Vertebral Augmentation: Is It Time to Get Past the Pain? A Consensus Statement from the Sardinia Spine and Stroke Congress.

Vertebral augmentation has been used to treat painful vertebral compression fractures and metastatic lesions in millions of patients around the world. An international group of subject matter experts have considered the evidence, including but not limited to mortality. These considerations led them to ask whether it is appropriate to allow the subjective measure of pain to so dominate the clinical decision of whether to proceed with augmentation. The discussions that ensued are related below.

Single Level Percutaneous Vertebroplasty for Vertebral Hemangiomata - A Review of Outcomes.

BACKGROUND: Percutaneous vertebroplasty is a minimally invasive technique to treat patients with symptomatic vertebral hermangiomata. OBJECTIVES: We present a single-operator series of cases to demonstrate the clinical outcomes and complication profiles for this technique. STUDY DESIGN: This is a retrospective multi-center cohort study. SETTING: Procedures were performed across multiple hospitals in Italy by a single proceduralist. METHODS: All patients with symptomatic vertebral hermangiomata that had percutaneous vertebroplasty over a 14-year period (March 1999 to April 2013) by a single proceduralist were included in this study. Information collected included demographic data, vertebral level of intervention, cement volume used, and the Visual Analogue Score for pain that was assessed pre- and post-intervention. Patients were followed up for a minimum of one year. RESULTS: Percutaneous vertebroplasty was performed for 50 patients. All patients had an improvement in pain, with 39 patients (78%) reporting complete pain relief. A unipedicular approach was undertaken in 41 cases (82%), and bipedicular approach in 8 patients (16%), while a transoral approach was used in one patient. The mean cement volume per vertebral level was 6.8 mL (1 - 18 mL). Recurrent symptoms occurred in 2 patients (4%) requiring repeat vertebroplasty. There were no cases of symptomatic cement leak, and no cases of procedural morbidity or mortality. LIMITATIONS: As a multicenter study conducted over a 14-year time period, there may be heterogeneity in procedural technique and rehabilitation protocols. There were no cases of cement leakage in our study, which could be an underreporting of cases. This is could be due to none of our patients receiving a post procedural computerized tomography scan, which is more sensitive in detecting cement leakage when compared to procedural fluoroscopy. CONCLUSION: Percutaneous vertebroplasty is associated with good post-procedural outcomes in patients with vertebral hermangiomata. Complications such as neurological injury and cement leakages are rare.

Safety and results of image-guided vertebroplasty with elastomeric polymer material (elastoplasty).

BACKGROUND: Image-guided elastoplasty is an innovative method for percutaneous vertebral augmentation with a silicone elastomeric material. Our aim was to evaluate its technical success, safety and efficacy as well as the rate of secondary fractures. METHODS: Nineteen patients (13 women and 6 men, age 72 ± 10 years, mean ± standard deviation) underwent elastoplasty between 2010 and 2016. A total of 33 vertebrae were treated. A total of 2-6 mL of silicone-based elastomeric polymer material (VK100) was used. Visual analogue scale (VAS) and Oswestry disability index (ODI) pain scores were used. RESULTS: In all cases, it was possible to complete the procedure (technical success 100%). No major complications occurred. In 6/19 (31.5%) patients, asymptomatic leakage of the material was observed during the procedure. Full pain recovery was obtained in 18/19 (94%) patients. One patient with a painful angioma did not experience any change in symptoms. VAS and ODI were significantly reduced after the procedure, from 7.9 ± 1.1 to 0.7 ± 1.4 and from 79.6 ± 12% to 9.9 ± 14% respectively (p < 0.001 for both comparisons). After vertebroplasty, 14 of 15 patients (93%) removed the brace and 16/19 (84%) completely stopped using any drugs for pain relief (p < 0.001 for both pre-procedure versus post-procedure comparisons). At a mean follow-up time of 26.5 ± 28.1 months (median 8.7 months, range 6-69 months), no secondary fracture occurred. CONCLUSION: Taking into consideration the relatively small sample size, image-guided elastoplasty seems to be a safe procedure providing effective pain control over time.

