- Email: [email protected]
Patient doses in cardiac catheterisation in Santa Catarina, Brazil
Radiation Physics and Chemistry xxx (xxxx) xxxx
Contents lists available at ScienceDirect
Radiation Physics and Chemistry journal homepage: www.elsevier.com/locate/radphyschem
Patient doses in cardiac catheterisation in Santa Catarina, Brazil Davi Alves da Silvaa, , Ana Figueiredo Maiaa, Rogério Machadoa, Vanessa Lorena Souza de Medeiros Freitasb, Regina Dal Castel Pinheiroc, Nadja Fernandade Andrade Francoc, Djeimis William Kremerc, Marcus Vinícius Navarrob ⁎
a
Departamento de Física, Universidade Federal de Sergipe, Sergipe, Brazil Laboratório de Produtos para Saúde, Instituto Federal da Bahia, Bahia, Brazil c Vigilância Sanitária do Estado de Santa Catarina, Santa Catarina, Brazil b
ARTICLE INFO
ABSTRACT
Keywords: Kerma area product Interventional radiology Cardiac catheterisation Dose
Interventional radiology is an area of medicine that uses ionising radiation to assist physicians in performing some procedures. Among these procedures, cardiac catheterisation stands out as one of the ones responsible for the highest patients’ doses. The aim of this study was to evaluate the averages of the Kerma Area Product (KAP) for cardiac catheterisation procedures registered in the compulsory registration system for medical expositions in Santa Catarina state (SIERI) during the years 2016 and 2017 and compare them with the KAP values obtained in other countries. From the total analysed procedures, 71.4% were performed in men and 28.6% in women. The mean KAP for men was between 39.0 and 46.7 Gy cm2 and between 36.7 and 41.3 Gy cm2 for women. For the 25 institutions analysed, the average KAP was between 8.48 and 84.0 Gy cm2, values within this range were found in studies conducted in other countries. The SIERI system is functioning properly for the registration of patient doses and KAP values, in general, were within the average values presented in the work done in several countries.
1. Introduction Interventional radiology is a branch of medicine that uses radiological images, guided by fluoroscopy, to perform diagnostic or therapeutic interventions. Cardiovascular procedures are the most common and long-lasting, resulting in high doses for patients (Lichtenstein et al., 1996; Hansson and Karambatsakidou, 2000; Andreou et al., 2016), and in some cases dose values may reach levels used in radiotherapy fractions (International Comission on Radiation Protection, 2000). In some cases, dose values can reach more than 3 Gy (Christakopoulos et al., 2016) which can lead to skin injuries (Vlietstra et al., 2004; Srimahachota et al., 2012). For this reason, there are several papers focused on patient dosimetry during cardiovascular procedures (Chida et al., 2010; Uniyal et al., 2016; Sulieman et al., 2018;) and the establishment of reference levels and dose optimization (Hart et al., 2009; IAEA, 2010; Maccia et al., 2015) The measurement quantity used to monitor patient dose in fluoroscopy is the Kerma Area Product (KAP), which is defined as the total dose in a perpendicular area to the incident radiation beam (International Commission on Radiation Units and Measurements, 2005). As the dose is inversely proportional and the area is directly
⁎
proportional to the square of the distance, KAP remains constant along the perpendicular axis of the beam. KAP is expressed in Gy cm2 or multiples. For a better dose monitoring in Santa Catarina, the dosimetry information in the registered establishments is based on a database that is part of the Information System of Ionising Radiation Expositions (SIERI). SIERI is a mandatory system that registers institutions working with ionising radiation, institutions must access and fill out information such as occupationally exposed workers dosimetry, occupation and identification number. For institutions that work with interventional radiology, it is necessary to provide information about the equipment used to perform the procedure and about the patient's dose as kerma, total radiation exposure time, KAP, type of procedure performed, age, sex and patient identification number. In order to obtain an overview of dose values in patients during interventional procedures, this study analysed 21,651 KAP values of cardiac catheterisation procedures between 1st January 2016 and 31st December 2017, in Santa Cantarina, Brazil, in establishments registered with SIERI. Cardiac catheterisation was chosen due to the greater number of procedures compared with other ones registered in SIERI. For an initial analysis, mean KAP values, per registered institution, was
Corresponding author. E-mail address: [email protected] (D.A. da Silva).
https://doi.org/10.1016/j.radphyschem.2019.03.012 Received 15 December 2018; Received in revised form 6 March 2019; Accepted 11 March 2019 Available online 12 March 2019 0969-806X/ © 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: Davi Alves da Silva, et al., Radiation Physics and Chemistry, https://doi.org/10.1016/j.radphyschem.2019.03.012
Radiation Physics and Chemistry xxx (xxxx) xxxx
D.A. da Silva, et al.
taken into account and then the results were compared with those found in other studies in different countries.
Table 2 Mean and median dose values per year and per gender.
2. Materials and method
Female
2016 2017 2016 2017
3920 3897 9010 10,511
30.32% 27.05% 69.68% 72.95%
Male
Female
2016 2017 2016 2017
41 37 47 39
27 25 32 23
± ± ± ±
64 58 70 68
Institution
Number of procedures
Min. - Max. (Gy cm2)
KAP (Gy cm2)
Median (Gy cm2)
Third quartile (Gy cm2)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
5 918 103 122 2819 934 450 1443 925 3124 1591 217 144 636 2200 620 2104 634 256 132 597 1199 10 340 128
2–212 1–430 0.003–69 8–75 0.4–137 0.7–118 0.0007–184 0.02–50 1–192 0.5–156 0.0008–112 8–30 0.01–170 2–133 0.0003–173 4–220 6–31.8 2–145 3–239 0.04–239 0.36–277 0.03–199 36–96.9 4–331 0.10–304
66 84 13 30 38 37 45 17 44 17 20 15 35 28 11 56 14 36 69 52 48 57 63 43 9
12 71 9 29 36 35 38 16 40 14 16 10 29 21 0.1 46 12 31 57 43 43 43 56 30 1
97 103 16 35 44 46 54 21 63 22 24 22 50 35 15 70 16 42 84 81 57 74 83 49 1
± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±
91 52 12 13 21 23 28 9 27 14 15 9 32 23 26 35 7 19 48 50 27 42 22 41 30
* KAP values are shown as mean ± S.D.
