Endometrial Ablation Research Articles

Endoscopy Guided Photoablation of Endometrial Cysts using a 980 nm Laser with a Contact Fiber in Mares.

In mares, endometrial cysts are associated with endometriosis and can cause maternal recognition failure or compromise and delay pregnancy diagnoses. Historical treatments were invasive and had adverse effects on the endometrium. Hysteroscopically guided laser therapy is easy and effective for endometrial cysts resection, with no deleterious effects for the endometrium. A 110 cm long and 1.0 cm wide endoscope is sterilely introduced in the uterus through the open cervix of an estrous mare after vulvar cleaning. The uterus is slowly infused with less than 1 L of physiologic solution and the laser fiber is inserted in the biopsy canal of the endoscope. Cysts are then cauterized with the 980 nm diode laser with a contact fiber set at 20‒2 5W in continuous mode. Each cyst is punctureduntil complete voiding of the cyst and shrinking of the cyst wall around the fiber. Uterine lavages with sterile saline solution are performed directly after the surgery and for one or two days as non-inflammatory fluid can be observed. This procedure is easy and quickly performed, with no obvious deleterious effects. Cysts resection makes ultrasound pregnancy diagnosis easier and, in some cases, could restore proper embryo migration in the uterine horns between day 6.5 and 17. However, this treatment does not improve the underlying histological lesions related to endometriosis. These considerations should be clearly expressed to the breeder before this procedure.

A Patient With Organic Hypermenorrhea Who Developed Massive Genital Hemorrhage During Treatment Of Acute-Phase Cerebral Infarction And Responded To Microwave Endometrial Ablation

Microwave endometrial ablation (MEA) has been attracting attention as a low-invasive treatment alternative to conventional total hysterectomy for systemic disease-induced hypermenorrhea, such as functional hypermenorrhea and blood coagulation abnormality, and organic disease-induced hypermenorrhea such as myoma of the uterus and adenomyosis. We report a patient with hypermenorrhea causing massive genital hemorrhage during anticoagulant therapy who demonstrated a complete response to MEA.
 The patient was 41 years old, gravida 3 para 1. Aphasia and articulation disorder developed during work and she visited the emergency department. Cerebral infarction was noted on head MRI and anticoagulant therapy was initiated. Hypermenorrhea had been observed from approximately 4 years prior, but she had not visited a gynecology department. As massive genital hemorrhage and progression of anemia (Hb: 4.6 g/dL) were observed during the menstrual period, she was referred to our department. Multiple myomas of the uterus were observed on ultrasonography and pelvic MRI, and the patient was diagnosed with organic hypermenorrhea. As there was acute-phase cerebral infarction, MEA was performed as treatment for hypermenorrhea. The postoperative course was smooth and menstruation resumed on postoperative day 21. On subjective evaluation using the visual analogue scale (VAS), both hypermenorrhea and dysmenorrhea markedly improved from 10 to 1. The course was smooth without complications and the postoperative course was also favorable.
 MEA is a low-invasive treatment method safely applicable within a short time, and it may be an effective hypermenorrhea treatment method during oral anticoagulant administration or for those with perioperative risk due to complications.

Atypical Endometrial Hyperplasia and Unexpected Cancers at Final Histology: A Study on Endometrial Sampling Methods and Risk Factors.

