European Heart Journal Advance Access originally published online on December 15, 2006
European Heart Journal 2007 28(2):183-189; doi:10.1093/eurheartj/ehl420
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Evaluation of a radiation protection cabin for invasive electrophysiological procedures
1 Cardiology–Electrophysiology, University Hospital Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium
2 Hôpital Cardiologique du Haut-Lévêque, University of Bordeaux-Pessac, France
Received 3 July 2006; revised 8 October 2006; accepted 16 November 2006; online publish-ahead-of-print 15 December 2006.
* Corresponding author. Tel: +32 16 34 42 48; fax: +32 16 34 42 40. E-mail address: hein.heidbuchel{at}uz.kuleuven.ac.be
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Abstract |
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Aims Complex invasive electrophysiological procedures may result in high cumulative operator radiation exposure. Classical protection with lead aprons results in discomfort while radioprotection is still incomplete. This study evaluated the usefulness of a radiation protection cabin (RPC) that completely surrounds the operator.
Methods and results The evaluation was performed independently in two electrophysiology laboratories (E1—Leuven, Belgium; E2—Bordeaux, France), comparing operator radiation exposure using the RPC vs. a 0.5 mm lead-equivalent apron (total of 135 procedures). E1 used thermoluminiscent dosimeters (TLDs) placed at 16 positions in and out of the RPC and nine positions in and out of the apron. E2 used more sensitive electronic personal dosimeters (EPD), placed at waist and neck. The sensitivity thresholds of the TLDs and EPDs were 10–20 µSv and 1–1.5 µSv, respectively. All procedures could be performed unimpeded with the RPC. Median TLD dose values outside protected areas were in the range of 57–452 µSv, whereas doses under the apron or inside the RPC were all at the background radiation level, irrespective of procedure and fluoroscopy duration and of radiation energy delivered. In addition, the RPC was protecting the entire body (except the hands), whereas lead apron protection is incomplete. Also with the more sensitive EPDs, the radiation dose within the RPC was at the sensitivity threshold/background level (1.3 ± 0.6 µSv). Again, radiation to the head was significantly lower within the RPC (1.9 ± 1.2 µSv) than with the apron (102 ± 23 µSv, P < 0.001).
Conclusion The use of the RPC allows performing catheter ablation procedures without compromising catheter manipulation, and with negligible radiation exposure for the operator.
Key Words: Radiofrequency catheter ablation • Radioprotection • Interventional cardiology
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Introduction |
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Over the last decades, the number and complexity of invasive electrophysiological procedures have dramatically increased. This may result in high cumulative operator radiation exposure that could lead to stochastic (mutations and carcinogenesis) and deterministic effects.1–7 Despite newer mapping and ablation technology, fluoroscopy will remain the main visualization technique for intracardiac catheter positioning. To limit occupational doses (usually required to be
20–50 mSv per year for whole body radiation), leaded radiation protection of operators is mandatory during these procedures. Traditional radiation protection generally includes a lead apron, goggles, and a thyroid shield. Lead aprons however are heavy, and result in operator discomfort and fatigue during prolonged procedures. Long-term orthopaedic problems are a wellknown complication in these operators.8,9 Moreover, some body parts remain unprotected. A radiation protection cabin (RPC) (Cathpax®, Lemer Pax, Carquefou, France) was developed as an alternative protection apparel. It uses 2 mm lead-equivalent walls, including transparent leaded plastic in its upper parts, to surround the operator on two sides and from above (Figure 1A). The RPC is mobile, adjustable in height, and is prepared with specifically designed drapes to provide sterile patient access (Figure 1B). Lead-reinforced anterior arm-holes allow catheter manipulation and are designed to further reduce forearm and whole body radiation exposure. Since the arm-holes are also covered with sterile drapes, the operators can easily turn towards the sterile table, as during regular procedures.
