Sean Tutton

Safeguards to Prevent Neurologic Complications after Epidural Steroid Injections: Consensus Opinions from a Multidisciplinary Working Group and National Organizations

Background: Epidural corticosteroid injections are a common treatment for radicular pain caused by intervertebral disc herniations, spinal stenosis, and other disorders. Although rare, catastrophic neurologic injuries, including stroke and spinal cord injury, have occurred with these injections. Methods: A collaboration was undertaken between the U.S. Food and Drug Administration Safe Use Initiative, an expert multidisciplinary working group, and 13 specialty stakeholder societies. The goal of this collaboration was to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections and produce consensus procedural clinical considerations aimed at enhancing the safety of these injections. U.S. Food and Drug Administration Safe Use Initiative representatives helped convene and facilitate meetings without actively participating in the deliberations or decision-making process. Results: Seventeen clinical considerations aimed at improving safety were produced by the stakeholder societies. Specific clinical considerations for performing transforaminal and interlaminar injections, including the use of nonparticulate steroid, anatomic considerations, and use of radiographic guidance are given along with the existing scientific evidence for each clinical consideration. Conclusion: Adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurologic injuries.

Prospective Evaluation of the PleurX Catheter When Used to Treat Recurrent Ascites Associated with Malignancy

PURPOSE To prospectively assess the safety of the PleurX catheter in the management of recurrent ascites in patients with advanced abdominal malignancy and the consequent quality of life among these patients. MATERIALS AND METHODS This was a multicenter, prospective study of PleurX catheters implanted between March 2004 and April 2005 for control of nonhepatic abdominal ascites associated with malignancy. A total of 34 subjects were included (age range, 40-81 years; mean age, 64.3 y) who underwent 440 drainage sessions. Subjects kept records of volume and frequency of ascites drainage and recorded any difficulties encountered with use of the device. Subjects assessed symptoms before device insertion and weekly for as long as 12 weeks. Serum laboratory values reflecting overall volume status were tracked. RESULTS All catheter insertions were successful without major procedural complications. Twenty-nine (85%) required no catheter intervention or separate therapeutic paracentesis during 12 weeks observation or until the patients death. Three needed a total of 13 interventions to restore catheter function. Before 12 weeks, 26 subjects died. Five discontinued catheter use as a result of catheter function despite the presence of ascites. Ascites resolved in five patients. Bloating and abdominal discomfort were significantly reduced at 2 and 8 weeks (P < .05). At weekly follow-up, 83%-100% of subjects reported their ascites to be well controlled. There were no significant changes in blood chemistry results between baseline and 12 weeks. One case of peritonitis at 10 weeks resolved with antibiotic treatment. CONCLUSIONS In terminally ill patients, PleurX catheter use resulted in improvement of ascites-related discomfort and was associated with low rates of serious adverse clinical events and catheter failure.

Position statement on percutaneous vertebral augmentation: a consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS).

Radiological Associa Radiology (M.D.K.), U Angeles; Departmen Diego, Medical Cen (M.E.J.), University o sion of Neurointerv Hospital, Boston, M (J.K.M.), Riverside M and Neurological Ins lenburg Radiology A ment of Radiology (A Neurological Surgery and Surgeons; Depa York–Presbyterian H York; Department of Chicago, Illinois; Iow Radiology Associates ment of Radiology (S kee, Wisconsin; D Christiana Care Healt (J.F.C.), Geisinger H Radiology (P.L.M.), V STANDARDS OF PRACTICE

Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions

Objective To assess the outcomes and safety after CT-guided percutaneous sacroplasty in patients with painful sacral insufficiency fractures or pathologic sacral lesions. Methods A retrospective multicenter analysis of consecutive patients undergoing CT-guided sacroplasty for painful sacral insufficiency fractures or sacral lesions was undertaken. The inclusion criteria consisted of severe sacral pain not responding to conservative medical management with imaging evidence of unilateral or bilateral sacral insufficiency fractures or lesions. Outcome measures included hospitalization status (inpatient or outpatient), pre-treatment and post-treatment visual analog scale (VAS) scores, analgesic use and complications. Patients were followed at approximately 1 month and for at least 1 year after their sacroplasty procedure. Results Two hundred and forty-three patients were included in the study, 204 with painful sacral insufficiency fractures and 39 with symptomatic sacral lesions. The average pre-treatment VAS score of 9.2±1.1 was significantly improved after sacroplasty to 1.9±1.7 in patients with sacral insufficiency fractures (p<0.001). The average pre-treatment VAS score of 9.0±0.9 in patients with sacral lesions was significantly improved after sacroplasty to 2.6±2.4 (p<0.001). There were no major complications or procedure-related deaths. One patient who was treated for a sacral insufficiency fracture experienced radicular pain due to local extravasation of cement that subsequently required surgical decompression for symptomatic relief. Conclusions CT-guided percutaneous sacroplasty is a safe and effective procedure in the treatment of painful sacral insufficiency fractures or lesions. It is associated with prompt and durable pain relief and should be considered as an effective treatment option in this patient population.

