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.

The use of minimally invasive interspinous process devices for the treatment of lumbar canal stenosis: a narrative literature review.

Minimally invasive interspinous process devices (IPD), including interspinous distraction devices (IDD) and interspinous stabilizers (ISS), are increasingly utilized for treating symptomatic lumbar canal stenosis (LCS). There is ongoing debate around their efficacy and safety over traditional decompression techniques with and without interbody fusion (IF). This study presents a comprehensive review of IPD and investigates if: (I) minimally invasive IDD can effectively substitute direct neural decompression and (II) ISS are appropriate substitutes for fusion after decompression. Articles published up to 22nd January 2020 were obtained from PubMed search. Relevant articles published in the English language were selected and critically reviewed. Observational studies across different IPD brands consistently show significant improvements in clinical outcomes and patient satisfaction at short-term follow-up. Compared to non-operative treatment, mini-open IDD was had significantly greater quality of life and clinical outcome improvements at 2-year follow-up. Compared to open decompression, mini-open IDD had similar clinical outcomes, but associated with higher complications, reoperation risks and costs. Compared to open decompression with concurrent IF, ISS had comparable clinical outcomes with reduced operative time, blood loss, length of stay and adjacent segment mobility. Mini-open IDD had better outcomes over non-operative treatment in mild-moderate LCS at 2-year follow-up, but had similar outcomes with higher risk of re-operations than open decompression. ISS with open decompression may be a suitable alternative to decompression and IF for stable grade 1 spondylolisthesis and central stenosis. To further characterize this procedure, future studies should focus on examining enhanced new generation IPD devices, longer-term follow-up and careful patient selection.

The evidentiary basis of vertebral augmentation: a 2019 update.

No aspect of neurointerventional practice has been associated with as longstanding contention and debate as to its effectiveness as has vertebroplasty (VP). Four blinded randomized controlled trials published since 2009 have demonstrated conflicting results regarding a conferred benefit in pain reduction and functional improvement for patients who undergo VP for osteoporotic vertebral compression fractures. Significant heterogeneity exists between each of these trials, which has resulted in difficulty for interventionalists and surgeons to translate the trial findings into routine clinical practice. In addition, patients and their families are ever more enlightened and enabled via the internet and social media to review both medical literature and websites. Without the proper background and context, their decisions may be lacking appropriate and necessary scientific discussion. This review article summarizes the randomized controlled trial data to date, with particular focus on the aforementioned four blinded studies. We will also evaluate the profound impact of the decrease in vertebral augmentation utilization on short- and long-term patient morbidity and mortality using available national and administrative datasets from both within the USA and internationally. We also consider future trial design to help evaluate this procedure and determine its role in modern neurointerventional practice.

A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study).

BACKGROUND CONTEXT: Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). OBJECTIVE: This study aimed to support a non-inferiority finding for the use of a titanium implantable vertebral augmentation device (TIVAD) compared to BKP. STUDY DESIGN: Prospective, parallel group, controlled comparative randomized study. PATIENT SAMPLE: Patients who presented with one or two painful OVCFs located between T7 and L4 aged <3 months, failed conservative treatment, and had an Oswestry Disability Index (ODI) score ≥30/100 were eligible for the study. OUTCOME MEASURES: The primary composite endpoint was defined as: reduction in VCF fracture-related pain at 12 months from baseline and maintenance or functional improvement (ODI) at 12 months from baseline, and absence of device-related adverse event or surgical reintervention. If the primary composite endpoint was successful, a fourth component (absence of adjacent level fracture) was added for analysis. If the analysis of this additional composite endpoint was successful, then midline target height restoration at 6 and 12 months was assessed. Secondary clinical outcomes included back pain intensity, ODI score, EQ-5D index score (range 0=death to 1=full health) and EQ-VAS score (range 0-100). METHODS: Patients were recruited in 13 hospitals across 5 countries and were randomly assigned (1:1) to either TIVAD or BKP with electronic randomization as described in the protocol. A total of 152 patients with OVCFs were initially randomized. Eleven patients were excluded (six met exclusion criteria, one with evidence of tumor, and four patients had T score out of requested range). Anterior vertebral body height ratio, midline vertebral body height ratio, and Cobb angle were measured preoperatively and postoperatively by an independent imaging core lab. Adjacent and subsequent fractures and safety parameters were recorded throughout the study. Cement extravasation was evaluated on X-rays. All patients were followed at screening at 5 days, 1 month, 6 months, and 12 months postoperatively. This study was supported by Vexim SA. Seven authors received study-specific support less than $10,000 per year and seven authors received no study-specific support. RESULTS: Among the 141 patients (78.7% female, mean age 73.3±9.5 years) who underwent surgery (TIVAD=68; BKP=73), 126 patients (89.4%) completed the 12-month follow-up period (TIVAD=61; BKP=65). The analysis of primary endpoint on the ITT population demonstrated non-inferiority of the TIVAD to BKP. The analysis of the additional composite endpoint demonstrated the superiority of TIVAD over BKP (p<0.0001) at 6 months (88.1% vs. 60.9%) and at 12 months (79.7% vs. 59.3%). Midline VB height restoration was more improved for TIVAD than for BKP at 6 months (1.14±2.61 mm vs. 0.31±2.22 mm); p=0.0246) and 12 months after surgery (1.31±2.58 mm vs. 0.10±2.34 mm; p=0.0035). No statistically significant differences were shown between procedures for improvement in functional capacity and quality of life. Pain relief was significantly more marked in the TIVAD group compared to the BKP group at 1 month (p=0.029) and at 6 months (p=0.021) after surgery. No patient required surgical reintervention or retreatment at the treated level. No symptomatic cement leakage was reported. Adverse events were similar for both groups (41.2% in the TIVAD group and 45.2% in the BKP group). The incidence of adjacent fractures was significantly lower after the TIVAD procedure than after BKP (12.9% vs. 27.3%; p=0.043). CONCLUSIONS: Study results demonstrated non-inferiority of the TIVAD to the predicate BKP with an excellent risk/benefit profile for results up to 12 months.

