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Radiation Protection Dosimetry (2022), Vol. 197, No. 3–4, pp. 230–236 https://doi.org/10.

1093/rpd/ncab182
Advance Access publication 4 January 2022

RADIATION DOSE FOR PATIENTS WITH KAWASAKI DISEASE


UNDERGOING FLUOROSCOPICALLY GUIDED CARDIAC
CATHETERIZATION

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Patricia Miranda1 , Eliseo Vano2 , Carlos Ubeda3, *, Ximena Figueroa3 , Paulina Doggenweiller1 ,
Marcus Oliveira 4 and Dandaro Dalmazzo5
1
Hemodynamic Department, Cardiovascular Service, Luis Calvo Mackenna Hospital, Antonio Varas 360,
Santiago, Chile
2
Radiology Department, Faculty of Medicine, Complutense University and IdIS, San Carlos Hospital, Calle
del Prof Martín Lagos, 28040 Madrid, Spain
3
Medical Technology Department, Health Sciences Faculty, Tarapaca University, 18 de septiembre 2222,
Arica, Chile
4
Department of Health Technology and Biology, Federal Institute of Bahia, R. Emídio dos Santos,
s/n - Barbalho, Salvador, Brazil
5
Faculty of Health and Odontology, Universidad Diego Portales, Santiago, Vergara 210, Chile
*Corresponding author: cubeda@uta.cl

Received 25 May 2021; revised 14 November 2021; editorial decision 8 December 2021; accepted 8 December
2021
The goal of the present study was to estimate the radiation dose for a group of 45 Kawasaki disease (KD) patients undergoing
fluoroscopically guided cardiac catheterization. The sample of procedures corresponds to a single hospital and was collected in
10 years. Anthropometric characteristics and the quantities of air kerma-area product (PKA ) among others were recorded for
each procedure. Monte Carlo PCXMC 2.0 software was used to estimate organ and effective doses. The PKA value of 7.2 Gy cm2
was proposed as the local Diagnostic Reference Level for KD. For organ absorbed doses, median values for thyroid, heart, lungs,
esophagus, skin, active bone and breast were 1.2; 2.2; 4.6; 2.7; 1.1; 1.2 and 2.7 mGy, respectively. For effective dose, the mean
value was 2.7 ± 2.5 mSv. This paper presents the first patient dose values for the KD using catheterization techniques, in Latin
America and the Caribbean Region.

reliable as children grow and the chest wall thickens.


INTRODUCTION
Echocardiography is also less reliable for detection of
Kawasaki disease (KD) is an acute and self-limiting vascular stenosis or thrombosis than for dilatation.
medium-vessel vasculitis of unknown etiology that The ‘gold standard’ for coronary artery assessment
especially affects infants and children (80% under is fluoroscopically guided cardiac catheterization
5 years of age) but can also occur in older children (FGCC). This procedure provides a detailed image
and adolescents(1, 2) . KD targets the coronary arteries of the coronary artery lumen and is very useful in
and other cardiovascular structures(3, 4) . defining regional flow-limiting stenosis and assessing
The long-term prognosis is determined by the ini- these conditions for potential intervention(1, 2, 6) .
tial and current level of coronary artery involvement. The FGCC is a minimally invasive and vital tech-
Patients with giant coronary aneurism are at risk nique, aiming to diagnose and/or possibly treat heart
for myocardial ischemia from coronary artery throm- disease, such as coronary artery stenosis or coronary
bosis and stenosis. Medical management of these aneurysms, among others(7) . However, FGCC and
patients is important, and is based on judicious use electrophysiological procedures are the most signifi-
of thromboprophylaxis and monitoring to identify cant contributors to radiation dose in children with
evolving stenosis. Invasive revascularization proce- heart disease(8, 9) . In Chile, the number of FGCC pro-
dures might be required for selected patients(1–3) . cedures carried out among the pediatric population
KD is now the most common cause of acquired ranged between 40 and 80 per 1 000 000 inhabitants
heart disease in children in developed countries(2) . In per year(10) .
Chile, the incidence of KD was 10.4 per 100 000 chil- Children patients undergoing FGCC procedures
dren under 5 years of age in 2011(5) , similar to other are known to be at potentially greater risk of
countries except Japan, Korea and the remainder of radiation-induced stochastic effects (i.e. cancer) and
Asian countries. mortality, compared with adult patients, due to the
With regard to cardiovascular testing during long- higher radiation sensitivity of children’s tissues and
term follow-up, echocardiographic measurements of to their longer lifespan for the possible development
the coronary artery lumen become progressively less of neoplasms(11, 12) . According to the International

