Use Of IUS Research Articles

Role of intraoperative ultrasound and MRI to aid grade of resection of pediatric low-grade gliomas: accumulated experience from 4 centers.

Pediatric low-grade gliomas (pLGG) are the most common brain tumors in children and achieving complete resection (CR)in pLGG is the most important prognostic factor. There are multiple intraoperative tools to optimize the extent of resection (EOR). This article investigates and discusses the role of intraoperative ultrasound (iUS) and intraoperative magnetic resonance imaging (iMRI) in thesurgical treatment of pLGG. The tumor registries at Tuebingen, Rome and Pretoria were searched for pLGG with the use of iUS and data on EOR. The tumor registries at Liverpool and Tuebingen were searched for pLGG with the use of iMRI where preoperative CR was the surgical intent. Different iUS and iMRI machines were used in the 4 centers. We included 111 operations which used iUS and 182 operations using iMRI. Both modalities facilitated intended CR in hemispheric supra- and infratentorial location in almost all cases. In more deep-seated tumor location like supratentorial midline tumors, iMRI has advantages over iUS to visualize residual tumor. Functional limitations limiting CR arising from eloquent involved or neighboring brain tissue apply to both modalities in the same way. In the long-term follow-up, both iUS and iMRI show that achieving a complete resection on intraoperative imaging significantly lowers recurrence of disease (chi-square test, p < 0.01). iUS and iMRI have specific pros and cons, but both have been proven to improve achieving CR in pLGG. Due to advances in image quality, cost- and time-efficiency, and efforts to improve the user interface, iUS has emerged as the most accessible surgical adjunct to date to aid and guide tumor resection. Since the EOR has the most important effect on long-term outcome and disease control of pLGG in most locations, we strongly recommend taking all possible efforts to use iUS in any surgery, independent of intended resection extent and iMRI if locally available.

Magnetic Resonance Enterography and Intestinal Ultrasound for the Assessment and Monitoring of Crohn's Disease.

Magnetic resonance enterography [MRE] and intestinal ultrasound [IUS] have developed rapidly in the past few decades, emerging as the primary non-invasive options for both diagnosing and monitoring Crohn's disease [CD]. In this review, we evaluate the pertinent data relating to the use of MRE and IUS in CD. We summarise the key imaging features of CD activity, highlight their increasing role in both the clinical and the research settings, and discuss how these modalities fit within the diagnostic pathway. We discuss how they can be used to assess disease activity and treatment responsiveness, including the emergence of activity scores for standardised reporting. Additionally, we address areas of controversy such as the use of contrast agents, the role of diffusion-weighted imaging, and point-of-care ultrasound. We also highlight exciting new developments, including the applications of artificial intelligence. Finally, we provide suggestions for future research priorities.

Intraoperative ultrasound for surgical resection of high-grade glioma and glioblastoma: a meta-analysis of 732 patients.

Here, we conducted a meta-analysis to explore the use of intraoperative ultrasound (iUS)-guided resection in patients diagnosed with high-grade glioma (HGG) or glioblastoma (GBM). Our aim was to determine whether iUS improves clinical outcomes compared to conventional neuronavigation (CNN). Databases were searched until April 21, 2023 for randomized controlled trials (RCTs) and observational cohort studies that compared surgical outcomes for patients with HGG or GBM with the use of either iUS in addition to standard approach or CNN. The primary outcome was overall survival (OS). Secondary outcomes include volumetric extent of resection (EOR), gross total resection (GTR), and progression-free survival (PFS). Outcomes were analyzed by determining pooled relative risk ratios (RR), mean difference (MD), and standardized mean difference (SMD) using random-effects model. Of the initial 867 articles, only 7 articles specifically met the inclusion criteria (1 RCT and 6 retrospective cohorts). The analysis included 732 patients. Compared to CNN, the use of iUS was associated with higher OS (SMD = 0.26,95%CI=[0.12,0.39]) and GTR (RR = 2.02; 95% CI=[1.31,3.1]) for both HGG and GBM. There was no significant difference in PFS or EOR. The use of iUS in surgical resections for HGG and GBM can improve OS and GTR compared to CNN, but it did not affect PFS. These results suggest that iUS reduces mortality associated with HGG and GBM but not the risk of recurrence. These results can provide valuable cost-effective interventions for neurosurgeons in HGG and GBM surgery.