Percutaneous management of bone metastases: state of the art, interventional strategies and joint position statement of the Italian College of MSK Radiology (ICoMSKR) and the Italian College of Interventional Radiology (ICIR).

Interventional radiology provides local management of bone metastases (BM) with a palliative intent in most cases, or with a curative intent in selected patients. Its role has rapidly expanded in the last decade, offering new treatment solutions often in combination with surgery, radiation therapy and medical treatments. The aim of the present paper is to increase awareness, acceptance and adoption of interventional radiology procedures for the treatment of BM; and to present the joint position of the Italian College of Musculoskeletal Radiology and the Italian College of Interventional Radiology.

Efficacy of an ethyl alcohol gel in symptomatic disc herniation.

PURPOSE: To evaluate the clinical outcome of DiscoGel® chemonucleolysis for symptomatic disc herniation in patients who fail conservative treatment. MATERIAL AND METHODS: Consecutive patients with symptomatic disc herniation confirmed on MRI who failed conservative management for at least 6 months were included. Visual analogue scale (VAS), Oswestry Disability Index (ODI) scores, and analgesic use were recorded at baseline, and 12 months after treatment. Multidetector CT (MDCT) was performed at baseline, and 12 months after treatment to assess for DiscoGel® extravasation and alteration in treated disc volume. In a unique long-term subgroup analysis of 31 patients, telephonic follow-up was performed utilizing VAS and ODI parameters 7 years after the procedure. RESULTS: A total of 87 disc herniations were treated in 71 patients; majority (54%) were treated at L4/5 and L5/S1. VAS score of 8 before treatment was reduced to 3 at 12 months after treatment (p = 0.0001); ODI score of 51 before treatment was reduced to 15 at 12 months after treatment (p = 0.0001). Analgesic use of 70.4% was reduced to 29.6% after treatment. There were no symptomatic procedural complications; MDCT revealed 1 asymptomatic peri-neural DiscoGel® extravasation. In the 31 subjects that underwent telephonic follow-up the VAS and ODI parameters maintained their values without statistically significant differences when compared with the 12-month follow-up. CONCLUSION: Patients with symptomatic disc herniation who failed conservative treatment and were treated with DiscoGel® chemonucleolysis achieved significant gains in pain relief and reduced disability without symptomatic complication. DiscoGel® chemonucleolysis is a feasible, minimally invasive technique for treatment of symptomatic disc herniation.

New Implant-Based Technologies in the Spine.

Vertebral compression fractures (VCFs) may result in a kyphotic deformity which can cause potential systemic complications secondary to respiratory and gastrointestinal dysfunction. The use of implants in the spine for VCF treatment represents a paradigm shift away from cement injection on its own, aiming to combine the analgesic and stabilizing effect of injecting cement into the vertebral body with vertebral height restoration and kyphotic angle correction. Spine implants which can be used for VCF treatment include stents, jacks, PEEK cages and fracture reduction systems. Lumbar spinal stenosis (LSS) with neurogenic intermittent claudication is one of the most commonly occurring spinal conditions, usually affecting people older than 50, which can cause disability and a reducted quality of life. Percutaneous interspinous spacers for the relief of symptoms caused by spinal stenosis can be used in patients who are not surgical candidates. The purpose of this article is to describe the basic concepts of spinal implantation in patients with VCF or spinal stenosis. The role of biomechanics and the different types of implants will be described. Controversies concerning techniques and products will be addressed. Finally, the necessity for an individually tailored approach for the use of different implants in different cases and anatomic locations will be emphasized.

