-
Research ArticleMulticenter Assessment of Radiation Exposure
during PediatricCardiac Catheterizations Using a Novel Imaging
System
Luke J. Lamers ,1 Brian H. Morray,2 Alan Nugent,3 Michael
Speidel,4 Petch Suntharos,5
and Lourdes Prieto5
1Department of Pediatrics, Cardiology Division, University of
Wisconsin School of Medicine and Public Health,Madison, WI 53792,
USA2Department of Pediatrics, Cardiology Division, University of
Washington School of Medicine, Seattle, WA 98195, USA3Department of
Pediatrics, Cardiology Division, University of Texas Southwestern
Medical Center, Dallas, TX 75235, USA4Department of Medical
Physics, University of Wisconsin School of Medicine and Public
Health, Madison, WI 53705, USA5Department of Pediatrics, Cardiology
Division, e Cleveland Clinic, Cleveland, OH 44195, USA
Correspondence should be addressed to Luke J. Lamers;
[email protected]
Received 8 May 2019; Revised 29 July 2019; Accepted 17 September
2019; Published 31 October 2019
Academic Editor: Matteo Tebaldi
Copyright © 2019 Luke J. Lamers et al.is is an open access
article distributed under the Creative Commons Attribution
License,which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly
cited.
Objectives. To quantify radiation exposure during pediatric
cardiac catheterizations performed by multiple operators on a
newimaging platform, the Artis Q.zen (Siemens Healthcare,
Forchheim, Germany), and to compare these data to
contemporarybenchmark values. Background. e Artis Q.zen has been
shown to achieve signicant radiation reduction during select types
ofpediatric cardiac catheterizations in small single-center
studies. No large multicenter study exists quantifying patient
doseexposure for a broad spectrum of procedures.Methods.
Retrospective collection of Air Kerma (AK) and dose area product
(DAP)for all pediatric cardiac catheterizations performed on this
new imaging platform at four institutions over a two-year time
period.Results. A total of 1,127 pediatric cardiac catheterizations
were analyzed. Compared to dose data from earlier generation Artis
Zeeimaging systems, this study demonstrates 70–80% dose reduction
(AK and DAP) for similar patient and procedure types.Compared to
contemporary benchmark data for common interventional procedures,
this study demonstrates an average percentreduction in AK and DAP
from the lowest dose saving per intervention of 39% for AK and 27%
for DAP for transcatheterpulmonary valve implantation up to 77%
reduction in AK and 70% reduction in DAP for atrial septal defect
closure. Conclusion.Use of next-generation imaging platforms for
pediatric cardiac catheterizations can substantially decrease
patient radiationexposure. is multicenter study denes new low-dose
radiation measures achievable on a novel imaging system.
1. Introduction
Fluoroscopically guided diagnostic and
interventionalcatheterizations play a vital role in the management
ofpatients with congenital heart disease (CHD). Due to
theincreasing procedural complexity and frequent need forrepeated
studies, these cardiac catheterizations may accountfor more
cumulative radiation exposure than all other im-aging modalities
combined throughout a CHD patient’slifetime. is radiation exposure
often begins early inchildhood, a time associated with greatest
long-term risk formalignancies [1, 2]. With increased recognition
of the
radiation risks, there have been concerted e£orts to
decreaseboth patient and operator exposure through implementationof
As Low As Reasonably Achievable (ALARA) principlesand standards
advocated by national radiation reductionquality improvement e£orts
[3, 4]. rough use of imagingguidelines set forth, several studies
have documented sig-nicant reduction in radiation exposure during
pediatriccatheterizations [5–7], and the current trend is away
fromdetailed high-quality imaging toward adequate image qualityto
perform procedures safely at the lowest acceptable dose.
While operators implement imaging techniques tolower dose,
recent years have seen concerted e£orts by
HindawiJournal of Interventional CardiologyVolume 2019, Article
ID 7639754, 7 pageshttps://doi.org/10.1155/2019/7639754
mailto:[email protected]://orcid.org/0000-0001-9736-3569https://creativecommons.org/licenses/by/4.0/https://creativecommons.org/licenses/by/4.0/https://doi.org/10.1155/2019/7639754
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manufacturers to reduce radiation exposure through
tech-nological processes. New system components and advancedimage
postprocessing algorithms offer potential for signif-icant decrease
in the radiation necessary for image gener-ation [8–11]. Novel
imaging systems are now available withcomplementary
metal-oxide-semiconductor (CMOS) flat-panel x-ray detectors (FD)
that increase the acquired imagebit depth and employ crystalline
silicon instead of amor-phous silicon as a photodetector. Both
improvements offerreduction in radiation dose to obtain similar
image qualitydue to better digitalization and lower detector noise.
