Association Between Diagnosis-to-Limb Revascularization Time and Clinical Outcomes in Outpatients With Chronic Limb-Threatening Ischemia: Insights From the CLIPPER Cohort.

BACKGROUND: The extent and consequences of ischemia in patients with chronic limb-threatening ischemia (CLTI) may change rapidly, and delays from diagnosis to revascularization may worsen outcomes. We sought to describe the association between time from diagnosis to endovascular lower extremity revascularization (diagnosis-to-limb revascularization [D2L] time) and clinical outcomes in outpatients with CLTI. METHODS AND RESULTS: In the CLIPPER cohort, comprising patients between 66 and 86 years old diagnosed with CLTI betweeen 2010 and 2019, we used Medicare claims data to identify patients who underwent outpatient endovascular revascularization within 180 days of diagnosis. We described the risk-adjusted association between D2L time and clinical outcomes. Among 1 130 065 patients aged between 66 and 86 years with CLTI, 99 221 (8.8%) underwent outpatient endovascular lower extremity revascularization within 180 days of their CLTI diagnosis. Among patients with D2L time <30 days, there was no association between D2L time and all-cause death or major lower extremity amputation. However, among patients with D2L time >30 days, each additional 10-day increase in D2L time was associated with a 2.5% greater risk of major amputation (hazard ratio, 1.025 [95% CI, 1.014-1.036]). There was no association between D2L time and all-cause death. CONCLUSIONS: A delay of >30 days from CLTI diagnosis to lower extremity endovascular revascularization was associated with an increased risk of major lower extremity amputation among patients undergoing outpatient endovascular revascularization. Improving systems of care to reduce D2L time could reduce amputations.

Treatment of adenomyosis, abdominal wall endometriosis and uterine leiomyoma with interventional radiology: A review of current evidences.

Interventional radiology shows promises in the field of women's health, particularly in pelvic interventions. This review article discusses the latest advancements in interventional radiology techniques for pelvic conditions affecting women including adenomyosis, abdominal wall endometriosis and uterine leiomyoma. Extraperitoneal endometriosis involving the abdominal wall may be treated by percutaneous thermal ablation, such as cryoablation, whereas uterine leiomyoma and adenomyosis can be managed either using percutaneous thermal ablation or using uterine artery embolization. Continued research and development in interventional radiology will further enhance the minimally-invasive interventions available for women's health, improving outcomes and quality of life for this large patient population of women.

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.

Recanalization of Proximal Fallopian Tube Obstruction in the Treatment of Infertility.

Infertility affects approximately 15% of patients worldwide, with up to 40% of cases attributed to tubal disease, and up to 25% of those being proximal fallopian tube obstruction (FTO). Evaluation of tubal patency can be performed via laparoscopic chromopertubation, hysterosalpingography, or hysterosalpingo-contrast-sonography (HyCoSy). In patients with proximal tubal obstruction, fallopian tube recanalization (FTR) can result in up to 100% technical success rate with pregnancy rates of 12.8 to 51%. More pregnancies occur when oil-soluble contrast media are used versus water-soluble contrast media. Complications of FTR are rare and include tubal perforation, ectopic pregnancy, and pelvic infection. Reocclusion of fallopian tubes may occur in 20 to 50% of patients; however, FTR may be repeated in these cases. Overall, FTR is underutilized in the treatment of infertility secondary to proximal FTO and it can obviate costly and time-consuming assistive reproductive techniques such as in vitro fertilization in some patients, as well as decreasing physical and emotional stress.

What predicts durable symptom relief of uterine fibroids treated with MRI-guided focused ultrasound? A multicenter trial in 8 academic centers.