4. Discussion SIERI is a system used for recording and monitoring doses in the state of Santa Catarina, Brazil, implemented in the year 2005. However, the volume of effective registration began in 2014, presenting its largest amount between 2016 and 2017. Cardiac catheterisation represents more than half (53.7%) of the procedures performed between 2016 and 2017, therefore, it is important to analyse the doses in this type of procedure. In addition, cardiac procedures are those which, in general, carry a larger dose for the patient. Among the cardiac catheterisations performed, in the two years, most (about 70%) were made in males, as observed in Table 1. A larger number of males were submitted to this type of procedure in other studies (Tsapaki et al., 2006; Buytaert et al., 2018; Sulieman et al., 2018). Table 2 shows that the mean KAP obtained for men in the two years is above the values obtained for women in the same period. This agrees with the work by Tsapaki et al. (2006), who found the values were 47 Gy cm2 and 61 Gy cm2 for women and men, respectively. A possible explanation for male doses being higher than female doses is that, in general, males have a higher weight and body mass index than females, and it is known that these two factors affect the patient's radiation dose (Ector et al., 2007; Shah et al., 2015; Crowhurst et al., 2018). In the KAP assessment, the mean values for the 25 institutions were between 8.48 and 84.0 Gy cm2, which is within the mean observed in the studies presented in Table 5. Separating the KAP averages by
Table 1 Number of cardiac catheterisations performed by year separated by gender. Percentage
MEDIAN (Gy cm2)
Table 3 Number of cardiac catheterisations separated by institution.
Between January 2008 and January 2018, 78,301 interventional procedures were registered in SIERI. About 65% (50,911) of the registered procedures were carried out between 2016 and 2017, including 27,338 cardiac catheterisations, representing about 53.7% of the interventional procedures performed in both years. Among the cardiac catheterisations performed in 2016, when analysed by gender, 30.32% were female and 69.98% were male; in 2017, 27.05% were female and 72.95% were male, according to Table 1. Table 2 shows the dose values distributed by gender and by year. There were 21,651 procedures considered as valid data, distributed among 25 different institutions, as shown in Table 3. Table 4 shows the dose distribution among the 25 institutions, separating dose by equipment from each institution. In order to preserve the identity of the institutions, each was randomly numbered from 1 to 25 and for those who had more than one piece of equipment, they were differentiated as 1 or 2. For the purpose of comparison, dose values for cardiac procedures obtained in several studies published in different countries are also presented in Table 5.
Number of procedures
KAP (Gy cm2)
*KAP values are shown as mean ± S.D.
3. Results
Year
Year
Male
This work was carried out with the support of the Departamento Estadual de Saúde de Santa Catarina, Brazil, through access to SIERI. SIERI is a database that, among other things, records KAP values obtained during interventional procedures performed in Santa Catarina. Although SIERI was implemented in 2005, the use and effective fulfilment began from 2014. For this work, data from the 1st of January 2016 to the 31st of December 2017 were used. In order to ensure data integrity, some exclusion criteria were adopted such as KAP values equal to zero, data that were outside the evaluation period and values outside a reasonable range. A coherence analysis was performed to exclude the data. First, it was verified whether the KAP unit of each equipment was registered correctly in the system and after that all values were converted to Gy cm2 (international system unit). Then, the values were checked to see if they were within an acceptable magnitude range; those outside this range were considered as a registration error and, therefore, excluded. Finally, an analysis between the Kerma magnitudes, KAP and exposure time was performed to find incoherent relations in the data that prove misplaced information, which was then excluded. About 5.6% of the registered data presented misplaced points and were filtered out. Dose values were separated by gender, year, institution and equipment, the results were then analysed using descriptive statistics through the mean, standard deviation, median and third quartile. Finally, the results were compared to each other and compared with other works performed in several countries.
Gender
Gender
2
Radiation Physics and Chemistry xxx (xxxx) xxxx
D.A. da Silva, et al.
Table 4 Dose distribution by institution separated by equipment. Institution
Equipment
Number of procedures
Min. - Max. (Gy cm2)
KAP (Gy cm2)
Median (Gy cm2)
Third quartile (Gy cm2)
1
1 2 1 1 2 1 1 1 2 1 1 1 1 2 1 1 2 1 1 1 2 1 1 2 1 1 1 1 1 1 1 2 1
3 2 918 2 101 122 2819 867 67 450 1443 925 1937 1187 1591 209 8 144 636 2041 159 620 2033 71 634 256 132 597 1199 10 5 335 128
2–12 97–212 1–430 6–27 0.003–69 8–75 0.4–137 0.2–20 1–118 0.0007–184 0.02–50 0.04–100 0.2–126 0.1–156 0.0008–112 107–976 6.32–62.2 0.01–170 1.60–133 0.50–181 0.0003–173 4.30–220 0.16–313 6.09–31.8 1.80–145 3.18–240 0.04–239 0.36–277 0.03–198 36.2–96.9 17.8–104 3.91–331 0.10–304
7 154 84 17 13 30 38 5 37 45 17 43 7 17 20 396 22 35 28 16 11 56 56 14 36 69 52 48 57 63 49 43 9
5 154 71.4 16.6 9.3 28.6 36.4 3.66 34.5 37.4 15.7 39.9 3.3 13.7 15.5 364 11 29 21 14 0.1 46 46 12 31 57 43 43 65 56 36 30 1
8.63 183 103 21.8 15.7 35.4 43.6 6.51 45.5 54.2 21.2 62.9 9.10 21.5 24.3 502 22 50 35 18 15 70 68 16 42 84 81 57 74 83 62 49 1
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±
5 81 52 15 12 13 21 4 23 29 9 26 10 14 15 189 19 32 23 11 26 35 40 7 19 48 50 27 42 22 35 41 30
* KAP values are shown as mean ± S.D.
