Volume 1 Issue 1
Reduction in Primary Operator Radiation Dose with Radiation Absorbing Drapes (REDUCE STUDY)
Vyom Mori1, Arun Mohanty1, Aman Makhija1, Raja Ram Mantri1, J P S Sawhney1, Rajiv Passey1, Bhuwanesh Kandpal1, Jignesh Vanani1, Ashish Kumar Jain1, Dipak Katare1
1 Department of Cardiology, Sir Ganga Ram Hospital, New Delhi-110060, India.
*Corresponding author: Vyom Mori, Department of Cardiology, Sir Ganga Ram Hospital, Old Rajinger Nagar, Delhi (2022) Reduction in Primary Operator Radiation Dose with Radiation Absorbing Drapes (REDUCE STUDY)1(1)
Copyright: ©2022 Vyom Mori, This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Received: 13 June 2022| Accepted :2 July 2022|Published:04th August, 2022
Keywords: RADPAD; radiation exposure; lower the better
Introduction: Radiation absorbing shields (RADPAD) have been designed with a goal of decreasing radiation exposure to the operators during catheterization procedures. We sought to investigate the impact of RADPAD on reduction in operator radiation exposure in catheterization laboratory.
Method: The shield used is commercially available RADPAD which is lead free, composed of a bismuth and barium with lead equivalency of 0.125 mm. 152 cases of diagnostic and therapeutic angiograms were allotted in 2:1 manner with or without the RADPAD. Screening time, Cine adjusted screening time (CAST), radiation dose of primary operator was measured in all procedures. The primary endpoint was to see the reduction in ratio of primary operator dose relative to CAST in those with RADPAD.
Results: Out of 152 procedures 5 were diagnostic and 147 were therapeutic angiograms. Mean CAST was 47.3 (6.7-182) in RADPAD group and 46.33 (5.82-146.45) in no RADPAD group. The PO/CAST was 0.089±0.078 in RADPAD group and 0.234±0.28 in no RADPAD, which was significantly reduced. The operator dose was also significantly reduced in RADPAD group.
Conclusion: In this study we observed 60% reduction in PO dose/CAST in RADPAD group compared to no RADPAD cohort. The absolute PO dose in RADPAD cohort was 54% less compared to no RADPAD cohort.
Cardiac catheterization laboratory is essential for therapeutic as well as diagnostic procedures in field of cardiology. Ionizing radiation remains an integral part of this laboratory. For staff members employed in a cardiac catheterization suite, chronic exposure to low-dose radiation confers a small but stochastic risk for inducing malignant disease, skin damage, or eye problems(1,3).There is six fold increase in radiation exposure and nearly 40 % of the increased exposure is related to Cardiovascular imaging and intervention(4). Significant radiation exposure has the potential to impact the health and well-being of interventional cardiologists and diseases like Brain Tumors (5,7), Cataracts(7), Thyroid Disease(8,9), cardiovascular diseases10, are reported in various studies. Atomic energy regulatory board (AERB) has recommended Whole body (Effective dose) as 20 mSv/year averaged over 5 consecutive years. Radiation exposure has been accepted as an occupational hazard for interventional cardiologist and other health care providers (HCP) who work with X ray-based imaging in general (1). However, it is very imperative that principle of ALARA (as low as reasonably achievable) should be practiced in every lab wherever HCPs deal with hazardous radiation. The RADPAD (Worldwide Innovations & Technologies, Inc., Kansas City, Kansas) is a sterile surgical drape containing radiation protection materials (bismuth and barium), placed appropriately on the patient between the imaging beam and the primary operator. It is known to reduce scatter radiation exposure to primary operator in routine catheterisation procedures. We sought to assess the efficacy of RADPAD drapes in reducing radiation dose experienced by operators during routine catheterization procedures in our hospital.
Study was a single centre experience of RADPAD use during catheterization procedures. This was a prospective observational study using radiation protection shield (RADPAD, Worldwide Innovations and Technologies Inc, KS, USA), which is lead free and composite of barium and bismuth. The shielding properties are certified by the manufacturer as 0.125 mm lead equivalent.
One RADPAD shield (Femoral 5300A- Y/Multipurpose 5511A-Y) was used for this study and were placed as per the standard placement instruction from the manufacturer as shown in Figure 1.
FIGURE 1: Figure showing appropriate placement of RADPAD during femoral/radial procedures.
