A Comparative Study of a Small Series of Patients (50 Patients) with Pelvic Varicose Veins Treated with Plugs Alone or Plugs and Polidocanol.

LEVEL OF EVIDENCE: Level 2. PURPOSE: To compare the safety and efficacy of vascular plug (VP) and vascular plug and polidocanol foam (VPPF) treatments for embolization in pelvic congestion syndrome (PCS). MATERIALS AND METHODS: A comparative, prospective, two-center study enrolled 50 women with PCS from January 2019 to January 2020. The patients were divided into two groups, and embolization was performed with VP (n = 25) and VPPF (n = 25) treatments. The mean age of the patients was 45.6 years ± 6.9. Three clinical parameters were assessed: abdominal pain, dyspareunia, and lower limb pain. The primary outcome (clinical success at 1 yr using a VAS), number of devices, procedure and fluoroscopy times, radiation doses, costs, and complications were compared. The participants were followed-up at 1, 3, 6, and 12 months. RESULTS: At the 1-year follow-up, clinical success did not significantly differ between the two groups (VP vs. VPPF) regarding the improvement of the symptoms analyzed (pelvic pain, dyspareunia, lower extremity pain, and other symptoms (p < 0.05)). The mean number of devices per case was 4 ± 1.1 for the VP group and 2 ± 0.31 for the VPPF group (p < 0.001). No major complications were recorded in either group. The VPPF group had a significantly longer fluoroscopy time (42.8 min ± 14.2 vs. 25.4 min ± 7) and longer radiation dose (VPPF air kerma 839.4 ± 513 vs. VP air kerma 658.4 mGy ± 355 (all p < 0.001)). CONCLUSIONS: Embolization for PCS resulted in pain relief in 90% of patients; the use of polidocanol did not demonstrate changes in the clinical outcome. The use of a VP alone was associated with decreased fluoroscopy time and radiation dose.

A New Removable Helical Metallic Stent for the Treatment of Tracheomalacia in Children: Study in Pathological Animal Model.

BACKGROUND: Congenital tracheomalacia is a pathology with no consensus of medical or surgical approach. The permanent nature and the major complications associated with metallic stents have limited their use over the years. The purpose of this study was to evaluate the feasibility of a helical stent design removal. METHODS: Ten dogs diagnosed with tracheal collapse and treated with the helical stent were involved in the study. Animals were classified into three groups depending on stent indwelling time. Prior to the removal, endoscopic evaluation was performed to assess endothelization grade, mucous accumulation, and the presence of stenosis. During the removal, bleeding, fracture, or impossibility of removal were noted. After the removal, all macroscopic mucosal changes were recorded. RESULTS: Technical success was 100%, without any complications. Complete epithelization of the stent was visualized in 7/10 animals. The removal procedure duration ranged from 2-12 min. At post-removal endoscopy, bleeding or epithelial damage, was visualized in any case. Stent fracture during removal occurred in one animal. CONCLUSIONS: The removal of a metallic stent with spiral geometry is feasible, simple, and without complications, regardless of the degree of neo-epithelialization.

Safety and Effectiveness of a New Electrical Detachable Microcoil for Embolization of Hemorrhoidal Disease, November 2020-December 2021: Results of a Prospective Study.

PURPOSE: The purpose of this study was to prospectively evaluate the efficacy and safety of a new, bare platinum, detachable microcoil as a metallic embolization agent in the treatment of hemorrhoidal disease. MATERIAL AND METHODS: This prospective single-center study evaluated a new, bare platinum, electrical, detachable microcoil (Prestige plus coil (Balt Montmorency France)) for use in vascular embolization in patients with hemorrhoidal disease. Between January 2020 and January 2021, 24 embolization procedures were performed in 21 patients (12 males, 9 females; mean age 44.3 ± 7.3). The inclusion criteria were: (a) participants with grade I, II and III hemorrhoidal disease on the Goligher classification; (b) patients older than 18 years of age with a score of greater than 4 on the French bleeding score (FBS) scale; (c) patients with scores greater than 2 on the scale of discomfort proposed by Tradi and Farfallah. (d) patients who underwent treatment that included the use of the new novel coil (Prestige plus coil (Balt)) as an embolic material. The exclusion criteria were participants who failed to provide informed consent and participants diagnosed with rectal bleeding due to other causes (cancer, fissures or others). Participants with severe renal insufficiency, non-correctable coagulation abnormalities and adverse reactions to the contrast medium not correctable with medication were also excluded. The symptoms, technical aspects, the transarterial approach, clinical and technical success complications and short-term outcomes were assessed. RESULTS: Technical success was obtained in 100% of the cases. Seventeen (80.9%) patients experienced improvements in their hemorrhoidal disease. The VAS and QL scores improved by 4 and 1.5 points (81.2% and 87.5%), respectively, after embolization (pV: 0001). Three (14.2%) patients underwent a second embolization due to rebleeding. One patient (4.7%) underwent surgery. No major complications were observed. Three patients had minor complications. The assessment of subjective post-treatment symptoms and QL surveys showed significant differences from the baseline survey. Likewise, the measurement of the degree of satisfaction using a telephone survey at 12 months revealed a high degree of patient satisfaction over 10 points (mean 8.3 ± 1.1). CONCLUSIONS: The present study demonstrates that the use of the new, platinum, detachable, electrical microcoil is safe and well-tolerated in the treatment of hemorrhoidal disease. KEY POINTS: Catheter-directed hemorrhoidal dearterialization (CDHD) is the procedure of embolization with embolic agents for the treatment of internal hemorrhoids. CDHD is a simple and safe procedure that is accepted by patients and preserves the anal sphincter; it presents few complications when metal devices or microspheres are used as embolic agents. As the recommended embolization agent in treatments, the Prestige electrical, detachable coil is a safe, easy-to-use and effective arterial embolic device.

