Implementing methods in the ELEGANCE registry to increase diversity in clinical research.

OBJECTIVE: Women and underrepresented minorities (URMs) who are at an increased risk of presenting with severe peripheral artery disease (PAD) and have different responses to treatment compared with non-Hispanic White males yet are underrepresented in PAD research. METHODS: ELEGANCE is a global, prospective, multi-center, post-market registry of PAD patients treated with drug-eluting device that aims to enroll at least 40% women and 40% URMs. The study design incorporates strategies to increase enrollment of women and URMs. Inclusion criteria are age ≥18 years and treatment with any commercially available Boston Scientific Corporation drug-eluting device marketed for peripheral vasculature lesions; exclusion criterion is life expectancy <1 year. RESULTS: Of 750 patients currently enrolled (951 lesions) across 39 sites, 324 (43.2%) are female and 350 (47.3%) are URMs (21.6% Black, 11.2% Asian, 8.5% Hispanic/Latino, and 5.3% other). Rutherford classification is distributed differently between sexes (P = .019). Treatment indication differs among race/ethnicity groups (P = .003). Chronic limb-threatening ischemia was higher for Black (38.3%) and Hispanic/Latino (28.1%) patients compared with non-Hispanic White (21.8%) and Asian patients (21.4%). De-novo stenosis was higher in Asian patients (92.3%) compared with Black, non-Hispanic White, and Hispanic/Latino patients (72.2%, 68.7%, and 77.8%, respectively; P < .001). Mean lesion length was longest for Black patients (162.7 mm), then non-Hispanic White (135.2 mm), Asian (134.8 mm), and Hispanic/Latino patients (128.1 mm; P = .008). CONCLUSIONS: Analyses of data from the ELEGANCE registry show that differences exist in baseline disease characteristics by sex and race/ethnicity; these may be the result of other underlying factors, including time to diagnosis, burden of undermanaged comorbidities, and access to care.

Reproductive Outcomes of Patients Undergoing Uterine Artery Embolization for Uterine Fibroids: Proceedings from The Dr. James B. Spies Summit for Uterine Fibroid Research- a Society of Interventional Radiology Foundation Research Consensus Panel.

Reproductive outcomes after uterine artery embolization (UAE) for the treatment of uterine fibroids are challenging to study, leaving several unanswered questions surrounding the future fertility of patients undergoing the procedure. Subject matter experts from Interventional Radiology, Diagnostic Radiology, Obstetrics & Gynecology, and Reproductive Medicine participated in a Society of Interventional Radiology Foundation Research Consensus Panel to discuss and prioritize critical research topics focusing on fertility and reproductive outcomes in patients undergoing UAE for symptomatic uterine fibroids. After presentations and discussion of research ideas, the panelists prioritized the following topics for further investigation: 1) a prospective study of factors that influence implantation and gene expression in patients undergoing UAE or myomectomy over 1 year, 2) refinement of a classification system for uterine fibroids that can allow for more focused study design, which may include burden of fibroid disease, and 3) conjoint analysis/discrete choice experiments to better characterize those patients for whom fertility preservation is a high priority.

Short-, Mid-, and Long-term Strategies to Manage the Shortage of Iohexol.

The recent iohexol shortage has precipitated disruptions in a pharmaceutical supply chain critical to radiologic imaging and has impacted global availability of iodinated contrast media (ICM). The shortage has created a national crisis in radiology departments, curtailing their ability to provide health care to patients who need contrast-enhanced examinations. Radiology departments are familiar with crisis management after more than 2 years of clinical and operational disruptions associated with the COVID-19 pandemic. The iohexol and subsequent ICM shortage has short-term (weeks), midterm (months), and long-term (years) implications. The purpose of this report is to provide strategies for dealing with the shortage in the near term and to discuss long-term issues and potential solutions to supply chain problems impacting radiology departments.

Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries.

