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.

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.

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.

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.

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.

Rescue Radioguided Laparoscopy Surgery for Meckel's Diverticulum: Technical Notes.

The extirpation of Meckel's diverticulum (MD) via conventional or laparoscopic surgery is the definitive treatment. However, certain circumstances may modify or alter this situation and require the application of exceptional measures.We report a case under our observation who previously had an exploratory abdominal laparotomy for a suspected MD; however, the findings were negative. At that time, the diagnosis was established based on low-level gastrointestinal bleeding and isotopic tests that confirmed the existence of the diverticulum. Given the findings of gamma-graphic exploration and the previous negative surgical exploration, a decision was made to remove the lesion by laparoscopic radioguided surgery.The patient underwent bilateral laparoscopic radioguided surgery using a gamma radiation detection probe. The exploration of the abdominal cavity noted the existence of the diverticulum about 60 to 70  cm from the ileocecal valve. In this way, it was possible to proceed with the resection of the bowel loop and perform an intracorporeal anastomosis termino lateral. The postoperative course was uneventful, and the patient was discharged on the fifth postoperative day.We believe that the combination of radioguided surgery and single photon emission computed tomography/computed tomography could be useful for treating lesions in locations that are surgically difficult because of the characteristics of the lesion itself or the peculiarities of an individual patient.

Radiodermitis after prostatic artery embolization: case report and review of the literature.

Prostate artery embolization (PAE) is a technically demanding new treatment option for benign prostatic hyperplasia. We present a case of radiation-induced dermitis in a 63-year-old patient after a technically successful PAE, due to high radiation exposure (KAP: 8,023,949 mGy cm(2)) and long fluoroscopy time (72 min). Anatomical and technical aspects are discussed, as well as recommendations to decrease radiation exposure in these procedures.

Metallic stents for tracheobronchial pathology treatment.

PURPOSE: To present the 7-year experience of the treatment of benign and malignant tracheobronchial stenoses using metallic stents. PATIENTS AND METHODS: One hundred twenty-three stents were inserted in 86 patients (74 benign and 12 malignant stenoses). Ninety-seven stents were placed in the trachea and 26 in the bronchi. The procedures were performed under fluoroscopic and flexible bronchoscopic guidance with the patient under light sedation. In cases of severe stenotic lesions or obstructions, laser resection was performed before stent placement. Clinical and functional pulmonary data were recorded before and 3 months after the procedure. Follow-up involved clinical data and radiographic techniques at 48 h and at 1-, 3-, 6-, and 12-month intervals. RESULTS: The technical success was 100 %. Dyspnea disappearance, forced expiratory volume in the first second, and pulmonary functional data improvement was observed in all patients (p < 0.001). Complications were detected in 23 patients (26.7 %). Mean follow-up time was 6.3 ± 1.2 months in patients with malignant lesions and 76.2 ± 2.3 months patients with in benign lesions. By the end of the study, 100 % of patients with malignant pathology and 6.7 % of patients with benign lesions had died. CONCLUSION: Endoluminal treatment of tracheobronchial stenosis with metallic stents is a therapeutic alternative in patients who are poor candidates for surgery. In unresectable malignant lesions, the benefit of metallic stenting is unquestionable. In benign lesions, the results are satisfactory, but sometimes other interventions are required to treat complications. New stent technology may improve these results.

Posterior circulation stroke after bronchial artery embolization. A rare but serious complication.

Bronchial artery embolization (BAE) is the treatment of choice for massive hemoptysis with rare complications that generally are mild and transient. There are few references in the medical literature with acute cerebral embolization as a complication of BAE. We report a case of intracranial posterior territory infarctions as a complication BAE in a patient with hemoptysis due to bronchiectasis.

Laparoscopic demonstration of vena cava wall penetration by inferior vena cava filters in an ovine model.

