Aims and Background: The purpose of this study was to assess the effectiveness and safety of Percutaneous Kyphoplasty as a new method of treatment for pain deriving from vertebral compression firactures (VCF). Patients and Methods: We treated sixteen patients with unremitting pain over spine, which increased particularly when pressure was applied over the spinous process, in absence of neurological signs and refractory to conventional medical therapy. Results: The method demonstrated swift pain relief associated with an evident augmentation in the resistance and restoration of the vertebral body's physiological shape. Polymethylmethacrylate (PMMA) leakages were not observed in the epidural space or foraminal area. The presence of complications such as pulmonary embolism involving the venous plexus, toxicity due to PMMA and infection due the procedure did not occur. Conclusion: Kyphoplasty is an effective, alternative, simple and safe treatment of vertebral collapse consequent to osteoporosis, aggressive haemangiomas, myelomas and metastases

Cesaroni,A

Fiori, R

MANENTI, GUGLIELMO

MASALA, SALVATORE

Massari,F

Nardi,P

SERGIACOMI, GIANLUIGI

SIMONETTI, GIOVANNI MARIA EGISTO

English

Masala, S

Cesaroni, A

Sergiacomi, G

Massari, F

Manenti, G

Nardi, P

Simonetti, G

Cineca Institutional Research Information System

Percutaneous kyphoplasty: New treatment for painful vertebral body fractures

Abstract. Aims and Background: The purpose of this studywas to assess the effectiveness and safety of PercutaneousKyphoplasty as a new method of treatment for pain derivingfrom vertebral compression fractures (VCF). Patients andMethods: We treated sixteen patients with unremitting painover spine, which increased particularly when pressure wasapplied over the spinous process, in absence of neurologicalsigns and refractory to conventional medical therapy. Results:The method demonstrated swift pain relief associated with anevident augmentation in the resistance and restoration of thevertebral body’s physiological shape. Polymethylmethacrylate(PMMA) leakages were not observed in the epidural space orforaminal area. The presence of complications such aspulmonary embolism involving the venous plexus, toxicity dueto PMMA and infection due the procedure did not occur.Conclusion: Kyphoplasty is an effective, alternative, simple andsafe treatment of vertebral collapse consequent to osteoporosis,aggressive haemangiomas, myelomas and metastases. Kyphoplasty is a recent treatment for vertebral compressionfractures (VCF), first employed by M. A. Reiley in 1997that, through the swelling of an inflatable bone tamp (IBT)into the collapsed vertebral body, elevates the endplates,thereby restoring the vertebral body height and creating avoid to be filled with cement. Kyphoplasty can be performedin the thoracic portion from T5 to T12 and in all lumbarlevels (1, 2). The importance of early diagnosis is shownfrom the increased probability of a favourable prognosis ifthis procedure is executed within three months from theoccurrence of the fracture (3). Although the mechanism ofpolymethylmethacrylate (PMMA) analgesic effect remainsunknown, the key element may be the stabilization ofmicrofractural fragments. In addition to this thermal andchemical mechanisms have been proposed. Patients and MethodsIndications. Kyphoplasty is a technique increasingly utilized in thefield of VCF based on primary and secondary osteoporosis(approximately 20% of women and more than 50% of men withosteoporosis have a secondary cause of bone loss) (4). Further, it isextremely useful in the treatment of aggressive vertebralhemangiomas and in the bone osteolytic metastases that complicate30% of the underlying primitive neoplasies. Additionally, kyphoplasty is indicated in the treatment ofdestructive multiple myeloma that is associated with VCF in 55-70% of the cases.Contraindications. The contraindications of kyphoplasty are dividedinto absolute and relative. The former consist of fractures withretropulsion of the fragments within neural foramen, local infection(osteomyelitis, discitis or epidural abscess), coagulative disorders,pain not related to vertebral collapse, steady asymptomaticfractures, effective medical therapy and pregnancy. The latter aredue to the inability