Multicenter clinical and imaging evaluation of targeted radiofrequency ablation (t-RFA) and cement augmentation of neoplastic vertebral lesions.

BACKGROUND: Treatment of spinal metastatic lesions by radiofrequency ablation (RFA) before cementation can potentially help in local tumor control and pain relief. This is often limited by access and tumor location. This study reports multicenter clinical and imaging outcomes following targeted RFA (t-RFA) and cement augmentation in neoplastic lesions of the spine. MATERIAL AND METHODS: A retrospective multicenter study of 49 patients with 72 painful vertebral lesions, evaluated for clinical and imaging outcomes following RFA and cement augmentation of spinal metastatic lesions, was undertaken. Visual Analogue Pain score (VAS) and Oswestry Disability Index (ODI) were obtained before and 2-4 weeks after treatment. Pre- and post-procedure imaging examinations including MRI and positron emission tomography (PET) were also evaluated. RESULTS: Mean ablation time was 3.7±2.5 min (range 0.92-15). Mean VAS scores decreased from 7.9±2.5 pre-procedure to 3.5±2.6 post-procedure (p<0.0001). Mean ODI scores improved from 34.9±18.3 to 21.6±13.8 post-procedure (p<0.0001). Post-contrast MRI resulted in a predictable pattern of decreased tumor volume and an enhancing rim. Metabolically active lesions in pre-procedure PET scans (n=10 levels) showed decreased fluorodeoxyglucose activity after ablation. CONCLUSIONS: t-RFA followed by vertebral augmentation in malignant vertebral lesions resulted in significant pain reduction and functional status improvement, with no major complications. t-RFA permitted access to vertebral lesions and real-time accurate monitoring of the ablation zone temperature. Post-procedure MRI and PET examinations correlated with a favorable tumor response and helped to monitor tumor growth and the timing of adjuvant therapy.

Diffusion-Weighted MRI Assessment of Adjacent Disc Degeneration After Thoracolumbar Vertebral Fractures.

OBJECTIVE: The purpose of this study was to assess, by the mean apparent diffusion coefficient (ADC), if a relationship exists between disc ADC and MR findings of adjacent disc degeneration after thoracolumbar fractures treated by anatomic reduction using vertebral augmentation (VAP). MATERIALS AND METHODS: Twenty non-consecutive patients (mean age 50.7 years; range 45-56) treated because of vertebral fractures, were included in this study. There were 10 A3.1 and 10 A1.2 fractures (AO classification). Surgical treatment using VAP was applied in 14 cases, and conservative in 6 patients. MRI T2-weighted images and mapping of apparent diffusion coefficient (ADC) of the intervertebral disc adjacent to the fractured segment were performed after a mean follow-up of 32 months. A total of 60 discs, 3 per patient, were analysed: infra-adjacent, supra-adjacent and a control disc one level above the supra-adjacent. RESULTS: No differences between patients surgically treated and those following a conservative protocol regarding the average ADC values obtained in the 20 control discs analysed were found. Considering all discs, average ADC in the supra-adjacent level was lower than in the infra-adjacent (1.35 ± 0.12 vs. 1.53 ± 0.06; p < 0.001). Average ADC values of the discs used as a control were similar to those of the infra-adjacent level (1.54 ± 0.06). Compared to surgically treated patients, discs at the supra-adjacent fracture level showed statistically significant lower values in cases treated conservatively (p < 0.001). The variation in the delay of surgery had no influence on the average values of ADC at any of the measured levels. CONCLUSIONS: ADC measurements of the supra-adjacent discs after a mean follow-up of 32 months following thoracolumbar fractures, showed that restoration of the vertebral collapse by minimally invasive VAP prevents posttraumatic disc degeneration.

Percutaneous stabilization of lumbar spine: a literature review and new options in treating spine pain.

Vertebral fracture (VF) is a common condition with >160,000 patients affected every year in North America and most of them with affected lumbar vertebrae. The management of VF is well known and defined by many protocols related to associated clinical neurological symptoms, especially in case of the presence or absence of myelopathy or radicular deficit. In this article, we will explore the percutaneous stabilization of the lumbar spine by showing the newest approaches for this condition.

Degenerative lumbar spinal stenosis treatment with Aperius™ PerCLID™ system and Falena® interspinous spacers: 1-year follow-up of clinical outcome and quality of life.

