Evaluation of Radiofrequency Endometrial Ablation: A 17-year Canadian Experience.

STUDY OBJECTIVE: The purpose of this study was to better elucidate radiofrequency endometrial ablation (REA) durability by assessing the probability of failure as defined by need for postablation hysterectomy. Age at index REA, duration from REA until hysterectomy, and REA failure (REAF) risk factors were analyzed. DESIGN: A retrospective cohort study was conducted using patient data between April 1, 2002, and March 31, 2019. REAF cases were identified using operative procedure codes. Cox proportional hazard regression assessed the effect of age at index REA on time to postablation hysterectomy. Kaplan-Meier survival curve evaluated timing of postablation hysterectomy, stratified by age at index REA. SETTING: This study was conducted at Regina General Hospital in Regina, Saskatchewan, Canada. PATIENTS: Patient population included those who were 21 years of age or older, were premenopausal, and had a history of heavy menstrual bleeding at the time of REA. INTERVENTIONS: The intervention under investigation was REA. MEASUREMENTS AND MAIN RESULTS: The overall probability of postablation hysterectomy was 22.6%. The probabilities of postablation hysterectomy were 36.1% for women younger than 30 years (n = 128), 28% for women 30 to 34.9 years old (n = 528), 29.6% for women 35 to 39.9 years old (n = 1152), and 17.6% for women 40 years and older (n = 2221). Characteristics associated with REAF included tubal occlusion, cesarean section, dysmenorrhea, and chronic pelvic pain (p <.01) among women younger than 40 years. Leiomyomas accounted for higher failure rates in women 40 years and older (p <.01). CONCLUSION: Postablation hysterectomy is more likely to occur in women younger than 40 years. REA can be considered in women aged 30 to 39.9 years old, who have no known REAF risk factors. Women younger than 40 years with REAF risk factors will experience higher rates of hysterectomy. Thus, the decision to proceed with REA should be individualized with careful consideration for the underlying causes of abnormal uterine bleeding, while respecting patient autonomy.

Endometrial cancer after endometrial ablation: a systematic review.

OBJECTIVE: To investigate whether a previously performed endometrial ablation is associated with the development and diagnosis of endometrial cancer. METHODS: First, a systematic review was performed of the articles reporting the incidence of endometrial cancer in patients treated with endometrial ablation. Second, a systematic review was performed to identify all individual cases of endometrial cancer after ablation to evaluate presenting symptoms, diagnostic work-up, potential risk factors, and the type and stage of the endometrial cancer. A systematic search was performed, using Medline, EMBASE, and the Cochrane Library databases, from inception through February 24, 2022. RESULTS: Based on 11 included studies, the incidence of endometrial cancer in a population of 29 102 patients with a prior endometrial ablation ranged from 0.0% to 1.6%.A total of 38 cases of endometrial cancer after ablation were identified. In 71% of cases (17 of 24 cases), vaginal bleeding was the first presenting symptom. With transvaginal ultrasound it was possible to identify and measure the endometrial thickness in eight cases. Endometrium sampling was successful in 16 of 18 described cases (89%). In 18 of 20 cases (90%) pathologic examination showed early-stage endometrioid adenocarcinoma (International Federation of Gynecology and Obstetrics stage I). CONCLUSION: Previous endometrial ablation is not associated with the development of endometrial cancer. Diagnostic work-up is not impeded by previous endometrial ablation. In addition, endometrial cancers after endometrial ablation are not detected at an advanced stage.

Long-term incidence of endometrial cancer after endometrial resection and ablation: A population based Swedish gynecologic cancer group (SweGCG) study.

INTRODUCTION: Minimally invasive methods to reduce menorrhagia were introduced in the 1980s and 1990s. Transcervical endometrial resection (TCRE) and endometrial ablation (EA) are two of the most frequently used methods. As none of them can guarantee a complete removal of the endometrium, there are concerns that the remaining endometrium may develop to endometrial cancer (EC) later in life. The primary aim was to analyze the long-term incidence of EC after TCRE and EA in a nationwide population. The secondary aim was to assess the two treatment modalities separately. MATERIAL AND METHODS: The Swedish National Patient Registry and National Quality Registry for Gynecological Surgery were used for identification of women who had TCRE or EA performed between 1997-2017. The cohort was followed from the first TCRE or EA until hysterectomy, diagnosis of EC, or death. Follow-up data were retrieved from the National Cancer Registry and the National Death Registry. Expected incidence for EC in Swedish women was calculated using Swedish data retrieved from the NORDCAN project after having taken into account differences of age and follow-up time. Cumulative incidence of EC after TCRE and EA, was calculated. A standardized incidence ratio was calculated based on the expected and observed incidence, stratified by age and year of diagnosis. RESULTS: In total, 17 296 women (mean age 45.1 years) underwent TCRE (n = 8626) or EA (n = 8670). Excluded were 3121 who had a hysterectomy for benign causes during follow up. During a median follow-up time of 7.1 years (interquartile range 3.1-13.3 years) the numbers of EC were 25 (0.3%) after TCRE and 2 (0.02%) after EA, respectively. The observed incidence was significantly lower than expected (population-based estimate) after EA but not after TCRE, giving a standardized incidence ratio of 0.13 (95% confidence interval [CI] 0.03-0.53) after EA and 1.27 (95% CI 0.86-1.88) after TCRE. Median times to EC were 3.0 and 8.3 years after TCRE and EA, respectively. CONCLUSIONS: There was a significant reduction of EC after EA, suggesting a protective effect, whereas endometrial resection showed an incidence within the expected rate.

