Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review.

OBJECTIVES: To evaluate uterine tamponade devices' effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols. SEARCH STRATEGY: PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021. STUDY SELECTION: Randomised and non-randomised comparative studies. OUTCOMES: Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy. RESULTS: All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76-7.14) and hysterectomy (RR 4.14, 95% CI 0.48-35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07-15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11-1.03) and hysterectomy (RR 0.49, 95% CI 0.04-5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32-2.81) and hysterectomy (RR 1.84, 95% CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon. CONCLUSIONS: The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting. TWEETABLE ABSTRACT: Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery.

A retrospective cohort study comparing a novel, spherical, resorbable particle against five established embolic agents for uterine fibroid embolisation.

AIM: To evaluate the effectiveness of a novel, resorbable, spherical embolic agent compared with other established agents, by studying percentage fibroid infarction (the best indicator of long-term symptom improvement) in patients undergoing uterine fibroid embolisation (UFE). MATERIALS AND METHODS: This retrospective cohort study examined six different embolic agents used for fibroid embolisation, including a new gelatin-based, fully resorbable, spherical agent. The primary effectiveness outcomes were magnetic resonance imaging (MRI)-determined dominant fibroid infarct percentage (DF%) and all fibroid percentage infarct (AF%) at 3 months post-embolisation. MRI-determined uterine artery patency rate was the secondary outcome. Chi-squared test (χ2), relative risk (RR) calculation (primary outcomes), and analysis of variance (ANOVA) (secondary outcome) were the statistical tests employed. RESULTS: One hundred and twenty patients were treated with six embolic agents (20 consecutive patients per group, overall mean age 44.8±6.4, initial uterine volume 570±472 ml, dominant fibroid volume 249±324 ml). Fibroid infarctrates were similar between the cohorts with no significant difference between the new gelatin-based resorbable particle and other embolics in either DF% (χ2=3.92, p=0.56) or AF% (χ2=2.83, p=0.73). Complete DF% RR=1.07 (0.90-1.27) and AF% RR=1.09 (0.85-1.41) suggest non-inferiority of the resorbable particle (d=0.67, p<0.05). A favourable uterine artery patency rate was demonstrated for the resorbable particle compared with gelatin slurry (82.5% versus 27.5%, p<0.001 after Bonferroni adjustment). CONCLUSIONS: This new gelatin-based, fully resorbable particle is an effective embolic agent for fibroid embolisation and achieves an infarct rate non-inferior to established embolics.

Combination of medical and surgical management in successful treatment of caesarean scar pregnancy: a case report series.

BACKGROUND: There is no clear consensus on the management of caesarean scar pregnancy (CSP), a complex and life-threatening condition. The objective of this study was to present a novel approach to management of CSP that combines medical therapy of multidose methotrexate and mifepristone with active surgical management by uterine curettage and consecutive local haemostasis. CASE PRESENTATION: We report on a prospective case series of six women with first trimester pregnancy, in whom the diagnosis of CSP was confirmed by 2D and color Doppler transvaginal ultrasound and serial hormone chorionic gonadotropin (hCG) testing. Women were between 23 and 36 years old and had at least one previous delivery by caesarean. At admission, gestational age ranged between 6 to 14 weeks, and serum hCG levels between 397 and 23,000 mUI/ml. Upon decision of pregnancy termination, medical management was undertaken in all cases and 1 mg/kg systemic Methotrexate was administered between 1 and 5 daily doses. Mifepristone was part of the treatment in cases with live pregnancy. Surgical management was employed for the cases were an embryo was seen by ultrasound, being prompted by inadequate response to Methotrexate and/or signs of miscarriage with vaginal bleeding. Curettage combined with local isthmic balloon or vaginal pack tamponade prevented further complications. High treatment rates with preservation of fertility was achieved in all patients except one who underwent hysterectomy for invasive placentation. Ultrasound and hCG levels surveillance ensured that the resolution of pregnancy was achieved. CONCLUSION: Women with history of delivery by caesarean section should be carefully monitored in future pregnancies for prompt diagnosis of CSP. Early diagnosis of CSP allows selection of successful conservative therapy. Through this case series we contribute with our experience to the body of knowledge about the management of this serious complication of early pregnancy.

Temporary Ligation of the Uterine Artery at Its Origin Using a Removable "Shoelace" Knot.

