Feasibility, safety, and efficacy of a new percutaneous interspinous device: a retrospective multicenter study.

PURPOSE: To evaluate safety and efficacy of the novel percutaneous interspinous device (PID) for the treatment of symptomatic degenerative lumbar spinal stenosis (DLSS) in 3 different centers. METHODS: From November 2016 to March 2020, 255 patients (male 125, mean age 71.2 years old range 49-91 years old) with neurogenic claudication, confirmed by electromyography, related to mono or bi-segmental lumbar central canal and/or foraminal stenosis were enrolled in the study. Magnetic resonance (MR) and/or computer tomography (CT), physical exam, and Visual Analogue Scale (VAS) and Zurich Claudication Questionnaire (ZCQ) were performed before and 6 months after the procedure. All treatments were performed under fluoroscopic guidance with local anesthesia and mild sedation. Technical success was defined as correct placement of the Lobster® (Demetrios Medical, Firenze, Italy) PID as demonstrated by computer tomography (CT) performed immediately after treatment; spinoplasty was performed in selected patients. RESULTS: PID placement was accomplished with a 99.6% success rate (257/258). The one device that was not implanted was due to a spinous process fracture. In 28 patients, more than 1 device was implanted in the same session (max 3 PIDs); 6 patients required a second implant in different session. A total of 172 prophylactic spinoplasties were performed (59.3%). No major complications occurred; 3 device misplacements were successfully treated with percutaneous retrieval and new device deployment. 99.6% of patients experienced clinical improvement. CONCLUSION: Lobster PID is an effective and safe minimally invasive decompression method for central canal and neural foraminal stenosis when patients are correctly selected.

Clinical and radiological outcomes following insertion of a novel removable percutaneous interspinous process spacer: an initial experience.

PURPOSE: To evaluate clinical and radiological outcomes of a series of patients treated with a removable percutaneous interspinous process spacer (IPS) (LobsterProject® Techlamed®) for symptomatic degenerative lumbar spinal stenosis (DLSS). METHODS: All patients treated in two centres with this IPS during 2019 were retrospectively reviewed. Procedures were performed under deep sedation or general anaesthesia by two interventional radiologists. Patients were clinically evaluated before intervention and at 3-month follow-up with Visual Analog Scales for pain (VAS), Oswestry Disability Index (ODI) and radiologically with MRI or CT scans. Neural foramina were independently measured for each patient on pre- and post-procedural CT scans by two radiologists. RESULTS: Fifty-nine patients were treated in the selected period of which fifty-eight had complete documentation (mean age 71.2 ± 9.2 years [55-92], 32 males, 26 females). Forty-eight interventions were performed under deep sedation and ten under general anaesthesia, without procedural complications. Clinical follow-up at 3 months showed a significant reduction of pain (VAS from 83 ± 9 to 29 ± 19, - 65%; p < 0.001) and an improvement in functional outcomes (ODI from 31 ± 12 to 13 ± 10%, - 58%; p < 0.001). There was one case of unsatisfactory positioning post procedure, two cases of posterior migration at 3-month follow-up and one case of spinous process fracture. Mean neural foramina area increased from 77 ± 23 to 95 ± 27 mm2 (+ 26%; p < 0.001) with very good inter-observer reliability (Cronbach's alpha = 0.899). CONCLUSION: Percutaneous minimally invasive insertion of a removable IPS device demonstrates a favourable safety profile, good clinical outcomes at 3 months, and apparent anatomical increase in foraminal dimensions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05203666-Release Date: 21st January 2022, retrospectively registered.

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.

Intra-osseous basivertebral nerve radiofrequency ablation (BVA) for the treatment of vertebrogenic chronic low back pain.

