Middle column Stent-screw Assisted Internal Fixation (SAIF): a modified minimally-invasive approach to rescue vertebral middle column re-fractures.

BACKGROUND: There is limited literature regarding the re-fracture of a previously augmented vertebral compression fracture (VCF). These re-fractures may present as an asymptomatic remodeling of the vertebral body around the cement cast while in other cases they involve the middle column, at the transition zone between the cement-augmented and non-augmented vertebral body. In the latter, a posterior wall retropulsion is possible and, if left untreated, might progress to vertebral body splitting, central canal stenosis, and kyphotic deformity. There is no consensus regarding the best treatment for these re-fractures. There are cases in which a repeated augmentation relieves the pain, but this is considered an undertreatment in cases with middle column involvement, posterior wall retropulsion, and kyphosis. METHODS: We report four cases of re-fracture with middle column collapse of a previously augmented VCF, treated with the stent-screw assisted internal fixation (SAIF) technique. A modified more postero-medial deployment of the anterior metallic implants was applied, to target the middle column fracture. This modified SAIF allowed the reduction and stabilization of the middle column collapse as well as the partial correction of the posterior wall retropulsion and kyphosis. RESULTS: Complete relief of back pain with stable clinical and radiographic findings at follow-up was obtained in all cases. CONCLUSIONS: In selected cases, the middle column SAIF technique is safe and effective for the treatment of the re-fracture with middle column collapse of a previously cement-augmented VCF. This technique requires precision in trocar placement and could represent a useful addition to the technical armamentarium for VCF treatment.

Safety and Effectiveness of Cell Therapy in Neurodegenerative Diseases: Take-Home Messages From a Pilot Feasibility Phase I Study of Progressive Supranuclear Palsy.

Mesenchymal stromal cells (MSCs) are multipotent cells with anti-inflammatory properties. Here we tested the safety of MSCs in patients with progressive supranuclear palsy (PSP; ClinicalTrials.gov: NCT01824121; Eudract No. 2011-004051-39). Seven patients were treated. To improve the safety, protocol adjustments were made during the performance of the study. The objectives of our work were: (1) to assess the safety of MSCs and (2) to identify critical issues in cell therapies for neurodegenerative diseases. Autologous MSCs from the bone marrow of PSP patients were administered through the internal carotid arteries. 1-year survival and number of severe adverse events were considered as safety endpoints. Clinical rating scales, neuropsychological assessments, gait and posture analysis, single-photon emission computed tomography, positron emission tomography, and brain magnetic resonance (BMR) were performed at different follow-up times. Peripheral blood levels of inflammatory cytokines were measured before and after cell infusion. Six of the seven treated patients were living 1 year after cell infusion. Asymptomatic spotty lesions were observed at BMR after 24 h in six of the seven treated patients. The last patient in the preliminary cohort (Case 5) exhibited transiently symptomatic BMR ischemic alterations. No severe adverse events were recorded in the last two treated patients. Interleukin-8 serum concentrations decreased in three patients (Case 2, 3, and 4). An adaptive study design, appropriate and up-to-date efficacy measures, adequate sample size estimation, and, possibly, the use of a cellular and/or allogeneic cell sources may help in performing phase II trials in the field.

Stellate ganglion block combined with intra-arterial treatment: a "one-stop shop" for cerebral vasospasm after aneurysmal subarachnoid hemorrhage-a pilot study.

