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.

Vertebral augmentation with spinal implants: third-generation vertebroplasty.

This article is to review the different types of vertebral augmentation implants recently becoming available for the treatment of benign and malignant spinal compression fractures. After a detailed description of the augmentation implants, we review the available clinical data. We will conclude with a summary of the advantages and disadvantages of vertebral implants and how they can affect the future treatment options of compression fractures.

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.

Spine Intervention-An Update on Injectable Biomaterials.

Back pain is the second most common reason for primary-care physician visits after the common cold. New understanding of the spine pathophysiology and biomechanics led to the development of novel injectable biomaterials to treat those pain generators. Although not all biomaterials are currently ready for common use, there is significant interest by the medical community to invest time, resources, and energy to optimize these injectables. This review introduces basic concepts and advancements in the field of bioinjectables tailored for the vertebral body. Also, we highlight advances in injectable biomaterials which were presented at the Groupe de Recherche Interdisciplinaire sur les Biomatériaux Ostéoarticulaires Injectables (GRIBOI) (Interdisciplinary Research Society for Injectable Osteoarticular Biomaterials) meeting in March 2018 in Los Angeles, CA. Indeed, multidisciplinary translational research and international meetings such as GRIBOI bring together scientists and clinicians with different backgrounds/expertise to discuss injectable biomaterials innovations tailored for the interventional pain management field.

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.

Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases.

BACKGROUND: Radiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM. METHODS: Fifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval. RESULTS: Twenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported. CONCLUSION: RFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

Treatment of metastatic spinal lesions with a navigational bipolar radiofrequency ablation device: a multicenter retrospective study.

BACKGROUND: Spinal metastatic lesions are a common occurrence among oncology patients and contribute to significant morbidity. Treatment options have been limited in their effectiveness and scope to this point. OBJECTIVE: This study aims to report the safety and efficacy of radiofrequency ablation (RFA) of malignant spinal lesions using a novel RFA bipolar tumor ablation system which includes a navigational electrode containing 2 active thermocouples. STUDY DESIGN: IRB approved multicenter retrospective review of patients receiving RFA as a treatment of metastatic osseous lesions between March 2012 and March 2013. SETTING: This study consists of patients from 5 large academic centers. METHOD: One hundred twenty-eight metastatic lesions were identified in 92 patients who underwent a total of 96 procedures. Cement augmentation was performed when the vertebral body was at risk or had a pathological fracture. Visual analogue scale (VAS) scores were obtained preoperatively as well as postoperatively at the one week, one month, and 6 month time points. Interval change in the patients' pain medications was recorded. Postoperative imaging was used to assess tumor burden at the treated level when available. RESULTS: RFA was technically successful in all of the lesions without complication or thermal injury. Our study demonstrated significant (P < 0.01) decreases in the VAS scores at one week, one month, and 6 months postoperatively. In our largest center, 54% of our patients experienced a decrease and 30% had no change in their pain medications postoperatively. Sixty-two percent of the spinal lesions in this largest institution were located in the posterior vertebral body. Post-ablation imaging confirmed size of ablation zones consistent with that measured by the thermocouples. LIMITATIONS: The main limitations of this study are the heterogeneous patient population, data set, and potential confounding variable of concurrent cement augmentation. CONCLUSION: The STAR System is an RFA device that was safely and effectively used in the treatment of spine metastatic osseous lesions. This new device allows RFA treatment of previously untreatable lesions with resultant reduction in pain that was not controlled by systemic or radiation therapy.

Spinal cord stimulators in an outpatient interventional neuroradiology practice.

