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.

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.

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.

Stenting and medical therapy for atherosclerotic renal-artery stenosis.

BACKGROUND: Atherosclerotic renal-artery stenosis is a common problem in the elderly. Despite two randomized trials that did not show a benefit of renal-artery stenting with respect to kidney function, the usefulness of stenting for the prevention of major adverse renal and cardiovascular events is uncertain. METHODS: We randomly assigned 947 participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy). RESULTS: Over a median follow-up period of 43 months (interquartile range, 31 to 55), the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (-2.3 mm Hg; 95% CI, -4.4 to -0.2; P=0.03). CONCLUSIONS: Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. (Funded by the National Heart, Lung and Blood Institute and others; ClinicalTrials.gov number, NCT00081731.).

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.

Factors Related to Late False Lumen Enlargement after Thoracic Stent-Graft Placement for Type B Aortic Dissection.

PURPOSE: To evaluate significant factors related to delayed aortic false lumen (FL) enlargement in patients who have undergone thoracic stent-graft placement for type B aortic dissection. MATERIALS AND METHODS: The study included 62 patients (45 male, 17 female) aged 26-80 years (mean age, 58.1 y) who underwent thoracic endovascular aortic repair for type B aortic dissection at a single institution between January 2005 and May 2015. Mean age of aortic dissections was 5.3 months (range, 0.1-73.3 mo). Maximum aortic diameter at presentation was 41.7 mm ± 8.3. The follow-up period ranged from 3 to 104 months (mean, 27.1 mo). Computed tomographic (CT) angiography studies were reviewed to identify FL diameter enlargements > 5 mm at different levels along and distal to the stent graft. Imaging findings and clinical variables were investigated to determine their correlation with FL enlargement. RESULTS: No significant difference was found between the ages of aortic dissections in patients with and without FL enlargement (P = .26). On follow-up CT angiography, 16 patients had 2 or more communication channels between the FL and the systemic circulation, 7 of whom showed FL enlargement > 5 mm (P = .007). Twenty-seven patients showed complete FL thrombosis, none of whom had FL enlargement (P < .001). CONCLUSIONS: Two or more communication channels between the FL and the systemic circulation represent a risk factor for FL enlargement regardless of the age of the dissection. Patients with thrombosis of the FL are less likely to experience FL enlargement.

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.

Key Concepts in Critical Limb Ischemia: Selected Proceedings from the 2015 Vascular Interventional Advances Meeting.

Over 500,000 patients each year are diagnosed with critical limb ischemia (CLI), the most severe form of peripheral artery disease. CLI portends a grim prognosis; half the patients die from a cardiovascular cause within 5 years, a rate that is 5 times higher than a matched population without CLI. In 2014, the Centers for Medicare and Medicaid Services paid approximately $3.6 billion for claims submitted by hospitals for inpatient and outpatient care delivered to patients with CLI. Although significant advances in diagnosis, treatment, and follow-up of patients with CLI have been made, many challenges remain. In this article, we summarize selected presentations from the 2015 Vascular Interventional Advances Conference related to the modern demographics, diagnosis, and management of patients with CLI.

Management of Uterine Fibroids: A Focus on Uterine-sparing Interventional Techniques.

Uterine fibroids occur in approximately 50% of women over the age of 40 years, and an estimated 50% of those are symptomatic. Menorrhagia is the most common symptom and the primary indication for treatment, although bulk symptoms often occur and can be treated. Pharmacotherapy is typically inadequate unless it can be expected to successfully bridge to menopause or allow for a less-invasive intervention. However, hormonal therapies have risks. Hysterectomy is still the most commonly performed procedure for symptomatic fibroids and has the lowest rate of reintervention (compared with myomectomy or uterine artery embolization [UAE]), but rates of more serious complications are higher and patient satisfaction and ability to return to normal activities may also be less favorable. Myomectomy is not necessarily less morbid than hysterectomy and may have a greater failure rate than UAE. Techniques and devices vary with little standardization, and operator experience is crucial to success. The largest studies of UAE show very low rates of serious complications and rapid recovery. UAE significantly improves symptoms related to uterine fibroids in 85%-90% of patients. Herein, this article will discuss the nature of fibroids and their diagnosis, pharmacotherapy, surgical treatment, and nonsurgical interventional treatment, including UAE and magnetic resonance-guided focused ultrasound. (©) RSNA, 2016.

