'Armed kyphoplasty' with posterior stabilization avoids corpectomy in complex thoracolumbar spine fractures: a case series.

BACKGROUND: Complex thoracolumbar fractures require reduction and stabilization. Posterior instrumentation alone and standard cement augmentation may represent undertreatment, while corpectomy has significant morbidity. In a series of unstable thoracolumbar fractures, we assessed the feasibility, safety, and results of 'armed kyphoplasty' (AKP) and surgical posterior stabilization (PS). METHODS: A total of 24 consecutive patients were treated with combined AKP and PS. Minimally invasive and open surgery techniques were used for PS. AKP was performed with C-arm or biplane fluoroscopic guidance, and screws were placed under navigation or fluoroscopic guidance. A postoperative CT scan and standing plain films were obtained. Patients were followed up according to clinical standards. Kyphosis correction (measured with regional Cobb angle), pain (measured with the Numeric Rating Scale), neurological status (measured with Frankel grade) were assessed. RESULTS: A total of 25 fractures of neoplastic (40%), traumatic (32%), and osteoporotic (28%) nature were treated. Open surgery and minimally invasive techniques were applied in 16/24 and 8/24 patients, respectively. Decompressive laminectomy was performed in 13 cases. No intraprocedural complications occurred. Two patients (8%) died due to underlying disease complications and three complications (12%) required re-intervention (one surgical site infection, one adjacent fracture, and one screw pull-out) in the first month. The mean Cobb angle was 20.14±6.19° before treatment and 11.66±5.24° after treatment (P<0.0001). No re-fractures occurred at the treated levels. CONCLUSIONS: Combined AKP and PS is feasible and effective in the treatment of complex thoracolumbar fractures of all etiologies. AKP avoided highly invasive corpectomy. Anterior and posterior support ensured stability, preventing implant failure and re-fracture. The complication rate was low compared with more invasive traditional 360° open surgical approaches.

Prevalence of amyloid in ligamentum flavum of patients with lumbar spinal stenosis.

BACKGROUND: Transthyretin (ATTR) amyloidosis is often diagnosed in an advanced stage, when irreversible cardiac damage has occurred. Lumbar spinal stenosis (LSS) may precede cardiac ATTR amyloidosis by many years, offering the opportunity to detect ATTR already at the time of LSS surgery. We prospectively assessed the prevalence of ATTR in the ligamentum flavum by tissue biopsy in patients aged >50 years undergoing surgery for LSS. METHODS: Ligamentum flavum thickness was assessed pre-operatively on axial T2 magnetic resonance imaging (MRI) slices. Tissue samples from ligamentum flavum were screened centrally by Congo red staining and immunohistochemistry (IHC). RESULTS: Amyloid in the ligamentum flavum was detected in 74/94 patients (78.7%). IHC revealed ATTR in 61 (64.9%), whereas amyloid subtyping was inconclusive in 13 (13.8%). Mean thickness of ligamentum flavum was significantly higher at all levels in patients with amyloid (p < .05). Patients with amyloid deposits were older (73.1 ± 9.2 vs. 64.6 ± 10.1 years, p = .01). No differences in sex, comorbidities, previous surgery for carpal tunnel syndrome or LSS were observed. CONCLUSIONS: Amyloid, mostly of the ATTR subtype, was found in four out of five patients with LSS and is associated with age and ligamentum flavum thickness. Histopathological work-up of ligamentum flavum might inform future decision making.

Image quality and radiation dose in spinal surgery: a comparison of three imaging systems in phantom.

