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Physica Medica 70 (2020) 169–175

Contents lists available at ScienceDirect

Physica Medica
journal homepage: www.elsevier.com/locate/ejmp

Original paper

Updating national diagnostic reference levels for interventional cardiology and T


methodological aspects
Roberto Sáncheza,b, , Eliseo Vañóa,b, José M. Fernández Sotoa, Jose Ignacio Tena, Javier Escaneda,

Clara Delgadoc, Bruno Garcíac, Francisco Carrera Magariñod, José Francisco Díaz Fernándezd,
Rafael Jesús Martinez Lunae, Miguel Angel Romero Morenoe, Antonio Catalánf, Francisco Bosa Ojedaf,
Francisco Javier Rosales Espizuag, Jesús Roberto Sáez Morenog, Xavier Pifarréh, Javier Goicoleah,
José Manuel Ordialesj, Juan Manuel Nogalesi, Ginés Martinezj, Paula Garcíak, Amparo Benedictok,
Manuel Francisco Rodriguez Castillol, Luis Pastor Torresl, Joan Fontm, Armando Bethencourtm,
María Jesús Cesterosn, Armando Pérezn, Eduardo Pinaro, Bonifacio Tobarrao
a
Hospital Clínico San Carlos, Madrid, Spain
b
Universidad Complutense de Madrid, Spain
c
Hospital Valle de Hebrón, Barcelona, Spain
d
Hospital Juan Ramón Jiménez, Huelva, Spain
e
Hospital Reina Sofía, Córdoba, Spain
f
Hospital Universitario de Canarias, Sta. Cruz de Tenerife, Spain
g
Hospital Universitario Basurto, Bilbao, Spain
h
Hospital Puerta de Hierro, Madrid, Spain
i
Hospital Universitario Infanta Cristina, Badajoz, Spain
j
Hospital de Mérida, Badajoz, Spain
k
Hospital de la Princesa, Madrid, Spain
l
Hospital Universitario Valme, Sevilla, Spain
m
Hospital Universitario Son Espases, Mallorca, Spain
n
Hospital de León, Spain
o
Hospital Virgen de Arrixaca, Murcia, Spain

ARTICLE INFO ABSTRACT

Keywords: The aim of this study is to propose national diagnostic reference levels (DRL) for updating in the field of interventional
Interventional cardiology cardiology and to include technical details to help plan optimization.
Patient doses Medical physics experts and interventional cardiologists from 14 hospitals provided patient dose indicators
Diagnostic reference levels from coronary angiography and percutaneous coronary interventions. Information about X-ray system dose
Optimization
settings and image quality was also provided.
The dose values from 30,024 procedures and 26 interventional laboratories were recorded. The national DRLs
proposed for coronary angiography and percutaneous coronary interventions were respectively 39 and 78 Gy·cm2 for
air kerma area product (PKA), 530 and 1300 mGy for air kerma at reference point (Ka,r), 6.7 and 15 min of fluoroscopy
time and 760 and 1300 cine images. 36% of the KAP meters required correction factors from 10 to 35%. The dose
management systems should allow these corrections to be included automatically. The dose per image in cine in
reference conditions differed in a factor of 5.5.
Including X-ray system dose settings in the methodology provides an insight into the differences between hospitals.
The DRLs proposed for Spain in this work were similar to those proposed in the last European survey. The poor
correlation between X-ray systems dose settings and patient dose indicators highlights that other factors such as op-
eration protocols and complexity may have more impact in patient dose indicators, which allows a wide margin for
optimization. Dose reduction technology together with appropriate training programs will be determinant in the future
reduction of patient dose indicators.


