Common design and data elements on rectal artery embolization for treatment of symptomatic internal hemorrhoidal disease: an interactive systematic review of clinical trials.

BACKGROUND: Internal hemorrhoids (IH) is a common medical condition that can result in morbidity secondary to bleeding and discomfort. Treatment for IH has traditionally consisted of dietary and conservative medical management, focal treatments including banding and sclerotherapy or hemorrhoidectomy. Recently, rectal artery embolization (RAE) has been studied as a potential treatment for bleeding predominant IH. We performed a common design and data element analysis of studies that report on RAE. MATERIALS AND METHODS: We conducted a qualitative systematic literature review for rectal artery embolization (RAE) for symptomatic hemorrhoidal disease. The screening process involved five online databases (PubMed, Embase, Google Scholar, DOAJ, and Scopus). Additionally, ClinicalTrials.gov was examined for active, unpublished completed studies. The initial search yielded 2000 studies, with 15 studies meeting the inclusion criteria after screening and assessment. The included studies comprised one RCT, one case series, one pilot study and 12 cohort studies. RESULTS: The population analysis revealed a male predominance across all studies, with varying cohort sizes. The baseline Goligher hemorrhoid grade was utilized in 80% of studies. The majority (73.3%) employed a transfemoral approach, and coils were the primary embolic material in 60% of studies, 26.6% were combination of coils and particles, and 6.6% were particles only. Patient selection criteria highlighted RAE's applicability for high surgical risk patients and those with anemia, chronic hematochezia, or treatment-refractory cases. Exclusion criteria emphasized factors such as previous surgeries, colorectal cancer, rectal prolapse, acute hemorrhoidal complications, and contrast allergy. Study designs varied, with cohort studies being the most common (12/15; 80%). Procedural details included the use of metallic coils and detachable micro-coils, with a high technical success rate reported in most studies ranging from 72 to 100%. The follow-up ranged from 1 to 18 months. The majority of studies reported no major immediate or post-procedural complications. CONCLUSION: While all studies focused on RAE as a treatment for IH, there was a great degree of heterogeneity among included studies, particularly regarding inclusion criteria, exclusion criteria, outcomes measures and timeframe. Future literature should attempt to standardize these design elements to help facilitate secondary analyses and increase understanding of RAE as a treatment option.

Performance Evaluation of a Miniature and Disposable Endovascular Robotic Device.

PURPOSE: The LIBERTY® Robotic System is a miniature, single-use device designed to facilitate remote-controlled navigation to intravascular targets. We aim to evaluate the robot's performance to manipulate a range of microguidewires and microcatheters during percutaneous endovascular procedures. MATERIALS AND METHODS: Six interventional radiologists performed selective robotic-assisted catheterization of eight pre-determined vascular targets in a pig model. The navigation time from the guiding catheter tip to the target vessel was recorded. Each physician with a clinical experience of 20 years completed a questionnaire to evaluate the ease of use, accuracy, and safety of the robotic operation. RESULTS: Most of the physicians reached the vascular targets in less than one minute. There was no angiographic evidence of vascular injury such as artery laceration or contusion. All physicians reported consensus about the high performance of the robot. CONCLUSION: The miniature disposable robot is effective at reaching a range of vessels in a porcine model. Physicians found the device intuitive and easy to operate remotely.

Regorafenib in patients with advanced Ewing sarcoma: results of a non-comparative, randomised, double-blind, placebo-controlled, multicentre Phase II study.