PURPOSE: To evaluate temporal trends, practice variation, and associated outcomes with the use of intravascular ultrasound (US) during deep venous stent placement among Medicare beneficiaries. MATERIALS AND METHODS: All lower extremity deep venous stent placement procedures performed between January 1, 2017, and December 31, 2019 among Medicare beneficiaries were included. Temporal trends in intravascular US use were stratified by procedural setting and physician specialty. The primary outcome was a composite of 12-month all-cause mortality, all-cause hospitalization, or repeat target vessel intervention. The secondary outcome was a composite of 12-month stent thrombosis, embolization, or restenosis. RESULTS: Among the 20,984 deep venous interventions performed during the study period, 15,184 (72.4%) utilized intravascular US. Moderate growth in intravascular US use was observed during the study period in all clinical settings. There was a variation in the use of intravascular US among all operators (median, 77.3% of cases; interquartile range, 20.0%-99.2%). In weighted analyses, intravascular US use during deep venous stent placement was associated with a lower risk of both the primary (adjusted hazard ratio, 0.72; 95% confidence interval [CI], 0.69-0.76; P < .001) and secondary (adjusted hazard ratio, 0.32; 95% CI, 0.27-0.39; P < .001) composite end points. CONCLUSIONS: Intravascular US is frequently used during deep venous stent placement among Medicare beneficiaries, with further increase in use from 2017 to 2019. The utilization of intravascular US as part of a procedural strategy was associated with a lower cumulative incidence of adverse outcomes after the procedure, including venous stent thrombosis and embolization.

Uterine Artery Embolization for Symptomatic Adenomyosis: Proceedings from a Society of Interventional Radiology Foundation Research Consensus Panel.

Adenomyosis poses an important diagnostic and therapeutic challenge in women's health because of a variety of clinical/imaging presentations and frequent coexistence with other benign gynecologic conditions. In recent years, uterine artery embolization (UAE) for the treatment of adenomyosis has shown encouraging and favorable outcomes and long-term symptom improvement. To expand the current understanding of adenomyosis pathophysiology, imaging diagnostic criteria, and treatment outcomes, the Society of Interventional Radiology Foundation gathered a multidisciplinary Research Consensus Panel with experts from diverse backgrounds. The topics addressed were centered around the following: (i) the clinical presentation and imaging findings to diagnose adenomyosis; (ii) the currently available medical, interventional, and surgical treatment options; and (iii) existing literature for and experiences with UAE in symptomatic disease. The panel acknowledged that before the pursuit of a clinical trial, it would be necessary to first evaluate the imaging criteria for adenomyosis and correlate them with pathology and symptoms to establish a noninvasive imaging classification system. Second priority was given to the development of a quality of life questionnaire to assess patient outcomes following treatment. The third priority was the performance of a prospective clinical trial comparing UAE with medical therapy, which would help establish UAE in the treatment algorithm and societal guidelines for symptomatic adenomyosis.

Geniculate Artery Embolization: Role in Knee Hemarthrosis and Osteoarthritis.

Roughly 37% of Americans 60 years of age and older experience chronic pain due to osteoarthritis (OA) of the knee. After conservative treatment (pharmacologic, physical therapy, and joint injections) fails, patients often require total knee arthroplasty to alleviate pain and regain knee function. Given the high economic burden of surgery paired with its invasive nature, many patients with this degenerative joint disease seek alternative treatment. Moreover, many patients with severe knee OA who also have comorbidities that preclude surgery-most often morbid obesity-are left without options. Geniculate artery embolization (GAE) is a minimally invasive intra-arterial intervention that was originally developed for the treatment of knee hemarthrosis that has recently been adapted for symptomatic knee OA. Through selective embolization of geniculate branches corresponding to the site of knee pain, GAE inhibits the neovascularity that contributes to the catabolic and inflammatory drive of OA. Preliminary trials over the past decade have demonstrated promising clinical results, including decreased pain and improved function and quality of life after treatment. Given such success, GAE provides another minimally invasive treatment option for knee OA to patients who feel reluctant to undergo or are ineligible for surgery. The authors review the radiographic manifestations and current standard of treatment of OA and hemarthrosis of the knee. Procedural technique, embolic selection, and clinical evidence for GAE in the treatment of OA and hemarthrosis of the knee are also explored. The online slide presentation from the RSNA Annual Meeting is available for this article. ©RSNA, 2021.

Non-operative management of biliary complications after Liver Transplantation in pediatric patients: A 30-year experience.

BACKGROUND: To evaluate the efficacy of percutaneous and endoscopic therapeutic interventions for biliary strictures and leaks following LT in children. METHODS: Retrospective analysis of 49 consecutive pediatric liver transplant recipients (27 girls, 22 boys, mean age at transplant 3.9 years) treated at our institution from 1989 to 2019 for biliary leak and/or biliary stricture was performed. Minimally invasive approach was considered clinically successful if it resulted in patency of the narrowed biliary segment and/or correction of the biliary leak. RESULTS: Forty-two patients had a stricture at the biliary anastomosis; seven had a biliary leak. After an average 13.8 years of follow-up, long-term clinical success with minimally invasive treatment (no surgery or re-transplant) was achieved for 24 children (57%) with biliary stricture and 4 (57%) with biliary leaks. Eight patients required re-transplant; however, only one was due to failure of both percutaneous and surgical management. For biliary strictures, failure of non-surgical management was associated with younger age at stricture diagnosis (p < .02). CONCLUSIONS: Percutaneous and endoscopic management of biliary strictures and leaks after LT in children is associated with a durable result in >50% of children.

Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis.

PURPOSE: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). RESULTS: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. CONCLUSIONS: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.

Intermediate to Long-Term Clinical Outcomes of Percutaneous Cryoablation for Renal Masses.

PURPOSE: The purpose of this study was to evaluate the effectiveness and adverse outcomes of percutaneous cryoablation (CA) for treatment of renal masses in a large cohort of patients. MATERIALS AND METHODS: This retrospective analysis included 299 CA procedures (297 masses in 277 patients) performed between July 2007 and May 2018 at a single institution. The mean patient age was 66.1 years (range, 30-93 years) with 65.8% being male. A total of 234 (78.8%) masses were biopsy-proven renal cell carcinoma (RCC). The mean maximal tumor diameter was 2.5 cm (range, 0.7-6.6 cm). Efficacy was assessed only for ablations of biopsy-proven RCC, whereas the evaluation of adverse events and renal function included all masses. Complications were graded according to the Society of International Radiology classification. RESULTS: Major complications occurred in 3.0% of procedures (n = 9), none of which resulted in death or permanent disability. The mean imaging follow-up period was 27.4 months (range, 1-115) for the 199 RCC patients (204 ablated tumors) with follow-up imaging available. Complete response on initial follow-up imaging at mean 4.2 months (range, 0.3-75.6) was achieved in 195 of 204 tumors (95.6%) after a single session and in 200 of 204 tumors (98.0%) after 1 or 2 sessions. Of the RCC patients achieving complete response initially, local recurrence during the follow-up period occurred in 3 of 200 tumors (1.5%). Metastatic progression occurred in 10 of 193 (5.2%) RCC patients without prior metastatic disease during follow-up. CONCLUSIONS: CA for renal masses is safe and remains efficacious through intermediate- and long-term follow-up.

FIRSTT study: randomized controlled trial of uterine artery embolization vs focused ultrasound surgery.

BACKGROUND: Uterine leiomyomas (fibroid tumors) cause considerable symptoms in 30-50% of women and are the leading cause of hysterectomy in the United States. Women with uterine fibroid tumors often seek uterine-preserving treatments, but comparative effectiveness trials are lacking. OBJECTIVE: The purpose of this study was to report treatment effectiveness and ovarian function after uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study. STUDY DESIGN: The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study, which is a randomized controlled trial of uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery, enrolled premenopausal women with symptomatic uterine fibroid tumors; women who declined randomization were enrolled in a parallel observational cohort. A comprehensive cohort design was used for outcomes analysis. Our target enrollment was 220 women, of which we achieved 41% (n=91) in the randomized and parallel arms of the trial. Primary outcome was reintervention for uterine fibroid tumors within 36 months. Secondary outcomes were change in serum anti-Müllerian hormone levels and standardized measures of fibroid symptoms, quality of life, pain, and sexual function. RESULTS: From 2010-2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 for magnetic resonance imaging-guided focused ultrasound surgery [27 randomized]; 40 for uterine artery embolization [22 randomized]); baseline clinical and uterine characteristics were similar between treatment arms, except for higher fibroid load in the uterine artery embolization arm. The risk of reintervention was higher with magnetic resonance imaging-guided focused ultrasound surgery than uterine artery embolization (hazard ratio, 2.81; 95% confidence interval, 1.01-7.79). Uterine artery embolization showed a significantly greater absolute decrease in anti-Müllerian hormone levels at 24 months compared with magnetic resonance imaging-guided focused ultrasound surgery. Quality of life and pain scores improved in both arms but to a greater extent in the uterine artery embolization arm. Higher pretreatment anti-Müllerian hormone level and younger age at treatment increased the overall risk of reintervention. CONCLUSION: Our study demonstrates a lower reintervention rate and greater improvement in symptoms after uterine artery embolization, although some of the effectiveness may come through impairment of ovarian reserve. Both pretreatment anti-Müllerian hormone level and age are associated with risk of reintervention. CLINICAL TRIAL REGISTRATION NUMBER: NCT00995878, clinicaltrials.gov.

