Percutaneous Vertebral Reconstruction (PVR) Technique of Pathological Compression Fractures: An Innovative Combined Treatment of Microwave Ablation, Bilateral Expandable Titanium SpineJack Implants Followed by Vertebroplasty.

(1) Background: to retrospectively evaluate safety and efficacy of combined microwave ablation (MWA) and bilateral expandable titanium SpineJack (SJ) implants followed by vertebroplasty (VP) for the treatment of painful thoracolumbar pathological vertebral compression fracture. (2) Methods: from July 2017 to October 2022, twenty-eight patients (13 women and 15 men; mean age 68 ± 11 years) with a history of primary neoplasm and thirty-six painful vertebral metastases with vertebral compression fracture underwent combined MWA and bilateral expandable titanium SpineJack implants with vertebroplasty. We analyzed safety through complications rate, and efficacy through vertebral height restoration and pain decrease, evaluated using a visual analogue scale (VAS), and Functional Mobility Scale (FMS), and local tumor control. Contrast-enhanced CT scans were performed at 1, 3, and 6 months and a contrast-enhanced spine MRI at 6 months after the procedure. (3) Results: Technical success rate was 100%. No procedure-related major complications or death occurred. Vertebral height restoration was observed in 22 levels (58%), with a mean anterior height restoration of 2.6 mm ± 0.6 and a mean middle height restoration of 4.4 mm ± 0.6 (p < 0.001). Mean VAS score of pain evaluation on the day before treatment was 6.3 ± 1.5 (range 4-9). At the 6-month evaluation, the median VAS score for pain was 0.4 ± 0.6 (range 0-2) with a mean reduction of 93.65% (6.8 ± 0.7 vs. 0.4 ± 0.6; p < 0.000) compared with baseline evaluation. Contrast-enhanced CT scans were performed at 1, 3, and 6 months and a contrast-enhanced spine MRI was performed at 6 months after the procedure, showing no local recurrence, implant displacement, or new fractures in the treated site. (4) Conclusions: combined microwave ablation and bilateral expandable titanium SpineJack implants with vertebroplasty is a safe and effective procedure for the treatment of pathological compressive vertebral fractures. The vertebral stabilization achieved early and persistent pain relief, increasing patient mobility, improving recovery of walking capacity, and providing local tumor control.

Re-expansion of vertebral compression fractures in patients with multiple myeloma with percutaneous vertebroplasty using spinejack implants: a preliminary and retrospective study.

Objective: To retrospectively evaluate the feasibility and effectiveness of vertebroplasty using Spinejack implantation for the treatment and stabilization of painful vertebral compression fractures, in patients diagnosed with Multiple Myeloma (MM), to allow both an effective pain reduction and a global structural spine stabilization. Materials and Methods: From July 2017 and May 2022 thirty-nine patients diagnosed MM, with forty-nine vertebral compression fractures underwent percutaneous Vertebroplasty using Spinejack Implants. We analyzed the feasibility and complications of the procedure, the decrease in pain using visual analogue scale (VAS) and Functional Mobility Scale (FMS). Results: The technical success rate was 100%. No procedure-related major complications or death occurred. In the 6-month follow-up, the mean VAS score decreased from 5.4 ± 1.0 to 0.2 ± 0.5 with a mean reduction of 96.3%. FMS decreased from 2.3 ± 0.5 vs. 1.2 ± 0.4 with a mean reduction of -47.8%. There were no major complications related to incorrect positioning of the Expandable Titanium SpineJack Implants. In five patients, a cement leak was observed with no associated clinical manifestations. The average length of hospital stay was 6-8 Hours6.6 ± 1.2 h. No new bone fractures or local disease recurrence occurred during a median contrast-enhanced CT follow-up of 6 months. Conclusions: Our results suggest that vertebroplasty, using Spinejack implantation for the treatment and stabilization of painful vertebral compression fractures, secondary to Multiple Myeloma is a safe and effective procedure with long - term pain relief and restoration of vertebral height.

Clinical Rationale of Using Steerable Technologies for Radiofrequency Ablation Followed by Cavity Creation and Cement Augmentation in the Treatment of Painful Spinal Metastases.