In 2015, Christopoulos et al. performed simulations with four different pieces of fluoroscopy equipment and obtained results between 23.72 and 92.28 Gy cm2. Considering these values, the results obtained in this present study, in general, lie within the range delimited by the researchers. Hansson and Karambatsakidou (2000) established 250 Gy cm2 as a safe threshold to prevent the appearance of skin erythema in the patient after interventional procedures. According to Tsapaki (2010) the Society of Interventional Radiology Safety and Health Committee established a 500 Gy cm2 threshold for a patient follow-up, while the International Atomic Energy Agency stablished 200 Gy cm2. Thus, the mean values obtained in this work are below these thresholds; only a few procedures exceeded these values. Due to the SIERI system generalization, it was not possible to know which procedures were diagnostic or therapeutic. In addition, the limitation of this study included the non-presentation of weight and body mass index of the patients for a statistical comparison with dose values. However, it is known that such factors affect patient doses as observed in the works of Ector et al. (2007), Shah et al. (2015) and Crowhurst et al. (2018). For a better visualization of the results, Fig. 1 presents median and third quartiles KAP values for each of the 25 institutions analysed by this work in comparison with suggested guidance levels by International Atomic Energy Agency (IAEA) for Coronary Angiography (CA) and Percutaneous Cardiovascular Intervention (PCI). Observing Fig. 1, 56% of third quartile values of this work are below IAEA suggested levels for CA and all values are below the levels for PCI.
Table 5 Dose values in several countries. Country
KAP (Gy cm2)
United States (Miller et al., 2012) Brazil (Cardoso et al., 2014) Sweden (Hansson and Karambatsakidou, 2000) Italy (Trianni et al., 2005) Greece (Tsapaki et al., 2006) United Kingdom (Public Health, 2016) Ireland (European Commission, 2014) United States (Christopoulos et al., 2015) Belgium (Buytaert et al., 2018)
65.7a 29.05a 73a
a b c
39.8a 47.0b (female)–61.0b (male) 40c 53.1c 23.72a–92.28a 83.8a (room A)–27.9a (room B)
Mean value. Median. 3rd quartile.
equipment, values obtained were between 4.76 and 396 Gy cm2, with 72.7% of the values up to 50 Gy cm2, 21.2% between 50 and 100 Gy cm2 and 6.1% above 100 Gy cm2. Observing the values in Table 5, it can be seen that about 94% of the equipment presented mean values within the range found in the literature for cardiac procedures. Although the institutions 13 and 25 have the same equipment model, the mean KAP values presented a great difference between them. The same occurred with the average values for the equipment 2 of institution 15 that differ from those found in institutions 17 (equipment 1), 21 and 23. The values found for institutions 15 (room 1) and 17 (room 2) are similar and also those obtained in the two rooms of institution 24. Some hypotheses about the great difference between values of the institutions can be related to the complexity of the cases that each institution attends, the experience of the operators and physicians and, also, the performance of the equipment.
5. Conclusion The KAP values found in this study were, in general, similar to those obtained in studies in several countries. It was also observed that most 3
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Christakopoulos, G.E., Christopoulos, G., Karmpaliotis, D., et al., 2016. Predictors of excess patient radiation exposure during chronic total occlusion coronary intervention: insights from a contemporary multicenter registry. Can. J. Cardiol. https://doi.org/ 10.1016/j.cjca.2016.11.002. Christopoulos, G., Christakopoulos, G.E., Rangan, B.V., et al., 2015. Comparison of radiation dose between different fluoroscopy systems in the modern catheterization laboratory: results from bench testing using an anthropomorphic phantom. Catheter. Cardiovasc. Interv. 86, 927–932. https://doi.org/10.1002/ccd.26007. Crowhurst, J.A., Whitby, M., Savage, M., et al., 2018. Factors contributing to radiation dose for patients and operators during diagnostic cardiac angiography. J. Med. Radiat. Sci. 1–10. https://doi.org/10.1002/jmrs.315. (doi: doi:10.1002/jmrs.315). Ector, J., Dragusin, O., Adriaenssens, B., Huybrechts, W., Willems, R., Ector, H., Heidbuechel, H., 2007. Obesity is a major determinant of radiation dose in patients undergoing pulmonary vein isolation for atrial fibrillation. J. Am. Coll. Cardiol. 50, 234–242. Hansson, B., Karambatsakidou, A., 2000. Relationships between entrance skin dose, effective dose and dose area product for patients in diagnostic and interventional cardiac procedures. Radiat. Prot. Dosim. 90, 141–144. https://doi.org/10.1093/ oxfordjournals.rpd.a033104. Hart, D., Hillier, M.C., Wall, B.F., 2009. National reference doses for common radiographic, fluoroscopic and dental X-ray examinations in the UK. Br. J. Radiol. 