STUDY OBJECTIVE: To demonstrate a technique of temporary ligation of the uterine artery at its origin. DESIGN: A step-by-step demonstration of the surgery in an instructional video. SETTING: A private hospital in Mumbai, India. INTERVENTION: The peritoneum over the pelvic side wall was dissected bilaterally to expose the uterine arteries at their origins. Using a polyglactin absorbable suture, a double thread loop was used to create a removable "shoelace" knot (Video 1). Both uterine arteries were ligated in this manner. The myomectomy was completed uneventfully, and the myoma bed was sutured in 2 layers using polyglactin sutures. Once suturing was completed, the shoelace knot was untied by simply pulling one end of the thread to restore blood supply to the uterus. Intraoperative blood loss was 30 mL, and the total operation time was 120 minutes. CONCLUSION: Laparoscopic ligation of the uterine arteries at their origin is known to reduce intraoperative blood loss [1,2]. However, in patients desiring future fertility, the effect of permanent ligation of these vessels bilaterally remains under study [3-5]. The removable "shoelace" knot is a low-cost, readily available alternative to metallic titanium clips that requires no special surgical expertise to implement.

Robot-assisted uterine artery embolization: a first-in-woman safety evaluation of the Magellan System.

PURPOSE: To provide a technical description of robot-assisted uterine artery embolization and to investigate the safety and feasibility of the Magellan (Hansen Medical, Mountain View, California, USA) robotic catheter in this complex arterial bed. MATERIALS AND METHODS: Five women (mean age, 48.8 y) underwent robot-assisted bilateral uterine artery embolization over a 10-month period using the Magellan robotic catheter. Demographic, clinicopathologic, and endovascular performance metric data (fluoroscopy and cannulation times) were recorded as well as short-term outcomes. RESULTS: Robotic cannulation of bilateral internal iliac and uterine arteries was successful in all cases. Median right and left internal iliac artery cannulation and total fluoroscopy times were 3 minutes (interquartile range [IQR], 1.5-4 min), 2 minutes (IQR, 1.5-4 min), and 11 minutes (IQR, 9.5-14 min). Median right and left uterine artery cannulation times were both 11 minutes (IQR, 6.5-15 min and 8-12 min, respectively). Technical success was 100%. All patients were discharged on postoperative day 1, and there were no major or access site complications. At 6 months after the procedure, all patients reported significant improvement of symptoms, with a median increase in health-related quality-of-life score of 58% (48.5%-61.75%). CONCLUSIONS: The use of the new-generation Magellan system in uterine artery embolization is feasible and appears to be safe. The additional navigational capability and added maneuverability of the NorthStar catheter (Hansen Medical, Mountain View, California) may facilitate selective catheterization of small iliac artery divisions and may be useful in any procedure where complex arterial selection is needed.

Live MR angiographic roadmapping for uterine artery embolization: a feasibility study.

PURPOSE: To assess the feasibility of live magnetic resonance (MR) angiography roadmapping guidance for uterine artery (UA) embolization (UAE) for fibroid tumors. MATERIALS AND METHODS: Twenty patients underwent UAE with live MR angiographic roadmapping. The pre-acquired MR angiography scan was coregistered with the live intraprocedural fluoroscopy stream to create a visual roadmap to direct the microcatheter during UAE. Patient radiation dose, as measured by dose-area product (DAP), procedure time, contrast medium volume, and fluoroscopy time, was recorded. For the first 10 patients, an additional parameter of contrast medium volume needed to catheterize each UA was recorded. RESULTS: In all 20 patients (40 UAs), the MR angiography overlay on live fluoroscopy was accurate and allowed for successful catheterization of the UA, resulting in a technical success rate of 100%. In the subset of the initial 20 UAs (ie, the first 10 patients) in which this data point was recorded, 17 (85%) were successfully catheterized with no iodinated contrast medium at all, by purely relying on the MR angiography roadmap. Mean procedure time was 45 minutes (range, 30-99 min), mean contrast agent dose was 75 mL (range, 46-199 mL), and mean DAP was 155 Gy · cm(2) (range, 37-501 Gy · cm(2)). CONCLUSIONS: Live MR angiographic roadmapping is feasible and accurate for catheter guidance during UAE.

Virtual reality simulation training in a high-fidelity procedure suite: operator appraisal.