All shields were used once only. All procedures were performed in a standard PHILLIPS FD20 Cath. Lab (Catheterisation laboratory), and with usual attention to good radiological practice such as careful collimation, hanging lead curtain beneath the patient table, movable leaded glass shield fixed to the ceiling. Standard personal shielding including a lead apron and protective thyroid collar were worn by the operator. The study was performed as part of a quality assurance program with a view to monitoring and reducing dose to staff in the interventional lab with no intervention done on patient, so local ethics committee approval was waived.
Study was all comers where use of RADPAD was allotted in 2:1 pattern to “with RADPAD” (Study Group) or “without RADPAD” (Control group). Radiation exposure to primary Operator (referred as primary operator dose) was measured using ALOKA PDM 127 personal dosimeter placed over left chest above the lead apron. Recorded doses were from the primary operator dosimeter for all the procedures (DOSE). Total fluoroscopy time and no of cine acquisitions were recorded for each procedure (ST). Patient and procedural details were recorded prospectively. To consider the factor of radiation exposure on account of CINE, which emits approximately 15 times (11) more radiation than fluoroscopy (non cine screening), we derived cine adjusted screening time (CAST), using average cine duration (observed to be 4 second), factor of fifteen and number of cine acquisition. The primary operator dose was then designated to CAST for relative dose exposure (Primary operator dose/CAST). The primary endpoint of the study was to see reduction in ratio of primary operator to CAST in procedures with RADPAD compared to control. The secondary objective was to see reduction in total radiation dose in the study group.
ST (Screening time), AK (Air kerma) and PO dose/CAST are shown in mean ± standard deviation. CAST and DOSE is measured in mean with range. One-Way ANOVA Calculator, including Tukey HSD test was used to compare mean values of radiation exposure. Scatterplot analysis and linear regression slopes of dose relative to CAST was performed. A p value 0.05 was accepted as statistically significant.
A total of 152 procedures were part of this study. Five were coronary angiograms and 147 were therapeutic interventional procedures. The basic demographics of the study population are enumerated in Table 1.
55 ± 9.5
53 ± 8.4
Acute Coronary Syndrome
Chronic total occlusion
TABLE 1: Basic demographics of the study population
*PCI-Percutaneous coronary intervention.
Basic characteristics in both the population were almost similar. Most of the patients were of stable angina in both the groups. Various diagnostic and therapeutic interventional procedures done in both the groups are mentioned with most of the procedures being single vessel PCI.
The procedural data and radiation measurements are enumerated in Table 2.
NO RADPAD (n=52)
Procedural data in study cohort
PO Dose/CAST (m rem/min.)
TABLE 2- Procedural data in both the study groups.
*ST- Screening time, *AK- Air Kerma, CAST- Cine adjusted screening time, *DOSE- Radiation as measured by dosimeter, *PO/CAST- Primary operator dose/Cine adjusted screening time.
Mean ST was numerically higher in control group and AK was numerically higher in study group. The CAST was higher in control group but it was not found to statistically significant (p - 0.3). The ratio of primary operator dose to CAST was significantly reduced in the study group (0.089±0.078) compared to the control group (0.234±0.28) (p < 0.00001). There was also significant reduction in the primary operator radiation dose in study group (3.67 mrem) compared to control group (8.12 mrem) (p < 0.00001). The mean patient dose in RADPAD cohort was 96.575 m rem in RADPAD cohort and 116.95 mrem in NO RADPAD cohort.
Our study has shown that with use of radiation shields (RADPAD) there was 60% reduction the ratio of primary operator to CAST and 54% reduction in the total operator dose exposure. The reduction in radiation exposure has been found to be statistically significant. Scatter plot analysis of the groups has been shown in FIGURE 2
FIGURE 2 - Scatter Plot Analysis of PO dose/CAST, suggesting radiation exposure more if RADPAD not used.
*PO- Primary operator dose, *CAST- Cine adjusted screening time
There was also 17% reduction in the patient radiation dose exposure. The reduced radiation exposure and its beneficial effects on the health care workers has not been assessed in our study. However any amount of radiation exposure is harmful with long term stochastic effects unknown in the health care workers working among radiation.
