Does a Novel Lead-Free Radiation Shield Improve Surgeon Protection Compared with Lead Apron Alone?

Abstract

Introduction:

The RADPAD is a novel lead-free shield that can be positioned directly in the surgical field to block scatter radiation. The primary objective of this study was to assess the effectiveness and added protection of the RADPAD compared with conventional lead during simulated percutaneous nephrolithotomy (PCNL).

Methods:

To simulate a PCNL, a radiographical phantom patient and a mannequin surgeon were utilized. Using a real-time dosimeter, radiation doses were measured in µSv at seven surgeon locations: head, neck, chest, abdomen, pelvis, forearm, and leg. Two shielding strategies were evaluated: conventional lead apron and thyroid shield (LATS) and triple-thickness RADPAD. The effectiveness of combining LATS with RADPAD was compared with baseline (no lead). Five trials of 5 seconds of fluoroscopy were conducted for each location and shielding combination. The Mann–Whitney U test was used to compare exposures with p < 0.05 considered significant.

Results:

LATS alone significantly reduced radiation exposure at all locations compared with baseline (>95%; p < 0.05) except the surgeon head, forearm, and leg. RADPAD alone significantly reduced radiation at all tested locations (p < 0.05), except the legs. Compared with LATS alone, RADPAD significantly reduced radiation exposure to the head (as much as 48%) and forearm (as much as 84%; p < 0.05). LATS with RADPAD yielded the greatest radiation reduction, performing significantly better than LATS alone at the head, pelvis, and forearm (p < 0.05). No device or combination significantly reduced radiation exposure to the leg.

Conclusions:

The LATS alone reduced radiation >95% at shielded sites, but provided no protection to the head, forearm, and leg. Addition of the RADPAD to conventional LATS functions as an effective and novel strategy that reduces radiation exposure at all measured sites except the legs and provides important protection to the head and arms of the surgeon without increasing the weight burden.

Keywords

percutaneous nephrolithotomy radiation protection urolithiasis surgical drapes fluoroscopy radiation exposure

Introduction

Radiation exposure remains a major concern across medical specialties. Urologists routinely engage in procedures involving ionizing radiation leading to considerable cumulative exposures. These exposures pose substantial health risks, such as the development of various malignancies, cataracts, and tissue damage.^1,2 In particular, during fluoroscopic-guided procedures such as percutaneous nephrolithotomy (PCNL), the majority of the radiation dose received by surgeons comes from scatter radiation.³ Therefore, it becomes imperative to implement effective radiation shielding measures to ensure the safety of urologists and all involved health care personnel.

The most common radiation protection for urologists includes a lead apron and thyroid shield (LATS). Additional personal protective garments, such as lead glasses, lead gloves, and other shielding devices, are less commonly utilized.^4,5 However, relying solely on LATS leaves the head and extremities exposed and vulnerable to radiation exposure.^6,7 Radiation exposure in these unshielded locations can damage DNA in circulating lymphocytes.⁸ Thus, it is important to consider additional shielding devices to protect these areas.

Recently, a novel lead-free surgical drape that can be placed directly on the patient to block scatter radiation has been developed. The RADPAD (RADPAD 5100A-O; Worldwide Innovations & Technologies, Inc., Lenexa, KS) is a sterile, lead-free drape constructed from bismuth and antimony that can be strategically placed directly in the surgical field, but outside of the primary radiation beam to block scatter radiation to the surgeon. Preliminary studies have demonstrated potential reductions in radiation exposure when using RADPAD drapes for procedures in electrophysiology, interventional cardiology, and interventional radiology.^9–14 However, no previous study has evaluated the use of RADPAD in urologic procedures.

The goal of this study was to evaluate the efficacy of the RADPAD alone and in combination with conventional lead shielding during a simulated PCNL. We hypothesized that use of a lead-free radiation shielding pad could enhance radiation protection to anatomical locations on the surgeon that are not normally shielded.

Methods

Phantom and mannequin setup

To simulate a patient, a radiographical phantom, with a density similar to the human body, was placed in a prone position on the operating table to generate scatter radiation. A GE 9900 OEC C-arm (GE, Boston, MA) set to automatic exposure control (AEC), with approximate settings of 85 kVp and 1.10 mA, was used throughout the experiment and was positioned vertically with the X-ray source placed directly under the radiographical phantom, 15 cm below the operating table, and the image intensifier positioned directly above the phantom. A human-sized mannequin (167 cm tall) was positioned standing at the bedside simulating a surgeon performing PCNL (Fig. 1). The distance between the mannequin and X-ray source was kept constant at 50 cm. Scatter radiation was tested at seven different locations on the surgeon: the head (forehead between the eyebrows), the neck (positioned at the thyroid), the chest, the abdomen, the pelvis, the forearm, and the leg (Fig. 2). In addition, radiation was measured on the posterior aspect of the phantom to test radiation exposure to the patient.