Purpose: Using optimal settings for x-ray scans is crucial for obtaining three-dimensional images of high quality while keeping the patient dose low. Our work compares dose and image quality (IQ) of three intraoperative imaging systems [O-arm cone-beam computed tomography (CBCT), ClarifEye C-arm CBCT, and Airo computed tomography] used for spinal surgery. Approach: Patients of 70, 90, and 110 kg were simulated with an anthropomorphic phantom by adding tissue-equivalent material. Titanium inserts were placed in the phantom spine for reproducing metal artifacts in the images. Organ dose was measured with thermo-luminescent dosimeters for effective dose (E) calculation. Subjective IQ was assessed by ranking the images acquired with the manufacturer-defined imaging protocols. Objective IQ was assessed with a customized Catphan phantom. Results: The ClarifEye protocols resulted in the lowest E ranging from 1.4 to 5.1 mSv according to phantom size and protocol. The highest E was measured for the high-definition protocol of O-arm (E 2.2 to 9 mSv) providing the best subjective IQ for imaging of the spine without titanium inserts. For the images with metal, the best IQ was obtained with ClarifEye. Airo (E 5.5 to 8.4 mSv) was ranked with the lowest IQ for images without metal while the rank improved for images with metal. Airo images had better uniformity, noise, and contrast sensitivity compared with CBCTs but worse high-contrast resolution. The values of these parameters were comparable between the CBCT systems. Conclusions: Both CBCT systems provided better IQ compared with Airo for navigation of lumbar spinal surgery for the original phantom. Metal artifacts particularly affect O-arm images decreasing the subjective IQ. The high spatial resolution of CBCT systems resulted in a relevant parameter for the visibility of anatomical features important for spine navigation. Low dose protocols were enough to obtain a clinically acceptable contrast-to-noise ratio in the bones.

The effect of perioperative psychological interventions on persistent pain, disability, and quality of life in patients undergoing spinal fusion: a systematic review.

PURPOSE: Patients undergoing spinal fusion are prone to develop persisting spinal pain that may be related to pre-existent psychological factors. The aim of this review was to summarize the existing evidence about perioperative psychological interventions and to analyze their effect on postoperative pain, disability, and quality of life in adult patients undergoing complex surgery for spinal disorders. Studies investigating any kind of psychological intervention explicitly targeting patients undergoing a surgical fusion on the spine were included. METHODS: We included articles that analyzed the effects of perioperative psychological interventions on either pain, disability, and/or quality of life in adult patients with a primary diagnosis of degenerative or neoplastic spinal disease, undergoing surgical fusion of the spine. We focused on interventions that had a clearly defined psychological component. Two independent reviewers used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) to perform a systematic review on different databases. Risk of bias was evaluated using the Downs and Black checklist. Given study differences in outcome measures and interventions administered, a meta-analysis was not performed. Instead, a qualitative synthesis of main results of included papers was obtained. RESULTS: Thirteen studies, conducted between 2004 and 2017, were included. The majority were randomized-controlled trials (85%) and most patients underwent lumbar fusion (92%). Cognitive behavioral therapy (CBT) was used in nine studies (69%). CBT in the perioperative period may lead to a postoperative reduction in pain and disability in the short-term follow-up compared to care as usual. There was less evidence for an additional effect of CBT at intermediate and long-term follow-up. CONCLUSION: The existing evidence suggests that a reduction in pain and disability in the short-term, starting from immediately after surgery to 3 months, is likely to be obtained when a CBT approach is used. However, there is inconclusive evidence regarding the long-term effect of a perioperative psychological intervention after spinal fusion surgery. Further research is necessary to better define the frequency, intensity, and timing of such an approach in relation to the surgical intervention, to be able to maximize its effect and be beneficial to patients.

Percutaneous thoraco-lumbar-sacral pedicle screw placement accuracy results from a multi-center, prospective clinical study using a skin marker-based optical navigation system.