82, 1–12. International Atomic Energy Agency, 2009. Establishing guidance levels in X ray guided medical interventional procedures: a pilot study. Safety Reports Series n. 59. Available at: 〈https://www-pub.iaea.org/MTCD/publications/PDF/pub1346_web. pdf〉. International Atomic Energy Agency, 2010. Patient Dose Optimization in Fluoroscopically Guided Interventional Procedures. (IAEA-TEDDOC-1641). International Comission on Radiation Protection, 2000. Avoidance of radiation injuries from medical interventional procedures. ICRP Publication 85. Ann. ICRP 30 (2). International Commission on Radiation Units and Measurements, 2005. Patient Dosimetry for X Rays Used in Medical Imaging. (Report 74. J. ICRU. 5, i). Lichtenstein, D.A., Klapholz, L., Vardy, D.A., et al., 1996. Chronic radiodermatitis following cardiac catheterization. Arch. Dermatol. 132, 663–667. Maccia, C., Malchair, F., Gobert, I., Louvard, Y., Lefevre, T., 2015. Assessment of local dose reference values for recanalization of chronic total occlusions and other occlusions in a high-volume catheterization center. Am. J. Cardiol. 116, 1179–1184. Miller, D.L., Hilohi, C.M., Spelic, D.C., 2012. Patient radiation doses in interventional cardiology in the U.S.: advisory data sets and possible initial values for U.S. reference levels. Med. Phys. 39 (10), 6276–6286. National Diagnostic Reference Levels, Public Health, England, 2016. Available at: 〈https://www.gov.uk/government/publications/diagnostic-radiology-nationaldiagnostic-reference-levels-ndrls/national-diagnostic-reference-levels-ndrls# national-drls-for-general-radiography-and-fluoroscopy〉. Radiation Protection nº 108. Diagnostic Reference Levels in Thirty-six European Countries. European Commission. 2014. Available at: 〈https://ec.europa.eu/energy/ sites/ener/files/documents/RP180%20part2.pdf〉. Shah, A., Das, P., Subkovas, E., Buch, A.N., Rees, M., Bellamy, C., 2015. Radiation dose during coronary angiogram: relation to body mass index. Heart Lung Circ. 24, 21–25. Srimahachota, S., Udayachalerm, T., Kupharang, T., et al., 2012. Radiation skin injury caused by percutaneous coronary intervention, report of 3 cases. Int. J. Cardiol. 154, e31–e33. https://doi.org/10.1016/j.ijcard.2011.05.016. Sulieman, A., Abdelrazig, A., Alkhorayef, M., et al., 2018. Patient effective doses and radiation risks in cardiac catheterization procedures. Radiat. Phys. Chem. 157, 54–59. https://doi.org/10.1016/j.radphyschem.2018.12.012. Trianni, A., Padovani, R., Foti, C., et al., 2005. Dose to cardiologists in haemodynamic and electrophysiology cardiac interventional procedures. Radiat. Prot. Dosim. 117, 111–115. Tsapaki, V., Magginas, A., Vano, E., et al., 2006. Factors that influence radiation dose in percutaneous coronary intervention. J. Interv. Cardiol. 19, 237–244. Tsapaki, V., 2010. Radiation dose in interventional cardiology. Imaging Med. 2 (3), 303–312. https://doi.org/10.2217/iim.10.20. Uniyal, S.C., Chaturvedi, V., Sharma, S.D., Rawat, A., 2016. Patient dosimetry during interventional cardiac procedures in a dedicated catheterization laboratory. Radiat. Prot. Dosim. 1–8. https://doi.org/10.1093/rpd/ncw286. Vlietstra, R.E., Wagner, L.K., Koenig, T., Mettler, F., 2004. Radiation burns as a severe complication of. J. Interv. Cardiol. 17, 131–142.
Fig. 1. Comparison of median values and third quartile with suggested guidance level by IAEA (IAEA, 2009).
cardiac interventional procedures were performed in men, as is noted in several other works. The realisation of this work was made possible by the SIERI system and the Departamento Estadual de Saúde de Santa Catarina who gave access to the system. Through the analysis of SIERI data, it was possible to obtain an overview of medical expositions during interventional procedures in the state of Santa Catarina with a very significant sample and then compare dose values with results from other countries. In this way, SIERI is an important tool for dose monitoring. When comparing Kerma Area Product values for the same equipment model used in different institutions, it was noted that there are cases in which the mean KAP differs significantly, even when considering the same type of procedure. This could be explained by performing a deeper analysis of the data, taking into account the difficulty of the procedure, the radiation exposure time, the operating conditions of the equipment and the physician's expertise, for example. The SIERI system is in full operation and fulfilling its purpose of dose registration. In order to be able to become an effective tool in the monitoring of doses in the state of Santa Catarina, it is necessary to implement some data registration improvements and analysis tools. With these improvements, SIERI could became a national tool for medical and occupational exposure monitoring and this system could help the national health surveillance agency to reach a reference level for interventional radiology in the future. References Andreou, K., Pantos, I., Tzanalaridou, E., et al., 2016. Patient radiation exposure and influencing factors at interventional cardiology procedures. Phys. Med. 32, 234. https://doi.org/10.1016/j.ejmp.2016.07.485. Buytaert, D., Eloot, L., Mauti, M., et al., 2018. Evaluation of patient and staff exposure with state-of-the-art X-ray technology in cardiac catheterization: a randomized controlled trial. J. Interv. Cardiol. 31, 1–8. https://doi.org/10.1111/joic.12553. Cardoso, C.O., Moraes, C.V., Teixeira, J.V.S., et al., 2014. Pattern of radiation exposure in healthcare professionals during coronary angiography. Rev. Bras. Cardiol. Invasiva 22 (4), 320–323. Chida, K., Ohno, T., Kakizakik, S., et al., 2010. Radiation dose to the pediatric cardiac catheterization and intervention patient. Am. J. Roentgenol. 195, 1175–1179.