Future scenarios and opportunities for interventional radiology in the post COVID-19 era.

Pandemic outbreak has led health systems worldwide into a rapid reorganization in response to coronavirus infections, forcing interventional radiology units to adapt. Interventional procedures have evolved in number, type and setting and have arguably been optimized as a direct consequence of this pandemic; a result that will undoubtedly lead to radical change within the specialty. This paper explores the future of interventional radiology from various perspectives, and forecasts the new opportunities that will be presented, from the adaptation of the interventional radiology staff and angiography suite, to the immunological environment, and through to digital medical education. We analyze the economic impact and the future relationship we can expect with the rest of the medical industry.

Transjugular intrahepatic portosystemic shunt (TIPS) in Spain. Clinical-epidemiological considerations in relation to a multicenter registry.

OBJECTIVE: this study aimed to determine the epidemiological, technical and clinical data of transjugular intrahepatic portosystemic shunt (TIPS) performed by Interventional Radiology departments in Spain. Furthermore, the total number of TIPS carried out in Spain was determined and compared with other countries. MATERIAL AND METHODS: a retrospective study was performed with the approval of the Ethical Committee of the Spanish Society of Interventional Radiology (SERVEI). A survey was performed with 31 items (demographic, technical and clinical data) for data acquisition on the current status of TIPS in Spain. The survey was sent to the 49 hospitals that SERVEI included in a previous registry with data of TIPS performed in Spain in 2016. RESULTS: of the 49 centers surveyed, 33 (67.35 %) replied to the survey. These centers had completed 265 of the 415 TIPS that year in Spain. The most frequent indication was upper GI bleeding from gastroesophageal varices, which accounted for 144 (54.33 %); 62.26 % of the TIPS were performed urgently and 37.7 % on a scheduled basis. The technical success was 89.16 ± 20.9 %, with a rebleeding rate of 17.9 %. Sixty-nine patients (26.03 %) presented complications, 19.62 % of them minor and 6.41 % major. The 30-day mortality related to the disease was 14.33 %, while mortality at one year was 18.49 %. CONCLUSION: notably in our study, the complications of TIPS did not show a clear relationship with the number of procedures performed. With regard to other countries like the United States and France, the number of TIPS in Spain per million inhabitants is currently substantially lower. There were no significant changes compared to the number completed in 2013.

Multicentre prospective study of drug-eluting bead chemoembolisation safety using tightly calibrated small microspheres in non-resectable hepatocellular carcinoma.

