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Page 1: Percutaneous Vertebroplasty: Complication Avoidance and ... · Percutaneous Vertebroplasty: Complication Avoidance and Technique Optimization John M. Mathis It has been 10 years since

Percutaneous Vertebroplasty: ComplicationAvoidance and Technique Optimization

John M. Mathis

It has been 10 years since percutaneous vertebro-plasty (PV) was introduced clinically into the UnitedStates. The procedure has grown in acceptance and isbecoming the standard of care for pain associatedwith compression fractures of the spine (1). It hasproved effective for this purpose and is generally safewhen used by well-trained and prudent physicians.We have learned of many pitfalls along the way, andstudents and physicians can learn from these lessonsearly in their careers to avoid complications and badoutcomes. This article will focus on 1) the avoidanceof complications, 2) the optimization of proceduretechnique, and 3) the application of PV to difficultcase situations.

Complication AvoidanceFortunately, complications with PV (Table 1) have

been for the most part uncommon. Awareness of thepotential for complications and attention to detail willallow one to avoid these in most circumstances.

Cement LeaksWithout question, cement leaks account for most

of the symptomatic complications resulting from PV(1–3). When treating osteoporotic compression frac-tures, symptomatic complications are expected lessthan 1% of the time. This increases to 2–5% whenosteolytic metastatic disease is treated (1). In bothclinical situations, the resultant complications aremost often associated with cement leakage from thevertebra and its subsequent compression of adjacentneurologic structures or embolic effects on the lungs.Cement leaks may be seen in 5–15% of routine cases.These leaks are generally small and are usually of noclinical consequence (Fig 1). This is the case regard-less of the location of the leak. In healthy individuals,the lungs will tolerate small emboli without symptoms(Fig 2). A large cement leak, however, can cause apulmonary infarct and multiple emboli may lead topulmonary compromise or even death (4).

Cement can also leak into the disk space. Thisaccounts for 25% or more of the total leaks. These

are not of consequence if small. There has beenspeculation that large disk leaks may predispose theadjacent vertebra to collapse. This has not beenproved, however, and I have not seen this effect in mypractice. Figure 3 demonstrates a subsequent fracturethat occurred away from a large disk leak. If a cementleak into the disk predisposes to an adjacent fracture,the statistical confirmation will be hard to obtain,because adjacent-level fractures after PV are knownto occur without leak (5, 6).

The most common consequence of a severe symp-tomatic cement leak occurs locally, producing nerveroot irritation (resulting in radiculopathy) or cordcompression (resulting in myelopathy) (Fig 4). Nerveroot irritation may be transient and treatable withnonsteroidal anti-inflammatory drugs or local steroidinjections. Persistent pain, however, may require sur-gical removal of the cement. Cord compression mayresult in paresis or paralysis. Serious and permanentcomplications have occurred with both PV and bal-loon-assisted PV (kyphoplasty; Fig 4). Substantial lo-cal cement leaks may also result in local pain exacer-bation (7; Fig 5). With any worsening of the clinicalsituation, a CT scan should be obtained to assess thesize and location of a suspected cement leak. A neu-rologic deficit should trigger an immediate neurosur-gical consult. Severe cord compression (resulting inparalysis) and death due to respiratory compromise(caused by large cement pulmonary emboli) haveoccurred. These complications should be rare or non-existent and generally result from poor operator tech-nique.

One may prevent substantial cement leaks by using1) high-resolution fluoroscopy (or rarely CT), 2) ad-equate cement opacification, and 3) interrupting orterminating the cement injection on first recognitionof a leak. Modern fluoroscopic equipment generally

Received March 13, 2003; accepted after revision April 9, 2003.Department of Radiology, Virginia College of Osteopathic Med-

icine, Blacksburg, VirginiaAddress correspondence to Dr. John M. Mathis, Department of

Radiology, 1900 Electric Road, Lewis-Gale Medical Center, Salem,VA 24153.