BACKGROUND: The REGOBONE multi-cohort study explored the efficacy and safety of regorafenib for patients with advanced bone sarcomas; this report details the Ewing sarcoma (ES) cohort. METHODS: Patients with relapsed ES progressing despite prior standard therapy, were randomised (2:1) to receive regorafenib or placebo. Patients on placebo could crossover to receive regorafenib after centrally confirmed progression. The primary endpoint was the progression-free rate at 8 weeks. With one-sided α of 0.05, and 80% power, at least 14/24 progression-free patients at 8 weeks were needed for success. RESULTS: From September 2014 to November 2019, 41 patients were accrued. 36 patients were evaluable for efficacy: 23 on regorafenib and 13 on placebo. Thirteen patients (56%; one-sided 95% CI [37.5%-[)) were progression-free at 8 weeks on regorafenib vs. 1 (7.7%; 95% CI [0.4%-[) on placebo. Median PFS was 11.4 weeks on regorafenib, and 3.9 weeks on placebo. Ten placebo patients crossed over to receive regorafenib after progression. The most common grade ≥3 regorafenib-related adverse events were pain (22%), asthenia (17%), thrombocytopenia (13%) and diarrhoea (13%). CONCLUSION: Although the primary endpoint was not met statistically in this randomised cohort, there is evidence to suggest that regorafenib might modestly delay tumour progression in relapsed ES after failure of prior chemotherapy.

Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial.

Background: Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient's symptoms improvement after PAE and medical treatment. Methods: A randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) defined by International Prostatic Symptom Score (IPSS) > 11 and quality of life (QoL) > 3, and BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0.5 mg/tamsulosin hydrochloride 0.4 mg per day). Randomisation was stratified by centre, IPSS and prostate volume with a minimisation procedure. The primary outcome was the 9-month IPSS change. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome. ClinicalTrials.gov Identifier: NCT02869971. Findings: Ninety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups, respectively. The 9-month change of IPSS was -10.0 (95% confidence interval [CI]: -11.8 to -8.3) and -5.7 (95% CI: -7.5 to -3.8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (-4.4 [95% CI: -6.9 to -1.9], p = 0.0008). The IIEF-15 score change was 8.2 (95% CI: 2.9-13.5) and -2.8 (95% CI: -8.4 to 2.8) in the PAE and CT groups, respectively. No treatment-related AE or hospitalisation was noticed. After 9 months, 5 and 18 patients had invasive prostate re-treatment in the PAE and CT group, respectively. Interpretation: In patients with BPH ≥50 ml and bothersome LUTS resistant to alpha-blocker monotherapy, PAE provides more urinary and sexual symptoms benefit than CT up to 24 months. Funding: French Ministry of Health and a complementary grant from Merit Medical.

Bringing Interventional Radiology to Mars!

At present, astronauts on space missions can get medical assistant from Earth. In the future, deep space missions such as missions to Mars will delay communication with physicians on Earth, making it impossible to get immediate support in urgent medical situations. On the spaceship, a polyvalent physician-astronaut could mainly perform small surgery and traumatology procedures. Interventional Radiology (IR) allows minimally invasive interventions and requires small devices. In these conditions of space constrains, IR presents significant benefits. To guarantee the technical realization of specific medical interventions during deep space missions, a team composed of interventional radiologists and space engineers, is developing the IR toolbox. The development of the toolbox intents to minimize the volume/weight of medical devices and to ensure the safety requirements for the crew. New scenarios of IR interventions have been developed to adapt the interventions to the spatial context, making possible the treatment of pathologies that are otherwise, on Earth, optimally treated surgically. Interventional radiology has a major role to play in the management of acute medical problems which may occur in the future story of deep space missions to the Moon, and further to Mars.

FairEmbo Concept for Postpartum Hemorrhage: Evaluation of the Efficacy of Suture Fragment Compared with Gelatin Sponge Torpedo Embolization in a Post-Gravid Swine Model.

BACKGROUND: Postpartum hemorrhage is the leading cause of maternal mortality in emerging countries. This study aims to evaluate the effectiveness and safety of uterine artery embolization (UAE) using suture fragment (FairEmbo concept) in a swine model. METHODS: Seven female swine uteri were embolized. The left uterine artery was embolized with 1 cm fragments of absorbable suture (Optime® 0), and with gelatin sponge torpedoes for the contralateral side for comparison. The embolization effectiveness and the time for arterial recanalization with digital subtraction angiography (DSA) controls at D0, D7, and M1, were evaluated. Follow-up protocol also included clinical monitoring and macroscopical analyses at M1. A Mann-Whitney test (significance at P 0.05) was used for statistics. RESULTS: A technical success was obtained for the seven arteries on each side, with no off-target embolization. The procedure time (10 min versus 3.7 min) and number of fragments (13.8 versus 5.7) required for complete occlusion were significantly greater in the FairEmbo group. All arteries were repermeabilized at M1. No necrosis was macroscopically visible at harvest at M1. CONCLUSION: This experimental study suggests that UAE with SBM FairEmbo method is feasible, safe, and effective in comparison with gelatin sponge procedure.