PURPOSE: To assess the safety and tolerability of transarterial drug-eluting bead chemoembolisation (DEB-TACE) using tightly calibrated 100-µm microspheres in hepatocellular carcinoma (HCC). METHOD: This multicentre prospective study included 131 patients with a 2-year follow-up. All patients had Child-Pugh scores ≤ B7, a good performance status, and Barcelona Clinic Liver Cancer stage A or B. Beads were loaded with 50 mg of doxorubicin per millilitre. Overall, 223 nodules were treated (mean size: 27.6 mm, average number of nodules per patient: 1.7). Toxicity was assessed using Common Terminology Criteria for Adverse Events 4.03 and response according to the modified Response Evaluation Criteria in Solid Tumours. The primary endpoint was safety. Secondary endpoints included technical success, post-embolisation syndrome (PES), local tumour response, and 2-year survival. RESULTS: A total of 214 DEB-TACE procedures were performed (mean per patient: 1.64), with a technical success rate of 97.6 % and a PES rate of 9.3 %. Major complications occurred in 6.8 % of patients and 4.1 % of procedures. There were no treatment-related deaths. Doxorubicin dose was an independent predictor of complications (p = 0.01). Four patients were lost to follow-up and 18 received liver transplants. Objective response rates were 74.6 %, 45.7 %, and 44.1 % at 6, 12, and 24 months, respectively. The cumulative 24-month overall survival rate was 55.96 %. Median survival was 22 months (interquartile range = 13-24). Co-morbidities and tumour response were independent predictors of survival (p = 0.0012 and 0.0052, respectively). Complications did not affect survival (p = 0.24). CONCLUSIONS: DEB-TACE with tightly calibrated 100-µm beads is safe and not associated with increases in biliary toxicity or complications. Tumour response and survival are in the expected range for chemoembolisation therapy. (Clinical trials ID: NCT02670122).

New tracheal stainless steel stent pilot study: twelve month follow-up in a rabbit model.

BACKGROUND: Canine tracheal collapse is a complex airway pathology without promising treatment results. Currently nitinol stents are the best surgical option; however, some professionals are doubting if stent placement is the best option due to the associated complications. OBJECTIVE: Determine the technical feasibility, safety, and long-term follow-up after the implantation of a new tracheal stent designed for canine tracheal collapse. METHODS: Thirteen healthy, adult female New Zealander rabbits were involved in this pilot study.A new intra-tracheal device (Reference number 902711 patent registered as CasMin-Twine) was implanted in ten animals. Deployment was performed under general anesthesia, making a puncture incision via a 21 Gauge needle in the intra-tracheal space where the stent was introduced with a screwing process. The device was fixed to the tracheal wall with a non-absorbable suture. Computerized Tomography (CT) and an endoscopy to study structural abnormalities were performed after 30, 90 and 365 days after stent placement. RESULTS: Technical and clinical success was 100%. There was no significant change in behavior or respiratory disorders. CT studies showed no significant alterations. After the 30 days, 60% of the animals showed partial endothelization in the endoscopy study, and only one animal still presented partial endothelization after 12 months. Mucus accumulation was only present in 40% of cases and classified as low, without respiratory consequences. Only one animal presented a single granuloma at caudal stent tip. CONCLUSIONS: This new tracheal stent (CasMin-Twine) is an effective and safe procedure with promising results, and also shows the possibility of removing the device after endothelization has been produced. New studies should be carried out to evaluate the effectiveness in patients with tracheomalacia. CLINICAL SIGNIFICANCE/IMPACT: This new product can give veterinarians a new option of treatment for this complicated pathology. Minimizing specific equipment for its deployment, CasMin-Twine will be more accessible for all professionals.

Catheter-directed aspiration thrombectomy and low-dose thrombolysis for patients with acute unstable pulmonary embolism: Prospective outcomes from a PE registry.

OBJECTIVES: To evaluate the efficacy and safety of aspiration thrombectomy in combination with low-dose catheter-directed thrombolysis for acute unstable pulmonary embolism (PE). BACKGROUND: Acute unstable (PE) is a life-threatening condition requiring treatment escalation, but many patients cannot receive full-dose systemic thrombolysis due to contraindications. METHODS: Eligible patients had a PE with sustained hypotension. We used a 115-cm, 8-F continuous aspiration mechanical thrombectomy catheter to perform mechanical thrombectomy, followed by catheter-directed thrombolysis with low-dose urokinase. The primary efficacy outcome was the change in the pulmonary artery pressure after aspiration thrombectomy and catheter-directed thrombolysis. Secondary efficacy outcomes were stabilization of hemodynamics post-procedure and survival to hospital discharge. The primary safety outcome was major procedure-related complications and major bleeding events. RESULTS: We included 54 patients with acute unstable PE. After thrombectomy, mean systolic pulmonary artery pressure decreased from 60.2 mm Hg to 55.2 mm Hg (P < 0.01), and to 40.5 mm Hg after catheter thrombolysis (P < 0.0001). The in-hospital PE-related death occurred in six patients (11%; 95% confidence interval [CI], 4.2-23%) at a mean follow-up of 1.1 days, and hemodynamics stabilized in the remaining 48 patients. Minor complications after thrombectomy included arrhythmias (4 of 48 patients, 8.3%; 95% CI, 2.3-20%), and minor bleeding episodes (3 of 48 patients; 6.2%; 95% CI, 1.3-17%). Major complication occurred in one patient (2.1%; 95% CI, 0.1-11%) who developed hemorrhagic transformation of paradoxical embolic stroke following catheter-directed thrombolysis. CONCLUSIONS: Aspiration thrombectomy followed by catheter-directed thrombolysis was overall effective and safe in treating patients with acute unstable PE.

