facilitated due to the standardisation of collected data and their storing. Using the platform, the participating facilities can establish their typical dose levels based on the median value, and compare them to DRLs. A disadvantage of the platform is the need to enter data manually, but it is opened for future upgrades for automatic data harvesting and analysis. Various practical approaches were used to overcome the lack of qualified human resources and insufficient understanding of the DRL and dose tracking concept and to motivate facilities to submit data.     

麻疹减毒活疫苗国家参考品的制备及标定

为了制备麻疹减毒活疫苗国家参考品,选用国内麻疹疫苗生产株沪191制备麻疹疫苗参考品。生产过程中严格控制精密性、水分含量,对候选参考品进行鉴别试验、水分含量、病毒滴度及无菌检查等检验。检验合格后组织进行候选参考品病毒滴度协作标定,共有5个实验室参加了协作标定。协作标定完成后,对实验室内变异、实验室间变异及国际参考品在不同实验室间的变异进行了分析。此外还对疫苗进行了热稳定性和实时稳定性分析。结果显示经5个实验室协作标定后,麻疹减毒活疫苗国家参考品的滴度为4.96±0.26 lgCC ID50/m l,实验室内部变异在1.09%～4.64%之间,实验室间变异为2.62%。国际参考品在不同实验室间的变异为4.19%。稳定性考核数据表明制备的参考品具有较好的稳定性,符合作为麻疹减毒活疫苗国家参考品的要求,滴度为4.96±0.26 lgCC ID50/m l。     

Validation of the MC-GPU Monte Carlo code against the PENELOPE/penEasy code system and benchmarking against experimental conditions for typical radiation qualities and setups in interventional radiology and cardiology

IntroductionInterventional procedures are associated with potentially high radiation doses to the skin. The 2013/59/EURATOM Directive establishes that the equipment used for interventional radiology must have a device or a feature informing the practitioner of relevant parameters for assessing patient dose at the end of the procedure. Monte Carlo codes of radiation transport are considered to be one of the most reliable tools available to assess doses. However, they are usually too time consuming for use in clinical practice. This work presents the validation of the fast Monte Carlo code MC-GPU for application in interventional radiology.MethodologiesMC-GPU calculations were compared against the well-validated Monte Carlo simulation code PENELOPE/penEasy by simulating the organ dose distribution in a voxelized anthropomorphic phantom. In a second phase, the code was compared against thermoluminescent measurements performed on slab phantoms, both in a calibration laboratory and at a hospital.ResultsThe results obtained from the two simulation codes show very good agreement, differences in the output were within 1%, whereas the calculation time on the MC-GPU was 2500 times shorter. Comparison with measurements is of the order of 10%, within the associated uncertainty.ConclusionsIt has been verified that MC-GPU provides good estimates of the dose when compared to PENELOPE program. It is also shown that it presents very good performance when assessing organ doses in very short times, less than one minute, in real clinical set-ups. Future steps would be to simulate complex procedures with several projections.