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RADIATION DOSE FOR PATIENTS WITH KAWASAKI DISEASE
Commission on Radiological Protection (ICRP), can be estimated to a reasonable approximation using
the first step in managing the risks from ionizing the Monte Carlo calculation methods, provided that
radiation should be to know the dose values imparted sufficient technical and geometrical data are available
to the patients during the imaging procedures(11) . on the X-ray examination technique(12) .
The modern X-ray systems used for interventional The study was conducted at the pediatric car-
cardiology produce patient radiation dose reports at diovascular service at Luis Calvo Mackenna Hospi-
the end of the procedures. If dose reports are not avail- tal (Santiago, Chile). For several years, this service

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able automatically, dose values should be recorded on had a biplane X-ray system (Siemens Axiom Artis
the patient’s clinical record chart, together with the BC, Siemens Inc., Erlangen, Germany) equipped with
procedure and patient identification. Interventional image intensifiers, which was installed in 2006 and
systems show different dose metrics, such as: air decommissioned in 2018. This system had specific
kerma-area product (PKA )(13) , air kerma at the imaging protocols for pediatric procedures and with
patient entrance reference point (Ka,r ), fluoroscopy a properly calibrated ionization transmission cham-
time and the number of cine series (and/or cine ber integrated into the collimator housing to mea-
images) according to the international standard for sure PKA , and Ka,r . This equipment was periodically
interventional fluoroscopy systems(14) . submitted to the quality control program during its
The ICRP has recommended that the appropriate 12 years of operational life, using the protocols agreed
dosimetric indicator for the probability of stochastic to during the European DIMOND and SENTINEL
radiation effects is the average organ absorbed programs(17–19) . This service has been involved in
dose. The radiation quantity ‘effective dose’ is used three technical cooperation projects since 2008 (RLA
in radiation protection to specify exposure limits 9057, RLA 9067 and RLA 9075), with the support
for workers and members of the public, to ensure of the IAEA(15, 16) . The totality of the dosimetric
that the occurrence of stochastic health effects data used in this study corresponded to the previous
is kept below unacceptable levels but it is also Siemens X-ray system.
used in imaging for comparison purposes between The study design was prospective case series(20) .
different imaging modalities (e.g. interventional, CT All pediatric patients with diagnosis of KD, who had
or radiopharmaceuticals)(11) . undergone FGCC from January 2008 to July 2018,
The goals of this study were: (a) to report the were screened for inclusion.
PKA and Ka,r in a sample of patients with KD; (b) For each patient, and from the patient dose reports
to establish local Diagnostic Reference Levels (DRLs) produced by the X-ray system, we recorded the fol-
and (c) to estimate organ absorbed dose and effective lowing data: procedure identification, patient age,
dose for a this group of patients undergoing FGCC in gender, weight, height, PKA , Ka,r , number of cine
Chile. The results of this paper were obtained as part series, total number of cine frames, fluoroscopy time,
of the International Atomic Energy Agency (IAEA) projection angle, patient number, X-ray tube voltage,
regional project in Latin America and the Caribbean filtration (mm Al) and additional filter (mm Cu). PKA
for the optimization of radiation protection in inter- values were corrected with the appropriate calibration
ventions guided by X-ray imaging(15, 16) . factor (0.81 in this system) for the frontal C-arm
(derived from the table and mattress attenuation mea-
sured for the X-ray beam qualities in the system used).
MATERIALS AND METHODS
No correction factor was necessary for the lateral C-
When referring to radiation dose values for patients, arm. DRLs will be set by calculating the third quartile
we used the quantity of PKA, proposed by the of the full database of patient dose values for the PKA
International Commission on Radiological Units quantity, as recommended by the ICRP(21) .
(ICRU)(13) .The quantity Ka,r , referred to in the Organ absorbed doses and effective doses were
standard IEC 60601-2-43(14) , is the incident air calculated using the Monte Carlo PCXMC 2.0
kerma without backscatter(13) at the patient entrance software(22) . The calculation was performed exam-
reference point. This point is intended to be rep- ining for each cine series extracted from patient
resentative of the position of the patient’s skin (in dose report the parameters of projection: field size;
adult patients) at the entrance site of the X-ray beam projection angle; patient number; patient height;
during an interventional procedure. For pediatrics, patient weight; patient age (0, 1, 5, 10, 15); X-ray
some corrections are needed to estimate the skin tube voltage (kV); filtration (mm Al); additional
doses(17) . For fluoroscopic systems with an isocentre, filter (mm Cu); focus-reference point distance
the interventional reference point is located along (FRD) (cm); X-ray beam width (cm at FRD);
the central ray of the X-ray beam at a distance of X-ray beam height (cm at FRD); coordinates of
15 cm from the isocentre in the direction of the focal a point inside the phantom, through which the
spot(14) . Organ absorbed doses and effective doses central axis of the X-ray beam is directed (Xref,
cannot be measured directly in patients undergoing Yref and Zref); arms in phantom (1 or 0); and
interventional cardiac procedures. Nonetheless, they input dose value (in our case the PKA was used).