P332 External validation of intestinal ultrasound scores to detect endoscopic activity in children and adults with Crohn's disease: A prospective cohort study

Abstract Background Intestinal ultrasound (IUS) scores were developed for adults and children with Crohn’s disease (CD) but have not been externally validated with endoscopy. This study aimed to externally validate all CD IUS scores with endoscopy. Methods Prospective cross-sectional study of children and adults with CD who underwent IUS and colonoscopy within 60 days. The International Bowel Ultrasound Segment Activity Score (IBUS-SAS), Simple Ultrasound Score for Crohn’s disease (SUS-CD), Simple Ultrasound Activity Score for Crohn’s disease (SUAS-CD), and Simple Pediatric Activity Ultrasound Score (SPAUSS) were compared to the Simple Endoscopic Score for Crohn’s disease (SES-CD). Primary outcomes were the area under the receiver operating curve (AUROC) for each IUS score for moderate (SES-CD ≥ 5) and any (SES-CD ≥ 3) CD activity. Secondary outcome was the correlation of IUS scores and SES-CD. Results 82 CD patients (53 (65%) children, 29 (35%) adults, 41 (50%) female; 50 (61%) ileocolonic disease location) underwent IUS of 150 (74 (49%) terminal ileum) bowel segments with IUS scores and SES-CD. In both children and adults, all scores performed with high accuracy to detect SES-CD ≥ 5 and moderate accuracy to detect SES-CD ≥ 3. To detect SES-CD ≥ 5 in children, a SUAS-CD ≥ 4.5 had the highest AUROC [95% CI] =0.91 [0.85-0.97] (sensitivity=90%, specificity=81%), followed by an IBUS-SAS ≥ 37.8 (AUROC=0.89 [0.83-0.96]), SPAUSS ≥ 4 (AUROC=0.89 [0.81-0.96]), and SUS-CD ≥ 2 (AUROC=0.88 [0.80-0.95]). To detect SES-CD ≥ 5 in adults, an IBUS-SAS ≥ 34.2 had the highest AUROC=0.85 [0.71-98] (sensitivity=70%, specificity=87%) followed by a SAUS-CD ≥ 5.45 (AUROC =0.84 [0.71-0.98]), SUS-CD ≥ 1 (AUROC=0.81 [0.65-0.97]), and SPAUSS ≥ 5 (AUROC=0.78 [0.65-0.97]). To detect SES-CD ≥ 3, SPAUSS ≥ 4 (AUROC=0.78 [0.69-0.87], sensitivity=56%, specificity=92%) and SUS-CD ≥ 3 (AUROC =0.78 [0.68-0.86], sensitivity=56%, specificity=89%) had the highest accuracy in children followed by a SAUS-CD ≥ 4.5 (AUROC=0.74 [0.63-0.86]) and IBUS-SAS ≥ 34 (AUROC=0.73 [0.62-0.84]). In adults, SAUS-CD ≥ 2.68 and IBUS-SAS ≥ 11.2 (AUROC = 0.68 [0.50-0.85], sensitivity=63%, specificity=72%) had the highest accuracy to detect SES-CD ≥ 3 followed by a SUS-CD ≥ 2.5 (AUROC = 0.65 [0.50-0.81]), and SPAUSS ≥ 6 (AUROC = 0.61 [0.45-0.77]). IUS scores moderately correlated with SES-CD in children and adults, of which the IBUS-SAS had the highest (r=0.66 in children vs. r=0.57 in adults). Conclusion CD IUS scores are accurate for the detection of endoscopic activity in children and adults. IUS scores may be more accurate in children and correlate better with endoscopy but more studies are needed. This data supports the use of IUS as an accurate monitoring tool, reflective of endoscopic activity.

P676 Intestinal ultrasound accurately predicts therapy failure in Crohn's disease patients during a biologics-induced remission

Abstract Background Intestinal Ultrasound (IUS) is a non-invasive modality that can assess disease activity, complications, and treatment follow-up in Crohn's disease (CD) patients. IUS is reliable, patient-friendly, and allows frequent monitoring of disease activity. While 3mm bowel wall thickness (BWT) was repeatedly found to correlate with intestinal inflammation, whether this threshold also best predicts clinically relevant future outcomes is still largely unknown. We aim to investigate the role of IUS to predict the risk of therapy failure in biologics-treated CD patients in clinical remission. Methods Our analysis included a retrospective cohort of CD patients in clinical remission (HBI≤4) induces by biologic drugs, who underwent IUS 12 (±2) months after induction. We examined the correlation of IUS activity parameters with future therapy failure (defined as drug discontinuation, dose escalation, new corticosteroid use, CD-related hospitalization, or surgery). Results A total of 57 patients (58% male), with ileal (65%) or ileocolonic (35%) CD, on biological therapy (28% infliximab, 51% adalimumab, 10.5% vedolizumab, 10.5% ustekinumab) were included. Therapy failure occurred in 54.3% (32.2% drug discontinuation, 45.2% dose escalation, 16.2% corticosteroid use and 6.4% hospitalization) during a median follow-up of 12 (IQR 5-22) months after IUS. Of all IUS parameters examined, therapy failure was associated only with increased BWT; BWT &amp;gt; 5mm (hazard ratio (HR) 2.3 [confidence interval (CI) 1.03-5.3], p= 0.041). Interestingly, there was risk plateauing with increased BWT above this cutoff (&amp;gt;5.5 mm (HR 2.2 [CI 1-5.10], p=0.048); &amp;gt;6mm (HR 2.6 [CI 1.17-6.12], p=0.019); &amp;gt;6.5 mm (HR 2.5 [CI 1.08-5.83], p=0.032)) (Figure 1). A BWT cutoff of 3mm could not discriminate patients with future treatment failure. Conclusion Our findings suggest that BWT of &amp;gt; 5 mm during clinical remission can predict subsequent treatment failure in CD patients treated with biologics. Our results support the use of IUS in monitoring CD during remission, and may point to a novel threshold predicting disease reactivation.