STUDY DESIGN: Prospective experimental uncontrolled trial. BACKGROUND: Vertebrogenic pain is a frequently underestimated cause of chronic low back pain (LBP). Vertebral endplate degeneration, characterized by cortical bone damage and subchondral bone inflammatory reaction, is a significant source of LBP, the responsible of the pain transmission being the Basivertebral Nerve (BVN). Radiofrequency ablation of the BVN (BVA) leads to thermal injury of nerve tissue and interruption of the of chronic vertebrogenic pain transmission. PURPOSE: The aim of this study is to evaluate the effectiveness, in terms of pain and disability reduction, of percutaneous (BVA) in treating patients affected by vertebrogenic chronic LBP. Moreover, as a secondary endpoint, the purpose is to assess the feasibility and safety of a percutaneous CT-guided technique. METHODS: We performed percutaneous CT-guided BVN ablation in 56 consecutive patients presenting with vertebrogenic chronic LBP in local anesthesia using an articulating bipolar radiofrequency electrode (STAR™ Tumor Ablation System Merit). A 1-month follow-up MRI was performed to evaluate the ablation area in order to assess the target success of the procedure. A 3-month follow-up CT study was performed to evaluate bone mineral density in order to exclude structural bone abnormalities that might have been induced by the treatment. Pre- and post-procedure pain and disability levels were measured using the visual analogue scale (VAS) and Oswestry Disability Index (ODI). A 2-cm improvement threshold was set as clinical success for the VAS score and a 10-point improvement threshold was set as clinical success for the ODI score. RESULTS: At 3- and 12-month follow-up, VAS and ODI scores decreased significantly compared to baseline. Clinical success was reached in 54/56 patients (96.5%) for pain and 54/56 patients (96.5%) for disability, exceeding significantly the MCID. CT-assisted targeting of the ablation zone was determined successful in 100% of patients. Mean operative time was 32 min. No immediate or delayed complications were detected. CONCLUSIONS: Percutaneous CT-guided intra-osseous BVA seems to be a safe, fast, and powerful technique for pain relief in patients with vertebrogenic chronic LBP, when the selection of patients is based on a multidisciplinary approach including both conventional Diagnostic Radiology and Nuclear Medicine imaging.

Percutaneous CT-guided lumbar trans-facet pedicle screw fixation in lumbar microinstability syndrome: feasibility of a novel approach.

STUDY DESIGN: Prospective experimental uncontrolled trial. BACKGROUND: Lumbar microinstability (MI) is a common cause of lower back pain (LBP) and is related to intervertebral disc degeneration that leads to inability to adequately absorb applied loads. The term "microinstability" has recently been introduced to denote a specific syndrome of biomechanical dysfunction with minimal anatomical change. Trans-facet fixation (TFF) is a minimally invasive technique that involves the placement of screws across the facet joint and into the pedicle, to attain improved stability in the spine. PURPOSE: In this study, we aimed to evaluate the effectiveness, in terms of pain and disability reduction, of a stand-alone TFF in treatment of patients with chronic low back pain (LBP) due to MI. Moreover, as a secondary endpoint, the purpose was to assess the feasibility and safety of a novel percutaneous CT-guided technique. METHODS: We performed percutaneous CT-guided TFF in 84 consecutive patients presenting with chronic LBP attributable to MI at a single lumbar level without spondylolysis. Pre- and post-procedure pain and disability levels were measured using the visual analogue scale (VAS) and Oswestry Disability Index (ODI). RESULTS: At 2 years, TFF resulted in significant reductions in both VAS and ODI scores. CT-guided procedures were tolerated well by all patients under light sedation with a mean procedural time of 45 min, and there were no reported immediate or delayed procedural complications. CONCLUSION: TFF seems to be a powerful technique for lumbar spine stabilization in patients with chronic mechanical LBP related to lumbar MI. CT-guided technique is fast, precise, and safe and can be performed in simple analgo-sedation.

Joint EANM/ESNR and ESCMID-endorsed consensus document for the diagnosis of spine infection (spondylodiscitis) in adults.

PURPOSE: Diagnosis of spondylodiscitis (SD) may be challenging due to the nonspecific clinical and laboratory findings and the need to perform various diagnostic tests including serologic, imaging, and microbiological examinations. Homogeneous management of SD diagnosis through international, multidisciplinary guidance would improve the sensitivity of diagnosis and lead to better patient outcome. METHODS: An expert specialist team, comprising nuclear medicine physicians appointed by the European Association of Nuclear Medicine (EANM), neuroradiologists appointed by the European Society of Neuroradiology (ESNR), and infectious diseases specialists appointed by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), reviewed the literature from January 2006 to December 2015 and proposed 20 consensus statements in answer to clinical questions regarding SD diagnosis. The statements were graded by level of evidence level according to the 2011 Oxford Centre for Evidence-based Medicine criteria and included in this consensus document for the diagnosis of SD in adults. The consensus statements are the result of literature review according to PICO (P:population/patients, I:intervention/indicator, C:comparator/control, O:outcome) criteria. Evidence-based recommendations on the management of adult patients with SD, with particular attention to radiologic and nuclear medicine diagnosis, were proposed after a systematic review of the literature in the areas of nuclear medicine, radiology, infectious diseases, and microbiology. RESULTS: A diagnostic flow chart was developed based on the 20 consensus statements, scored by level of evidence according to the Oxford Centre for Evidence-based Medicine criteria. CONCLUSIONS: This consensus document was developed with a final diagnostic flow chart for SD diagnosis as an aid for professionals in many fields, especially nuclear medicine physicians, radiologists, and orthopaedic and infectious diseases specialists.