Chitosan-based coatings in the prevention of intravascular catheter-associated infections.

Central venous access devices play an important role in patients with prolonged intravenous administration requirements. In the last years, the coating of these devices with bactericidal compounds has emerged as a potential tool to prevent bacterial colonization. Our study describes the modification of 3D-printed reservoirs and silicone-based catheters, mimicking central venous access devices, through different approaches including their coating with the well known biocompatible and bactericidal polymer chitosan, with the anionic polysaccharide alginate; also, plasma treated surfaces were included in the study to promote polymer adhesion. The evaluation of the antimicrobial action of those surface modifications compared to that exerted by a model antibiotic (ciprofloxacin) adsorbed on the surface of the devices was carried out. Surface characterization was developed by different methodologies and the bactericidal effects of the different coatings were assayed in an in vitro model of Staphylococcus aureus infection. Our results showed a significant reduction in the reservoir roughness (≤73%) after coating though no changes were observed for coated catheters which was also confirmed by scanning electron microscopy, pointing to the importance of the surface device topography for the successful attachment of the coating and for the subsequent development of bactericidal effects. Furthermore, the single presence of chitosan on the reservoirs was enough to fully inhibit bacterial growth exerting the same efficiency as that showed by the model antibiotic. Importantly, chitosan coating showed low cytotoxicity against human keratinocytes, human lung adenocarcinoma epithelial cells, and murine colon carcinoma cells displaying viability percentages in the range of the control samples (>95%). Chitosan-based coatings are proposed as an effective and promising solution in the prevention of microbial infections associated to medical devices.

Spanish Society of Vascular and Interventional Radiology (SERVEI) Bibliometric Study (2010-2015): What, How, and Where do Spanish Interventional Radiologists Publish?

PURPOSE: We analyzed the scientific production of members of the Spanish Society of Vascular and Interventional Radiology (SERVEI) from 2010 to 2015. MATERIALS AND METHODS: We retrospectively analyzed the indexed scientific productivity of all SERVEI members for the last 6 years as measured by bibliometric indexes. Different databases were used (e.g., PubMed, Scopus, Web of Knowledge) to retrieve the total number of publications, number of citations, and h-index. Every article was assigned the impact factor of its publication year and its corresponding quartile according to Journal Citation Reports. The relationships between all of these parameters and the Spanish region, the gender and age of the interventional radiologists (IRs), and their connection to the university environment were also studied. RESULTS: A total of 519 scientific articles from 247 SERVEI members working in 118 Spanish hospitals were included, an average of 0.3 articles per interventionist/year. Most of the manuscripts were published in impact journals (52.2%) and placed in the lowest quartile (Q4). Navarre, Aragon, and Catalonia were the regions with the highest publication rate during the period studied (1.7, 0.92, and 0.6 publications per interventionist/year, respectively). Only 57 articles (12.6%) were published in 11 of the 125 journals under the category of Radiology, Nuclear Medicine, and Medical Imaging according to JCR. CONCLUSIONS: The scientific production of the Spanish IRs in the last 6 years is difficult to interpret. However, more than 50% of IRs published one article in the last 6 years. Finally, it would be advisable to repeat this study over a period of time in order to compare.

Stent-induced tracheal stenosis can be predicted by IL-8 expression in rabbits.

BACKGROUND: Bare metal stents may cause complications like fibrous encapsulation, granulation and tracheal stenosis. We investigated the behaviour of three commercially available stents in vivo (rabbits) and in vitro (coculture of those stents with epithelial and fibroblast cell lines). Also, we investigated whether development of tracheal stenosis could be predicted by any biological marker. MATERIALS AND METHODS: The tracheae of 30 rabbits were implanted with either nitinol stents, with or without paclitaxel elution, or a cobalt-based stent. An additional ten rabbits underwent mock implantation (controls). Serial peripheral venous blood samples were taken throughout the study, and several cytokines measured. Animals were euthanized on day 90, with immediate tracheal endoscopy and lavage performed, then necropsy. RESULTS: Rabbits with cobalt-based stent exhibited more inflammation and the highest stenosis incidence, with reduced survival. Both in vivo and in vitro, this stent induced higher IL-8 levels than nitinol stents. Most important, the presence of stent-induced tracheal stenosis was closely associated to increase in IL-8 expression in blood just 1 day after tracheal stent implantation: a 1·19-fold increase vs. baseline had 83% sensitivity, 83% specificity, 77% positive predictive value, 88% negative predictive value and 83% accuracy to predict development of stenosis. CONCLUSIONS: The cobalt-based stent had the highest incidence of tracheal inflammation and stenosis. On the other hand, the paclitaxel-eluting nitinol stent did not prevent those complications and provoked a marked reaction compared with the bare nitinol stent. Early increase in IL-8 expression in blood after stent implantation could predict development of tracheal stenosis in rabbits.