Systematic Review: Applications of Intraoperative Ultrasonography in Spinal Surgery

As a result of increased practicality and decreased costs and radiation, interest has increased in intraoperative ultrasonography (iUS) in spinal surgery applications; however, few studies have provided a robust overview of its use in spinal surgery. We synthesize findings of existing literature on use of iUS in navigation, pedicle screw placement, and identification of anatomy during spinal interventions. PRISMA guidelines were used in this systematic review. Studies were identified through PubMed, Scopus, and Google Scholar databases using the search string. Abstracts mentioning iUS in spine applications were included. On full-text review, exclusion criteria were implemented, including outdated studies or those with weak topic relevance or statistical power. On elimination of duplicates, multireviewer screening for eligibility, and citation search, 44 articles were analyzed. Navigation using iUS is safe, effective, and economical. iUS registration accuracy and success are within clinically acceptable limits for image-guided navigation. Pedicle screw instrumentation with iUS is precise, with a favorable safety profile. Anatomic landmarks are reliably identified with iUS, and surgeons are overwhelmingly successful in neural or vascular tissue identification with iUS modalities, including standard B mode, Doppler, and contrast-enhanced ultrasonography. iUS use in traumatic reduction of fractures properly identifies anatomic structures, intervertebral disc space, and vasculature. iUS eliminates radiation, decreases costs, and provides sufficient accuracy and reliability in identification of anatomic and neurovascular structures in various spinal surgery settings.

P335 Utility of Intestinal Ultrasound in Monitoring Disease Activity in Ulcerative Colitis Patients Treated with Biologics

Abstract Background Given the invasive nature and high cost of frequent and repeated endoscopies needed to monitor UC, search for non-invasive diagnostic alternative is warranted. Intestinal ultrasound is a cost-effective, well-tolerated, non-invasive and readily available „point-of-care“ tool for the management of patients with Crohn’s disease. The role and widespread use of IUS for UC is still limited. We aimed to evaluate association between UC disease activity assessed by IUS on one hand and standard clinical, biochemical, and endoscopic parameters on the other one. Methods A single center, noninterventional retrospective chart review of adult UC patients treated with biologics at a tertiary center was performed. Routine clinical (stool frequency score – SFS, and rectal bleeding score – RBS), biochemical (FC), endoscopic (Mayo Endoscopic Subscore - MES), and IUS parameters (bowel wall thickness - BWT and colonic wall hyperemia assessed by colour Doppler imaging - CDS) were assessed before initiating biologics. Normal distribution was assessed using Shapiro-Wilk tests. Spearman correlation coefficients were calculated and ROC analysis was carried out. Results Total of, 44 patients (50% females, mean age, 37.4 ±, 14.05 years) with predominantly extensive UC (75%) were analysed. Positive correlation was observed between combination of BWT and level of CDS with SFS (rs = 0.68, p &amp;lt;, 0.01, N = 33) as well as with RBS (rs = 0.44, p &amp;lt;, 0.01, N = 34). Moreover FC values were in positive correlation with BWT (rs = 0.54, p &amp;lt;, 0.01, N = 36), levels of CDS (rs = 0.66, p &amp;lt;, 0.01, N = 33) and combination of BWT coupled with level of CDS (rs = 0.7, p &amp;lt;, 0.01, N = 33). In case of clinical active UC (SFS, 2/3 + RBS, 2/3 + FC &amp;gt;150 mg/g) correlation coefficient between FC level and BWT coupled with level of CDS rises to rs = 0.72, p &amp;lt;, 0.01, N = 30. Positive correlation of CDS with MES (rs = 0.65, p &amp;lt;, 0.01, N = 16) as well as between combination of BWT + level of CDS with MES (rs = 0.6, p &amp;lt;, 0.02, N = 16) was observed. Interestingly, positive correlation between BWT and MES didn′t reach statistical significance (rs = 0.42, p = 0.1, N = 16). The area under the curve (AUC) for the FC values and disease activity (defined as SFS, 2/3 + RBS, 2/3 + BWT &amp;gt;4 mm + presence of CDS) was, 0.96 (SE:, 0.03;, 95% CI, 0.89–0.99, p&amp;lt;0.01). FC values &amp;gt;134 mg/g were associated with active disease (sensitivity, 89.3%, specificity, 87.5%). Conclusion Results of this study show a good correlation between IUS and clinical, biochemical and endoscopic parameters of UC disease severity. IUS as a monitoring tool can be helpful in estimation of UC disease activity and can guide daily management of patients treated with biologics.