© American Society of Neuroradiology

TABLE 1: Vertebroplasty complications

Cement leaks:Should be of no consequence if smallLarge leaks may cause local or radicular pain, neurologic damage,

pulmonary embolus, or deathInaccurate needle placement:

Injury to nerve root or spinal cordInjury to adjacent organs (eg lungs)

Pain exacerabation:May occur due to substantial leaks into adjacent tissue or veinsMay occur without leak (transient pain flair)

Infection (rare)Bleeding (rare without coagulopathy or anticoagulation)

AJNR Am J Neuroradiol 24:1697–1706, September 2003

Technical Note

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has adequate capability for the average PV case.Heavy individuals, severe osteoporosis, osteolytic de-struction of the vertebra, and anatomic locations that

preclude good visualization (eg, high thoracic verte-bra obscured by the shoulders in the lateral projec-tion) may warrant the use of other imaging tech-

FIG 2. Portion of a chest radiograph afterPV showing small radiopaque cement em-boli (white arrows) in peripheral pulmonaryvessels. This patient had no pulmonarysymptoms.

FIG 3. A, Lateral radiograph of the spineshowing a moderately compressed verte-bra (black arrow).

B, Postvertebroplasty, there are largeleaks of cement (black arrows) into theadjacent disk spaces.

C, Six months later, the patient returnedwith a second fracture (white arrow). Thisfracture is not an adjacent level. Adjacentlevels did not fracture despite the largedisk leaks.

FIG 1. A, Lateral radiograph during ver-tebroplasty showing cement extendingto the posterior vertebral margin (blackarrow).

B, Post-PV CT scan demonstrates a smallleak into the epidural venous plexus (blackarrow). This leak was asymptomatic.

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niques such as combined CT and fluoroscopicguidance. Biplane fluoroscopy is not a necessity forPV, but it does make visualization in two projectionssimpler and faster (1). One must visualize the treatedvertebra from two projections numerous times duringthe procedure regardless of whether single or biplanefluoroscopy is used.

Good cement opacification is also crucial to beingable to recognize an early cement leak while it issmall. Because there is presently no cement specifi-cally made and optimized for PV in the United States,the addition of an opacification agent is required. Inthe United States, the opacification agent of choicehas been barium sulfate. Sterile barium sulfate isadded to bring the barium quantity to 30% by weight(8, 9). This allows one to see adequately even smallquantities of cement during fluoroscopy (Fig 6).

With high-resolution fluoroscopy and adequate ce-ment opacification, one can see early leaks and inter-rupt or terminate a problematic cement injection.Early termination of the injection will limit the size ofthe leak and usually prevents it from becoming sig-nificant. Venography, originally touted as helping to

predict leaks, is generally no longer a routine part ofthe PV procedure (10, 11). It has been recognizedthat venography does not accurately predict the pathof cement because of the marked difference in theflow characteristics of radiographic contrast materialused for venography and bone cement (9). PV hasbeen performed in large numbers of patients withoutvenography with no increase in risk or complication(10). It is not a routine part of most busy practicestoday.

Pain ExacerbationAn idiopathic pain flare or pain increase can un-

commonly be seen following PV without an associ-ated cement leak or hematoma (7). This occurs im-mediately after the procedure and may requirenarcotic analgesics for control. As with any complica-tion or untoward result, a CT scan should be imme-diately obtained to ensure that there is no mechanicalcause for the pain (eg, leak into neural foramina andnerve root compression). The etiology of this idio-pathic pain may be local ischemia or increased pres-

FIG 4. A, Postvertebroplasty CT scandemonstrates large cement leaks into thespinal canal, neural foramin (black arrow),and perispinus region. This patient hadparesis and radiculopathy.

B, Postkyphoplasty CT scan showslarge leaks into the spinal canal (black ar-rows), which created paraplegia.

FIG 5. A, Postkyphoplasty CT scan. The lateral wall was disrupted by the balloon inflation, and a large cement leak into themediastinum resulted (white arrow). For weeks following the procedure, this patient had severe, persistent pain.

B, Lateral radiography after vertebroplasty with a slow-set PMMA. The needles were withdrawn and the cement was still liquid enoughto flow into the needle tracts and into the soft tissue (white arrows). This created local discomfort to pressure.

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sure in the intertrabecular space during injection. Ifthe CT shows no leak, however, the pain can beexpected to be self-limiting, with resolution occurringwithin a few hours.