4
Contents lists available at ScienceDirect
Radiation Physics and Chemistry journal homepage: www.elsevier.com/locate/radphyschem
Patient doses in cardiac catheterisation in Santa Catarina, Brazil Davi Alves da Silvaa, , Ana Figueiredo Maiaa, Rogério Machadoa, Vanessa Lorena Souza de Medeiros Freitasb, Regina Dal Castel Pinheiroc, Nadja Fernandade Andrade Francoc, Djeimis William Kremerc, Marcus Vinícius Navarrob ⁎
a
Departamento de Física, Universidade Federal de Sergipe, Sergipe, Brazil Laboratório de Produtos para Saúde, Instituto Federal da Bahia, Bahia, Brazil c Vigilância Sanitária do Estado de Santa Catarina, Santa Catarina, Brazil b
ARTICLE INFO
ABSTRACT
Keywords: Kerma area product Interventional radiology Cardiac catheterisation Dose
Interventional radiology is an area of medicine that uses ionising radiation to assist physicians in performing some procedures. Among these procedures, cardiac catheterisation stands out as one of the ones responsible for the highest patients’ doses. The aim of this study was to evaluate the averages of the Kerma Area Product (KAP) for cardiac catheterisation procedures registered in the compulsory registration system for medical expositions in Santa Catarina state (SIERI) during the years 2016 and 2017 and compare them with the KAP values obtained in other countries. From the total analysed procedures, 71.4% were performed in men and 28.6% in women. The mean KAP for men was between 39.0 and 46.7 Gy cm2 and between 36.7 and 41.3 Gy cm2 for women. For the 25 institutions analysed, the average KAP was between 8.48 and 84.0 Gy cm2, values within this range were found in studies conducted in other countries. The SIERI system is functioning properly for the registration of patient doses and KAP values, in general, were within the average values presented in the work done in several countries.
1. Introduction Interventional radiology is a branch of medicine that uses radiological images, guided by fluoroscopy, to perform diagnostic or therapeutic interventions. Cardiovascular procedures are the most common and long-lasting, resulting in high doses for patients (Lichtenstein et al., 1996; Hansson and Karambatsakidou, 2000; Andreou et al., 2016), and in some cases dose values may reach levels used in radiotherapy fractions (International Comission on Radiation Protection, 2000). In some cases, dose values can reach more than 3 Gy (Christakopoulos et al., 2016) which can lead to skin injuries (Vlietstra et al., 2004; Srimahachota et al., 2012). For this reason, there are several papers focused on patient dosimetry during cardiovascular procedures (Chida et al., 2010; Uniyal et al., 2016; Sulieman et al., 2018;) and the establishment of reference levels and dose optimization (Hart et al., 2009; IAEA, 2010; Maccia et al., 2015) The measurement quantity used to monitor patient dose in fluoroscopy is the Kerma Area Product (KAP), which is defined as the total dose in a perpendicular area to the incident radiation beam (International Commission on Radiation Units and Measurements, 2005). As the dose is inversely proportional and the area is directly
⁎
proportional to the square of the distance, KAP remains constant along the perpendicular axis of the beam. KAP is expressed in Gy cm2 or multiples. For a better dose monitoring in Santa Catarina, the dosimetry information in the registered establishments is based on a database that is part of the Information System of Ionising Radiation Expositions (SIERI). SIERI is a mandatory system that registers institutions working with ionising radiation, institutions must access and fill out information such as occupationally exposed workers dosimetry, occupation and identification number. For institutions that work with interventional radiology, it is necessary to provide information about the equipment used to perform the procedure and about the patient's dose as kerma, total radiation exposure time, KAP, type of procedure performed, age, sex and patient identification number. In order to obtain an overview of dose values in patients during interventional procedures, this study analysed 21,651 KAP values of cardiac catheterisation procedures between 1st January 2016 and 31st December 2017, in Santa Cantarina, Brazil, in establishments registered with SIERI. Cardiac catheterisation was chosen due to the greater number of procedures compared with other ones registered in SIERI. For an initial analysis, mean KAP values, per registered institution, was
Corresponding author. E-mail address: [email protected] (D.A. da Silva).
https://doi.org/10.1016/j.radphyschem.2019.03.012 Received 15 December 2018; Received in revised form 6 March 2019; Accepted 11 March 2019 Available online 12 March 2019 0969-806X/ © 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: Davi Alves da Silva, et al., Radiation Physics and Chemistry, https://doi.org/10.1016/j.radphyschem.2019.03.012
Radiation Physics and Chemistry xxx (xxxx) xxxx
D.A. da Silva, et al.
taken into account and then the results were compared with those found in other studies in different countries.
Table 2 Mean and median dose values per year and per gender.
2. Materials and method
Female
2016 2017 2016 2017
3920 3897 9010 10,511
30.32% 27.05% 69.68% 72.95%
Male
Female
2016 2017 2016 2017
41 37 47 39
27 25 32 23
± ± ± ±
64 58 70 68
Institution
Number of procedures
Min. - Max. (Gy cm2)
KAP (Gy cm2)
Median (Gy cm2)
Third quartile (Gy cm2)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
5 918 103 122 2819 934 450 1443 925 3124 1591 217 144 636 2200 620 2104 634 256 132 597 1199 10 340 128
2–212 1–430 0.003–69 8–75 0.4–137 0.7–118 0.0007–184 0.02–50 1–192 0.5–156 0.0008–112 8–30 0.01–170 2–133 0.0003–173 4–220 6–31.8 2–145 3–239 0.04–239 0.36–277 0.03–199 36–96.9 4–331 0.10–304
66 84 13 30 38 37 45 17 44 17 20 15 35 28 11 56 14 36 69 52 48 57 63 43 9
12 71 9 29 36 35 38 16 40 14 16 10 29 21 0.1 46 12 31 57 43 43 43 56 30 1
97 103 16 35 44 46 54 21 63 22 24 22 50 35 15 70 16 42 84 81 57 74 83 49 1
± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±
91 52 12 13 21 23 28 9 27 14 15 9 32 23 26 35 7 19 48 50 27 42 22 41 30
* KAP values are shown as mean ± S.D.
