Multicenter Quantification of Radiation Exposure and Associated Risks for Prostatic Artery Embolization in 1476 Patients.

Background Prostatic artery embolization (PAE) is a safe, minimally invasive angiographic procedure that effectively treats benign prostatic hyperplasia; however, PAE-related patient radiation exposure and associated risks are not completely understood. Purpose To quantify radiation dose and assess radiation-related adverse events in patients who underwent PAE at multiple centers. Materials and Methods This retrospective study included patients undergoing PAE for any indication performed by experienced operators at 10 high-volume international centers from January 2014 to May 2021. Patient characteristics, procedural and radiation dose data, and radiation-related adverse events were collected. Procedural radiation effective doses were calculated by multiplying kerma-area product values by an established conversion factor for abdominopelvic fluoroscopy-guided procedures. Relationships between cumulative air kerma (CAK) or effective dose and patient body mass index (BMI), fluoroscopy time, or radiation field area were assessed with linear regression. Differences in radiation dose stemming from radiopaque prostheses or fluoroscopy unit type were assessed using two-sample t tests and Wilcoxon rank sum tests. Results A total of 1476 patients (mean age, 69.9 years ± 9.0 [SD]) were included, of whom 1345 (91.1%) and 131 (8.9%) underwent the procedure with fixed interventional or mobile fluoroscopy units, respectively. Median procedure effective dose was 17.8 mSv for fixed interventional units and 12.3 mSv for mobile units. CAK and effective dose both correlated positively with BMI (R2 = 0.15 and 0.17; P < .001) and fluoroscopy time (R2 = 0.16 and 0.08; P < .001). No radiation-related 90-day adverse events were reported. Patients with radiopaque implants versus those without implants had higher median CAK (1452 mGy [range, 900-2685 mGy] vs 1177 mGy [range, 700-1959 mGy], respectively; P = .01). Median effective dose was lower for mobile than for fixed interventional systems (12.3 mSv [range, 8.5-22.0 mSv] vs 20.4 mSv [range, 13.8-30.6 mSv], respectively; P < .001). Conclusion Patients who underwent PAE performed with fixed interventional or mobile fluoroscopy units were exposed to a median effective radiation dose of 17.8 mSv or 12.3 mSv, respectively. No radiation-related adverse events at 90 days were reported. © RSNA, 2024 See also the editorial by Mahesh in this issue.

Outcomes and Comparative Analysis of the Initial Results of Standard Balloon Angioplasty Versus Drug-Coated Balloons Alone Versus in Association With Laser-Excimer Atherectomy in the Treatment of Femoropopliteal Artery In-Stent Restenosis (INTACT).

BACKGROUND: Despite improved patency with newer-generation nitinol stents, one-half of patients will require secondary interventions for in-stent restenosis (ISR). The best treatment strategy remains unclear. This study aimed to compare drug-coated balloons (DCBs) used alone or in association with excimer laser atherectomy (ELA) to simple percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal-ISR. METHODS: The INTACT trial is a multicenter, prospective, triple-arm randomized trial conducted across 14 centers from December 2015 to November 2019. Patients Rutherford Class 2-5 with ISR≥70% were followed-up for 18 months. The primary efficacy endpoint was recurrent ISR>70% by duplex ultrasound analysis. The primary safety endpoint was major adverse events (MAEs) defined as death, major amputation, or target lesion revascularization (TLR). RESULTS: Around 134 subjects were randomized to PTA alone (n=41), PTA+DCB (n=43) or PTA+ELA+DCB (n=50). Procedural success was similar (p=.74), as was clinical success (p=.17). The number of recurrent ISR>70% decreased after PTA+ELA+DCB (30.0%; p=.04) and PTA+DCB (30.2%; p=.05) compared to PTA alone (51.2%). Primary patency was higher after PTA+ELA+DCB (log-rank p=.04) and PTA+DCB (log-rank p=.02) compared to PTA alone at 12 months (78.7% and 70.4% vs 61.5%) and 18 months (61.6% and 67.7% vs 37.3%). Freedom from MAEs was lower after PTA+DCB (27.9%) compared to PTA alone (53.7%; p=.02) but did not differ with PTA+ELA+DCB (40.0%). It was primarily driven by TLR; 2 major amputations occurred after PTA+ELA+DCB (4.0%; p=.18). CONCLUSION: This independent study demonstrated a decrease in recurrent ISR>70% and increase in primary patency up to 18 months after PTA+ELA+DCB and PTA+DCB compared to PTA alone in the treatment of FP-ISR. It did not show an increase in MAEs but could have lacked power. CLINICAL IMPACT: This multicenter, prospective, triple-arm randomized, controlled trial focuses on the results of adjunctive therapies, such as excimer laser atherectomy (ELA) and/or drug-coated balloons (DCBs) in the treatment of in-stent restenosis (ISR) in femoropopliteal lesions in 134 patients. It has the originality of being an independent study funded by a grant from the French Ministry of Health. This study confirms a significant decrease in recurrent ISR >70% and increase in primary patency up to 18 months after the use of ELA+DCB and DCBs compared to simple percutaneous transluminal angioplasty in the treatment of femoropopliteal ISR without an increase in major adverse events.

Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction.

PURPOSE: To report 36-month outcomes and subgroup analysis of the ABRE study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease. METHODS: The ABRE study was a prospective, multicenter, nonrandomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5 years [SD ± 15.9], 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality-of-life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. RESULTS: Primary, primary-assisted, and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8%, and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the postthrombotic syndrome group, and 97.1% in the nonthrombotic iliac vein lesion group through 36 months. The overall mean lesion length was 112.4 mm (SD ± 66.1). There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets. CONCLUSIONS: Results from the ABRE study demonstrated sustained patency with a good safety profile after implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.

Society of Interventional Radiology Research Reporting Standards for Genicular Artery Embolization.

Genicular artery embolization (GAE) is an emerging, minimally invasive therapy to address the global burden of knee osteoarthritis (OA) and the unmet needs for medically refractory disease. Although total knee arthroplasty has been a standard intervention for severe cases, GAE is developing into a promising alternative, particularly for patients ineligible for or unwilling to undergo surgery. GAE targets the inflammatory cascade underlying OA pathophysiology by arresting neoangiogenesis and preventing pathological neoinnervation, offering potential pain relief. Although early studies have established safety and short-term effectiveness, ensuing studies are needed to validate long-term safety, durability, and comparative effectiveness and to optimize patient selection, embolic agent selection, and administration techniques. Standardized reporting guidelines are therefore essential to enhance transparency and reproducibility across clinical trials, facilitating data aggregation and comparison. This Society of Interventional Radiology (SIR)-endorsed reporting standards consensus document provides a framework to harmonize future research efforts and to improve the interpretation of outcomes.

Perioperative management of venous recanalization in a patient with inherited antithrombin deficiency: case report.

Background: Inherited antithrombin (AT) deficiency (ATD) is a severe thrombophilia causing venous thromboembolism, which can be complicated by postthrombotic syndrome (PTS). Venous recanalization, used to treat PTS, often requires a temporary withdrawal of anticoagulant therapy. In ATD patients, there is a risk of insufficient perioperative anticoagulation due to altered heparin response. Key Clinical Question: There is no consensus on how to manage perioperative anticoagulation in ATD patients. Clinical Approach: Warfarin-unfractionated heparin transition could be a more reliable strategy than low-molecular-weight heparin transition because unfractionated heparin anti-Xa activity not only reflects heparin-bound AT but also AT's activity, which correlates strongly with therapeutic anticoagulation. Biological monitoring could thus decrease the number of plasma-derived AT supplementation. Conclusion: This study describes a successful perioperative management of anticoagulation for venous recanalization that could be suggested to type 1 ATD patients with PTS.

Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.

PURPOSE: The purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA). MATERIALS AND METHODS: This prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092). The main inclusion criterion was diagnosis of KOA according to a visual analogue scale (VAS) pain score ≥ 40 mm (score range: 0-100 mm), despite conservative treatment for at least three months. Treatment efficacy was assessed using changes in VAS pain score, Mean Western Ontario & McMaster Universities osteoarthritis (WOMAC) function score (normalized to 100; score ranging from 0 to100) and outcome measures in rheumatoid arthritis clinical trials (OMERACT)-Osteoarthritis Research Society (OARSI) set of responder criteria. RESULTS: Twenty-two consecutive participants (13 women; mean age, 66 ± 9 [standard deviation (SD)]) were included and underwent GAE. Emulsion consisted in a mixture of ioversol and ethiodized oil (ratio 1:3, respectively) prepared extemporaneously. The rate of serious adverse events attributed to GAE within one month was 5% (1/22), corresponding to reversible worsening of renal function. Immediate technical success rate was 100%. Mean VAS pain score dropped from 74.4 ± 16.5 (SD) mm at baseline to 37.2 ± 26.7 (SD) mm at three months (P < 0.001). Mean WOMAC function score (normalized to 100: score ranging from 0 to 100) decreased from 57.3 ± 17.1 (SD) at baseline to 33.5 ± 25.9 (SD) at three months (P < 0.001). At three months, 16 out of 22 participants (73%) were considered responders according to the OMERACT-OARSI set of responder criteria, including high improvement in either pain or WOMAC function, or improvement in both pain and WOMAC function. CONCLUSION: GAE using an ethiodized oil-based emulsion is safe and improves pain and function in participants with KOA for at least three months.