of the patient to stay in the prone positionduring the procedure, the severe compression of the vertebralbody, the missing integrity of pedicles or joint facets, the spread oftumor within the epidural space and, finally, an allergy connectedto the medium contrast agents (5-7).Technique. All the patients were subjected to a thorough clinicalexamination in order to determine the symptomatic vertebral level,which is revealed by acute pain and tenderness over the spine at ornear the level of radiographic compression deformity (4). Radiographic examinations (Figure 1) and CT were preliminarilyperformed to evaluate the location, severity and the extension ofthe collapsed vertebra, as well as to ascertain the visibility of thevertebral pedicles and the integrity of the posterior wall . Magneticresonance is fundamental in the pre-treatment diagnosis and in thefollow-up to evaluate the success of the procedure; the presence ofintraspongious edema, particularly in fat suppression sequences,testifies to a recent fracture. 149Correspondence to: Salvatore Masala, MD, Department ofDiagnostic Radiology, “Tor Vergata” University General Hospital,81 Oxford Street-00133, Rome, Italy. Tel: +039-0620902401, Fax:+039-0620902404, e-mail: salva.masala@tiscali.itKey Words: Osteoporosis, myeloma, metastases, vertebralcompression fracture, kyphoplasty.in vivo 18: 149-154 (2004)Percutaneous Kyphoplasty: New Treatment for Painful Vertebral Body FracturesSALVATORE MASALA1, ALESSANDRO CESARONI2, GIANLUIGI SERGIACOMI1, ROBERTO FIORI 1, FRANCESCO MASSARI1, GUGLIELMO MANENTI1, PIERVITTORIO NARDI2 and GIOVANNI SIMONETTI11Department of  Diagnostics for Images and Interventional Radiology, University of Rome “Tor Vergata”; 2Department of Neurosurgery, Policlinico “Casilino” General Hospital, Rome, Italy0258-851X/2004 $2.00+.40Written informed consent was obtained from the patients. Giventhe suffering connected to the inflation of the tamp, the procedureis carried out under general anaesthesia (1). The patient is placed in prone position on the angiographictable; to obtain the maximum extension of the spine, two rolls ofsoft material are inserted transversally, respectively under the chestand the pelvis (1-5). After confining the vertebra and itscorresponding pedicles to be treated with the radiologic tube inantero-posterior projection, a small cutaneous incision is made inthe dorsal or lumbar area. Then a bone biopsy needle of 11/13gauge is introduced through the posterior portion of the pedicles,sloping anteriorly, medially and caudally (1-5) (Figure 2A 1,2,3). The access to the vertebral body is normally transpedicular,however eventually one can opt for an inter-costo-vertebralentrance into the thoracic levels or posterolateral for lumbar levels(8). To achieve a better restoration of vertebral body morphology,we prefer to treat levels bilaterally. Once the exact position of theneedle has been verified, a Kirshner wire is introduced coaxially.The biopsy device is then extracted and replaced by a workingcannula (outer diameter (OD) 4.2 mm; inner diameter (ID) 3.6mm) with the edge positioned 3mm beyond the posterior wall. Forthe successive passage of the IBT an intravertebral bone channelis created a few millimetres from the anterior cortex margin usinga drill tip (3.3 mm in diameter). Under fluoroscopic guidance in lateral projection the IBT ispushed forward carefully and placed, checking with the auxilium oftwo radiopaque markers, the exact positioning of the balloon, in theanterior 2/3 of the vertebra. The IBT can have a length of 15 or 20mm with a maximum volume respectively of 4 and 6 ml. The tampsin the two hemivertebrae are stretched simultaneously with a mixtureof contrast medium to 60% (9). Through circumferential impactionof the cancellous bone at the periphery, additional support isprovided to the cortical shell and a void is created internally. Theinflation is stopped when one of the following conditions occur: areduction of the fracture, achievement of maximum pressure (20atm), complete dilatation of the balloon or, lastly, if the tamp abutsthe cortical somatic surface (1-9) (Figure 2B 1,2,3). Meanwhile the cement is prepared by combining liquid monomerand powder cement polymer; everything is amalgamated until itforms into a paste