PURPOSE: To verify the penetration of struts and hooks of two inferior vena cava (IVC) filters (Günther tulip retrievable filter [GTF] and Celect filter) through the vena cava wall and to assess local or systemic complications resulting from this penetration. MATERIALS AND METHODS: Eight IVC filters were placed in the IVC of four ewes for 30 days (1 GTF and 1 Celect filter in each ewe). Angiographic and laparoscopic examinations of the animals were performed to demonstrate the penetration through the vena cava wall, and the filters were removed under laparoscopic control. Specimens were extracted for anatomicopathological and histologic examination. RESULTS: Two-projection cavography showed a filter leg seemingly out of the vena cava in 19 of 32 legs (59.3%). Laparoscopy showed 7 real penetrating legs (5 Celect filters and 2 GTFs) out of the 14 legs that could be identified by laparoscopy owing to technique limitations. Neither laparoscopy nor necropsy showed any sign of wall hemorrhage or other injuries. Histologic examination showed intimal remodeling and slight thickening of adventitial tissue around filter legs. CONCLUSIONS: GTFs and Celect filters can produce a real penetration 1 month after implantation. This penetration did not lead to any complications in the IVC or surrounding tissues and did not compromise the subject's health in any of the studied cases.

Endovascular treatment of a haemodynamically unstable massive pulmonary embolism using fibrinolysis and fragmentation. Experience with 111 patients in a single centre. Why don't we follow ACCP recommendations?

INTRODUCTION: Fibrinolysis is recommended in several consensus documents for the treatment of a haemodynamically unstable massive pulmonary embolism (HUMPE). MATERIAL AND METHODS: A total of 111 patients were treated in a single centre from January 2001 to December 2009. They were 55 males and 56 females diagnosed with HUMPE (systolic arterial pressure>90 mmHg) with at least two of the following criteria: Miller index>0, ventricular dysfunction, and need of vasoactive drugs. Local fibrinolysis with urokinase was performed in all cases, and fragmentation with a pig-tail catheter in the majority of them. An inferior vena cava (IVC) filter was implanted in 94 patients as a prophylactic measure. RESULTS: Technical success was 100%. The Miller index improved from 0.7 ± 0.12, pre-treatment, to 0.09 ± 0.16. The mean pulmonary arterial pressure fell from 39.93 ± 7.0 mmHg to 20.47 ± 3.3 mmHg in the 30-90 days review. Of the 94 patients with IVC filters implanted, 79% were withdrawn satisfactorily. Seven patients died: 3 due to their neoplasia, 3 due to right cardiac failure at 1, 7 and 30 days, and another died of a brain haemorrhage in the first 24 hours. There were complications in 12.6% of the cases, of which 4.5% were major. CONCLUSION: Local fibrinolysis with fragmentation achieves a rapid return to normal of the pulmonary pressure and is a safe and effective method for the treatment of HUMPE.

Fluoroscopic management of complications after colorectal stent placement.

Colorectal self-expanding metal stents have been widely used as a bridge to surgery in patients with acute malignant colonic obstruction by allowing a single-stage operation, or as a definitive palliative procedure in patients with inoperable tumors. Colonic stents are placed under either fluoroscopic or combined endoscopic and fluoroscopic guidance, with similar technical-success and complication rates. Placement of colonic stents is a very safe procedure with a low procedure-related mortality rate, but serious complications can develop and reinterventions are not uncommon. Most of the complications can be treated by minimally invasive or conservative techniques, while surgical interventions are required for most patients with perforation.

[Image-guided minimally invasive treatment of pulmonary arterial hypertension due to embolic disease]. / Tratamiento de la hipertensión arterial pulmonar postembólica mediante técnicas mínimamente invasivas guiadas por imagen.

OBJECTIVE: Although surgical pulmonary thromboendarterectomy is the treatment of choice for pulmonary hypertension due to chronic thrombotic and/or embolic disease, minimally invasive endovascular techniques such as angioplasty or placement of a metallic stent can provide acceptable results when surgery is not indicated or has been refused by the patient. PATIENTS AND METHODS: Eight patients (5 men, 3 women; mean age, 62.6 years) were treated. The patients were in New York Heart Association (NYHA) class III or IV and had a mean pulmonary artery pressure of 40 mm Hg and more, a capillary wedge pressure of 15 mm Hg or less, or a Miller index greater than 0.5. In all cases, diagnosis was based on Doppler echocardiography, pulmonary angiography, hemodynamic evaluation, and ventilation-perfusion scintigraphy. All patients received fibrinolytic therapy and underwent angioplasty. A metallic stent was implanted in 3 patients. Follow-up echocardiographic assessment and ventilation-perfusion scans were scheduled at 1, 3, 6, and 12 months. RESULTS: The procedures were technically successful in all cases. The mean follow-up period was 18.7 months. Minor complications were extrasystoles (3 cases), slight bruising at the site of puncture (1 case), and rectal bleeding that resolved without treatment (1 case). One patient died from an unknown cause 24 hours after the procedure. In all other cases, improvements were noted in NYHA functional class, in hemodynamics demonstrated by echocardiography, and in vascular structure as shown by arteriography and scintigraphy. CONCLUSIONS: Minimally invasive endovascular interventions can help improve pulmonary arterial hypertension due to chronic thrombotic and/or embolic disease in patients for whom medical or surgical treatment is not possible.