Endovascular Management of Vascular Complications in Ehlers-Danlos Syndrome Type IV.

(1) Background: The vascular type of Ehlers-Danlos syndrome (vEDS) is a rare genetic connective tissue disorder caused by pathogenic variants in the COL3A1 gene that result in arterial and organ fragility and premature death. We present five cases of vEDS that highlight the diagnosis and treatment challenges encountered by clinicians with these patients. (2) Case presentations: we present the cases of five patients with vascular complications of vEDS who were successfully managed using endovascular interventions or hybrid techniques at our institution from 2005 to 2022. (3) Conclusions: These data emphasize that a multidisciplinary approach is needed for vEDS patients and that when endovascular or hybrid treatment is performed in a timely manner by a skilled team of interventional radiologists, good results can be achieved. Our report also demonstrates that the prognosis of vEDS patients has improved over the past 20 years with a new prevention program including celiprolol therapy, physical activity adaptation and limitation, and scheduled monitoring by expert clinicians.

Rectal Artery Embolization for Hemorrhoidal Disease: Anatomy, Evaluation, and Treatment Techniques.

Chronic hemorrhoidal disease is a common anorectal condition that leads to hemorrhoidal hyperplasia, which affects millions of people worldwide and is a significant medical and socioeconomic issue. Rectal bleeding is one of the main chronic symptoms. Recurrent rectal bleeding can alter an individual's quality of life and, more rarely, cause anemia. Pain is less common, occurring only in the event of complications such as congestive exacerbation, external hemorrhoidal thrombosis, or fissures. The most standard treatment involves dietary and hygiene measures, use of phlebotonic drugs, and nonsurgical treatment such as infrared photocoagulation or elastic band ligation. Excisional treatments such as hemorrhoidectomy and hemorrhoidopexy are the reference standards for treatment of hemorrhoidal disease. Embolization of the rectal arteries (ie, emborrhoid) has recently emerged as an effective treatment option, with few reported adverse effects, minimal blood loss, and a same-day hospital procedure. Hemorrhoid embolization is performed by using femoral or radial access. The inferior mesenteric artery and then the superior rectal arteries are catheterized with a microcatheter. Embolization can be performed by using different agents. Studies have shown improvement in symptoms and high technical success rates after treatment. The basic principles of hemorrhoid embolization that must be understood to achieve effective treatment, including those related to patient evaluation, the arterial anatomy, basic embolization, and published results, are reviewed. An invited commentary by Thompson and Kelley is available online. ©RSNA, 2022.

Efficacy and safety of prostate artery embolization for patients with lower urinary tract symptoms and indwelling urinary catheter: A retrospective multicenter study.

