Utility of Intraoperative Neuromonitoring to Protect Against Adjacent Nerve Injury in Musculoskeletal and Lymph Nodal Cryoablation.

PURPOSE: To demonstrate the utility of intraoperative neuromonitoring (IONM) as an effective method of passive thermoprotection against cryogenic injury of neural structures during musculoskeletal and lymph node cryoablation. MATERIAL AND METHODS: 29 patients (16 male, mean age and range, M: 68.6 and 45-90, F: 62.6 and 28-88) underwent 33 cryoablations of musculoskeletal and lymph node lesions. Transcranial electrical motor evoked potentials (MEPs) and somatosensory evoked potentials (SSEPs) of target nerves were recorded throughout the ablations. Significant change was defined as waveform amplitude reduction greater than 30% (MEP) and 50% (SSEP). The primary outcomes of this study were immediate post-procedural neurological deficits and frequency of significant MEP and SSEP amplitude reductions. RESULTS: Significant amplitude reductions were detected in 54.5% (18/33) of MEP tracings and 0% (0/33) of SSEP tracings. Following each occurrence of significant amplitude reductions, freeze cycles were promptly terminated. Intra-procedurally, 13 patients had full recovery of amplitudes to baseline, 11 of which had additional freeze cycles completed. In 5/33 (15.2%) of cryoablations, there were immediate post-procedure neurological deficits (Moderate Adverse Events). Unrecovered MEPs conferred a relative risk for neurological sequela of 23.2 (95% confidence interval [CI], 3.22-167.21; P=0.0009) vs. those with recovered MEPs. All five patients had complete neurologic recovery by twelve months. CONCLUSION: IONM is a reliable, safe method of passive thermoprotection of neurological structures during cryoablation. It provides early detection of changes in nerve conduction, which when addressed quickly, may result in complete restoration of MEP signals within the procedure and minimize risk of cryogenic neural injury.

Balancing Safety and Efficacy to Determine the Most Suitable Size of Imaging-Visible Embolic Microspheres for Bariatric Arterial Embolization in a Preclinical Model.

OBJECTIVES: To identify the most suitable size of imaging-visible embolic agents with balanced safety and efficacy for bariatric arterial embolization (BAE) in a preclinical model. MATERIALS AND METHODS: Twenty-seven pigs were divided into 3 cohorts. In Cohort I, 16 pigs were randomized to receive (n = 4 each) 40-100-µm microspheres in 1 or 2 fundal arteries, 70-340-µm radiopaque microspheres in 2 fundal arteries, or saline. In Cohort II, 3 pigs underwent renal arterial embolization with either custom-made 100-200-µm, 200-250-µm, 200-300-µm, or 300-400-µm radiopaque microspheres or Bead Block 300-500 µm with microsphere distribution assessed histologically. In Cohort III, 8 pigs underwent BAE in 2 fundal arteries with tailored 100-200-µm radiopaque microspheres (n = 5) or saline (n = 3). RESULTS: In Cohort I, no significant differences in weight or ghrelin expression were observed between BAE and control animals. Moderate-to-severe gastric ulcerations were noted in all BAE animals. In Cohort II, renal embolization with 100-200-µm microspheres occluded vessels with a mean diameter of 139 µm ± 31, which is within the lower range of actual diameters of Bead Block 300-500 µm. In Cohort III, BAE with 100-200-µm microspheres resulted in significantly lower weight gain (42.3% ± 5.7% vs 51.6% ± 2.9% at 8 weeks; P = .04), fundal ghrelin cell density (16.1 ± 6.7 vs 23.6 ± 12.6; P = .045), and plasma ghrelin levels (1,709 pg/mL ± 172 vs 4,343 pg/mL ± 1,555; P < .01) compared with controls and superficial gastric ulcers (5/5). CONCLUSIONS: In this preclinical model, tailored 100-200-µm microspheres were shown to be most suitable for BAE in terms of safety and efficacy.

Angiographic Revascularization after Bariatric Embolization in a Swine Model.