Bridging the Gender Gap in the Society of IR: A Benchmark Study.

PURPOSE: To evaluate the evolving representation of women in the Society of Interventional Radiology (SIR). MATERIALS AND METHODS: A retrospective review of the available gender demographic data of various SIR subgroups between 2008 and 2017 was performed. The gender makeup of the following groups was analyzed: SIR membership, SIR Executive Council members and officers, Annual Meeting invited speakers, committee chairs, Journal of Vascular and Interventional Radiology (JVIR) first and senior authors, JVIR editorial board, IR Quarterly (IRQ) authors, and active interventional radiology (IR) residents and fellows. RESULTS: From 2008 to 2017, the percentage of female representation in SIR members doubled (from 6% to 13.1%). In the same period, female representation also significantly increased in Executive Council members (0% to 20%) and officers (0% to 50%), SIR Annual Meeting presenters (5.1% to 15.4%), and JVIR first authors (10% to 14.5%) and senior authors (7.1% to 11.9%). From 2012 to 2017, there were increases in female representation among SIR committee chairs (21% to 28%) and IRQ authors (4.5% to 27%). However, the percentage of female IR residents and fellows did not significantly change between 2008 and 2017 (11% vs 16.2%; P = .51). CONCLUSIONS: Women interventional radiologists are underrepresented within SIR, representing only 9.2% of active IR physicians. There has been a steady increase in female representation within most areas of SIR evaluated in this study. Although these trends are reassuring, efforts toward increasing recruitment and retention of women in IR need to improve in light of the infancy of IR as a residency program.

Expanding the Teaching Toolbox: Characterizing Utility of a Web-Based Lecture Series in Educating Future Colleagues and Referrers about the Field of IR.

Opportunities for interventional radiology (IR) education and exposure remain limited at medical institutions without a local IR presence, thereby excluding a medical student population with potential to pursue careers in IR or become referring providers to IR. The purpose of this study was to evaluate the efficacy of a Webinar-based IR elective as an educational tool for outreach to US medical schools lacking local preclinical IR exposure. Our early results indicate that a Webinar-based IR lecture series can serve as an effective method for educating future physicians about the field of IR and when to consult IR for patient management.

Uterine Artery Embolization following Cesarean Delivery but prior to Hysterectomy in the Management of Patients with Invasive Placenta.

PURPOSE: To evaluate outcomes of patients with placenta accreta spectrum (PAS) disorders who underwent uterine artery embolization (UAE) following cesarean delivery but before hysterectomy. MATERIALS AND METHODS: A retrospective review of patients with PAS treated with cesarean-hysterectomy (C-hyst) was performed. Patients in the UAE group underwent UAE after cesarean delivery but before hysterectomy; patients in the control group underwent C-hyst alone. Estimated blood loss (EBL), transfusion requirements, length of intensive care unit (ICU) stay, and adverse events were evaluated. RESULTS: The study included 31 patients, 7 in the UAE group and 24 in the control group. Median EBL, transfusion requirements, and length of ICU stay in the UAE group compared with control group were 1,500 mL (range, 500-2,000 mL) vs 2,000 mL (range, 1,000-4,500 mL) (P = .04), 150 mL (range, 0-650 mL) vs 550 mL (range, 0-3,125 mL) (P = .10), and 0 d (range, 0-1 d) vs 0.5 d (range, 0-2 d) (P = .07). All patients in the UAE group had placenta increta; patients in the control group had placenta accreta (29%), increta (54%), and percreta (17%) (P = .10). Subgroup analysis of patients with placenta increta demonstrated that the UAE group had a significant decrease in median EBL (P = .004), transfusion requirements (P = .009), and length of ICU stay (P = .04). No adverse events following UAE were noted. CONCLUSIONS: UAE following cesarean delivery but before hysterectomy in patients with placenta increta appears to be safe and effective in decreasing EBL, transfusion requirements, and length of ICU stay compared with C-hyst alone.

Outcomes after Peripancreatic Fluid Drainage in Patients with Simultaneous Pancreas-Kidney Transplantation.