Background: Up to 40% of women with atypical endometrial hyperplasia (AEH) can reveal endometrial cancer (EC) at hysterectomy. The pre-operative endometrial sampling method (ESM) and some independent cancer predictors may affect this outcome. The present study aimed to compare the rate of EC at hysterectomy in women with AEH undergoing dilation and curettage (D&C), hysteroscopically-guided biopsy (HSC-bio), or hysteroscopic endometrial resection (HSC-res). The secondary outcome was to compare the reliability of ESMs in women showing independent variables associated with EC. Methods: Two-hundred-and-eight consecutive women with AEH and undergoing hysterectomy between January 2000 and December 2017 were analyzed retrospectively. Based on pre- and post-test probability analysis for EC, three ESMs were compared: D&C, HSC-bio, and HSC-res. Univariate and multivariate analyses were performed to assess risk factors predicting cancer on final histology. Finally, the patient’s characteristics were compared between the three ESM groups. Results: D&C and HSC-bio included 75 women in each group, while HSC-res included 58 women. Forty-nine women (23.6%) revealed cancer at hysterectomy (pre-test probability). Post-test probability analysis showed that HSC-res had the lowest percentage of EC underestimation: HSC-res = 11.6%; HSC-bio = 19.5%; D&C = 35.3%. Patient characteristics showed no significant differences between the three ESMs. Multivariate analysis showed that body mass index ≥40 (Odds Ratio (OR) = 19.75; Confidence Intervals (CI) 2.193–177.829), and age (criterion > 60 years) (OR = 1.055, CI 1.002–1.111) associated significantly with EC. In women with one or both risk factors, post-test probability analysis showed that HSC-res was the only method with a lower EC rate at hysterectomy compared to a pre-test probability of 44.2%: HSC-res = 19.96%; HSC-bio = 53.81%; D&C = 63.12%. Conclusions: HSC-res provided the lowest rate of EC underestimation in AEH, also in women showing EC predictors. These data may be considered for better diagnostic and therapeutic planning of AEH.

Algorithm for management of patients of the period of menopausal transition with recurrence of anomalous uterine bleeding associated with beneficial proliferative changes of endometry

Aim. To compile an algorithm for managing patients during the menopausal transition with a relapse of abnormal uterine bleeding associated with benign proliferative changes in the endometrium and evaluate its outcomes.
 Materials and methods. The observation of 150 patients aged 4555 years who had recurrence of abnormal uterine bleeding due to benign proliferative changes of the endometrium. All patients underwent hysteroresectoscopic ablation of the endometrium according to the monopolar coagulation-vaporization technique using Olympus equipment (Japan). The patients were divided into two groups. One group was formed by 98 women who, before hysteroscopic ablation of the endometrium, received hormonal preparations for 14 months, with the help of which suppressive changes in the uterine mucosa up to 34 mm were achieved. The other group consisted of 52 patients of the menopausal transition who did not receive preoperative drug therapy, and the thinning of the endometrium before hysterectomy was performed instrumentally. After hysteroresectoscopy, the period of clinical and instrumental observation was 2 years.
 Results. Based on the results of the study, an algorithm has been compiled for the treatment of women during the menopausal transition with abnormal uterine bleeding, including at the first stage a clinical, laboratory and instrumental examination with the selection of a group of patients to be treated by endometrial ablation, and at the second stage, measures for the preoperative thinning of the uterine mucosa, at the third stage performing hysteroresectoscopic ablation of the endometrium; and at the fourth stage dynamic monitoring during ie 2 years. The preoperatively achieved medical atrophy of the endometrium, followed by hysteroresectoscopy, contributes to an improvement of 20.3% in the results of treatment of patients in comparison with mechanical thinning of the endometrium before hysteroresectoscopy. In general, the developed algorithm increases the effectiveness of anti-relapse treatment to 92.8%.
 Conclusion. In practical health care, the proposed algorithm should be used, including successive steps. Following the algorithm, a differentiated approach to the choice of therapeutic tactics is carried out, taking into account not only morphological changes in the endometrium, but also the associated gynecological and somatic pathology of the patient, as well as justifying the conduct of preoperative preparation for hysteroresectoscopic ablation of the endometrium and determining the order of subsequent dynamic observation.

Fibroid: A common problem and its advanced management

Uterine fibroids are the most common gynaecological disorder, classically requiring surgery when symptomatic. Although attempts at finding a nonsurgical cure date back to centuries, it is only around the middle of the last century that serious attempts at a medical treatment were carried out. Initially, both progestins and estrogen–progestin combinations have been utilized, although proof of their usefulness is lacking. A major step forward was achieved when peptide analogues of the GnRH were introduced, first those with super agonist properties and subsequently those acting as antagonists. Because both types of analogues produce hypoestrogenism, their use is limited to a maximum of 6 months and, so they can’t be used routinely but utilized as an adjuvant treatment before surgery with overall good results. Over the last decade, new, nonpeptidic, orally active GnRH-receptor blockers Elagolix and another development of selective progesterone receptor modulators, sometimes referred to as “antiprogestins of choice is Ulipristal acetate are promising.Large clinical trials have proven the effectiveness of Ulipristal in the long-term medical therapy of fibroids, caution must taken for liver complications. All selective progesterone receptor modulators produce unique endometrial changes that are today considered benign, reversible, and without negative consequences. Long-term medical treatment of fibroids seems possible today, especially in premenopausal women. Surgical treatments are myomectomy, radiofrequency ablation procedure, endometrial ablation, uterine artery embolization, magnetic resonance-guided focused ultrasound myolysis are effective and reserved for the women who desires to keep uterus, and morcellation . Still Hysterectomy is the definitive treatment for fibroid and the techniques of surgery is inclining towards minimum invasive surgery.