FIG. 1.

Experimental setup. A PCNL was simulated, and radiation exposure was tested using combinations of LATS and RADPAD. (a) Mannequin without radiation shielding. (b) Mannequin with LATS and RADPAD. LATS = lead apron and thyroid shield; PCNL = percutaneous nephrolithotomy.

FIG. 2.

Sites measured for radiation exposure. (a) head, (b) thyroid, (c) chest, (d) abdomen, (e) pelvis, (f) forearm, and (g) leg.

Two different protection strategies were studied: (1) a 0.35 mm equivalent lead thickness conventional apron and thyroid shield on the surgeon (LATS) and (2) a triple thickness RADPAD drape measuring 87.5 × 30.5 cm placed directly over the surgical drape on the side of the phantom and outside of the direct radiation beam. These two strategies were compared to no lead or RADPAD, which acted as the control.

Radiation was measured using an ED3 Extremity Dosimeter (Rotunda Scientific Technologies LLC, Mansfield, OH) that reports real-time equivalent dose in µSv. Radiation exposure was first measured on each site without any shielding to establish a baseline value and then using the different shields with various combinations, giving a total of four different protection combinations at each site. The dosimeter sensor was positioned at each site, and all shielding combinations were tested before the dosimeter was repositioned to the next subsequent location to avoid any variation in positioning during trials.

For each site-protection combination, five trials were performed. During each trial, the C-arm was operated with continuous fluoroscopy for 5 seconds using AEC mode, and the equivalent dose recorded by the dosimeter was noted.

Statistical analysis

All data were entered into MS Excel (Microsoft, Redmond, WA), and the mean radiation exposure and percentage reduction from baseline for each site using each of the different combinations were calculated. Statistical testing was performed using SPSS version 27 (IBM, Armonk, NY). The Kolmogorov–Smirnov test was performed and demonstrated that the data were not normally distributed. The Mann–Whitney U test was used to perform head-to-head comparisons to determine which combinations led to a statistically significant reduction in radiation exposure compared with the others, with p < 0.05 considered significant.

Results

All shielding compared with baseline

The use of LATS resulted in >95% reductions in radiation exposure to the shielded areas (neck, chest, abdomen, pelvis) compared with baseline levels. LATS did not decrease radiation dose to the head, forearms, or legs. The use of RADPAD alone reduced radiation exposure at all sites except the legs compared with baseline, providing the greatest reduction at the head (47.62% reduction). Among all combinations, LATS+RADPAD had the most substantial reduction in comparison with baseline. This combination had the greatest total reduction at the abdomen (99.11% reduction), pelvis (99.36% reduction), and forearm (86.14% reduction) (Table 1 and Fig. 3). No single shielding device provided significant reduction in radiation to the legs.

Table 1.

Mean Radiation Dose for Each Shielding Combination and Site

Site	Head	Neck	Chest	Abdomen	Pelvis	Forearm	Leg
Baseline	2.10 ± 0.14	1.62 ± 0.11	4.30 ± 0.14	6.76 ± 0.27	9.42 ± 0.22	4.04 ± 0.15	7.02 ± 0.38
LATS	2.18 ± 0.13	0.02 ± 0.045	0.06 ± 0.055	0.10 ± 0.00	0.16 ± 0.055	4.64 ± 0.15	7.54 ± 0.26
RADPAD	1.10 ± 0.12	0.88 ± 0.045	1.86 ± 0.18	1.44 ± 0.11	1.26 ± 0.11	0.64 ± 0.089	6.54 ± 0.23
LATS + RADPAD	1.32 ± 0.08	0.02 ± 0.045	0.06 ± 0.055	0.06 ± 0.055	0.06 ± 0.055	0.56 ± 0.055	6.64 ± 0.55
Comparisons (p-values)
Baseline vs LATS	0.329	0.006	0.007	0.005	0.008	0.008	0.073
Baseline vs RADPAD	0.008	0.006	0.008	0.009	0.009	0.0047	0.055
Baseline vs LATS + RADPAD	0.008	0.006	0.007	0.008	0.008	0.008	0.139
LATS vs RADPAD	0.008	0.005	0.008	0.009	0.008	0.007	0.055
LATS vs LATS + RADPAD	0.008	1.000	1.000	0.008	0.031	0.008	0.139

Bold values indicate significant difference.

