Percutaneous vertebroplasty: Assessment of radiation dose to the operator and patient using two different injection systems

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1 Percutaneous vertebroplasty: Assessment of radiation dose to the operator and patient using two different injection systems Poster No.: C-1930 Congress: ECR 2010 Type: Scientific Exhibit Topic: Interventional Radiology - Non-Vascular Authors: G. Tsoumakidou, S. Loos, L. Mertz, X. Buy, T. Moser, A. Gangi; Strasbourg/FR Keywords: Vertebroplasty, Radiation Exposure, Injector systems Keywords: Interventional non-vascular, Percutaneous DOI: /ecr2010/C-1930 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. Page 1 of 33

2 Purpose Percutaneous Interventional Radiology procedures have shown continual and substantial improvements over the last two decades (owing to the rapid improvement of imaging technology and increased popularity: due to the reduced hospitalization cost and low risk that they enable). Percutaneous vertebroplasty is a therapeutic, image-guided procedure used, mainly, for consolidation and pain management in cases of recent compression fractures and osteolytic metastases. However, this procedure could implement high radiation doses, both to patients and personnel. The purpose of our study was to assess radiation dose delivered to the operator and the patient and the comfort of injection of cement for the operator during vertebroplasty. Two different injection systems were used and compared in terms of: radiation dose, comfort, and safety of injection. Page 2 of 33

3 Fig.: Interventional Radiology Theatre used for vertebroplasty and other non-vascular procedures (Flat Panel XperCT, Philips). References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Page 3 of 33

4 Images for this section: Fig. 0: Interventional Radiology Theatre used for vertebroplasty and other non-vascular procedures (Flat Panel XperCT, Philips). Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 4 of 33

5 Methods and Materials Institutional Review Board approval was obtained for this study and informed written consent was obtained from all patients enrolled. Percutaneous vertebroplasty was performed in 30 patients (73 levels), with osteoporotic fractures (52 levels) and osteolytic metastases (21 levels), by three experienced interventional radiologists. The number of fractured vertebral bodies treated varied from one to five. In 3 patients we performed vertebroplasty in 5 vertebras in the same session. Patients were radomly divided in two groups, for two different cement injection systems. For group I a screw-injector system (Cemento Gun, Optimed, Ettligen, Germany) was used, and for group II, a luer lock syringe (Medallion Luer-lock syringe, Merit Medical, Utah, USA). Fig.: Dedicated screw-syringe for cement injection used in group I (Cemento Gun, Optimed, Ettligen, Germany). It includes a 10 ml syringe (reservoir) loaded on the device, a screw system for advancing the syringe plunger and a connector tube to maximize distance between operator and radiation field. If a leak is detected, the injection can be stopped immediately and the pressure relieved by reversing the screw. References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Page 5 of 33

6 Fig.: Luer-lock syringe (loaded on the vertebroplasty needle) used for manual cement injection in group II (Medallion Luer-Lock syringe, Merit Medical, Utah, USA). References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Data was prospectively collected. Patient's size (height) and weight was not different between the groups. The etiology of the fracture (osteoporotic or osteolytic), the vertebral levels, and the fractured segment were similar between both groups. Dosimetry A radiophysicist assisted the team for each single procedure for the positioning of the Thermoluminescent Dosimeter (TLD). TLD tablets were used to measure radiation dose to the right and the left hand of the operator. A TLD badge was placed under the lead apron of the radiologist to measure radiation dose to the thorax (left side). Radiation delivered to the patient was obtained from the fluoroscopy machine, during injection time and per vertebroplasty level. All TLDs were placed only during cement injection time, and were changed after each level of vertebroplasty for multi-level vertebroplasties. Page 6 of 33

7 Vertebroplasty Technique The technique of vertebroplasty was similar in both groups and only for the cement injection, a different system, chosen by randomisation was used (either a dedicated cement injector system or a luer-lock syringe). The procedure was performed under Fluoroscopic guidance. A unilateral approach was performed in all cases. The transpedicular and the intercosto-pedicicular approach was used for the lumbar and thoracic level, respectively. Fig.: Intercosto-vertebral unilateral approach used for all thoracic level vertebroplasties. The tube is rotated 35# from the patient's sagittal plane to obtain an oblique view, so that the head of the rib and the pedicle are viewed end-on and appear as rings. The needle is advanced through the costovertebral joint. Once the the posterior wall level is crossed the needle is advanced using the lateral projection till the tip reaches the anterior third of the vertebral body close to the anterior margin. References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Page 7 of 33