with high viscosity. The PMMA is charged intodedicated cannulas (OD 3.4 mm; 1.5 ml) and moved forward throughthe working cannula until the correspondence of the third anterior ofthe void. Immediately after the acrylic cement is pushed with lowpressure utilizing a blunt plunger stylet under continuous fluoroscopicguidance. The filling volume is usually 1-2 ml greater than that whichis obtained with the balloon, which allows the cement to distributeitself effectively inside the cancellous bone (10) (Figure 2C 1,2,3). Tocomplete the procedure all cannulas are extracted, the cutaneousincisions are sutured and the patient is instructed to remain in bedfor the next four hours (10) (Figure 2D 1,2,3). The most commonly encountered complication is localized painand tenderness at the needle sites in the first 72 hours after theprocedure, usually caused by local bruising or hematoma, which canbe resolved with mild analgesics (4). The length of the process foreach vertebra is around 35-45 minutes. A traditional radiographic andCT inspection is performed after the procedure to evaluate theresults obtained (Figure 3). The release is generally the following day. Results From January to July 2003, we treated 16 patients (F=9,M=7; ages ranged from 63 to 82 years, mean age 72.3) withvertebral collapse. Respectively 12 (F=8, M=4) hadfractures consequent to osteoporosis and 4 (F=1, M=3)due to primary and metastatic osteolityc neoplasms (3myelomas and 1 lung metastasis). All patients underwent asingle level treatment (Dorsal 8 number of patients 2, D11n= 1, D12 n=3, Lumbar 1 n=1, L2 n=5, L3 n= 3 L4 n=1). The procedure was successfully performed on ourpatients, whose improvements were swift and persistent inreducing all symptoms, decreasing from an average of 8.2points of VAS to 2.4 (VAS of Huskisson = Visual analogscale, pain score with points assigned subjectively frompatient pre- and post-procedure in a range between 0absence of grief and 10 maximum pain). Resistance wasconsiderably increased and normal vertebral bodymorphology was restored. A reduction of the kyphosis anglein vivo 18: 149-154 (2004)150Figure1. Preoperative radiograph, lateral view, vertebral collapse on L1 level.was noted both clinically and radiologically with a positiveeffect on the lumbar compensatory hyperlordosis (5)(Figure 4). We did not find any conditions where there wereextravasations of PMMA in the epidural or foraminal siteswith marrow or radicular compression (11-17). DiscussionPercutaneous injection of PMMA bone cement into thevertebral body, described for the first time by Galibert et al.in 1984 (18) as " Vertebroplasty ", and succesfully appliedto the treatment of C2 aggressive hemangiomas, is also usedon VCF secondary to osteolytic tumors and osteoporosis. The vertebral fractures are generated when thecombination of the axial and rotational charges on the spineexceed the resistance offered by the vertebral body (12).The VCF is defined as a reduction in height, which must beat least 20% beyond its initial dimensions. In relation to itsseverity, it is distinguished as mild 20-25%, moderate 25-40%, or severe>40% (2). The most frequent locations arethe third inferior of the thorax and the superior lumbarlevels, correlated to different kinetics of the two segments,and followed by the thoracic third medium and inferiorlumbar. The cervical vertebrae and the third superior ofthorax are rarely involved (19,20). Primary osteoporosis isresponsible for about 85% of VCF, while secondaryosteoporosis and neoplasty determine the remaining 15%(1). The presence of a vertebral fracture puts the individualin the following years at a 5 times greater risk of having asecond VCF, which in almost 20% of the cases occurs withina one-year period (21-23).Acute complications of VCF include urinary retention,transient ileus and eventually a painful symptomatology; thelong-term complications, in more than a third of these patients,are chronic pain, depression, insomnia, low quality of life andfinally a progressive kyphosis of the spine. The sagittaldeformity of the spine is without a doubt one of the most graveconsequences of VCF. It is associated with a loss of height andMasala et al: Percutaneous Kyphoplasty151Figure 2. Kyphoplasty treatment performed at L1 level. Sequential