Corresponding author at: Medical Physics Dpt., Hospital Clínico San Carlos, Profesor Martín Lagos sn, 28040 Madrid, Spain.
E-mail address: robsan03@ucm.es (R. Sánchez).

https://doi.org/10.1016/j.ejmp.2020.01.014
Received 12 July 2019; Received in revised form 5 December 2019; Accepted 14 January 2020
1120-1797/ © 2020 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.
R. Sánchez, et al. Physica Medica 70 (2020) 169–175

1. Introduction automatic dose management systems: the sample was then considered
to have average or normal complexity and average patient size. Other
Interventional cardiology is one of the medical practices with the participants selected smaller samples (≥30 cases as recommended by
highest radiation doses to patients. In some complex cases, high doses ICRP [4]) by means of manual recording, provided the procedure had
likely to produce deterministic effects in the skin might be reached standard complexity and standard patient size (65–95 kg) in line with
[1,2]. The benefits of minimally invasive medical practices are un- the criteria agreed to be part of the DOCCACI program. In all the
questionable both in diagnosis and therapy, as they minimize the risks centres involved one interventional cardiologist and one medical phy-
derived from open surgery and reduce patient recovery time after in- sics expert (MPE) were tasked with collecting and sending the data
terventions. In order to both benefit from these medical procedures and according to the agreed criteria. For those laboratories with large
ensure the radiation protection of patients, the European regulation samples (> 100 cases) it was considered that the few cases of high
requires the member states of the European Union to establish, to complexity were unlikely to bias the median values. 3 out of the 29
regularly review and to use diagnostic reference levels (DRLs) [3]. The interventional rooms did not reach the minimum sample size of 30
International Commission on Radiological Protection (ICRP) [4] defines cases and were therefore not included in the analysis.
the DRLs as “a form of investigation level used to aid in optimisation of All data is received at the central database to be reviewed and if any
protection in the medical exposure of patients”, using “a commonly and inconsistency is detected (wrong units, missing or wrong information),
easily measured quantity that assesses the amount of radiation used to corrections are applied in agreement with the data senders. To obtain
perform a medical task”. In the case of interventional practices, the DRL the DRLs, the median of patient dose indicators was calculated for each
quantities are the air kerma area product (PKA, also abbreviate as KAP) interventional laboratory. The national DRLs to be proposed were cal-
and the air kerma at the patient entrance reference point (Ka,r). culated as the third quartile of the medians distribution.
Fluoroscopy time (tf) and the number of acquired images (N) are also
recommended. In the case of a national DRL, the numerical value of 2.2. Additional information to help in optimization: X-ray systems
DRLs should be set as the 3rd quartile of the medians of the DRL
quantity observed at multiple health centres. The changes in tech- Each program participant working in the X-ray units performed a
nology, the emergence of new image modalities and the use of DRLs in commonly agreed quality control protocol. The entrance air kerma rate
optimization prompt changes in the values of DRLs. Reviewing DRLs is in fluoroscopy (K a, e ) and entrance air kerma per image (K a, e ) in cine
therefore a necessity and ICRP recommends doing it every 3–5 years were measured in reference conditions: a 20 cm PMMA phantom lo-
[4]. In 2009, the Cardiac Catheterization working group from the cated at isocentre and the image detector at approximately 5 cm from
Spanish Society of Cardiology launched the DOCCACI program the phantom. The default or most used radiation modes/protocol were
(Spanish acronym for Dosimetry and quality criteria in interventional tested. A test object 18FG from the University of Leeds (Leeds test ob-