Multicenter clinical trial of the conformable stent graft for the treatment of acute, complicated type B dissection.

OBJECTIVE: The treatment of acute, complicated type B aortic dissection has evolved in the past several decades. Thoracic endovascular aortic repair when anatomy is suitable, has been regarded as the preferable treatment to seal the primary entry tear, redirect and re-establish adequate true lumen flow, and thereby promote aortic remodeling. This study was designed to determine the safety and efficacy of a conformable thoracic endoprosthesis device for patients with acute, complicated type B aortic dissection, defined as malperfusion or rupture or both. METHODS: Between January 2010 and January 2012, 50 patients with complicated type B aortic dissection from 26 sites in the United States were included in this prospective, multicenter, nonrandomized single-arm study. The primary safety end point was all-cause mortality through 30 days after treatment, and the primary efficacy end point was exclusion of the primary entry tear (Core Laboratory adjudicated) at 1-month follow-up. Secondary end points included false lumen thrombosis, dissection-based reintervention rate, and aortic rupture. RESULTS: All device implants were successfully completed. Six patients (12%) required additional device implantations ≤1 year from the index procedure. There was no conversion to open repair at 1 year. Exclusion of the primary entry tear at 30 days occurred in 97.5% of patients. All-cause mortality through 30 days was 8%. Survival was 88% at 1 year and 85% at 2 years. At 1 year after treatment, 35.1% of patients had experienced a decrease of ≥5 mm in overall diameter in the treated segment of the aorta. From pretreatment to the 36-month follow-up, the average minimum true lumen area increased by 206.3 mm(2), and the average maximum false lumen area decreased by 313.4 mm(2). The 30-day stroke rate was 18%; none were fatal, and one permanent deficit occurred. Four patients (8%) experienced spinal cord ischemia of any severity but without any permanent or significant deficits. New aortic dissection (3 retrograde, 2 de novo) occurred in five patients (10%). The secondary intervention rate was 18%. CONCLUSIONS: Treatment with the conformable thoracic endovascular aortic repair device produced favorable perioperative and intermediate level clinical and anatomic outcomes. In particular, an operative mortality of 8% in this cohort is comparable to that noted in a Society for Vascular Surgery objective performance criteria publication. Late survival in our cohort compares favorably with historical data referable to complicated type B dissection.

Retrograde pedal access technique for revascularization of infrainguinal arterial occlusive disease.

PURPOSE: To evaluate limb salvage after recanalization of lower extremity arteries using retrograde pedal access in patients with critical limb ischemia (CLI). MATERIALS AND METHODS: A retrospective review was performed of all patients in whom retrograde pedal arterial access was used for recanalization of infrainguinal occlusive disease between September 2002 and January 2013. Treatment was performed in 99 limbs in 92 patients (64 men and 28 women; median age, 71.6 y; range, 44-91 y) with CLI and no appropriate venous conduit for surgical bypass. Treated limbs were classified as Rutherford class 5 or 6 in 88% and class 4 in 12%. Retrograde and antegrade accesses were combined when occlusions could not be crossed from the antegrade direction. The treated occlusive segments were limited to the femoropopliteal arteries in 22% of procedures, runoff arteries in 32%, or both segments in 46%. Technical success was defined as successful crossing of the lesion and achievement of inline flow to the pedal vessel. Kaplan-Meier analysis was performed to determine limb salvage rate. RESULTS: Technical success was achieved in 88 of 99 (89%) treated limbs. Stents were placed for suboptimal angioplasty results in 41 of 88 (47%) successfully treated limbs. Major complications occurred in 8 of 99 (8%) procedures, 3 of which resulted in periprocedural mortality. Median follow-up was 8 months (mean, 17 mo; range, 1-98 mo). The limb salvage rate for technically successful cases was 74% at 6 months, 64% at 12 months, and 55% at 24 months. CONCLUSIONS: Retrograde pedal access is a viable revascularization technique for achieving limb salvage in patients with CLI.