PURPOSE: Delayed cerebral ischemia (DCI) is a frequent cause of morbidity and mortality in patients with cerebral vasospasm (CV) following aneurysmal subarachnoid hemorrhage (aSAH). Refractory CV remains challenging to treat and often leads to permanent deficits and death despite aggressive therapy. We hereby report the feasibility and safety of stellate ganglion block (SGB) performed with a vascular roadmap-guided technique to minimize the risk of accidental vascular puncture and may be coupled to a diagnostic or therapeutic cerebral angiography. METHODS: In addition to a detailed description of the technique, we performed a retrospective analysis of a series of consecutive patients with refractory CV after aSAH that were treated with adjuvant roadmap-guided SGB. Clinical outcomes at discharge are reported. RESULTS: Nineteen SGB procedures were performed in 10 patients, after failure of traditional hemodynamic and endovascular treatments. Each patient received 1 to 3 SGB, usually interspaced by 24 h. In 4 patients, an indwelling microcatheter for continuous infusion was inserted. First SGB occurred on average 7.3 days after aSAH. SGB was coupled to intra-arterial nimodipine infusion or balloon angioplasty in 9 patients. SGB was technically successful in all patients. There were no technical or clinical complications. CONCLUSION: Adjuvant SGB may be coupled to endovascular therapy to treat refractory cerebral vasopasm within the same session. To guide needle placement, using a roadmap of the supra-aortic arteries may decrease the risk of complications. More prospective data is needed to evaluate the therapeutic efficacy, durability, and safety of SGB compared with the established standard of care.

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.

Mechanical Cavity Creation with Curettage and Vacuum Suction (Q-VAC) in Lytic Vertebral Body Lesions with Posterior Wall Dehiscence and Epidural Mass before Cement Augmentation.

Background and Objectives: We describe a novel technique for percutaneous tumor debulking and cavity creation in patients with extensive lytic lesions of the vertebral body including posterior wall dehiscence prior to vertebral augmentation (VA) procedures. The mechanical cavity is created with a combination of curettage and vacuum suction (Q-VAC). Balloon kyphoplasty and vertebral body stenting are used to treat neoplastic vertebral lesions and might reduce the rate of cement leakage, especially in presence of posterior wall dehiscence. However, these techniques could theoretically lead to increased intravertebral pressure during balloon inflation with possible mobilization of soft tissue tumor through the posterior wall, aggravation of spinal stenosis, and resultant complications. Creation of a void or cavity prior to balloon expansion and/or cement injection would potentially reduce these risks. Materials and Methods: A curette is coaxially inserted in the vertebral body via transpedicular access trocars. The intravertebral neoplastic soft tissue is fragmented by multiple rotational and translational movements. Subsequently, vacuum aspiration is applied via one of two 10 G cannulas that had been introduced directly into the fragmented lesion, while saline is passively flushed via the contralateral cannula, with lavage of the fragmented solid and fluid-necrotic tumor parts. Results: We applied the Q-VAC technique to 35 cases of thoracic and lumbar extreme osteolysis with epidural mass before vertebral body stenting (VBS) cement augmentation. We observed extravertebral cement leakage on postoperative CT in 34% of cases, but with no clinical consequences. No patients experienced periprocedural respiratory problems or new or worsening neurological deficit. Conclusion: The Q-VAC technique, combining mechanical curettage and vacuum suction, is a safe, inexpensive, and reliable method for percutaneous intravertebral tumor debulking and cavitation prior to VA. We propose the Q-VAC technique for cases with extensive neoplastic osteolysis, especially if cortical boundaries of the posterior wall are dehiscent and an epidural soft tissue mass is present.

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.

Acute hemifacial ischemia as a late complication of carotid stenting.

Concerns about carotid artery stenting (CAS) center primarily on procedural complications like acute occlusion, stroke, and long-term intrastent restenosis. External carotid artery (ECA) thrombosis is observed during CAS follow-up, but it often remains asymptomatic or, at worst, results in jaw claudication. We report here a case of late occlusion of the ECA after CAS with symptoms of acute homolateral facial ischemia as well as pain, cyanosis, tongue numbness, and skin coldness. The patient was submitted to local thrombolysis and balloon angioplasty with regression of symptoms after recanalization. With this report, we add a caveat about blockage of the ECA ostium during CAS.

Finding a new therapeutic approach for no-option Parkinsonisms: mesenchymal stromal cells for progressive supranuclear palsy.