InfectionInfection following PV has been rare, with only one

case reported in the medical literature (12). As withany surgically implanted device (in this case, bonecement), it seems prudent to administer intravenousantibiotics immediately before PV. A common choiceis 1 g of cephazolin. The low incidence of infectiongenerally does not warrant adding antibiotic to thebone cement. Whereas this practice was found bene-ficial in immunocompromised hip-replacement pa-tients (13), in patients with a normal immune systemthe added expense and resultant alteration of themechanical properties of the cement outweigh thebenefits.

BleedingVenous bleeding after PV can be substantial along

the needle tracts (following needle removal); how-ever, local pressure for 3–5 minutes will minimizesubcutaneous hematoma and local tenderness follow-ing the procedure. Patients with a coagulopathy orreceiving anticoagulation medication (especially withcoumadin) should have bleeding abnormalities cor-rected before PV (9).

The transpedicular approach places the needle en-try site into the bone along the dorsal aspect of the

vertebral posterior element and in a position easilycompressed with local skin pressure (Fig 7). Thisapproach, therefore, offers the greatest margin ofsafety for being able to control local bleeding easily.Parapedicular and posterior-lateral approaches placethe needle entry site more laterally and may makehemostasis with local pressure more problematic.

Technique Optimization

As already discussed, high-quality imaging equip-ment and appropriate cement opacification are a ba-sic requirement to successful and safe PV. Additionalissues should be observed, as well, to refine the pro-cedure to the fullest extent.

Patient ComfortModern PV is almost always performed in patients

who are awake and must lie prone on the radio-

TABLE 2: “No-Sting” Anesthetic Mixture

Solution Composition

Solution 1: 0.5%lidocainea

Lidocaine 4% (4 cc); lactated ringer’s(24 cc); bicarbonate (2 cc);epinephrine (0)

Solution 2: 0.5% lidocainewith epinephrinea

Lidocaine 4% (4 cc); lactated ringer’s(24 cc); bicarbonate (2 cc);epinephrine (0.15 cc of 1:1,000)

a This solution is preservative free and should be discarded at theend of each workday.

FIG 6. Radiograph showing appropriately opacified cement (white arrow) that can be easily seen even in very small quantities.

FIG 7. Drawing depicting the needle entry site into the bone (black arrow) for a transpedicular approach. Following removal of theneedle, local pressure allows one to easily achieve hemostasis in this situation.

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graphic or operative table for 30–60 minutes. Patientcomfort on the table is therefore an essential prepa-ratory requirement. This may be accomplished byproviding added padding to the table and by usingarm supports that position the arms comfortably for aprolonged period (9).

Conscious sedation is commonly employed duringPV, by using a combination of fentanyl (Sublimase;Abbott Labs, Chicago, IL) and midazolam (Versed;Roche, Manati, PR), titrated to the individual pa-tient’s needs (1, 9). Many elderly patients have co-morbidities (such as cardiac and pulmonary disease)that increase their risk with heavy conscious sedation.Judicious use of local anesthetics can reduce (and insome cases eliminate) the need for intravenous seda-tion. This requires that local anesthetics be used inadequate quantities and injected into the skin, subcu-taneous tissue, and periosteoum of the bone at theneedle entry sites. It is well known that a reduction inthe discomfort associated with the introduction of thelocal anesthetic is obtained by mixing the anestheticwith bicarbonate. The resultant mix is still substan-tially painful. A “no-sting” mix is available (Table 2)and is recommended. It is used in our department forall procedures requiring a local anesthetic.

Needle TechniqueIt has been established that adequate biomechani-

cal augmentation of a compressed vertebra can beobtained with a single-needle introductory system aslong as the cement fill crosses the midline (14). Thistechnique has been used clinically with success withan adequate fill obtained approximately 70% of thetime with a single needle. The single-needle tech-nique, however, fails often enough that I still teachand recommend a two-needle technique for the rou-tine PV, especially for the less-experienced operator.Placing a second needle takes only an additional 3–5minutes and allows much more flexibility during thecement injection. If a less than optimum cementspread or cement leak is experienced, the operatorcan move to the second needle and finish the injec-tion without having to mix cement a second time.When using a single needle, less optimum cement fills

and larger leaks are tolerated while trying to finishthe procedure through the one cannula.