Pattern of use of intraoperative ultrasound in surgery for brain tumors influences outcomes in glial tumors.

Background Intraoperative ultrasound (iUS) imaging has emerged as a promising adjunct in glioma surgery with both, 2-dimensional (2D) as well as navigated 3-dimensional (n3D), modes increasingly being used. Methods We analyzed our decade-long experience of 1075 brain tumor (807, 75% gliomas) cases operated using iUS. A retrospective chart and electronic records review was performed. The primary aim was to understand the patterns of use of iUS mode and its purpose of application (as a localizing tool or as a resection control modality) as well as to evaluate its impact on the extent of resection. Results The use of iUS increased over time, especially with the introduction of n3DUS though 2DUS remained the more commonly used mode (63%) overall during this period. For biopsies (156 cases), both 2D, as well as n3D iUS, were used as a localizing tool only. Lesion localization was the major purpose for use of iUS even for tumor resections (61%). Resection control was performed more often for gliomas (46.5% compared to 16.5% in non-glial tumors). n3DUS was the preferred modality as a resection control tool irrespective of histological class. GTR (gross total resection) was achieved in 53.1% cases overall, while in glial and non-glial tumors it was 44.7% and 80.7%, respectively. GTR was higher when iUS was used as a resection control modality. The US and MR defined EOR (extent of resection) showed substantial agreement (κ = 0.678) with high diagnostic accuracy of 84% for glial tumors. In glial tumors, iUS was used more often in eloquent tumors and GTR rates were slightly higher than when iUS was not used. Conclusion iUS is a versatile tool and is a useful surgical adjunct for glioma surgeons. Besides its proven benefit as a localizing tool, when used as a tool for resection control it improves the resection rates. n3DUS may offer benefits over 2DUS as a resection control modality, though the evidence is still evolving.

Point-of-care Intestinal Ultrasound in IBD Patients: Disease Management and Diagnostic Yield in a Real-world Cohort and Proposal of a Point-of-care Algorithm.

IntroductionIntestinal ultrasound [IUS] is useful for assessment of inflammation, complications, and treatment follow-up in inflammatory bowel disease [IBD] patients. We aimed to study outcomes and impact on disease management for point-of-care [POC] IUS in IBD patients.MethodsTwo patient cohorts undergoing POC IUS [January 2016–July 2018 and October 2019–December 2019] were included retrospectively. Disease management after IUS was analysed and IUS outcomes were compared with symptoms, biomarkers, and additional imaging within 8 weeks from IUS. To study differences in use of IUS over time, cohorts were compared.ResultsIn total, 345 examinations (280 in Crohn’s disease [CD]/65 in ulcerative colitis [UC]) were performed. Present inflammation on IUS was comparable between symptomatic and asymptomatic CD [67.6% vs 60.5%; p = 0.291]. In 60%, IUS had impact on disease management with change in medication in 47.8%. Additional endoscopy/magnetic resonance imaging [MRI] was planned after 32.8% examinations, showing good correlation with IUS in 86.3% [ρ = 0.70, p <0.0001] and 80.0% [ρ = 0.75, p <0.0001] of cases, respectively. Faecal calprotectin was higher in active versus inactive disease on IUS [664 µg/g vs 79 µg/g; p <0.001]. Over the years, IUS was performed more frequently to monitor treatment response and the use of MRI was reduced within the cohort.ConclusionsPOC IUS affects clinical decision making and could detect preclinical relapse in CD patients, with potential to reduce additional endoscopy or MRI. In addition, the paradigm expands towards monitoring treatment and close follow-up for IUS. Based on our results, we propose a POC IUS algorithm for follow-up of IBD patients.