OBJECTIVE: To identify variables predictive of durable clinical success after MRI-guided focused ultrasound (MRgFUS) treatment of uterine fibroids. MATERIALS AND METHODS: In this prospective, multicenter trial, 99 women with symptomatic uterine fibroids were treated using MRgFUS. Pelvic MRI was obtained at baseline and treatment day. The Uterine Fibroid Symptom-Quality of Life questionnaire was used to calculate a symptom severity score (SSS) at baseline and 6, 12, 24, and 36 months following treatment. Clinical, imaging, and treatment variables were correlated with symptom reduction sustained through the 12- and 24-month time points using univariable and multivariable logistic regression analyses. A novel parameter, the ratio of non-perfused volume to total fibroid load (NPV/TFL), was developed to determine association with durable outcomes. RESULTS: Post-treatment, mean symptom severity decreased at the 6-, 12-, 24-, and 36-month follow-ups (p < 0.001, all time points). In univariable analysis, three variables predicted treatment success (defined by ≥ 30-point improvement in SSS) sustained at both the 12-month and 24-month time points: increasing ratio of NPV/TFL (p = 0.002), decreasing total fibroid load (p = 0.04), and the absence of T2-weighted Funaki type 2 fibroids (p = 0.02). In multivariable analysis, the NPV/TFL was the sole predictor of durable clinical success (p = 0.01). Patients with ratios below 30% had less improvement in SSS and lacked durable clinical response compared with those between 30-79 (p = 0.03) and ≥ 80% (p = 0.01). CONCLUSION: Increased non-perfused volume relative to total fibroid volume was significantly associated with durable reduction of symptoms of abnormal uterine bleeding and bulk bother. CLINICAL RELEVANCE STATEMENT: Patient selection for sustained clinical benefit should emphasize those with likelihood of achieving high ablation ratios, as determined by imaging (e.g., device access, Funaki type) and by considering the total fibroid load, not just the primary symptomatic fibroid. TRIAL REGISTRATION: Clinical trial ID: NCT01285960. KEY POINTS: • Patient selection/treatment approach associated with durable symptom relief in MRI-guided focused ultrasound ablation of uterine fibroids remains unclear. • The ablation ratio, non-perfused volume/total fibroid volume, was positively associated with sustained symptom relief in both bleeding and bulk bother at 1- and 2-year follow-ups. • Selecting patients with imaging features that favor a high ratio of ablation to total fibroid load (including non-targeted fibroids) is the main factor in predicting durability of symptom relief after uterine fibroid treatment.

Racial Differences in Presentation and Outcomes After Peripheral Arterial Interventions: Insights From the NCDR-PVI Registry.

BACKGROUND: We assess the rates of device use and outcomes by race among patients undergoing lower extremity peripheral arterial intervention using the American College of Cardiology National Cardiovascular Data Registry-Peripheral Vascular Intervention (PVI) registry. METHODS: Patients who underwent PVI between April 2014 and March 2019 were included. Socioeconomic status was evaluated using the Distressed Community Index score for patients' zip codes. Multivariable logistic regression was used to assess factors associated with utilization of drug-eluting technologies, intravascular imaging, and atherectomy. Among patients with Centers for Medicare and Medicaid Services data, we compared 1-year mortality, rates of amputation, and repeat revascularizations. RESULTS: Of 63 150 study cases, 55 719 (88.2%) were performed in White patients and 7431 (11.8%) in Black patients. Black patients were younger (67.9 versus 70.0 years), had higher rates of hypertension (94.4% versus 89.5%), diabetes (63.0% versus 46.2%), less likely to be able to walk 200 m (29.1% versus 24.8%), and higher Distressed Community Index scores (65.1 versus 50.6). Black patients were provided drug-eluting technologies at a higher rate (adjusted odds ratio, 1.14 [95% CI, 1.06-1.23]) with no difference in atherectomy (adjusted odds ratio, 0.98 [95% CI, 0.91-1.05]) or intravascular imaging (adjusted odds ratio, 1.03 [95% CI, 0.88-1.22]) use. Black patients experienced a lower rate of acute kidney injury (adjusted odds ratio, 0.79 [95% CI, 0.72-0.88]). In Centers for Medicare and Medicaid Services-linked analyses of 7429 cases (11.8%), Black patients were significantly less likely to have surgical (adjusted hazard ratio, 0.40 [95% CI, 0.17-0.96]) or repeat PVI revascularization (adjusted hazard ratio, 0.42 [95% CI, 0.30-0.59]) at 1 year compared with White patients. There was no difference in mortality (adjusted hazard ratio [0.8-1.4]) or major amputation (adjusted hazard ratio, 2.5 [95% CI, 0.8-7.6]) between Black and White patients. CONCLUSIONS: Black patients presenting for PVI were younger, had higher prevalence of comorbidities and lower socioeconomic status. After adjustment, Black patients were less likely to have surgical or repeat PVI revascularization after the index PVI procedure.