(1) Background: Cement distribution after radiofrequency ablation of spinal metastases can be unpredictable due to various tumor factors, and vertebral augmentation requires advanced devices to prevent cement leakage and achieve satisfactory filling. The purpose of this study is to evaluate the safety and efficacy of a platform of steerable technologies with an articulating radiofrequency ablation (RFA) probe and targeted cavity creation before vertebral augmentation in the treatment of painful spinal metastases. (2) Methods: Sixteen patients (mean age, 67 years) underwent RFA in conjunction with vertebral augmentation after the creation of a targeted balloon cavity for metastatic spinal disease and were followed up to 6 months. Pain and functional mobility were assessed before treatment and postoperatively using the Visual Analogue Score (VAS) and Functional Mobility Scale (FMS). Complications, predictability of cement distribution, anatomical restoration, and local recurrence were collected. Technical success was defined as successful intraoperative ablation and predictable cement distribution after cavity creation without major complications. (3) Results: Sixteen patients with 21 lesions were treated for tumors involving the thoracolumbar spine. All treatments were technically successful and were followed by targeted cavity creation and vertebral augmentation. A statistically significant reduction in median VAS score was observed before treatment and 1 week after RFA treatment (p < 0.001). A total of six of the seven patients who reported limited painful ambulation before treatment reported normal ambulation 1 month after treatment, while the remaining patient reported no improvement. Patients who reported wheelchair use before treatment improved to normal ambulation (four/eight) or limited painful ambulation (four/eight). The improvement in mobility before and after treatment was statistically significant (p = 0.002). Technical success was achieved in all the combined procedures. (4) Conclusions: The combined treatment of RFA and vertebral augmentation with a steerable platform that allows the creation of a targeted cavity prior to cement injection proved to be a safe and effective procedure in our patient sample, resulting in improved quality of life as assessed by the Visual Analogue Score (VAS) and Functional Mobility Scale (FMS).

Percutaneous CT-Guided Microwave Ablation Combined with Pedicle Screw Fixation Followed by Vertebroplasty (MASFVA): Initial Experience of a Minimally Invasive Treatment of Vertebral Metastases with Extension to the Vertebral Pedicle.

(1) Background: The aim of this study was to retrospectively evaluate the safety and efficacy of a combined CT-guided percutaneous microwave ablation (MWA) and pedicle screw fixation followed by vertebroplasty (MASFVA) for the treatment and stabilization of painful vertebral metastases with vertebral pedicle involvement. (2) Methods: from January 2013 to January 2017 11 patients with 16 vertebral metastatic lesions (7 men and 5 women; mean age, 65 ± 11 years) with vertebral metastases underwent CT-guided microwave ablation and screw fixation followed by vertebroplasty (MASFVA). Technical success, complication rate, pain evaluation using a visual analogue scale (VAS), Oswestry Disability Index (ODI) and local tumor control were examined. (3) Results: Technical success rate was 100%. No procedure-related major complications occurred. VAS score decreased from 6.8 ± 0.7 to 0.6 ± 0.6. ODI score decreased from 3.1 ± 0.7 to 1.2 ± 0.4. All patients could walk independently without neurological complication after one week from the procedure. No new bone fractures or local disease recurrence occurred during a median follow-up of 12 months. (4) Conclusions: Our results suggest that MWA and percutaneous pedicle screw fixation followed by vertebroplasty for the treatment of painful vertebral metastases is a safe and effective procedure for painful vertebral metastases with vertebral pedicle involvement, allowing pain relief and local tumor control.

Safety and Feasibility of Steerable Radiofrequency Ablation in Combination with Cementoplasty for the Treatment of Large Extraspinal Bone Metastases.

Background: Radiofrequency ablation (RFA) and cementoplasty, individually and in concert, has been adopted as palliative interventional strategies to reduce pain caused by bone metastases and prevent skeletal related events. We aim to evaluate the feasibility and safety of a steerable RFA device with an articulating bipolar extensible electrode for the treatment of extraspinal bone metastases. Methods: All data were retrospectively reviewed. All the ablation procedures were performed using a steerable RFA device (STAR, Merit Medical Systems, Inc., South Jordan, UT, USA). The pain was assessed with a VAS score before treatment and at 1-week and 3-, 6-, and 12-month follow-up. The Functional Mobility Scale (FMS) was recorded preoperatively and 1 month after the treatment through a four-point scale (4, bedridden; 3, use of wheelchair; 2, limited painful ambulation; 1, normal ambulation). Technical success was defined as successful intraoperative ablation and cementoplasty without major complications. Results: A statistically significant reduction of the median VAS score before treatment and 1 week after RFA and cementoplasty was observed (p < 0.001). A total of 6/7 patients who used a wheelchair reported normal ambulation 1 month after treatment. All patients with limited painful ambulation reported normal ambulation after the RFA and cementoplasty (p = 0.003). Technical success was achieved in all the combined procedures. Two cement leakages were reported. No local recurrences were observed after 1 year. Conclusions: The combined treatment of RFA with a steerable device and cementoplasty is a safe, feasible, and promising clinical option for the management of painful bone metastases, challenging for morphology and location, resulting in an improvement of the quality of life of patients.