BACKGROUND: The trophic, anti-apoptotic and regenerative effects of bone marrow mesenchymal stromal cells (MSC) may reduce neuronal cell loss in neurodegenerative disorders. METHODS: We used MSC as a novel candidate therapeutic tool in a pilot phase-I study for patients affected by progressive supranuclear palsy (PSP), a rare, severe and no-option form of Parkinsonism. Five patients received the cells by infusion into the cerebral arteries. Effects were assessed using the best available motor function rating scales (UPDRS, Hoehn and Yahr, PSP rating scale), as well as neuropsychological assessments, gait analysis and brain imaging before and after cell administration. RESULTS: One year after cell infusion, all treated patients were alive, except one, who died 9 months after the infusion for reasons not related to cell administration or to disease progression (accidental fall). In all treated patients motor function rating scales remained stable for at least six-months during the one-year follow-up. CONCLUSIONS: We have demonstrated for the first time that MSC administration is feasible in subjects with PSP. In these patients, in whom deterioration of motor function is invariably rapid, we recorded clinical stabilization for at least 6 months. These encouraging results pave the way to the next randomized, placebo-controlled phase-II study that will definitively provide information on the efficacy of this innovative approach. Trial registration ClinicalTrials.gov NCT01824121.

Autologous mesenchymal stem cell therapy for progressive supranuclear palsy: translation into a phase I controlled, randomized clinical study.

BACKGROUND: Progressive Supranuclear Palsy (PSP) is a sporadic and progressive neurodegenerative disease which belongs to the family of tauopathies and involves both cortical and subcortical structures. No effective therapy is to date available. METHODS/DESIGN: Autologous bone marrow (BM) mesenchymal stem cells (MSC) from patients affected by different type of parkinsonisms have shown their ability to improve the dopaminergic function in preclinical and clinical models. It is also possible to isolate and expand MSC from the BM of PSP patients with the same proliferation rate and immuphenotypic profile as MSC from healthy donors. BM MSC can be efficiently delivered to the affected brain regions of PSP patients where they can exert their beneficial effects through different mechanisms including the secretion of neurotrophic factors.Here we propose a randomized, placebo-controlled, double-blind phase I clinical trial in patients affected by PSP with MSC delivered via intra-arterial injection. DISCUSSION: To our knowledge, this is the first clinical trial to be applied in a no-option parkinsonism that aims to test the safety and to exploit the properties of autologous mesenchymal stem cells in reducing disease progression. The study has been designed to test the safety of this "first-in-man" approach and to preliminarily explore its efficacy by excluding the placebo effect. TRIAL REGISTRATION: NCT01824121.

Italian multicenter experience with flow-diverter devices for intracranial unruptured aneurysm treatment with periprocedural complications--a retrospective data analysis.

INTRODUCTION: We report the experiences of 25 Italian centers, analyzing intra- and periprocedural complications of endovascular treatment of intracranial aneurysms using Silk (Balt Extrusion, Montmorency, France) and pipeline embolization devices (EV3 Inc, Irvine California). METHODS: Two hundred seventy-three patients with 295 cerebral aneurysms, enrolled in 25 centers in Italy and treated with the new flow-diverter devices, were evaluated; 142 patients were treated with Silk and 130 with pipeline (in one case, both devices were used). In 14 (5.2 %) cases devices were used with coils. Aneurysm size was >15 mm in 46.9 %, 5-15 mm in 42.2 %, and <5 mm in 10.8 %. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 163 cases (55.2 %), cavernous ICA in 76 (25.7 %), middle cerebral artery in 11 (3.7 %), PCoA in 6 (2 %), and ACoA in 2 (0.7 %); the vertebrobasilar system accounted for 32 cases (10.8 %) and PCA in 5 (1.7 %). RESULTS: Technical adverse events occurred with 59 patients (21.6 %); 5 patients died after ischemic events, 10 to hemorrhagic complications, and 1 from external ventricular drain positioning. At 1 month, morbidity and mortality rates were 3.7 % and 5.9 %, respectively CONCLUSION: Our retrospective study confirms that morbidity and mortality rates in treatment with FDD of unruptured wide-neck or untreatable cerebral aneurysms do not differ from those reported in the largest series.