intraoperative and fluoroscopic images: A) 11 G needle placed with transpedicularapproach; B) inflation of the balloon catheters; C) filling of the performed cavity with PMMA; D) post-procedure control.a reduction of volumes in the thoracic and abdominal cavities.In consequence to this it generates pulmonary compression,with a reduction of vital capacity (VC) to 9% for each levelfractured and of "forced expiratory volume to 1 second"(FEV1), as well as gastrointestinal dysfunction. Moreover,there is a major risk of death compared to the age-matchedcontrols (adjusted mortality risk 1.6) (1,16,21,24,25). Percutaneous kyphoplasty is similar to vertebroplasty inthat it involves the introduction of bone cement into thevertebral body but also attempts to restore the vertebral bodyheight (97% vs. 30%) (23), to minimize spinal deformity(reduction angle of kyphosis) and its clinical sequelae.  Vertebroplasty’s reported rates of complications are 1.3%in osteoporosis, 2.5% in spinal angiomas and 10% inmetastatic disease (26). Because it is necessary for theinjection of PMMA in the cancellous bone to have a highpressure and a low viscosity for filling, there is an elevatedconfirmation of cement extravasations. They are present in65% of the treatments of VCF due to metastases in multipleareas, in 30-60% of the fractures from myeloma and in 30%of osteoporotic fractures mainly in the intervertebral space(10,27,28). Pulmonary embolism and spinal compressionscan derive from the extrusion of cement, although they arerare potential complications.The reduction/injection procedure of kyphoplasty decreasesthe risk of leakage of cement thanks to the contained effectof the void created from the tamp in the vertebral body (29).In the cavity the injection of PMMA is performed at lowpressure and with a highly viscous cement. Moreover, thequantitative composition of volume to be injected ispreventively determined evaluating that which is utilized bythe contrast agent during the inflation of the tamp (22). In our experience, kyphoplasty has demonstrated itself tobe an effective method, both simple and safe, for thetreatment of vertebral compression fractures. Thecombination of the balloon and the cement provides aprecocious and long lasting pain relief, associated with anevident increase in the resistance and restoration of thenormal shape of the vertebral body. in vivo 18: 149-154 (2004)152Figure 3. Postoperative radiograph, lateral view, vertebral collapse on L1 level.Figure 4. Local Kyphosis angle (assessed on the lateral radiograph bymeasuring the angle obtained by a line parallel to the inferior endplate ofthe fractured vertebra and that of the vertebra one level above)AcknowledgementsThe authors thank Kyphon Inc. (Sunnyvale, CA, USA) forproviding the equipment and technical support for this study.References1 Ahrar K, Schomer DF and Wallace MJ: Kyphoplasty for thetreatment of vertebral compression fractures. Semin InterventRadiol 19(3): 235-43, 2002.2 McKiernan F, Jensen R and Faciszewski T: The dynamicmobility of vertebral compression fractures. J Bone Miner Res18(1): 24-9, 2003.3 Hardouin P, Fayada P, Leclet H and Chopin D: Kyphoplasty.Joint Bone Spine 69(3): 256-61, 2002.4 Stallmeyer MJ, Zoarski GH and Obuchowski AM: Optimizingpatient selection in percutaneous vertebroplasty. J Vasc IntervRadiol 14(6): 683-96, 2003.5 Fourney DR, Schomer DF, Nader R, Chlan-Fourney J, Suki D,Ahrar K, Rhines LD and Gokaslan ZL: Percutaneousvertebroplasty and kyphoplasty for painful vertebral bodyfractures in cancer patients. J Neurosurg 98(1 Suppl): 21-30, 2003.6 Linville DA 2nd: Vertebroplasty and kyphoplasty. South Med95(6): 583-7, 2002.7 Ledlie JT and Renfro M: Balloon kyphoplasty: one-yearoutcomes in vertebral body height restoration, chronic pain, andactivity levels. J Neurosurg 98(1 Suppl): 36-42, 2003.8 Gangi A, Wong LLS, Guth S and Dietemann JL: Percutaneousvertebroplasty: indications, technique, and results. SeminIntervent Radiol 19(3): 265-70, 2002.9 Theodorou DJ, Theodorou SJ, Duncan TD, Garfin SR andWong WH: Percutaneous balloon kyphoplasty for thecorrection of spinal deformity in painful vertebral bodycompression fractures. Clin Imaging 26(1): 1-5, 2002.10 Dudeney S, Lieberman IH, Reinhardt MK and Hussein M:Kyphoplasty in the treatment