PURPOSE: To assess the face and content validity of a novel, full physics, full procedural, virtual reality simulation housed in a hybrid procedure suite. METHODS AND MATERIALS: After completing 60 minutes of hands-on training in uterine artery embolization and coronary angioplasty, 24 radiologists and 18 cardiologists with mean 10 years of endovascular experience assessed the functionality of a comprehensive hybrid procedure suite simulation (Orcamp; Orzone, Gothenburg, Sweden). RESULTS: C-arm and operating table functionality and realism were reliably (α = 0.0.89-0.92) rated highly (80/100). Performance realism of the catheter, guide wire, fluoroscopy image, electrocardiogram, and vital signs readout also reliably and statistically significantly predicted subjects' overall positive assessment (mean = 87/100) of the simulation experience in a multiple regression model (α = .83; r = 0.85 and r(2) = 0.67; P < .0001). CONCLUSIONS: This study reports a quantitative evaluation of a comprehensive simulation of an authentic procedure suite for image-guided intravascular procedures. This new facility affords the opportunity for trainers to provide higher fidelity training of operative technical, procedural, and management skills in the realistic context of a complete procedure suite with all its complexities and potential distractions.

Salvage utilization of selective and super selective embolization in emergency by use of a-magnetic coil and nano-particles in gynecology.

INTRODUCTION: Pelvic arteries embolization (PAE) can be described as an obstetric procedure effective in emergencies, to use especially in managing uncontrollable acute uterine hemorrhage, if resistant to medical therapy. This procedure leads to immediate control of hemorrhages and restores cardiovascular status, especially in critical patients. PAE can be used as an alternative to removing organs. PURPOSE OF STUDY: To utilize the PAE in local anesthesia for management of acute uterine hemorrhage for cervical myoma in a critical patients, a fertile woman with concomitant cardiovascular stroke and in high-dosage of antithrombosis therapy, with severe anemia. MATERIAL ANDS METHODS: This procedure was used in an University affiliated Hospital, by a selective catheterization of the left hypogastric artery with an a-magnetic coil and super-selective catheterization of the right uterine artery, instilling a mixture of micro-particles and an absorbable haemostatic gelatin. RESULTS: Authors have successfully completed this procedure in 40 minutes in local anaesthesia, showed by stopping of iodated contrast fluid in vascular myoma network, with subsequent cervical myomectomy, whilst preserving uterus. CONCLUSION: PAE allows, through super-selective catheterization of both uterine arteries or selective catheterization of hypogastric arteries, to instill a mixture of micro-particles, absorbable haemostatic gelatins or endovascular coils, mixed with iodated contrast fluid and, thereby, to stop bleeding. This procedure leaded to an immediate control of hemorrhages and restores cardiovascular status, as an alternative to removing organs.

The Lublin Protocol of the Uterine Arteries Embolization in the Treatment of Symptomatic Uterine Fibroids.

Uterine fibroids are benign tumors originating from smooth muscle tissue, constituting uterine muscle stroma. Uterine fibroids are the most common benign tumors found in women. In 20%-50% of women, fibroids are asymptomatic and do not require any treatment. The main symptoms of uterine fibroids are profuse menstrual bleeding, abnormal uterine bleeding, and pressure symptoms. Pressure symptoms can cause pelvic pain syndrome, urination disorders, and constipation. The treatment methods that are currently used include surgical treatment, pharmacological therapy, and minimally invasive procedures. The most commonly applied minimally invasive method is the embolization of uterine arteries. This procedure is currently a widely accepted method of treatment for symptomatic uterine fibroids and has been recognized as such by the National Institute for Health and Clinical Excellence in the guidelines for heavy menstrual bleeding. This is a complicated procedure and requires close cooperation between gynecologists and interventional radiologists. We present a protocol applicable to uterine artery embolization in the treatment of symptomatic uterine fibroids. The protocol is divided into five section. The first two section are intended for gynecologists and interventional radiologists, explaining how to qualify and prepare a patient for embolization in a step-by-step manner. Section three, which is directed at interventional radiologists, explains how embolization should be done. Section four is directed at gynecologists or hospital ward doctors who look after the patients after embolization. This section of the protocol offers a method for treating post-embolization pain using the Patient Controlled Analgesia (PCA) pump. Section five completes the procedure with an assessment of the effects and late complications of uterine artery embolization. All five section create a uniform protocol directed at clinicians, experts, and researchers new to the field.

Comparison of four embolic materials at uterine artery embolization by using postprocedural MR imaging enhancement.