This study evaluated fundal arteriole angiographic revascularization after embolization with embolic microspheres of 3 different diameters in a swine model (16 swine, 31 arterioles). In the 50-µm group, 7 of 11 (64%) arterioles recanalized completely, 3 of 11 (27%) arterioles recanalized partially, and 1 of 11 (9%) arterioles had collateralization (no recanalization). In the 100- to 300-µm group, 7 of 10 (70%) arterioles recanalized completely and 3 of 10 (30%) arterioles) recanalized partially. In the 300- to 500-µm group, 7 of 10 (70%) arterioles recanalized completely, 1 of 10 (10%) arterioles recanalized partially, and 2 of 10 (20%) arterioles had collateralization. No difference was found between the groups in the degree of recanalization (P = .64). All embolized arterioles exhibited some degree of angiographic revascularization, irrespective of the microsphere size.

The number of microspheres in Y90 radioembolization directly affects normal tissue radiation exposure.

PURPOSE: In Y90 radioembolization, the number of microspheres infused varies by more than a factor of 20 over the shelf-life of the glass radioembolization device. We investigated the effect of the number of Y90 microspheres on normal liver tissue. METHOD: Healthy pigs received lobar radioembolization with glass Y90 microspheres at 4, 8, 12, and 16 days post-calibration, representing a > 20× range in the number of microspheres deposited per milliliter in tissue. Animals were survived for 1-month post-treatment and the livers were explanted and scanned on a micro CT system to fully characterize the microscopic distribution of individual microspheres. A complete 3D microdosimetric evaluation of each liver was performed with a spatially correlated analysis of histopathologic effect. RESULTS: Through whole-lobe microscopic identification of each microsphere, a consistent number of microspheres per sphere cluster was found at 4, 8, and 12 days postcalibration, despite an 8-fold increase in total microspheres infused from days 4 to 12. The additional microspheres instead resulted in more clusters formed and, therefore, a more homogeneous microscopic absorbed dose. The increased absorbed-dose homogeneity resulted in a greater volume fraction of the liver receiving a potentially toxic absorbed dose based on radiobiologic models. Histopathologic findings in the animals support a possible increase in normal liver toxicity in later treatments with more spheres (i.e., ≥ day 12) compared to early treatments with less spheres (i.e., ≤ day 8). CONCLUSION: The microdosimetric evidence presented supports a recommendation of caution when treating large volumes (e.g., right lobe) using glass 90Y microspheres at more than 8 days post-calibration, i.e., after "2nd week" Monday. The favorable normal tissue microscopic distribution and associated low toxicity of first week therapies may encourage opportunities for dose escalation with glass microspheres and could also be considered for patients with decreased hepatic reserve.

Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) Trial: Results at 1 Year.

Background Bariatric embolization is a new endovascular procedure to treat patients with obesity. However, the safety and efficacy of bariatric embolization are unknown. Purpose To evaluate the safety and efficacy of bariatric embolization in severely obese adults at up to 12 months after the procedure. Materials and Methods For this prospective study (NCT0216512 on ClinicalTrials.gov ), 20 participants (16 women) aged 27-68 years (mean ± standard deviation, 44 years ± 11) with mean body mass index of 45 ± 4.1 were enrolled at two institutions from June 2014 to February 2018. Transarterial embolization of the gastric fundus was performed using 300- to 500-µm embolic microspheres. Primary end points were 30-day adverse events and weight loss at up to 12 months. Secondary end points at up to 12 months included technical feasibility, health-related quality of life (Short Form-36 Health Survey ([SF-36]), impact of weight on quality of life (IWQOL-Lite), and hunger or appetite using a visual assessment scale. Analysis of outcomes was performed by using one-sample t tests and other exploratory statistics. Results Bariatric embolization was performed successfully for all participants with no major adverse events. Eight participants had a total of 11 minor adverse events. Mean excess weight loss was 8.2% (95% confidence interval [CI]: 6.3%, 10%; P < .001) at 1 month, 11.5% (95% CI: 8.7%, 14%; P < .001) at 3 months, 12.8% (95% CI: 8.3%, 17%; P < .001) at 6 months, and 11.5% (95% CI: 6.8%, 16%; P < .001) at 12 months. From baseline to 12 months, mean SF-36 scores increased (mental component summary, from 46 ± 11 to 50 ± 10, P = .44; physical component summary, from 46 ± 8.0 to 50 ± 9.3, P = .15) and mean IWQOL-Lite scores increased from 57 ± 18 to 77 ± 18 (P < .001). Hunger or appetite decreased for 4 weeks after embolization and increased thereafter, without reaching pre-embolization levels. Conclusion Bariatric embolization is well tolerated in severely obese adults, inducing appetite suppression and weight loss for up to 12 months. Published under a CC BY-NC-ND 4.0 license. Online supplemental material is available for this article.