STUDY DESIGN: Prospective multi-center study. OBJECTIVE: The study aimed to evaluate the accuracy of pedicle screw placement using a skin marker-based optical surgical navigation system for minimal invasive thoraco-lumbar-sacral pedicle screw placement. METHODS: The study was performed in a hybrid Operating Room with a video camera-based navigation system integrated in the imaging hardware. The patient was tracked with non-invasive skin markers while the instrument tracking was via an on-shaft optical marker pattern. The screw placement accuracy assessment was performed by three independent reviewers, using the Gertzbein grading. The screw placement time as well as the staff and patient radiation doses was also measured. RESULTS: In total, 211 screws in 39 patients were analyzed for screw placement accuracy. Of these 32.7% were in the thoracic region, 59.7% were in the lumbar region, and 7.6% were in the sacral region. An overall accuracy of 98.1% was achieved. No screws were deemed severely misplaced (Gertzbein grading 3). The average time for screw placement was 6 min and 25 secs (± 3 min 33 secs). The average operator radiation dose per subject was 40.3 µSv. The mean patient effective dose (ED) was 11.94 mSv. CONCLUSION: Skin marker-based ON can be used to achieve very accurate thoracolumbarsacral pedicle screw placements.

Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial.

INTRODUCTION: Discogenic pain is the cause of pain in 26%-40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel 'GelStix' is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation. We hypothesise that treatment with GelStix will lead to greater reduction in pain intensity at 6 months post-treatment compared with patients receiving sham treatment. METHODS AND ANALYSIS: This is a parallel group, randomised sham-controlled double-blind, multicentre trial to assess whether the GelStix device is superior to sham in reducing pain intensity in patients with chronic discogenic low back pain. The study will be conducted in two regional hospitals in Europe. Seventy-two participants will be randomised in a 1:1 ratio. The primary outcome will be the change in pain intensity between preoperative baseline and at 6 months postintervention. Secondary outcomes were disability, quality of life, the patient's global impression of change scale, the use of pain medication and the disc degeneration process assessed by means of MRI. For change in pain intensity, disability, health-related quality of life and disc height, mean values will be compared between groups using linear regression analysis, adjusted for treatment centre. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE2982) and by the Medical Ethical Committee Arnhem-Nijmegen, the Netherlands (2016-2944). All patients that agree to participate will be asked to sign an informed consent form. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. TRIAL REGISTRATION NUMBER: NCT02763956. PROTOCOL VERSION: 7.1, 18 November 2020.

Intradiscal oxygen-ozone chemonucleolysis versus microdiscectomy for lumbar disc herniation radiculopathy: a non-inferiority randomized control trial.

BACKGROUND CONTEXT: Low back pain with or without radicular leg pain is an extremely common health condition significantly impacting patient's activities and quality of life. When conservative management fails, epidural injections providing only temporary relief, are frequently utilized. Intradiscal oxygen-ozone may offer an alternative to epidural injections and further reduce the need for microdiscectomy. PURPOSE: To compare the non-inferiority treatment status and clinical outcomes of intradiscal oxygen-ozone with microdiscectomy in patients with refractory radicular leg pain due to single-level contained lumbar disc herniations. STUDY DESIGN / SETTING: Multicenter pilot prospective non-inferiority blocked randomized control trial conducted in three European hospital spine centers. PATIENT SAMPLE: Forty-nine patients (mean 40 years of age, 17 females/32 males) with a single-level contained lumbar disc herniation, radicular leg pain for more than six weeks, and resistant to medical management were randomized, 25 to intradiscal oxygen-ozone and 24 to microdiscectomy. 88% (43 of 49) received their assigned treatment and constituted the AS-Treated (AT) population. OUTCOME MEASURES: Primary outcome was overall 6-month improvement over baseline in leg pain. Other validated clinical outcomes, including back numerical rating pain scores (NRS), Roland Morris Disability Index (RMDI) and EQ-5D, were collected at baseline, 1 week, 1-, 3-, and 6-months. Procedural technical outcomes were recorded and adverse events were evaluated at all follow-up intervals. METHODS: Oxygen-ozone treatment performed as outpatient day surgeries, included a one-time intradiscal injection delivered at a concentration of 35±3 µg/cc of oxygen-ozone by a calibrated delivery system. Discectomies performed as open microdiscectomy inpatient surgeries, were without spinal instrumentation, and not as subtotal microdiscectomies. Primary analyses with a non-inferiority margin of -1.94-point difference in 6-month cumulative weighted mean leg pain NRS scores were conducted using As-Treated (AT) and Intent-to-Treat (ITT) populations. In post hoc analyses, differences between treatment groups in improvement over baseline were compared at each follow-up visit, using baseline leg pain as a covariate. RESULTS: In the primary analysis, the overall 6-month difference between treatment groups in leg pain improvement using the AT population was -0.31 (SE, 0.84) points in favor of microdiscectomy and using the ITT population, the difference was 0.32 (SE, 0.88) points in favor of oxygen-ozone. The difference between oxygen-ozone and microdiscectomy did not exceed the non-inferiority 95% confidence lower limit of treatment difference in either the AT (95% lower limit, -1.72) or ITT (95% lower limit, -1.13) populations. Both treatments resulted in rapid and statistically significant improvements over baseline in leg pain, back pain, RMDI, and EQ-5D that persisted in follow-up. Between group differences were not significant for any outcomes. During 6-month follow-up, 71% (17 of 24) of patients receiving oxygen-ozone, avoided microdiscectomy. The mean procedure time for oxygen-ozone was significantly faster than microdiscectomy by 58 minutes (p<.0010) and the mean discharge time from procedure was significantly shorter for the oxygen-ozone procedure (4.3±2.9 hours vs. 44.2±29.9 hours, p<.001). No major adverse events occurred in either treatment group. CONCLUSIONS: Intradiscal oxygen-ozone chemonucleolysis for single-level lumbar disc herniations unresponsive to medical management, met the non-inferiority criteria to microdiscectomy on 6-month mean leg pain improvement. Both treatment groups achieved similar rapid significant clinical improvements that persisted and overall, 71% undergoing intradiscal oxygen-ozone were able to avoid surgery.

