Computed Tomography-guided Vertebroplasty for Pain Management ...

Original Article

Computed Tomography-guided Vertebroplasty for Pain Management in Patients with Vertebral Body Fractures ShigeruKozima1,2 Alejandra de Salazar1 German Espil2 Celina Siffredi2 Luciana Ferrari1 Carolina Mora1 Juan Garralda2 Jairo Hernández Pinzón1 Ricardo Cobeñas1 Martin Aguilar1 Nebil Larrañaga2 Alejandra Salamida1 1 2

ImagingDepartment, Centro de Educación Médica eInvestigaciones Clínicas (CEMIC), Ciudad Autónoma de Buenos Aires, Argentina ImagingDepartment, Hospital General de Agudos Dr. Cosme Argerich, Ciudad Autónoma de Buenos Aires, Argentina

Abstract. Objetive: Describe the technique and results in terms of pain improvement and complicationswhenperforming this procedure under computed tomography (CT) guidance. Materials and Methods A descriptive observational study of a 108-case series ofpercutaneous vertebroplasty guided by computed tomography performed in twouniversity hospitals between May 2007 and May 2017. All procedures were performedwith local anesthesia on an outpatient basis, pain was assessed by means of the Visual Analogue Scale (VAS). Results A total of 125vertebroplasties were performed. In 87.9% (n = 95) of thepatients, the procedure was performed in one vertebral body in 8.3% (n = 9) and 3.7%(n = 4) of the patientshad two or three vertebrae cemented, respectively. The range ofpain according to VAS prior to treatment varied between 5 and 10, where 94%(n = 102) of the patients manifested a 10/10 intensity; after treatment, the rangeof pain varied between 0 and 7 where 98% of the population reported a value less than orequal to 3. Three complications were reported, each in three different patients: one pulmonary thromboembolismdueto methylmethacrylate, one extravasation in to the Batson plexus and oneextravasation of cement to the interdiscal space. Conclusion CT-guided percutaneous vertebroplasty offers an undeniable immediateimprovement of pain in patients with fracture of one or more vertebral bodies, with alow rate of complications.

Introduction

Materials and Methods

Percutaneous vertebroplasty (PV) consists in the percutaneous injection of bone cement (usually methylmethacrylate). This technique started to be used in the mid-1980s, being initially described in the treatment of symptomatic vertebral hemangioma.1,2 Since then, the indication for this method has extended to the treatment of vertebral body compression fractures related to trauma, osteoporosis, metastases and multiple myeloma.3-6 PV is considered to relieve pain associated with compression fractures by rupture of pain receptors and to reduce dynamic compressive forces to damaged vertebra by intrabone injection of methylmethacrylate7, in the absence of direct symptoms of compression, destruction of the vertebral wall and the presence of epidural involvement, which may be relative contraindications.8 The objective of this article is to describe the technique and results as regards pain improvement, as well as potential complications that may arise when performing this procedure under computed tomography (CT) guidance.

This study was approved by our Institutional Review Board. It is a descriptive observational study conducted in a series of 108 patients who underwent CT-guided PV as part of standard of care management of pain between May 2007and May 2017, at two university hospitals. All procedures were performed by the same interventional radiologist, with the assistance of diagnostic imaging residents and specialists. The criteria for performing PV included: fracture of one or more vertebral bodies of up to 12 months’ duration, with or without damage to the cortical bone or fragment dispersion. Criteria for not performing the procedure were: posterior wall defect of the vertebral body involved, vertebral wedging, and absence of bone marrow in the remnant vertebral body and patients with untreatable coagulopathy. CT scanners used included64-detector Philips Gemini (Eindhoven, The Netherlands), 16-detector Philips MX (Cleveland, Ohio, USA) and 16-detector Toshiba Aquilion (Tokyo, Japan). Image acquisition parameters were: at first acquisition 1 mm every 0.5- mm slice-thickness, FOV 340-450, 512 matrix, 120

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Rev. Argent. Radiol. 2018;82(1): 2-12