cardiology) to promote national DRLs for the interventional cardiology jects LTD, North Yorkshire, UK) located at the isocentre was used for
procedures [5,6]. The DOCCACI group provided data and gave advice the evaluation of image quality. The MPE in charge in each centre
to the program DOPOES II [7] of the national authority to estimate evaluated the images of the test object by visual inspection as re-
collective doses and to establish DRLs. Other countries have promoted commended by the test object manufacturer. The number of 8 mm
national surveys [8–16,29,30] to the same end. In Europe, some surveys copper low contrast details and the groups of lead bar patterns observed
have also been fostered at regional level [17–20]. were recorded for the different C-arm radiation modes. Although the
In this work, the DOCCACI group has updated the Spanish DRLs for visual inspection may vary according to the observer, it can still give
the period 2014–2017 to be proposed to the national authority as na- valuable information. The PKA meter was checked for consistency using
tional DRLs for coronary angiography and percutaneous transluminal a calibrated dose meter and for one beam quality – cine mode and 80 kV
coronary angioplasty. Information on X-ray systems dose settings was and no filtration or the lowest additional filtration available – and with
included to help in the optimization. the C-arm at 90° to avoid table and mattress absorption. If the PKA meter
introduced any bias to the dose indicators provided by the modality,
2. Materials and methods PKA and Ka,r were corrected. As these procedures are performed mostly
with the tube under couch, the beam crosses the examination table and
Since 2009, the DOCCACI group has been working on the proposal mattress that absorb part of the X-ray energy before reaching the pa-
of DRLs for interventional cardiology. 14 hospitals, all of them from the tient. Their transmission is a complex function that depends strongly on
national public health service and 13 of them university hospitals in- beam quality, beam angle and beam size. The effect of couch and
cluding 29 interventional laboratories, compiled information about mattress transmission was measured at reference conditions to obtain
patient dose indicators from January 2014 to December 2017. These 14 its average value: 80 kV, cine mode with the lowest beam filtration. The
hospitals represent all in all 18% of the institutions that declare inter- couch transmission can be used to estimate the air kerma area product
ventional cardiology activity to the Spanish Society of Cardiology1. at patient entrance PKA,corr. When the PKA is used to estimate organ and
effective doses, the couch and mattress attenuation should be con-
sidered.
2.1. Patient dose indicators
Bivariate correlations (Pearson r and Spearman ρ) were studied
between the dose delivered by the interventional units Ka,e and the
Participants collected dose indicators from patient procedures in-
medians of the PKA and Ka,r for CA and PTCA using the software SPSS
cluding PKA, air kerma at patient entrance reference point (Ka,r),
(IBM, USA). While Pearson correlation coefficient seeks for linear re-
fluoroscopy time (Tf), total number of cine series and images. Coronary
lationships, Spearman correlation coefficient (based in rank correla-
angiography (CA) and percutaneous transluminal coronary angioplasty
tion) may inform on other kind of non-linear dependences between
(PTCA) were investigated, as they are the most frequently performed
variables.
procedures (89% of the total interventional cardiology procedures). In
the group of PTCA, ad-hoc PTCAs were also included.
3. Results
Some participants provided more than 100 cases (up to 2095) using
3.1. Patient dose indicators
1
See the web site of the hemodynamic working group from the Spanish
Society of Cardiology. https://www.hemodinamica.com/cientifico/registro-de- A total of 30,024 cases (16631 diagnostic and 13,393 therapeutic)
actividad/. were recorded for the period 2014–2017. The average ± standard