Implementation of Intraoperative Ultrasound Localization for Breast-Conserving Surgery in a Large, Integrated Health Care System is Feasible and Effective

BackgroundIntraoperative ultrasound (IUS) localization for breast cancer is a noninvasive localization technique. In 2015, an IUS program for breast-conserving surgery (BCS) was initiated in a large, integrated health care system. This study evaluated the clinical results of IUS implementation.MethodsThe study identified breast cancer patients with BCS from 1 January to 31 October 2015 and from 1 January to 31 October 2019. Clinicopathologic characteristics were collected, and localization types were categorized. Clinical outcomes were analyzed, including localization use, surgeon adoption of IUS, day-of-surgery intervals, and re-excision rates. Multivariate logistic regression analysis was performed to evaluate predictors of re-excision.ResultsThe number of BCS procedures increased 23%, from 1815 procedures in 2015 to 2226 procedures in 2019. The IUS rate increased from 4% of lumpectomies (n = 79) in 2015 to 28% of lumpectomies (n = 632) in 2019 (p < 0.001). Surgeons using IUS increased from 6% (5 of 88 surgeons) in 2015 to 70% (42 of 60 surgeons) in 2019. In 2019, 76% of IUS surgeons performed at least 25% of lumpectomies with IUS. The mean time from admission to incision was shorter with IUS or seed localization than with wire localization (202 min with IUS, 201 with seed localization, 262 with wire localization in 2019; p < 0.001). The IUS re-excision rates were lower than for other localization techniques (13.6%, vs 19.6% for seed localization and 24.7% for wire localization in 2019; p = 0.006), and IUS predicted lower re-excision rates in a multivariable model (odds ratio [OR], 0.59).ConclusionsIn a high-volume integrated health system, IUS was adopted for BCS by a majority of surgeons. The use of IUS decreased the time from admission to incision compared with wire localization, and decreased re-excision rates compared with other localization techniques.

Transmural Response and Transmural Healing Defined by Intestinal Ultrasound: New Potential Therapeutic Targets?

Intestinal ultrasound [IUS] is a useful modality to monitor patients with inflammatory bowel disease [IBD]. Little is known about the use of IUS and appropriate definitions for transmural response [TR] and healing [TH]. We aimed to establish the use of IUS in monitoring TH as a potential target in routine medical practice. Based on the prospective, non-interventional, multicentre studies TRUST and TRUST&UC, we conducted a post-hoc analysis of 351 IBD patients with increased bowel wall thickness [BWT]. We analysed the rates of patients achieving TR and TH, comparing three definitions of TH. In 137 Crohn's disease [CD] patients, the predictive value of TR and TH was investigated for the clinical and sonographic outcome at week 52. Within 12 weeks of treatment intensification, 65.6% [n = 118] of CD patients and 76.6% [n = 131] of ulcerative colitis [UC] patients showed a TR. Depending on the definition, 23.9-37.2% [n = 58/67/43] of CD patients and 45.0-61.4% [n = 90/105/77] of UC patients had TH at week 12. CD patients with TH were more likely to reach clinical remission at week 12 (odds ratio [OR] 3.33 [1.09-10.2]; p = 0.044) and a favourable sonographic outcome (OR 5.59 [1.97-15.8]; p = 0.001) at week 52 compared with patients without TH. IUS response and TH in a relevant proportion of patients suggests that IUS is a useful method to assess transmural inflammatory activity in daily clinical practice. TR and TH are predictive for the sonographic outcome at week 52.

Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease: Promising, but Work in Progress.

Intestinal ultrasound (IUS) is increasingly used and promulgated as a noninvasive monitoring tool for children with inflammatory bowel disease because other diagnostic modalities such as colonoscopy and magnetic resonance imaging cause significant stress in the pediatric population. The most important parameters of inflammation that can be assessed using IUS are bowel wall thickness and hyperemia of the bowel wall. Research has shown that IUS has the potential to be a valuable additional point-of-care tool to guide treatment choice and to monitor and predict treatment response, although evidence of its accuracy and value in clinical practice is still limited. This review gives an update and overview of the current evidence on the use and accuracy of IUS in children with inflammatory bowel disease.

Challenges and Opportunities of Intraoperative 3D Ultrasound With Neuronavigation in Relation to Intraoperative MRI.