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Two electrophysiology centres (University of Leuven, E1, and University of Bordeaux, E2) performed independent but complementary studies to evaluate the efficiency of this new RPC in comparison with classical operator protection by a conventional apron, goggles, and thyroid shield. The primary objective of our trial was to prove that the RPC provides full radioprotection, so that working without conventional protection apparel is safe. The secondary objective of our study was to show that working with the RPC does not negatively impact procedure outcome.
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Methods |
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X-ray equipment
The X-ray system used in centre E1 was a Siemens Bicor Top biplane system with image intensifier. The image intensifier field size was 23 cm. The settings used in clinical practice during ablation procedures were: pulsed fluoroscopy at 3.125 frames/s and pulsed acquisition (cine) mode at 12.5 frames/s. The system has automatic brightness control on each tube to generate an optimal x-ray beam. The image intensifier was positioned as closely as possible to the chest with a source-to-image distance of about 100 cm. Both tubes have dose–area product (DAP) meters indicating the summed cumulative DAP in cGy.cm2. Total fluoroscopy time (in minutes) is also shown. Cumulative DAP is a surrogate measurement for the total amount of radiation energy delivered to the patient, hence serving as a relative indication of the scatter-dose to the operator.
Centre E2 used a monoplane non-pulsed Digitron Siemens imaging system. The frame rate in acquisition mode was 12.5 frames/s and the field size was 27 cm. Image intensifier was positioned similarly. The system has automatic brightness control and a fluoroscopy time meter but no incorporated DAP meter.
Both centres routinely used optimal collimation to minimize patient and operator exposure.
Ablation procedure
Both centres compared electrophysiological procedures with protection provided by classical means ‘APRON’ (lead apron, thyroid collar, and goggles) or by the RPC. Measurements were performed in 35 procedures in centre E1 (25 RPC and 10 APRON) and in 80 procedures in centre E2 (40 RPC and 40 APRON). Patients were prospectively randomized in E2.
The procedures in centre E1 comprised different types. There was no prospective randomization since the main objective was to compare radiation doses in protected areas (RPC or APRON) vs. unprotected areas so that every patient served as its own control. Studies were chosen so that a clinically relevant wide spectrum of fluoroscopy duration and radiation doses could be evaluated [nine diagnostic procedures; 15 paroxysmal supraventricular tachycardia—AV nodal reentrant tachycardia or accessory pathway, seven right atrial flutter, and four atrial fibrillation (AF)]. Inclusion into the study and allocation to RPC or APRON groups depended on the availability of TLDs. The study population consisted of one-third of the procedures performed during the 3 month time period of the study. All procedures were performed by the same operator.
In contrast, all procedures in centre E2 uniformly consisted of ablation for AF that are known to be relatively complex, prolonged, and associated with larger radiation doses.10 A total of 80 consecutive patients were included (52 ± 9 years; 77% male), and randomized to RPC or APRON after inclusion (simply by tossing a coin). There were no drop-outs after inclusion. Three operators performed the procedures.
The AF ablation strategy for AF in both centres consisted of the electrical isolation of pulmonary veins, verified by mapping with a circumferential catheter and routine cavotricuspid isthmus ablation.11 Additional linear lesions were applied if arrhythmia persisted after isolation of pulmonary veins.
Evaluation of RPC use
The RPC was positioned as soon as fluoroscopy was needed during the procedures, i.e. after initial punctures of veins and/or arteries. Lead protection flaps above and under the table were routinely used in E1 (Figure 1), and a lead glass screen above the table in E2, irrespective of the use of the RPC or lead apron during the procedures. All procedures used a fully femoral access, which is the standard approach for all ablations in our centres. The procedure and fluoroscopy duration were compared between RPC and APRON groups to evaluate if the RPC was affecting catheter manipulation. Any need to remove the RPC during procedures was prospectively evaluated.