Evaluation of image quality and task performance for a mobile C-arm with a complementary metal-oxide semiconductor detector.

We assessed interventional radiologists' task-based image quality preferences for two- and three-dimensional images obtained with a complementary metal-oxide semiconductor (CMOS) flat-panel detector versus a hydrogenated amorphous silicon (a-Si:H) flat-panel detector. CMOS and a-Si:H detectors were implemented on identical mobile C-arms to acquire radiographic, fluoroscopic, and cone-beam computed tomography (CBCT) images of cadavers undergoing simulated interventional procedures using low- and high-dose settings. Images from both systems were displayed side by side on calibrated, diagnostic-quality displays, and three interventional radiologists evaluated task performance relevant to each image and ranked their preferences based on visibility of pertinent anatomy and interventional devices. Overall, CMOS images were preferred in fluoroscopy ( p = 0.002 ) and CBCT ( p = 0.004 ), at low-dose settings ( p = 0.001 ), and for tasks associated with high levels of spatial resolution [e.g., fine anatomical details ( p = 0.006 ) and assessment of interventional devices ( p = 0.015 )]. No significant difference was found for fluoroscopic imaging tasks emphasizing temporal resolution ( p = 0.072 ), for radiography tasks ( p = 0.825 ), when using high-dose settings ( p = 0.360 ), or tasks involving general anatomy ( p = 0.174 ). The image quality preferences are consistent with reported technical advantages of CMOS regarding finer pixel size and reduced electronic noise.

Verification of a method to detect glass microspheres via micro-CT.

INTRODUCTION: The ability to determine the microscopic distribution of glass microspheres in 90 Y radioembolization has important applications in post-treatment microdosimetry and cluster analysis. Current methods are time-intensive and labor-intensive and thus are typically only applied to small samples. MATERIALS AND METHODS: A high-resolution micro-CT image with a voxel size of 8.74 µm was acquired of phantoms containing ~25 µm-diameter glass microspheres embedded in tissue-equivalent materials that were optically transparent, which allowed true microsphere locations to be determined using transmission light microscopy. A 3-stage algorithm was developed to estimate the number and locations of microspheres in tissue regions. The stages are thresholding the CT image and discarding regions with insufficient voxels, estimating the number of microspheres in each region using the values of the detected and neighboring region voxels and estimating locations for each microsphere using the outputs of the previous two stages. Two different methods for estimating the number of microspheres in each region were derived, as were five methods for localizing microspheres. Metrics for each stage were computed, and the mean absolute error (MAE) between the dose to 72 µm voxels of the true and estimated dose maps created from the microsphere locations was used as the figure of merit for overall algorithm performance. Microsphere locations identified in the optical micrograph were used as the gold standard for the metrics of all stages. The method's utility was then demonstrated using a specimen from a human neuroendocrine tumor (NET) treated with glass 90 Y microspheres. RESULTS: The stage detecting regions containing microspheres found 100% of microspheres inside regions. The number of incorrectly detected regions without microspheres was 1.5% of the total number of regions. In stage 2, with these parameters, nearly 94% of the actual number of spheres in each region was correctly counted, and only 5% of the estimated sphere quantities in each region were false positives. The MAE between the true dose maps and dose maps estimated using the full algorithm with optimal parameter and method choices was 4.2%. A total of 5,713 glass microspheres were identified as being distributed heterogeneously in the NET specimen with a maximum tumor dose of >2500 Gy and 46% of the specimen receiving <20 Gy. CONCLUSIONS: This work developed and evaluated a method to detect and estimate the three-dimensional locations of glass microspheres in whole tissue samples that require less manual effort than traditional methods. This method could be used to gain important insights into the heterogeneity of microsphere distributions that would be useful for improving radioembolization treatment planning.