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R. Sánchez, et al. Physica Medica 70 (2020) 169–175

deviation of patient weight and height were 80 ± 16 kg and Therefore, checking for consistency and automatically correcting any
165 ± 10 cm. Table 1 shows the sample sizes presented by each centre device that provides values of radiation dose is a necessity to avoid
for each interventional laboratory. In Fig. 1a)–h) the medians of patient major errors. Dose management systems that record information from
dose indicators are presented for all X-ray systems participating in the modalities should have the capability of including correction factors for
survey. dose values. Regulators, clinicians and manufacturers make a great
Table 2 shows the national diagnostic reference levels proposed for effort to record the X-ray doses delivered to patients: if deviations
updating. of ± 35% in dose records are considered as acceptable, these dose
Table 3 shows the diagnostic reference levels proposed for updating records are nonetheless bound to contain important errors.
compared with the DRLs proposed for the period 2009–2013. The couch and mattress transmission factor resulted in 0.75 on
average with a standard deviation of 0.11. An important fraction of the
3.2. Additional information to help in optimization: X-ray systems X-ray beam can be absorbed by the couch and mattress due to the
undercouch geometry of these interventional systems. The exact
From the PKA-meters consistency check performed in 29 X-ray sys- transmission depends on beam quality and X-ray system angulation,
tems, 18 X-ray systems (64%) were found to have correction factors two variables that continuously change during interventional proce-
close to unity ( ± 10%), 4 X-ray systems needed to be corrected in more dures and are therefore difficult to assess for every procedure. But to get
than 10% but less than 20%, 5 X-ray systems required a correction the best patient collective doses, the average couch and mattress
factor between 20 and 30% and the most biased PKA -meter had a transmission should be applied to estimate real patient doses. In the
correction factor of 0.67, i.e. the system overestimated the dose in 36%. absence of correction, collective doses would be overestimated by
In general, there was a tendency for the modalities to overestimate the around 25%.
PKA. In reference conditions (20 cm of PMMA), results in dose rate reveal
The average couch and mattress transmission was estimated as important differences between X-ray systems. Differences in a factor of
0.75 ± 0.07 (1sd) and ranged from a minimum of 0.63 to a maximum 5 are found between the lowest and the highest values in all operation
of 0.92. modes. Concerning cine mode, a deviation factor of 5.5 between max-
Fig. 2 shows the entrance surface air kerma rate at 20 cm PMMA in imum and minimum dose per image could be partially explained by the
reference conditions delivered by different X-ray systems for fluoro- fact that some systems with the lowest doses per image are equipped
scopy and cine modes. with devices for dose reduction. This is the case of centre 1 with three
For the different X-ray systems tested in the research program, the X-ray systems from the same manufacturer, one of them with a dose
range between minimum and maximum K a, e was [3,15.5] mGy/min for reduction system providing a dose per image in cine 4.7 times lower
the fluoroscopy low mode, [7.6, 29.1] mGy/min for fluoroscopy
medium, and [10, 50] mGy/min for fluoroscopy high. The range in Ka,e Table 1
per image for cine mode resulted in [0.04, 0.22] mGy/img (factor of Sample sizes provided by different centres. All systems have the default cine
5.5). mode with 15 images per second with the exception of centre 7 that had
The correlation between X-ray system dose settings (dose per image 12.5 ips. * Room 3 from centre 1 has dose reduction technology.
in cine, dose rate in fluoroscopy measured with 20 cm PMMA in re- Centre Room Year of Image Number Number Manual or
ference conditions) and patient dose (median values of PKA and Ka,r) installation intensifier of CA of PTCA automatic
was studied. The highest – although not statistically significant – cor- or Flat recording
Pannel
relation coefficient found was the Spearman correlation τ = 0.16
(p = 0.24) for the cine setting in coronary angiography. The highest 1 1 2009 FP 1837 712 Automatic
correlations found were the number of cine images and the fluoroscopy 2 2009 FP 2095 1416
time with the air kerma area product (r = 0.612 and 0.519 respec- 3* 2014 FP 217 151
tively). 2 1 2007 FP 122 81 Manual
Fig. 3a) and b) present the results for the evaluation of image 2 2007 FP 103 119
quality with test object (at the isocentre) in reference conditions (20 cm 3 2012 FP 60 60

PMMA). The low contrast detectability and the high contrast spatial 3 1 2009 FP 542 1137 Automatic
resolution are presented for every X-ray system tested. The maximum, 2 2010 FP 358 818

minimum and mean ± standard deviation for the low contrast sensi- 4 1 2008 FP 34 61 Manual
tivity were 7–14 observed objects and 11 ± 2 for fluoroscopy low, 5 1 2008 FP 1241 624 Automatic
from 8 to 16 and 12 ± 2 for fluoroscopy medium, from 8 to 18 and 2 2008 FP 1048 482
13 ± 2 for fluoroscopy high and from 9 to 16 with 13 ± 2 for cine. In 6 1 2006 FP 134 255 Manual
the case of high contrasts spatial resolution the observed groups ranged
7 1 2001 II 692 784 Automatic
from 7 to 15 with 13 ± 2 (mean ± sd) for fluoroscopy low, from 8 to
16 and 14 ± 2 for fluoroscopy medium, from 8 to 17 and 14 ± 2 for 8 1 2008 FP 858 801 Automatic

fluoroscopy high and from 9 to 18 with 14 ± 2 for cine. 9 1 2007 FP 1756 1191 Automatic