Use of Intraoperative Computed Tomography Improves Outcome of Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Single-Center Retrospective Cohort Study.

OBJECTIVE: To provide data about surgical workflow, accuracy, complications, radiation exposure, and learning curve effect in patients who underwent minimally invasive (MIS) transforaminal lumbar interbody fusion with navigation coupled with mobile intraoperative computed tomography. METHODS: A retrospective analysis was performed of data from consecutive patients who underwent single- or double-level MIS transforaminal lumbar interbody fusion at a single institution; mobile intraoperative computed tomography combined with a navigation system was used as the sole intraoperative imaging method to place pedicular screws; decompression and interbody fusion were performed through a 22-mm tubular retractor. Clinical data, perioperative complications, accuracy of pedicular screw placement, and radiation exposure were analyzed. A learning curve effect on surgical time and accuracy was assessed. RESULTS: A total of 408 screws in 100 patients were analyzed. In all cases, spinal navigation allowed for identification of pedicular trajectories and greatly facilitated nerve root decompression through the MIS approach. Overall accuracy according to Heary classification was 95.3%. Nineteen screws (4.7%) presented a minor lateral breach (<2 mm), not clinically significant. Surgical time, blood loss, and patient radiation exposure compared favorably with reported values from other series using three-dimensional navigation. A learning curve effect on surgical time, but not on screw accuracy, was identified. CONCLUSIONS: MIS transforaminal lumbar interbody fusion can now be performed without any radiation exposure to the surgeon and operating room staff, with almost absolute accuracy during screw positioning and tubular decompression. A learning curve effect on surgical time, but not on overall screw accuracy, may be expected.

The 'armed concrete' approach: stent-screw-assisted internal fixation (SAIF) reconstructs and internally fixates the most severe osteoporotic vertebral fractures.