Safety and efficacy of microwave endometrial ablation for patients with previous uterine surgery: a pilot study.

MEA (microwave endometrial ablation) is a treatment that can control hypermenorrhea. With the increase in the number of caesarean sections and myomectomies, an increasing number of patients with MEA have undergone previous incision of the uterine myometrium. Uterine perforation is major complication. Here we compared the incidence of complications and recurrence between groups with or without previous uterine surgery. 35 patients who underwent MEA were enrolled in the study. We assessed the thickness of uterine myometrium by MRI and transvaginal ultrasonography (TV-US). 12 patients (34%) had previous uterine surgery; Among 12 patients with previous uterine surgery, 6 (50%) showed thinning of the myometrium. No patient showed any complications. There was no difference in recurrence rate between two groups (1/12 = 8% and 2/23 = 8%, respectively). MEA can be performed safely and effectively even for patients with previous uterine surgery.IMPACT STATEMENTWhat is already known on this subject? MEA (microwave endometrial ablation) is a treatment that can control hypermenorrhea.A few serious complications have been reported, including uterine perforation and intestinal injury. There have been no collective reports on women with a history of uterine surgery, and the decision to perform MEA and the detailed procedures have not been clarified.What do the results of this study add? No patient who received MEA showed any complication regardless of previous uterine surgery. There was no difference in recurrence rate of hypermenorrhea between groups with and without previous uterine surgery. MEA could be performed safely and effectively in patients with previous uterine surgery preoperative imaging and intraoperative ultrasoundsWhat are the implications of these findings for clinical practice and/or further research? Curently, with the increase in the number of caesarean sections and myomectomies, the increasing number of patients with MEA have undergone previous incision of the uterine myometrium and this causes thinning of the myometrium. MEA can be safely performed without losing any therapeutic effect, even in patients with a history of uterine surgery, by using MRI and TV-US as preoperative evaluations.

Post procedural pregnancy occurrence risk after endometrial ablation.

OBJECTIVE: The objective of the study was to analyse the pregnancy rate after curettage, 1G (Endometrial resection) and 2G (Endometrial ablation) procedures in women with abnormal uterine bleeding (AUB-O,E,N) to evaluate the rate of pregnancy following these procedures and to improve pre and post-therapeutic women information. METHODS: This retrospective study analyzed data extracted from the French Hospital medical information database. All hospital stays with a diagnostic code for AUB and an appropriate surgical procedure coded between 2009 and 2015 were identified. A total of 109,884 women were included. Of these, 88,165 were followed up for 18 months, 80,054 for 24 months and 33,251 for 60 months. Outcomes were compared between second generation (2G) procedures, first-generation (1G) procedures (endometrial resection) and curettage. The rate of pregnancy was the primary end point. RESULTS: 7863 women underwent a 2G surgical procedure (7.2%), 39,935 a 1G procedure (36.3%) and 38,923 a curettage (35.4%). The mean age of the women was 46 years (IC.95: 36.7-52.5), with no difference in age between groups. The rate of pregnancy after 2G, 1G and curettage was respectively 13 (1.5%), 617 (10.1%) and 1025 (11.1%). The primary endpoint was significantly different between 2G and 1G and curettage (p<0.0001) CONCLUSION: 2G procedures result in lower risk of pregnancy without requiring specific training for surgeons. However, endometrial ablation cannot be considered as a sterilization method nor an effective contraceptive procedure. In the absence of sterilization of either partner, women should continue to use contraception whatever their age and menstrual status.

Hysteroscopic Access and Uterine Cavity Evaluation 12 Months after Endometrial Ablation with the Cerene Cryotherapy Device.