Thermal endometrial ablation for abnormal uterine bleeding due to endometrial pathology: an alternative to hysterectomy

<strong>Introduction: </strong>Among women of reproductive age Abnormal Uterine Bleeding (AUB) due to a primary endometrial pathology (AUB-E) occurs in up to 25%, and it has a significant adverse impact on their quality of life. In Sri Lanka, hysterectomy continues to be the commonest modality for the treatment of AUB-E not responding to medical therapy. Thermal Endometrial Ablation (TEA) is an alternative option for the management of women with AUB-E. <strong> </strong> <strong>Objective: </strong>To describe the effectiveness, short and long term complications, patient satisfaction and cost of TEA in the management of women with AUB-E in Sri Lankan setting. <strong> </strong> <strong>Method: </strong>Thirty women with AUB-E underwent TEA under regional anaesthesia at the Academic Department of Obstetrics and Gynaecology of the Teaching Hospital Mahamodara, Galle (THMG) during the period of November 2012 to April 2015. Data was collected using an interviewer administrated questionnaire at discharge, two weeks, three, six, 12 and 24 months post procedure. The effectiveness, short and long term complications, patient satisfaction and cost of TEA in the management of women with AUB-E were studied. Abdominal Hysterectomy (AH) was offered for the patients with treatment failure. <strong> </strong> <strong>Result: </strong>Mean age and Body Mass Index of the women were 46 years (SD 4.8) and 25 Kg/m2 (SD 2.3) respectively. Short term minor complications (abdominal cramps, excessive vaginal discharge and vomiting) were observed in three women (10%). There were no major complications. At the end of 12 months, almost half the women were amenorrhoeic with an improvement rate of 90%. At the end of the two years seven ( 23%) had amenorrhoea and 20 (67%) had reduced per vaginal bleeding. Three women underwent AH at three, six and 12 months post procedure respectively, due to treatment failure. The approximate cost of an AH was LKR 49,000. The cost of one TEA device and one TEA installation system were LKR 120,000 and LKR 4,500,000 respectively. <strong> </strong> <strong>Conclusion: </strong>TEA was an effective alternative to AH for the treatment of AUB-E, and had no major complications. However, it was more expensive when compared to AH.

Progestogen-releasing intrauterine systems for heavy menstrual bleeding.

Progestogen-releasing intrauterine systems for heavy menstrual bleeding.

Histologic findings in hysterectomies after endometrial ablation

BackgroundEndometrial ablation for abnormal uterine bleeding is used as a less invasive alternative to hysterectomy, however, in cases of treatment failure hysterectomy may be finally performed. The histologic changes in these post-treatment uteri are not well-described. ObjectiveTo describe the histological findings in post-endometrial ablation uteri. Study designDuring a ten-year period, 321 patients were treated with endometrial ablation. Twenty-five patients (7.8%), 10 treated with NovaSure® and 15 treated with ThermaChoice® endometrial ablation were finally subjected to hysterectomy mostly due to persistent uterine bleeding. Histologic features of these hysterectomies are described. ResultsThe patients’ age ranged from 33 to 73 years (mean 44.5) and 34–53 (mean 42) for the NovaSure® and ThermaChoice® group, respectively. The time from endometrial ablation to hysterectomy was 2–24 months (mean 8.8) and 2–60 months (mean 23.2) for the two groups, respectively (p = 0.01). Hysterectomies performed later (mean 22 months) showed no fibrosis (p = 0.04) compared with those performed earlier (mean 5 months). Endometrial lining was found more frequently in hysterectomies performed later (mean 13 months) than those performed earlier (mean 2 months, p = 0.0004). Abundant necrotic tissue of myometrial origin was found in 28% of the cases, but it was not associated with the time of hysterectomy (p = 0.2). A zonation effect and vascular changes also seen. Granulomatous reaction was not found. Ten patients (40%) harbored adenomyosis and another three (12%) extensive leiomyomas/diffuse leiomyomatosis. ConclusionNecrosis, fibrosis and vascular changes are found during the first year of post-thermal uterine effect. Hysterectomies performed later show less prominent changes and almost normal endometrial lining. Adenomyosis is found in an important part of post-endometrial ablation hysterectomies.