Treatment of Osteoporotic Vertebral Compression Fractures: Applicability of Appropriateness Criteria in Clinical Practice.

BACKGROUND: Appropriate treatment choice for osteoporotic vertebral compression fractures (OVCF) is challenging due to patient heterogeneity. Using the RAND/UCLA method, an international multidisciplinary expert panel established patient-specific criteria for the choice between non-surgical management (NSM), vertebroplasty (VP), and balloon kyphoplasty (BKP). OBJECTIVES: To assess the applicability of the appropriateness criteria in real-life practice. STUDY DESIGN: Prospective observational study. SETTING: Eight practices of experts who participated in the panel study, including 2 interventional radiologists, one internal medicine specialist, 2 neurosurgeons, and 3 orthopedic/trauma surgeons. Practices were located in Belgium, Germany, Italy, Switzerland, and the United Kingdom. METHODS: Using an online data capture program, participants documented the clinical profile (age, gender, previous VCFs, time since fracture, magnetic resonance imaging (MRI) findings, evolution of symptoms, impact of symptoms on quality of life, spinal deformity, ongoing fracture process, and presence of pulmonary dysfunction) and treatment choice for consecutive patients who consulted them for OVCF. RESULTS: In total 426 patients were included. BKP was the most frequently chosen treatment option (49%), followed by VP (34%) and NSM (14%). When compared with the panel recommendations, inappropriate treatment choices were rare (5% for NSM, 2% for VP, none for BKP). Treatment choice was strongly associated with the clinical variables used in the panel study. Differences in treatment decisions between interventional radiologists and surgeons were largely determined by differences in patient characteristics, with time of clinical presentation being the dominant factor. LIMITATION: The study population was restricted to the practices of the participants of the panel study. CONCLUSION: This international, multi-specialty utilization review showed excellent applicability of, and good adherence with RAND/UCLA-based recommendations on treatment choice in OVCF.

Midterm Clinical and Radiologic Outcomes after Percutaneous Interspinous Spacer Treatment for Neurogenic Intermittent Claudication.

PURPOSE: To evaluate the midterm clinical and radiologic outcome of percutaneous interspinous process spacer (IPS) treatment for neurogenic intermittent claudication (NIC) in patients who fail conservative treatment. METHODS: Consecutive patients with NIC, lumbar spinal stenosis confirmed on magnetic resonance imaging, failure of conservative management for at least 6 months, and treatment with percutaneous IPS were included. Visual analog scale (VAS) and Oswestry Disability Index (ODI) scores were recorded at baseline, 1 month, 1 year and 3 years after treatment. Spinal canal and foraminal cross-sectional areas were calculated from multidetector computed tomography at baseline and 1 year. RESULTS: There were 80 patients treated with 94 IPS devices; 83% of patients received a single IPS; 78% of IPS devices were placed at L4-L5. An IPS dislocation was the single periprocedural major complication. VAS score of 8.1 ± 2 before treatment was reduced to 4.4 ± 2 at 1 month after treatment (P = .0001); ODI score of 23.3 ± 10 before treatment was reduced to 11.7 ± 8.5 at 1 month after treatment (P = .0001). These significant reductions were durable at 1-year and 3-year follow-up evaluations (P < .01). Spinal canal and foraminal cross-sectional area increased by 15% at 1 year (P = .0001). CONCLUSIONS: Patients with NIC who failed conservative treatment and were treated with percutaneous IPS achieved significant gains in pain relief and reduced disability that remained durable at 3-year clinical follow-up evaluation. This outcome was accompanied by significant increases in spinal canal and foraminal cross-sectional areas at the treated level.

Treatment of painful Modic type I changes by vertebral augmentation with bioactive resorbable bone cement.