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Figure 1 (A)Under the scanner laser light guidance, the skin is marked at the site of puncture, according to the residual thickness of the vertebral body to be treated. An 8- to 11-gauge needle was used. (B) After soft tissue disinfection and local anesthesia with lidocaine, using a 10-cc syringe a wheal is created mainly at skin-subcutaneous level (3cc); along the tract of the subcutaneous cell tissue (3 cc) and when reaching the periosteum the rest of the 10 cc, after a small skin incision with a scalpel; the bone needle is placed in the planned needle tract. (C and D) Using pressure with a twisting motion until the periosteum is traversed, the needle is left in a fixed position trying not to penetrate the bone marrow if possible. (E) A first control is performed to check the needle position and if necessary correct the direction towards the central portion of the vertebral body. If access to the center of the vertebral body is not possible, bilateral puncture is performed (what occurred in 1 case). (F) Once the needle has been placed, the acrylic cement is prepared; the mixture isprepared in the same plastic container of the ampoule, where the powder containing methyl methacrylate with barium (subiton RO or vertebra) and the solvent are pouredto prepare the cement, being mixed until a mixture of toothpaste consistency is achieved. (G and H) The stylet is removed from the needle and a 5-cc syringe is loaded with 3.5 cc of the preparation for manual injection. This manual maneuver usually allows us to inject up to 2 cc (I) in bolus (depending on the extent of wedging and fractures of the vertebral body). (J) The material left in the needle is pushed using a stylet and we continue injecting this material to complete 3 cc or until theresistance encountered prevents the stylet from advancing further (with the cement not having reached its hard consistency yet). (K) The needle is removed and tomographic control is performed.


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Computed Tomography-guided Vertebroplasty for Pain Management in Patients with Vertebral Body Fractures

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Fig. 2.Example of a procedure.Patient with wedge fracture of the L1 vertebral body. Computed tomography (CT) of the lumbar spine was performed. (A) Sagittal image shows pre-treatment vertebral wedging. Axial (B), sagittal (C) and coronal (D) views show location of the cement in the vertebral body upon completion of the procedure (arrows).

Fig. 3 Percentage and number of percutaneous vertebroplasties (PVs) according to vertebral body.


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Kv, 100 mA. Once the fractured vertebra had been selected, measurements taken and marks had been placed on the patient’s skin, subsequent 3-mm series were acquired every 3 mm, approximately 20 slices with the same FOV per series. A standard filter was used, with reconstruction being performed in axial, sagittal and coronal slices for guiding the puncture site, the direction and point to which the needle should be advanced.

For local pain management, nonsteroidal anti-inflammatory drugs were administered for up to two days post-procedure; pain was assessed on the Visual Analog Scale (VAS) from 0 (no pain) to 10 (the maximum level of pain) at two hours post-procedure with the patient in the standing position. Data were prospectively collected in a datasheet, processed using the Stata 14 statistical software (StataCorp LLC, College Station Texas), and reported by descriptive statistics.

Technique Used

Results

The steps followed for performing the CT-guided VP are illustrated in Fig. 1. The procedure was performed, in all cases, under local anesthesia with continuous monitoring of vital signs and on an outpatient basis. Upon completion of the procedure, the patient was placed in the dorsal position for approximately two hours for managing hemostasis and pain, possibly caused by puncture or by an inflammatory reaction secondary to the heat generated by hardening of the methacrylate.

One-hundred and twenty-five VPs were performed in 108 patients (19 men and 89 women) with a mean age of 71 years old +/ - 10.65 and a range between 25 and 101 years (Fig. 2). In 87.9% (n = 95) of patients the procedure was performed in a vertebral body, in 8.3% (n = 9) and in 3.7% (n = 4) of the patients two and three vertebrae were cemented, respectively. The vertebral body in which most PVs were performed was L1, followed by L2 and D12 (Fig. 3). The main indications for the procedure were traumatic and osteoporotic fractures, lytic metastases, myelomas and Still disease (Table 1). Pre-treatment pain score according to the VAS ranged between 5 and 10, where 94% (n = 102) of patients reported 10/10 intensity; post-treatment pain score ranged between 0 and 7, where 98% of the population reported a value equal to or less than 3 (Table 2). The injection of no more than 3cc at the above mentioned consistency did not result in leakage into the spinal canal in any case; main complications included pulmonary embolism (PE) in one patient (Fig. 4), extravasation of contrast material into the Batson venous plexus in one patient (Fig. 5) and into the intervertebral space in another patient (Fig. 6). In the former case, the patient experienced lumbar pain close to the

