M.R. Hopkins

Prediction of Treatment Outcomes After Global Endometrial Ablation

OBJECTIVE: To report rates of amenorrhea and treatment failure after global endometrial ablation and to estimate the association between patient factors and these outcomes by developing and validating prediction models. METHODS: From January 1998 through December 2005, 816 women underwent global endometrial ablation with either a thermal balloon ablation or radio frequency ablation device; 455 were included in a population-derived cohort (for model development), and 361 were included in a referral-derived cohort (for model validation). Amenorrhea was defined as cessation of bleeding from immediately after ablation through at least 12 months after the procedure. Treatment failure was defined as hysterectomy or reablation for patients with bleeding or pain. Logistic and Cox proportional hazard regression models were used in model development and validation of potential predictors of outcomes. RESULTS: The amenorrhea rate was 23% (95% confidence interval [CI] 19–28%) and the 5-year cumulative failure rate was 16% (95% CI 10–20%). Predictors of amenorrhea were age 45 years or older (adjusted odds ratio [aOR] 2.6, 95% CI 1.6–4.3); uterine length less than 9 cm (aOR 1.8, 95% CI 1.1–3.1); endometrial thickness less than 4 mm (aOR 2.7, 95% CI 1.2–6.3); and use of radio-frequency ablation instead of thermal balloon ablation (aOR 2.8, 95% CI 1.7–4.9). Predictors of treatment failure included age younger than 45 years (adjusted hazard ratio [aHR] 2.6, 95% CI 1.3–5.1); parity of 5 or greater (aHR 6.0, 95% CI 2.5–14.8); prior tubal ligation (aHR 2.2, 95% CI 1.2–4.0); and history of dysmenorrhea (aHR 3.7, 95% CI 1.6–8.5). After global endometrial ablation, 23 women (5.1%, 95% CI 3.2–7.5%) had pelvic pain, three (0.7%, 95% CI 0.1–1.9%) were pregnant, and none (95% CI 0–0.8%) had endometrial cancer. CONCLUSION: Population-derived rates and predictors of treatment outcomes after global endometrial ablation may help physicians offer optimal preprocedural patient counseling. LEVEL OF EVIDENCE: II

Global endometrial ablation for menorrhagia in women with bleeding disorders

OBJECTIVE: To evaluate the efficacy of global endometrial ablation in women with bleeding disorders who presented with menorrhagia. METHODS: A records-linkage system was used to construct a retrospective cohort of 41 women with bleeding disorders (coagulopathy) and a reference group of 111 randomly selected women without bleeding disorders from a pool of 943 women who underwent global endometrial ablation (with thermal balloon ablation technology or bipolar radiofrequency ablation technology) for menorrhagia at Mayo Clinic (Rochester, Minnesota) from January 1995 through December 2005. Demographic data, type of global endometrial ablation therapy and reablation, and hysterectomy data were extracted from the database. RESULTS: There was no significant difference in baseline age, parity, body mass index, uterine size, type of global endometrial ablation therapy, or duration of follow-up between the groups. Two women (5%) in the coagulopathy group had hysterectomy or reablation, compared with 8 (7%) in the reference group (Fisher exact test, P=.728). A Kaplan-Meier plot showed no difference in the time to treatment failure between the groups (log-rank test, P=.534). Procedural-related complications were generally minor and infrequent (9 of 152 [6%]). Complications were equally distributed in the coagulopathy (4 of 41) and reference groups (6 of 111) (Fisher exact test, P=.267). CONCLUSION: Global endometrial ablation is an effective treatment choice for women with coagulopathy presenting with menorrhagia. LEVEL OF EVIDENCE: II

Endometrial Cancer After Endometrial Ablation: Systematic Review of Medical Literature