A critical appraisal of the quality of low back pain practice guidelines using the AGREE II tool and comparison with previous evaluations: a EuroAIM initiative.

PURPOSE: To assess the methodologic quality of guidelines for the management of low back pain (LBP) and compare their recommendations. METHODS: No ethics committee approval was needed for this systematic review. In March 2017, a systematic search was performed using MEDLINE, EMBASE, National Guideline Clearinghouse, and National Institute for Health and Clinical Excellence to find practice guidelines of assessment and management of LBP. The evaluation of guidelines quality was performed independently by four authors using the AGREE II tool, and the results were compared with previous appraisals performed in 2004 and 2009. RESULTS: Of 114 retrieved guidelines, eight were appraised. All except one reached the level of "acceptable" in overall result, with two of them reaching the highest scores. Only two guidelines reached a level of "acceptable" in every domain; the others had at least one domain with low scores. The guidelines had the higher scores (range = 63-94%) on "Scope and purpose" and "Clarity of presentation" (47-89%). "Stakeholder Involvement" has the highest variability between the guidelines results (40-96%). "Rigor of Development" reached an intermediate mean result (34-90%), "Applicability" (42-70%), and "Editorial Independence" (38-85%). Only three guidelines had a radiologist among authors and reached higher scores compared to guidelines without a radiologist among the authors. Compared to previous assessments, low-level guidelines were 53% in 2004, 36% in 2009, and 13% in 2017. CONCLUSIONS: Considering all guidelines, only one had a "low" overall score, while half of them were rated as of "high" quality. Future guidelines might take this into account to improve clinical applicability.

Percutaneous removal and replacement of a novel percutaneous interspinous device.

Objective: The aim of this study is to explain the technique used for removing and replacing a novel percutaneous interspinous device (PID).Procedure: Three male patients, with a mean age of 66 years (range 62-72), were included in the study due to displacement (N = 2) or misplacement (N = 1) of the novel PID. This occurred after a mean of 23.3 ± 10.5 days from the initial placement (range 13-34) at the L4-L5 level (N = 1) and L3-L4 level (N = 2). Following the removal of the PID, four new devices were implanted.Conclusion: The novel PID can be safely removed either immediately after its placement during the procedure or after a certain period of days or months from its implantation. The removal procedure can be performed percutaneously under imaging guidance, by closing the four retractable wings, using the same instrumentation as utilized during the initial implantation.

Coccygeoplasty: preliminary experience with this new alternative treatment of refractory coccydynia in patients with coccyx hypermobility.

BACKGROUND: Coccydynia has many causes, including fracture, subluxation, and hypermobility of sacrococcygeal segments. Existing treatments are limited in their effectiveness. Coccygeoplasty (CP) is a relatively new, minimally invasive treatment that appears to address this difficult clinical challenge. OBJECTIVE: To describe clinical results at the time of the procedure and at 3- and 12-months' follow-up of patients with coccydynia related to subluxation and coccyx hypermobility treated with the CP technique. Additionally, to determine if there is any correlation between the final imaging and clinical results at 3- and 12-months' follow-up. METHODS: A prospectively maintained database was used, and all patients who underwent CP for chronic coccydynia between January 2005 and October 2018 were retrospectively reviewed. All the patients had painful hypermobility (greater than 25°) with anterior flexion confirmed on radiological imaging. Alternative causes of coccydynia were excluded using CT and MRI. Procedures were performed under local anesthesia with combined fluoroscopic and CT guidance. Clinical follow-up was performed at two time points: 3 and 12 months after treatment using the Visual Analogue Scale (VAS). RESULTS: Twelve patients were treated in a single center. No procedural complications occurred. At 3- and 12-months' follow-up, the majority (75%) of patients had significantly lower VAS scores than at baseline, with mean changes of 3.5 and 4.9, respectively. There was no pain recurrence at 12 months and just one patient had no improvement of the pain. Follow-up CT images confirmed fixation of the sacrococcygeal bone segments in nine patients; however, no correlation was found between final imaging results and clinical outcome (p=0.1). CONCLUSIONS: Patients with refractory painful coccyx subluxation and hypermobility undergoing CP have a favorable clinical response at 3- and 12-months' follow-up. Further studies are required to validate this technique and to identify predictors of treatment response. Coccygeoplasty may be considered a reasonable alternative to coccygectomy.