Table 1: Percentage and frequency of main causes of percutaneous vertebroplasty (VP) Etiology

Frequency %

Traumatic Fracture Osteoporotic Fracture Lytic bone metastases Myeloma Still’s Disease Total

103 95 1 1 2 2 1 1 1 1 108 100

Table 2: Pre- and post-VP Visual Analog Scale (VAS) VAS

Pre-VP Frequency

Pre-VP rate

0 0 1 0 2 0 3 0 4 0 5 1 7 2 8 2 9 1 10 102 Total 108

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Post-VP frequency

0 0 0 0 0 1 2 2 1 94 100

63 25 13 5 0 1 1 0 0 0 108

Post-VP rate 58 23 12 5 0 1 1 0 0 0 100

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site of puncture, although not exactly at the cemented vertebral level. Upon administration of non-steroidal analgesics, the patient’s symptoms improved and she was discharged. The following day, she experienced pleuritic pain; therefore, a chest CT scan was performed, which showed spontaneously dense material occupying the lumen of a segmental pulmonary artery. The patient was hospitalized for 72 hours; received anticoagulation therapy, symptoms resolved and she was discharged with no subsequent complications. The other two cases were asymptomatic, discharged within 2 hours post-procedure and followed-up at 24 and 36 hours, with no subsequent complications. In three cases, a bilateral approach was required for VP (Fig. 7). In one patient, the procedure could not be performed due to the extent of vertebral wedging (Fig. 8); therefore this case was not included in the statistical analysis.

Discussion VP has arisen as a widely accepted method for the management of refractory pain from vertebral body fractures9. At our institutions this technique has been implemented since 2007 as a valuable therapeutic option with a significant benefit for the patient as regards pain management, lower consumption of analgesics and restoration of mobility. CT guidance is useful forcontrol of the posterior vertebral wall, which is difficult when lateral fluoroscopy is used as the only visualization plane; however, fluoroscopy guidance has a good performance for monitoring cranio-caudal cement leakage.10In addition, because of real-time monitoring, most interventional radiologists prefer this imaging method for guiding VPs. In our case, the reasons for choosing CT guidance were the

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Fig. 4 Female patient with fracture in L4 vertebral body. A vertebroplasty was performed with a complication consisting in embolism towards the anterior external vertebral venous plexus(transparent arrows). (A) Sagittal CT scan of the lumbar spine and (B) Axial CT scan of the lumbar spine. (C) and (D) Axial non-enhanced CT scan of the chest shows in the right lower lobehyperdense lineal images relative to distal branches of the pulmonary artery, corresponding to cement emboli (white arrows), associated with pulmonary infarction (asterisk).


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possibility of performing 3D reconstruction of the vertebra involved and of planning the site and direction of puncture in the axial plane, thus making it possible to accurately choose the methacrylate injection site to avoid bilateral vertebral puncture, as performed by some authors.11 This option of vertebral reconstruction in the three planes is an excellent tool for positioning the needle to inject cement at the core of the vertebral body, and for this purpose, as well as for detecting extraosseouscement, it may be even superior to fluoroscopy guidance, as reported by Pitton et al.10 and Schmidt et al.12, respectively. In our case, under CT-guidance we have achieved adequate positioning of the cannula for cement injection and good control for detection of cement leakage into the Batson venous plexus as reported by other authors.10In this study, most patients undergoing VP were women with traumatic fractures. Despite the evident pain improvement after the procedure, it should be noted that there are very few blinded, randomized,

placebo- or activetreatment-controlled studies to evaluate the actual efficacy and effectiveness of this procedure. The two first clinical trials of this type were published in August 200913, 14 and suggested that VP was not superior to placebo; however, in both, placebo consisted in the injection of a short-acting analgesic into the periosteum; therefore we consider that the placebo used was actually an active treatment. In contrast to the reports of the trials mentioned above, a prospective unblinded research study (The VERTOS Study)15, showed that VP was better for pain relief when compared with optimal medical treatment 1 day and 2 weeks after treatment. These results are more consistent with our experience with this procedure. It is important to mention that VP is not free of risks. There have been several reports of soft tissue lesions, nerve roots compression, pulmonary embolism and cardiorespiratory failure from cement spread through the perivertebral veins and inferior vena cava to the pulmonary circulation, a fact that has been reported in other publications16, with a retrospective es-

