NovaSure impedance controlled system for endometrial ablation: three-year follow-up on 107 patients

OBJECTIVE: This study was undertaken to assess the safety, efficacy, and data durability of the NovaSure ablation at 3 years after the procedure in women with menorrhagia secondary to dysfunctional uterine bleeding (DUB). STUDY DESIGN: A prospective, single-arm, observational pilot study (Canadian Task Force classification II-1) was carried out at a specialized center for gynecologic endoscopy with 107 premenopausal women with menorrhagia secondary to DUB. NovaSure ablation was performed in 107 patients. Pictorial Blood loss Assessment Chart diary sampling was used to assess menstrual blood loss. Ablation was performed without any type of endometrial pretreatment. RESULTS: No intraoperative or postoperative complications were observed. Treatment time averaged 94 seconds; 65% of the patients reported amenorrhea. Hysterectomy was avoided in 97.2% of patients at 3-year follow-up. CONCLUSION: Long-term clinical results demonstrate that the NovaSure system is a safe and effective method for treatment of women with menorrhagia secondary to DUB, yielding high amenorrhea and success rates, with low re-treatment rates.     

Endometrial ablation with the NovaSure system in Iran

Objective

To evaluate the rate of response to treatment with the NovaSure endometrial ablation device among Iranian women with menorrhagia.

Methods

Twenty 35-50-year-old women with menorrhagia who were referred to Arash Hospital, Tehran, Iran, in 2008 were enrolled. They underwent endometrial ablation via the NovaSure system and were followed-up for 2 years.

Results

The incidence of amenorrhea was 30.0% at the end of the 2-year follow-up period. Hypomenorrhea was reported by 40.0% of women. The mean number of days of bleeding per month decreased significantly, from 30.0 ± 6.4 days before treatment to 3.1 ± 2.6 days after 2 years (P < 0.001). The severity of bleeding decreased significantly within 2 years after treatment (P < 0.001). In total, 85.0% of women were satisfied and 90.0% had responded to treatment—as defined by amenorrhea, hypomenorrhea, or return to normal menstruation.

Conclusion

The NovaSure system is effective and should be considered by gynecologists for the treatment of menorrhagia.     

Long-term outcome of hysteroscopic endometrial ablation without endometrial preparation

OBJECTIVE: To describe the three-step hysteroscopic endometrial ablation (EA) technique without endometrial preparation, and its long-term outcomes. STUDY DESIGN: Four hundred and thirty-eight premenopausal women with menorrhagia or menometrorrhagia underwent three-step hysteroscopic EA, which consists of rollerball ablation of the fundus and cornual regions, a cutting loop endomyometrial resection of the rest of the cavity, and rollerball redessication of the whole pre-ablated uterine cavity. The main outcome measures were menstrual status, level of satisfaction with the procedure, and the need for repeat ablation or hysterectomy. Questionnaires were completed for 385 women (87.9%) with a mean follow-up of 48.2 months. RESULTS: One hundred and eighty-four responders (47.8%) reported amenorrhea; 177 (46%) had light to normal flow. One patient (0.3%) underwent repeat ablation and 20 (5.2%) underwent hysterectomy: 15 (3.9%) because of endometrial ablation failure and 5 (1.3%) because of indications unrelated to the ablation (three cases of atypical endometrial hyperplasia and two cases of fibroids). Two hundred and ninety-two patients (75.8%) were very satisfied, and 78 (20.3%) satisfied with the results. No major complications occurred and three women (0.8%) became pregnant during the follow-up period. CONCLUSIONS: EA is safe and effective means of treating of menorrhagia and menometrorrhagia in premenopausal women, and helps avoid hysterectomy in 95% of patients suffering from heavy bleeding, with or without uterine fibroids. Women should be informed that the procedure is not contraceptive and that pregnancy is possible after treatment.     