PURPOSE: The purpose of this multicenter study was to evaluate the clinical success at three months of prostate artery embolization (PAE), assess PAE safety in centers with various experiences and identify factors associated with PAE success. PATIENTS AND METHODS: This multicenter, retrospective study included patients who underwent PAE for lower urinary tract symptoms (LUTS) including those with indwelling urinary catheter. PAE clinical success was defined as either 25% improvement of the International Prostate Symptom Score (IPSS) or 1-point improvement of quality of life (QoL) score, or catheter removal at three months. Multivariable analyses were performed using a logistic regression adjusted on patient variables, technical parameters and center experience in PAE. RESULTS: A total of 383 men (mean age, 68.4 ± 9.7 [standard deviation] years; range: 46-94) with LUTS, including 99 (25.8%) patients with indwelling urinary catheter, were included in seven centers from January 2017 to March 2019. Five patients reported major complications (1.3%), three (0.8%) penile ulceration, three (0.8%) acute urinary retention, one (0.3%) prostatic abscess, and 56 (14.6%) minor complications. Follow up data were available for 271 patients (center 1: n = 159; other centers: n = 112). Clinical success was reported in 232 patients (85.6%). In multivariable analyses, presence of cardiovascular comorbidities (diabetes, stroke history, myocardial infarction and lower limb artery disease) was the single independent variable inversely associated with PAE clinical success (odds ratio = 0.396; 95% confidence interval: 0.17-0.91; P = 0.029). There was no center effect. CONCLUSION: Our results show that PAE is safe and effective in centers with various PAE experiences. Cardiovascular comorbidity is the single independent variable associated with PAE failure.

Angiographic and histopathological study on bronchial-to-pulmonary vascular anastomoses on explants from patients with cystic fibrosis after bronchial artery embolisation.

LABELLED BACKGROUND: Haemoptysis is a life-threatening complication of cystic fibrosis (CF). One treatment is bronchial artery embolisation (BAE) using embolic-microspheres (EMs). During BAE, pulmonary arteries can be seen on digital subtracted angiography while iodine containing contrast material injection is performed in the bronchial artery. This suggests that EMs could go from bronchial to nontarget pulmonary arteries. The aim was to evaluate if EMs could be found inside pulmonary arteries on lung explants after BAE in transplanted CF patients. METHODS: Retrospective observational study including patients with CF who underwent lung transplantation and had previously needed BAE. Clinical, chest CT angiography, and angiographic data were reviewed from medical records. Pathology examination of lung explants was performed to analyze the EMs anatomical localisation. RESULTS: Eight patients were included between 2013 and 2015, four males with a mean age of 29 (19-45) years. All patients had bronchial artery hypertrophy on CT and bronchial-to-pulmonary artery shunting during BAE. On pathology examination, EM ≤800 µm were found in the pulmonary arteries in all patients and were responsible for distal branch occlusions. Two pulmonary infarcts were observed on CT angiography after BAE and confirmed histopathologically. CONCLUSIONS: EM migration from the bronchial to pulmonary arteries is a common occurrence after BAE in patients with advanced stage CF. Although BAE is a highly effective means of controlling haemoptysis in CF, studies on the optimal particle size are needed to preserve pulmonary artery circulation, because these results suggest that low size EMs could lead to nontarget embolisation.

Evaluation of Multiple Embolic Agents for Embolization of the Superior Rectal Artery in an Animal Model.

OBJECTIVE: To prospectively compare the safety of transcatheter embolization of superior rectal arteries in healthy pigs with multiple agents such as coils, spheres and liquids. MATERIALS AND METHODS: Nine adult domestic pigs (three males, mean weight: 60 kg [50-70]) were randomly assigned to the embolization group: copolymer of ethylene vinyl alcohol (EVOH)-Onyx® (group 1, n = 3), microspheres 500 µ (group 2, n = 3), 2-mm micro-coils (group 3, n = 3). After a selective angiogram has been acquired, the embolic agent was infused at the distal part of rectal arteries. An angio-CT was performed before and after each embolization. After one week, angiography was repeated prior to euthanasia. At necropsy, the anorectal juncture was removed for histopathologic examination. RESULTS: At necropsy, 100% of animals embolized with Onyx developed a significant necrosis zone of the distal part of the rectum. Histological examination revealed a mural infarction. For the micro-coil and microsphere groups, gross examination of the intestines did not reveal any evidence of ischaemia. The coils were found in the distal arterial vasculature of the meso-rectum, allowing a downstream revascularization by collaterals. The microspheres and onyx in the rectal wall, more distally. CONCLUSION: Microspheres appear to induce fewer histologic complications than the liquid embolic agent and provide a more distal occlusion than micro-coils. These results suggest that, for superior rectal artery embolization, a super-selective embolization using spheres in human clinical conditions should be more effective and as safe as coil embolization. EVOH might be an unsafe embolization agent for haemorrhoids.