Cement SelectionAll PV cases are presently performed with polym-

ethylmethacrylate (PMMA) as the bone cement. Sev-eral types of cement are available, although no ce-ment is presently approved for use specifically for PVin the United States. PMMA cements fall into twogeneral categories: rapid set (eg, Simplex P; How-medica, Rutherford, NJ) or slow set (eg, Cranioplas-tic; DePuy, Blackpool, England) types. Most inexpe-rienced operators initially feel more comfortable byusing the slow-set varieties, because these materialsallow more working time of the cement at roomtemperature; however, the rapid-set materials offerdefinite advantages that quickly surface as one expe-riences the inevitable cement leaks common with thisprocedure. When a leak occurs while using a rapid-setcement, waiting only 1–2 minutes will usually allowsufficient polymerization of the injected cement toplug the leak and allow additional cement to be in-jected safely. This is less often the case with theslow-set material. Also, the slow-set cements stay liq-uid longer in the body and therefore retain theirpotential for leak longer (Fig 5), even along the nee-dle tract if the needle is removed too soon. If CTguidance is elected, the slow-set material is advanta-geous, because the procedure is usually prolongedcompared with PV with fluoroscopic guidance. Expe-rience with both cements can be a definite advantage,and appropriate selection can simplify certain diffi-cult situations.

Difficult Case SituationsDealing with difficult or complex-case situations

also falls under the general heading of techniqueoptimization. Apart from the techniques used forthe routine PV case, there are technical consider-ations that will aid these special situations that aremore difficult or have specific potential pitfalls. Thesecase situations will be dealt with individually in thissection.

FIG 8. A, T2 sagittal MR imaging demon-strating a high signal intensity collection(black arrow) below the superior endplateof this compressed vertebra. This repre-sents a fluid-filled vertebral cleft.

B, Lateral radiograph showing an air-filled cleft (black arrow) in a compressionfracture.

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Clefts and Cavities.—Cavities in the vertebral bodycan form as a result of compression trauma. Theseareas are often seen on MR imaging (T2 weighting)as bright bands below the endplate (Fig 8A; 15, 16).These cavities are fluid-filled spaces that probablyresult from local rebound of the endplate followingcompression, leaving a space that ultimately fills withair or fluid. When filled with air, this cavity (or cleft)can be seen fluoroscopically or radiographically (Fig8B). These clefts may be an indication of nonunion ofthe bone and can demonstrate movement of the bonewith change in patient position or respiration (17).This motion can be responsible for persistent (orpermanent) pain lasting many months after the actualfracture. To treat these fractures adequately, the cav-ity must be completely filled with bone cement. For-

tunately, this is usually easy to accomplish, becausethe cement often seeks the cavity preferentially, re-gardless of position of the needle tip (Fig 9). Thispathologic situation also presents an excellent oppor-tunity to achieve some vertebral height restorationduring the PV procedure (Fig 10; 18); however, theimportant point here is that the cleft or cavity must besufficiently filled to prevent future motion. With thisaccomplished, these cavities are dependably good re-sponders for pain relief after PV.

Osteolytic Metastases.—Destructive metastatic le-sions can present some of the most challenging andcomplication-prone problems that will be faced dur-ing a PV. Osteolytic metastatic involvement, almostby definition, creates destruction of the vertebra andproduces a situation where cement leaks are very

FIG 9. A, Lateral radiograph showingearly cement filling of a cleft below thesuperior endplate (black arrow) of a com-pressed vertebra. Note that the needletips are separated from the cleft and thecleft is filling preferentially.

B, Anterioposterior view of the samevertebra at completion of the vertebro-plasty. The cleft (black arrow) has beencompletely filled with cement. Relativelylittle cement has been deposited into therest of the vertebra. This typically results ingood pain relief without the need for re-peat filling of the noncleft portion of thevertebra.

FIG 10. A, Lateral radiograph demon-strating marked compression of a lowerthoracic vertebra. Note the 18° of kypho-sis before vertebroplasty.

B, With mild extension of the body,some height was restored to vertebra dur-ing vertebroplasty. This postvertebro-plasty image shows that the kyphosis hasbeen reduced to 9°.