PURPOSE: To determine the clinical outcomes of patients who underwent image-guided drainage of peripancreatic fluid collections after simultaneous pancreas-kidney (SPK) transplantation. MATERIALS AND METHODS: A retrospective review of all patients who underwent peripancreatic fluid collection drainage after SPK, from January 2000 to August 2017, at a single institution was performed. Patient characteristics, surgical technique, medication regimen, microbial analysis, and clinical outcomes were reviewed. Thirty-one patients requiring a total of 41 drainages were included in this study. The median age was 44 years (range 30-58 years), and median time between SPK and drainage was 28 days (range 8 to 3,401 days). Fisher's exact test, unpaired Student t-tests, and Pearson correlations were used for statistical analysis. RESULTS: Fever (51%) and abdominal pain (31%) were the most common presenting symptoms. The average amount of fluid drained at the time of drain placement was 97 mL (SD 240 mL). The average time spent with a drain in place was 33 days (SD 31 days). Microorganisms were isolated in the fluid of 22 of 41 drainages (54%), with mixed gastrointestinal flora being the most common. No further intervention was needed in 34 of 41 drainages (82%). However, drainage failed in 5 of 31 patients (16%), requiring surgical intervention with removal of the pancreas transplant. CONCLUSIONS: Percutaneous drainage of peripancreatic fluid collections after SPK transplantation is a safe and effective treatment option.

Operator Dose Reduction during Transjugular Liver Biopsy Using a Radiation-Attenuating Drape: A Prospective, Randomized Study.

PURPOSE: To assess the effectiveness of disposable radiation-absorbing surgical drapes on operator radiation dose during transjugular liver biopsy (TJLB). MATERIALS AND METHODS: This dual-arm prospective, randomized study was conducted between May 2017 and January 2018 at a single institution. TJLB procedures (N = 62; patient age range, 19-80 y) were assigned at a 1:1 ratio to the use of radiation-absorbing surgical drapes or standard surgical draping. The primary outcome was cumulative radiation equivalent dose incident on the operator, as determined by an electronic personal dosimeter worn at the chest during each procedure. Cumulative kerma-area product (KAP), total fluoroscopy time, and total number of exposures used during each liver biopsy procedure were also determined. RESULTS: Mean radiation dose incident on the operator decreased by 56% with the use of radiation-absorbing drapes (37 µSv ± 35; range, 4-183 µSv) compared with standard draping (84 µSv ± 58; range, 11-220 µSv). Radiation incident on the patient was similar between groups, with no significant differences in mean KAP, total fluoroscopy time, and number of exposures acquired during the procedures. CONCLUSIONS: Use of disposable radiation-absorbing drapes reduces scatter radiation to interventionalists performing TJLB.

Feasibility of Antegrade Contrast-enhanced US Nephrostograms to Evaluate Ureteral Patency.

Purpose To demonstrate the feasibility of contrast material-enhanced ulrasonographic (US) nephrostograms to assess ureteral patency after percutaneous nephrolithotomy (PCNL) in this proof-of-concept study. Materials and Methods For this HIPAA-compliant, institutional review board-approved prospective blinded pilot study, patients undergoing PCNL provided consent to undergo contrast-enhanced US and fluoroscopic nephrostograms on postoperative day 1. For contrast-enhanced US, 1.5 mL of Optison (GE Healthcare, Oslo, Norway) microbubble contrast agent solution (perflutren protein-type A microspheres) was injected via the nephrostomy tube. Unobstructed antegrade ureteral flow was defined by the presence of contrast material in the bladder. Contrast-enhanced US results were compared against those of fluoroscopic nephrostograms for concordance. Results Ten studies were performed in nine patients (four women, five men). Contrast-enhanced US demonstrated ureteral patency in eight studies and obstruction in two. One patient underwent two studies, one showing obstruction and the second showing patency. Concordance between US and fluoroscopic assessments of ureteral patency was evaluated by using a Clopper-Pearson exact binomial test. These results were perfectly concordant with fluoroscopic nephrostogram results, with a 95% confidence interval of 69.2% and 100%. No complications or adverse events related to contrast-enhanced US occurred. Conclusion Contrast-enhanced US nephrostograms are simple to perform and are capable of demonstrating both patency and obstruction of the ureter. The perfect concordance with fluoroscopic results across 10 studies demonstrated here is not sufficient to establish diagnostic accuracy of this technique, but motivates further, larger scale investigation. If subsequent larger studies confirm these preliminary results, contrast-enhanced US may provide a safer, more convenient way to evaluate ureteral patency than fluoroscopy. © RSNA, 2016 Online supplemental material is available for this article.

Contrast Enhanced Ultrasound as a Radiation-Free Alternative to Fluoroscopic Nephrostogram for Evaluating Ureteral Patency.