Inaddition, x-ray tubes have been introduced that changedfrom
classic coil filaments for photon generation to flatemitters, which
maximize contrast, spatial, and temporalresolution through
generation of more coherent focal spots,leading to further
radiation dose reduction.
In light of ever-increasing complexity and duration
ofinterventional procedures, the possibility of reducing radi-ation
burden to both patient and user is of high interest. Inthis regard,
a next-generation imaging platform, the ArtisQ.zen, introduced by
Siemens Healthcare (Forchheim,Germany) for commercial use in 2014
implements the abovedescribed FD and x-ray tube generation
technologies andsignificantly decreases radiation doses while
preservingimage quality. Two small single-center studies assessing
thisimaging platform for pediatric cardiac
catheterizationsdemonstrate 50–70% reduction in radiation
exposurecompared to previous generation Siemens imaging plat-forms
[10] and to published benchmark data for a singleintervention [11].
Variability in operator imaging strategiesand system settings is
known to exist between institutions,and a large patient population
assessment of the radiationreduction capabilities of the Q.zen
system does not exist.*us, the primary aim of this study was to
define radiationexposure for diagnostic and interventional
catheterizationsfrom a larger representative sample of pediatric
CHD pa-tients from multiple centers and to compare these
exposuredata to published contemporary benchmarks [12].
2. Methods
2.1. Data Collection. *is study was conducted as a multi-center
retrospective case review of radiation data for allconsecutive
pediatric cardiac catheterizations performed onQ.zen imaging
platforms at four participating institutionsfrom February 1, 2014
to September 1, 2016. IRB approvalwas obtained at each
participating site in accordance withinstitutional requirements.
Centers provided standard im-aging protocols and system settings
for comparison. CHDpatients >18 years of age were excluded.
Removal of theantiscatter grid and utilization of the air gap
technique wasstandard imaging for patients
-
biopsy. Center D patients were younger and smaller with
noisolated right heart catheterization data as this center doesnot
have a pediatric heart transplant program.
Default weight-based detector dose rates, fluoroscopy,and
cineangiography system settings are summarized inTables 2 and 3.
Pertinent differences between centers areobserved for both operator
imaging techniques and systemsettings. Center B imaging frame rates
for fluoroscopy (4–7.5pulses/s) and cineangiography (7.5–15
frames/s) were thelowest for all weights, and Center B system
settings also hadthe lowest nGy/s for image generation for each
weightclassification.
3.2. Radiation Exposure by Procedure Type and
SpecificIntervention. Overall median fluoroscopy time was 15minutes
(IQR 8–27), median AK was 37mGy (14–87), andmedian DAP was 224
μGy·m2 (84–671). *e fraction ofprocedural AK from fluoroscopy was
45% (27–70%) withonly a single case that exceeded 2,000mGy.
Measures ofweight-based exposure data with interquartile ranges
fordiagnostic procedures, interventions, and right heart
cath-eterizations with biopsy are summarized in Table 4. Com-paring
this cohort to reference data obtained on a previousgeneration
imaging system from the same manufacturer(Artis Zee, Siemens
Healthineers, Forchheim, Germany)[13] with similar fluoroscopy
times and patient weights, thecurrent study demonstrates a lowering
in median AK from135 to 37mGy (73% reduction) and median DAP from
760to 224 μGy·m2 (70% reduction), respectively. Similar
dosereduction was demonstrated for diagnostic procedures(n� 312)
(73% reduction in AK and 61% for DAP), in-terventions (n� 603) (79%
reduction in AK and 75% forDAP), and right heart catheterizations
(n� 214) (89% re-duction in both AK and DAP).
Table 5 provides dose data for six selected
interventionalprocedure types from the study cohort. Compared
tocontemporary radiation dose benchmarks from the pro-spective
C3PO-QI study [12], the average percent reductionin AK and DAP
ranged from the lowest dose saving perintervention of 39% for AK
and 27% for DAP for trans-catheter pulmonary valve (TPV)
implantation up to 77%reduction in AK and 70% reduction in DAP for
ASD closure.Percent reduction in DAP/kg values for the six
individualinterventions compared to the C3PO-QI was as follows:PDA
closure 59% reduction, ASD closure 74% reduction,balloon aortic
valve 66% reduction, balloon pulmonary valve60% reduction,
coarctation intervention 50% reduction, andTPV 23% reduction.
Figures 1–3 represent trends in quarterly proceduralfluoroscopy
time and dose (AK and DAP) for the cohort.*ere are no statistically
significant trends in dose data overtime. If the first quarter data
of 2014 are eliminated, atimeframe during which the new system
settings were beingestablished, procedural dose trends are
virtually unchangedfrom early 2014 through 2016, suggesting that
the docu-mented dose savings are attributed to system
technicaladvances independent of operator practices.