BACKGROUND: The treatment of severe osteoporotic vertebral compression fractures (VCFs) with middle-column (MC) involvement, high fragmentation, large cleft and/or pedicular fracture is challenging. Minimally invasive 'stent-screw-assisted internal fixation' (SAIF) can reduce the fracture, reconstruct the vertebral body (VB) and fix it to the posterior elements. OBJECTIVE: To assess feasibility, safety, technical and clinical outcome of the SAIF technique in patients with severe osteoporotic VCFs. METHODS: 80 treated vertebrae were analyzed retrospectively. Severe VCFs were characterized by advanced collapse (Genant grade 3), a high degree of osseous fragmentation (McCormack grade 2 and 3), burst morphology with MC injury, pediculo-somatic junction fracture, and/or large osteonecrotic cleft. VB reconstruction was evaluated on postprocedure radiographs and CT scans by two independent raters. Clinical and radiological follow-ups were performed at 1 and 6 months. RESULTS: SAIF was performed at 28 thoracic and 52 lumbar levels in 73 patients. One transient neurological complication occurred. VB reconstruction was satisfactory in 98.8% of levels (inter-rater reliability 96%, κ=1). Follow-up at 1 month was available for 78/80 levels and at 6 months or later (range 6-24, mean 7.9 months) for 73/80 levels. Significant improvement in the Visual Analog Scale score was noted at 1 and 6 months after treatment (p<0.05). Patients reported global clinical benefit during follow-up (Patient's Global Impression of Change Scale 5.6±0.9 at 1 month and 6.1±0.9 at 6 months). Fourteen new painful VCFs occurred at different levels in 11 patients during follow-up, treated with vertebral augmentation or SAIF. Target-level stability was maintained in all cases. CONCLUSIONS: SAIF is a minimally invasive, safe, and effective treatment for patients with severe osteoporotic VCFs with MC involvement.

Use of Intraoperative CT Improves Accuracy of Spinal Navigation During Screw Fixation in Cervico-thoracic Region.

STUDY DESIGN: A retrospective analysis of a single-center consecutive series of patients. OBJECTIVE: To test the hypothesis that using a mobile intraoperative computed tomography in combination with spinal navigation would result in better accuracy of lateral mass and pedicle screws between C3 and T5 levels, compared to cone-beam computed tomography and traditional 2D fluoroscopy. SUMMARY OF BACKGROUND DATA: Use of spinal navigation associated with 3D imaging has been shown to improve accuracy of screw positioning in the cervico-thoracic region. However, use of iCT imaging compared to a cone-beam CT has not been fully investigated in these types of surgical interventions. METHODS: We retrospectively analyzed a series of patients who underwent posterior cervico-thoracic fixations using different intraoperative imaging systems in a single hospital. We identified three different groups of patients: Group A, operated under 2D-fluoroscopic guidance without navigation; Group B: O-arm guidance with navigation; Group C: iCT AIRO guidance with navigation. Primary outcome was the rate of accurately placed screws, measured on intra or postoperative CT scan with Neo et al. classification for cervical pedicles screws and Gertzbein et al. for thoracic pedicle screws. Screws in cervical lateral masses were evaluated according to a new classification created by the authors. RESULTS: Data on 67 patients and 495 screws were available. Overall screw accuracy was 92.8% (95.6% for lateral mass screws, 81.6% for cervical pedicle screws, and 90% for thoracic pedicle screws). Patients operated with iCT AIRO navigation had significantly fewer misplaced screws (2.4%) compared to 2D-fluoroscopic guidance (9.1%) and O-arm navigation (9.7%) (P = 0.0152). Accuracy rate of iCT navigation versus O-arm navigation was significantly higher (P = 0.0042), and there was no statistically significant difference in surgical time between the three Groups (P = 0.5390). CONCLUSION: Use of high-quality CT associated with spinal navigation significantly improved accuracy of screw positioning in the cervico-thoracic region.Level of Evidence: 3.

Effective dose and image quality for intraoperative imaging with a cone-beam CT and a mobile multi-slice CT in spinal surgery: A phantom study.