Twelve-month outcomes of Eustachian tube procedures for management of patulous Eustachian tube dysfunction.

OBJECTIVE: To determine the 12-month effectiveness of transnasal-transoral endoscopic surgical procedures for eliminating symptoms of patulous Eustachian tube dysfunction (PETD). STUDY DESIGN: Retrospective chart review METHODS: Patients with medically refractory PETD underwent one of the following procedures: 1) shim (catheter) insertion, 2) calcium hydroxyapatite injection, 3) patulous Eustachian tube (ET) reconstruction, or 4) obliteration of the ET lumen. Time to recurrence of any PETD symptoms was recorded, and success was determined as complete symptom resolution at 12 months. The frailty model, an extension of the Cox proportional hazards model, was used for the survival analysis. RESULTS: A total of 241 procedures were performed in 80 patients. Median duration of symptom relief after surgery was 5.0 months (interquartile range [IQR]: 1.1-15.5 months) and varied by procedure type, ranging from 3.0 months (IQR: 0.7-7.0 months) for calcium hydroxyapatite injection to 20.6 months (3.4-35.9 months) for obliteration. Compared to shim insertion, the risk of 12-month failure was significantly higher for calcium hydroxyapatite injection (hazard ratio [HR] = 2.18; 95% confidence interval [CI] 1.29, 3.67; P = 0.004) and patulous ET reconstruction (HR = 1.62; 95% CI 1.04, 2.52; P = 0.035). Patients undergoing shim insertion (52.2%) and obliteration (81.8%) were likely to require pressure equalization tubes or to have had otitis media with effusion. CONCLUSION: Although all procedures potentially resulted in symptom resolution, placement of a shim or obliteration of the ET lumen was more likely to achieve 12-month resolution of PETD symptoms and more likely to result in otitis media with effusion than hydroxyapatite injection or patulous ET reconstruction. LEVEL OF EVIDENCE: Level 4 Laryngoscope, 129:222-228, 2019.

Bariatric Arterial Embolization for Obesity: A Review of Early Clinical Evidence.

Obesity is a worldwide public health epidemic that leads to increased morbidity, mortality, and cost burden to health care. Although bariatric surgery has been recognized as a standard invasive treatment for obesity, it is accompanied by relatively high morbidity and cost burden, as well as limited treatment outcome. Therefore, alternative treatments with lower morbidity and cost for surgery that target patients who are obese, but not morbidly obese, are needed. A minimally invasive trans-catheter procedure, named bariatric arterial embolization or bariatric embolization (BAE), has been identified as a potential solution, based on its safety and preliminary efficacy profiles. The purpose of this review is to introduce up-to-date clinical data and discuss future directions for BAE for the treatment of obesity.

Safe Intraoperative Neurophysiologic Monitoring During Posterior Spinal Fusion in a Patient With Cochlear Implants.

