BEDOYA R. ET AL. ARTÍCULO DE INVESTIGACIÓN FIRST DOSE VALUES IN INTERVENTIONAL PROCEDURES. A PILOT INVESTIGATION IN PANAMA RESUMEN El propósito del estudio fue establecer para pacientes adultos, los primeros niveles referenciales diagnósticos (NRDs) en procedimientos intervencionistas cardiológicos (IC) y no cardiológicos (INC) en Panamá. Se trabajo en el principal hospital del seguro social del país, donde se registro para cada procedimiento, el tiempo de fluorosocopia (TF), el producto dosis area (PDA) y la dosis acumulativa (DA). El estudio incluyo a 188 pacientes sometidos a procedimientos IC. Los resultados obtenidos mostraron que el rango de TF usado fue desde 9,85 a 19,37 min. El rango de valores para el PDA fue desde 11,02 a 21,60 Gycm2 y, el rando de la DA fue desde 1,43 a 2,88 Gy. Además, se incluyo una segunda muestra de 208 pacientes, sometidos a procedimiento INC. Los procedimientos fueron categorizadas en tres regiones anatómicas: cabeza, tórax y abdomen. El respectivo rango de valores para el PDA, TF y DA en cabeza fueron 1,099 a 248,82 Gy cm2, 7 a 34 min y 0,41 a 12,79 Gy, respectivamente. El respective rango de valores para el PDA, TF y DA en tórax fueron 99 a 8642 Gy cm2, 0,21 a 22,52 min y 0,007 a 0,418 Gy, respectivamente. El respective rango de valores para el PDA, TF y DA en abdomen fueron 0,22 a 36,71 Gy cm2, 1,03 a 76,06 min y 0,018 a 7,39 Gy, respectivamente. CORRESPONDENCIA Raquel Bedoya1 Maria Fernandez2 1.Radiation Petaquilla Panama. Protection Officer, Gold, Panama, 2.Radiation Protection Officer, Hospital Santo Tomas, Panama, Panama. Correo autor: bedoya_raquel@hotmail.com Este trabajo, representa un primer esfuero para establecer (NRDs) en procedimientos IC y NIC. Se recomienda ampliar la muestra de hospitales y procedimientos. Palabras claves: Niveles referenciales diagnósticos, procedimientos intervencionistas, producto dosis area. ABSTRACT The objective of this study was to establish the first diagnostic reference levels (DRLs) for adult patients in interventional cardiology (IC) and noncardiological (NIC) procedures in Panama. The study was carried out in the country’s leading public hospital. Fluoroscopy time (FT), dose area product (DAP) and cumulative dose (CD) were recorded for each procedure. The study included 188 patients subjected to IC procedures. The results obtained showed that FT ranged from 9.85 to 19.37 min. The range of DAP values was from 11.02 to 21.60 Gy cm2, and CD values ranged from 1.43 to 2.88 Gy. A second sample of 208 patients, subjected to NIC procedures, was also included. The procedures were categorized by three anatomical regions: head, thorax and abdomen. The respective ranges of values for DAP, FT and CD for head were: 1.099 to 248.82 Gy cm2, 7 to 34 min and 0.41 to 12.79 Gy, respectively. The respective ranges of values for DAP, FT and CD for thorax were: 99 to 8642 Gy cm2, 0.21 to 22.52 min and 0.007 to 0.418 Gy, respectively. The respective ranges of values for DAP, FT and CD for abdomen were: 0.22 to 36.71 Gy cm2, 1.03 to 76.06 min and 0.018 to 7.39 Gy, respectively. This study represents an initial attempt to establish DRLs in IC and NIC procedures. It is recommended to broaden the sample of hospitals and procedures. Keywords: Diagnostic reference levels, interventional procedures, dose area product. INTRODUCTION The interventional cardiology (IC) and interventional non Particularly, the IC procedures are associated with high cardiology (INC) procedures have increased substantially radiation dose, due to the long fluoroscopy time (FT) and in the last years, becoming a subject of public health. to the great number of cine frames (1). High radiation doses Rev. cienc. salud med. Volumen 3, Número 2, Mayo de 2016. 20 FIRST DOSE VALUES IN INTERVENTIONAL PROCEDURES. A PILOT INVESTIGATION IN PANAMA ARTÍCULO DE INVESTIGACIÓN during IC procedures affect the patients, as well as, to the MATERIALS AND METHODS medical personnel. An interventional X ray system with digital flat panel The patients can undergo erythema and other damages to used in the IC and INC procedures was used during the the skin . These injuries can to arrive to be severe until investigation: General Electric Innova 3100. X ray system point which sometimes the patient presents ulcerations or was equipped with an ionization transmission chamber necrosis at level of the tissue, which they require treatments integrated into the collimator housing to measure dose– prolonged for the injurious and irreversible effects of the area product (DAP), equivalent to air kerma-area product (6). radiation, in