PURPOSE: To compare the effective dose (ED) and image quality (IQ) of O-arm cone-beam CT (Medtronic, Minneapolis, MN, USA) and Airo multi-slice CT (Brainlab AG, Munich, Germany) for intraoperative-CT (i-CT) in spinal surgery. METHODS: The manufacturer-defined protocols available in the O-arm and Airo systems for three-dimensional lumbar spine imaging were compared. Organ dose was measured both with thermo-luminescent dosimeters and GafChromic films in the Alderson RadiationTherapy anthropomorphic phantom. A subjective analysis was performed by neurosurgeons to compare the clinical IQ of the anthropomorphic phantom images acquired with the different i-CT systems and imaging protocols. Image uniformity, noise, contrast-to-noise-ratio (CNR), and spatial resolution were additionally assessed with the Catphan 504 phantom. RESULTS: O-arm i-CT caused 56% larger ED than Airo due to the high definition (HD) imaging protocol. The noise was larger for O-arm images leading to a lower CNR than that measured for Airo. Moreover, scattering and beam hardening effects were observed in the O-arm images. Better spatial resolution was measured for the O-arm system (9 lp/cm) than for Airo (4 lp/cm). For all the investigated protocols, O-arm was found to be better for identifying anatomical features important for accurate pedicle screw positioning. CONCLUSIONS: According to phantom measurements, the HD protocol of O-arm offered better clinical IQ than Airo but larger ED. The larger noise of O-arm images did not compromise the clinical IQ while the superior spatial resolution of this system allowed a better visibility of anatomical features important for pedicle screw positioning in the lumbar region.

Cervical Radiculopathy Caused by a Vertebral Artery Loop: Is a Focused Fluoroscopic-Guided Cervical Epidural Steroid Injection a Possible Treatment Modality?

We describe a case of a patient suffering with cervical radiculopathy due to vertebral artery loop with nerve root compression, treated with an epidural steroid injection. A 37-year-old man presented with a 2-year history of right-sided radicular pain along the C7 dermatome. Imaging showed a right-sided loop of the vertebral artery at the V1-V2 transition with contact on the C7 nerve root. The pain was resistant to conservative treatment, and the decision was made to perform a focused fluoroscopy-guided translaminar epidural steroid injection near the C7 nerve root. The procedure was uneventful, and the symptoms resolved completely after the procedure. Targeted epidural steroid injection might be a useful and safe diagnostic and therapeutic approach in patients affected by cervical radiculopathy due to a VA loop. To our knowledge, this is the first case of a VA loop associated with cervical radiculopathy treated with this technique.

Stent screw-assisted internal fixation (SAIF): clinical report of a novel approach to stabilizing and internally fixating vertebrae destroyed by malignancy.

OBJECTIVE: Severe lytic cancerous lesions of the spine are associated with significant morbidity and treatment challenges. Stabilization and restoration of the axial load capability of the vertebral body (VB) are important to prevent or arrest vertebral collapse. Percutaneous stent screw-assisted internal fixation (SAIF), which anchors a VB stent/cement complex with pedicular screws to the posterior vertebral elements, is a minimally invasive, image-guided, 360° internal fixation technique that can be utilized in this patient cohort. The purpose of this study was to assess the feasibility, safety, and stabilization efficacy of VB reconstruction via the SAIF technique in a cohort of patients with extensive lytic vertebral lesions, who were considered to have an unstable or potentially unstable spine according to the Spinal Instability Neoplastic Score (SINS). METHODS: This study was a retrospective assessment of a prospectively maintained database of a consecutive series of patients with neoplastic extensive extracompartmental osteolysis (Tomita type 4-6) of the VB treated with the SAIF technique. VB reconstruction was assessed on postprocedure plain radiographs and CT by two independent raters. Technical and clinical complications were recorded. Clinical and imaging follow-ups were assessed. RESULTS: Thirty-five patients with extensive osteolytic metastatic lesions of the VB underwent 36 SAIF procedures. SAIF was performed as a stand-alone procedure in 31/36 cases and was associated with posterior surgical fixation in 5/36 (4/5 with decompressive laminectomy). In 1 case an epidural cement leak required surgical decompression. VB reconstruction was categorized as satisfactory (excellent or good rating) by the two raters in 34/36 cases (94.5%) with an interrater reliability of 94.4% (Cohen's kappa of 0.8). Follow-up, ranging from 1 to 30 months, was available for 30/36 levels. Long-term follow-up (6-30 months, mean 11.5 months) was available for 16/36 levels. Stability during follow-up was noted in 29/30 cases. CONCLUSIONS: SAIF provides 360° nonfusion internal fixation that stabilizes the VB in patients with extensive lytic lesions that would otherwise be challenging to treat.