PURPOSE: Spinal cord stimulation is a known modality for the treatment of chronic back and neck pain. Traditionally, spine surgeons and pain physicians perform the procedures. We report our experience in performing neuromodulation procedures in an outpatient interventional neuroradiology practice. METHODS: A retrospective analysis of medical records of all trial and permanent implantation patients over a period of 4 years was performed. 45 patients (32 men) of median age 47 years were included in the study. The primary diagnoses were 23 cases of failed back or neck surgery syndrome, 12 cases of spinal stenosis, 4 cases of axial pain, 3 cases with reflex sympathetic dystrophy, 1 case of peripheral vascular disease, 1 case of phantom limb and 1 case of post-concussion syndrome. RESULTS: Thirty-four trials were performed in an outpatient clinic while 11 trials were performed in hospital outpatient settings. Trial periods were 3-7 days. 27 patients (60%) who reported ≥50% pain relief underwent a permanent implantation. An interventional neuroradiologist performed 17 implantations, while spine surgeons performed 10 implantations. 23 implants were epidural (19 lumbar and 4 cervical) and four implants were subcutaneous. During the follow-up period, three patients had infections (13%) and required removal of the device and two cases (8%) reported lead migration. CONCLUSIONS: Neuromodulation procedures can be performed safely in an outpatient interventional radiology setting. Although the infection rate was relatively higher in this study population, the other complication rates and trial-to-implant ratio are similar to published data.

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.

Comparison between radiofrequency targeted vertebral augmentation and balloon kyphoplasty in the treatment of vertebral compression fractures: addressing factors that affect cement extravasation and distribution.

BACKGROUND: Both vertebroplasty and balloon kyphoplasty have been described for treatment of vertebral compression fractures. Vertebroplasty is known for its high leakage rate compared with balloon kyphoplasty. In vitro studies have shown that high-viscosity cements significantly decrease the incidence of cement leakage and increase the predictability of cement fill in cancellous bonelike substrates compared with low-viscosity cements. OBJECTIVE: This study compares the incidence and pattern of cement leakage in cases treated with standard balloon kyphoplasty (BKP) and a novel vertebral augmentation procedure, radiofrequency targeted vertebral augmentation (RF-TVA). STUDY DESIGN: Retrospective evaluation of postoperative radiographs. SETTING: Single center inpatient and outpatient population. METHODS: Two methods of vertebral augmentation were utilized. Conventional bipedicular BKP and RF-TVA, a novel unipedicular technique which uses a navigational osteotome to create targeted, bone sparing cavities and RF energy to deliver an ultra-high viscosity cement at a consistent rate via a remote controlled, automated hydraulic delivery system. Postoperative radiographs of patients treated with the 2 techniques were critically analyzed for the incidence and location of cement leakage. Eighty consecutive patients with 106 treated levels were included. Thirty-five patients with 49 levels in the BKP and 45 patients with 57 levels in RF-TVA group were evaluated. RESULTS: Leakages less than 1-2 mm were not reported since they may not represent any clinical significance. In the BKP group, 6 leakages (12%) were reported (3 discal, 2 venous, one paravaertebral, and no epidural). In the RF-TVA group, a total of 3 leakages (5%) were reported, (one discal, 2 venous, no paravaertebral or epidural). Using contingency analysis for leakage per level, there was a statistical difference for leakage between RF-TVA and standard BKP, P < 0.01. LIMITATIONS: Retrospective study, single center. CONCLUSIONS: The RF-TVA technique may provide an approximately 50% reduction in leakage rate when compared to standard BKP. This may be related to the combination of controlled delivery of radiofrequency activated (high viscosity) cement at a fixed, low rate of delivery into site-specific channels created using a navigational osteotome. Additionally, based on the unipedicular access and remotely controlled cement delivery RF-TVA may decrease procedural invasiveness and physician radiation exposure, respectively.INSTITUTIONAL REVIEW: This study was approved by the Institutional Review Board.

Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions.