Data are limited regarding the occurrence of endometrial cancer after endometrial ablation (EA). A systematic review of the English-language medical literature was performed of cases of endometrial cancer after EA. This review included the present case report involving a 47-year-old woman with a diagnosis of stage IA, grade 1 endometrial adenocarcinoma 5 years after radiofrequency EA. The systematic literature review identified 22 endometrial cancer cases occurring after EA. Most (76.5%) were stage I at diagnosis. Time to endometrial cancer diagnosis ranged from 2 weeks to 10 years following EA. All but 3 cases involved patients with known endometrial cancer risk factors. To our knowledge, the present case is the first reported occurrence of endometrial cancer after radiofrequency EA. Endometrial cancer has been detected after EA at variable intervals. Occurrence of endometrial cancer after EA is low, yet it continues to be difficult to quantify through retrospective analyses.

Pathologic Characteristics of Hysterectomy Specimens in Women Undergoing Hysterectomy after Global Endometrial Ablation

STUDY OBJECTIVE To describe uterine pathologic features in women who underwent hysterectomy because of failed global endometrial ablation (GEA). DESIGN Retrospective cohort study from 1998 through 2005 (Canadian Task Force classification III). SETTING Tertiary referral center. PATIENTS Sixty-nine women who underwent hysterectomy because of GEA failure. INTERVENTIONS Pathology reports were available for 67 patients. Descriptions of hysterectomy specimens after GEA were reviewed. MEASUREMENTS AND MAIN RESULTS Rates of pathologic findings in hysterectomy specimens after failed GEA were determined. Reasons for hysterectomy in the 67 patients with available pathology reports were bleeding in 34 (51%), pain in 19 (28%), and bleeding and pain in 14 (21%). The pathology reports of these specimens showed leiomyomas in 33 specimens (49%); intramural myomas were present in 15 women (44%) who underwent hysterectomy because of bleeding and 8 women (42%) who underwent hysterectomy because of pain. Hematometra was identified in 7 pathologic specimens (10%). Specifically, hematometra was identified in specimens from 5 of 19 women who underwent hysterectomy because of pain (26%). CONCLUSION Hematometra was a significant finding in women who underwent hysterectomy because of persistent pain after GEA. A possible pathologic predictor of GEA failure may be intramural leiomyomas.

Efficacy and safety of global endometrial ablation after cesarean delivery: a cohort study

OBJECTIVE The objective of the study was to evaluate the efficacy and safety of global endometrial ablation in women with a history of cesarean delivery. STUDY DESIGN We performed a historical cohort study of patients who underwent endometrial ablation for menorrhagia between 1998 and 2005. Outcome measures included amenorrhea, treatment failure, and operative complications. Time to treatment failure was compared using Kaplan-Meier analysis. Risk adjustments were performed using Cox and logistic regression models. RESULTS Of 704 patients meeting inclusion criteria, 162 (23%) had a history of 1 or more cesarean deliveries. Women with and without a history of cesarean delivery had comparable rates for 5 year cumulative endometrial ablation failure, amenorrhea, treatment failure, and operative complications. The type of ablation device and number of previous cesarean deliveries did not affect any outcomes. CONCLUSION The efficacy and safety of endometrial ablation are comparable in women with or without a history of cesarean delivery.

Efficacy of bipolar radiofrequency endometrial ablation vs thermal balloon ablation for management of menorrhagia: A population-based cohort.