INTRODUCTION: Low back pain is one of the most common causes of seeking medical attention in industrialized western countries. End plate degenerative changes in the acute phase, formally referred to as Modic type I, represent a specific cause. The aim of this study is to evaluate the effectiveness of vertebral augmentation with calcium sulfate and hydroxyapatite resorbable cement in patients with low back pain resistant to conservative treatment whose origin can be recognized in Modic type I changes. METHODS: From February 2009 to October 2013, 1,124 patients with low back pain without radicular symptoms underwent physical and imaging evaluation. Stringent inclusion criteria elected 218 to vertebral augmentation with resorbable cement. Follow-up period was 1 year. RESULTS: One hundred seventy-two (79 %) patients improved quickly during the first 4 weeks after treatment. Forty-two (19 %) patients showed a more gradual improvement over the first 6 months, and at 1 year, their pain level did not differ from that of the previous group. In both groups, pain did not resolved completely, but patients showed significant improvement in their daily life activities. Two (1 %) patients did not show any improvement. Two (1 %) patients died for other reasons. There were no complications related to the procedures. CONCLUSION: Vertebroplasty with bioactive resorbable bone cement seems to be an effective therapeutic option for patients with low back pain resistant to conservative treatment whose origin could be recognized in Modic type I end plate degenerative changes.

Vertebral augmentation with nitinol endoprosthesis: clinical experience in 40 patients with 1-year follow-up.

PURPOSE: This study was designed to assess the clinical outcomes of patients treated by vertebral augmentation with nitinol endoprosthesis (VNE) to treat painful vertebral compression fractures. METHODS: Forty patients with one or more painful osteoporotic VCF, confirmed by MRI and accompanied by back-pain unresponsive to a minimum 2 months of conservative medical treatment, underwent VNE at 42 levels. Preoperative and postoperative pain measured with Visual Analog Scale (VAS), disability measured by Oswestry Disability Index (ODI), and vertebral height restoration (measured with 2-dimensional reconstruction CT) were compared at last follow-up (average follow-up 15 months). Cement extravasation, subsequent fractures, and implant migration were recorded. RESULTS: Long-term follow-up was obtained in 38 of 40 patients. Both VAS and ODI significantly improved from a median of 8.0 (range 5-10) and 66 % (range 44-88 %) to 0.5 (range 0-8) and 6 % (range 6-66 %), respectively, at 1 year (p < 0.0001). Vertebral height measurements comparing time points increased in a statistically significant manner (ANOVA, p < 0.001). Overall cement extravasation rate was 9.5 %. Discal and venous leakage rates were 7.1 and 0 % respectively. No symptomatic extravasations occurred. Five of 38 (13.1 %) patients experienced new spontaneous, osteoporotic fractures. No device change or migration was observed. CONCLUSIONS: VNE is a safe and effective procedure that is able to provide long-lasting pain relief and durable vertebral height gain with a low rate of new fractures and cement leakages.

Effectiveness of percutaneous screws for treatment of degenerative lumbar low back pain.

BACKGROUND: The purpose of this retrospective observational study was to demonstrate the efficacy of a percutaneous screws system in the treatment of lumbar pain caused by high-level disc degeneration combined with facet joint hypertrophy and canal stenosis especially in the L5-S1 levels. METHODS: Thirty-eight patients (25 males, 13 females, mean age 63 years) with lumbar pain and/or neuralgia-claudication were treated with interpeduncular dynamic screws. Diagnosis was based on clinical\medical history evaluation and X-ray, CT, and MR examinations. All patients completed the visual analogic scale (VAS) for evaluation of clinical efficacy and pain measurement both before and after (1 month and after 2 years) the procedure. Patients also were given the Oswestry disability index (ODI) before and after treatment. The area of the neuroforamina also was measured. RESULTS: Thirty-eight intervertebral spaces were treated. The VAS pain scale showed a reduction of pain symptoms at 1 month and after 2 years (VAS pre 8.7 ± 1.1; after 1 month 5.1 ± 2.2; after 2 years 6.5 ± 2.1; p = 0.001). ODI also showed improvement (pre 56.7 ± 18.6 %; after 1 month: 31.9 ± 26.3%; after 2 years: 42 ± 24.2 %, p = 0.001). The study showed a widening of the neuroforaminal area of 15.5 % in the right neuroforamen and 17 % in the left ones (right foraminal area pre 0.94 mm(2), post 1.08 mm(2); left foramina area pre 0.95 mm(2), post 1.11 mm(2)). In addition, the spinal canal area displayed a statistically significant reduction (pre = 1.97 and post = 2.23; p < 0.0001). CONCLUSIONS: Our study indicates that patients treated with dynamic screws have VAS pain reduction as well as ODI improvement. Moreover, we found a statistically significant widening of the neuroforaminal area.