8 Fig.: Unipedicular unilateral approach used for all lumbar vertebroplasties. The stay in the ring technique was used to advance the beveled needle through the pedicle to the vertebral body. Once the the posterior wall level was crossed the needle was advanced using the lateral projection till the tip reaches the anterior third of the vertebral body close to the anterior margin. References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR A 10-G beveled needle was advanced under combined AP and lateral view till the margin of the anterior and middle third of the vertebral body was reached. The needle should lie in the midline on AP view. All cement injections were performed using a strict lateral fluoroscopic projection with the tube placed on the opposite side of the operator. In 16 patients, group I (37 levels) cement injection was performed using a dedicated screw-injector system. Page 8 of 33

9 Fig.: Cement injection using the dedicated screw-syringe in group I. The connector tube adds distance from the X-Ray tube. References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR In 14 patients, group II (36 levels) a luer-lock syringe was used for cement injection. Cement injection was done during its pasty phase and was stopped whenever epidural or paravertebral opacification was observed or when the cement reached the dorsal quarter of the vertebral body. Page 9 of 33

10 Careful monitoring of the cement volume and the possible cement leaks per level of vertebroplasty was performed. All operators at the end of each vertebroplasty characterized the easiness and comfort of the cement injection using a one to three scale, with one and three being the least and most comfortable injection, respectively. Fig.: Table 1.Data was prospectively collected. (Type of fracture: I=superior endplate, II=inferior endplate, III=anterolateral, IV=posterior wall). References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Statistical Analysis Statistical analysis was performed using the SPSS 16.0 software for Macintosh. Statistical significance was determined at a probability level (p) less than The results are expressed as mean±sd. Comparison among groups was performed using the Pearson's Chi-square test. Page 10 of 33

11 Images for this section: Fig. 0: Dedicated screw-syringe for cement injection used in group I (Cemento Gun, Optimed, Ettligen, Germany). It includes a 10 ml syringe (reservoir) loaded on the device, a screw system for advancing the syringe plunger and a connector tube to maximize distance between operator and radiation field. If a leak is detected, the injection can be stopped immediately and the pressure relieved by reversing the screw. Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 11 of 33

12 Fig. 0: Cement injection using the dedicated screw-syringe in group I. The connector tube adds distance from the X-Ray tube. Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 12 of 33

13 Fig. 0: Luer-lock syringe (loaded on the vertebroplasty needle) used for manual cement injection in group II (Medallion Luer-Lock syringe, Merit Medical, Utah, USA). Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Fig. 0: Table 1.Data was prospectively collected. (Type of fracture: I=superior endplate, II=inferior endplate, III=anterolateral, IV=posterior wall). Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 13 of 33

14 Results Percutaneous vertebroplasty was performed in 30 patients (73 levels). No major complication was noted. Mean radiation dose on the right hand was 48.22± µgy with the screw injector system and ± µgy with the Luer Lock syringes. Mean radiation dose on the left hand was 27.03± µgy with the screw injector system and 78.67± µgy with the Luer Lock syringes. Radiation dose was found to be significantly lower on both hands of the radiologist using the screw-injector system than the luer-lock syringe. Right hand: mean dose 48.22± and ± µgy for group I and II respectively, p< Left hand: mean dose 27.03± and 78.67± µgy for group I and II respectively, p= Page 14 of 33

15 Fig.: The dose to right and left hand of the radiologist was significantly higher when the injection was done using a luer-lock syringe, in comparison to the dedicated screwinjector system. References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR A non-significant difference was found for the doses calculated under the radiologist's apron (1.05±1.153 µgy and 1.33±1.549 µgy for Group I and II, respectively, p=0.387) 2 2 and for the patient (913.11± cgy.cm and ± cgy. cm for group I and II, respectively, p=0.48). Page 15 of 33

16 Fig.: There was no statistical significant difference between the two groups for the radiation dose delivered to the radiologist under the apron (left side of the thorax). References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Page 16 of 33

17 Fig.: No statistical significant difference was found between the two groups for the radiation dose delivered to the patient (as measured by the fluoroscopy machine during the cement injection time). References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR The duration of the injection, volume of cement injected and number of leaks were not different between the groups. Cement injection was considered more convenient by all operators using the screwinjector system. In group I and for 36 (out of 37) vertebral levels (97%) the comfort of cement injection was level III (very comfortable injection), where as for group II, level of comfort III was found only for 8 (out of 36) vertebral levels (22%), (p<0.001). Page 17 of 33