Interventional Radiology in Obstetrics and Gynecology: Updates in Women's Health.

Interventional radiology has had an expanding role in women's health over the past few decades, with recent accelerated growth and development. Interventional radiology is fundamental in the treatment of multiple conditions that affect women, including pelvic venous disease, uterine fibroids, and adenomyosis, and in postpartum management. Patient workup, classification, and treatment techniques have continued to evolve as interventional radiology has become more prevalent in the treatment of patients affected by these conditions. The authors provide a review of the pathophysiology of, patient workup for, and treatment of pelvic venous disease and uterine artery embolization for various disease processes. The authors also highlight updates from the past 5-10 years in diagnosis, classification, and treatment strategies. © RSNA, 2023 Quiz questions for this article are available in the supplemental material.

Use of n-Butyl-2-Cyanoacrylate for Fallopian Tube Embolization via Selective Catheterization in a Rabbit Model: Feasibility Study for Potential Nonsurgical Sterilization.

PURPOSE: To determine whether fallopian tube embolization with n-butyl-2-cyanoacrylate (nBCA) administered via a microcatheter in a rabbit model was technically feasible and resulted in short-term tubal occlusion. MATERIALS AND METHODS: In 10 female New Zealand white rabbits, the 2 cervices were cannulated using a 5-F catheter and hydrophilic guide wire transvaginally. Salpingography confirmed tubal patency bilaterally. A 2.4-F microcatheter was advanced to the distal fallopian tube, and nBCA/ethiodized oil was administered as the microcatheter was withdrawn to fill the length of the tube. A metallic coil was deployed prior to nBCA administration in half of the fallopian tubes. Rabbits were evaluated for tubal occlusion with salpingography at 1 month, followed by euthanasia and histopathologic analysis. Inflammation and fibrosis were graded from 0 (normal) to 3 (severe). RESULTS: Fallopian tube embolization was technically successful in 17 (85%) of 20 fallopian tubes. Thirteen (76%) of 17 embolized fallopian tubes were occluded at 1 month on salpingography (nBCA only, 7/9; nBCA and coil, 6/8). On histopathologic analysis, direct or indirect evidence of occlusion was observed in 14 (82%) of 17 fallopian tubes. Mild or early fibrosis was observed in 65% of the tubes. The mean inflammation and fibrosis scores for the embolized tubes were 0.62 and 0.94, respectively. CONCLUSIONS: This pilot study demonstrated that embolization of rabbit fallopian tubes using nBCA administered via a microcatheter is technically feasible and results in occlusion of most fallopian tubes in the short term with minimal inflammation. Investigation of efficacy in preventing pregnancy over the long term is warranted.

Appropriate Use of Intravascular Ultrasound During Arterial and Venous Lower Extremity Interventions.

BACKGROUND: There has been growing use of intravascular ultrasound (IVUS) during lower extremity arterial and venous revascularization. Observational data suggest that the use of IVUS can improve periprocedural and long-term outcomes, but largescale prospective data remain limited. Consensus opinion regarding the appropriate use of IVUS during peripheral intervention is needed. OBJECTIVES: The purpose of this consensus document is to provide guidance on the appropriate use of IVUS in various phases of peripheral arterial and venous interventions. METHODS: A 12-member writing committee was convened to derive consensus regarding the appropriate clinical scenarios for use of peripheral IVUS. The group iteratively created a 72-question survey representing 12 lower extremity arterial interventional scenarios. Separately, a 40-question survey representing 8 iliofemoral venous interventional scenarios was constructed. Clinical scenarios were categorized by interventional phases: preintervention, intraprocedure, and postintervention optimization. Thirty international vascular experts (15 for each survey) anonymously completed the survey instrument. Results were categorized by appropriateness using the median value and disseminated to the voting panel to reevaluate for any disagreement. RESULTS: Consensus opinion concluded that IVUS use may be appropriate during the preintervention phase for evaluating the etiology of vessel occlusion and plaque morphology in the iliac and femoropopliteal arteries. IVUS was otherwise rated as appropriate during iliac and femoropopliteal revascularization in most other preintervention scenarios, as well as intraprocedural and postprocedural optimization phases. IVUS was rated appropriate in all interventional phases for the tibial arteries. For iliofemoral venous interventions, IVUS was rated as appropriate in all interventional phases. CONCLUSIONS: Expert consensus can help define clinical procedural scenarios in which peripheral IVUS may have value during lower extremity arterial and venous intervention while additional prospective data are collected.