PURPOSE: To test the hypothesis that not all embolic materials are equivalent by using postprocedural magnetic resonance (MR) imaging enhancement of uterine fibroids in patients treated with uterine artery embolization (UAE). MATERIALS AND METHODS: Approval and a waiver of consent from the institutional human investigations committee was received for this study. The study was HIPAA compliant. A total of 84 women who underwent 6-month MR imaging follow-up constituted this retrospective study. Within this group, 25 women were treated with Contour polyvinyl alcohol (PVA) particles, 23 were treated with Contour SE particles, 19 were treated with Embosphere microspheres, and 17 were treated with Bead Block microspheres. Pre- and postprocedural MR imaging results were analyzed for the total number of fibroids present in the uterus of each patient and for the percentage of individual fibroid enhancement. Enhancement of individual fibroids was measured with quartile intervals. Greater than 25% residual enhancement of a fibroid after embolization was considered an incomplete infarction. The overall percentage change in enhancement was calculated for each patient. Bivariate analysis by using generalized linear modeling and one-way analysis of variance was used to assess differences in infarction with different embolic materials. RESULTS: Among patients treated with Contour and Embosphere, there was a mean reduction in enhancement by 76.60% and 83.07%, respectively, compared with a mean reduction of 52.53% and 49.78% in patients treated with Bead Block and Contour SE, respectively. There was a significant difference in postembolization enhancement between Bead Block and Embosphere, Bead Block and Contour, Contour SE and Embosphere, and Contour SE and Contour. CONCLUSION: Patients treated with Bead Block or Contour SE demonstrated a reduced degree of infarction at follow-up MR imaging compared with patients treated with Contour or Embosphere.

The Gandras catheter for uterine artery embolization: the procedure-driven development of a novel medical device.

Uterine artery embolization (UAE) is a safe and effective therapy for women suffering from symptomatic fibroid tumors of the uterus. In order to complete the procedure, the interventionalist must be able to catheterize both uterine arteries from a single femoral puncture site. The uterine arteries are subsequently embolized, or occluded, to stasis by injecting small particles mixed with radio opaque contrast under fluoroscopic guidance. Historically, it has been necessary to use several different catheters of varying shapes, lengths and materials to accomplish the catheterization of both uterine arteries when performing UAE. Every catheter exchange increases the length and difficulty of the procedure. The risk and radiation dose of any interventional radiological procedure is directly proportional to its overall duration. Thus if a single catheter could achieve the objective of catheterizing the bilateral uterine arteries for UAE throughout the procedure, its use would decrease the length of the procedure and consequently decrease the overall risk to the patient, thus representing an improvement over the technology currently available. The purpose of this paper is to outline the anatomical and technical considerations that governed the development of an ideal catheter to perform UAE, the Gandras catheter.

The Relationship Between Gelatin Sponge Preparation Methods and the Incidence of Intrauterine Synechia Following Uterine Artery Embolization for Postpartum Hemorrhage.

PURPOSE: To evaluate the relationship between gelatin sponge preparation methods and the incidence of intrauterine synechia following uterine artery embolization (UAE) for postpartum hemorrhage (PPH). MATERIALS AND METHODS: In a retrospective monocentric study, we used data from 20 consecutive UAE procedures (19 patients) for PPH, performed in 2007-2016, in which gelatin sponge had been used. The gelatin sponge was processed either into a slurry by pumping it back and forth about 10 times through two syringes connected to a three-way stopcock or into pledgets using a scalpel and small scissors to obtain pieces approximately 2 × 2 × 2 mm in size. Patient information was obtained from medical records, and the data were compared between patients treated with the slurry (n = 7) or pledgets (n = 13) forms. Due to the lack of follow-up data and hysterectomy after UAE, the sample size was 6 and 12 because 1 patient with 2 procedures was excluded. RESULTS: The rate of intrauterine synechia was significantly higher in the slurry group (5/6, 83.3%) than that in the pledgets group (0/12, 0%; P < 0.001). In contrast, there were no significant differences in population characteristics, such as the incidence of placenta accreta, non-placental diseases, and severity of shock (DIC score, shock index, or blood loss) between the groups. CONCLUSIONS: Although non-randomization and small sample size were the two main limitations, our observations suggest that UAE using gelatin sponge slurry may be associated with a high incidence of intrauterine synechia compared to UAE using pledgets.