The Increasing Role of CT-Guided Cryoablation for the Treatment of Liver Cancer: A Single-Center Report.

Purpose: Cryoablation (CrA) is a minimally invasive treatment that can be used in primary and metastatic liver cancer. The purpose of this study was to assess the effectiveness of CrA in patients with hepatocellular carcinoma (HCC) and liver metastases. Methods: We retrospectively evaluated the patients who had CrA for HCC or liver metastases between 2015 and 2020. Technical success, complete ablation, CrA-related complications, local tumor progression, local recurrences, and distant metastases were evaluated in the study population. In patients with HCC, the median survival was also estimated. Results: Sixty-four liver tumors in 49 patients were treated with CrA (50 metastases and 14 HCC). The mean tumor diameter was 2.15 cm. The mean follow-up was 19.8 months. Technical success was achieved in the whole study population. Complete tumor ablation was observed after one month in 92% of lesions treated with CrA (79% and 96% in the HCC Group and metastases Group, respectively, p < 0.001). Local tumor progression occurred in 12.5 of lesions, with no difference between the study groups (p = 0.105). Sixteen patients (33%) developed local recurrence (45% and 29% in the HCC Group and metastases Group, respectively, p = 0.477). Seven patients (14%) developed distant metastases in the follow-up period. Ten patients (20.8%) underwent redo CrA for local recurrence or incomplete tumor ablation. Minor complications were observed in 14% of patients. In patients with HCC, the median survival was 22 months. Conclusions: CrA can be safely used for treatment of HCC and liver metastases not amenable of surgical resection. Further studies are necessary to better define the role of CrA in the multidisciplinary treatment of liver malignancies.

The Role of a Navigational Radiofrequency Ablation Device and Concurrent Vertebral Augmentation for Treatment of Difficult-to-Reach Spinal Metastases.

AIMS: The purpose of this study was to assess the effectiveness of a navigational radiofrequency ablation device with concurrent vertebral augmentation in the treatment of posterior vertebral body metastatic lesions, which are technically difficult to access. Primary outcomes of the study were evaluation of pain palliation and radiologic assessment of local tumor control. MATERIALS AND METHODS: Thirty-five patients with 41 vertebral spinal metastases involving the posterior vertebral body underwent computed tomography-guided percutaneous targeted radiofrequency ablation, with a navigational radiofrequency ablation device, associated with vertebral augmentation. Twenty-one patients (60%) had 1 or 2 metastatic lesions (Group A) and fourteen (40%) patients had multiple (>2) vertebral lesions (Group B). Changes in pain severity were evaluated by visual analog scale (VAS). Metastatic lesions were evaluated in terms of radiological local control. RESULTS: The procedure was technically successful in all the treated vertebrae. Among the symptomatic patients, the mean VAS score dropped from 5.7 (95% CI 4.9-6.5) before tRFA and to 0.9 (95% CI 0.4-1.3) after tRFA (p < 0.001). The mean decrease in VAS score between baseline and one week follow up was 4.8 (95% CI 4.2-5.4). VAS decrease over time between one week and one year following radiofrequency ablation was similar, suggesting that pain relief was immediate and durable. Neither patients with 1-2 vertebral metastases, nor those with multiple lesions, showed radiological signs of local progression or recurrence of the tumor in the index vertebrae during a median follow up of 19 months (4-46 months) and 10 months (4-37 months), respectively. CONCLUSION: Treatment of spinal metastases with a navigational radiofrequency ablation device and vertebral augmentation can be used to obtain local tumor control with immediate and durable pain relief, providing effective treatment in the multimodality management of difficult-to-reach spinal metastases.