4. Discussion
*is is the first multicenter study of radiation exposure
inpediatric CHD patients following cardiac
catheterizationsperformed on a state-of-the art imaging system
employing anew flat panel detector technology. *is study
demonstratesa large decrease in measured patient dose for
diagnostic andinterventional catheterizations when compared to
dataobtained from similar patients and procedures performed ona
previous generation imaging system from the samemanufacturer [13].
*e present study also included a DAP/kg analysis for six selected
interventional catheterizationprocedures for comparison to recently
published data [12].*e DAP/kg data along with the standard measures
total AKand DAP decreased substantially for all interventions.
As operators aim to decrease dose through application ofALARA
strategies, decreasing fluoroscopy and cineangiog-raphy frame rates
are simple and effective adjustments thatcan be made without
significant compromise in imagequality. Application of additional
ALARA concepts such aslimiting the number of cineangiograms to what
is necessary,limiting use of lateral imaging, and avoiding
unnecessarymeasurements that are available noninvasively has
beenshown to decrease radiation dose to less than we report[7, 14]
without compromise to patient safety or proceduraloutcomes. It is
well known that different pediatric centersuse site-specific
imaging protocols and system settingsconfirmed by the current
study. *e majority of imaging forthis study was obtained at less
than 10 pulses/second forfluoroscopy with one center consistently
imaging at 4 pulses/second and less than 15 frames/second for
cineangiograpy.Detector dose rates also varied by center and
patient weights.Despite these variations in the participating
center imagingtechniques, we did not identify a center with
consistentlylower dose data when similar patient and procedure
typeswere compared, and there was no trend toward lower doseover
time with increased operator familiarity with the sys-tem. *us, a
major difference responsible for the reduceddose between the
current study and that of Glatz et al. [13]
Table 1: Center-specific case data.
Center Age (months)Median (range)Weight (kg)
Median (range) Diagnostic (n) Intervention (n) RHC± biopsy
(n)
A 41 (0–215) 13.5 (2.4–97) 128 229 76B 88 (0–216) 23 (2.4–85) 25
51 81C 42 (0–214) 14 (2.2–131) 89 188 56D 14 (0–215) 9.2 (1.1–81)
69 135 0Cohort 37 (0–216) 13.2 (1.1–131) 311 603 213
Journal of Interventional Cardiology 3
-
Table 2: Fluoroscopy detector dose rate by center and patient
weight.
CenterWeight Average of all
categories
-
appears to be due to the upgrade within the CMOS-baseddetectors
of the system as kV limits are set to allow copperfiltration at
0.2–0.6mm and image postprocessing softwarefor the two generations
of equipment are similar. *istechnological advance generates lower
noise within thedetector for similar X-ray image impressions
allowing alower dose (15–23 nGy/pulse for the Q.zen vs. 23–29
nGy/pulse for the Artis Zee) to generate images.
*e two main sources of fluoroscopic and cineangiog-raphy image
degradation are quantum and electronic noise[15]. Quantum noise is
caused by scattered photons due tointeractions with objects in the
x-ray beam. Electronic noisepurely resides in the detector, and in
contrast to quantumnoise, does not vary with radiation dose. For
conventionalimaging, quantum noise dominates electronic noise as
thelimiting factor in image quality. In the past, dose settingshave
approached the limit at which electronic noise dom-inates quantum
noise and no further dose reduction could
occur. Since the introduction of flat-panel
detectors,manufacturing material of the detector array has
beenamorphous silicon semiconductors, due to availability andease
of manufacturing. Only recently have detector-basedCMOS elements
become available that employ crystallinesilicon instead of
amorphous silicon as a photodetector forthe interventional market.
*ese CMOS-based detectorshave the benefit of reduced electronic
noise, with fasterreadout and less spatial blur [16]. *is allows
users to furtherreduce the dose per frame until a new, lower
electronic noisethreshold is met. *is difference keeps the image
quality andimpression to the user constant, allowing use of the
sameimage postprocessing, while lowering the patient dose.
*e dose reduction documented in this study is largelydue to
technological advances in detector properties. Othermanufactures
have recently achieved similar degrees of dosereduction between
system generations with technologicadvances within other parts of
the image generation path-way. Sullivan et al. report radiation
data pre- and post-upgrade of an AlluraXper FD 20/10 system to
theAlluraClarity (Philips Healthcare, Best, the Netherlands)and
demonstrate use of Clarity was associated with a 58%reduction in
DAP for all pediatric cardiac catheterizationprocedures after
adjustment for fluoroscopy time, BSA, andprocedure type, albeit
from a high level of radiation exposurewith the prior system
generation [8]. AlluraClarity is asoftware upgrade to the
fluoroscopy system that digitallyenhances images obtained with
lower radiation dosesthrough technological advances within the
image acquisitionchain. *e system image postprocessing software
andhardware were upgraded, while the x-ray tube, the
biplaneflat-panel detectors, and other image acquisition
equipmentwas not, so the dose savings were largely due to
imagepostprocessing as there was no change in image
generation,filtration, or collimation capabilities [8]. Similar
dose re-duction has been demonstrated for adults with use of
Claritytechnology for coronary angiography and angioplasty
andvascular and neurovascular interventions [17–19].
