Implications of IR Being a Primary Specialty on the Professional Organizational Relationship between Interventional and Diagnostic Radiology.

The recent awarding of primary specialty status to interventional radiology (IR) invites a re-examination of the long-standing relationship between IR and diagnostic radiology (DR). In this new era, it is important to evaluate how the organizations that represent these 2 specialties can best contribute to strengthening a growth in collaborations and partnerships that will benefit their members and patients. Areas of organizational focus with the potential to enhance the future for both groups include combining efforts directed toward advocacy and government relations, developing practice models to create successful IR and DR working relationships, and providing more data to demonstrate the value of IR above and beyond the work relative value units and professional revenues that IR generates.

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.

A Randomized, Double-Blind, Sham-Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis.

OBJECTIVE: Preliminary evidence suggests that vagus nerve stimulation (VNS) may have some benefit in patients with rheumatoid arthritis (RA); however, prior studies have been small and/or uncontrolled; this study aimed to address that gap. METHODS: This randomized, double-blind, sham-controlled trial enrolled patients aged 18 to 75 years with active RA who had failed conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and were naïve to biologic and/or targeted synthetic DMARDs. All patients received an auricular vagus nerve stimulator and were randomized 1:1 to active stimulation or sham. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Secondary endpoints included mean changes in disease activity score of 28 joints with C-reactive protein (DAS28-CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI). RESULTS: A total of 113 patients (mean age 54 years; 82% female) enrolled, and 101 patients (89.4%) completed week 12. ACR20 response at week 12 was 25.0% for active stimulation versus 26.9% for sham (difference vs. sham, -1.9; 95% CI, -18.8, 14.9, P = 0.823). The least square mean ± SE change in DAS28-CRP was -0.95 ± 0.16 for active stimulation and -0.66 ± 0.16 for sham (P = 0.201); in HAQ-DI it was -0.19 ± 0.06 for active stimulation and -0.02 ± 0.06 for sham (P = 0.044). Adverse events occurred in 17 patients (15%); all were mild or moderate. CONCLUSION: Auricular VNS did not meaningfully improve RA disease activity. If VNS with other modalities is pursued in the future for the treatment of RA, larger, controlled studies will be needed to understand its utility.

Pre-operative uterine artery embolization before hysterectomy or myomectomy: a single-center review of 53 patients.

PURPOSE: To assess outcomes of planned pre-operative uterine artery embolization (UAE) in patients with uterine fibroids at high risk for bleeding prior to hysterectomy or myomectomy. MATERIALS & METHODS: A retrospective review of 53 consecutive patients who underwent planned UAE followed by surgery from 2004 to 2019 was performed in a subset of patients deemed high risk for bleeding by the referring surgeon due to bulky fibroids and/or adhesions. Characteristics of the largest fibroid, total number of fibroids, embolic agents, estimated blood loss (EBL), complications, and other factors were collected. RESULTS: 53 patients (mean age = 41) had an elective UAE prior to a hysterectomy 24 (45%) or myomectomy 29 (55%). Median interval between UAE & surgery was 21.6 h (range 1.75 h-57 days). Of the myomectomies, 13 (45%) were open, 15 (52%) hysteroscopic and 1 laparoscopic. Mean number of fibroids/patient was 4.1 (SD 1.3), mean fibroid volume was 328 cm3 (range 11-741), and the mean fibroid diameter in longest dimension was 7.4 cm (range 3.2-15). Mean EBL was 90 (SD 99.5 mL). Three (10%) myomectomy patients required blood transfusion. All hysterectomies were via a laparotomy. Mean fibroid volume was 1699 cm3 (range 93-9099 cm3) with a mean maximum diameter of 16.2 cm (range 6.5-29.6) and an average of 2.4 (SD 1.7) fibroids. Mean EBL was 352 (SD 220 mL). Four (17%) hysterectomy patients required an intra- or post-operative blood transfusion. At a mean 1-year follow-up (range 1 month-14 years), 70% of UAE-myomectomy patients and 74% of UAE-hysterectomy patients reported symptom resolution. Three (6%) patients were readmitted: one for osteodiscitis, one wound dehiscence, and one for an infected retained fibroid after myomectomy. CONCLUSION: Planned pre-operative UAE resulted in intraoperative blood loss similar to "all-comer" myomectomy and hysterectomy patients in the literature. Further studies may elucidate which patients would be the best candidates for this staged treatment paradigm.