addition to the increase of the long term Different dosimetric quantities are displayed on the in-room probability to develop some neoplasy . monitors. In addition to the DAP, cumulative dose (CD) is (2) (3) also shown. This quantity is referred to in the standard IEC Radiation injury has occurred in patients during complex 60601-2-43 as equivalent to the incident air kerma without interventional procedures cardiac and non-cardiac, have backscattering at the patient entrance reference point (7). been severe. During these procedures the patients have received more than 2 Gy at the skin. But the dangerous The X-ray system was evaluated in terms of dose and quality is a large number of patients that are not followed up after image. The performance tests were: potential accuracy or received this radiation dose . tube potential (kV), (3) tube current (mA), maximum dose rate, automatic compensation, high contrast resolution and For medical exposition is not dose limit applied to the patient, low contrast detectability, applying the Spanish protocol nevertheless, is important to determine if the radiation dose and Protocol for the Quality Control Radiodiagnostic that these receives during the interventional procedures OIEA/ARCAL XLIX are excessive or not, considering the thresholds established semiconductor detector UNFORS IX (6, 10) and Al20 phantom. for the appearance of effects or injuries in the organism The Al20 phantom was composed of 2 absorber aluminium due to radiation or comparisons with diagnostic reference equivalent. The plate has 10mm of thickness, a copper levels (DRLs) established in other populations. DRLs as and lead absorber of 2mm thickness. For high contrast measurable values have been defined in publications of the resolution used the Nuclear Associates 07-647 RF/QC test International Commission of Radiological Protection (ICRP) tool and for the detectability low contrast was used the RMI- and in the Basic Security Norms (BSN) No. 115 151-3585 (4, 5) , allow (11) (8, 9) . Tests were performed using a . The tests realized for quality image focused of direct way to verify situations where dose levels to the in the monitor, to determine the capacity to solve as very patient are exceptionally high. The ICRP recommends that small anatomical structures as the blood vessels. DRLs be used to optimize patient doses. By previous and considering the need establish these levels, the objective After, the performance tests to X ray system the of our work was to the establishment of the first DRLs in the methodology on national surveys recommended by the IC and INC studies made in Panama, for indirectly to avoid European Commission Consortium’s “Safety and Efficacy the appearance of the determinist effects protecting of that for New Techniques and Imaging Using New equipment form to the patient and paramedical staff exposure In order to Support European Legislation” (SENTINEL) has been to carry out this, also the performance of each x-ray system followed. The following data were recorded from each was verified. procedure: procedure identification, patient age, gender, Rev. cienc. salud med. Volumen 3, Número 2, Mayo de 2016. 21 BEDOYA R. ET AL. ARTÍCULO DE INVESTIGACIÓN fluoroscopy time (FT), DAP and CD. in this study and others authors. Statistical calculations for patient dose values were performed with the SPSS 17 software package (12) . DISCUSSION Differences between two independent (normally distributed) samples were tested for significance with the One Simple T In terms of the measurements made, it was found that the Test (95% confidence level). accuracy potential and maximum dose rates were within acceptable ranges (see Tables 1). The Panamanian norm that contemplates to the check of RESULTS the equipment performance for the generators radiation is the Basic Norms of Protection No. 110, Resolution Table 1 report the performance parameters evaluated in the No. 27 of the 24 of October of 1995 in their Section 3a X ray system. The top group of pair lines that can be solved on “Optimization of the Protection relative to the exposure in the monitor was 11 that correspond to 2.5 pl/mm and 5 medical exhibitions”. Protocols of evaluation were prepared mm, 4 mm and 2 mm and can be observed the two rows of based on recommendations of the International Agency parallel circles which they correspond to 6 mm of diameter. of Energy Atomic (IAEA) and the American College of Radiology (ACR) in relation to the tests of performance and Table 2 show a comparison of the DAP, FT and CD between criteria of tolerance (13). diagnostic and