LATS = lead apron and thyroid shield; LATS + RADPAD = lead apron and thyroid shield with RADPAD.

FIG. 3.

Radiation exposure (µSv) comparison between different shielding strategies and baseline by site: (a) head, (b) neck, (c) chest, (d) abdomen, (e) pelvis, (f) forearm, (g) leg. The y-axis represents radiation dose (µSv), and the x-axis represents each shielding strategy.

RADPAD and LATS

When comparing LATS to RADPAD, LATS demonstrated significantly greater radiation reduction in shielded areas, including the neck, chest, abdomen, and pelvis. RADPAD outperformed LATS in reducing radiation at the head (49.54% reduction) and forearm (86.21% reduction). Both RADPAD and LATS showed no significant difference in radiation reduction at the legs (Table 1 and Fig. 3).

Combination shielding and LATS

When comparing LATS alone to the combination of LATS and the RADPAD, LATS+RADPAD had a significantly greater reduction in radiation at the head (39.45% reduction), abdomen (40% reduction), and forearm (87.93% reduction). There was no significant difference at the neck, chest, pelvis, or legs (Table 1 and Fig. 3).

Discussion

Our study is the first to evaluate the combined efficacy of lead aprons and nonlead drapes in a simulated PCNL setting. Our study demonstrated that LATS alone reduces radiation exposure to shielded sites of the body by >95%. However, traditional LATS provides inadequate protection to the head, forearm, and legs. This deficiency is mitigated using a nonlead drape placed over the patient to shield the surgeon from scatter radiation. Our data showed that the RADPAD significantly reduced radiation to the head as much as 48% and forearm as much as 84%. When comparing the performance of each shielding device, LATS significantly outperformed RADPAD at the neck, chest, abdomen, and pelvis. LATS+RADPAD resulted in the greatest reduction in radiation, performing significantly better than LATS alone at the head, pelvis, and forearm. No single shielding device or combination led to a significant reduction in radiation exposure to the legs. Our findings on the RADPAD are consistent with prior clinical research which showed that the RADPAD reduced radiation dose to the hands and eyes during cardiac resynchronization implant procedures. Jones and colleagues demonstrated that using the RADPAD provided a 65% reduction in radiation to the surgeon’s hands and 40% reduction to the eyes.¹⁰ Similarly, Sharma and colleagues demonstrated a 39% radiation reduction at eye level and 54% radiation reduction at hand level.¹⁴

Beneficial uses of the RADPAD over traditional lead protection in fluoroscopic procedures include added protection to the head and forearm, lightweight design, and nontoxic composition. Traditionally, certain locations have been neglected in procedures involving fluoroscopy. This includes the head, forearms, and legs, as these remain uncovered when only wearing a lead apron with thyroid shield. Neglecting these areas may have serious consequences for the health of physicians. Studies have shown that circulating hematopoietic stem cells, circulating lymphocytes, and epithelial cells in these areas are susceptible to DNA damage when exposed to radiation.⁸ One study had shown that surgeons who use fluoroscopy have an elevated risk of developing left brain glial tumors.¹⁵ In addition, radiation has been shown to cause degradation of articular cartilage and may contribute to the development of arthritis in exposed joints.¹⁶ The addition of radiation protection drapes, such as the RADPAD, may minimize these risks, as our study has shown that it reduces radiation to both the head and forearm areas.

It is important to acknowledge the existing poor compliance with radiation shielding in current medical practice, where as few as 50% of surgeons wear thyroid shields and even fewer use lead eye protection.^17,18 Consistent with our findings, previous studies have also demonstrated that even with compliance to wearing a lead apron and thyroid shield, the protection is confined to the trunk.¹⁹ Consequently, this inadequacy leaves critical anatomical regions, such as the forearms and head of the surgeon, exposed to a potentially harmful amount of ionizing radiation. These findings underscore the multifaceted challenges that prevent the widespread adoption of comprehensive protective equipment in clinical settings. One prominent obstacle is the weight and discomfort associated with wearing protective gear leading to musculoskeletal strain. A study on interventional radiologists has shown that heavy lead aprons, combined with prolonged standing and awkward postures during procedures, contribute significantly to the prevalence of back and neck pain, with 60.7% of radiologists reporting symptoms that can limit their ability to work.²⁰ The RADPAD is a rectangular sterile shield that can be placed on top of conventional surgical drapes. This positioning provides additional radiation protection for the surgeon with no added weight burden or impact upon mobility for the surgeon.