Computing oxygen-enhanced ventilation maps using correlation analysis

Correlation maps of oxygen‐enhanced ventilation were obtained in nine healthy volunteers using complete and selected image series. The complete series included all images acquired with the subjects alternately inhaling room air and 100% oxygen. The selected series were the subsets of the complete series and included only co‐registered images that showed matched diaphragmatic position at maximal expiration. Cross‐correlation was computed between the time response function of each pixel and the input function representing the alternation between periods of room air and 100% oxygen inhalation. The confidence level for the correlation analysis was set to 0.01. Pulmonary parenchymal anatomy was consistently reproduced throughout the lung, even in anterior slices where published data have reported correlation problems. The overall average correlation coefficient was 0.66 ± 0.07 for the complete series and 0.75 ± 0.08 for the selected series. It was concluded that correlation analysis could be used to reconstruct qualitative oxygen‐enhanced ventilation maps. Magn Reson Med 49:591–594, 2003.

Minimal aortic injury after blunt trauma: Selective nonoperative management is safe

BACKGROUND An increasing number of minimal aortic injuries (MAIs) are being identified with modern computed tomography (CT) imaging techniques. The optimal management and natural history of these injuries are unknown. We have adopted a policy of selective multidisciplinary nonoperative management of MAI. This study examines our experience with these patients from July 2004 to June 2009. METHODS Retrospective chart review of all blunt trauma patients who underwent chest CT angiography to evaluate for blunt aortic injury (BAI) was undertaken. All patients deemed to have a MAI were managed nonoperatively, and those with a severe aortic injury underwent repair. Data collected included age, mechanism of injury, Injury Severity Score, type and location of aortic injury, intensive care unit length of stay (LOS), overall LOS, ventilator days, disposition, and mortality. In addition, all BAIs were graded according to the Presley Trauma Center CT Grading System of Aortic Injury. RESULTS Forty-seven patients with BAI were identified. Thirty-two were classified as severe injuries, and 15 were considered MAI (32%). Nineteen underwent operative repair, 13 underwent endovascular stent graft repair, and 15 were managed nonoperatively. The average Injury Severity Score was 31 ± 10, and the average age was 44 ± 20 with no significant difference across treatment groups. There was no difference in overall or intensive care unit LOS. The nonoperative group had a shorter duration of ventilator days (1.1 vs. 4.28, p = 0.02). There were five deaths, none in the nonoperative group. None of these patients required subsequent intervention. All nonoperative patients had follow-up imaging at median of 4 days; on CT chest angiography, five injuries had resolved, eight had stable intimal flaps or pseudoaneurysm, and two had no detectable injury on subsequent aortogram. CONCLUSION Almost one-third of our BAI were safely managed nonoperatively. Patients with MAI should be considered for selective nonoperative management in a multidisciplinary approach with close radiographic follow-up. We recommend that patients with MAIs should be considered for selective nonoperative management.

Recurrence after microwave ablation of liver malignancies: a single institution experience

BACKGROUND Microwave ablation (MWA) is increasingly used to achieve local control for liver tumours. This study sought to examine a monocentric experience with MWA, with a primary hypothesis that primary tumour histology was a significant predictor of early recurrence. METHODS Retrospective single-institution review identified consecutive patients with liver tumours treated by MWA. Cox proportional hazards models assessed significance of prognostic variables. RESULTS Seventy-two patients (43 female, 60%) underwent 83 MWA procedures for 157 tumours. Tumour histologies included hepatocellular cancer (10 operations), colorectal metastases (39), metastatic carcinoid (20) and other (14). The median tumour size was 2.0 cm. A concomitant liver resection was performed in 50 cases (60%). Crude peri-operative morbidity and mortality rates were 16% and 1%, respectively. The median follow-up was 16 months. Ablations were complete for 149 out of 157 tumours (95%). The median overall and recurrence-free survivals were 36 and 18 months, respectively. There was no difference in time to recurrence between the primary tumour types. In multivariable models, recurrence-free survival was independently associated with the use of neoadjuvant [hazard ratio (HR): 2.90, 95% confidence interval (CI): 1.09-7.76, P = 0.034] and adjuvant chemotherapy (HR: 0.36, 95% CI: 0.15-0.82, P = 0.016). CONCLUSIONS MWA is a safe and feasible approach for local control of liver tumours. While chemotherapy administration was associated with time to recurrence after MWA, larger studies are needed to corroborate these findings.