Vertebral body stent augmentation to reconstruct the anterior column in neoplastic extreme osteolysis.

BACKGROUND: Extensive lytic lesions of the vertebral body (VB) increase risk of fracture and instability and require stabilization of the anterior column. Vertebral augmentation is an accepted treatment option, but when osteolysis has extensively destroyed the VB cortical boundaries (a condition herein defined as 'extreme osteolysis'), the risk of cement leakage and/or insufficient filling is high. Vertebral body stents (VBSs) might allow partial restoration of VB height, cement containment, and reinforcement, but their use in extreme osteolysis has not been investigated. OBJECTIVE: To assess retrospectively the feasibility and safety of VBS augmentation in patients with 'extreme osteolysis' of the VB. METHODS: We retrospectively analyzed 41 treated vertebrae (from T1 to L5). VB reconstruction was assessed on postprocedure CT images and rated on a qualitative 4-point scale (poor-fair-good-excellent). Clinical and radiological follow-up was performed at 1 month and thereafter at intervals in accordance with oncological protocols. RESULTS: VBS augmentation was performed at 12 lumbar and 29 thoracic levels, with bilateral VBS in 23/41. VB reconstruction was judged satisfactory (good or excellent) in 37/41 (90%) of levels. Bilateral VBS received higher scores than unilateral (p=0.057, Pearson's X2). We observed no periprocedural complications. Cement leaks (epidural or foraminal) occurred at 5/41 levels (12.2%) without clinical consequences. Follow-up data were available for 27/29 patients, extending beyond 6 months for 20 patients (7-28 months, mean 15.3 months). VBS implant stability was observed in 40/41 cases (97.5%). CONCLUSIONS: Our results support the use of VBS as a minimally invasive, safe and effective option for reconstructing the anterior column in prominent VB osteolysis.

Stent-screw-assisted internal fixation: the SAIF technique to augment severe osteoporotic and neoplastic vertebral body fractures.

OBJECTIVES: To describe a new technique to obtain minimally invasive but efficient vertebral body (VB) reconstruction, augmentation, and stabilization in severe osteoporotic and neoplastic fractures, combining two pre-existing procedures. The implant of vertebral body stents (VBS) is followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws that act as anchors to the posterior elements for the cement/stent complex. The screws reduce the risk of stent mobilization in a non-intact VB cortical shell and bridge middle column and pedicular fractures. This procedure results in a 360° non-fusion form of vertebral internal fixation that may empower vertebral augmentation and potentially avoid corpectomy in challenging fractures. PROCEDURE DETAILS: This report provides step-by-step procedural details, rationale, and proposed indications for this procedure. The procedure is entirely percutaneous under fluoroscopic guidance. Through transpedicular trocars the VBS are inserted, balloon-expanded and implanted in the VB. Over k-wire exchange the transpedicular screws are inserted inside the lumen of the stents and cement is injected through the screws to augment the stents and fuse the screws to the stents. APPLICATIONS: This technique may find appropriate applications for the most severe osteoporotic fractures with large clefts, high-degree fragmentation and collapse, middle column and pedicular involvement, and in extensive neoplastic lytic lesions. CONCLUSIONS: Stent-Screw-Assisted Internal Fixation (SAIF) might represent a minimally invasive option to obtain VB reconstruction and restoration of axial load capability in severe osteoporotic and neoplastic fractures, potentially obviating the need for more invasive surgical interventions in situations that would pose significant challenges to standard vertebroplasty or balloon kyphoplasty.

Use of the Airo mobile intraoperative CT system versus the O-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients.