therapeutic procedures in IC. Of the 188 evaluated studies to adult patients, 137 were Table 3 report a comparison between the percentile 75 of masculine patients, which represent 73% and 51 feminine DAP values in IC procedures in this study and others works. patients with a 27%. This is very agreed to which they mainly reflect the statistic registered in the country for The table 4 showed the comparison of the DAP, FT and CD causes of death by ischaemic diseases the heart and in between anatomical regions in INC. masculine sex (14) , by the behavior according to the sort in the lifestyles and attention of health. The women are put The tables 5, 6 and 7 showed the comparison of DAP, CD under with more regularity health controls that the men and and FT between anatomical regions for in INC procedures have more healthful lifestyles. Table 1: Performance tests of the X ray system General Electric, Innova 3100. Performance Test* Accuracy Potential maximum dose rate Values obtained kVpanel kVmeasured mApanel mAmeasured 60 60 0.75 0.752 70 70 1.50 1.495 80 80 3.00 3.001 100 100 9.00 8.995 120 100 12.00 12.004 120 120 120 120 * For compensate used a phantom Al20 of 20mmAl + 2mm Cu thickness Acceptance criteria Results Conformity 5% 0% Yes 0.27% ≤10R/min 9.80R/min **2.18mGy/s more or less 4.16R/min Rev. cienc. salud med. Volumen 3, Número 2, Mayo de 2016. 22 9.51R/min Yes FIRST DOSE VALUES IN INTERVENTIONAL PROCEDURES. A PILOT INVESTIGATION IN PANAMA ARTÍCULO DE INVESTIGACIÓN For IC was evaluated 188 procedures, of which 150 cardiac European studies (16, 17, 18), in some were the double. catheterizations diagnostic and 38 therapeutic of coronary For the values of FT was not observed statistically significant angioplasty and positioning of stent. Of the procedures difference (p=0.08) between the diagnoses and therapeutic diagnoses 46 they correspond to feminine patients and 104 procedures, in the same way the results of DAP and the to masculine, whereas for therapeutic the 5 of feminine sex CD statistically significant differences with values of p=0.10 and 33 masculine. and p=0.09 either respectively (Table 2). In its majority the cardiological procedures that took end Table 2: Comparison of the DAP, FT and CD between diagnostic and was the denominated cardiac catheterization for the therapeutic procedures in IC. diagnostic evaluation of the cardiac muscle and sometimes Parameter it finished in treatment during the same session, in which the FT is much greater. The obtained values of DAP and FT varied between procedures, that variation can be attributed to the capacity General Electric Innova 3100 Procedure Procedure Sig (p) Diagnostic therapeutic FT (min) 11.02 21.60 0.08 DAP (Gycm2) 9.85 19.37 0.10 CD (Gy) 1.43 2.58 0.09 and skill of physicians, the complexity of the procedure and In addition, of the comparison of the mean DAP values, application of attention protocols. the values of the percentile 75 for the diagnostic and therapeutic examinations of this study were compared with The CD for studies realized in the equipment this value fall the values of international works, which were smaller to the within the range of threshold reported for the appearance referenced (18 - 21) how are given in Table 3. of opacity crystalline in a single irradiation (0.5 – 2.0 Gy) for humans, deduced of accidental and radiotherapy expositions (15) Table 3: Comparison between the percentile 75 of DAP values in IC . Although, in the IC the irradiated region mainly is the thorax, and INC studies realized like the procedures in this study and others works. Neofotistou Tsapaki Balter Sánchez This cerebral procedures, that in their mayority finish in the Procedure et al. et al. et al. et al. work phase of treatment for example the angiosplaty with [19] (2003) [18] [20] [21] (2012) embolization and positioning of coils, where the ocular (Gycm2) (2003) (2008) (2011) (Gycm2) surface was irradiated directly. It is important indicate, that this mean value of 1.43 Gy for (Gycm2) (Gycm2) (Gycm2) Diagnostic 45.0 60.4 50.0 44.0 12.42 Therapeutic 75.0 80.7 125.0 78.0 25.87 the CD in the cineangiograph, increased the probability of deterministic effects in the skin and significant risk of As it were to be expect the therapeutic cardiological studies appearance of cancer induce like effect stochastic, since presented the values of FT, DAP and CD greater in relation has been demonstrated firmly for dose from the 100 mGy to the studies diagnostic. For DAP and CD the values were is an increase of the probability of deterministic effects and almost the double. the risk of cancer by radiation (15). For the CD of 1.43 Gy in IC procedures, almost represents The results of the mean FT for cardiological studies the double in relation to the mean value reported (17). But, it diagnostic in adults was greater to the values considered in does not reach the value of the threshold of 2 Gy after the Rev. cienc. salud med. Volumen 3, Número 2, Mayo de 2016. 