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; llamers@pediatrics.wisc.edu

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:llamers@pediatrics.wisc.eduhttps://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

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

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Figure 2: Quarterly cumulative Air Kerma trend across centers(adjusted by center, age, and weight). P value� 0.4.

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Figure 1: Quarterly total fluoroscopy time trends. P value� 0.6.

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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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