OBJECTIVE: To assess the outcomes and safety after CT-guided percutaneous sacroplasty in patients with painful sacral insufficiency fractures or pathologic sacral lesions. METHODS: A retrospective multicenter analysis of consecutive patients undergoing CT-guided sacroplasty for painful sacral insufficiency fractures or sacral lesions was undertaken. The inclusion criteria consisted of severe sacral pain not responding to conservative medical management with imaging evidence of unilateral or bilateral sacral insufficiency fractures or lesions. Outcome measures included hospitalization status (inpatient or outpatient), pre-treatment and post-treatment visual analog scale (VAS) scores, analgesic use and complications. Patients were followed at approximately 1 month and for at least 1 year after their sacroplasty procedure. RESULTS: Two hundred and forty-three patients were included in the study, 204 with painful sacral insufficiency fractures and 39 with symptomatic sacral lesions. The average pre-treatment VAS score of 9.2±1.1 was significantly improved after sacroplasty to 1.9±1.7 in patients with sacral insufficiency fractures (p<0.001). The average pre-treatment VAS score of 9.0±0.9 in patients with sacral lesions was significantly improved after sacroplasty to 2.6±2.4 (p<0.001). There were no major complications or procedure-related deaths. One patient who was treated for a sacral insufficiency fracture experienced radicular pain due to local extravasation of cement that subsequently required surgical decompression for symptomatic relief. CONCLUSIONS: CT-guided percutaneous sacroplasty is a safe and effective procedure in the treatment of painful sacral insufficiency fractures or lesions. It is associated with prompt and durable pain relief and should be considered as an effective treatment option in this patient population.

Feasibility, safety and cement leakage in vertebroplasty of osteoporotic and malignant compression fractures using ultra-viscous cement and hydraulic delivery system.

BACKGROUND: The major complications arising from vertebroplasty or kyphoplasty are related to leakage of cement beyond the confines of the collapsed vertebral body. Traditionally, a liquid (low viscosity) cement is used in most vertebroplasty systems available on the market, coupled with mechanical injection devices or one mL syringes. OBJECTIVES: The purpose of this study is to evaluate the feasibility and safety, as well as study cement leakage patterns, in vertebroplasty performed for both osteoporotic and malignant vertebral compression fractures using ultraviscous cement injected by the hydraulic CONFIDENCE Vertebral Augmentation System. STUDY DESIGN: Retrospective evaluation of postoperative images. SETTING: Single center inpatient and outpatient population. METHODS: A retrospective evaluation of clinical charts and postoperative X-ray imaging was performed in 122 cases; a total of 214 levels were treated. The study group comprised a total of 163 levels of benign osteoporotic fractures and 51 levels of various malignant lesions. The degree of leakage, seen in postoperative films, was assessed at each treated level using a strict 4-point scale (none, mild, moderate, severe). RESULTS: For benign lesions, there was no leakage in 82 levels (50%), mild venous leakage in 38 levels (23%), moderate venous leakage in 4 levels (2%), mild disc leakage in 28 levels (17%), moderate disc leakage in 7 levels (4%), mild paravertebral leakage in 2 levels (1%), and moderate paravertebral leakage in 2 levels (1%). No severe leakage or epidural leakage were seen. For malignant lesions, there was no leakage in 25 levels (49%), mild venous leakage in 12 levels (24%), moderate venous leakage in 4 levels (8%), mild disc leakage in 7 levels (14%), moderate disc leakage in one level (2%), mild paravertebral leakage in one level (2%), and one level showed a mild epidural leakage (2%). LIMITATIONS: Retrospective study, single center. CONCLUSION: Percutaneous cement augmentation in osteoporotic and malignant compression fractures using a highly viscous cement that can be safely controlled and injected via a hydraulic system can be performed safely without significant complications. The leakage rate and patterns were similar in both benign and malignant compression fractures. The use of highly viscous cement may decrease the complication rate in malignant lesions that has been traditionally described to exhibit more cement leakage with low viscosity cement.

Vertebroplasty technique in metastatic disease.

The purpose of this article is to review the current state of the art of using vertebral augmentation techniques for treating symptomatic spinal fractures that are associated with malignant lesions and to present potential future trends in treatments for this patient population. Epidemiology and biomechanical ramifications of these lesions are summarized, and treatment regimes, clinical outcomes, complications, and technical issues associated with treatments are presented. Potential future trends and new technologies for performing vertebral body augmentation in patients with metastatic spinal lesions are also discussed in this article.

Spinal cord stimulation: a basic approach.

Chronic back pain and other refractory pain syndromes are a documented burden on our society. They also are a huge cost in quality of life and dollars spent on health care. Neuromodulation and specifically dorsal column stimulation of the spinal cord has been shown to decrease pain with minimal risk to the patient. We describe in this article the basic techniques and methods of both the stimulation trial and the permanent implantation of the leads and generator. With advanced imaging and the minimally invasive approach we further explain how to minimize any risk associated with this percutaneous procedure.