PURPOSE: Evaluation of the efficacy of the Falena(®) and Aperius™ PerCLID™ interspinous devices in the treatment of degenerative lumbar spinal stenosis with neurogenic intermittent claudication refractory to conservative treatment. MATERIALS AND METHODS: We retrospectively analyzed data from 24 patients (20 male and 4 female patients; 61 ± 7 years old), treated with an implantation of the AperiusTM PerCLID™ system, and from 35 patients (29 male and 6 female patients; 65 ± 9 years old) treated with the Falena(®) interspinous device.Patient pain intensity was evaluated by a 10-point visual analog scale (VAS), with a score (ranging from 0 = no pain to 10 = unbearable pain) that was collected before the procedure, at baseline; and at months 1, 6 and 12 after the interventional procedure. The assessment of quality of life (QOL) impairment was evaluated by the Oswestry Disability Index (ODI) questionnaire, which was administered beforehand at baseline; and at months 1, 6 and 12 after the interventional procedure. The vertebral canal area was measured by magnetic resonance imaging (MRI) scans before the treatment and at the one-year follow-up. RESULTS: All patients completed the study with no complications. Both the Falena group and Aperius group of surgery patients showed a statistically significant reduction of their VAS and ODI scores at the 6- and 12-month follow-up (p < 0.0001). A statistically significant increase in the vertebral canal area was observed both in the group that received Falena (p < 0.0001) and in the group that received Aperius (p = 0.0003). At the 1-year follow-up, we observed that there was a higher increase of vertebral canal area in those patients whom were treated with the Falena device (p < 0.001). CONCLUSIONS: The implantation of Falena(®) and Aperius™ PerCLID™ interspinous devices is an effective and safe procedure, in the medium term.

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.

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.

Medial branch neurotomy in low back pain.

INTRODUCTION: This study aimed to assess the effectiveness of pulsed radiofrequency medial branch dorsal ramus neurotomy in patients with facet joint syndrome. METHODS: From January 2008 to April 2010, 92 patients with facet joint syndrome diagnosed by strict inclusion criteria and controlled diagnostic blocks undergone medial branch neurotomy. We did not exclude patients with failed back surgery syndrome (FBSS). Electrodes (20G) with 5-mm active tip were placed under fluoroscopy guide parallel to medial branch. Patients were followed up by physical examination and by Visual Analog Scale and Oswestry Disability Index at 1, 6, and 12 months. RESULTS: In all cases, pain improvement was statistically significant and so quality of life. Three non-FBSS patients had to undergo a second neurotomy because of non-satisfactory pain decrease. Complications were reported in no case. CONCLUSIONS: Medial branch radiofrequency neurotomy has confirmed its well-established effectiveness in pain and quality of life improvement as long as strict inclusion criteria be fulfilled and nerve ablation be accomplished by parallel electrode positioning. This statement can be extended also to FBSS patients.

Percutaneous vertebroplasty in multiple myeloma vertebral involvement.

STUDY DESIGN AND OBJECTIVE: The aim of this study was to assess the effectiveness and safety of percutaneous vertebroplasty, a new technique for the treatment of vertebral pain deriving from fracture or gross osteolytic lesion due to multiple myeloma spinal involvement. SUMMARY OF BACKGROUND DATA: Spinal osteolytic lesions are frequently associated with hematologic malignancies due to primary localization of disease (multiple myeloma and rarely lymphoma) or secondary effect of intensive corticosteroid therapy. METHODS: We treated 64 patients (34 males, 30 females; mean age 71.4+/-9.6 y) with pain refractory to conventional medical therapy (analgesics, bed-rest, bracing with orthopedic devices for more than 3 wk) localized in spine, in the absence of neurologic signs. RESULTS: This treatment generated swift pain relief associated with an evident augmentation in vertebral resistance. Average preprocedural pain level for all patients was reported to be 8.04+/-1.4 whereas average pain level at 1 and 6 months follow-up period was 1.82+/-1.84 and 1.92+/-1.68, respectively. Although preprocedure and postprocedure demonstrated a statistically significant reduction in numeric pain scores (P<0.01), the pain level at 1 and 6 months was not considered statistically significant. No procedure-related complications were observed in either leakages of polymethylmethacrylate in the epidural or foraminal area or in complications of pulmonary embolism for venous plexus involvement. CONCLUSIONS: Vertebroplasty is widely considered as an alternative, effective, simple, and safe technique in the treatment of neoplastic vertebral localizations consequent to hematologic malignancies. The same injection of polymethylmethacrylate can be executed before radiation therapy treatment, synergizing its delayed analgesic action to pain, after failure or in the case of local recurrences.