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P. MIRANDA ET AL.
Table 1. Total frequency by gender [male (M) and female (F)]. Median, minimum (min) and maximum (max) values for age,
weight, height and body mass index grouped by gender.

Gender Frequency Age (years) Weight (kg) Height (m) Body mass index
(kg/m2 )
Median(Min–max) Median (Min–max) Median (Min–max) Median (Min–max)

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F 13 5.6 (0.6–12.6) 27 (5.8–54.9) 1.27 (0.6–1.6) 16.7 (14.6–23.4)
M 32 10.8 (2.0–14.2) 41 (9.3–80.0) 1.44 (0.7–1.8) 19.1 (13.6–27.7)
Total 45 8.9 (0.6–14.2) 32.4 (5.8–80.0) 1.37 (0.6–1.8) 18.6 (13.6–27.7)

Table 2. Results for PKA (Qxx are quartiles; SD are the standard deviations) by gender [male (M) and female (F)].

Gender Q25 PKA (Gy cm2 ) Q50 PKA (Gy cm2 ) Q75 PKA (Gy cm2 ) Mean PKA (Gy cm2 ) SD PKA (Gy cm2 )

F 1.1 2.2 3.9 3.2 2.9


M 1.7 3.1 9.9 6.7 7.5
Total 1.5 2.9 7.2 5.7 6.7

Table 3. Results for Ka,r (Qxx are quartiles; SD are the standard deviations) by gender [male (M) and female (F)].

Gender Q25 Ka,r (mGy) Q50 Ka,r (mGy) Q75 Ka,r (mGy) Mean Ka,r (mGy) SD Ka,r (mGy)

F 13.6 29.6 47.6 39.9 40.7


M 23.2 34.1 80.9 62.9 65.1
Total 22.1 32.4 72.0 56.3 59.6

To incorporate the contribution of the fluoroscopy DISCUSSION


series in the doses calculated using the PCXMC
software, the PKA contribution of the fluoroscopy The FGCC are typically divided into two groups
series was distributed proportionally to the contri- for patient dose evaluation, diagnostic (normal
bution of the cine series, as validated in one of our diagnostic and complex diagnostic) and thera-
previous papers(10) . Absorbed doses were calculated peutic (aortic angioplasty, pulmonary angioplasty,
and analyzed for the seven heavily irradiated organs. pulmonary angioplasty with stent, atrial septal
All dosimetric data collected were tabulated defect closure, aortic valvuloplasty, pulmonary
and statistically analyzed with SPSS software IBM, valvuloplasty, patent ductus arteriosus closure with
2018(23) . The proposed analysis has been exclusively coil, patent)(24) . In this case, patients with KD
descriptive for all the variables studied. were undergoing only diagnostic procedures using
FGCC(10, 24) . Generally, these procedures could be
classified as complex diagnostic procedures or those
with higher doses to the patient because: (a) there are
RESULTS no catheters specifically designed for children; (b) the
Table 1 shows the anthropometric characteristics of need to study other vessels such as the axillary and
the 45 subjects. Table 2 summarizes the quartiles, inguinal, since they can present giant aneurysms and
means and standard deviations (SDs) for the PKA (c) in small patients with high heart frequency, the
values for all procedures. Table 3 summarizes the use of cine mode with higher numbers of frames per
quartiles, means and SDs for the Ka,r values for all second is required.
procedures. Table 4 shows mean, SD and median According to Table 1, although the sample of 45
values for organ absorbed doses to active bone pediatric procedures (29% girls and 71% boys) can be
marrow, heart, lungs, thyroid, esophagus, skin and considered small to support specific DRLs for PKA ,
breast for all procedures. Table 5 summarizes the and Ka,r , the sample sizes in pediatrics, in general,
quartiles, means and SDs for the effective dose values are smaller than in adults and ICRP has recognized
for all procedures. the possibility of using small samples for pediatric

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RADIATION DOSE FOR PATIENTS WITH KAWASAKI DISEASE
Table 4. Mean, standard deviation (±SD) and median values for organ absorbed doses in active bone marrow, heart, lungs,
thyroid, esophagus, skin and breast by gender [male (M) and female (F)].