Combined Microwave Ablation and Osteosynthesis for Long Bone Metastases.

Background and Objectives: The purpose of this study was to evaluate the feasibility, safety and efficacy of microwave ablation (MWA) in combination with open surgery nail positioning for the treatment of fractures or impending fractures of long bone metastases. Material and Methods: Eleven patients (four men, seven women) with painful bone metastases of the humerus, femur or tibia with non-displaced fractures (one case) or impending fractures (10 cases) underwent open MWA in combination with osteosynthesis by locked nail positioning. Pain intensity was measured using a VAS score before and after treatment. CT or MRI were acquired at one month before and 1, 3, 6, 12 and 18 months after treatment. Results: All procedures were successfully completed without major complications. The level of pain was significantly reduced one month after treatment. For the patients with humerus metastases, the complete recovery of arm use took 8 weeks, while for the patients with femoral metastases the complete recovery of walking capacity took 11 weeks. The VAS score ranged from 7 (4-9) before treatment to 1.5 (0-2.5) after treatment. During a mid-term follow-up of 18 months (range 4-29 months), none of the patients showed tumor relapse or new fractures in the treated site. Two patients died due to tumor disease progression. Conclusion: Results of this preliminary study suggest that combined MWA and surgical osteosynthesis with locked nails is a safe and effective treatment for pathological fractures or malignant impending fractures of long bone metastases of the humerus, femur and tibia. Further analyses with larger cohorts are warranted to confirm these findings.

Percutaneous Microwave Ablation Under CT Guidance for Hepatocellular Carcinoma: a Single Institutional Experience.

BACKGROUND: Microwave ablation (MWA) is an emerging treatment for treatment of patients with hepatocellular carcinoma (HCC) not amenable of surgical resection. PATIENTS AND METHODS: We searched for patients diagnosed as having small-, medium-, and large HCCs treated with MWA under CT guidance between 2010 and 2014. The main outcomes of interest were rates of complete ablation, complications, and overall survival. Rates of complete ablation were compared with Chi-square test, and estimated survival rates were calculated by means of Kaplan-Meier method. RESULTS: Thirty-two patients with 45 HCC nodules received MWA. Seventeen (37.8%) nodules were <3 cm (small), 15 (33.3%) between 3 and 5 cm (medium), and 13 (28.9%) > 5 cm (large). Complete ablation was obtained in 94.1% of small tumors, 80% of medium tumors, and 53.8% of large tumors (p = 0.03). Two patients had HCC located in risk area (paracardiac position). Minor complications occurred after seven procedures (15.5%). Estimated median survival was 37 months (95% confidence interval 11.97-62.02). One-year OS was 82.7%, 2-year survival 68.9%, and 3-year survival 55.2%. CONCLUSION: MWA is a versatile ablative method that can be applied in HCC at various stages, and also in lesions located in risk areas.

Cryoablation of Primary Breast Cancer in Patients with Metastatic Disease: Considerations Arising from a Single-Centre Data Analysis.

BACKGROUND: Patients presenting with stage IV breast cancer might benefit by removal of the primary tumor. We report our experience with CT-guided cryoablation of the primary tumor, with the aim of evaluating its role in this subgroup of patients. PATIENTS AND METHODS: Data of 35 patients with mean age of 58 years with breast cancer at stage IV submitted to CT-guided cryoablation of the primary tumor between 2010 and 2016 were prospectively evaluated. All patients, except three, were preoperatively and postoperatively evaluated with breast MRI to assess the extent of tumor necrosis. Retreatment was performed in case of incomplete ablation. RESULTS: Mean tumor size was 3.02 ± 1.4 cm. Six patients had multicentric disease. Complete tumor necrosis was 85.7% and 100% at 2-month and 6-month follow-up, respectively, as 5 patients with tumors > 3 cm required a redo cryoablation. No patient developed major complications. Minor side effects occurred in 30 patients (82%). All patients were discharged the same day of the procedure. During a mean follow-up of 46 months (range 3-84), 7 patients (20%) experienced local recurrences that were treated with redo cryoablation, and 7 (20%) died for disease progression. CONCLUSIONS: Our results suggest that cryoablation of the primary tumor is safe and effective in the treatment of patients presenting with stage IV breast cancer.

CT-guided percutaneous screw fixation plus cementoplasty in the treatment of painful bone metastases with fractures or a high risk of pathological fracture.