Criteria for the appropriate treatment of osteoporotic vertebral compression fractures.

BACKGROUND: The heterogeneity of patients with osteoporotic vertebral compression fractures (VCF) necessitates a tailored approach of balancing the benefits and limitations of available treatments. Current guidelines are divergent, sometimes contradictory, and often insufficiently detailed to guide practice decisions. OBJECTIVES: This study aimed at establishing treatment recommendations at the patient-specific level. STUDY DESIGN: Using the RAND/UCLA Appropriateness Method (RAM), the appropriateness of different treatment options for osteoporotic VCFs was assessed. SETTING: The assessment was conducted by a European multidisciplinary panel of 12 experts. METHODS: The appropriateness of non-surgical management (NSM), vertebroplasty (VP), and balloon kyphoplasty (BKP) was determined for 128 hypothetical patient profiles. These were unique combinations of clinical factors considered relevant to treatment choice (time since fracture, MRI findings, impact and evolution of symptoms, spinal deformity, ongoing fracture process, and pulmonary dysfunction). After 2 individual rating rounds and plenary meetings, appropriateness statements (appropriate, inappropriate, and uncertain) were calculated for all clinical scenarios. RESULTS: Disagreement dropped from 31% in the first round to 7% in the second round. Appropriateness outcomes showed specific patterns for the 3 treatments. For three-quarters of the profiles, only one treatment was considered appropriate: NSM 25%, VP 6%, and BKP 45%. NSM was usually appropriate in patients with a negative MRI or a positive MRI without other unfavorable conditions (poor outcomes for the other variables). VP was usually appropriate in patients with a positive MRI, time since fracture ≥ 6 weeks, and no spinal deformity. BKP was recommended for all patients with an ongoing fracture process, and also in most patients with a positive MRI and ≥ 1 other unfavorable factor. LIMITATIONS: The prevalence of the patient profiles in daily practice is yet unknown. CONCLUSION: The panel results may help to support treatment choice in the heterogeneous population of patients with osteoporotic VCF.

Percutaneous vertebral augmentation assisted by PEEK implant in painful osteolytic vertebral metastasis involving the vertebral wall: experience on 40 patients.

BACKGROUND: Vertebral metastases are associated with significant pain, disability, and morbidity. Open surgery for fracture stabilization is often inappropriate in this cancer population due to a poor risk-benefit profile, particularly if life expectancy is short. Vertebroplasty and kyphoplasty are appealing adjunctive procedures in patients with malignancy for alleviation of intractable pain. However, these patients have a higher risk of serious complications, notably cement extravasation. STUDY DESIGN: We prospectively evaluated clinical results of polyetheretherketone (PEEK) implant (Kiva) assisted vertebroplasty performed in malignant painful osteolytic lesions at risk for cement extravasation due to vertebral wall involvement. SETTING: Department of Interventional Radiology, Institute for Cancer Research and Treatment, Candiolo, Turin, Italy METHODS: Forty patients (22 women; mean age 66.8 ± 12.4), suffering from a painful spine malignancy with vertebral wall involvement not responding to conventional therapies and without surgical indications, underwent vertebral augmentation with Kiva intravertebral implant for pain palliation. The procedure was performed with moderate sedation and local anesthesia under combined digital fluoroscopy and computed tomography guidance. After the coil-shaped PEEK implant was deployed within the vertebral lesion, bone cement was injected under continuous digital fluoroscopic control. Patients were discharged from the hospital the next procedural day. The Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI), analgesic requirement, and use of external brace support were evaluated to determine efficacy. The primary end-point was safety and efficacy at one month after the procedure. However, all the patients were scheduled to be followed-up at month 3, 6, and every 6 months thereafter. Follow-up was prospectively evaluated in all patients after Kiva with clinical interviews. The Institution's Internal Review Board approved this study. RESULTS: Median pre-treatment VAS of 10 (range 6 - 10) significantly (P < 0.001) dropped to one (range 0 - 3), with all patients achieving a clinically relevant benefit on pain at one month. Differences in pre- and post-treatment analgesic therapy were significant (P < 0.001). All patients no longer use an external brace after Kiva. In 7 out of 43 (16.3%) treated vertebrae a bone cement leakage was detected. LIMITATIONS: This is a not randomized study. Participants were limited to 40 patients. CONCLUSION: The Kiva System potentially represents a novel and effective minimally invasive treatment option for patients suffering from severe pain due to osteolytic vertebral metastases.