Gender Thyroid (mGy) Heart (mGy) Lungs (mGy) Esophagus (mGy) Active bone (mGy) Breasts (mGy)

Mean ± SD Median Mean ± SD Median Mean ± SD Median Mean ± SD Median Mean ± SD Median Mean ± SD Median

F 1.9 ± 1.4 1.3 4.2 ± 5.0 2.2 7.9 ± 9.4 4.0 4.4 ± 4.8 2.7 1.8 ± 1.9 1.1 5.0 ± 7.6 2.7

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M 2.0 ± 2.2 1.1 3.7 ± 3.0 2.3 7.5 ± 6.5 4.6 4.3 ± 3.6 2.6 2.1 ± 2.0 1.2 4.3 ± 3.9 2.6
Total 1.9 ± 2.0 1.2 3.9 ± 3.7 2.2 7.6 ± 7.4 4.6 4.4 ± 3.9 2.7 2.0 ± 1.9 1.2 4.5 ± 5.2 2.6

Table 5. Results for effective dose (Qxx are quartiles; SD are the standard deviations) by gender [male (M) and female (F)].

Gender Q25 (mSv) Q50 (mSv) Q75 (mSv) Mean (mSv) SD (mSv)

F 0.8 1.6 2.6 2.8 3.1


M 1.2 1.6 3.7 2.7 2.3
Total 1.1 1.6 3.7 2.7 2.5

studies(21) . Furthermore, the sample is relatively small protection and can be used for patient dose audits(21) .
for presenting the values of organ absorbed dose and But for pediatrics other approaches may be used.
effective dose as being fully representative results for If nationwide only one hospital is in charge of
this group of patients, however, it should be taken certain pediatric pathologies (as is the case of KD
into consideration that it is difficult to obtain larger in Chile) it is considered appropriate, to report in
samples for this pathology. This study was conducted addition to the median (typical) values, also the
in the public hospital that performs ∼50% of all third quartile considered (in this cases) as a local
pediatric FGCC procedures in Santiago (capital of DRL for these pathologies. This third quartile value
the Chile country with 7 014 702 inhabitants)(25) . (considered our local DRL) may be used by other
Furthermore, the population of patients with giant countries in the Latin American Region. In any
aneurysms is usually small, and all efforts made in case, in Table 2, we included both values: median
the acute stage of the disease are focused on avoiding (as ‘typical value’ and third quartile as suggested
these giant aneurysms in children. local DRL for KD). In addition, and as suggested
Table 2 shows PKA values for all the proce- by ICRP 135, the interquartile range serves as an
dures. According to the IAEA Dosimetry Code indicator of dispersion of the data. It should be
of Practice(26) , the PKA quantity was originally noted that ICRP, in its report 135 recommends:
introduced to determine energy imparted to patient, ‘Flexibility is necessary for procedures where few
since it is a quantity that can be related to the data are available (e.g. interventional procedures in
stochastic risk of cancer induction and allows the paediatric patients)’ and ‘When regional or national
organ doses to be estimated. Moreover, the PKA DRL values are not available, local practice may
quantity is recommended by the ICRP 135 report, be compared with appropriate available published
for the purpose of establishing DRLs, which are data. This is especially relevant for paediatric
essential tools in the management of patient dose, due to the scarcity of national or regional DRL
and therefore, in optimizing radiation protection by values’.
taking into account the clinical benefits for patients. Since there are no DRLs published for KD and,
Median values of PKA from the procedures performed this paper presents the results of a patient dose evalu-
in a particular catheterization room can be compared ation program spanning the last 10 years in the largest
with local or national DRLs to identify whether the pediatric hospital in Chile, which manages ∼50% of
values obtained for that particular clinical indication all pediatric FGCC procedures carried out in the
with that X-ray system are higher or lower than country and where effort has already been invested
the existing DRLs, and thereby to decide whether in optimization, the values we obtained could be
any corrective actions might be appropriate. Where considered provisional local DRLs. Q75 PKA values
the number of facilities or X-ray rooms is small, in our sample were 3.9 and 9.9 Gy cm2 for female and
the median of the distribution of values of the male patients, respectively. However, DRLs should
DRL quantity is recommended as a ‘typical value’. not be grouped by sex, but rather by age and weight
This comparison of local practice data with the of patients. Therefore, as provisional DRL for KD,
existing DRLs values is the first step in optimizing we propose the value of 7.2 Gy cm2 . This value is