OBJECTIVE: To evaluate the feasibility and effectiveness of computed tomography (CT)-guided percutaneous screw fixation plus cementoplasty (PSFPC), for either treatment of painful metastatic fractures or prevention of pathological fractures, in patients who are not candidates for surgical stabilization. MATERIALS AND METHODS: Twenty-seven patients with 34 metastatic bone lesions underwent CT-guided PSFPC. Bone metastases were located in the vertebral column, femur, and pelvis. The primary end point was the evaluation of feasibility and complications of the procedure, in addition to the length of hospital stay. Pain severity was estimated before treatment and 1 and 6 months after the procedure using the visual analog scale (VAS). Functional outcome was assessed by improved patient walking ability. RESULTS: All sessions were completed and well tolerated. There were no complications related to either incorrect positioning of the screws during bone fixation or leakage of cement. All patients were able to walk within 6 h after the procedure and the average length of hospital stay was 2 days. The mean VAS score decreased from 7.1 (range, 4-9) before treatment to 1.6 (range, 0-6), 1 month after treatment, and to 1.4 (range 0-6) 6 months after treatment. Neither loosening of the screws nor additional bone fractures occurred during a median follow-up of 6 months. CONCLUSIONS: Our results suggest that PSFPC might be a safe and effective procedure that allows the stabilization of the fracture and the prevention of pathological fractures with significant pain relief and good recovery of walking ability, although further studies are required to confirm this preliminary experience.

Combined Microwave Ablation and Cementoplasty in Patients with Painful Bone Metastases at High Risk of Fracture.

PURPOSE: To retrospectively evaluate the effectiveness of computed tomography-guided percutaneous microwave ablation (MWA) and cementoplasty in patients with painful bone metastases at high risk of fracture. MATERIALS AND METHODS: Thirty-five patients with 37 metastatic bone lesions underwent computed tomography-guided MWA combined with cementoplasty (polymethylmethacrylate injection). Vertebrae, femur, and acetabulum were the intervention sites and the primary end point was pain relief. Pain severity was estimated by visual analog scale (VAS) before treatment; 1 week post-treatment; and 1, 6, and 12 months post-treatment. Functional outcome was assessed by improved patient walking ability. Radiological evaluation was performed at baseline and 3 and 12 months post-procedure. RESULTS: In all patients, pain reduction occurred from the first week after treatment. The mean reduction in the VAS score was 84, 90, 90 % at week 1, month 1, and month 6, respectively. Improved walking ability occurred in 100 and 98 % of cases at the 1- and 6-month functional outcome evaluations, respectively. At the 1-year evaluation, 25 patients were alive, and 10 patients (28 %) had died because of widespread disease. The mean reduction in the VAS score and improvement in surviving patients' walking ability were 90 and 100 %, respectively. No patients showed evidence of local tumor recurrence or progression and pathological fracture in the treated sites. CONCLUSION: Our results suggest that MWA combined with osteoplasty is safe and effective when treating painful bone metastases at high risk of fracture. The number of surviving patients at the 1-year evaluation confirms the need for an effective and long-lasting treatment.

Pelvic floor failure: MR imaging evaluation of anatomic and functional abnormalities.

Pelvic floor failure is a common disorder that can seriously jeopardize a woman's quality of life by causing urinary and fecal incontinence, difficult defecation, and pelvic pain. Multiple congenital and acquired risk factors are associated with pelvic floor failure, including altered collagen metabolism, female sex, vaginal delivery, menopause, and advanced age. A complex variety of fascial and muscular lesions that range from stretching, insertion detachment, denervation atrophy, and combinations of pelvic floor relaxation to pelvic organ prolapse may manifest in a single patient. Thorough preoperative assessment of pelvic floor failure is necessary to reduce the rate of relapse, which is reported to be as high as 30%. Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes analysis of anatomic damage on axial fast spin-echo (FSE) T2-weighted images and functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation. This article presents high-resolution FSE T2-weighted MR images that permit detailed assessment of anatomic lesions and briefly describes pelvic floor pathophysiology, associated clinical symptoms, and patterns of dysfunction seen with dynamic MR imaging sequences. MR imaging is a powerful tool that enables radiologists to comprehensively evaluate pelvic anatomic and functional abnormalities, thus helping surgeons provide appropriate treatment and avoid repeat operations.