Outcomes of Coverage of the Left Subclavian Artery during Endovascular Repair of the Thoracic Aorta.

PURPOSE: To report outcomes of coverage of the left subclavian artery (LSCA) during thoracic endovascular aortic repair (TEVAR). MATERIALS AND METHODS: A retrospective review was performed of 285 patients (160 male) with a mean age of 62 years (range, 13-91 y) who underwent TEVAR at a single institution between March 2005 and May 2013. The LSCA was covered to obtain an adequate proximal landing zone, and a selective LSCA revascularization and embolization strategy was employed. All patient outcomes were recorded including neurologic complications, left arm claudication, endoleak rates, and repeat procedures. RESULTS: The origin of the LSCA was covered in 98/285 (34%) patients. Median follow-up was 533 days (range, 2-2,895 d). Cerebrovascular accident (CVA) rates for covered LSCA and noncovered groups were 11/98 (11%) and 5/188 (3%), respectively (P = .005). LSCA was revascularized at time of initial TEVAR in 44/98 (45%) patients. Of the remaining 54 patients, 10 (19%) required subsequent revascularization for claudication. LSCA embolization was done to prevent or treat endoleak in 41/98 (42%) patients, with 33/98 (34%) patients undergoing LSCA embolization at the time of LSCA coverage and 8 of the remaining 65 (12%) patients requiring subsequent embolization for persistent endoleak. CONCLUSIONS: Coverage of the LSCA during TEVAR is feasible with low complication rates, although it carries an increased risk of CVA. The selective LSCA revascularization and embolization strategy was well tolerated. A more liberal strategy may be required to decrease the rate of delayed revascularization and embolization procedures to treat arm claudication and endoleaks, respectively.

Outcomes of Hypertensive Patients with Renal Fibromuscular Dysplasia Compared with Patients with Concomitant Atherosclerotic Renal Artery Stenosis following Endovascular Therapy.

PURPOSE: To examine if the outcomes after endovascular treatment in hypertensive patients with renal artery fibromuscular dysplasia (FMD) and incidental atherosclerotic renal artery stenosis (ARAS) differ from the outcomes in patients with FMD alone. MATERIALS AND METHODS: All cases of patients with renal artery FMD undergoing percutaneous transluminal angioplasty during the period 2002-2012 were reviewed. The patients with complete data before and after the procedure were identified (N = 84). Based on the procedural reports, these patients were separated into two cohorts: patients with isolated FMD (n = 59) and patients with concomitant atherosclerotic renal artery stenosis and FMD (ARAS-FMD) (n = 25). The medical record of each patient was reviewed for baseline blood pressure, antihypertensive medication use, and renal function data and the same data after the procedure. Procedural details including the angiographic findings, the number of stents placed, the average number of revascularization procedures, and the number of patients requiring more than one revascularization procedure were noted. RESULTS: The study population included 68 patients (FMD, n = 46; ARAS-FMD, n = 22). Patients in the FMD and ARAS-FMD cohorts experienced comparable significant decreases in systolic and mean arterial pressures after endovascular intervention. There was no change in the number of antihypertensive medications after the procedure within or between groups. Patients in the ARAS-FMD cohort had lower baseline estimated glomerular filtration rates (P = .007); however, renal function stabilized in both groups after endovascular therapy. CONCLUSIONS: Patients with ARAS-FMD respond to endovascular therapy with outcomes similar to patients with isolated renal artery FMD.

Anti-platelet and anti-hypertension medication use in patients with fibromuscular dysplasia: Results from the United States Registry for Fibromuscular Dysplasia.

Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular artery FMD involvement in isolation (OR=2.31, p<0.0001) or a history of previous intervention for FMD (OR=1.52, p=0.036). A greater number of anti-HTN medications was evident in isolated renal versus isolated cerebrovascular FMD patients. Factors associated with a greater number of anti-HTN medications were older age (OR=1.03 per year, p<0.0001), history of HTN (OR=24.04, p<0.0001), history of CAD (OR=2.71, p=0.0008) and a history of a previous therapeutic procedure (OR=1.72, p=0.001). In conclusion, in FMD, medication use varies based on vascular bed involvement. Isolated renal FMD patients receive more anti-HTN agents and there is greater anti-platelet agent use among patients with cerebrovascular FMD. Further studies correlating medication use in FMD with clinically meaningful patient outcomes are necessary.

Secondary procedures following thoracic aortic stent grafting in the first 3 years of the VALOR test and VALOR II trials.

PURPOSE: To compare the durability of thoracic endovascular aortic repair (TEVAR) in two similar clinical trials that used early- and later-generation stent grafts. MATERIALS AND METHODS: Secondary procedures from the prospective, nonrandomized, multicenter, clinical trial databases of the test arm of the VALOR and VALOR II trials were analyzed at 3 years. Descriptive and statistical analyses were employed to compare the rate of and potential predictors for secondary procedures. RESULTS: A total of 127 and 96 patients were available for a minimum of 3 years of follow-up in the test arm of VALOR and VALOR II, respectively. By the first year after the index procedure, VALOR II patients were significantly less likely to have undergone a secondary procedure versus patients in the test arm of VALOR (odds ratio [OR], 0.08; 95% confidence interval [CI], 0.01-0.63; P = .02), with most procedures performed for type I endoleak. Multivariate predictors at 3 years for the need for a secondary procedure in the VALOR test arm were maximum aneurysm diameter (P = .002) and aneurysm length (P = .01), both of which remained significant at the end of the study period. The estimated freedoms from secondary procedures in the VALOR test arm and VALOR II at 3 years were 85.1% (95% CI, 78.5%-89.8%) and 94.9% (95% CI, 88.8%-97.7%), respectively (P < .001). CONCLUSIONS: The rate of secondary procedures after TEVAR differed between the two cohorts, being substantially lower in the VALOR II trial at 1 year of follow-up. This finding suggests significant benefit from advances in some combination of operator experience, imaging systems, treatment planning, and device design.

Short-term rebleeding rates for isolated gastric varices managed by transjugular intrahepatic portosystemic shunt versus balloon-occluded retrograde transvenous obliteration.

PURPOSE: To assess the short-term rebleeding rate associated with the use of a transjugular intrahepatic portosystemic shunt (TIPS) compared with balloon-occluded retrograde transvenous obliteration (BRTO) for management of gastric varices (GV). MATERIALS AND METHODS: A single-center retrospective comparison of 50 patients with bleeding from GV treated with a TIPS or BRTO was performed. Of 50 patients, 27 (17 men and 10 women; median age, 55 y; range, 31-79 y) received a TIPS with covered stents, and 23 (12 men and 11 women; median age, 52 y; range, 23-83 y) underwent a BRTO procedure with a foam sclerosant. All study subjects had clinical and endoscopic evidence of isolated bleeding GV and were hemodynamically stable at the time of the procedure. Clinical and endoscopic follow-up was performed. Kaplan-Meier analysis was used to evaluate rebleeding rates from the GV. RESULTS: The technical success rate was 100% in the TIPS group and 91% in the BRTO group (P = .21). Major complications occurred in 4% of the patients receiving TIPS and 9% of patients the undergoing BRTO (P = .344). Encephalopathy was reported in 4 of 27 (15%) patients in the TIPS group and in none of the patients in the BRTO group (0%; P = .12). At 12 months, the incidence of rebleeding from a GV source was 11% in the TIPS group and 0% in the BRTO group (P = .25). CONCLUSIONS: BRTO appears to be equivalent to TIPS in the short-term for management of bleeding GV. Further comparative studies are warranted to determine optimal management strategies in individual patients.