Malformação arteriovenosa uterina: um relato de caso / Uterine arteriovenous malformation: a case report

O presente estudo tem como objetivo relatar o caso de uma paciente com malformação arteriovenosa uterina, efetivamente tratada com embolização seletiva e com fertilidade preservada. A malformação arteriovenosa uterina é uma alteração vascular rara até então pouco descrita na literatura. A paciente do sexo feminino apresentou quadro de sangramento uterino anormal, com início 30 dias após um abortamento, sem realização de curetagem, de uma gestação resultante de fertilização in vitro. Foram, então, realizados exames de imagem, que levaram ao diagnóstico de malformação arteriovenosa uterina. O tratamento de escolha foi a embolização arterial seletiva, com resolução do caso. Após sete meses, nova fertilização in vitro foi realizada, encontrando-se na 36a semana de gestação. São necessários mais estudos sobre essa malformação a fim de que sejam estabelecidos os métodos mais eficazes para o manejo de casos futuros, especialmente quando há desejo de gestar.

The present study aims to report the case of a patient with uterine arteriovenous malformation, effectively treated with selective embolization and with preserved fertility. Uterine arteriovenous malformation is a rare vascular disorder that has so far been rarely described in the literature. Female patient presented with abnormal uterine bleeding, starting 30 days after an abortion without subsequent curettage, of a pregnancy resulting from in vitro fertilization. Imaging tests were then performed that led to the diagnosis of uterine arteriovenous malformation. The treatment of choice was selective arterial embolization, with successful results. After seven months, a new in vitro fertilization was performed, being in the 36th week of pregnancy. Further studies on this pathology are needed in order to establish the most effective methods for the management of future cases, especially when there is a desire to become pregnant.

Radiation Exposure During Uterine Fibroid Embolization (UFE): A Confounder-Controlled Comparison Between a State-of-the-Art Angiography Unit and a Conventional Angiography unit.

PURPOSE: To compare radiation exposure of a state-of-the-art and a conventional angiography unit in patients undergoing uterine fibroid embolization (UFE). MATERIALS AND METHODS: Between January 2009 and December 2016, 286 patients underwent UFE in our Interdisciplinary Fibroid Center. The inclusion criteria for this retrospective analysis were first-time transarterial embolization for symptomatic fibroids, bilateral embolization, procedures applying a state-of-the-art (Group 1) or a conventional angiography unit (Group 2), and bilateral technical success with an adequate embolization endpoint after the injection of microspheres. Study endpoints included radiation exposure, major complications, morphological success (MRI), and clinical success (questionnaire on quality-of-life). Propensity score matching controlled for confounders. RESULTS: The inclusion criteria were met by 58 (Group 1) and 177 (Group 2) patients. After propensity score matching, there was no significant difference between Group 1 (n = 46) and Group 2 (n = 92) regarding age, body-mass index, volume of the dominant fibroid and the uterus, fluoroscopy time, and amount of embolic agent (p ≥ 0.10 each). The dose-area product was significantly lower in Group 1 than in Group 2 (1159.0 cGycm2 vs. 3123.5 cGycm2; p < 0.001), while major complication rates (both groups 0 %) and dominant fibroid devascularization (both groups 100 %) were equal (p > 0.99). There were no significant differences between both groups regarding shrinkage of the dominant fibroid and the uterus and no relevant differences regarding patient-reported quality-of-life. CONCLUSION: A state-of-the-art angiography unit has the potential to reduce radiation exposure in patients undergoing UFE without increasing the risk of major complications and with comparably high morphological and clinical success. KEY POINTS: · A state-of-the-art angiography unit potentially reduces radiation exposure in patients undergoing UFE.. · Reduced radiation exposure does not seem to negatively influence the rate of major complications.. · Reduced exposure does not seem to negatively affect morphological and clinical success.. CITATION FORMAT: · Sommer C, Voigt W, Oliger MK et al. Radiation Exposure During Uterine Fibroid Embolization (UFE): A Confounder-Controlled Comparison Between a State-of-the-Art Angiography Unit and a Conventional Angiography unit. Fortschr Röntgenstr 2018; 190: 250 - 258.

Flexible robotics in pelvic disease: does the catheter increase applicability of embolic therapy?

Interventional radiology procedures, equipment, and techniques as well as image guidance have developed dramatically over the last few decades. The evidence for minimally invasive interventions in vascular and oncology fields is rapidly growing and several procedures are considered the first line management. However, radiation exposure, image guidance and innovative solutions to known anatomical challenges are still lagging behind. Robotic technology and its role in surgery have been developing at a steady speed. Endovascular robotics are following suit with a different set of problems and targets. This article discusses the advances and limitations in one aspects of endovascular robotic, namely pelvic pathology that includes aneurysms, fibroids, benign prostatic hypertrophy and vascular malformation.