10 1 2007 FP 381 224 Automatic


4. Discussion 2 2007 FP 174 105

11 1 2004 FP 1177 741 Automatic


IEC standard [21] states that the interventional systems shall dis- 2 2016 FP 712 617
play the values of PKA and Ka,r and shall not exceed their values in ± 12 1 2010 FP 102 64 Manual
35%. Spanish recommendations say that the deviation should be lower 2 2011 FP 32 79
than ± 20% [22]. Checking these values is recommended in many 13 1 2013 FP 35 44 Manual
national quality control protocols [23]. It should be easy for a medical 2 2010 FP 230 203
physics expert to check if a dose meter introduces bias greater 14 1 2012 FP 839 650 Automatic
than ± 10% at least in reference conditions. From the results on PKA- 2 2011 FP 1147 1264
meter calibration, we realized that a significant number of X-ray sys- 3 2012 FP 645 710
tems (35%) needed correction factors greater than 10%. The PKA-meter Total: 16,631 13,393
with the highest bias needed a correction factor of 0.64 (36%).

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R. Sánchez, et al. Physica Medica 70 (2020) 169–175

Fig. 1. For each interventional room, the median values of the main patient dose indicators. Horizontal lines represent the 3rd quartile of all medians as the proposed
diagnostic reference levels. Each interventional laboratory was identified at abscissa axis as “No. Center_No. X-ray system”. Some participants did not provide the
number of images and centre 7 did not provide Ka,r.

than the other two X-ray systems and similar fluoroscopy dose rate in practices and have obtained reductions of 50% in patient dose (or
the low mode (see centre 1 and rooms 1–3 in Fig. 2). In room 1_3, the higher) while keeping an acceptable image quality [24–28].
total PKA (with fluoroscopy and cine contributions) resulted between 53 While the differences in entrance air kerma per image vary in a
and 60% (for PTCA and CA respectively) lower than 1_1 or 1_2 (Fig. 1). factor of five, the differences in image quality scoring differ in a factor
In the last few years, some manufacturers have developed hardware of nearly two. The evaluation was performed by visual inspection and
and software to reduce the dose delivered to patient in interventional by different expert observers and usually led to small differences. When

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R. Sánchez, et al. Physica Medica 70 (2020) 169–175

Table 2
Proposed national DRLs for coronary angiography (CA) and angioplasty (PTCA). PKA and Ka,r are corrected only if the PKA-meter introduced any bias. PKA, couch-corr is
corrected for the bias of the PKA-meter and also for the couch and mattress transmission.
Procedure N PKA (Gycm2) Ka,r (mGy) FT (min) no. Series no. Images

CA 16,631 39 532 6,7 10 759


PTCA 13,393 78 1319 15 18 1337

Table 3 propose corrective actions. The different Spanish Autonomous Com-


DRLs from different periods are compared. munities have their own audit systems to follow the results of these
CA PTCA actions.
When the correlation between typical patient dose indicators
Period 2009-13 2014-17 2009-13 2014-17 (median of PKA) and X-ray system dose settings (air kerma rate in
2
fluoroscopy and air kerma per image in cine in reference conditions)
PKA (Gy·cm ) 42 39 89 78
T fluoro (min) 6,7 6,7 15 15
was investigated, no significant correlation (τ = 0.17; p = 0.24) was
N series 10 10 21 18 found. The X-ray systems with the lowest dose settings could have been
N images 780 759 1300 1337 expected to deliver lower doses to patients. This is true for some rooms
like in the case of 1_3 but is not reflected in the global results. If more
factors were taken into account like kV, filtration, pulse rate… then
high differences were found, they had to be investigated, as was the maybe a more complete analysis could be addressed, but such a thing
system with lowest image quality (centre 6) with only 9 low contrast was not possible in this study. We also have to keep in mind that the
details and 9 resolution groups visible in cine mode, while the average values of dose rate or dose per image at reference conditions were
was 13 low contrast details and 14 resolution groups respectively. Its measured with the default operation modes in the X-ray systems. So it
low image quality was re-evaluated and confirmed, and the compar- may occur that in some cases, an overuse of high dose operation modes
isons with other systems in the group led to the replacement of the X- increased the overall patient dose indicators. Other variables are also to
ray system in 2017. be taken into account like the number of cine images and the fluoro-
In spite of the different sample sizes between participants, using the scopy time that are likely to produce high values of patient dose with
methodology recommended by ICRP [4] all the centers have the same low values of dose per image in cine or dose rate in fluoroscopy. There
importance in the estimation of the DRLs, provided that they contribute is a wide variety of median values for fluoroscopy times (2.4–8 min in
with a minimum of cases per interventional room. Fig. 1 shows how CA and between 7 and 20 min for PTCA) and for the number of images
different the median values for PKA are in the different centres. At between centres (between 453 and 839 images for CA and 693–1600
Centre 1, laboratory 3 obtained the lowest PKA and Ka,r for CA and PTCA for PCTA), which implies that there is still a wide margin for optimi-
and at the same time one of the highest fluoroscopy times and the zation. These high differences show the importance of including
highest number of images. The X-ray system 3 at centre 1 is equipped fluoroscopy time and number of images in the DRLs as recommended
with a dose reduction system, which can explain such an odd result. We by ICRP [4]. Medical physics experts should facilitate this information
see how in this case, dose reduction systems can help reduce patient to clinicians to help them achieve the appropriate image quality and
dose indicators. In Fig. 2 where the entrance air kerma per image in radiation dose for patients. As commented in the introduction, the
reference conditions is represented, X-ray system 1_3 has the lowest current European regulation highlights the importance of the respon-
value (0.04 mGy/img). In Fig. 3 that shows the results of image quality sibility shared by physicians and medical physics experts in optimiza-
with tests object, we can check that the same X-ray system at Centre 1_3 tion. We should all focus on achieving the optimal fluoroscopy time and
produced similar results in cine mode with respect to the other systems number of images required to produce an acceptable clinical outcome.
in the same centre: 12 details for low contrast sensitivity and 14 bar The impact of complexity factors in patient dose indicators should
groups for high contrasts resolution. Some rooms exceed the former therefore be evaluated and considered in the future for interventional
DRL. These centres have the responsibility to investigate the causes and