World federation of interventional and therapeutic neuroradiology (WFITN) federation assembly neurointerventional surgery safety checklist.

Over the last 10 years, there has been a rise in neurointerventional case complexity, device variety and physician distractions. Even among experienced physicians, this trend challenges our memory and concentration, making it more difficult to remember safety principles and their implications. Checklists are regarded by some as a redundant exercise that wastes time, or as an attack on physician autonomy. However, given the increasing case and disease complexity along with the number of distractions, it is even more important now to have a compelling reminder of safety principles that preserve habits that are susceptible to being overlooked because they seem mundane. Most hospitals have mandated a pre-procedure neurointerventional time-out checklist, but often it ends up being done in a cursory fashion for the primary purpose of 'checking off boxes'. There may be value in iterating the checklist to further emphasize safety and communication. The Federation Assembly of the World Federation of Interventional and Therapeutic Neuroradiology (WFITN) decided to construct a checklist for neurointerventional cases based on a review of the literature and insights from an expert panel.

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.

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.

Sacroplasty in a patient with bone metastases from hepatocellular carcinoma. A case report.

Bone metastases account for 10% to 30% of secondary tumors in all cancer types. In patients with primary hepatocellular carcinoma (HCC), bone metastases are usually treated by nonoperative procedures including pain medication, radiotherapy, hormone therapy, chemotherapy, and bisphosphonates. Surgical treatments include vertebrectomy, reconstruction with a cage or polymethylmethacrylate bone cement, and stabilization with pedicle screws. Sacroplasty to treat bone metastases from HCC has been rarely reported in the literature. We describe the case of a patient with vertebral metastases of HCC treated by this approach. A 65-year-old man had undergone a hepatic segmentectomy in 2004. In May 2008, after several weeks of back pain and bed rest, the patient underwent computed tomography and magnetic resonance imaging of the abdominal and pelvic spine, which revealed metastatic lesions in S1-S5 on the right and S1-S2 on the left. Sacroplasty was performed on all lesions without complications. The patient was discharged from the hospital the same day of the procedure. Two months later, he reported pain relief and improvement in walking. Due to the technical feasibility, low complication rate, and immediate relief of symptoms, sacroplasty for HCC metastases of the sacrum may be considered a valid therapeutic option.

Successful use of percutaneous interspinous spacers and adjunctive spinoplasty in a 9 year cohort of patients.

PURPOSE: Lumbar spinal canal stenosis and lumbar spinal foraminal stenosis are common, degenerative pathologies which can result in neurogenic claudication and have a negative impact on function and quality of life. Percutaneous interspinous devices (PIDs) are a recently-developed, minimally-invasive, alternative treatment option. This study details a 9 year single-centre experience with PIDs and examines the complementary use of spinous process augmentation (spinoplasty) to reduce failure rates. METHODS: A retrospective cohort assessment of 800 consecutive patients who presented to a specialized spine hospital was performed with 688 receiving treatment. Inclusion was based on high-grade stenosis, failure of conservative management and electromyography. 256 had a PID alone while 432 had concurrent polymethyl methacrylate (PMMA) augmentation of the adjacent spinous processes. The patients were followed up at 3 and 12 months using the Zurich Claudication Questionnaire (ZCQ) and Oswestry Disability Index (ODI). RESULTS: Both groups showed marked improvement in the patients' ZCQ scores (3.2 to 1.3) and ODI scores (32 to 21), with strong satisfaction results (1.7). The symptom recurrence rate from complications for the group which received concurrent spinous process augmentation was reduced when compared with the PID alone cohort (<1% vs 11.3%). CONCLUSION: This study demonstrates the efficacy of percutaneous interspinous devices in treating lumbar spinal stenosis. It also provides evidence that concurrent spinous process augmentation reduces the rate of symptom recurrence.

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.

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.