4. Discussion SIERI is a system used for recording and monitoring doses in the state of Santa Catarina, Brazil, implemented in the year 2005. However, the volume of effective registration began in 2014, presenting its largest amount between 2016 and 2017. Cardiac catheterisation represents more than half (53.7%) of the procedures performed between 2016 and 2017, therefore, it is important to analyse the doses in this type of procedure. In addition, cardiac procedures are those which, in general, carry a larger dose for the patient. Among the cardiac catheterisations performed, in the two years, most (about 70%) were made in males, as observed in Table 1. A larger number of males were submitted to this type of procedure in other studies (Tsapaki et al., 2006; Buytaert et al., 2018; Sulieman et al., 2018). Table 2 shows that the mean KAP obtained for men in the two years is above the values obtained for women in the same period. This agrees with the work by Tsapaki et al. (2006), who found the values were 47 Gy cm2 and 61 Gy cm2 for women and men, respectively. A possible explanation for male doses being higher than female doses is that, in general, males have a higher weight and body mass index than females, and it is known that these two factors affect the patient's radiation dose (Ector et al., 2007; Shah et al., 2015; Crowhurst et al., 2018). In the KAP assessment, the mean values for the 25 institutions were between 8.48 and 84.0 Gy cm2, which is within the mean observed in the studies presented in Table 5. Separating the KAP averages by
Table 1 Number of cardiac catheterisations performed by year separated by gender. Percentage
MEDIAN (Gy cm2)
Table 3 Number of cardiac catheterisations separated by institution.
Between January 2008 and January 2018, 78,301 interventional procedures were registered in SIERI. About 65% (50,911) of the registered procedures were carried out between 2016 and 2017, including 27,338 cardiac catheterisations, representing about 53.7% of the interventional procedures performed in both years. Among the cardiac catheterisations performed in 2016, when analysed by gender, 30.32% were female and 69.98% were male; in 2017, 27.05% were female and 72.95% were male, according to Table 1. Table 2 shows the dose values distributed by gender and by year. There were 21,651 procedures considered as valid data, distributed among 25 different institutions, as shown in Table 3. Table 4 shows the dose distribution among the 25 institutions, separating dose by equipment from each institution. In order to preserve the identity of the institutions, each was randomly numbered from 1 to 25 and for those who had more than one piece of equipment, they were differentiated as 1 or 2. For the purpose of comparison, dose values for cardiac procedures obtained in several studies published in different countries are also presented in Table 5.
Number of procedures
KAP (Gy cm2)
*KAP values are shown as mean ± S.D.
3. Results
Year
Year
Male
This work was carried out with the support of the Departamento Estadual de Saúde de Santa Catarina, Brazil, through access to SIERI. SIERI is a database that, among other things, records KAP values obtained during interventional procedures performed in Santa Catarina. Although SIERI was implemented in 2005, the use and effective fulfilment began from 2014. For this work, data from the 1st of January 2016 to the 31st of December 2017 were used. In order to ensure data integrity, some exclusion criteria were adopted such as KAP values equal to zero, data that were outside the evaluation period and values outside a reasonable range. A coherence analysis was performed to exclude the data. First, it was verified whether the KAP unit of each equipment was registered correctly in the system and after that all values were converted to Gy cm2 (international system unit). Then, the values were checked to see if they were within an acceptable magnitude range; those outside this range were considered as a registration error and, therefore, excluded. Finally, an analysis between the Kerma magnitudes, KAP and exposure time was performed to find incoherent relations in the data that prove misplaced information, which was then excluded. About 5.6% of the registered data presented misplaced points and were filtered out. Dose values were separated by gender, year, institution and equipment, the results were then analysed using descriptive statistics through the mean, standard deviation, median and third quartile. Finally, the results were compared to each other and compared with other works performed in several countries.
Gender
Gender
2
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Table 4 Dose distribution by institution separated by equipment. Institution
Equipment
Number of procedures
Min. - Max. (Gy cm2)
KAP (Gy cm2)
Median (Gy cm2)
Third quartile (Gy cm2)
1
1 2 1 1 2 1 1 1 2 1 1 1 1 2 1 1 2 1 1 1 2 1 1 2 1 1 1 1 1 1 1 2 1
3 2 918 2 101 122 2819 867 67 450 1443 925 1937 1187 1591 209 8 144 636 2041 159 620 2033 71 634 256 132 597 1199 10 5 335 128
2–12 97–212 1–430 6–27 0.003–69 8–75 0.4–137 0.2–20 1–118 0.0007–184 0.02–50 0.04–100 0.2–126 0.1–156 0.0008–112 107–976 6.32–62.2 0.01–170 1.60–133 0.50–181 0.0003–173 4.30–220 0.16–313 6.09–31.8 1.80–145 3.18–240 0.04–239 0.36–277 0.03–198 36.2–96.9 17.8–104 3.91–331 0.10–304
7 154 84 17 13 30 38 5 37 45 17 43 7 17 20 396 22 35 28 16 11 56 56 14 36 69 52 48 57 63 49 43 9
5 154 71.4 16.6 9.3 28.6 36.4 3.66 34.5 37.4 15.7 39.9 3.3 13.7 15.5 364 11 29 21 14 0.1 46 46 12 31 57 43 43 65 56 36 30 1
8.63 183 103 21.8 15.7 35.4 43.6 6.51 45.5 54.2 21.2 62.9 9.10 21.5 24.3 502 22 50 35 18 15 70 68 16 42 84 81 57 74 83 62 49 1
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±
5 81 52 15 12 13 21 4 23 29 9 26 10 14 15 189 19 32 23 11 26 35 40 7 19 48 50 27 42 22 35 41 30
* KAP values are shown as mean ± S.D.