Furthermore, it is vital to acknowledge the emerging concerns regarding health risks linked to the detectable presence of lead on the surfaces of many conventional lead shields.²¹ These health concerns are especially significant given the potential for lead exposure through skin contact or as lead particles become airborne in the clinical environment. The coverings of lead aprons can degrade, which increases the risk of lead exposure and thus increases the risk of cancer and lung disease.²² The RADPAD, on the other hand, is made from environmentally safe metals such as bismuth which is nontoxic to humans. These factors combined not only highlight the need for more effective and comfortable protective solutions but also underscore the importance of adopting lead-free alternatives like the RADPAD to enhance radiation safety in the health care setting.

Although the RADPAD was effective for shielding locations not normally protected by LATS, including the forearm and head, the RADPAD, similar to conventional LATS, did not provide significant protection to the legs. When operating the C-arm in the standard configuration with the source beneath the patient, the surgeon’s legs will receive the largest amount of scatter radiation. Because of the positioning of the RADPAD on the side of the patient, it primarily provided reduced scatter radiation to the head and forearm, but was not in the path of scatter radiation bouncing downward toward the surgeon’s legs. Subsequently, there was no reduction in dose to the surgeon’s legs provided by the RADPAD. Similarly, LATS does not fully cover the legs, leaving them inadequately protected. In a study conducted by Ramanan and colleagues, it was revealed that vascular surgeons are subjected to an average of 69 minutes of fluoroscopy time during an endovascular procedure, resulting in a median leg radiation dose of 54.2 µSv without leg protection and a radiation dose of 2.7 µSv with leg protection leading to a 95% reduction in scatter radiation.²³ Although the typical renal access during PCNL involves significantly less exposure, the cumulative impact of radiation remains a cause for concern, particularly when considering the frequent exposure experienced by urologists. Protecting surgeons’ legs from radiation exposure is of paramount importance, as the consequences of radiation exposure to the legs are alarming, as it has been linked to skin damage and malignancies.²⁴ Notably, this damage has been detected in the circulating lymphocytes of surgeons, a concerning finding that was notably absent when surgeons were equipped with lower leg shielding.²⁵ Given that neither the RADPAD nor LATS provide adequate leg protection, the use of lower leg shielding could be a potential solution to this issue.

Our study has inherent limitations. The mannequin used to represent the surgeon in our study does not perfectly mimic the actions and movements of an actual surgeon, as it was positioned at a fixed distance, thereby potentially affecting the real radiation levels to which a surgeon may be exposed. Similarly, the phantom does not completely replicate the density of all types of patients encountered during PCNL. In addition, our study’s scenario of 5 seconds of fixed fluoroscopy differs from live PCNL procedures, which often involve fluoroscopy durations ranging from several seconds to minutes. Despite these constraints, the reductions in scatter radiation exposure seen in our study provide compelling evidence supporting the adoption of lead-free shields in addition to a lead apron with a thyroid shield. To corroborate these findings, future studies in actual urologic procedures are warranted.

Conclusion

The LATS alone reduced radiation to >95% at shielded sites, but provided no protection to the head, leg, and forearm. The RADPAD alone was not sufficient to replace lead as it provided less protection for vital organs than the LATS. However, additional use of RADPAD resulted in a 48% and 84% reduction to the head and forearm, respectively. This indicates that although lead-free radiation drapes such as the RADPAD are not yet ready to replace traditional LATS, they enhance radiation protection to the head and arms without adding weight or discomfort to the surgeon.

Authors’ Contributions

J.-L.Q.: Conceptualization (lead), data curation (lead), formal analysis (supporting), investigation (lead), methodology (equal), resources (equal), supervision (supporting), validation (supporting), visualization (lead), writing—original draft (lead), and writing—review and editing (lead). K.H.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (supporting), resources (equal), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). A.F.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (equal), resources (equal), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). D.J.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (supporting), resources (supporting), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). R.C.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (supporting), resources (supporting), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). U.L.K.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (supporting), resources (supporting), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). G.S.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (supporting), resources (supporting), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). D. Daniel B.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (supporting), resources (supporting), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). A.S.A.: Conceptualization (supporting), data curation (supporting), formal analysis (lead), investigation (supporting), methodology (supporting), resources (supporting), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). A.A.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (supporting), resources (supporting), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). Z.O.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (supporting), resources (equal), supervision (supporting), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting). D. Duane B.: Conceptualization (supporting), data curation (supporting), formal analysis (supporting), investigation (supporting), methodology (supporting), resources (equal), supervision (lead), validation (supporting), visualization (supporting), writing—original draft (supporting), and writing—review and editing (supporting).

Footnotes

Author Disclosure Statement

The authors have no conflicts of interest to disclose.

Funding Information

This research received no external funding.

Abbreviation Used

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