[Experience With Different Single-Stage Selective Arterial Catheterization Procedures During X-Ray Endovascular Interventions to Reduce a Radiation Dose for Patients].

Objective: To evaluate the impact of single-stage selective arterial catheterizations during X-ray endovascular interventions to reduce obtained radiation doses in the treatment of patients. Material and Methods: X-ray endovascular interventions were carried out in the operating room equipped with a flat detector digital angiography system (Axiom Artis dTA, Siemens Medical System). The impact of single-stage selective arterial catheterization procedures was analyzed during endovascular interventions for coronary heart disease and uterine myomas on the time course of changes in the collective effective radiation doses for patients in the period 2013 to 2015. Results: Analysis of the findings showed that single-stage selective coronary angiography using a universal (multipurpose) radial coronary catheter and single-stage X-ray endovascular uterine artery embolization techniques could reduce collective effective doses for patients from 5.86 persons-Sv in 2013 to 1.6 persons-Sv in 2015. Conclusion: Different single-stage selective catheterization procedures used during endovascular interventions into the coronary and uterine arteries can reduce radiation doses for patients.

Randomized comparison of long and short vascular sheaths in reduction of the operator radiation exposure during uterine artery embolization.

OBJECTIVE: To introduce a method in which a long sheath is used instead of the traditional short sheath, to reduce the radiation exposure of operators in uterine artery embolization (UAE). METHODS: 52 patients undergoing UAE were randomly divided into two groups before the procedure: an 11-cm short sheath was used in Group A (n = 25), and a 45-cm-long sheath was used in Group B (n = 27); the 45-cm-long sheath was only partly inserted such that the hub of the sheath was approximately 34 cm caudal to the groin puncture site. All the procedures were standard bilateral UAE operations through unilateral approach. The other parameters of the two groups were kept the same, including the fluoroscopy conditions and the pelvic radiation field size. The thermoluminescent personal dosemeters were attached to the left wrist and left outer side of the thyroid collar of the operator during each operation. The radiation exposure of the operator, procedure duration and fluoroscopy time of each procedure were recorded. Statistical analysis was performed using independent samples t-test. RESULTS: The radiation exposure of both the left hand and thyroid of the operator was significantly reduced with the long sheath compared with the short sheath (89.5 ± 7.2 µGy vs 186.7 ± 12.6 µGy, p < 0.001, and 54.1 ± 5.5 µGy vs 63.9 ± 7.4 µGy, p < 0.001, respectively). No significant differences were found in the procedure duration and fluoroscopy time between the two groups (p > 0.1). CONCLUSION: Using a long sheath in UAE could significantly reduce the radiation exposure to the interventionists without extending the procedure duration or fluoroscopy time. ADVANCES IN KNOWLEDGE: For the first time, we introduce a simple and convenient method to reduce the radiation exposure of the operator in the UAE procedure.

A preclinical study of the safety and efficacy of Occlusin™ 500 Artificial Embolization Device in sheep.

INTRODUCTION: This study evaluated the safety, effectiveness, and biodegradation of a new embolic agent, Occlusin™ 503 Artificial Embolization Device (OCL 503). The agent consists of biodegradable poly-lactic-co-glycolic acid microspheres (150-212 µm) coated with type I bovine collagen and was compared with Embosphere® Microspheres (300-500 µm) in this controlled study of uterine artery embolization (UAE) in sheep. METHODS: Unilateral UAE was performed in 32 adult ewes randomly assigned. Vessels were embolized to effective stasis. The cohort was divided into four groups, which were sacrificed at 1, 3, 6, and 12 months. RESULTS: Both agents were 100% effective in achieving stasis. At 6 months, all OCL 503-treated arteries were occluded, the microspheres degraded with time, and at 12 months all four animals examined demonstrated recanalization. OCL 503 was found in the untreated uterine artery in one animal with no other evidence of non target embolization. In the Embosphere-treated group, all vessels remained occluded and microspheres were detected in the contralateral uterine artery in 6 of 15 examined vessels and in 10 vaginal, 2 ovarian, and 1 vesical artery. No procedural-related complications were seen in either group. CONCLUSIONS: OCL 503 is as effective an embolic agent as Embosphere® Microspheres when embolizing ovine uterine arteries and resorbs with time, allowing recanalization of the treated arteries. No device-related issues or adverse events were observed.