In 2015, Christopoulos et al. performed simulations with four different pieces of fluoroscopy equipment and obtained results between 23.72 and 92.28 Gy cm2. Considering these values, the results obtained in this present study, in general, lie within the range delimited by the researchers. Hansson and Karambatsakidou (2000) established 250 Gy cm2 as a safe threshold to prevent the appearance of skin erythema in the patient after interventional procedures. According to Tsapaki (2010) the Society of Interventional Radiology Safety and Health Committee established a 500 Gy cm2 threshold for a patient follow-up, while the International Atomic Energy Agency stablished 200 Gy cm2. Thus, the mean values obtained in this work are below these thresholds; only a few procedures exceeded these values. Due to the SIERI system generalization, it was not possible to know which procedures were diagnostic or therapeutic. In addition, the limitation of this study included the non-presentation of weight and body mass index of the patients for a statistical comparison with dose values. However, it is known that such factors affect patient doses as observed in the works of Ector et al. (2007), Shah et al. (2015) and Crowhurst et al. (2018). For a better visualization of the results, Fig. 1 presents median and third quartiles KAP values for each of the 25 institutions analysed by this work in comparison with suggested guidance levels by International Atomic Energy Agency (IAEA) for Coronary Angiography (CA) and Percutaneous Cardiovascular Intervention (PCI). Observing Fig. 1, 56% of third quartile values of this work are below IAEA suggested levels for CA and all values are below the levels for PCI.
Table 5 Dose values in several countries. Country
KAP (Gy cm2)
United States (Miller et al., 2012) Brazil (Cardoso et al., 2014) Sweden (Hansson and Karambatsakidou, 2000) Italy (Trianni et al., 2005) Greece (Tsapaki et al., 2006) United Kingdom (Public Health, 2016) Ireland (European Commission, 2014) United States (Christopoulos et al., 2015) Belgium (Buytaert et al., 2018)
65.7a 29.05a 73a
a b c
39.8a 47.0b (female)–61.0b (male) 40c 53.1c 23.72a–92.28a 83.8a (room A)–27.9a (room B)
Mean value. Median. 3rd quartile.
equipment, values obtained were between 4.76 and 396 Gy cm2, with 72.7% of the values up to 50 Gy cm2, 21.2% between 50 and 100 Gy cm2 and 6.1% above 100 Gy cm2. Observing the values in Table 5, it can be seen that about 94% of the equipment presented mean values within the range found in the literature for cardiac procedures. Although the institutions 13 and 25 have the same equipment model, the mean KAP values presented a great difference between them. The same occurred with the average values for the equipment 2 of institution 15 that differ from those found in institutions 17 (equipment 1), 21 and 23. The values found for institutions 15 (room 1) and 17 (room 2) are similar and also those obtained in the two rooms of institution 24. Some hypotheses about the great difference between values of the institutions can be related to the complexity of the cases that each institution attends, the experience of the operators and physicians and, also, the performance of the equipment.
5. Conclusion The KAP values found in this study were, in general, similar to those obtained in studies in several countries. It was also observed that most 3
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Christakopoulos, G.E., Christopoulos, G., Karmpaliotis, D., et al., 2016. Predictors of excess patient radiation exposure during chronic total occlusion coronary intervention: insights from a contemporary multicenter registry. Can. J. Cardiol. https://doi.org/ 10.1016/j.cjca.2016.11.002. Christopoulos, G., Christakopoulos, G.E., Rangan, B.V., et al., 2015. Comparison of radiation dose between different fluoroscopy systems in the modern catheterization laboratory: results from bench testing using an anthropomorphic phantom. Catheter. Cardiovasc. Interv. 86, 927–932. https://doi.org/10.1002/ccd.26007. Crowhurst, J.A., Whitby, M., Savage, M., et al., 2018. Factors contributing to radiation dose for patients and operators during diagnostic cardiac angiography. J. Med. Radiat. Sci. 1–10. https://doi.org/10.1002/jmrs.315. (doi: doi:10.1002/jmrs.315). Ector, J., Dragusin, O., Adriaenssens, B., Huybrechts, W., Willems, R., Ector, H., Heidbuechel, H., 2007. Obesity is a major determinant of radiation dose in patients undergoing pulmonary vein isolation for atrial fibrillation. J. Am. Coll. Cardiol. 50, 234–242. Hansson, B., Karambatsakidou, A., 2000. Relationships between entrance skin dose, effective dose and dose area product for patients in diagnostic and interventional cardiac procedures. Radiat. Prot. Dosim. 90, 141–144. https://doi.org/10.1093/ oxfordjournals.rpd.a033104. Hart, D., Hillier, M.C., Wall, B.F., 2009. National reference doses for common radiographic, fluoroscopic and dental X-ray examinations in the UK. Br. J. Radiol. 82, 1–12. International Atomic Energy Agency, 2009. Establishing guidance levels in X ray guided medical interventional procedures: a pilot study. Safety Reports Series n. 59. Available at: 〈https://www-pub.iaea.org/MTCD/publications/PDF/pub1346_web. pdf〉. International Atomic Energy Agency, 2010. Patient Dose Optimization in Fluoroscopically Guided Interventional Procedures. (IAEA-TEDDOC-1641). International Comission on Radiation Protection, 2000. Avoidance of radiation injuries from medical interventional procedures. ICRP Publication 85. Ann. ICRP 30 (2). International Commission on Radiation Units and Measurements, 2005. Patient Dosimetry for X Rays Used in Medical Imaging. (Report 74. J. ICRU. 5, i). Lichtenstein, D.A., Klapholz, L., Vardy, D.A., et al., 1996. Chronic radiodermatitis following cardiac catheterization. Arch. Dermatol. 