OBJECTIVE: Cochlear implants are generally considered a contraindication for any procedure requiring electrical stimulation near the implant. We present a case of a patient undergoing intraoperative transcranial electrical motor-evoked potential monitoring with a cochlear implant without adverse outcomes. PATIENT: A 12-year-old girl with a history of VACTERL presented with worsening congenital kyphosis and bilateral severe-to-profound hearing loss. Since age 7 the patient used a cochlear implant in the right ear and hearing aid in the left ear. Physical examination and magnetic resonance imaging in 2016 revealed a left-sided 66-degree thoracolumbar kyphosis at T11 making the patient a candidate for surgical correction. INTERVENTIONS: She underwent a posterior spinal fusion surgery, performed with intraoperative transcranial electrical motor-evoked potential monitoring. Steps were taken to mitigate electrical stimulation of the patient's cochlear implant. MAIN OUTCOME MEASURES: Postoperative impedance of individual channels, audiometry, and neural response testing were compared with preoperative measurements. RESULTS: Significant (>10%) impedance changes were observed postoperatively in channels 1, 2, 4, and 6; however, the net variation across all the channels was low (3%). The patient reported no hearing changes, and no significant changes in hearing threshold were seen in postoperative audiometric testing or neural response testing. CONCLUSION: We present a case of successful posterior spinal fusion with intraoperative neurophysiological monitoring via transcranial electrical stimulation, in a patient with a cochlear implant. With proper precautions, motor-evoked potential monitoring can be safely performed in a patient with a cochlear implant.

Mobile C-Arm with a CMOS detector: Technical assessment of fluoroscopy and Cone-Beam CT imaging performance.

PURPOSE: Indirect-detection CMOS flat-panel detectors (FPDs) offer fine pixel pitch, fast readout, and low electronic noise in comparison to current a-Si:H FPDs. This work investigates the extent to which these potential advantages affect imaging performance in mobile C-arm fluoroscopy and cone-beam CT (CBCT). METHODS: FPDs based on CMOS (Xineos 3030HS, 0.151 mm pixel pitch) or a-Si:H (PaxScan 3030X, 0.194 mm pixel pitch) sensors were outfitted on equivalent mobile C-arms for fluoroscopy and CBCT. Technical assessment of 2D and 3D imaging performance included measurement of electronic noise, gain, lag, modulation transfer function (MTF), noise-power spectrum (NPS), detective quantum efficiency (DQE), and noise-equivalent quanta (NEQ) in fluoroscopy (with entrance air kerma ranging 5-800 nGy per frame) and cone-beam CT (with weighted CT dose index, CTDIw , ranging 0.08-1 mGy). Image quality was evaluated by clinicians in vascular, orthopaedic, and neurological surgery in realistic interventional scenarios with cadaver subjects emulating a variety of 2D and 3D imaging tasks. RESULTS: The CMOS FPD exhibited ~2-3× lower electronic noise and ~7× lower image lag than the a-Si:H FPD. The 2D (projection) DQE was superior for CMOS at ≤50 nGy per frame, especially at high spatial frequencies (~2% improvement at 0.5 mm-1 and ≥50% improvement at 2.3 mm-1 ) and was somewhat inferior at moderate-high doses (up to 18% lower DQE for CMOS at 0.5 mm-1 ). For smooth CBCT reconstructions (low-frequency imaging tasks), CMOS exhibited ~10%-20% higher NEQ (at 0.1-0.5 mm-1 ) at the lowest dose levels (CTDIw ≤0.1 mGy), while the a-Si:H system yielded slightly (~5%) improved NEQ (at 0.1-0.5 lp/mm) at higher dose levels (CTDIw ≥0.6 mGy). For sharp CBCT reconstructions (high-frequency imaging tasks), NEQ was ~32% higher above 1 mm-1 for the CMOS system at mid-high-dose levels and ≥75% higher at the lowest dose levels (CTDIw ≤0.1 mGy). Observer assessment of 2D and 3D cadaver images corroborated the objective metrics with respect to a variety of pertinent interventional imaging tasks. CONCLUSION: Measurements of image noise, spatial resolution, DQE, and NEQ indicate improved low-dose performance for the CMOS-based system, particularly at lower doses and higher spatial frequencies. Assessment in realistic imaging scenarios confirmed improved visibility of fine details in low-dose fluoroscopy and CBCT. The results quantitate the extent to which CMOS detectors improve mobile C-arm imaging performance, especially in 2D and 3D imaging scenarios involving high-resolution tasks and low-dose conditions.