[Abdominal abscess drainage. Advantages of fibrinolytic agents]. / Drenaje de colecciones abscesificadas abdominales. Ventajas del uso de fibrinolíticos.

Image-guided percutaneous abscess drainage has become the standard method of treatment for most abdominal abscesses. In many cases, it should be considered the treatment of choice, but there are certain circumstances that require specific approaches and methods. Typical abscesses within solid parenchymal organs or those in the peritoneal spaces can be reliably detected by imaging techniques and efficiently drained. Abscesses that are multiple or long and circuitous require careful placement of one or more catheters. Management of the drainage catheters includes irrigation with saline solution to prevent obstruction. Despite the use of saline irrigations and large caliber catheters, catheter drainage sometimes fails and conventional surgery is required. In selected cases, fibrinolytic agents have been proved to be effective in shortening drainage times and length of hospital stay. The use of fibrinolytic agents in the drainage of some anatomical sites, such as the spleen and pancreas, is controversial and the technique should be meticulously selected. Successful treatment is most likely when an interdisciplinary approach is used. The present article reviews the state of the art of the use of fibrinolytic agents to improve percutaneous abdominal abscess drainage.

Retrievability of uncoated versus paclitaxel-coated Günther-Tulip IVC filters in an animal model.

PURPOSE: To compare in a pilot study, the retrievability and inferior vena cava (IVC) wall reaction elicited by uncoated and paclitaxel-coated Günther-Tulip filters in the animal model. MATERIALS AND METHODS: Three groups with five pigs each underwent infrarenal IVC implantation of Günther-Tulip filters. Paclitaxel-coated filters were used in Groups A and B and uncoated filters were used in Group C. Filters were removed at 14, 19, 22, 26, and 30 days after implantation. A laparotomy was performed to remove filters from animals in group A and filters from animals in groups B and C that could not be retrieved via the right transjugular approach. Filter-induced venous wall changes were evaluated by examination of IVC venography, feasibility of filter removal at different implantation times, and laparotomy and microscopic findings. Feasibility of filter retrieval and venous wall changes were correlated. RESULTS: IVC cavography showed no abnormality. Filters in animals in group B were uneventfully removed by a right jugular approach. Uncoated filter removal was not feasible in three of five animals in group C (19, 22, and 26 days). Microscopically, animals in group A had absent filter-induced IVC wall changes at 14, 19, 22, and 26 days and minimal changes at 30 days post implantation; animals in group B had absent filter-induced IVC wall changes at 14, 19, and 22 days and minimal changes at 26 and 30 days; animals in group C had moderate filter-induced IVC wall changes at 14 days and severe changes at 19, 22, 26, and 30 days. CONCLUSIONS: This pilot study suggests that endothelial reaction to the presence of IVC filters in the porcine model is diminished by addition of paclitaxel coating to these filters. Further studies are necessary to substantiate these results.

Colon stenting: a review.

Up to 85% of patients who present with colonic obstruction have a colorectal cancer. Between 7% and 29% of these patients present with total or partial intestinal obstruction. Only 20% of these patients presenting with acute colonic obstruction due to malignancy survive 5 years. Emergent surgical intervention in patients with colonic obstruction is associated with significant morbidity and mortality rates. Only 40% of patients with obstructive carcinoma of the left colon can be treated with surgical resection without the need for a colostomy. The use of a temporary or permanent colostomy has a significant impact on quality of life. The decompressive effect seen with colonic stenting is a durable, simple, and effective palliative treatment of patients with advanced disease. Stent deployment provides an effective solution to acute colonic obstruction and allows surgical treatment of the patient in an elective and more favorable condition. In addition, colonic stenting reduces costs and avoids the need for a colostomy.