Fluorescein angiography-based diagnosis for retinopathy of prematurity: expert-non expert comparison.

PURPOSE: To evaluate accuracy and inter-rater reliability of RetCam fundus images and digital camera fluorangioscopic images in acute retinopathy of prematurity (ROP) by comparing diagnoses given by trainee ophthalmologists with those provided by expert ophthalmologists. 
 METHODS: This is a multicenter retrospective observational study of diagnostic data from 48 eyes of 24 premature infants with classical ROP, stage II, as evaluated by RetCam 3 and fluorescein angiography (FA). Average gestational age was 25.4 weeks, average weight 804.7 g. A staging grid (with ocular fundus divided into 3 concentric zones) and 24 15° sectors centered around the optic papilla were superimposed on 360° retina photomontages (Photoshop) made from RetCam and FA images. Non expert vs expert diagnosis agreement was measured for each sector by means of Cohen kappa (Fleiss, 1981).
 RESULTS: A high degree of concordance was found. Inter-rater agreement between expert and non expert interpretations of retinal photomontages was greater for fluorangiographic images than for RetCam images, with κ = 0.61-1 for 120/152 (78.9%) sectors examined on the RetCam images and κ = 0.61-1 for 168/198 (84.8%) sectors examined on the FA images.
 CONCLUSIONS: The FA images appear to be easier to interpret than RetCam images, both by expert and non expert ophthalmologists. The results confirm that FA is a good examination technique with a high degree of reliability, even where trainee practitioners are involved. This suggests that retinopathy management can be improved by entrusting diagnostic responsibilities to trainee ophthalmologists, in order to extend access to correct diagnosis, recognition of threshold lesions, and prompt treatment.

Lutein and zeaxanthin supplementation in preterm very low-birth-weight neonates in neonatal intensive care units: a multicenter randomized controlled trial.

BACKGROUND: Human milk feeding protects against oxidative stress-induced damage in preterm neonates, including severe multifactorial diseases such as retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), and bronchopulmonary dysplasia (BPD). The carotenoids, which are not found in formula milk, might play a key role in these actions. METHODS: A multicenter, double-blind, randomized controlled trial was conducted in three tertiary Italian neonatal intensive care units. All preterm infants < 32(+6) weeks' gestational age were eligible and were randomized to a single, oral, daily 0.5-mL dose of carotenoid supplementation (0.14 mg lutein + 0.0006 mg zeaxanthin) or placebo (5% glucose solution) from birth till 36 weeks' corrected gestational age. Primary outcomes were threshold ROP, NEC > second stage, and BPD. Surveillance for detection of these diseases and for intolerance/adverse effects was performed. RESULTS: No treatment-related adverse effect was documented in the 229 analyzed infants, whose clinical/demographical characteristics were similar in the two groups. Threshold ROP incidence did not significantly differ in treated (6.2%) versus not treated infants (10.3%; p = 0.18). The same occurred for NEC (1.7% versus 5.1%; p = 0.15) and BPD (4.5% versus 10.3%; p = 0.07). Noteworthy, the progression rate from early ROP stages to threshold ROP was decreased by 50% (0.30 versus 0.44; p = 0.23). CONCLUSION: Lutein/zeaxanthin supplementation in preterm infants is well tolerated. No significant effect was seen on threshold ROP, NEC, or BPD. The decreasing trends of these outcomes in the treatment group need to be assessed and confirmed on larger sample-sizes.