OBJECTIVE: Navigation-enabling technology such as 3D-platform (O-arm) or intraoperative mobile CT (iCT-Airo) systems for use in spinal surgery has considerably improved accuracy over that of traditional fluoroscopy-guided techniques during pedicular screw positioning. In this study, the authors compared 2 intraoperative imaging systems with navigation, available in their neurosurgical unit, in terms of the accuracy they provided for transpedicular screw fixation in the thoracic and lumbar spine. METHODS: The authors performed a retrospective analysis of clinical and surgical data of 263 consecutive patients who underwent thoracic and lumbar spine screw placement in the same center. Data on 97 patients who underwent surgery with iCT-Airo navigation (iCT-Airo group) and 166 with O-arm navigation (O-arm group) were analyzed. Most patients underwent surgery for a degenerative or traumatic condition that involved thoracic and lumbar pedicle screw fixation using an open or percutaneous technique. The primary endpoint was the proportion of patients with at least 1 screw not correctly positioned according to the last intraoperative image. Secondary endpoints were the proportion of screws that were repositioned during surgery, the proportion of patients with a postoperative complication related to screw malposition, surgical time, and radiation exposure. A blinded radiologist graded screw positions in the last intraoperative image according to the Heary classification (grade 1-3 screws were considered correctly placed). RESULTS: A total of 1361 screws placed in 97 patients in the iCT-Airo group (503 screws) and in 166 in the O-arm group (858 screws) were graded. Of those screws, 3 (0.6%) in the iCT-Airo group and 4 (0.5%) in the O-arm group were misplaced. No statistically significant difference in final accuracy between these 2 groups or in the subpopulation of patients who underwent percutaneous surgery was found. Three patients in the iCT-Airo group (3.1%, 95% CI 0%-6.9%) and 3 in the O-arm group (1.8%, 95% CI 0%-4.0%) had a misplaced screw (Heary grade 4 or 5). Seven (1.4%) screws in the iCT-Airo group and 37 (4.3%) in the O-arm group were repositioned intraoperatively (p = 0.003). One patient in the iCT-Airo group and 2 in the O-arm group experienced postoperative neurological deficits related to hardware malposition. The mean surgical times in both groups were similar (276 [iCT-Airo] and 279 [O-arm] minutes). The mean exposure to radiation in the iCT-Airo group was significantly lower than that in the O-arm group (15.82 vs 19.12 mSv, respectively; p = 0.02). CONCLUSIONS: Introduction of a mobile CT scanner reduced the rate of screw repositioning, which enhanced patient safety and diminished radiation exposure for patients, but it did not improve overall accuracy compared to that of a mobile 3D platform.

Perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and non-cardiac surgery: a consensus document from Italian cardiological, surgical and anaesthesiological societies.

Optimal perioperative antiplatelet therapy in patients with coronary stents undergoing surgery still remains poorly defined and a matter of debate among cardiologists, surgeons and anaesthesiologists. Surgery represents one of the most common reasons for premature antiplatelet therapy discontinuation, which is associated with a significant increase in mortality and major adverse cardiac events, in particular stent thrombosis. Clinical practice guidelines provide little support with regard to managing antiplatelet therapy in the perioperative phase in the case of patients with non-deferrable surgical interventions and/or high haemorrhagic risk. Moreover, a standard definition of ischaemic and haemorrhagic risk has never been determined. Finally, recommendations shared by cardiologists, surgeons and anaesthesiologists are lacking. The present consensus document provides practical recommendations on the perioperative management of antiplatelet therapy in patients with coronary stents undergoing surgery. Cardiologists, surgeons and anaesthesiologists have contributed equally to its creation. On the basis of clinical and angiographic data, the individual thrombotic risk has been defined. All surgical interventions have been classified according to their inherent haemorrhagic risk. A consensus on the optimal antiplatelet regimen in the perioperative phase has been reached on the basis of the ischaemic and haemorrhagic risk. Aspirin should be continued perioperatively in the majority of surgical operations, whereas dual antiplatelet therapy should not be withdrawn for surgery in the case of low bleeding risk. In selected patients at high risk for both bleeding and ischaemic events, when oral antiplatelet therapy withdrawal is required, perioperative treatment with short-acting intravenous glycoprotein IIb/IIIa inhibitors (tirofiban or eptifibatide) should be taken into consideration.