Current and Future Surgical and Interventional Management Options for Adenomyosis.

Historically, hysterectomy has been the recommended treatment for patients with adenomyosis. However, in the past two decades, various uterine-sparing treatment methods have emerged. These range from excisional techniques such as adenomyomectomy or wedge resection to uterine artery embolization, radiofrequency thermal ablation, hysteroscopic excision, endometrial ablation, and high-intensity focused ultrasound. While largely investigative for the treatment of adenomyosis, these procedures have demonstrated improvement in symptoms including abnormal uterine bleeding, dysmenorrhea, pelvic pain, and overall quality of life. However, long-term data including fertility and obstetric outcomes are needed. Future research is needed to better understand the impact of these uterine-preserving techniques to expand our armamentarium for the treatment of adenomyosis.

The Impact of Spinal Anesthesia and Use of Oxytocin on Fluid Absorption in Patients Undergoing Operative Hysteroscopy: Results from a Prospective Controlled Study.

ObjectiveThe aim of this study was to determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy.Patients and MethodsA prospective controlled study was conducted in premenopausal patients who had hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid deficit was studied.ResultsA total of 88 patients were studied. Sixty-two cases were done under general anesthesia (control group) and 26 cases were performed with spinal anesthesia and the use of oxytocin infusion (study group). There was a statistically significant less mean fluid deficit in the study group than control group in the endometrial polypectomy patients (220±36 mL vs 392±178 mL, respectively, P value 0.010, 95% C.I.: 163–276) and the myomectomy patients (308±66 mL vs 564±371 mL, respectively, P value 0.003, 95% C.I.: 239–378). In the endometrial resections, there was also a statistically significant less mean fluid deficit in the study than the control group (P value ˂ 0.001). Regarding septal resection, there was no statistically significant difference in the mean fluid deficit between the two groups (P value 0.833).ConclusionSpinal anesthesia combined with intravenous oxytocin infusion in operative hysteroscopy results in a statistically significant reduction in the glycine fluid deficit than the general anesthesia. We also recommend studying the effects of this combination in operative hysteroscopy using bipolar devices with isotonic solutions.

Invasive Procedural Treatments for Symptomatic Uterine Fibroids: A Cost Analysis.

The aim of this study was to evaluate the contemporary use of procedural interventions to treat symptomatic uterine fibroids and assess associated health care system costs. Using the IBM Watson MarketScan Commercial Claims and Encounters database for 2009 to 2015 and relevant International Classification of Diseases diagnosis codes, women aged 18 to 55 years with clinically significant uterine fibroids were identified. Using Current Procedural Terminology codes, relevant procedural interventions were identified (hysterectomy, endometrial ablation, myomectomy, and uterine fibroid embolization [UFE]). Costs were defined as total actual payments by insurers and patients (per procedure and per episode of care) and were adjusted and compared using generalized linear models. Of 241,757 invasive procedures for fibroids, hysterectomy was most common (76.5%), followed by endometrial ablation (14.5%), myomectomy (4.7%), and UFE (4.3%). Hysterectomy was more common in older women and those in rural areas (65.2% of patients <40 years of age, 77.6% of those 40-49 years of age, and 83.6% of those 50-55 years of age; 83.9% of patients outside versus 75.3% within metropolitan statistical areas). Per procedure, adjusted mean costs were $3,188 (95% confidence interval [CI], $3,114-$3,264) for hysterectomy, $2,781 (95% CI, $2,695-$2,870) for ablation, $4,436 (95% CI, $4,256-$4,623) for myomectomy, and $6,161 (95% CI, $5,736-$6,617) for UFE. Adjusted mean costs for entire episodes of care were $14,676 (95% CI, $14,496-$14,858) for hysterectomy, $6,702 (95% CI, $6,534-$6,875) for endometrial ablation, $14,791 (95% CI, $14,465-$15,125) for myomectomy, and $13,873 (95% CI, $13,182-$14,599) for UFE. Of invasive procedures for symptomatic uterine fibroids, hysterectomy was used more frequently than endometrial ablation, myomectomy, and UFE combined. Per procedure and per episode, ablation was least costly. Costs per episode were similar for hysterectomy, myomectomy, and UFE.