STUDY OBJECTIVE: To evaluate whether physical access and the ability to systematically assess the postablation uterine cavity were preserved at 12 months after endometrial ablation with the Cerene cryotherapy device (ChannelMedsystems, Emeryville, CA). DESIGN: A prospective, multicenter, single-arm study. SETTING: In the clinic at 8 US sites and outpatient hospital setting at 2 sites in Canada and 1 site in Mexico. PATIENTS: A total of 230 (of 242) subjects continued in the study at the Month 12 visit after ablation. Two hundred twenty-three subjects were available for a diagnostic hysteroscopic evaluation. INTERVENTIONS: Subjects who had previously been treated with a 2.5-minute cryoablation of the endometrium utilizing the Cerene device underwent a diagnostic hysteroscopy at the Month 12 follow-up visit. MEASUREMENTS AND MAIN RESULTS: The uterine cavity was accessible in 220 of 223 subjects (98.7%) and not accessible in 3 (1.3%) because of pain (n = 2) and cervical stenosis (n = 1). Visualization of the uterine cavity was possible in 204 of 220 subjects (92.7%) with one or both tubal ostia identified in 89.2% (182 of 204) of subjects. Both tubal ostia were visible in 160 of 204 subjects (78.4%) and one ostium in 22 of 204 subjects (10.8%). The cavity was not visualized in the remaining 16 of 220 subjects (7.2%) because of intrauterine adhesions (n = 14), technical difficulties (n = 1), or menstruation (n = 1). In 95.6% (195 of 204) of subjects where the cavity was visualized, the hysteroscopic view was judged adequate to evaluate the uterine cavity for pathologic change. No significant complications occurred during the hysteroscopic evaluations. CONCLUSION: This is the largest study to date conducted to hysteroscopically evaluate the postablation uterine cavity. Uterine cavity assessment with in-office hysteroscopy 1 year after the use of the Cerene cryotherapy device is attainable, enabling both diagnostic and therapeutic procedures within the endometrial cavity.

Tubal interruption and subsequent surgery for pain after endometrial ablation: A retrospective cohort study.

BACKGROUND: Endometrial ablation (EA) is an alternative to hysterectomy for abnormal uterine bleeding (AUB), with reduced recovery time and fewer operative risks. However, post-ablation pain may be associated with subsequent surgery, including hysterectomy. It is uncertain what factors affect surgery rates for post-ablation pain, particularly with respect to timing and technique of tubal interruption. AIM: To evaluate the relationship between tubal interruption and post-ablation pain and subsequent surgery. MATERIALS AND METHODS: We conducted a retrospective cohort study involving 324 patients at a Melbourne tertiary hospital from 2009 to 2020. The primary outcome was subsequent pelvic surgery for pain following EA. RESULTS: Pain following EA was reported by 29.7% of patients, with 10.5% of patients undergoing subsequent surgery for pain. Patients with tubal interruption were more likely to undergo subsequent surgery for pain than those with no tubal interruption (odds ratio (OR): 3.49, 95% CI: 1.59-7.66; P = 0.002). Tubal ligation was strongly associated with subsequent surgery for pain (OR: 3.12, 95% CI: 1.48-6.57; P = 0.003). In contrast, those with salpingectomy did not have an increased risk of subsequent surgery for pain, compared to those with no tubal interruption (OR: 1.5; 95% CI 0.32-7.13). Pre-ablation pain (adjusted OR: 2.98, 95% CI: 1.37-6.48; P = 0.006) and previous caesarean section (OR: 2.66; 95% CI: 1.13-6.25; P = 0.025) were also associated with subsequent surgery for pain. CONCLUSION: Our results suggest that tubal interruption, pre-ablation pain and previous caesarean section are associated with subsequent surgery for pain. These results can better inform preoperative counselling regarding the risk of subsequent surgery after EA.

Complication Rates after Endometrial Ablation in Ontario: A Cohort Analysis of 76 446 Patients.

STUDY OBJECTIVES: Endometrial ablation (EA) is an alternative to hysterectomy for the management of heavy menstrual bleeding; however, EA is not without risk. Our objective was to determine complication rates in women undergoing EA in the province of Ontario over a 15-year time period. The primary outcome was a composite of multiple complications within 30 to 180 days of surgery. The secondary outcomes included mortality, length of hospital stay, hospital readmission, and emergency department visit within 30 days of discharge. DESIGN: Retrospective cohort study using Cochran-Armitage test for trend. SETTING: Administrative data from the Canadian province of Ontario, assessing patients undergoing surgery in a publicly funded healthcare system. PATIENTS: Women in Ontario undergoing a primary EA over a 15-year time period. INTERVENTIONS: The intervention was a primary EA. MEASUREMENTS AND MAIN RESULTS: We assessed for genitourinary complication, fistula, gastrointestinal complication, pain, control of bleeding, blood transfusion, infectious complication, venous thromboembolism, fluid overload, thermal injury, and other injuries related to surgery. The secondary outcomes included 1-month and 6-month mortality, length of hospital stay, hospital readmission, and emergency department visit within 30 days of discharge. A total of 76 446 primary EAs were evaluated from 2002 to 2017, with the number of EAs per year increasing over the study period by 47%. Complications were seen in 4.8% of the cohort, with the complication rate being relatively stable over time. Although 6.2% of the cohort re-presented to the emergency department, <1% required readmission, and <0.05% died within 180 days. On multivariable analysis, the risk of complications increased with a preoperative diagnosis of other than bleeding (odds ratio [OR] 2.89; 95% confidence interval [CI], 2.61-3.21; p <.001), previous abdominal surgery (OR 1.42; 95% CI, 1.28-1.56; p <.001), and American Society of Anesthesiologists score 3+ (OR 1.37; 95% CI, 1.27-1.48; p <.001). CONCLUSION: Primary EA is associated with complications in <5% of the patients, with serious complications infrequent.

Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding (HMB) is common in otherwise healthy women of reproductive age, and can affect physical health and quality of life. Surgery is usually a second-line treatment of HMB. Endometrial resection/ablation (EA/ER) to remove or ablate the endometrium is less invasive than hysterectomy. Hysterectomy is the definitive treatment and can be via open (laparotomy) approach, or via minimally invasive approaches (vaginally or laparoscopically). Each approach has its own advantages and risk profile. OBJECTIVES: To compare the effectiveness, acceptability and safety of endometrial resection or ablation versus different routes of hysterectomy (open, minimally invasive hysterectomy, or unspecified route) for the treatment of HMB. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility specialised register, CENTRAL, MEDLINE, Embase and PsycINFO (July 2020), and reference lists, grey literature and trial registers. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared techniques of endometrial resection/ablation with hysterectomy (by any technique) for the treatment of HMB in premenopausal women. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 10 RCTs (1966 participants) comparing EA/ER to hysterectomy (open (abdominal), minimally invasive (laparoscopic or vaginal), or unspecified (or at surgeon's discretion) route of hysterectomy). The results were rated as moderate-, low- and very low-certainty evidence. Endometrial resection/ablation versus open hysterectomy We found two trials. Women having EA/ER are probably less likely to perceive an improvement in HMB compared to women having open hysterectomy (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.84 to 0.95; 2 studies, 247 women; moderate-certainty evidence) and probably have a 13% risk of requiring further surgery for treatment failure (compared to 0 on the open hysterectomy group; 2 studies, 247 women; moderate-certainty evidence). Both treatments probably lead to similar quality of life at two years (mean difference (MD) -5.30, 95% CI -11.90 to 1.30; 1 study, 155 women; moderate-certainty evidence) and satisfaction rate at one year (RR 0.91, 95% CI 0.82 to 1.00; 1 study, 194 women; moderate-certainty evidence). There may be no difference in serious adverse events (RR 1.29, 95% CI 0.32 to 5.20; 2 studies, 247 women; low-certainty evidence). EA/ER probably reduces time to return to normal activity compared to open hysterectomy (MD -21.00 days, 95% CI -24.78 to -17.22; 1 study, 197 women; moderate-certainty evidence). Endometrial resection/ablation versus minimally invasive hysterectomy We found five trials. The proportion of women with perception of improvement in HMB at two years may be similar between groups (RR 0.97, 95% CI 0.90 to 1.04; 1 study, 79 women; low-certainty evidence). Blood loss may be higher in the EA/ER group when assessed using the Pictorial Blood Assessment Chart (MD 44.00, 95% CI 36.09 to 51.91; 1 study, 68 women; low-certainty evidence). Quality of life is probably lower in the EA/ER group compared to the minimally invasive hysterectomy group at two years according to the 36-item Short Form (SF-36) (MD -10.71, 95% CI -15.11 to -6.30; 2 studies, 145 women; moderate-certainty evidence) and Menorrhagia Multi-Attribute Scale (RR 0.82, 95% CI 0.70 to 0.95; 1 study, 616 women; moderate-certainty evidence). EA/ER probably increases the risk of further surgery for HMB compared to minimally invasive hysterectomy (RR 7.70, 95% CI 2.54 to 23.32; 4 studies, 922 women; moderate-certainty evidence) and treatments probably have similar rates of any serious adverse events (RR 0.75, 95% CI 0.35 to 1.59; 4 studies, 809 women; moderate-certainty evidence). Women with EA/ER are probably less likely to be satisfied with treatment at one year (RR 0.90, 95% CI 0.85 to 0.94; 1 study, 558 women; moderate-certainty evidence). We were unable to pool data for time to return to work or normal life because of extreme heterogeneity (99%); however, the three studies reporting this all had the same direction of effect favouring EA/ER. Endometrial resection/ablation versus unspecified route of hysterectomy We found three trials. EA/ER may lead to a lower perception of improvement in HMB compared to unspecified route of hysterectomy (RR 0.89, 95% CI 0.83 to 0.95; 2 studies, 403 women; low-certainty evidence). Although EA/ER may lead to similar quality of life using the SF-36 General Health Perception at two years' follow-up (MD -1.90, 95% CI -8.67 to 4.87; 1 study, 209 women; low-certainty evidence), the proportion of women with improvement in general health at one year may be lower (RR 0.85, 95% CI 0.77 to 0.95; 1 study, 185 women; low-certainty evidence). EA/ER probably has a risk of 5.4% of requiring further surgery for treatment failure (compared to 0 with total hysterectomy; 2 studies, 374 women; moderate-certainty evidence) and reduces the proportion of women with any serious adverse event (RR 0.21, 95% CI 0.06 to 0.80; 2 studies, 374 women; moderate-certainty evidence). Both treatments probably lead to a similar satisfaction rate at one year' follow-up (RR 0.96, 95% CI 0.88 to 1.04; 3 studies, 545 women; moderate-certainty evidence). EA/ER may lead to shorter time to return to normal activity (MD -18.90 days, 95% CI -24.63 to -13.17; 1 study, 172 women; low-certainty evidence). AUTHORS' CONCLUSIONS: Endometrial resection/ablation (EA/ER) offers an alternative to hysterectomy as a surgical treatment for HMB. Effectiveness varies with EA/ER compared to different hysterectomy approaches. The perception of improvement in HMB with EA/ER is probably lower compared to open and unspecified route of hysterectomy, but may be similar compared to minimally invasive. Quality of life with EA/ER is probably similar to open and unspecified route of hysterectomy, but lower compared to minimally invasive hysterectomy. Further surgery for treatment failure is probably more likely with EA/ER compared to all routes of hysterectomy. Satisfaction rates also vary. EA/ER probably has a similar rate of satisfaction compared to open and unspecified route of hysterectomy, but a lower rate of satisfaction compared to minimally invasive hysterectomy. The proportion having any serious adverse event appears similar in all groups, but specific adverse events did reported difference between EA/ER and different routes. We were unable to draw conclusions about the time to return to normal activity, but the direction of effect suggests it is likely to be shorter with EA/ER.