Fig. 2. An estimation of entrance surface air kerma rate for fluoroscopy and cine operation modes for all X-ray systems tested and using reference conditions
described (20 cm PMMA).

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R. Sánchez, et al. Physica Medica 70 (2020) 169–175

Fig. 3. An estimation of image quality using test object (18 FG Leeds) for all X-ray systems tested and using the reference conditions described (20 cm PMMA). The
number of objects seen by observers are represented. Upper figure shows the low contrast sensitivity and lower shows results on high contrast spatial resolution.

Table 4 small reduction in PKA (−5%) that might not be significant. As regards
DRLs in terms of PKA in Gy·cm2 for interventional cardiology found in literature PTCA, although the same fluoroscopy time was recorded in both per-
and compared with this study. iods and the number of cine images was quite similar (−2%), the PKA
CA PTCA dropped by 14%. To explain this reduction in PKA, an analysis with
variables that are not included in this study like collimation would be
DIMOND18 2003 57 94 necessary. Many factors can affect these results like the addition of
SENTINEL19 2008 45 85
hospitals to the survey with new angiographic units, but we may also
EURADOS20 2018 35 87
UK8 2009 29 50 assume that this progressive reduction in patient dose indicators can be
USA9 2012 83 193 partly the outcome of the training programs in radiation protection and
Belgium10 2009 71 106 patient dose optimization for interventional practices. In particular in
France11 2017 26 60 Spain, since 1999 all interventionalists must obtain an official certifi-
Crotatia12 2010 32 72
Bulgaria13 2012 40 140
cation on radiological protection in interventional practices issued by
Grece14 2013 53 129 the health authority. A board examination is required to obtain this
Ireland15 2009 42 84 certification.
Germany29 2019 28 48 In Table 4, we show for comparison the DRLs in terms of PKA
Finland30 2019 30 75
published in previous European surveys.
This study 39 78
It can be noted that the national DRLs proposed in this study are
similar to the ones obtained in the last European survey. The value for
procedures as suggested by ICRP [4]. CA resulted 11% higher and for PTCA 8% lower. Should improvement
Table 3 shows the DRLs for CA and PTCA proposed for the period in dose reduction continue to be implemented in the new X-ray systems,
2009–2013 versus the ones proposed now. As regards CA, there is a along with the optimization of fluoroscopy time and number of cine

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R. Sánchez, et al. Physica Medica 70 (2020) 169–175

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