Hysteroscopic endometrial resection vs. hysterectomy for abnormal uterine bleeding: impact on quality of life and sexuality. Evidence from a systematic review of randomized controlled trials.

The aim of this systematic review is to summarize the current evidence regarding the effectiveness of hysterectomy and hysteroscopic endometrial resection in improving quality of life (QoL), sexual function and psychological wellbeing of women abnormal uterine bleeding. We performed a systematic literature search in PubMed/MEDLINE and Embase for original studies written in English (registered in PROSPERO 2019 CRD42019133632), using the terms 'endometrial ablation', 'endometrial destruction', 'endometrial resection', 'hysterectomy', 'menorrhagia', 'dysfunctional uterine bleeding', 'quality of life', 'sexuality' published up to April 2019. Our literature search produced 159 records. After exclusions, nine studies were included showing the following results: both types of treatment significantly improve QoL and psychological wellbeing; hysterectomy is associated with higher rates of satisfaction; hysterectomy is not associated with a significant deterioration in sexual function. Hysterectomy is currently more advantageous in terms of improving abnormal uterine bleeding and satisfaction rates than hysteroscopic endometrial destruction techniques. Furthermore, there is some evidence of a greater improvement in general health for women undergoing hysterectomy. However, high-quality prospective randomized controlled trials should be implemented to investigate the effectiveness of hysterectomy and endometrial ablation in the improvement of QoL outcomes in larger patient cohorts.

Abstract 64: Chartsweep: A Hipaa-compliant Tool To Automate Chart Review For Plastic Surgery Research

Purpose: Retrospective chart review (RCR) is the process of manual patient data review to answer research questions. Large study populations and heterogeneous data make this a tedious, biased and error-prone process1. The authors therefore designed and developed ChartSweep, a HIPAA-compliant Windows (Microsoft, WA, USA) application leveraging the Python coding language to streamline and expedite the RCR process while remaining faithful to its methodological rigor as outlined by Matt and Matthew. ChartSweep is open-source and can be customized for use with any electronic medical record system as part of any study requiring retrospective chart review. Methods: ChartSweep is a tool developed at the Massachusetts General Hospital. It uses the Selenium Python library to pull information from electronic medical records and securely store it in.csv,.txt,.pdf or.jpeg format. As a proof-of-concept, a retrospective review of 172 patient records stored in Epic (electronic medical record storage) was performed to identify subjects who had undergone radiofrequency ablation (RFA) of the greater or lesser occipital nerves (for treatment of migraine headache). The first search was conducted manually according to standard RCR methodology, the second automatically using ChartSweep. Automated ChartSweep output was then reviewed and patient charts describing RFA in other contexts (lumbar ablation, endometrial ablation) were manually excluded. Total time required for each review and discrepancies between data output were evaluated. Results: Overall manual review time was 1,371 minutes (23 hours) with a mean evaluation time per medical record of 8 minutes. Automated ChartSweep review was significantly faster requiring 56 minutes overall, and 0.3 minutes per patient record (P< 0.0001). Time saved was 7.6 minutes per chart and 1,315 minutes (21.9 hours) total. Both reviews identified 16 patients who had undergone RFA out of 172 total patients. Conclusion: Open-source Python libraries as leveraged by ChartSweep significantly accelerate the retrospective chart review process in plastic surgery research. Quality of data review is not compromised. Further analyses with larger study populations are required to validate ChartSweep as a reliable research tool. 1Matt, V., Matthew, H. J. J. o. e. e. f. h. p. The retrospective chart review: important methodological considerations. 2013;10.