A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding.

STUDY OBJECTIVE: To evaluate the safety and effectiveness of a novel cryoablation device (Cerene Cryotherapy Device, Channel Medsystems, Emeryville, CA) in premenopausal women with heavy menstrual bleeding owing to benign causes. DESIGN: A prospective, multi-center, single-arm, open label, non-randomized study. SETTING: At 11 academic and private practices in North America: 8 clinic sites in the United States, and 3 outpatient hospital sites (1 in Mexico and 2 in Canada). PATIENTS: A total of 242 subjects comprise the intent-to-treat population. Subject demographics were similar to other published endometrial ablation studies performed. INTERVENTIONS: Subjects were treated with a single-use disposable cryoablation device (Cerene) which delivers a 2.5-minute treatment to the endometrium. Analgesia and local anesthesia were administered per investigator discretion; intravenous sedation was used in only 3% of subjects and no general anesthesia was used. MEASUREMENTS AND MAIN RESULTS: There were no device or procedure-related serious adverse events, nor unanticipated adverse device effects. Cerene cryoablation was effective in reducing menstrual blood loss, which was measured by pictorial blood loss assessment chart (PBLAC) score. Mean score dropped from 360.6 at pretreatment (±332.1) to 51 at 12 months posttreatment (±64.1), with 81% of 230 evaluable subjects reporting a PBLAC score of ≤75 and 85% of evaluable subjects reporting a PBLAC score of ≤ 100. The median pain rating was ≤2 (mild) throughout the treatment. Of 223 subjects that underwent hysteroscopic evaluation at 12 months, the uterine cavity was visualized in 220 subjects. Quality of life improved with 90% of reporting subjects indicating satisfied or very satisfied at month 12. CONCLUSION: This study demonstrated that Cerene cryoablation is safe and effective, offering the benefits of reduced menstrual blood loss with limited use of pain medication, high patient tolerability, quality of life improvement, and preserved access to the uterine cavity.

Vascular Pseudoinvasion After Endometrial Ablation.

Vascular pseudoinvasion or displacement of tumor or normal endometrial tissue is a potential pitfall in uterine pathology. The proposed mechanisms of this phenomenon are mostly associated with the uterine manipulator used during minimally invasive hysterectomies. The aim of this report is to describe vascular pseudoinvasion in a still unreported setting, that of a postendometrial ablation hysterectomy, and to provide a summary of studies dealing with artifactual or nonmalignant myometrial vessel involvement by normal or neoplastic endometrial tissue.

Pathological findings in the endometrium after microwave endometrial ablation.