PURPOSE: We compared contrast enhanced ultrasound and fluoroscopic nephrostography in the evaluation of ureteral patency following percutaneous nephrolithotomy. MATERIALS AND METHODS: This prospective cohort, noninferiority study was performed after obtaining institutional review board approval. We enrolled eligible patients with kidney and proximal ureteral stones who underwent percutaneous nephrolithotomy at our center. On postoperative day 1 patients received contrast enhanced ultrasound and fluoroscopic nephrostogram within 2 hours of each other to evaluate ureteral patency, which was the primary outcome of this study. RESULTS: A total of 92 pairs of imaging studies were performed in 82 patients during the study period. Five study pairs were excluded due to technical errors that prevented imaging interpretation. Females slightly predominated over males with a mean ± SD age of 50.5 ± 15.9 years and a mean body mass index of 29.6 ± 8.6 kg/m2. Of the remaining 87 sets of studies 69 (79.3%) demonstrated concordant findings regarding ureteral patency for the 2 imaging techniques and 18 (20.7%) were discordant. The nephrostomy tube was removed on the same day in 15 of the 17 patients who demonstrated antegrade urine flow only on contrast enhanced ultrasound and they had no subsequent adverse events. No adverse events were noted related to ultrasound contrast injection. While contrast enhanced ultrasound used no ionizing radiation, fluoroscopic nephrostograms provided a mean radiation exposure dose of 2.8 ± 3.7 mGy. CONCLUSIONS: A contrast enhanced ultrasound nephrostogram can be safely performed to evaluate for ureteral patency following percutaneous nephrolithotomy. This imaging technique was mostly concordant with fluoroscopic findings. Most discordance was likely attributable to the higher sensitivity for patency of contrast enhanced ultrasound compared to fluoroscopy.

Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis.

BACKGROUND: Uterine fibroids are a common problem for reproductive-aged women, yet little comparative effectiveness research is available to guide treatment choice. Uterine artery embolization and magnetic resonance imaging-guided focused ultrasound surgery are minimally invasive therapies approved by the US Food and Drug Administration for treating symptomatic uterine fibroids. The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study is the first randomized controlled trial to compare these 2 fibroid treatments. OBJECTIVE: The objective of the study was to summarize treatment parameters and compare recovery trajectory and adverse events in the first 6 weeks after treatment. STUDY DESIGN: Premenopausal women with symptomatic uterine fibroids seen at 3 US academic medical centers were enrolled in the randomized controlled trial (n = 57). Women meeting identical criteria who declined randomization but agreed to study participation were enrolled in a nonrandomized parallel cohort (n = 34). The 2 treatment groups were analyzed by using a comprehensive cohort design. All women undergoing focused ultrasound and uterine artery embolization received the same postprocedure prescriptions, instructions, and symptom diaries for comparison of recovery in the first 6 weeks. Return to work and normal activities, medication use, symptoms, and adverse events were captured with postprocedure diaries. Data were analyzed using the Wilcoxon rank sum test or χ2 test. Multivariable regression was used to adjust for baseline pain levels and fibroid load when comparing opioid medication, adverse events, and recovery time between treatment groups because these factors varied at baseline between groups and could affect outcomes. Adverse events were also collected. RESULTS: Of 83 women in the comprehensive cohort design who underwent treatment, 75 completed postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization (mean [SD], 405 [146] vs 139 [44] min; P <.001). Of women undergoing focused ultrasound (n = 43), 23 (53%) underwent 2 treatment days. Immediate self-rated postprocedure pain was higher after uterine artery embolization than focused ultrasound (median [interquartile range], 5 [1-7] vs 1 [1-4]; P = .002). Compared with those having focused ultrasound (n = 39), women undergoing embolization (n = 36) were more likely to use outpatient opioid (75% vs 21%; P < .001) and nonsteroidal antiinflammatory medications (97% vs 67%; P < .001) and to have a longer median (interquartile range) recovery time (days off work, 8 [6-14] vs 4 [2-7]; P < .001; days until return to normal, 15 [10-29] vs 10 [10-15]; P = .02). There were no significant differences in the incidence or severity of adverse events between treatment arms; 86% of adverse events (42 of 49) required only observation or nominal treatment, and no events caused permanent sequelae or death. After adjustment for baseline pain and uterine fibroid load, uterine artery embolization was still significantly associated with higher opioid use and longer time to return to work and normal activities (P < .001 for each). Results were similar when restricted to the randomized controlled trial. CONCLUSION: Women undergoing uterine artery embolization have longer recovery times and use more prescription medications, but women undergoing focused ultrasound have longer treatment times. These findings were independent of baseline pain levels and fibroid load.