Measurement of radiation exposure to the operator
Measurement methods to assess the scattered radiation to the operator were as follows. Centre E1 used thermoluminiscent dosimeters (TLDs) with two elements per card (Harshaw TLD 100, Thermo Electron Corporation, Waltham, MA, USA). All TLDs were calibrated with X-ray beams identical to those used in clinical practice. The sensitivity threshold for the TLDs is around 10–20 µSv.12 In the RPC group, radiation was measured at 16 points on the cabin's walls, eight inside and eight outside (Figure 2, left pane, P1–P8). Positions P1–P3 were located on the left side lateral wall of the cabin, i.e. at the side of the radioscopy equipment (at 170, 100, and 20 cm height from the floor, respectively). Positions P4–P7 were situated on the frontal wall (at a height of 195, 2 x 125, and 70 cm from the floor, respectively). P8 was located centrally at the top wall (above the operator's head). Hence, for each ablation procedure, data from 16 TLD cards (eight outside and eight inside) were available. In the APRON group, exposure to the operator was measured with the same type of TLDs, of which nine were now attached to the chest (under and above the lead apron), left hand, right hand, axilla, thyroid (outside the collar), forehead, left leg, and waist (outside lead apron) (Figure 2, right panel).
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Centre E2 used more sensitive electronic personal dosimeters (EPDs; Mk2, Siemens AG, Munich, Germany). The EPDs were placed at the anterior waist (under the apron) and neck level (outside the thyroid collar). The waist dosimeter recording was termed ‘body radiation’ dose, whereas the neck dosimeter recording was termed ‘head radiation’ dose. The sensitivity threshold for the EPD was lower than for the TLD, being around 1–1.5 µSv.12,13
Background dose measurements in both catheter labs (in the absence of radioscopy) showed values at the sensitivity threshold of the dosimeters (i.e. ± 10 and ± 1.5 µSv for TLDs and EPDs, respectively).
Statistical analysis
Summary values are given as mean ± SD or median ± IQR (interquartile range) and data were compared using a two-sided Student's t-test or non-parametric Mann–Whitney test for normally and not-normally distributed values, respectively. A P-value < 0.05 was considered significant.
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Results |
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RPC use
Only the initial punctures and introduction of sheaths were performed before placement of the RPC. Draping the RPC required an average of 4 min work of the nurse. All ablation procedures could be fully completed with the RPC, including all catheter introduction, positioning and manipulation, all transseptal punctures, and exchange of long guiding sheaths. There was no need to remove the RPC during any procedure. During four procedures, left femoral arterial sheaths were placed via the RPC. No emergency occurred.
In centre E2, which randomized 80 procedures prospectively between RPC and APRON, the mean procedure duration and fluoroscopy times tended to be shorter in the RPC group (RPC vs. APRON: 162 ± 38 vs. 181 ± 77 min, P = 0.07; 43.8 ± 17 vs. 57.5 ± 30 min, P = 0.08), indicating that the RPC did not negatively affect catheter manipulation. In centre E1, procedure duration and fluoroscopy time were higher in some RPC procedures due to the selection of more complex procedures (Table 1). They were similar however when the four AF procedures, two PSVT procedures targeting two arrhythmias (case 21 and 22), and a complex redo flutter ablation (case 20) were excluded from the RPC group (n = 18 vs. 10; procedure time: 107 ± 31 min RPC vs. 105 ± 22 min APRON, P = 0.87; fluoroscopy duration: 25.1 ± 11.1 min vs. 21.7 ± 5 min, P = 0.27).
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Operator radiation protection
Tables 1 and 2 present the results of the radiation measurements for each case in the RPC and APRON groups in centre E1. Clinical characteristics [age, sex, height, weight, body mass index (BMI)] were similar between both groups. Also the externally applied radiation energy per minute fluoroscopy, as measured by the DAP per minute, was identical in both groups (122.2 ± 64.2 vs. 117.3 ± 74.9 cGy.cm2/min, P = 0.86). The doses outside the RPC or apron (white columns in Table 1 and 2) showed very similar values for unprotected areas, with medians ranging from 57 to 452 µSv and from 45 to 335 µSv, respectively. In six of the 25 procedures, doses outside the cabin at P2 were even > 1000 µSv. High doses were measured at the left hand and at the inferior and left side of the operator. Also exposure to the head was substantial (85 µSv). In analogy, there were highly concordant low dose values under the apron and at all sites within the RPC. These doses were at the sensitivity threshold of the TLDs (10–20 µSv) but covered nearly the entire body of the operator within the RPC, in contrast to limited surface under the lead apron.