The acceptance of MEA in Japan is well demand due to its outstanding effectiveness and safety. Infrequently, a repeat MEA or hysterectomy is needed for recurrent menorrhagia in case of failure ablation. The reasons of recurrent menorrhagia subsequent MEA treatment are unclear. The objective of current study is to identify the possible causes of menorrhagia repetition following MEA, together with the observation of histological changes in the endometrium due to this treatment compared with normal cycling endometrial tissue. A total of 170 patients, 8 (4.7%) of them carried out hysterectomy after 16.8 months (range, 2-29 months) of MEA treatment. Normal (n = 47) and MEA (n = 8) treated paraffin embedded endometrial tissue were prepared for hematoxylin and eosin (H&E) and immunostaining study to recognize the histological changes in the endometrium as a result of MEA treatment. The histological features observed increased tubal metaplasia (TM) including negative expression of the estrogen receptor (ER) and progesterone receptor (PR) in the endometrium subsequent MEA treatment. Increased TM together with the absence of ER and PR expression might be a reasonable explanation for repetition menorrhagia in cases of failure ablation. Further study is required to clarify the molecular mechanisms of tubal metaplasia and the expression loss of hormone receptor in the endometrium as a result of MEA treatment. Current studies propose that low dose estrogen-progestin may not be effective with recurrent menorrhagia patient's due to the inadequacy of hormone receptor expression in the endometrium following MEA.

Intrauterine fundal anaesthesia during endometrial ablation in the office: A randomised double-blind, non-inferiority trial.

OBJECTIVE: To evaluate the effect of intrauterine fundal anaesthesia during outpatient endometrial ablation. STUDY DESIGN: A randomised, double-blinded non-inferiority trial was performed in one hospital and one independent treatment center in the Netherlands. A total of 96 women who were planned for a NovaSure® endometrial ablation under local anaesthesia between December 2015 and February 2018 were included in this trial. These women were randomised to paracervical anaesthesia combined with hysteroscopic fundal infiltration with anaesthestics or paracervical anaesthesia combined with hysteroscopic fundal infiltration with saline. The primary outcome was pain during ablation. To study non-inferiority of paracervical anaesthesia without fundal anaesthesia, we assessed the co-primary endpoints Faces Pain Score and Numeric Rating Score. Secondary outcomes included pain scores at other moments during and after the procedure, postoperative use of analgesics, satisfaction, side-effects and complications. The primary outcomes were tested with a non-inferiority margin (2.0 points on changes in pain), and the secondary outcomes were compared using conventional statistical methods. RESULTS: Paracervical anaesthesia without fundal anaesthesia did not establish non-inferiority to the combination of paracervical anaesthesia and fundal infiltration with anaesthetics when both primary outcome variables of pain were taken into account (Numeric Rating Scale 5.0 versus 3.9 (mean difference 1.2 (95% CI 0.1-2.2)) and Faces Pain Score 5.4 versus 4.8 (mean difference 0.6 (95% CI -0.3-1.5))). Secondary pain scores measured during the procedure were higher or similar in women receiving fundal infiltration with saline as compared to women who received fundal infiltration with anaesthetics. After the procedure, there were no differences in reported pain scores, satisfaction, and side-effects. In the group who received fundal infiltration with saline, more women were admitted to the hospital because of severe pain (3 versus 0 women) and endometritis (1 versus 0 women). CONCLUSION: This study did not confirm non-inferiority of paracervical anaesthesia without fundal anaesthesia to the combination of paracervical anaesthesia with fundal anaesthesia in the reduction of pain during endometrial ablation and therefore provides no reason to leave out fundal anaesthesia. We recommend to use fundal anaesthesia combined with paracervical anaesthesia to reduce pain during endometrial ablation in the office.

Endometrial ablation or resection versus levonorgestrel intra-uterine system for the treatment of women with heavy menstrual bleeding and a normal uterine cavity: a systematic review with meta-analysis.