The higher reduction in radiation dose in our study was due to use of dosimeter at chest level because that’s the maximum exposed part to radiation. Besides this RADPAD also prevents the relative radiation exposure at chest level compared to other body parts (12). In RECAP trial, use of RADPAD in catheterization laboratory lead to 20% reduction in relative dose exposure compared to NO RADPAD group and 44% reduction compared to SHAMPAD group (13). Use of drapes in CRT (Cardiac resynchronization therapy) has lead to 65% reduction in dose exposure and hand level and 40% reduction at eye level (14). RADPAD use during coronary angiography lead to 59% reduction in relative radiation exposure to the primary operator even during angiography (15). In an Indian study of 65 patients the drape reduced the radiation exposure to the operator by 39%.16 The study also concluded that maximum radiation is in left anterior oblique projection (16). Our study has shown the primary operator dose reduction of similar magnitude. Usually in diagnostic angiograms the radiation dose is 2-3 mSV but during complex PCI like bifurcations, CTO (Chronic total occlusion) or multivessel disease the exposure rises to as much as 10-15 mSV. The interventional cardiologists have an adjusted odds ratio of 4.5 for cancer, 9 for cataract, 1.7 for hypertension and 1.9 for hypercholesterolemia due to long hours of radiation exposure (17). Our study also measured the radiation dose exposure at patient level, which was found to be reduced by 17% in study group compared to control. Thus on addition to traditional radiation protection devices it becomes amenable to use this drapes. The goal should be to achieve as low as possible radiation exposure to the operator and prevent long term occurring occupational hazards.
There are three limitations of our study. One is our study is prospective observational study but however we tried to balance the baseline charecteristics between both groups. Second is we measured operator dose exposure only at the chest level rather than measuring at other body parts. Third is its limited experience single centre study.
The study showed the use of RADPAD leads to significant reduction in radiation exposure to the primary operator. Thus, with use of drapes the goal of ALARA can be achieved. How its going to effect the long-term consequences of radiation in health care workers is yet not determined. Hence whenever possible for those working long hours amongst radiation use of sterile drapes for preventing the exposure should be considered.
- Venneri L, Rossi F, Botto N, Andreassi MG, Salcone N, et al. (2009) Cancer risk from professional exposure in staff working in cardiac catheterization laboratory: insights from the National Research Council's Biological Effects of Ionizing Radiation VII Report. Am Heart J.;157(1):118-124.
- Koenig TR, Wolff D, Mettler FA, Wagner LK. (2001) Skin injuries from fluoroscopically guided procedures: part 1, characteristics of radiation injury. AJR Am J Roentgenol.;177(1):3-11.
- Vano E, Gonzalez L, Fernández JM, Haskal ZJ. (2008) Eye lens exposure to radiation in interventional suites: caution is warranted. Radiology;248(3):945-953.
- Vañó E, González L, Guibelalde E, Fernández JM, Ten JI.(1998) Radiation exposure to medical staff in interventional and cardiac radiology. Br J Radiol.;71(849):954-960.
- Finkelstein MM. (1998) Is brain cancer an occupational disease of cardiologists? Can J Cardiol.;14(11):1385-1388.
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- Jacob S, Boveda S, Bar O, Brézin A, Maccia C, et al.(2013) Interventional cardiologists and risk of radiation-induced cataract: results of a French multicenter observational study. Int J Cardiol.;167(5):1843-1847.
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- Sylvester CB, Abe JI, Patel ZS, Grande-Allen KJ.(2018) Radiation-Induced Cardiovascular Disease: Mechanisms and Importance of Linear Energy Transfer. Front Cardiovasc Med.;5:5.
- Shah B, Mai X, Tummala L, Kliger C, Bangalore S, et al.(2014) Effectiveness of fluorography versus cineangiography at reducing radiation exposure during diagnostic coronary angiography. Am J Cardiol.;113(7):1093-1098. (1), 118-124
- Kloeze C, Klompenhouwer EG, Brands PJ, Van Sambeek MR, Cuypers PW, et al (2014) Editor’s choice–use of disposable radiation-absorbing surgical drapes results in significant dose reduction during EVAR procedures. Eur J Vasc Endovasc Surg.;47:268–272.
- Vlastra W, Delewi R, Sjauw KD, Beijk MA, Claessen BE, et al.(2017) Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. Circ Cardiovasc Interv;10(11):e006058.
- Jones MA, Cocker M, Khiani R, Foley P, Qureshi N,et al (2014) The benefits of using a bismuth-containing, radiation-absorbing drape in cardiac resynchronization implant procedures. Pacing Clin Electrophysiol.;37(7):828-833.
- Kherad B, Jerichow T, Blaschke F, Noutsias M, Pieske B, et al (2018) Efficacy of RADPAD protective drape during coronary angiography. Herz.;43(4):310-314.
- Shah P, Khanna R, Kapoor A, Goel PK.(2018) Efficacy of RADPAD protection drape in reducing radiation exposure in the catheterization laboratory-First Indian study. Indian Heart J.;70 Suppl 3(Suppl 3):S265-S268.
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