18 Using the screw-injector system there was no need for multiple syringes (larger amount of cement loaded on the injector set), where as there was better control of the speed of the injection, and the ability to inject viscous cement without using force. Fig.: Group I: Degree of comfort during injection, as assessed by the radiologist (degree 3=very comfortable, 2=less comfortable, 1=difficult injection). Cement injection was considered comfortable (degree of comfort 3=97%) using the dedicated injectionsystem. References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Page 18 of 33

19 Fig.: Group II: Degree of comfort during injection, as assessed by the radiologist (degree 3=very comfortable, 2=less comfortable, 1=difficult injection). Cement injection was considered less comfortable (degree of comfort 2=75%), when the luer-lock syringe was used. References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Page 19 of 33

20 Fig.: Table 2. Results of our data collected. Radiation dose to the right and left hand of the operator was significantly higher when cement injection was done using the luer-lock syringe. There was no difference for the radiation dose measured under the radiologist's apron and the radiation dose delivered to the patient. The total volume of cement injected, the duration of the injection and number of leaks were similar between the groups. Cement injection was more comfortable using the dedicated screw-injectore system. (Degree of comfort of the radiologist in a I to III scale. I is the least and III the most comfortable injection). References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Page 20 of 33

21 Images for this section: Fig. 0: Table 2. Results of our data collected. Radiation dose to the right and left hand of the operator was significantly higher when cement injection was done using the luer-lock syringe. There was no difference for the radiation dose measured under the radiologist's apron and the radiation dose delivered to the patient. The total volume of cement injected, the duration of the injection and number of leaks were similar between the groups. Cement injection was more comfortable using the dedicated screw-injectore system. (Degree of comfort of the radiologist in a I to III scale. I is the least and III the most comfortable injection). Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 21 of 33

22 Fig. 0: The dose to right and left hand of the radiologist was significantly higher when the injection was done using a luer-lock syringe, in comparison to the dedicated screwinjector system. Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 22 of 33

23 Fig. 0: There was no statistical significant difference between the two groups for the radiation dose delivered to the radiologist under the apron (left side of the thorax). Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 23 of 33

24 Fig. 0: No statistical significant difference was found between the two groups for the radiation dose delivered to the patient (as measured by the fluoroscopy machine during the cement injection time). Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 24 of 33

25 Fig. 0: Group I: Degree of comfort during injection, as assessed by the radiologist (degree 3=very comfortable, 2=less comfortable, 1=difficult injection). Cement injection was considered comfortable (degree of comfort 3=97%) using the dedicated injectionsystem. Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 25 of 33

26 Fig. 0: Group II: Degree of comfort during injection, as assessed by the radiologist (degree 3=very comfortable, 2=less comfortable, 1=difficult injection). Cement injection was considered less comfortable (degree of comfort 2=75%), when the luer-lock syringe was used. Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 26 of 33

27 Conclusion Vertebroplasty is used to treat osteoporotic and osteolytic vertebral fractures with excellent and rapid results on pain control. It has been shown that radiologists who perform vertebroplasty may potentially receive high radiation doses. Using a dedicated screw-injector system for cement injection, reduces radiation dose delivered to the radiologist during vertebroplasty and adds convenience to the procedure. The injector sets allow to inject the cement with more distance and are much more convenient for the operator. The mean radiation dose is near four times more on the hand closer to the beam using the luer-lock syringe than with an injector set. The cost of the injector systems is higher than the luer-lock syringes. Nevertheless, the safety (less radiation to the radiologist) and the comfort that they offer makes their use legitimate. Maintaining operator exposure at a level that is as low as reasonably achievable (ALARA principle) requires that consideration be given to the equipment, training of the personnel and need for constant awareness. Page 27 of 33

28 Fig. References: Interventional Radiology, University Hospital of Strasbourg - Strasbourg/ FR Page 28 of 33

29 Images for this section: Fig. 0 Interventional Radiology, University Hospital of Strasbourg - Strasbourg/FR Page 29 of 33

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33 Personal Information Georgia Tsoumakidou Non-Vascular Interventional Radiology Department, University Hospital, Strasbourg, France Page 33 of 33