Results of an American College of Radiology-Society of Interventional Radiology Membership Survey on Exclusive Contracts and the Attitudes of Interventional Radiologists.

PURPOSE: To assess the attitudes of interventional radiologists (IRs) and diagnostic radiologists (DRs) toward exclusive contracts and independently practicing IRs who may request privileges at a hospital where an exclusive contract exists with a different group of radiologists. MATERIALS AND METHODS: A total of 22,400 survey instruments were distributed to 4,490 IRs and 17,910 DRs in the United States. Statistical evaluation included multivariate ordinal logistic regression analysis with calculation of the odds ratios and forest plots. RESULTS: Completed surveys were received from 525 (11.69%) IRs and 401 (2.23%) DRs. Given the low response rate of DRs, data analysis was focused on IRs. Early-career IRs and those in outpatient practices had a more positive attitude toward independent IRs who requested admitting and/or procedural privileges. A supermajority of both IRs and DRs who responded to the survey agreed that the importance of IR to hospital and health system contracts will increase. CONCLUSIONS: This survey identified many interrelated and complex variables that significantly affected the attitudes of IRs in various practice settings toward independent IRs requesting hospital admitting and/or procedural privileges. It will benefit independent IRs seeking admitting privileges to better understand some of the factors that impact the potential willingness of the radiology groups and other IRs with exclusive hospital contracts to work toward mutually beneficial practice paradigms, especially as more clinically oriented IRs complete their training in the new, integrated residency programs.

Interventional Radiology Workforce Shortages Affecting Small and Rural Practices: A Report of the SIR/ACR Joint Task Force on Recruitment and Retention of Interventional Radiologists to Small and Rural Practices.

Radiology practices characterized as small and rural are challenged to recruit and retain interventional radiologists. Lack of access to interventional radiologic services results in a failure to meet the needs of patients, hospitals, and other community stakeholders. Acknowledging this challenge, the ACR's Commission on General, Small, Emergency and/or Rural Practice and Commission on Interventional and Cardiovascular Imaging and the Society of Interventional Radiology partnered to establish a joint task force to study this issue and identify strategies the ACR and the Society of Interventional Radiology should take to improve small and rural practice recruitment and retention of interventional radiologists. This report describes the deliberations and recommendations of the task force.

Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3.

OBJECTIVE: This analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs). METHODS: This was a post hoc analysis of the phase III, randomised, double-blind, active-controlled, FINCH 3 study (clinicaltrials.gov NCT02886728). Patients received once-daily oral filgotinib 200 or 100 mg plus once-weekly oral MTX ≤20 mg (FIL200 + MTX and FIL100 + MTX), filgotinib 200 mg monotherapy (FIL200), or oral MTX monotherapy (MTX-mono) for up to 52 weeks. PPFs investigated were seropositivity for rheumatoid factor or anticyclic citrullinated peptide antibodies, high-sensitivity C reactive protein (CRP) ≥4 mg/L, Disease Activity Score in 28 joints with CRP (DAS28(CRP)) >5.1, and presence of erosions. Filgotinib efficacy and safety in patients with all four PPFs at baseline were explored versus MTX-mono within this subgroup and compared informally with the overall population. RESULTS: Of 1249 patients in FINCH 3, 510 (40.8%) had all PPFs. Efficacy of FIL200 + MTX among these patients was comparable to the overall population, with higher rates of 20%/50%/70% improvement from baseline by American College of Rheumatology criteria, DAS28(CRP) <2.6, and remission; greater improvement in physical function and pain; and better inhibition of structural damage relative to MTX-mono. FIL100 + MTX and FIL200 were not consistently more efficacious versus MTX-mono. Safety of filgotinib in patients with PPFs was comparable to the overall population; no new safety signals were observed. CONCLUSION: FIL200 + MTX efficacy and safety in patients with multiple PPFs were similar to the overall population.

Fibromuscular dysplasia: A comprehensive review on evaluation and management and role for multidisciplinary comprehensive care and patient input model.