of osteolytic vertebral compressionfractures as a result of multiple myeloma. J Clin Oncol 20(9):2382-7, 2002.11 Peters KR, Guiot BH, Martin PA and Fessler RG: Vertebroplastyfor osteoporotic compression fractures: current practice andevolving techniques. Neurosurgery 51(5 Suppl): 96-103, 2002.12 Mathis JM, Barr JD, Belkoff SM, Barr MS, Jensen ME andDeramond H: Percutaneous vertebroplasty: a developingstandard of care for vertebral compression fractures. AJNR AmJ Neuroradiol 22(2): 373-81, 2001.13 Ryu KS, Park CK, Kim MC and Kang JK: Dose-dependentepidural leakage of polymethylmethacrylate after percutaneousvertebroplasty in patients with osteoporotic vertebralcompression fractures. J Neurosurg 96(1 Suppl): 56-61, 2002.14 Harrington KD: Major neurological complications followingpercutaneous vertebroplasty with polymethylmethacrylate : acase report. J Bone Joint Surg Am 83-A(7): 1070-3, 2001.15 Padovani B, Kasriel O, Brunner P and Peretti-Viton P: Pulmonaryembolism caused by acrylic cement: a rare complication ofpercutaneous vertebroplasty. AJNR Am J Neuroradiol 20(3): 375-7, 1999.16 Amar AP, Larsen DW, Esnaashari N, Albuquerque FC, LavineSD and Teitelbaum GP: Percutaneous transpedicularpolymethylmethacrylate vertebroplasty for the treatment ofspinal compression fractures. Neurosurgery 49(5): 1105-14, 2001.17 Shapiro S, Abel T and Purvines S: Surgical removal of epiduraland intradural polymethylmethacrylate extravasation complicatingpercutaneous vertebroplasty for an osteoporotic lumbarcompression fracture. Case report. J Neurosurg 98(1 Suppl): 90-2,2003.18 Galibert P, Deramond H, Rosat P and Le Gars D: Preliminarynote on the treatment of vertebral angioma by percutaneousacrylic vertebroplasty. Neurochirurgie 33(2): 166-8, 1987.19 Wu SS, Lachmann E and Nagler W: Current medical,rehabilitation, and surgical management of vertebral compressionfractures. J Womens Health (Larchmt) 12(1): 17-26, 2003.20 Papaioannou A, Watts NB, Kendler DL, Yuen CK, Adachi JDand Ferko N: Diagnosis and management of vertebral fracturesin elderly adults. Am J Med 113(3): 220-8, 2002.21 Zoarski GH, Snow P, Olan WJ, Stallmeyer MJ, Dick BW,Hebel JR and De Deyne M: Percutaneous vertebroplasty forosteoporotic compression fractures: quantitative prospectiveevaluation of long-term outcomes. J Vasc Interv Radiol 13(2 Pt1): 139-48, 2002.22 Belkoff SM, Mathis JM, Fenton DC, Scribner RM, Reiley MEand Talmadge K: An ex vivo biomechanical evaluation of aninflatable bone tamp used in the treatment of compressionfracture. Spine 26(2): 151-6, 2001.23 Higgins KB, Harten RD, Langrana NA and Reiter MF:Biomechanical effects of unipedicular vertebroplasty on intactvertebrae. Spine 28(14): 1540-8, 2003.24 Garfin SR, Yuan HA and Reiley MA: New technologies in spine:kyphoplasty and vertebroplasty for the treatment of painfulosteoporotic compression fractures. Spine 26(14): 1511-5, 2001.25 Coumans JV, Reinhardt MK and Lieberman IH: Kyphoplastyfor vertebral compression fractures: 1-year clinical outcomesfrom a prospective study. J Neurosurg 99(1 Suppl): 44-50, 2003.26 Reidy D, Ahn H, Mousavi P, Finkelstein J and Whyne CM: Abiomechanical analysis of intravertebral pressures duringvertebroplasty of cadaveric spines with and without simulatedmetastases. Spine 28(14): 1534-9, 2003.27 Lieberman IH, Dudeney S, Reinhardt MK and Bell G: Initialoutcome and efficacy of "kyphoplasty" in the treatment ofpainful osteoporotic vertebral compression fractures. Spine26(14): 1631-8, 2001.28 Mousavi P, Roth S, Finkelstein J, Cheung G and Whyne C:Volumetric quantification of cement leakage followingpercutaneous vertebroplasty in metastatic and osteoporoticvertebrae. J Neurosurg 99(1 Suppl): 56-9, 2003.29 Phillips FM, Todd Wetzel F, Lieberman I and Campbell-HuppM: An in vivo comparison of the potential for extravertebralcement leak after vertebroplasty and kyphoplasty. Spine 27(19):2173-8, 2002.Received August 18, 2003Revised November 18, 2003Accepted January 29, 2004Masala et al: Percutaneous Kyphoplasty153

Masala,S

Sergiacomi,G

Manenti,G

Archivio della Ricerca - Università di Roma Tor vergata

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Percutaneous kyphoplasty: New treatment for painful vertebral body fractures

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