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P. MIRANDA ET AL.
higher than those reported in one of our investiga- According to TsujiiN et al.,(33) would show a
tions for other procedures such as: aortic angioplasty good correlation with results of FCGG for the
(1.0 Gy cm2 ), pulmonary angioplasty (2.6 Gy cm2 ), measurements of coronary artery abnormalities. Kim
aortic valvuloplasty (2.3 Gy cm2 ), patent ductus arte- et al.(34) report the application of CTCA in children
riosus closure with coil (1.2 Gy cm2 ), etc(24) . with KD and effective dose values were 2.6 ± 2.6 mSv.
For Ka,r quantity (see Table 3), median values were Similarly, Duan et al.(35) report mean effective dose
29.6 and 34.1 mGy for female and male patients, values of 0.36 ± 0.06 mSv. In a study assessing the

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respectively. These values are obviously lower than doses from various pediatric protocols in infants with
those shown in adult samples, and in most cases, the a 64-slice CT scanner using a phantom, effective
threat of producing radiation-related skin injuries is dose values were of 1.49 ± 0.10–4.66 ± 0.40 mSv.
low (according to ICRP Publication 85(27) , the thresh- For a 256-slice CT, this effective dose values were
old for deterministic effects on skin or transient ery- 1.12 ± 0.11–6.87 ± 0.56 mSv(36) . In any case, it
thema is 2000 mGy), when procedures are conducted should be noted the large inaccuracies of the effective
by trained cardiologists with X-ray systems and pro- dose estimations (>30%) when comparing different
cedures optimized as part of the quality assurance imaging modalities and the impact of the patient size
program, as was the case in this study. in these evaluations.
On the other hand, the results showed in Table 4,
indicate that heart doses are far from the thresh-
old of may be as low as 500 mGy recommended by CONCLUSIONS
the ICRP(28) for circulatory diseases in the cardio-
vascular system during FGCC, reaching a value of Papers calculating the PKA and Ka,r and estimating
2.2 mGy for the median. The median values for thy- organ absorbed dose and effective dose are practically
roid, lungs, esophagus, skin, active bone and breasts nonexistent for the KD patients undergoing FGCC.
(only females) were 1.2, 4.6, 2.7, 1.1, 1.2 and 2.7 mGy, This paper presents the first patient dose values for
respectively. KD disease catheterization, in Latin America and the
A review article published by Harbron et al.(29) Caribbean region. Can be considered small the sam-
stated that effective dose values for interventional ple size to support specific DRLs. However, the sam-
cardiac procedures in pediatrics are generally within ple sizes in pediatrics, in general, are smaller than in
the range from 3 mSv to 15 mSv, but in our case, for adults. The FGCC is the gold standard for evaluation
KD, the range found was much lower (see Table 5). of coronary artery abnormalities in KD. However,
Yakoumaskis et al. (30) , El Sayed et al. (31) and Bar- radiation doses should be measured and reported
naoui et al. (32) , reported average effective dose values to allow optimization, considering the relevance of
of 3.7, 3.4 and 4.8 mSv, respectively, for diagnostic radiation risks in this population of children and
procedures using FGCC. In our study, the mean effec- young people. FGCC is an invasive procedure that
tive dose value for KD was 2.7 ± 2.5 mSv as shown allows information to be obtained, not only about the
in Table 5. Uncertainties in the case of this study coronary arteries, but also in other affected median
are similar to the ones described in ours previous arteries in these patients with KD and giant coronary
studies(10, 25) . The real X-ray tube voltage, filtration aneurism.
and additional filter were used only for the cine series
but not for fluoroscopy runs. For the PKA values, due
to the fluoroscopy runs (distributed proportionally ACKNOWLEDGMENTS
to the cine series), global uncertainty is estimated
as ∼10%. Besides, PCXMC software suggests 2% The current work has been carried out as part of the
statistical uncertainty. The impact of variations in three technical cooperation projects since 2008 (RLA
focus-to-surface distance was 2% (doing several sim- 9057, RLA 9067 and RLA 9075) with the support
ulations). Radiation field sizes were circular and the of the International Atomic Energy Agency (IAEA).
square equivalent was calculated, with an estimated One of the authors (C. Ubeda) also acknowledges
uncertainty of 5% in this respect. Therefore, total the support of the Research Directorate at Tara-
uncertainty for organ doses may hence be ∼20%. paca University, through Senior Research Project
Other sources of uncertainty such as the difference No. 7713-18.
between phantom and patient anatomy (including
size or organ positions) were not considered.
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