Fibromuscular dysplasia is a nonatherosclerotic, under-recognized disorder primarily seen in middle-aged women. It can lead to several complications, such as hypertension, headaches, dissections, aneurysms, myocardial infarctions, and cerebrovascular accidents, to name a few. This article provides a comprehensive review of current literature on epidemiology, etiology, diagnosis, treatment, and long-term surveillance and fibromuscular dysplasia management. In addition, it renders the role of education and prevention for patients living with this condition and family screening. Lastly, it emphasizes the importance of a comprehensive multidisciplinary care model and patient input, given the complexity of this disease and its systemic presence and protean manifestations.

Use of a Commercially Available Clinical Decision Support Tool to Expedite Prior Authorization in Partnership With a Private Payer.

PURPOSE: The aim of this study was to determine if a clinical decision support (CDS) tool could be used in partnership with a private payer to successfully expedite the prior authorization process for advanced (ie, MRI, CT, PET, nuclear medicine) imaging requests. METHODS: A single academic institution integrated a commercially available CDS tool utilizing the ACR Appropriateness Criteria into the ordering process for outpatient advanced imaging tests within the electronic health record. Ordering providers could elect to use the CDS tool or ignore the available technology. In partnership with a health care insurance company and a contracted radiology benefits management company, orders deemed as "usually indicated" by the CDS tool underwent expedited prior authorization in a pilot program from June 2018 to October 2019. RESULTS: Providers used the CDS tool for 15% (1,453 of 9,640) of outpatient advanced imaging orders. Of these orders with elective CDS scores, 69% (n = 997) qualified for an expedited prior authorization process. CONCLUSIONS: Under specific circumstances, a commercially available CDS tool was used in partnership with a private payer and a radiology benefits management company to expedite prior authorization of outpatient advanced imaging examination orders deemed likely to be appropriate by multispecialty professional guidelines.

Five-Year Outcomes From the United States Pivotal Trial of Valiant Captivia Stent Graft for Blunt Aortic Injury.

BACKGROUND: The Clinical PeRformancE of the Valiant Thoracic Stent Graft with Capitvia Delivery System for the EndovaSCUlar treatment of Blunt Thoracic Aortic Injuries (RESCUE) study evaluating thoracic endovascular repair using the Valiant Captivia endograft for blunt thoracic aortic injury reported promising 30-day outcomes. We now describe 5 years of follow-up of this cohort. METHODS: Fifty patients (mean age 40.7 ± 17.4 years, 76% male, mean injury severity score 38 ± 14.4) were treated for blunt thoracic aortic injury (2010 to 2012) with this endograft. Seventy percent (n = 35) of blunt thoracic aortic injury extent was grade III or higher. Extent of arch repair required full (40%) or partial (18%) left subclavian artery coverage. At 5 years, clinical and imaging compliance was 90.3% (28 of 31) and 67.7% (21 of 31), respectively. RESULTS: Thirty-day mortality was 8%. Three additional patients died of non-device-related causes (respiratory failure, infection, metastatic cancer) through 5-year follow-up, yielding a Kaplan-Meier survival of 85.2% through 5 years. Neither stroke nor spinal cord ischemia was observed at 5 years. Two type II endoleaks seen at 30 days resolved spontaneously, and no additional endoleaks were described in the study cohort through 5 years. No secondary endovascular procedures or conversion to open surgery were reported through 5 years. Four subjects underwent left subclavian revascularization for symptomatic indications. Finally, complete exclusion of the traumatic injury was maintained with no incidences of stent graft kinking, fracture, loss of patency, or migration through 5 years in all patients. CONCLUSIONS: This multicenter clinical trial describes excellent 5-year outcomes and durable exclusion of blunt thoracic aortic injury using a novel stent graft system. Thoracic endovascular repair with this endograft appears to be a safe and effective treatment option for patients with blunt thoracic aortic injury.

An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis.