BACKGROUND: Endometrial ablation/resection and the levonorgestrel intra-uterine system (LNG-IUS) are well-established treatment options for heavy menstrual bleeding to avoid more invasive alternatives, such as hysterectomy. OBJECTIVE: The aim was to compare the efficacy and safety of endometrial ablation or resection with the LNG-IUS in the treatment of premenopausal women with heavy menstrual bleeding and to investigate sources of heterogeneity between studies. SEARCH METHODS: We searched the databases MEDLINE, EMBASE, CENTRAL, Web of Science, Biosis and Google Scholar as well as citations and reference lists published up to August 2019. Two authors independently screened 3701 citations for eligibility. We included randomized controlled trials published in any language, comparing endometrial ablation or resection to the LNG-IUS in the treatment of premenopausal women with heavy menstrual bleeding and a normal uterine cavity. OUTCOMES: Thirteen studies (N = 884) were eligible. Two independent authors extracted data and assessed the quality of included studies. Random effect models were used to compare the modalities and evaluate sources of heterogeneity. No significant differences were observed between endometrial ablation/resection and the LNG-IUS in terms of subsequent hysterectomy (primary outcome, risk ratio (RR) = 1.13, 95% CI 0.60 to 2.11, P = 0.71, I2 = 14%, 12 studies, 726 women), satisfaction, quality of life, amenorrhea and treatment failure. However, side effects were less common in women treated with endometrial ablation/resection compared to the LNG-IUS (RR = 0.52, 95% CI 0.37 to 0.71, P < 0.001, I2 = 0%, 10 studies, 580 women). Three complications were reported in the endometrial ablation/resection group and none in the LNG-IUS group (P = 0.25). Mean age of the studied populations was identified as a significant source of heterogeneity between studies in subgroup analysis (P = 0.01). In fact, endometrial ablation/resection was associated with a higher risk of subsequent hysterectomy compared to the LNG-IUS in younger populations (mean age ≤ 42 years old, RR = 5.26, 95% CI 1.21 to 22.91, P = 0.03, I2 = 0%, 3 studies, 189 women). On the contrary, subsequent hysterectomy seemed to be less likely with endometrial ablation/resection compared to the LNG-IUS in older populations (mean age > 42 years old), although the reduction did not reach statistical significance (RR = 0.51, 95% CI 0.21 to 1.24, P = 0.14, I2 = 0%, 5 studies, 297 women). Finally, sensitivity analysis taking into account the risk of bias of included studies and type of surgical devices (first and second generation) did not modify the results. Most of the included studies reported outcomes at up to 3 years, and the relative performance of endometrial ablation/resection and LNG-IUS remains unknown in the longer term. WIDER IMPLICATIONS: Endometrial ablation/resection and the LNG-IUS are two excellent treatment options for heavy menstrual bleeding, although women treated with the LNG-IUS are at higher risk of experiencing side effects compared to endometrial ablation/resection. Otherwise, younger women seem to present a lower risk of eventually requiring hysterectomy when treated with the LNG-IUS compared to endometrial ablation/resection.

Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years after Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding.

STUDY OBJECTIVE: Patients who have undergone endometrial ablation may present a diagnostic challenge when they subsequently develop vaginal bleeding, pelvic pain, or postmenopausal bleeding. Extensive scarring of the uterine cavity often precludes evaluation and/or conservative treatment. For further research on this topic, we performed hysteroscopic examination in study subjects a mean duration of 4 years after they had undergone water vapor endometrial ablation. DESIGN: Prospective, multicenter, observational clinical study. SETTING: Eight private practice or outpatient sites in the United States and Mexico. PATIENTS: Seventy subjects who had completed their 36-month follow-up in the AEGEA Pivotal Trial. INTERVENTIONS: Diagnostic hysteroscopy. MEASUREMENTS AND MAIN RESULTS: The subjects were screened for general health and infection and underwent diagnostic hysteroscopy. Menstrual bleeding status was recorded. The video of the hysteroscopic examination was analyzed by an independent reviewer, who assessed uterine cavity access and visualization of the cornua and tubal ostia as well as characterized adhesions on the basis of the criteria by March et al. An independent reviewer also subjectively assessed whether Pipelle endometrial biopsy or intrauterine device placement would be feasible. Uterine cavity access was achieved in 90% (63/70) of subjects. Among subjects with cavity access, the cornua and ostia were visualized in 79% (50/63) and adhesions were absent in 75% (47/63), with only 2 women having severe adhesions (3%, 2/63). Biopsy was projected to be feasible in 86% (62/70) and intrauterine device placement in 60% (42/70) of all subjects. The subjects' bleeding statuses were not correlated with uterine cavity access. The results were consistent for subjects with large uterine cavities and International Federation of Gynecologic and Obstetrics type II to VI myomas ≤4 cm. CONCLUSION: Water vapor endometrial ablation preserved an accessible uterine cavity and visualization of the ostia in most subjects, with minimal incidence of severe adhesions, a mean of 4 years after the ablation procedure.

High-intensity Focused Ultrasound for Treatment of Type 2 Submucous Myomas More Than 4 Centimeters in Diameter Prior to Hysteroscopic Myomectomy.

STUDY OBJECTIVE: To assess the feasibility of treating type 2 submucous myomas more than 4 cm in diameter with high-intensity focused ultrasound (HIFU) prior to hysteroscopic myomectomy (HM). DESIGN: Retrospective case series evaluating HIFU treatment of type 2 submucous myomas before HM, with efficacy compared with baseline (i.e., before treatment). SETTING: Teaching hospital. PATIENTS: Five women with type 2 submucous myomas more than 4 cm in diameter (mean, 5.6 cm; range, 4.7-6.3 cm). The mean age of the patients was 40.6 years (31-47 yr); median age 42 years. INTERVENTIONS: Type 2 submucous myomas were treated with HIFU. HM was performed in one step. MEASUREMENTS AND MAIN RESULTS: The time between HIFU and HM was 136 days. The mean volumes of the corpora and myomas were significantly less after HIFU. The mean shrinkage of the corpora and myomas (volume before HIFU/volume before HM × 100%) were 41.4 ± 18.1% and 67.6 ± 17.0%, respectively, which did not differ statistically. All 5 of the submucous myomas changed from type 2 to type 1 or type 0 after HIFU treatment. The percentage of the uterine cavity occupied by the myoma at baseline and after HIFU was 38.8% ± 2.8% and 78.0 ± 21.4%, respectively, a significant increase associated with HIFU. The hemoglobin increased with HIFU, significantly with an elevated value of 11.0 ± 7.5. CONCLUSION: Treatment of type 2 submucous myomas more than 4 cm in diameter with HIFU before HM was effective, with reductions in myoma type (from 2 to 1 or 0) and shrinkage of myoma size. HIFU as a pretreatment should increase the safety of HM.