Pediatric brain arteriovenous malformation recurrence: a cohort study, systematic review and meta-analysis.

BACKGROUND: Recurrence following obliteration of brain arteriovenous malformations (AVMs) is common in children surgically treated, but recurrences following endovascular (EVT) and radiosurgical approaches are scantily reported. OBJECTIVE: To analyze the rates and risk factors for AVM recurrence after obliteration in a single-center cohort of children with ruptured AVMs treated with multimodal approaches, and to carry out a comprehensive review and meta-analysis of current data. METHODS: Children with ruptured AVMs between 2000 and 2019 enrolled in a prospective registry were retrospectively screened and included after angiographically determined obliteration to differentiate children with/without recurrence. A complementary systematic review and meta-analysis of studies investigating AVM recurrence in children between 2000 and 2020 was aggregated to explore the overall recurrence rates across treatment modalities by analyzing surgery versus other treatments. RESULTS: Seventy children with obliterated AVMs were included. AVM recurrences (n=10) were more commonly treated with EVT as final treatment (60% in the recurrence vs 13.3% in the no-recurrence group, p=0.018). Infratentorial locations were associated with earlier and more frequent recurrences (adjusted relative risk=4.62, 95% CI 1.08 to 19.04; p=0.04).In the aggregate analysis, the pooled rate of AVM recurrence was 10.9% (95% CI 8.7% to 13.5%). Younger age at presentation was associated with more frequent recurrences (RR per year increase, 0.97, 95% CI 0.93 to 0.99; p=0.046). CONCLUSION: Location of infratentorial AVMs and younger age at presentation may be associated with earlier and more frequent recurrences. The higher rates of recurrence in patients with AVMs obliterated with EVT questions its role in an intent-to-cure approach and reinforces its position as an adjunct to surgery and/or radiosurgery.

Hemorrhoid embolization: A review of current evidences.

Hemorrhoids are local vascular structure dilations in the lower rectum, associated with morbidity and reduced quality of life. Endovascular coil or particle embolization of the superior rectal arteries, known as Emborrhoid technique, is a minimally invasive, image-guided therapy that targets the hemorrhoidal plexus and reduces hemorrhage. The purpose of this review was to analyze the results of published studies to determine the efficacy, clinical outcomes, and morbidities associated with the endovascular occlusion of hemorrhoidal arteries for the treatment of internal hemorrhoids. Current evidences suggest that hemorrhoids treated by Emborrhoid technique using microcoils, embolic particles or a combination is safe with no reported serious complications. Hemorrhoid embolization can preserve the anal tone without direct anorectal trauma and maintain the hemorrhoidal tissue in place requiring minimal local wound care on an outpatient basis. However, due to the paucity of high-quality trials, further research is warranted to evaluate its long-term outcomes, compare its efficacy with other treatment modalities, and fully assess its role in the treatment of hemorrhoid.

Arterial Spin Labeling for the Etiological Workup of Intracerebral Hemorrhage in Children.