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possible (2, 3). It is not just the possibility of cementleaking into the spinal canal that carries risk. Tumormay be displaced into the canal, even without leak ofcement, and this can also create cord or nerve rootcompression (19). It is generally not a good idea toattempt PV if there is already extension of tumor intothe spinal canal. To monitor the effect of the cementinjection on the spinal canal and neural elements, one

may mark the thecal sac by introducing myelographiccontrast before the PV. In the lumbar area it is easyto capture the contrast and still use fluoroscopic guid-ance during the cement injection (Fig 11A). In thethoracic and cervical areas, however, CT becomesvery effective for monitoring the injection and look-ing for cement or tumor that may be displaced intothe canal (Fig 11B). CT does not allow easy real-time

FIG 11. A, Lateral radiograph during ver-tebroplasty of a compression fracture dueto breast carcinoma. Note that the thecalsac was first opacified with myelographiccontrast. This allows one to watch fordeformation of the thecal sac that wouldindicate tumor displacement during cementintroduction.

B, With the thecal sac opacified, axialCT scans provide the most sensitivemethod to monitor PV for thecal sac com-pression created by tumor displaced dur-ing cement injection.

FIG 12. A, Sagittal T1 MR imaging (mid-line) showing complete central compres-sion of T11.

B, Sagittal T1 MR imaging (lateral verte-bral margin) reveals considerable residualmarrow space that could be filled withcement during vertebroplasty.

FIG 13. A, Lateral radiograph of an extremely collapsed lower thoracic vertebra. Superior and inferior endplates are identified (blackarrows). There is a small air-filled cleft; 13-gauge needles are being introduced via transpedicular route.

B, A lateral image showing one 13-gauge needle in good position before vertebroplasty.C, Final image after bipedicular vertebroplasty. Good filling of the vertebra was achieved despite the severe collapse. The patient had

a good pain response to the procedure.

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monitoring of the cement injection, but by using slow-set cement, one can inject small aliquots of cement(0.1–0.2 mL) followed by imaging to observe theeffect. Even with a cement leak, these small quantitieswill allow early recognition without much risk of aclinical complication.

Vertebral Collapse.—Extremely compressed verte-bra pose a technical challenge for percutaneous ce-ment augmentation. When compressed more than75%, just getting a needle into the vertebral body canbe difficult; however, we have learned that many ofthese vertebrae can be treated successfully with PVand produce good pain relief (19, 20). In addition, avertebra that appears almost completely collapsedmay have substantial sparing of its height laterally.This occurs because many vertebrae collapse more inthe center than they do along the lateral edges (Fig12). With care, it is quite common to be able to get a

13-gauge needle system into the lateral aspect ofthese vertebrae and successfully perform PV (Fig 13).Because of the marked central collapse, a bipedicularapproach is useful, because it allows better bilateralvertebral filling. Patients presenting with pain associ-ated with an extreme vertebral collapse should havean attempt at treatment. The amount of cement forthis treatment will be smaller than for less com-pressed vertebra. It is obvious that, because of thechallenging technical nature of these compressions,they should not be one’s first case. They can, however,present a good opportunity for successful pain relief(20).

Refracture after PV.—The literature contains littlediscussion of vertebral refracture following PV. Frac-ture of other vertebra after PV is not unusual andmay require treatment of several levels over thecourse of months or years. As our treatment numbers

FIG 14. A, Lateral radiograph following atwo-level vertebroplasty.

B, Follow-up lateral radiograph after re-fracture of both previously treated levels.Both levels show height loss comparedwith image shown in panel A.

C, With the patient placed in mild exten-sion on the angiographic table, the twovertebrae show height restoration andthe development of internal clefts (whitearrows).

D, The final image following vertebro-plasty retreatment. The clefts shown inpanel C have been filled with cement. Theprocedure eliminated the patient’s pain,and this fixation has been durable for morethan 2 years.