Venous Gas Embolism during Hysteroscopic Endometrial Ablation: Report of 5 Cases and Review of the Literature.

STUDY OBJECTIVE: To highlight the circumstances, presentation, and treatment of venous gas embolism (VGE) and provide guidance and propose potential changes in surgical practice and perioperative monitoring to minimize the adverse consequences and sequalae of this potentially serious complication. DESIGN: A case series. SETTING: A university-affiliated teaching hospital. PATIENTS: Five women developed VGE during hysteroscopic endometrial ablation. INTERVENTIONS: From 1990 through 2014, the principle author (G.A.V.) performed 5249 primary and 458 repeat hysteroscopic endometrial ablations under general anesthesia using a monopolar 26F (9-mm) resectoscope connected to a peristaltic pump-driven active inflow and outflow irrigation and distension system (1.5% glycine) and an 8-mm monopolar loop electrode at a 120-W continuous (cut) and/or a 3- to 5-mm rollerball interrupted (coagulation) waveform or a combination of them. MEASUREMENTS AND MAIN RESULTS: Among 5707 procedures, we encountered 5 (0.09%, 1/1140) incidents of VGE during primary ablations. All patients exhibited the same symptoms of ventilatory and hemodynamic decompensation, beginning with a reduction in end-tidal carbon dioxide and arterial oxygen desaturation. All patients recovered after immediate cessation of the surgery and resuscitation including ventilatory support with 100% O2 and intravenous fluids. CONCLUSIONS: Although entrainment of some air/gas bubbles is common during hysteroscopy, life-threatening/fatal VGE is rare (1/1140 cases). Situational awareness and strict adherence to certain principles including understanding the conditions, prerequisites, and pathophysiology of VGE; attention to surgical principles and operative technique; close communication with the anesthesiologist; and early therapeutic intervention are of paramount importance to avoid this rare but potentially serious complication.

Comparison of Combined Bipolar Radiofrequency Impedance-Controlled Endometrial Ablation with Levonorgestrel Intrauterine System versus Bipolar Radiofrequency Endometrial Ablation Alone in Women with Abnormal Uterine Bleeding.

STUDY OBJECTIVE: This study aims to evaluate the efficacy of the combination of bipolar radiofrequency impedance-controlled endometrial ablation (NovaSure; Hologic Inc., Bedford, MA) and levonorgestrel intrauterine system (LNG-IUS; Mirena; Schering AG, Berlin, Germany) placement in comparison with NovaSure endometrial ablation alone in patients with abnormal uterine bleeding (AUB). DESIGN: A propensity score matching study. SETTING: Beijing Tiantan Hospital, Capital Medical University, Beijing, China. PATIENTS: A retrospective study was conducted on 246 patients with AUB who underwent NovaSure endometrial ablation with (NovaSure+LNG-IUS group) or without (NovaSure group) LNG-IUS between January 2013 and August 2016. To overcome selection bias, propensity score matching was used to establish a 1:1 match between these 2 groups. Accordingly, 41 patients were included in each group. INTERVENTION: NovaSure endometrial ablation, immediately followed by LNG-IUS insertion in the NovaSure+LNG-IUS group, and NovaSure endometrial ablation alone in the control group. MEASUREMENTS AND MAIN RESULTS: Follow-up assessments performed at postablation months 6, 12, and 24 revealed the following: The rate of amenorrhea (78.05% vs 46.34%, 85.37% vs 53.65%, and 87.80% vs 58.54%, respectively; p <.005) and the rate of dysmenorrhea remission (100% vs 70.59%, 100% vs 64.70%, and 100% vs 64.70% [p <.05, p <.01, and p <.01], respectively) were significantly higher in the NovaSure+LNG-IUS group than in the NovaSure group. The rate of reinterventions was similar for both groups at postablation month 6. However, at postablation months 12 and 24, these rates were significantly lower in the NovaSure+LNG-IUS group than in the NovaSure group (0 vs 14.63% and 2.44% vs 21.95% [p <.05 and p <.01], respectively). CONCLUSION: For women with AUB, the combination of NovaSure endometrial ablation and LNG-IUS is more effective than NovaSure alone in achieving amenorrhea, alleviating dysmenorrhea and reducing reinterventions.