Percutaneous image-guided augmentation for spinal metastatic tumors.

The purpose of this article is to review the current state of the art for treating symptomatic spinal fractures associated with malignant lesions by image-guided interventional techniques. Epidemiology, clinical presentation, and biomechanical ramifications of these lesions are summarized. A suggested treatment algorithm is also presented. The second part of the article deals with how to approach these lesions, explaining the issues that pertain to patient evaluation, preoperative, operative, and postoperative treatment regimes. Tips for certain difficult situations and potential complications are also discussed.

Interventional techniques in managing persistent pain after vertebral augmentation procedures: a retrospective evaluation.

BACKGROUND: Based on systematic reviews, it appears that at least 10% of patients may continue to suffer with residual or persistent pain after successful vertebral or sacral augmentation procedures. OBJECTIVE: To report and evaluate the incidence and prevalence of different spinal injections in patients who received vertebroplasty, kyphoplasty, and sacroplasty procedures for both benign and malignant compression fractures. DESIGN: A retrospective case review. METHODS: Retrospective review of all cases of vertebroplasty, sacroplasty, and kyphoplasty performed in a 12-month period in a single outpatient setting of interventional radiology was conducted. RESULTS: In a 12-month period starting from October 2005 to September 2006, 144 patients underwent cement augmentation procedures. Of the 144, 34 patients required a spinal injection procedure for residual or persistent pain within a 1-year period after the augmentation procedure. Twenty-four patients required epidural steroid injections, 6 patients required intercostal nerve blocks, 5 patients required trigger point injections, 5 patients required sacroiliac joint injections, and 1 patient required facet joint injections. Nine patients who required lumbar epidural steroid injections and all patients who required intercostal nerve blocks and had underwent a thoracic cement augmentation procedure. CONCLUSION: A small proportion of patients undergoing percutaneous cement augmentation for vertebral compression fractures or sacral insufficiency fractures potentially require spinal injections to treat residual pain after the procedure.

Carotid arteries: contrast-enhanced US angiography--preliminary clinical experience.

B-mode ultrasonographic (US) angiography enhanced with a microbubble-based US contrast agent (FS069) was evaluated in human subjects with carotid artery disease. Results at contrast material-enhanced US angiography and duplex US were compared with those at conventional angiography. Both US angiography and duplex US accurately depicted stenoses of 70% or more compared with those depicted at conventional angiography. The percentage diameter stenosis of the internal carotid artery measured at US angiography strongly correlated with that measured at conventional angiography (r = 0.988). The percentage area stenosis measured at US angiography strongly correlated with ex vivo measurements of the resected carotid plaque at magnetic resonance imaging (r = 0.979). US angiography depicted unsuspected wall irregularities, ulceration, and dissection.

BOLD and perfusion response to finger-thumb apposition after acetazolamide administration: differential relationship to global perfusion.

The authors studied the effects of altering global cerebral blood flow on both blood oxygen level-dependent (BOLD) response and perfusion response to finger-thumb apposition. A PICORE/QUIPSS II protocol was used to collect interleaved BOLD-weighted and perfusion-weighted images on eight finger-thumb apposition trials. Subjects were studied on a drug-free day and on a day when acetazolamide was administered between the second and third trials. After acetazolamide administration, resting cortical perfusion increased an average of 20% from preadministration levels, whereas the BOLD response to finger-thumb apposition decreased by an average of 35% in the S1M1 hand area. Contrary to predictions from the exhausted cerebrovascular reserve hypothesis and the oxygen limitation model, an effect of acetazolamide on cerebral blood flow response in the S1M1 hand area was not observed. Across the acetazolamide trials, BOLD response was inversely correlated with resting cortical perfusion for individual subject data. These results suggest that resting perfusion affects the magnitude of the BOLD response and is thus an important confounding factor in fMRI studies, and that the physiologic systems that increase cerebral blood flow in response to acetazolamide administration and systems that increase cerebral blood flow in response to altered neural activity appear to have additive effects.