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Similar findings were recorded in centre E2, using more sensitive EPDs. Table 3 presents the results for each of the 80 procedures. Clinical characteristics were not different in both groups. The radiation dose in protected areas (i.e. at waist level, ‘body radiation’) was at the sensitivity threshold of the dosimeters, i.e. at background values (1.3 ± 0.6 µSv for RPC and 3.0 ± 2.2 µSv for APRON). When the radiation dose was normalized for fluoroscopy time, there was no statistical difference between RPC and lead aprons, as expected (0.029 ± 0.006 µSv/min for RPC and 0.052 ± 0.015 µSv/min for APRON; P = 0.12) However, radiation to the head was significantly lower within the RPC (1.9 ± 1.2 vs. 102 ± 23 µSv for the APRON group, P < 0.001).
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Discussion |
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Main findings
The present study demonstrates that the RPC allows unimpeded performance of complex electrophysiological procedures. It provides at least the same level of radiation protection as a lead apron, but covering nearly the entire body of the operator. This observation was reproducible in two centres using different methods, evaluating complementary aspects of radiation protection. In both centres, the radiation doses measured within the RPC are at background levels, irrespective of procedure and fluoroscopy duration and of externally applied radiation energy.
The doses measured in the APRON groups and outside the RPC confirm that electrophysiology operators are exposed to relatively high dose levels, corresponding to those reported in the literature.2–7 Scattered radiation poses a risk for stochastic effects to the operator.4,5 Annual exposure to the cardiologist's head has been reported to be in the range of 20–30 mSv per year.6 Apart from theoretical considerations, there are indications of increased risk of brain tumours in medical radiation workers because of absence of head protection,4 although discussion remains on the probability and size of the excess risk in interventional cardiologists.14 We observed that at all sites within the RPC, doses were universally very low. Since dose values measured inside the RPC did not exceed the dosimeter's sensitivity threshold in either centre, our data do not allow to precisely calculate effective operator doses and corresponding carcinogenic risks or risk reduction. However, the remaining stochastic risk of cancer and genetic effects for the operator is likely to be negligible. Therefore, the dose reduction with the RPC certainly represents benefit over the use of a lead apron and contributes like other measures to a dose reduction to ‘as low as reasonably achievable’ (ALARA principle).7,15,16 The assurance about background-level doses and the guaranteed safety of a fully protected cranium are an imporant psychological factor for the motivation of interventional cardiologists and may be important from a medico-legal viewpoint.
Recent technological advances such as non-fluoroscopic mapping and even remote catheter steering have reduced our reliance on fluoroscopy.17,18 However, although less fluoroscopy is required using these systems, protection will remain mandatory. Because the RPC is designed to shield only the operator, other staff in the catheterization lab (fellows, technicians, anesthesiologists) have to wear lead aprons. Moreover, the RPC should not preclude use of classical lead protection flaps above and below the table at the level of the patient's waist (like in Figure 1) to optimize ALARA personnel exposure during procedures with femoral access. Personal dosimeter for all staff will remain a legal obligation. RPC are also used to protect maintenance personnel in the nuclear industry. In fact, the RPC evaluated here was derived from the practice in nuclear industry where similar systems are used routinely to protect the staff.