Ideally,manufacturers will continue to scrutinize each step in
the
2014
-1st
quar
ter
600
500
400
300
200
100
0
2014
-2nd
qua
rter
2014
-3rd
qua
rter
mG
y
2014
-4th
qua
rter
2015
-1st
quar
ter
2015
-2nd
qua
rter
Cumulative air kerma (mGy)
2015
-3rd
qua
rter
2015
-4th
qua
rter
2016
-1st
quar
ter
2016
-2nd
qua
rter
2016
-3rd
qua
rter
P value = 0.4
Figure 2: Quarterly cumulative Air Kerma trend across
centers(adjusted by center, age, and weight). P value� 0.4.
2014
-1st
quar
ter
80
70
60
50
40
30
20
10
0
2014
-2nd
qua
rter
2014
-3rd
qua
rter
Min
utes
2014
-4th
qua
rter
2015
-1st
quar
ter
2015
-2nd
qua
rter
Total fluoroscopy time (minutes)
2015
-3rd
qua
rter
2015
-4th
qua
rter
2016
-1st
quar
ter
2016
-2nd
qua
rter
2016
-3rd
qua
rter
P value = 0.6
Figure 1: Quarterly total fluoroscopy time trends. P value�
0.6.
2014
-1st
quar
ter
6000
5000
4000
3000
2000
1000
0
2014
-2nd
qua
rter
2014
-3rd
qua
rter
mG
y ∗
m2
2014
-4th
qua
rter
2015
-1st
quar
ter
2015
-2nd
qua
rter
Cumulative DAP (uGy ∗ m2)
2015
-3rd
qua
rter
2015
-4th
qua
rter
2016
-1st
quar
ter
2016
-2nd
qua
rter
2016
-3rd
qua
rter
P value = 0.2
Figure 3: Quarterly cumulative dose area product (DAP)
trendacross centers (adjusted by center, age, and weight). P value�
0.2.
Journal of Interventional Cardiology 5
-
image generation process searching for further dose saving,image
preserving technologies, while at the same time re-searchers
experiment with alternative interventional imag-ing strategies such
as MRI-guided procedures that wouldeliminate procedural radiation
exposure.
Efforts to reduce lifetime radiation exposure are im-portant,
particularly in CHD patients who are often exposedto high-lifetime
doses as a result of repeated procedures anddiagnostic testing.
Every pediatric radiation exposure studydiscusses the theoretical
long-term increase risk for malig-nancy that is estimated to be
6.5% greater than baseline forCHD patients with the highest levels
of radiation exposure[1]. Operator’s diligent application of ALARA
concepts hasthe greatest potential to decrease radiation exposure
[7, 14].In addition, this study demonstrates that use of
upgradedimaging systems can reduce radiation exposure by
25–75%,depending on procedure type compared to published ra-diation
dose benchmarks in pediatric cardiac catheterization[12]. *is
information should prompt children’s hospitals toconsider
modernizing their imaging systems to significantlyreduce exposure
to all who work and require procedureswithin pediatric
catheterization laboratories.
5. Study Limitations
Image quality was not directly evaluated in this study or inthe
previous publications which served as a basis of com-parison.
Consequently, it was not possible to determine if thedifferences in
dose were correlated with differences in imagequality. Furthermore,
there were variations in patientpopulation, procedure type, and
operator experience acrossthe participating sites, which were
difficult to control for. Astudy design that controls for these
factors may enable moreprecise comparisons of dose and
determination of the dosereduction attributable to the x-ray
technology.
Abbreviations
CHD: Congenital heart diseaseALARA: As low as reasonably
achievableCMOS: Complementary metal-oxide-semiconductorFD:
Flat-panel X-ray detectorsAK: Air kermamGy: MilligrayDAP: Dose area
productμG·m2: microgray×meter squaredμG·m2/kg: Dose area product
divided by kilogramsPDA: Patent ductus arteriosusASD: Atrial septal
defectTPV: Transcatheter pulmonary valve.
Data Availability
*e data used to support the findings of this study are in-cluded
within the article.
Disclosure
Preliminary study data were presented at the Society
forCardiovascular Angiography and Interventions National
Meeting in 2017 and is referenced in the following
link:https://onlinelibrary.wiley.com/doi/full/10.1002/ccd.27053.
Conflicts of Interest
*e authors declare that they have no conflicts of interest.
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