BACKGROUND AND PURPOSE: Pediatric nontraumatic intracerebral hemorrhage accounts for half of stroke in children. Early diagnostic of the causative underlying lesion is the first step toward prevention of hemorrhagic recurrence. We aimed to investigate the performance of arterial spin labeling sequence (ASL) in the acute phase etiological workup for the detection of an arteriovenous shunt (AVS: including malformation and fistula), the most frequent cause of pediatric nontraumatic intracerebral hemorrhage. METHODS: Children with a pediatric nontraumatic intracerebral hemorrhage between 2011 and 2019 enrolled in a prospective registry were retrospectively included if they had undergone ASL-magnetic resonance imaging before any etiological treatment. ASL sequences were reviewed using cerebral blood flow maps by 2 raters for the presence of an AVS. The diagnostic performance of ASL was compared with admission computed tomography angiography, other magnetic resonance imaging sequences including contrast-enhanced sequences and subsequent digital subtraction angiography. RESULTS: A total of 121 patients with pediatric nontraumatic intracerebral hemorrhage were included (median age, 9.9 [interquartile range, 5.8-13]; male sex 48.8%) of whom 76 (63%) had a final diagnosis of AVS. Using digital subtraction angiography as an intermediate reference, visual ASL inspection had a sensitivity and a specificity of, respectively, 95.9% (95% CI, 88.5%-99.1%) and 79.0% (95% CI, 54.4%-94.0%). ASL had a sensitivity, specificity, and accuracy of 90.2%, 97.2%, and 92.5%, respectively for the detection of the presence of an AVS, with near perfect interrater agreement (κ=0.963 [95% CI, 0.912-1.0]). The performance of ASL alone was higher than that of other magnetic resonance imaging sequences, individually or combined, and higher than that of computed tomography angiography. CONCLUSIONS: ASL has strong diagnostic performance for the detection of AVS in the initial workup of intracerebral hemorrhage in children. If our findings are confirmed in other settings, ASL may be a helpful diagnostic imaging modality for patients with pediatric nontraumatic intracerebral hemorrhage. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: 3618210420, 2217698.

Percutaneous lung and liver CT-guided ablation on swine model using microwave ablation to determine ablation size for clinical practice.

PURPOSE: Microwave ablation (MWA) provides an effective treatment of lung and liver tumors but suffers from a lack of reproducibility of ablation size among currently available technologies. In-vitro evaluations are far removed from clinical practices because of uninfused tissue. This study is in-vivo preclinical testing of a new MWA system on swine lungs and liver. MATERIALS AND METHODS: All ablations were performed under CT guidance and multiple algorithms were tested with a power of 50, 75, and 100 W for durations of 3, 5, 8, 10, and 15 min. A 3 D-evaluation of the ablation zone was carried out using enhanced-CT. The sphericity index, coefficients of variation, and energy efficiency (which corresponds to the volume yield according to the power supplied) were calculated. RESULTS: Fifty liver and 48 lung ablations were performed in 17 swine. The sphericity index varies from 0.50 to 0.80 for liver ablations and from 0.40 to 0.69 for lung ablations. The coefficient of variation was below 15% for 4/5 and 4/8 protocols for lung and liver ablations, respectively. The energy efficiency seems to decrease with the duration of the ablation from 0.60 × 10-3 cm3/J (75 W, 3 min) to 0.26 × 10-3 cm3/J (100 W, 15 min) in the liver and from 0.57 × 10-3 cm3/J (50 W, 10 min) to 0.42 × 10-3 cm3/J (100 W, 12 min) in the lungs. CONCLUSION: A shorter treatment time provides the best energy efficiency, and the best reproducibility is obtained for a 10 min treatment duration. The system tested provides an interesting reproducibility in both lung and liver measurements. Our results may help interventional radiologists in the optimal selection of treatment parameters.

Advanced image guidance for prostatic artery embolization - a multicenter technical note.

BACKGROUND: Prostatic artery embolization (PAE) is associated with patients' quality of life improvements and limited side effects compared to surgery. However, this procedure remains technically challenging due to complex vasculature, anatomical variations and small arteries, inducing long procedure times and high radiation exposure levels both to patients and medical staff. Moreover, the risk of non-target embolization can lead to relevant complications. In this context, advanced imaging can constitute a solid ally to address these challenges and deliver good clinical outcomes at acceptable radiation levels. MAIN TEXT: This technical note aims to share the consolidated experience of four institutions detailing their optimized workflow using advanced image guidance, discussing variants, and sharing their best practices to reach a consensus standardized imaging workflow for PAE procedure, as well as pre and post-operative imaging. CONCLUSIONS: This technical note puts forth a consensus optimized imaging workflow and best practices, with the hope of helping drive adoption of the procedure, deliver good clinical outcomes, and minimize radiation dose levels and contrast media injections while making PAE procedures shorter and safer.