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have increased, however, we occasionally see vertebrathat refractured after treatment with PV. This mayoccur when too little cement is injected, resulting inless than optimal biomechanical reinforcement thevertebra. Belkoff et al performed an ex vivo study onosteoporotic cadaver vertebrae, randomized to vari-ous injection volumes, to determine the quantity ofcement needed to restore the original vertebralstrength after fracture. This indicated about 2.5–3.0mL in the upper thoracic spine, 3.0–4.0 mL in thethoraco-lumbar junction, and 6.0–8.0 mL in the lowerlumbar spine (21). We know that pain relief has beenpoorly correlated (if at all) with the quantity of ce-ment injected. This is not the case with biomechanicalreinforcement. Some vertebra prove to be so fragilethat even with reasonable amounts of cement injectedto produce pain relief, there is still a risk of refracture.Figure 14 shows such a case of refracture and asuccessful repeat PV. Repeat imaging and physical

examination is needed to establish that there is nonew fracture that would better explain the patient’srecurrence of symptoms. When a recurrent fracture isdiagnosed, it should be retreated with PV. This can bechallenging, because the initial cement can pose asubstantial problem for needle placement and injec-tion; however, these vertebrae can be successfullyretreated with good pain relief.

The potential for a refracture of a vertebra after PVshould be considered when the appropriate imaging andexamination findings are obtained. The presentationwould include new pain consistent to the site of priorPV, progression of height loss in the vertebra since thePV, and MR imaging findings that show recurrence orincreased marrow edema in the treated vertebra. Obvi-ously, MR imaging should demonstrate no other causeof the recurrent pain (eg, new fracture).

Multilevel Therapy.—The primary indication for PVhas been, and remains, pain relief. This has generallylimited the indication for PV to treating vertebralfractures that are deemed to be painful by ancillarytests including imaging and physical examination.Compression fractures or metastatic involvement tothe vertebra without associated pain are not, as yet,believed to be good indications for PV. At present,multilevel therapy is reimbursed only when there areindications of acute fractures with associated pain.Multilevel therapy, however, is a real issue to be dealtwith on a regular basis. Some 20–30% of casespresent with two or more acute compressions thatneed therapy. Usually all acute injuries must betreated to get adequate pain relief. In addition, newfractures are common in patients with osteoporosisand may lead to multiple therapies and ultimatelymultilevel PV. This can occur with metastatic involve-ment of the vertebra as well.

The question often arises as to why we do notinitially treat multiple levels in an attempt to slow orstop the cascade of fractures that may occur in theseverely osteoporotic patient. The reasons are numer-ous. First, we do not, as yet, have any way of predict-ing the sites of future fractures. Some clustering isknown to occur, but it is just as frequent to seefractures occur away from the original fracture ortreatment site. Second, there is some risk to multi-level therapy that presently is not quantified. By vir-tue of their hydraulic nature, all cement injectionspush marrow material (or, less likely, cement) out ofthe vertebra, and this ultimately ends up in the lungs.Small quantities are well tolerated, but in large quan-tities (or small quantities with preexisting pulmonarycompromise) this can create symptomatic events. An-ecdotal reports of death secondary to pulmonarycompromise following multilevel therapy are known.We do not know an absolute safe number of verte-brae that can be treated without risk of pulmonaryside effects. Our general rule has been to treat threeor fewer vertebra at a single session. In addition, thecentral marrow space (of which the spine is a primarycomponent) becomes the location of hematopoiesis isolder adults. Filling all or most of the vertebra couldlead to anemia or extramedulary hematopoiesis.

FIG 15. Anterioposterior radiograph showing six vertebraetreated with vertebroplasty. Ultimately, 10 levels were treated inthis patient.

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Multilevel therapy can be accomplished success-fully when approached with caution. Mathis et alreported the first seven-level therapy in 1998 in a35-year-old lupus patient with multiple compressionssecondary to high-dose steroid therapy (22). Thetreatments were divided, and the patient has hadmany years without pain or subsequent fracture (withlupus under control and no longer receiving high-dose steroids). I have treated as many as ten levels ina single individual with good results but always divid-ing therapy into multiple sessions (Fig 15). Prophy-lactic therapy is still avoided.

ConclusionPV is becoming common in many practices inter-

nationally. It has been embraced by physicians andpatients alike as a needed and welcome therapy forpainful compression fractures of the spine where gen-erally no good therapy existed. It is now becoming thestandard of care for these compression fractures inthe United States. PV is a simple procedure and isoften performed on an outpatient basis. Pain reliefhas been high and risks low, when performed byexperienced physicians who exercise good judgment.With this growing experience, we will be able to tackleand treat successfully more complex cases and expandthe utility of this procedure.

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1706 MATHIS AJNR: 24, September 2003