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.

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.

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.

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.

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.

Magnetic resonance comparison of left-right heart volumetric and functional parameters in thalassemia major and thalassemia intermedia patients.

OBJECTIVES: To evaluate a population of asymptomatic thalassemia major (TM) and thalassemia intermedia (TI) patients using cardiovascular magnetic resonance (CMR). We supposed that TI group could be differentiated from the TM group based on T2(∗) and that the TI group could demonstrate higher cardiac output. METHODS: A retrospective analysis of 242 patients with TM and TI was performed (132 males, 110 females; mean age 39.6 ± 8 years; 186 TM, 56 TI). Iron load was assessed by T2(∗) measurements; volumetric functions were analyzed using steady-state-free precession sequences. RESULTS: Significant difference in left-right heart performance was observed between TM with iron overload and TI patients and between TM with iron overload and TM without iron overload (P < 0.05); no significant differences were observed between TM without iron overload and TI patients. A significant correlation was observed between T2(∗) and ejection fraction of right ventricle- (RV-) ejection fraction of left ventricle (LV); an inverse correlation was present among T2(∗) values and end-diastolic volume of LV, end-systolic volume of LV, stroke volume of LV, end-diastolic volume of RV, end-systolic volume of RV, and stroke volume of RV. CONCLUSIONS: CMR is a leading approach for cardiac risk evaluation of TM and TI patients.

Dark blood versus bright blood T2 acquisition in cardiovascular magnetic resonance (CMR) for thalassaemia major (TM) patients: evaluation of feasibility, reproducibility and image quality.

OBJECTIVES: To compare the effectiveness of dark blood (DB) versus bright blood (BB) sequences. To assess the intra and inter-observer variability and inter-study reproducibility between BB versus DB. To evaluate image quality level in the two sequences. METHODS: In a setting of 138 patients we performed CMR using cardiac gated Gradient-multiecho single breath-hold BB and DB sequences in the middle ventricular septum. Each acquisition was repeated during the same exam. Truncation method was used to account for background noise. Image quality (IQ) was assessed using a 5 point grading scale and image analysis was conducted by 2 experienced observers. RESULTS: Compared with the conventional BB acquisition, the coefficient of correlation and significance of the DB technique was superior for intra-observer reproducibility (p<0.001), inter-observer reproducibility (p<0.001) and inter-study reproducibility (p<0.001). The variability is also lower for DB sequences for T2* values <14 ms. Assessment of artifacts showed a superior score for DB versus BB scans (4 versus 3, p<0.001). CONCLUSIONS: Improvement in terms of inter observer and inter study variability using DB sequences was obtained. The greatest disparity between them was seen in inter-study reproducibility and higher IQ in DB was seen. Study demonstrates better performance of DB imaging compared to BB in presence of comparable effectiveness.

Relationship between myocardial T2 values and cardiac volumetric and functional parameters in ß-thalassemia patients evaluated by cardiac magnetic resonance in association with serum ferritin levels.

PURPOSE: Myocardial T2 cardiovascular magnetic resonance provides a rapid and reproducible assessment of cardiac iron load in thalassemia patients. Although cardiac involvement is mainly characterized by left ventricular dysfunction caused by iron overload, little is known about right ventricular function. The aim of this study was to assess the relationship between T2 value in myocardium and left-right ventricular volumetric and functional parameters and to evaluate the existing associations between left-right ventricles volumetric and functional parameter, myocardial T2 values and blood ferritin levels. MATERIALS AND METHODS: A retrospective analysis of 208 patients with ß-thalassemia major and thalassemia intermedia was performed (109 males and 99 females; mean age 37.7 ± 13 years; 143 thalassemia major, 65 thalassemia intermedia). Myocardial iron load was assessed by T2 measurements, and volumetric functions were analyzed using the steady state free precession sequence. RESULTS: A significant correlation was observed between EFLV and T2 (p=0.0001), EFRV and T2 (p=0.0279). An inverse correlation was present between DVLV and T2 (p=0.0468), SVLV and T2 (p=0.0003), SVRV and T2 (p=0.0001). There was no significant correlation between cardiac T2 and LV-RV mass indices. A significant correlation was observed between T2 and serum ferritin levels (p<0.001) and between EFLV and serum ferritin (p<0.05). CONCLUSION: Myocardial iron load assessed by T2 cardiac magnetic resonance is associated with deterioration in left-right ventricular function; this is more evident when T2 values fall below 14 ms. CMR appears to be a promising approach for cardiac risk evaluation in TM patients.