IntroductionNeuronavigation greatly improves the surgeons ability to approach, assess and operate on brain tumors, but tends to lose its accuracy as the surgery progresses and substantial brain shift and deformation occurs. Intraoperative MRI (iMRI) can partially address this problem but is resource intensive and workflow disruptive. Intraoperative ultrasound (iUS) provides real-time information that can be used to update neuronavigation and provide real-time information regarding the resection progress. We describe the intraoperative use of 3D iUS in relation to iMRI, and discuss the challenges and opportunities in its use in neurosurgical practice.MethodsWe performed a retrospective evaluation of patients who underwent image-guided brain tumor resection in which both 3D iUS and iMRI were used. The study was conducted between June 2020 and December 2020 when an extension of a commercially available navigation software was introduced in our practice enabling 3D iUS volumes to be reconstructed from tracked 2D iUS images. For each patient, three or more 3D iUS images were acquired during the procedure, and one iMRI was acquired towards the end. The iUS images included an extradural ultrasound sweep acquired before dural incision (iUS-1), a post-dural opening iUS (iUS-2), and a third iUS acquired immediately before the iMRI acquisition (iUS-3). iUS-1 and preoperative MRI were compared to evaluate the ability of iUS to visualize tumor boundaries and critical anatomic landmarks; iUS-3 and iMRI were compared to evaluate the ability of iUS for predicting residual tumor.ResultsTwenty-three patients were included in this study. Fifteen patients had tumors located in eloquent or near eloquent brain regions, the majority of patients had low grade gliomas (11), gross total resection was achieved in 12 patients, postoperative temporary deficits were observed in five patients. In twenty-two iUS was able to define tumor location, tumor margins, and was able to indicate relevant landmarks for orientation and guidance. In sixteen cases, white matter fiber tracts computed from preoperative dMRI were overlaid on the iUS images. In nineteen patients, the EOR (GTR or STR) was predicted by iUS and confirmed by iMRI. The remaining four patients where iUS was not able to evaluate the presence or absence of residual tumor were recurrent cases with a previous surgical cavity that hindered good contact between the US probe and the brainsurface.ConclusionThis recent experience at our institution illustrates the practical benefits, challenges, and opportunities of 3D iUS in relation to iMRI.

Provider Attitudes and Practices Regarding Intrauterine System (IUS) Insertion in Adolescents With and Without Bleeding Disorders for Management of Heavy Menstrual Bleeding.

Heavy menstrual bleeding (HMB) may be the sentinel event for identifying a patient with a bleeding disorder (BD). The levonorgestrel intrauterine system (LNG IUS) has been proposed as a treatment for HMB in adolescents with and without BDs; however, no standard protocols for LNG IUS insertion in these populations exist. Providers were surveyed regarding the use of the LNG IUS in adolescents with HMB, with and without BD. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: An institutional review board-approved survey assessing provider attitudes, LNG IUS insertion practices, and patient outcomes in adolescents with HMB, with and without BD, was electronically distributed to 3523 providers in the fields of hematology, adolescent medicine, and obstetrics and gynecology. Descriptive analysis was performed. A total of 312 respondents across all 3 specialties completed the survey. Nearly 100% of respondents considered the LNG IUS safe and effective treatment for adolescents with HMB, both with and without BD. Additionally, 66% of providers chose LNG IUS as the ideal treatment for HMB in patients with BD. Differences were noted in clinical setting for LNG IUS insertion, peri-procedural medication use, and post-procedure follow-up among specialties. Providers across all specialties reported low complication rates related to IUS insertion and use in both patient groups. Providers considered the LNG IUS safe and effective treatment for HMB in adolescents with and without a diagnosed BD. Practice patterns regarding LNG IUS insertion in this population vary. Further research is necessary to explore IUS outcomes in adolescent patients with HMB, with and without BD, and to inform evidence-based protocols for LNG IUS insertion.

A Reliability Study: Strong Inter-Observer Agreement of an Expert Panel for Intestinal Ultrasound in Ulcerative Colitis.

BackgroundIntestinal ultrasound [IUS] is a promising and non-invasive cross-sectional imaging modality in the diagnosis and monitoring of ulcerative colitis [UC]. Unlike endoscopy, where standardized scoring for evaluation of disease activity is widely used, scoring for UC with IUS is currently unavailable. Therefore, we conducted a study to assess the reliability of IUS in UC among expert sonographists in order to identify robust parameters.MethodsThirty patients with both clinically active [25] and quiescent [five] UC were included. Six expert sonographers first agreed upon key IUS parameters and grading, including bowel wall thickness [BWT], colour Doppler signal [CDS], inflammatory fat [i-fat], loss of bowel wall stratification [BWS], loss of haustrations and presence of lymph nodes. Thirty video-recorded cases were blindly reviewed.ResultsInter-observer agreement was almost perfect for BWT (intra-class correlation coefficient [ICC]: 0.96) and substantial for CDS [κ = 0.63]. Agreement was moderate for presence of lymph nodes [κ = 0.41] and fair for presence of i-fat [κ = 0.36], BWS [κ = 0.24] and loss of haustrations [κ = 0.26]. Furthermore, there was substantial agreement for presence of disease activity on IUS [κ = 0.77] and almost perfect agreement for disease severity [ICC: 0.93]. Most individual parameters showed a strong association with IUS disease activity as measured by the six readers.ConclusionIUS is a reliable imaging modality to assess disease activity and severity in UC. Important individual parameters such as BWT and CDS are reliable and could be incorporated in a future UC scoring index. Standardized acquisition and assessment of UC utilizing IUS with established reliability is important to expand the use of IUS globally.

Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: results of a prospective 5-year study

STUDY QUESTIONWhat is the bleeding pattern during second consecutive levonorgestrel-releasing intrauterine system (LNG-IUS) use?SUMMARY ANSWERConsecutive use of LNG-IUS is associated with a predictable bleeding pattern, characterized by the absence of the initial period of irregular bleeding seen after interval insertion of an LNG-IUS and a non-bleeding pattern in the vast majority of women.WHAT IS KNOWN ALREADYWith increased popularity of the LNG-IUS for long-term birth control and treatment of heavy menstrual bleeding (HMB), consecutive use of the system is becoming more frequent. One previous study showed 60% amenorrhea rate in consecutive IUS users; however, the sample size was small.STUDY DESIGN, SIZE, DURATIONA prospective multicenter study in four European countries recruited women who wished to continue with LNG-IUS use immediately after the first 5-year period. A total of 204 women were followed up until the end of the first year of the second IUS. Thereafter 170 women continued into the extension phase of the study up to the full 5 years of use of the second IUS and 144 women continued to the end of the study.PARTICIPANTS, SETTING, METHODSA total of 170 women (mean age 39 years) who had been using their first LNG-IUS for between 4 years 3 months and 4 years 9 months, either for contraception or for treatment of HMB, and who planned to replace the device with a new LNG-IUS, were recruited and followed up to 5 years of the second IUS use. A total of 17 centers in four European countries were involved in the study. Bleeding patterns were analyzed using daily bleeding diaries using 90-day reference periods (RP) for the first year of the second IUS use and for the last RP of each year during Years 2–5 of use.MAIN RESULTS AND THE ROLE OF CHANCEApproximately 70% of women were free of bleeding during Years 2–5 and up to 49% were amenorrheic. There was a slight increase in the number of bleeding/spotting days of ∼3 days during the first RP immediately after the placement of the second IUS, whereafter the number of bleeding/spotting days returned to the level preceding the second IUS insertion or below that. Absence of bleeding was associated with high overall satisfaction and continuation rates. No serious adverse events assessed as related to the LNG-IUS use occurred during the 5-year period. The cumulative expulsion rate during the 5-year study period was 1.2%. The sample size was large enough to study bleeding patterns, and subjects are likely to represent typical consecutive IUS users, and therefore, the role of chance is small.LIMITATIONS, REASONS FOR CAUTIONThe women represent a selected group as they had already successfully used their first IUS for almost 5 years and were willing to continue its use—however, this is currently a common clinical situation. The results may therefore not be extrapolated to first-time users of the LNG-IUS.WIDER IMPLICATIONS OF THE FINDINGSThese data are of importance when counseling women who are making decisions concerning long-term contraception.STUDY FUNDING/COMPETING INTEREST(S)This study was funded by Bayer Pharma AG. P.I. and T.S. are full-time employees of Bayer Pharma AG. O.H. and K. G-D. have received consultancy fees from Bayer Pharma AG. The publication was developed jointly by all authors without third-party involvement and no honoraria were paid for any authors for their contribution to this manuscript.TRIAL REGISTRATION NUMBERNCT00393198.

Complication Rates Associated with Levonorgestrel Intrauterine System Use in Adolescents with Developmental Disabilities

Study ObjectiveTo assess the complication rates with the use of the levonorgestrel intrauterine system (LNG IUS) in adolescents with developmental disabilities. DesignRetrospective chart review of all adolescents with developmental disabilities taken to the operating room for LNG IUS insertion between January 2000 and July 2009 at the Royal Children's Hospital, Melbourne, Australia. Cases identified from the surgical database, and medical records reviewed. Main Outcome MeasuresComplication rates with LNG IUS use in adolescents with development disabilities: non-insertion, uterine perforation, infection, and expulsion. ResultsFifty-six adolescents with developmental disabilities had an attempted LNG IUS insertion. The average age at insertion was 15.6 years (range 10.5-21.5 y). The LNG IUS was used as first line therapy in 14 cases (25%). Pre-insertion ultrasonography was ordered in 48% of cases, out of which 5 cases had uterine lengths <6 cm. Despite this, 4 of these cases had successful insertions. Two insertion attempts were abandoned intra-operatively (3.6%); one due to inadequate uterine length of 4 cm, and the other due to anatomic distortion. One spontaneous expulsion occurred at approximately 5 months (1.9%). Four IUDs were removed prematurely (7.4% withdrawal rate); 1 for persistent abdominal pain, 1 for irregular bleeding, and 2 for suspected malpositions. There were no documented cases of infection, perforation, or pregnancy. ConclusionOur experience in this population has been very positive and confirms that complication rates are comparable to that in adults.