All the procedures in this study could completely be carried out using the RPC without compromising catheter manoeuvrability, as indicated by similar procedure durations. The RPC allowed normal positioning of the RAO and LAO tubes in centre E1, and free movement of the monoplane system in centre E2; also cranial or caudal tilts are possible with the RPC. Transseptal or left femoral punctures and exchange of long guiding sheaths do not pose problems. The arm-holes of the RPC are steriley draped, so that the operator can move his hands with ease towards the patient or take them out and turn towards the sterile table to pick up objects. Therefore, the RPC does not require an extra nurse and allows full normal movement of the operator. Its sterile draping only needs a few minutes. No emergency occurred, but removing the RPC requires 30 sec. This would not pose problems if needed for resuscitation or other manoeuvres. Pericardial puncture seems feasible through the RPC since the table can be moved freely, creating unobstructed access to the epigastric region.
Moreover, other subjective advantages of the RPC were not measured in this study but warrant mentioning: the use of the RPC considerably decreased fatigue and sweating during these procedures and it did not compromise communication between the operator and staff or patient. Orthopaedic problems are increasingly reported in interventional cardiologists, largely due to the strain of wearing lead aprons while bending over the patient during long, complex procedures.8,9 In the present study, operators reported no back discomfort when using the RPC and we expect that the use of the RPC would reduce long-term orthopaedic problems while enabling those with early orthopaedic problems to continue working without the risk of further physical deterioration.
Limitations
The use of other access routes (e.g. subclavian or jugular) has not been evaluated in our study since all procedures in our centres are routinely performed via a femoral approach. Although moving the cabin is easy (wheels), hindrance by parts of the RX equipment prevents easy exchange from femoral to other access points. Implementation of the RPC for routine use requires a change to femoral-only access. The same holds true for pacemaker or ICD implantation, although RPC modifications are being developed to allow these approaches. We did not formally test the cabin for coronary angiography or PTCA but we experienced no problems when using the RPC for arterial punctures, transseptal punctures, or exchange of long sheaths over guide wires. Given this experience, the RPC even seems feasible for performing coronary angiography and revascularization procedures. It has not been formally tested for this purpose yet. The height of the arm-holes of the cabin can be adjusted to operator size, creating no additional difficulty during catheterizations by tall or short operators. Very tall operators (>2.05 m) may not fit under the roof of the cabin (although the wheels could be raised) and a step-up platform for very small operators can be combined with the RPC. Really obese operators could experience more steric hindrance with the cabin than without.
No formal evaluation of operator comfort was carried out in this study. This would require a prospective design as endpoint and have to rely on objective measures of sweating (e.g. weight loss) and questionnaires about orthopaedic effects. Especially, evaluation of the the long-term impact of working with the RPC would require much longer follow-up.
We did not observe a straight correlation between total DAP per procedure and the actual radiation doses measured with TLDs. This may be due to other variables like different angles of the radioscopy tubes between patients and different proportions of LAO and RAO use. These factors were not evaluated in this study.
The different radioscopy systems, types of ablation, and measurement techniques in both centres preclude a direct comparison of doses and dose-reduction. The use of continuous fluoroscopy in centre E2 may have contributed to the apparently higher protection. Also different sensitivity thresholds of the dosimeters preclude such comparison. Each dosimeter has its own unique advantages and disadvantages. The electronic dosimeter measures exposure in real-time through interaction of the radiation with electrically powered detector(s). It is generally calibrated to high-energy photons and can significantly over- or under-respond to photon energies that are not near the calibration energy.19 TLDs are relatively small devices that rely on the response of radiation-sensitive crystals to quantify radiation exposure. TLD dose results are better calibrated and are commonly accepted for radiation dose measurements.20 The disadvantage of a TLD is that it is not a real-time device that the user can read directly.
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Conclusion |
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We conclude that the use of the RPC allows to perform catheter ablation procedures without hindrance and with negligible radiation exposure for the operator.
Conflict of interest: none declared.
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Footnotes |
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This paper was guest edited by Prof. Fred Wittkampf, Heart Lung Center, Utrecht, The Netherlands
The first two authors have contributed equally to this manuscript. 
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References |
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