23 BEDOYA R. ET AL. ARTÍCULO DE INVESTIGACIÓN erythema or reddening of the skin. But it observed in the registered by other referenced authors and a 50% minor collected data some studies with prolonged FT values of that Miller et al (22). entrance surface air kerma superior to this threshold. How showed in the Table 6, the comparison of the percentile Of total 208 INC procedures was analyzed, 23 were realized 75 values CD obtained in this study for the head was major at the region of the head which represented a 11.06%, 34 (6.73 Gy). The region of the abdomen which was of 1.13 Gy were realized at the abdomen (16.35%), were at the region compared with the IAEA reference (23) was 1.5 times greater of the thorax (0.043%) and 142 extremities (68.27%). and 1.7 times smaller comparing with Miller (22). 98 procedures corresponded to feminine sex, which For the FT values reported in this study (Table 7), the represented a 47.12% and 110 to masculine sex what was anatomical region that registered major value was at a 52.88%. The average as far as the age was of 64.05 the head (20.29 minutes). But this value was minor with years. reference to the other works (22, 23). In the Table 4 observed that for DAP, FT and CD the Table 4: Comparison of the DAP, FT and CD between anatomical regions for INC. Anatomical region Head Abdomen Thorax DAP (Gycm2) CD(Gy) FT (min) Mean, median Mean, median Mean, median (range) (range) (range) 220.54; 120.24 1.94; 0.99 15.23;13.18 (1.099 -248.52) (0.41 – 12.79) (7 - 34.00) 50.00; 22.60 0.63; 0.17 15.16;8.20 (0.22- 36.71) (0.018 – 7.39) (1,03 – 76,06) 24.55; 12.76 0.16; 0.05 11.54 ; 7.81 (99.00 – 8642.00) (0.007 – 0.418) (0.21 -2252) highest values was obtained in the region of the head with Table 5: Comparison of DAP between anatomical regions for in INC 220 Gy.cm2, 15.03 minutes and 1.94 Gy respectively. For the abdomen values were major that the thorax. However, it does not reach the value of the threshold of 2 Gy as the procedures in this study and others works. Authors DAP (Gycm2) Abdomen IC procedures, but some procedures showed FT values D. Miller, 2009[26] prolonged of entrance surface air kerma superior to this IAEA-Vienna [23] 210.50 Head Thorax 141.25 296.00 - 97.22 threshold. Table 6: Comparison of CD between anatomical regions for in INC A comparison of the percentile 75 values DAP obtained by anatomical region was observed that in the head registered procedures in this study and others works. Authors greater value (161.59 Gy.cm2). For the abdomen was 40.32 CD (Gy) Abdomen Head Thorax 3.12 Gy.cm2 and thorax 43.57 Gy.cm2, However compared with D. Miller, 2009[26] 1.93 5.65 the results of others authors in countries like Chile, the USA IAEA-Vienna [23] 0.75 1.13 and Austria, this value at the head was inferior to the data Rev. cienc. salud med. Volumen 3, Número 2, Mayo de 2016. 24 FIRST DOSE VALUES IN INTERVENTIONAL PROCEDURES. A PILOT INVESTIGATION IN PANAMA ARTÍCULO DE INVESTIGACIÓN These obtained results constitute a significant step for the the skin, nevertheless for therapeutic the mean doses that establishment of the DRLs in the country, which require were observed over 2 Gy. This implies that the probability extending the data summary as much for diagnostic and was high that during an interventionist study in these rooms therapeutic procedures. of haemodynamic a patient suffered damages by exposure to the radiation and the probability of stochastic effects Table 7: Comparison of FT between anatomical regions for in INC incremented also. With the collect data the base settled procedures in this study and others works. down to initiate the task of establishment the DRLs in the Authors country. But, it is necessary to extend the amount of data TF (minutes) Abdomen Head Thorax D. Miller, 2009[26] 25.10 142.00 52.75 IAEA-Vienna [23] 18.82 31.25 and include more equipment and other hospitals. ACKNOWLEDGMENTS I acknowledge to Dr. Eloy Gibbs by the support offered. CONCLUSIONS For the X ray equipment used in the interventional studies REFERENCES is required to update the protocol of the test performance according to the new technology, for example, it must 1. 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