BACKGROUND: ABP 501 was evaluated in a phase 3 single-arm, open-label extension (OLE) study to collect additional safety and efficacy data in patients with rheumatoid arthritis (RA). METHODS: Subjects completing the final visit in the parent phase 3 randomized, double-blind, controlled equivalence study comparing the efficacy and safety of the biosimilar ABP 501 with adalimumab reference product (RP) were enrolled in this open-label extension (OLE) study. All subjects received 40 mg ABP 501 every other week for 68 weeks. Key safety endpoints included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and anti-drug antibody (ADA) incidences. Efficacy endpoints included ACR20 (at least 20% improvement in American College of Rheumatology core set measurements from baseline) and Disease Activity Score 28-joint count C-reactive protein (DAS28-CRP) change from baseline. RESULTS: Among 466/467 patients treated with ABP 501, 229 transitioned from the ABP 501 arm of the parent study (ABP 501/ABP 501) and 237 from the adalimumab RP arm (RP/ABP 501); 412/467 (88.2%) patients completed the study. The overall TEAE incidence was 63.7% (297/466); grade ≥ 3 TEAE incidence was 9.0% (42/466). The incidence of TEAEs leading to discontinuation of investigational product was 3.6% (17/466). The SAE incidence was 9.9% (46/466). Overall, 18.2% (85/466) of subjects developed binding ADAs and 6.9% (32/466) developed neutralizing ADAs in the OLE study. The ACR20 response rate was 73.3% (340/464 subjects) at OLE baseline, and 78.8% (327/415 subjects) at week 70 of the OLE study. The overall mean DAS28-CRP change from the parent study baseline was - 2.25 at the OLE study baseline (n = 440), - 2.36 at week 4 (n = 463), - 2.41 at week 24 (n = 450), - 2.55 at week 48 (n = 433), and - 2.60 at week 70 (n = 412). Efficacy was maintained throughout the study. CONCLUSIONS: Efficacy previously demonstrated in the parent study was maintained in this OLE study with no new safety findings. Long-term safety, immunogenicity, and efficacy were similar in the ABP 501/ABP 501 and RP/ABP 501 groups. The single switch from RP to ABP 501 did not impact immunogenicity. TRIAL REGISTRATION: ClinicalTrial.gov, NCT02114931.

Acute lower gastrointestinal bleeding: predictive factors and clinical outcome for the patients who needed first-time mesenteric conventional angiography.

PURPOSE: We aimed to investigate patients with lower gastrointestinal bleeding who presented to the emergency department requiring initial conventional angiography. We report risk-stratified and mesenteric conventional angiography outcomes. METHODS: We retrospectively reviewed patients with lower gastrointestinal bleeding between 2001 and 2012. We included all consecutive patients with clinical lower gastrointestinal bleeding with a requirement of further angiography and possible embolization. Patients who had prior interventions or surgery were excluded. RESULTS: A total of 88 patients (35 women, 53 men) with a median age of 71 years (range, 23-99 years) were included in the analysis. Conventional angiography was positive and endovascular treatment was intended in 35 patients. Once the source of bleeding was found angiographically, endovascular treatment had a technical success rate of 90.3% and clinical success rate of 71.4%. Overall early rebleeding rate (<30 days) was 14.8% and late rebleeding rate (>30 days) was 13.6%. CONCLUSION: Identifying the source of lower gastrointestinal bleeding remains to be a clinical and angiographic challenge. Although we did not observe an association between mortality and clinical success, increased early rebleeding rates were associated with higher mortality rates.

Midterm Follow-up of Ureteral Embolization Using Vascular Plugs and N-Butyl Cyanoacrylate Glue.

This is a retrospective study of 9 consecutive female patients who underwent ureteral embolization via a "sandwich" technique with two vascular plugs and N-butyl cyanoacrylate glue for ureteral fistulae unresponsive to urinary diversion. Average age was 61 years (range, 39-77 y), average duration of diversion was 48 days (range, 2-120 d), and average follow-up was 11 months (range, 4-23 mo). Seven patients (78%) experienced immediate resolution of urinary leakage, and the other 2 (22%) required unilateral repeat treatment for resolution of leakage. Symptom resolution lasted throughout the follow-up period for all patients. Bilateral internal iliac artery pseudoaneurysms developed in 1 patient and were treated with embolization and stent placement.

Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.

OBJECTIVES: ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. METHODS: In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. RESULTS: A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. CONCLUSIONS: Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. TRIAL REGISTRATION NUMBER: NCT01970475; Results.