KAST Study: The Kiva System As a Vertebral Augmentation Treatment-A Safety and Effectiveness Trial: A Randomized, Noninferiority Trial Comparing the Kiva System With Balloon Kyphoplasty in Treatment of Osteoporotic Vertebral Compression Fractures.

Study Design. The KAST (Kiva Safety and Effectiveness Trial) study was a pivotal, multicenter, randomized control trial for evaluation of safety and effectiveness in the treatment of patients with painful, osteoporotic vertebral compression fractures (VCFs). Objective. The objective was to demonstrate noninferiority of the Kiva system to balloon kyphoplasty (BK) with respect to the composite primary endpoint. Summary of Background Data. Annual incidence of osteoporotic VCFs is prevalent. Optimal treatment of VCFs should address pain, function, and deformity. Kiva is a novel implant for vertebral augmentation in the treatment of VCFs. Methods. A total of 300 subjects with 1 or 2 painful osteoporotic VCFs were randomized to blindly receive Kiva (n = 153) or BK (n = 147). Subjects were followed through 12 months. The primary endpoint was a composite at 12 months defined as a reduction in fracture pain by at least 15 mm on the visual analogue scale, maintenance or improvement in function on the Oswestry Disability Index, and absence of device-related serious adverse events. Secondary endpoints included cement usage, extravasation, and adjacent level fracture. Results. A mean improvement of 70.8 and 71.8 points in the visual analogue scale score and 38.1 and 42.2 points in the Oswestry Disability Index was noted in Kiva and BK, respectively. No device-related serious adverse events occurred. Despite significant differences in risk factors favoring the control group at baseline, the primary endpoint demonstrated noninferiority of Kiva to BK. Analysis of secondary endpoints revealed superiority with respect to cement use and site-reported extravasation and a positive trend in adjacent level fracture warranting further study. Conclusion. The KAST study successfully established that the Kiva system is noninferior to BK based on a composite primary endpoint assessment incorporating pain-, function-, and device-related serious adverse events for the treatment of VCFs due to osteoporosis. Kiva was shown to be noninferior to BK and revealed a positive trend in several secondary endpoints. Level of Evidence: 1

Percutaneous bone lesion ablation

Benign tumors and metastatic bone lesions can be treated by ablation techniques performed either alone or in combination with other percutaneous techniques. Ablation techniques include ethanol or acetic acid injection and thermal ablation by means of energy deposition [including laser, radiofrequency, microwave, cryoablation, radiofrequency ionization and magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU)]. Goal definition of the therapy is crucial: ablation techniques can be proposed as curative treatments in benign bone tumors or oligometastatic disease (<3 lesions). Alternatively, these techniques can be proposed as palliative treatments aiming at reduction of pain, local control of the disease and tumor decompression. Depending on the lesion’s location ablation can be combined with cementation with or without further metallic augmentation; local tumor control can be enhanced by combining ablation with transarterial bland embolization or chemoembolization. Thermal ablation of bone and soft tissues is characterized by high success and relatively low rates of potential complications, mainly iatrogenic thermal damage of surrounding sensitive structures. Successful thermal ablation requires a sufficient ablation volume and thermal protection of the surrounding vulnerable structures. This article will describe the general principles governing ablation and the mechanism of action for each technique and in addition will review the literature about safety and effectiveness of percutaneous imaging-guided ablation for benign and malignant (primary and metastatic) lesions.

Successful Treatment of Tumor-Induced Osteomalacia with CT-Guided Percutaneous Ethanol and Cryoablation

CONTEXT Tumor-induced osteomalacia is a rare condition usually caused by benign mesenchymal tumors. When the tumor can be found, patients are usually managed by wide excision of the tumor. OBJECTIVE We report a 51-yr-old male with clinical and biochemical evidence of tumor-induced osteomalacia caused by a mesenchymal tumor in the right iliac bone. He declined surgery and appears to have been successfully managed by computed tomography-guided percutaneous ethanol ablation and percutaneous cryoablation. RESULTS Our patient appears to have had an excellent clinical and biochemical response to computed tomography-guided percutaneous ethanol ablation and percutaneous cryoablation. We found one prior case of image-guided ablation using radiofrequency ablation for tumor-induced osteomalacia. CONCLUSIONS Although the standard treatment for tumor-induced osteomalacia is wide excision of the tumor, image-guided ablation may be an option in patients who cannot have appropriate surgery or who decline surgery.