Endometrial autotransplantation in rabbits: Potential for fertility restoration in severe Asherman’s syndrome

ObjectiveUterine transplantation is now considered a feasible treatment for women with absolute uterine factor infertility and has been successfully performed for a woman with Asherman’s syndrome (AS). The endometrium is a clinically and histologically distinct entity from the surrounding myometrium. Endometrial transplantation (ETx) may offer a less invasive option, with less immunogenic impact, to restore fertility in women with severe AS. The objective of this study was to assess the feasibility of ETx by evaluating surgical and reproductive outcomes following endometrial autotransplantation in a rabbit model. Study designA longitudinal study assessing surgical, biochemical, radiological, reproductive and histological outcomes following endometrial autotransplantation in ten New Zealand white rabbits. ResultsTen procedures were performed, including 8 endometrial auto-transplants (ETx) and 2 endometrial resections (ER), to control against endometrial regeneration. Eight procedures were successful, whereas two rabbits from the ETx group died intra-operatively. Three rabbits were euthanised at 48, 72 and 96 h post-operatively to assess gross and histological appearances. Two rabbits, one from the ETx group and one from the ER group, died four weeks and eight weeks post-operatively. Three rabbits subsequently underwent two cycles of in-vitro fertilization. The first cycle resulted in an implantation rate of 57% in the un-operated uteri. In two rabbits who underwent ETx, an implantation rate of 28.6% was seen. In the second cycle, an implantation rate of 61.9 % (13 implantations) was observed in the control uteri. In the two ETx females, an implantation rate of 14.3 % was seen. No pregnancies were seen in either cycle in the animals who underwent ER. Despite successful implantations in both cycles in the ETx rabbits, no livebirths were achieved. Following death or euthanasia there was gross and microscopic evidence of viable endometrium following ETx, but not following ER. ConclusionThis study has revealed, for the first time, the feasibility of ETx with gross and microscopic evidence of viable endometrium, and the demonstration of clinical pregnancies. Whilst further studies are essential, and the achievement of successful livebirths fundamental, ETx may offer a potential fertility restoring opportunity for women with severe, treatment refractory cases of AS.

Long-term outcome of endometrial ablation therapy with Cavaterm Thermal Balloon in patients with abnormal uterine bleeding

Objective:The purpose of this study was to evaluate the long-term outcome of endometrial ablation (EA) therapy with Cavaterm Thermal Balloon in patients with abnormal uterine bleeding (AUB).Material and MethodsThe retrospective cross-sectional study was performed on 209 patients who referred to Shahid Sadoughi Hospital in Yazd, Iran between March 2010 and September 2017 with AUB undergoing EA therapy. The data was collected by a questionnaire from the medical records of patients and phone call. The primary and secondary outcomes post EA therapy (from six months to seven years post-operatively) were assessed in patients.Results:The mean age of participants was 45.9±5.9 years and the mean follow-up duration was 21.2±13.2 months. The rate of treatment response was 95% in the first six months and 92.1% thereafter. The prevalence of amenorrhea was 41.2%. The patient satisfaction rate at the end of follow-up duration was 81.3%. Dysmenorrhea completely resolved in 32.6%. Moreover, 1.4% of patients became pregnant during follow-up. By the end of follow-up, four (1.9%) patients had a hysterectomy due directly to treatment failure.Conclusion:This study showed that EA surgery with Cavaterm Thermal Balloon was an effective treatment for AUB. The procedure was safe and was associated with a very low rate of postoperative adverse events. The patient satisfaction rate was favorable.

Prognostic Factors for the Failure of Endometrial Ablation: A Systematic Review and Meta-analysis

(Abstracted from Obstet Gynecol 2019;134:1269–1281) An important health problem affecting approximately 30% of women is heavy menstrual bleeding, which has a major effect on their quality of life. A frequently used minimally invasive procedure that can destroy or remove the endometrial tissue is endometrial ablation (EA).