132, 663–667. Maccia, C., Malchair, F., Gobert, I., Louvard, Y., Lefevre, T., 2015. Assessment of local dose reference values for recanalization of chronic total occlusions and other occlusions in a high-volume catheterization center. Am. J. Cardiol. 116, 1179–1184. Miller, D.L., Hilohi, C.M., Spelic, D.C., 2012. Patient radiation doses in interventional cardiology in the U.S.: advisory data sets and possible initial values for U.S. reference levels. Med. Phys. 39 (10), 6276–6286. National Diagnostic Reference Levels, Public Health, England, 2016. Available at: 〈https://www.gov.uk/government/publications/diagnostic-radiology-nationaldiagnostic-reference-levels-ndrls/national-diagnostic-reference-levels-ndrls# national-drls-for-general-radiography-and-fluoroscopy〉. Radiation Protection nº 108. Diagnostic Reference Levels in Thirty-six European Countries. European Commission. 2014. Available at: 〈https://ec.europa.eu/energy/ sites/ener/files/documents/RP180%20part2.pdf〉. Shah, A., Das, P., Subkovas, E., Buch, A.N., Rees, M., Bellamy, C., 2015. Radiation dose during coronary angiogram: relation to body mass index. Heart Lung Circ. 24, 21–25. Srimahachota, S., Udayachalerm, T., Kupharang, T., et al., 2012. Radiation skin injury caused by percutaneous coronary intervention, report of 3 cases. Int. J. Cardiol. 154, e31–e33. https://doi.org/10.1016/j.ijcard.2011.05.016. Sulieman, A., Abdelrazig, A., Alkhorayef, M., et al., 2018. Patient effective doses and radiation risks in cardiac catheterization procedures. Radiat. Phys. Chem. 157, 54–59. https://doi.org/10.1016/j.radphyschem.2018.12.012. Trianni, A., Padovani, R., Foti, C., et al., 2005. Dose to cardiologists in haemodynamic and electrophysiology cardiac interventional procedures. Radiat. Prot. Dosim. 117, 111–115. Tsapaki, V., Magginas, A., Vano, E., et al., 2006. Factors that influence radiation dose in percutaneous coronary intervention. J. Interv. Cardiol. 19, 237–244. Tsapaki, V., 2010. Radiation dose in interventional cardiology. Imaging Med. 2 (3), 303–312. https://doi.org/10.2217/iim.10.20. Uniyal, S.C., Chaturvedi, V., Sharma, S.D., Rawat, A., 2016. Patient dosimetry during interventional cardiac procedures in a dedicated catheterization laboratory. Radiat. Prot. Dosim. 1–8. https://doi.org/10.1093/rpd/ncw286. Vlietstra, R.E., Wagner, L.K., Koenig, T., Mettler, F., 2004. Radiation burns as a severe complication of. J. Interv. Cardiol. 17, 131–142.
Fig. 1. Comparison of median values and third quartile with suggested guidance level by IAEA (IAEA, 2009).
cardiac interventional procedures were performed in men, as is noted in several other works. The realisation of this work was made possible by the SIERI system and the Departamento Estadual de Saúde de Santa Catarina who gave access to the system. Through the analysis of SIERI data, it was possible to obtain an overview of medical expositions during interventional procedures in the state of Santa Catarina with a very significant sample and then compare dose values with results from other countries. In this way, SIERI is an important tool for dose monitoring. When comparing Kerma Area Product values for the same equipment model used in different institutions, it was noted that there are cases in which the mean KAP differs significantly, even when considering the same type of procedure. This could be explained by performing a deeper analysis of the data, taking into account the difficulty of the procedure, the radiation exposure time, the operating conditions of the equipment and the physician's expertise, for example. The SIERI system is in full operation and fulfilling its purpose of dose registration. In order to be able to become an effective tool in the monitoring of doses in the state of Santa Catarina, it is necessary to implement some data registration improvements and analysis tools. With these improvements, SIERI could became a national tool for medical and occupational exposure monitoring and this system could help the national health surveillance agency to reach a reference level for interventional radiology in the future. References Andreou, K., Pantos, I., Tzanalaridou, E., et al., 2016. Patient radiation exposure and influencing factors at interventional cardiology procedures. Phys. Med. 32, 234. https://doi.org/10.1016/j.ejmp.2016.07.485. Buytaert, D., Eloot, L., Mauti, M., et al., 2018. Evaluation of patient and staff exposure with state-of-the-art X-ray technology in cardiac catheterization: a randomized controlled trial. J. Interv. Cardiol. 31, 1–8. https://doi.org/10.1111/joic.12553. Cardoso, C.O., Moraes, C.V., Teixeira, J.V.S., et al., 2014. Pattern of radiation exposure in healthcare professionals during coronary angiography. Rev. Bras. Cardiol. Invasiva 22 (4), 320–323. Chida, K., Ohno, T., Kakizakik, S., et al., 2010. Radiation dose to the pediatric cardiac catheterization and intervention patient. Am. J. Roentgenol. 195, 1175–1179.
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