Duration of use of a levonorgestrel IUS amongst nulliparous and adolescent women

Background Intrauterine devices are cost-effective if used for 2 or more years. Early discontinuation may lead to reduced cost-effectiveness of this method and unintended pregnancy if other contraceptives are not used. This study sought to examine rates and reasons for discontinuation of IUS use in adolescents versus older women and nulliparous versus parous women, as these groups may be more likely to discontinue use. Study Design Retrospective cohort study of women receiving a levonorgestrel IUS between June 2005 and April 2008 was conducted. Medical records were reviewed for all visits following placement of the IUS; rates and reasons for IUS discontinuation were calculated and categorized. Data were examined under two scenarios: (1) assuming that all women not seen for follow-up continued IUS use and (2) only including women with follow-up visits. Cox regression was used to control for age, parity, race and marital status in comparing rates of IUS discontinuation and expulsion in nulliparous versus parous women and adolescents versus older women. Results Of the 828 women included in this analysis, 104 (12.6%) were nulliparous, and 131 (15.8%) were ≤20 years of age. Nulliparous women were not more likely than parous women to have expelled their IUS [hazard ratio (95% confidence interval), 1.40 (0.57, 3.43)]. Adolescent women were more likely to experience expulsion than older women, although this did not reach statistical significance [hazard ratio, 1.49 (0.76, 2.92)]. When we looked at reasons for IUS removal, we found that nulliparous women were not more likely than parous women to have their IUS removed because of dissatisfaction with the contraceptive method (6.7% vs. 11.5%, p=.15) or desire to become pregnant (1.9% vs. 2.6%, p=.50). Similarly, adolescents were not more likely than older women to have their IUS removed because of dissatisfaction with the contraceptive method (10.7% vs. 10.9%, p=.94) or desire to become pregnant (3.1% vs. 2.4%, p=.43). Conclusions Adolescents and nulliparous women are not more likely to prematurely discontinue use of their IUS than adult or parous women.

Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study

The LNG-IUS has increasingly been used for contraception, treatment of menorrhagia and endometrial protection during hormone replacement therapy since mid-1990s. Thus, many women use the LNG-IUS consecutively. However, published data on the bleeding pattern regarding consecutive use of the LNG-IUS is scarce. We performed a prospective 15-month multicentre study on the bleeding profile, removal and insertion procedures and safety of the second LNG-IUS in fertile-aged women who had used their first LNG-IUS between 4 years 3 months and 4 years 9 months and who opted for the insertion of a second IUS immediately after removal of the first IUS. Bleeding data were reported descriptively starting from the last 90 days of the first IUS use and continuing for up to 1 year. Of the 234 subjects screened, 204 (87%) entered the trial. The median number of bleeding/spotting days during the last 90 days of the first LNG-IUS was 7 (25 and 75% percentiles 0 and 15). Due to bleeding associated with the insertion procedure, this increased to 8 days (4 and 18) during the first 90-day reference period, thereafter decreasing to 4 (0 and 10) days during the second to fourth reference periods. Only one expulsion and no pregnancies, pelvic inflammatory diseases or perforations occurred. A total of 12 subjects (5.9%) prematurely discontinued the study: five due to an adverse event and seven due to other reasons (inclusive of loss to follow-up). This study confirms the favourable bleeding profile and safety of consecutive use of the LNG-IUS.

Use of the levonorgestrel-releasing intrauterine system in breast cancer patients

To study the recurrence of breast cancer among patients who were using the levonorgestrel-releasing intrauterine system (LNG IUS). A retrospective, controlled cohort analysis. Six Belgian hospitals. We identified 79 breast cancer patients who used the LNG IUS, and we selected a control group of 120 patients with no history of LNG IUS use and who were closely matched for age at diagnosis, tumor stage, tumor grade, and treatment modalities. Two subgroups were identified: [1] breast cancer patients who continued using the LNG IUS after diagnosis and [2] breast cancer patients who began using an LNG IUS after treatment for breast cancer. Patient's data were collected and survival analysis was performed. Breast cancer recurrence rate. There was a recurrence rate of 21.5% (17/79) among LNG IUS users and of 16.6% (20/120) among the control group (adjusted hazard ratio, 1.86; 95% confidence interval, 0.86-4.00; no statistically significant difference). Subgroup analysis showed that women using the LNG IUS (n = 38) at the time of breast cancer diagnosis (and who continued its use) had a statistically significantly increased risk of recurrence (adjusted hazard ratio, 3.39; 95% confidence interval, 1.01-11.35) compared with patients in the control group. There was 47.4% (18/38) nodal involvement in this subgroup, and all patients who recurred had metastatic disease. Overall, we did not find an increased risk of breast cancer recurrence associated with use of the LNG-IUS. However, in a subgroup analysis of women who developed breast cancer while using an LNG IUS and who continued to use the LNG IUS, we found a higher risk of recurrence of borderline statistical significance. Additional research is needed to confirm or refute these findings.