Abstract No. 415 Uterine artery embolization for anticoagulant-associated uterine bleeding

Abnormal uterine bleeding (AUB) affects up to two thirds of women on anticoagulation (AC) therapy. In women on AC for venous thromboembolism (VTE), AUB is linked to recurrent VTE, likely due to interrupted therapy. Treatment options for anticoagulant-associated AUB (AA-AUB) are limited, as estrogen-containing treatments increase thrombotic risk and endometrial ablation or hysterectomy lead to infertility. While uterine artery embolization (UAE) is a well-established treatment for symptomatic fibroids, its role in acute AA-AUB is limited to case reports. This study describes a series of patients who underwent UAE for the treatment of acute AA-AUB, focusing on technique, safety and outcomes. The institutional review board approved this retrospective review on 16 patients who underwent UAE for acute AA-AUB at a single academic medical center between Feb 2014 and Feb 2019. Three board-certified interventional radiologists performed UAE cases using 500-700 micron tris-acryl gelatin microspheres (Merit Medical Systems). In one case, tris-acryl gelatin microspheres were used in combination with Gelfoam. Medical, surgical, and radiologic records were reviewed. Statistical analysis were performed using MATLAB version R2018b (Mathworks). 16 patients were included with mean age 42 ± 7, on warfarin (38%), heparin drip (38%), or NOACs (25%). All patients demonstrated concurrent fibroids and/or adenomyosis and no patient had known endometrial malignancy. VTE, due to various etiologies, was the most common indication (88%) for AC. Cessation of acute AA-AUB was noted in the short term, defined as 3 days post-UAE, in 15 (94%) patients. 2 patients (12.5%) ultimately underwent hysterectomy due to failure of UAE to control AA-AUB in either the short or long term. Among patients who did not undergo hysterectomy for whom follow-up data was available, 9 (90%) maintained menses post-UAE. All patients were able to re-initiate or continue anticoagulation following UAE. UAE is an effective treatment strategy for acute AA-AUB. As an initial alternative to hysterectomy, endometrial ablation, or medical management, UAE allows patients to preserve menses and continue anticoagulation.Tabled 1Demographics Total cases16 Age (years)42 ± 7Indication for anticoagulation Cardiac valve prothesis1 Coronary arterial stent1 Venous thromboembolism14Timing of medical management of AA-AUB Concurrent with UAE7 Failure leading to UAE5 Not attempted4Anticoagulation post-UAE Re-initiated (previously held)6 Continued (not previously held)10 Stopped0Cessation of AUB post-UAE Resolved in short and long term10 Resolved in short term only; long term control with conservative or medical management3 Resolved in short term only; long term control with hysterectomy1 Resolved in short term; unable to assess long term efficacy due to hysterectomy for other indication1 Did not resolve, leading to hysterectomy1Loss of menses post-UAE No9 Yes1 N/A (hysterectomy shortly after UAE)2 N/A (inadequate follow up)4 Open table in a new tab