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Fig. 5 Patient with compression fracture of the L1 vertebral body. (A) Sagittal CT scan of the lumbar spine shows fracture prior to the procedure. (B) Sagittal CT scan of the lumbar spine shows control vertebroplasty material during the procedure. (C) and (D) Axial CT scan of the lumbar spine shows passage of the cement to Batson’s plexus (arrows).

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timate of 4.6% to 8.1% of pulmonary cement embolisms.17 It is known that low-viscosity cementis associated with leakage into adjacent tissues18. We think that a sufficiently high viscosity causing no resistance to the injection of the material reduces leakage; for this reason, in our patients we have used cement of a consistency similar to that of toothpaste. This, together with the fact that we injected a maximum amount of 3 mL (Pittonetet al.10 used an average of 4.5 mL), may account for our low rate of complications. The most serious complication was one case of pulmonary embolism (PE) from cement; this number is below the mean reported in the systematic review by Krueger et al.19 and well below the figures reported by studies included and identified as searching and reporting the risk in their samples (between 3.5% and 23%). In our experience, in spite of not using fluoroscopy, there was no case of cement leakage into the intramedullary space, as reported by other authors (1% in the series studied by Pittonetet al.10). It is worth mentioning that this procedure was performed using only local anesthesia, thus avoiding cardiorespiratory

risks in elderly patients. At the same time, this enabled continuous communication with the patient during the procedure for detecting radicular pain, neurological deficit or local complications. Weaknesses of our study include not following the exclusion criteria proposed in the Standards Practice Guidelines of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE)20, the absence of a long-term systematic followup of patients, which did not allow us to describe more accurately their progress or delayed occurrence of adverse events such as fractures of the adjacent vertebral bodies or late embolisms, as reported by other authors.10,17 In addition, this being a case-series descriptive study, it has the limitations inherent to this epidemiological design, such as personal subjectivity in reporting pre- and post-procedure results, which may be a potential measurement bias. There is also a lack of comparison with other treatments or VP techniques. Finally, we should mention that as this study represents the experience of a single interventional radiologist who performed all the procedures, replication of our results by other authors is limited.

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Fig. 6 Patient with fracture of T12 vertebral body. CT scan of the lumbar spine: (A) axial view shows positioning of the bone needle at the level of the left pedicle. (B) Coronal view, (C) 3D reconstruction and (D) sagittal view, which shows the passage of the vertebroplasty cement into the T12-L1 intervertebral space (white arrow).


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Fig. 7 Patient with fracture in T12 and L1 vertebral bodies, requiring bilateral approach for vertebroplasty in L1. (A) Sagittal CT scan of the lumbar spine shows pre-treatment compression fracture; Axial (B), coronal (C) and sagittal (D) views show dense material afterpolymethylmethacrylate(PMMA) injection (arrows)

Conclusion In our setting, percutaneous vertebroplasty offers an undeniable immediate improvement of pain in patients with fracture of one or more vertebral bodies, being a procedure that may be performed under CT guidance in a simple manner and on outpatient basis, with local anesthesia and a very low rate of complications.

Ethical responsibilities Protection of human subjects and animals.The authors declare that no experiments were performed on humans or animals for this investigation.

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Confidentiality of data.The authors declare that they have followed the protocols of their work center on the publication of patient data. Right to privacy and informed consent.The authors declare that no patient data appear in this article.

Conflicts of interest The authors declare no conflicts of interest, except for Dr. Kozima, who declares a possible conflict of interest as member of the executive committee of SAR and Drs. Espil and Hernández Pinzón, who declare a possible conflict of interest as reviewers for RAR.