Percutaneous vertebroplasty: multi-centric results from EVEREST experience in large cohort of patients.

PURPOSE: The purpose of this study was to prospectively evaluate results and complications of percutaneous vertebroplasty (PV) performed in 6 different Italian Centres belonging to the European VErtebroplasty RESearch Team (E.VE.RES.T) in a large series of patients. MATERIALS AND METHODS: Follow-up was obtained in 4547 patients (3211 females and 1336 males; mean age 70.2 years) that underwent PV for a total of 13.437 treated vertebrae. Procedures were performed by using fluoroscopic guidance or combined CT-fluoroscopic guidance. All patients underwent PV in local anaesthesia except for second cervical vertebrae treated with a trans-oral approach that required general anaesthesia. RESULTS: 4004 out of 4547 (88.0%) patients reported significant pain relief (difference>or=2 point in pain evaluated with an 11-point visual analogue scale; p<0.0001) within 48 h: an average of 7.7 ± 0.4 dropped to 1.8 ± 0.6 in the osteoporotic patients; 8.3 ± 0.4 to 2.4 ± 0.4 in metastases; 8.3 ± 0.4 to 1.7 ± 1.0 in myeloma; 6.2 ± 3.5 to 0.3 ± 0.2 in angioma and 7.4 ± 0.4 to 1.4 ± 0.9 in trauma. 430 osteoporotic patients (13%) were retreated for a subsequent fracture; in 302/430 patients (70.2%), the new fracture occurred in the contiguous vertebra. No major neurologic complications were reported and the most frequent minor complication was venous leakage (20.5%). CONCLUSIONS: This large series of patients confirms that percutaneous vertebroplasty is an effective and safe procedure in the treatment of vertebral fractures. Best results are obtained in the treatment of myeloma and trauma.

Effectiveness of a bone substitute (CERAMENT™) as an alternative to PMMA in percutaneous vertebroplasty: 1-year follow-up on clinical outcome.

PURPOSE: The aim of the study was to evaluate the efficacy of an injectable and partly absorbable calcium bone cement (CERAMENT™, Bone Support, Sweden) in the treatment of osteoporotic or traumatic vertebral fractures by percutaneous vertebroplasty. METHODS: From March 2009 to October 2010 an open, prospective study in two centres was performed. 33 patients with symptomatic vertebral fractures were enrolled. Patients were included based on evaluation by X-ray, CT, and MRI. Clinical evaluation by Visual Analogue Scale (VAS, 0-10) and Oswestry Disability index test (ODI, 0-100 %) was performed before the operation as well as 1, 6 and 12 months after the procedure. Radiology assessment post-procedure was carried out by X-ray, CT, and MRI at 1, 6 and 12 months post-op. Intake of analgesic medications pre- and post-procedure was monitored. RESULTS: 66 vertebral bodies underwent percutaneous vertebroplasty. VAS score demonstrated a significant decrease from 8.61 (SD 19.8) pre-operatively to 2.48 (SD 2.36) at 1 month. The score was 2.76 (SD 2.68) at 6 months and 1.36 (SD 1.33) at the latest follow up. ODI score dropped significantly from 58.86 pre-op to 26.94 at 6 months and further down to 7.61 at 12 months. No re-fractures or adjacent level fractures were reported. CONCLUSION: Data show that CERAMENT can be a substitute of PMMA in the treatment of osteoporotic and traumatic vertebral fractures, especially in young patients.

Vertebroplasty using transoral approach in painful malignant involvement of the second cervical vertebra (C2): a single-institution series of 25 patients.