STUDY OBJECTIVE To compare the efficacy of bipolar radiofrequency ablation (RFA) and thermal balloon ablation (TBA) using treatment failure and postprocedure amenorrhea as outcome measures. DESIGN Population-based cohort study (Canadian Task Force classification II-2). SETTING Two medical centers in the upper Midwest. PATIENTS Using the medical records linkage system of the Rochester Epidemiology Project, we identified 455 residents of Olmsted County, Minnesota, who underwent global endometrial ablation because of menorrhagia from January 1, 1998, through December 31, 2005. Amenorrhea was defined as complete cessation of menstruation that started immediately after ablation and lasted at least 12 months. Treatment failure was defined as necessity of repeat ablation or hysterectomy because of persistent bleeding or pain. Time to treatment failure for each procedure was compared using Kaplan-Meier plots. Relevant clinical data and complications were abstracted from medical records. Risk adjustments were performed using Cox and logistic regression models. INTERVENTIONS Radiofrequency ablation (n=255) and thermal balloon ablation (n=200). MEASUREMENTS AND MAIN RESULTS Mean (SD) patient age was 43.3 (5.5) years, and median follow-up was 2.2 years. The 3-year cumulative failure rate was 9% (95% confidence interval [CI], 5%-16%) for RFA and 12% (95% CI, 7%-16%) for TBA (p=.26). The difference remained nonsignificant after adjusting for known predictors of treatment failure such as age, parity, pretreatment dysmenorrhea, and tubal ligation (adjusted HR, 0.7; 95% CI, 0.4-1.4; p=.31). However, women had significantly higher rates of amenorrhea after RFA compared with TBA (32% vs 14%; p <.001). This difference remained significant after adjusting for known predictors of amenorrhea such as age, uterine length, and endometrial thickness (adjusted odds ratio, 2.9; 95% CI, 1.7-4.8; p <.001). Complications were infrequent and similar in the 2 groups. CONCLUSION Both RFA and TBA were equally effective treatments for menorrhagia in a population-based cohort. However, women who underwent RFA were 3 times more likely to have postprocedure amenorrhea.

Safety of culdotomy as a surgical approach: implications for natural orifice transluminal endoscopic surgery.

Data from this study support the feasibility and safety of utilizing the cul-de-sac as an access port to the peritoneal cavity for natural orifice transluminal endoscopic surgery.

Health-related quality of life and patient satisfaction after global endometrial ablation for menorrhagia in women with bleeding disorders: a follow-up survey and systematic review

OBJECTIVE The purpose of this study was to describe health-related quality of life and satisfaction after global endometrial ablation in women with bleeding disorders and a systematic review of the literature. STUDY DESIGN A follow-up survey was mailed to 36 patients with bleeding disorders and 110 reference patients (no coagulopathies) who underwent global endometrial ablation for menorrhagia. The survey included a generic (SF-12) and menorrhagia multi-attribute utility scale questionnaires. RESULTS Ninety-six women (66%) responded. The total menorrhagia multiattribute utility scale score increased from 35-100 in bleeding disorder cohort (P = .03) and from 48-100 in the reference cohort (P < .001). Although postablation SF-12 mental domain scores were comparable in both cohorts (55 vs 55; P = .67), physical domain scores were lower in the bleeding disorder cohort (50 vs 56; P < .001). High satisfaction was reported by both cohorts (95% vs 84%; P = .60). CONCLUSION Global endometrial ablation improved health-related quality of life for women with bleeding disorders and had high satisfaction rates.

Endometrial ablation for the treatment of heavy menstrual bleeding in obese women

To compare the efficacy and safety of endometrial ablation (EA) among obese versus non‐obese women.

Term pregnancy with intraperitoneal levonorgestrel intrauterine system: a case report and review of the literature

BACKGROUND The risk of adverse effects of fetal exposure to the levonorgestrel intrauterine system (LNG-IUS) has not been established. STUDY DESIGN In this case report and literature review, we describe a pregnant patient with an intraperitoneal LNG-IUS and the subsequent maternal and neonatal outcomes. A systematic literature search was performed to identify similar clinical reports. The MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, CENTRAL, Web of Science and Scopus databases were searched from inception through March 2007. RESULTS The pregnancy progressed uneventfully and culminated in the elective cesarean delivery of a full-term healthy boy. Of the 35 pregnancies identified in the literature review (34 pregnancies with intrauterine LNG-IUS and 1 term delivery with intraperitoneal LNG-IUS), congenital anomalies were reported in 2 infants (6%). CONCLUSIONS Fetal exposure to LNG-IUS is associated with a low frequency of congenital anomalies.