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Fig. 8 Patient with Genant grade 3 compression fracture of L1 vertebral body, not allowing cement placing. (A) Magnetic Resonance Imaging (MRI) of the lumbar spine, sagittal T2-weighted image. (B) Sagittal CT scan of the lumbar spine and (C) Coronal CT scan of the lumbar spine showing compressed vertebral body (arrows).

References 1

Galibert P, Deramond H, Rosat P, Le Gars D. [Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty]. Neurochirurgie 1987;33(02):166–168 2 Peh WCG, Gilula LA, Peck DD. Percutaneous vertebroplasty for severe osteoporotic vertebral body compression fractures. Radiology 2002;223(01):121–126 3 Barragán-Campos HM, Vallée J-N, Lo D, et al. Percutaneous vertebroplasty for spinal metastases: complications. Radiology 2006;238(01):354–362 4 Calmels V, Vallée J-N, Rose M, Chiras J. Osteoblastic and mixed spinal metastases: evaluation of the analgesic efficacy of percutaneous vertebroplasty. AJNR Am J Neuroradiol 2007;28 (03):570–574 5 Cotten A, Dewatre F, Cortet B, et al. Percutaneous vertebroplasty for osteolytic metastases and myeloma: effects of the percentage of lesion filling and the leakage of methyl methacrylate at clinical follow-up. Radiology 1996;200(02):525–530 6 Mont’Alverne F, Vallée JN, Cormier E, et al. Percutaneous vertebroplasty for metastatic involvement of the axis. AJNR Am J Neuroradiol 2005;26(07):1641–1645 7 Jensen ME, Evans AJ, Mathis JM, Kallmes DF, Cloft HJ, Dion JE. Percutaneous polymethylmethacrylate vertebroplasty in the treatment of osteopo-

rotic vertebral body compression fractures: technical aspects. AJNR Am J Neuroradiol 1997;18 (10):1897–1904 8 Saliou G, Kocheida M, Lehmann P, et al. Percutaneous vertebroplasty for pain management in malignant fractures of the spine with epidural involvement. Radiology 2010;254(03): 882–890 9 Debussche-Depriester C, Deramond H, Fardellone P, et al. Percutaneous vertebroplasty with acrylic cement in the treatment of osteoporotic vertebral crush fracture syndrome. En: Proceedings of the XIV Symposium Neuroradiologicum. Berlín: Springer; 1991:149–152 10 Pitton MB, Herber S, Koch U, Oberholzer K, Drees P, Düber C. CTguided vertebroplasty: analysis of technical results, extraosseous cement leakages, and complications in 500 procedures. Eur Radiol 2008;18(11):2568–2578 11 Tan Z, Di Z, Mao X, Zhang J, Zou R, Wang Q. Percutaneous vertebroplasty guided by preoperative computed tomography measurements. Indian J Orthop 2016;50(06):622–628 12 Schmidt R, Cakir B, Mattes T, Wegener M, Puhl W, Richter M. Cement leakage during vertebroplasty: an underestimated problem? Eur Spine J 2005;14(05):466–473 13 Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med 2009;361(06):569–579 14 Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med


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2009;361(06):557–568 15 Voormolen MHJ, Mali WPTM, Lohle PNM, et al. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neuroradiol 2007;28(03):555–560 16 Saracen A, Kotwica Z. Complications of percutaneous vertebroplasty. Medicine (Baltimore) [Internet]. Junio 2016;95 (24). Disponible en: http:// www.ncbi.nlm.nih.gov/pmc/articles/ PMC4998452/. (accedido Junio 2017) 17 Layton KF, Thielen KR, Koch CA, et al. Vertebroplasty, first 1000 levels of

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a single center: evaluation of the outcomes and complications. AJNR Am J Neuroradiol 2007;28(04):683–689 18 Baroud G, Crookshank M, Bohner M. High-viscosity cement significantly enhances uniformity of cement filling in vertebroplasty: an experimental model and study on cement leakage. Spine 2006;31(22):2562–2568 19 Krueger A, Bliemel C, Zettl R, Ruchholtz S. Management of pulmonary cement embolism after percutaneous vertebroplasty and kyphoplasty: a systematic review of the literature. Eur Spine J 2009;18(09):1257–1265 20 Tsoumakidou G, Too CW, Koch G, et al. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol 2017;40(03):331– 342