Abstract P5-11-15: Estetrol for treatment of advanced ER+/HER2- breast cancer

Abstract Introduction: A high dose of the fetal estrogen estetrol (E4) is anticipated to have anti-tumor effects in patients with advanced, anti-estrogen resistant, ER+/HER2- breast cancer (BC). It will most likely also improve patient’s quality of life by reducing symptoms of estrogen deficiency such as hot flushes, arthralgia, sleep disturbances, vaginal dryness, mood changes and depression, bone loss and fractures and cognition. The ABCE4 study is performed in Germany in this patient population. The main objectives of the study are to assess safety and tolerability of three doses of E4, to determine anti-tumor response and to evaluate estrogen deficiency symptoms. Study design: This is a multi-center, open-label, phase IB/IIA, dose-escalation study with a 3 + 3 cohort design, whereby successive cohorts of 3 patients receive 20 mg, 40 mg and 60 mg E4 per day by oral administration. Dose limiting toxicity (DLT), safety and wellbeing are evaluated after 4, 8 and 12 weeks of treatment. Occurrence of DLT at completion of phase IB after 4 weeks treatment determines escalation to the next higher dose. Objective anti-tumor effects are assessed by computer tomography scanning and evaluated according to RECIST criteria before and after 12 weeks of treatment. Thereafter treatment may continue based on an evaluation of the patient and her treating physician. In view of the small numbers required for this study design no statistical testing was performed. Results: A total of 12 postmenopausal women with progressive, heavily pre-treated advanced BC have been enrolled. Nine patients completed Phase IB. One patient in the 20 mg group discontinued the study during Phase IIA due to disease progression after 9,5 weeks of E4 treatment. She died 3 weeks later. Eight patients completed both the Phase IB and IIA part of the study. None of the patients experienced a DLT. All three E4 doses were well tolerated by all patients. In total 38 adverse events were reported. Adverse events were mainly of mild or moderate intensity. The following 8 events were considered possibly related to E4 treatment: increased endometrial thickness, spotting (2 patients), dry skin, pruritus, edema, fatigue (2 patients), alopecia and acid regurgitation. Seven events fulfilled the criteria of seriousness from which one was considered to be related to E4 treatment. This patient experienced moderate vaginal bleeding after 36 weeks treatment with 20 mg E4 and was hospitalized for hysteroscopy and endometrial ablation with full recovery thereafter. Importantly five of the eight patients who completed treatment with E4 reported subjective improvement and “felt much better” than before the start of E4 treatment. This was described by one of the patients as: ‘”feeling less down and exhausted; instead feeling much more optimistic, powerful and positive when taking E4”. Five patients completing 12 weeks E4 treatment showed objective anti-tumor effects with stable disease (n=4) and one remission. All five continued E4 treatment. Tumor assessment after 24 weeks of E4 treatment showed again stable disease in 4 patients. Conclusion: We conclude that daily doses of 20 mg, 40 mg and 60 mg E4 are well tolerated without DLTs. The majority of patients experienced favorable subjective effects and four patients treated for 24 weeks or longer showed stable disease and tumor remission respectively. Treatment with E4 meets the criteria for further investigation and development of E4 as a new drug for the treatment of anti-estrogen resistant advanced breast cancer. Final dose selection of E4 will take place in September 2019. Citation Format: Marcus Schmidt, Arnd Hönig, Yvette Zimmerman, Carole Verhoeven, Katrin Almstedt, Marco Battista, Hans Georg Lenhard, Jan Krijgh, Herjan Coelingh Bennink. Estetrol for treatment of advanced ER+/HER2- breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-11-15.

Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety &amp; Effectiveness

Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety &amp; Effectiveness

Outpatient endometrial ablation: audit of outcomes and patient satisfaction

Endometrial ablation in outpatient setting is associated with shorter hospital stay and quicker recovery. The primary outcome of this observational study was initiation and completion of procedure and secondary outcome measures were pain during the procedure and complications. The study was conducted in outpatient women’s health clinic of Bolton Foundation NHS Trust UK, between March 2015 and July 2017. Out of 151 patients, all had oral analgesia at home. The procedure was initiated and completed in 83% cases. The median time for procedure was 78.5 s with range (34–120 s). The median intraoperative and immediate post-op pain score was 8 and 2, respectively. Post-procedure hysteroscopy confirmed intact cavity in all. Post-op analgesia was required in 2% cases. Eight-nine percent were discharged immediately, 10% had to be rested and observed for 30–60 min. None had serious complications. Ninety percent were satisfied with outpatient service and would recommend to friends and family.Impact StatementWhat is already known on this subject? Second-generation endometrial ablation is an effective first-line management option for heavy menstrual bleeding. Outpatient procedure is associated with shorter hospital stay, quicker recovery and avoids general anaesthesia and its complications.What do the results of this study add? This observational study confirmed that it was suitable to start the procedure in 83% cases. Once started, it was possible to complete in 100%. The most common cause for not being able to start the procedure was intolerability to the patients. The median immediate post-procedure pain score was 2 which was highly acceptable to patients. 90% of patients who underwent the outpatient endometrial ablation would choose to have further hysteroscopic procedures as outpatient.What are the implications of these findings for clinical practice and/or further research? Patients should be given choice for endometrial ablation either with or without general anaesthesia. Patients should be carefully selected for outpatient procedure taking into account informed consent, tolerability of speculum examination and endometrial pipelle biopsy as well as understanding anticipation of some discomfort. Further randomised controlled trials should be carried out to determine patient satisfaction with endometrial ablation with or without general anaesthesia.