BACKGROUND: Vertebroplasty is a minimally invasive procedure demonstrated to be safe and effective in the treatment of painful osteoporotic and malignancy related fractures when performed in the thoracolumbar spine. Multiple randomized and nonrandomized reports have demonstrated its effectiveness. Conversely, transoral vertebroplasty (TOV) to treat the second cervical vertebra (C2) has been described in only a few case reports. OBJECTIVES: Prospective evaluation of clinical results of TOV performed in malignant painful osteolytic lesions of C2. STUDY DESIGN: TOV was performed in 25 consecutive patients suffering from high-grade cervical pain due to malignant involvement of C2 who failed conservative therapies and did not have surgical indications. Follow-up was prospectively evaluated with clinical interviews in all patients. The Internal Review Board approved this study. SETTING: Institute for Cancer Research and Treatment METHODS: Twenty-five patients (16 women and 9 men; mean age 59.3 ± 11.5) suffering from a painful malignant involvement of C2 who did not respond to conventional therapies and did not have surgical indications, underwent TOV for pain palliation. The procedure was performed under general anesthesia with combined digital fluoroscopy and computed tomography guidance. After a beveled vertebroplasty needle was manually advanced up to the posterior odontoid wall, bone cement was injected under continuous digital fluoroscopic control. Patients were discharged from the hospital the next procedural day. The Visual Analog Scale (VAS) for pain, analgesic requirement, and use of external cervical cast support were used for evaluating efficacy. The main end point was safety and efficacy at day 15 after the procedure. Furthermore, all the patients were scheduled to be followed-up at months one, 3, and 6, and every 6 months thereafter. RESULTS: The median pretreatment VAS of 8 (range 5-10) significantly dropped (P < 0.0001) to 0 (range 0-10), with 20 patients (80%) achieving complete pain relief at day 15 after TOV. Differences in pre- and post-treatment analgesic therapy were significant (P < 0.001). Twenty-three patients no longer used a cervical cast after TOV (92%, P < 0.001). At median overall follow-up of 16 months (range 6-60 months), the projected proportion of patients free from worsening pain at 6, 12, and 24 months was 96%, 96% and 92% respectively. LIMITATIONS: A randomized study of only 25 patients. CONCLUSION: TOV is safe, effective, and long-lasting in the treatment of cervical pain resulting from malignant involvement of C2.

Percutaneous vertebroplasty in multiple myeloma: prospective long-term follow-up in 106 consecutive patients.

PURPOSE: Percutaneous vertebroplasty (PV) is a minimally invasive procedure involving the injection of bone cement within a collapsed vertebral body. Although this procedure was demonstrated to be effective in osteoporosis and metastases, few studies have been reported in cases of multiple myeloma (MM). We prospectively evaluated the safety and efficacy of PV in the treatment of vertebral compression fractures (VCFs) resulting from MM. MATERIALS AND METHODS: PV was performed in 106 consecutive MM patients who had back pain due to VCFs, the treatment of which had failed conservative therapies. Follow-up (28.2 ± 12.1 months) was evaluated at 7 and 15 days as well as at 1, 3, 6, 12, 18, and every 6 months after PV. Visual analog scale (VAS) pain score, opioid use, external brace support, and Oswestry Disability Index (ODI) score were recorded. RESULTS: The median pretreatment VAS score of 9 (range 4-10) significantly (P < 0.001) decreased to 1 (range 0-9) after PV. Median pre-ODI values of 82% (range 36-89%) significantly improved to 7% (range 0-82%) (P < 0.001). Differences in pretreatment and posttreatment use of analgesic drug were statistically significant (P < 0.001). The majority of patients (70 of 81; 86%) did not use an external brace after PV (P < 0.001). CONCLUSION: PV is a safe, effective, and long-lasting procedure for the treatment of vertebral compression pain resulting from MM.

Percutaneous vertebral augmentation for painful osteolytic vertebral metastasis: a case report.