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.

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.

Intravascular ultrasound guidance for lower extremity arterial and venous interventions.

This review details the utility of intravascular ultrasound (IVUS) for the management of peripheral artery and venous disease. The purpose of this document is to provide an update in the use of IVUS in peripheral arterial and venous pathology and demonstrate the use of IVUS as a practical diagnostic imaging procedure to evaluate and treat peripheral vascular disorders. IVUS, a diagnostic tool that relies on sound waves to produce precise images of the vessel being evaluated, was originally introduced to the medical community for the purposes of peripheral artery imaging, though it was quickly adapted for coronary interventions with positive outcomes. The utility of IVUS includes vessel measurement, pre- and post-procedural planning, treatment optimisation, and detection of thrombus, dissection or calcium severity. While angiography remains the standard imaging approach during peripheral intervention, multiple observational studies and small prospective trials have shown that in comparison, IVUS provides more accurate imaging detail, which may improve procedural outcomes. IVUS can also address limitations of angiography, including the need to administer contrast medium and eliminate the ambiguity associated with other forms of imaging. This review provides contemporary examples of where IVUS is being used during peripheral intervention as well as representative imaging to serve as a resource for the practising clinician.

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.

Tunneled Peritoneal Catheter vs Repeated Paracenteses for Recurrent Ascites: A Cost-Effectiveness Analysis.

PURPOSE: To compare the cost-effectiveness of tunneled peritoneal catheter (TPC) versus serial large-volume paracenteses (LVP) for patients with recurrent ascites. MATERIALS AND METHODS: Retrospective, single-institution analysis of 100 consecutive patients undergoing LVP and eventual TPC placement (2015-2018) was performed with extraction of procedural complications and hospital admissions. LVPs were associated with 17 adverse events (AEs) while only 9 AEs occurred after TPC placement. While undergoing routine LVP, the patients had 30 hospitalizations monthly (177 days in total) and 10 hospitalizations monthly (51 days) after TPC placement. A cost-effectiveness analysis with Markov modeling was performed comparing TPC and LVP. Costs were based on Medicare reimbursement rates. Statistical analyses include base case calculation, Monte Carlo simulations, and deterministic sensitivity analyses. RESULTS: TPC placement was the dominant strategy with a comparable health benefit of 0.08060 quality-adjusted life-years (QALY) (LVP: 0.08057 QALY) at a lower cost of $4151 (LVP: $8401). Probabilistic sensitivity analysis showed TPC was superior in 97.49% of simulations. Deterministic sensitivity analysis demonstrated the superiority of TPC compared to LVP if the TPC complication rate was < 9.47% per week and the complication rate for LVP was > 1.32% per procedure. TPC was more cost-effective when its procedural cost was < $5427 (base case: 1174.5), and remained as such when the cost of LVP was varied as much as $10,000 (base case: $316.48). CONCLUSION: In this study, TPC was more cost-effective than LVP in patients with recurrent ascites due to the reduced risk of infection, emergency department visits, and length of hospitalization stays.

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.

Interventional Radiologist's Approach to Fallopian Tube Recanalization.

Fallopian tube obstruction (FTO) is a common cause of female infertility. In the setting of proximal FTO, fallopian tube recanalization (FTR) is a minimally invasive, ambulatory procedure with a technical success rate of up to 100%, with minimal postprocedural adverse events. One-year pregnancy rate following FTR is approximately 41%, with successful delivery of full-term infants in 84% of pregnancies. This minimally invasive, outpatient, image-guided procedure is an alternative to vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) and should be top-of-mind in the setting of infertility due to proximal FTO.