Benign biliary strictures refractory to standard bilioplasty treated using polydoxanone biodegradable biliary stents: retrospective multicentric data analysis on 107 patients.

OBJECTIVES: To assess mid-term outcome of biodegradable biliary stents (BBSs) to treat benign biliary strictures refractory to standard bilioplasty. METHODS: Institutional review board approval was obtained and patient consent was waived. 107 patients (61 males, 46 females, mean age 59 ± 16 years), were treated. Technical success and complications were recorded. Ninety-seven patients (55 males, 42 females, aged 57 ± 17 years) were considered for follow-up analysis (mean follow-up 23 ± 12 months). Fisher's exact test and Mann-Whitney U tests were used and a Kaplan-Meier curve was calculated. RESULTS: The procedure was always feasible. In 2/107 cases (2 %), stent migration occurred (technical success 98 %). 4/107 patients (4 %) experienced mild haemobilia. No major complications occurred. In 19/97 patients (18 %), stricture recurrence occurred. In this group, higher rate of subsequent cholangitis (84.2 % vs. 12.8 %, p = 0.001) and biliary stones (26.3 % vs. 2.5 %, p = 0.003) was noted. Estimated mean time to stricture recurrence was 38 months (95 % C.I 34-42 months). Estimated stricture recurrence rate at 1, 2, and 3 years was respectively 7.2 %, 26.4 %, and 29.4 %. CONCLUSION: Percutaneous placement of a BBS is a feasible and safe strategy to treat benign biliary strictures refractory to standard bilioplasty, with promising results in the mid-term period. KEY POINTS: • Percutaneous placement of a BBS is 100 % feasible. • The procedure appears free from major complications, with few minor complications. • BBSs offer promising results in the mid-term period. • With a BBS, external catheter/drainage can be removed early. • BBSs represent a new option in treating benign biliary stenosis.

Tracheal Self-Expandable Metallic Stents: A Comparative Study of Three Different Stents in a Rabbit Model.

INTRODUCTION: The objective of this study was to assess tracheal reactivity after the deployment of different self-expandable metal stents (SEMS). MATERIAL AND METHODS: Forty female New Zealand rabbits were divided into four groups. Three groups received three different SEMS: steel (ST), nitinol (NiTi), or nitinol drug-eluting stent (DES); the fourth group was the control group (no stent). Stents were deployed percutaneously under fluoroscopic guidance. Animals were assessed by multi-slice, computed tomography (CT) scans, and tracheas were collected for anatomical pathology (AP) study. Data from CT and AP were statistically analyzed and correlated. RESULTS: The DES group had the longest stenosis (20.51±14.08mm vs. 5.84±12.43 and 6.57±6.54mm in NiTi and ST, respectively, day 30; P<.05), and higher granuloma formation on CT (50% of cases). The NiTi group showed the lowest grade of stenosis (2.86±6.91% vs. 11.28±13.98 and 15.54±25.95% in DES and ST, respectively; P<.05). The AP study revealed that the ST group developed intense proliferative reactivity compared to the other groups. In the DES group, a destructive response was observed in 70% of the animals, while the NiTi was the least reactive stent. CT was more effective in detecting wall thickening (positive correlation of 68.9%; P<.001) than granuloma (not significant). CONCLUSIONS: The ST group developed granulomas and significant stenosis. NiTi was the least reactive stent, while DES caused significant lesions that may be related to drug dosage. This type of DES stent is therefore not recommended for the treatment of tracheobronchial stenosis.

TIPS treatment in a patient with severe lower gastrointestinal bleeding with a misdiagnosis of cirrhotic portal hypertension.

Abernethy malformation is a rare abnormal embryological development of splanchnic venous system characterised by the presence of a congenital extrahepatic portosystemic shunt. We present a rare case of an adult male patient that was admitted with severe lower gastrointestinal bleeding, requiring multiple blood transfusions. The patient's medical history and the laboratory tests performed led to the misdiagnosis of a congenital Abernethy malformation. We present a rare case, discussing the reasons for the misdiagnosis and we conclude that management of clinical data and imaging are highly important to discard these types of congenital malformations that can mimic a portal hypertension condition.