INTRODUCTION: Vertebral metastases are associated with significant pain, disability, and morbidity. Open surgery for fracture stabilization is often inappropriate in this population due to a poor risk-benefit profile, particularly if life expectancy is short. Percutaneous vertebroplasty and kyphoplasty are appealing adjunctive procedures in patients with malignancy for alleviation of intractable pain. However, these patients have higher risk of serious complications, notably cement extravasation. Described in this report is a case of a painful osteolytic vertebral metastasis that was successfully treated by a novel percutaneous vertebral augmentation system. CASE PRESENTATION: A 42-year-old Caucasian female presented with a history of metastatic lung cancer unresponsive to radiation and chemotherapy with symptoms inadequately controlled by opiates over the previous 6 months. Magnetic resonance imaging and spiral computed tomography with two-dimensional reconstruction showed an osteolytic vertebral metastasis with complete involvement of the T10 vertebral body, extending to the cortical vertebral wall anteriorly and posteriorly. The patient was treated with percutaneous vertebral augmentation (Kiva® VCF Treatment System, Benvenue Medical, Inc, Santa Clara, CA) utilizing a novel coil-shaped polyetheretherketone implant designed to minimize the risk of cement extravasation. After the minimally invasive procedure, bone cement distribution within the vertebral body was ideal, with no observed cement extravasation. No complications were reported, pain completely resolved within 24 hours, and use of intravenous narcotics was progressively diminished within 1 week. Complete pain relief was maintained throughout 4 months of follow-up. CONCLUSION: The Kiva System represents a novel and effective minimally invasive treatment option for patients suffering from severe pain due to osteolytic vertebral metastasis.

Percutaneous vertebroplasty in osteoporotic patients: an institutional experience of 1,634 patients with long-term follow-up.

PURPOSE: To assess long-term clinical outcome of percutaneous vertebroplasty (PV). MATERIALS AND METHODS: PV was performed in 1,634 patients (1,387 women; median age 73 years ± 9.3) with painful osteoporotic vertebral compression fractures (VCFs). All patients had back pain that persisted for ≥ 2 months with a concordant magnetic resonance imaging study. After PV, medical therapy for osteoporosis was continued, and patients were prospectively evaluated (follow-up 11.8-44.9 months, mean 25.0 months). Visual analog scale (VAS), Oswestry Disability Index (ODI), analgesic drug use, and use of external brace support were recorded at baseline and during follow-up. New occurrences of symptomatic vertebral fractures were recorded. RESULTS: The mean VAS score of 7.94 significantly improved to 1.12 at the primary endpoint (P < .001). Differences in patterns of analgesic usage compared with baseline values were highly statistically significant (marginal homogeneity test, P < .001). Median ODI values of 82% before treatment significantly decreased to 6% (P < .001). Before intervention, 1,279 patients wore a brace; 1,167 (91.2%) patients did not wear a brace after PV (χ(2) = 31.005, P < .0001). A new painful fracture with a significant higher proportion of contiguous vertebrae (63.6%) occurred in 214 (13.1%) patients (z = 7.59, P = .025). CONCLUSIONS: PV can provide durable pain relief and improvement in ambulation in patients with VCFs.

Painful pathologic fracture of the humerus: percutaneous osteoplasty with bone marrow nails under hybrid computed tomography and fluoroscopic guidance.

A case of a 75-year-old patient with a painful pathologic humeral shaft fracture, with unacceptably high surgical risk and unsatisfactory analgesia is reported. In this case, impaired arm function and persistent pain with conservative management resulted in a poor quality of life. Palliation with image-guided percutaneous osteoplasty was considered. Because of potential cement leakage, inadequate fracture reduction, the site of the fracture, and the mobility of the joints in that area, image-guided percutaneous delivery of metallic bone marrow nails implanted together with polymethyl methacrylate (PMMA) osteoplasty was performed. This procedure achieved humeral shaft stabilization, bone fragment alignment, fracture reduction, and pain relief.

Vertebral augmentation: 7 years experience.

Percutaneous vertebroplasty and kyphoplasty are procedures used to treat pain associated with vertebral compression fractures. Controversies are still open regarding indications, efficacy and safety of the procedures, and regarding the potential benefits, advantages and shortcomings of PV versus KP.Aim of this article is to report 7 years' experience in vertebral augmentation of the E.VE.RES.T. (European VErtebroplasty RESearch Team) group. The main topics are the treatments of hemangioma and malignant lesions, technically challenging cases such as vertebra plana, multifragmented fractures, multilevel treatments, refracture of augmented vertebra, and treatment of cervical junction and sacrum.