Thermal endometrial ablation in dysfunctional uterine bleeding: an economic comparison of bipolar ablation and balloon ablation

Objective: A bipolar radio-frequency impedance-controlled endometrial ablation system is more effective than balloon ablation in the treatment of dysfunctional uterine bleeding. The aim of the present study was to compare the costs of both treatments, and to perform a cost-effectiveness analysis. Study design: An economic evaluation was set up alongside a randomised clinical trial comparing bipolar radio-frequency endometrial ablation and balloon ablation in 126 patients with dysfunctional uterine bleeding. Data on resources used for treatment and lost production time were prospectively collected, and costs of both treatments were calculated. Results: Mean direct medical costs per patient were €1638 for bipolar ablation and €1545 for thermal balloon ablation with a mean difference of €93 (95% CI €45–140, P-value 0.01). Mean indirect medical costs were just over €200 in each group. Incorporation of the costs of post-ablation hysterectomies resulted in mean costs of €2006 and €2053 in the balloon group (P-value 0.01). In the balloon group, the cost per satisfied patient was €2333 compared to €2112 in the bipolar group. Similarly, in the bipolar group the cost per amenorrhoeic patient was €4361 and in the balloon group €12831. Conclusions: The direct costs of bipolar ablation were higher than the costs of balloon ablation. However, after inclusion of the retreatment costs, bipolar ablation was less expensive than balloon ablation.     

Hysterectomy after endometrial ablation

OBJECTIVES: Our purpose was to determine the number of women undergoing hysterectomy after endometrial ablation and the indications for the subsequent surgery. STUDY DESIGN: Forty-two premenopausal women, who had severe menorrhagia associated with a clinically normal examination result, underwent rollerball endometrial ablation between November 1990 and December 1991. Thirty-seven women whom we gave ongoing care were evaluated by chart review. Four women who received care elsewhere were interviewed by telephone. One woman was lost to follow-up. Patients were followed up a minimum of 4 years. Age, parity, operating time, endometrial preparation, preablation sterilization, and preablation dysmenorrhea were assessed in regard to subsequent hysterectomy. Patient satisfaction was assessed at 24 months. Life-table analysis was performed to determine cumulative probability of hysterectomy. RESULTS: Fourteen of the 41 women (34%) underwent hysterectomy within 5 years after rollerball endometrial ablation. Continued abnormal menstrual bleeding and menstrual pain were significantly associated with subsequent hysterectomy. Eleven of the 14 cases of hysterectomy were associated with gross abnormality such as myomas, adenomyosis, endometriosis, and chronic hematosalpinx. A linear relationship between hysterectomy and time was noted. CONCLUSION: On the basis of our findings one third of women undergoing rollerball endometrial ablation for menorrhagia can expect to have a hysterectomy within 5 years. If the linear relationship noted during the first 5 years is extrapolated, theoretically, all women may need hysterectomy by 13 years. Most patients undergo hysterectomy because of significant pelvic abnormality. Further studies with long-term follow-up are needed to define the role of endometrial ablation for menorrhagia. (Am J Obstet Gynecol 1996;175:1432-7.)     

Bipolar radio frequency endometrial ablation compared with balloon endometrial ablation in dysfunctional uterine bleeding: impact on patients' health-related quality of life

OBJECTIVE: To compare health-related quality of life (HRQoL) after bipolar radio frequency ablation and thermal balloon ablation in women with dysfunctional uterine bleeding. DESIGN: Randomized clinical trial. SETTING: Teaching hospital. PATIENT(S): Women suffering from dysfunctional uterine bleeding. INTERVENTION(S): Bipolar radio frequency ablation and thermal balloon ablation. MAIN OUTCOME MEASURE(S): Patients were asked to complete HRQoL questionnaires at baseline, and at 2 days, 2 weeks, 3 months, 6 months, and 12 months after surgery. The questionnaires contained the medical outcomes study Short-Form 36 (SF-36), the Self-rating Depression Scale, the Rotterdam Symptom Checklist, State-Trait Anxiety Inventory, and a structured clinical history questionnaire. RESULT(S): Data on HRQoL were available on at least two different time points in 115 of 126 randomized patients. HRQoL improved significantly over time in both groups, except for the domain of general health in the SF-36. None of the dimensions showed a significant difference between both groups, neither was there a significant interaction between time and treatment effect. CONCLUSION(S): Both methods significantly improved HRQoL in women with dysfunctional uterine bleeding. However, despite better amenorrhea and satisfaction rates after bipolar radio frequency ablation, there was no difference in HRQoL between the two groups.     

Patient outcomes following an endometrial thermal balloon ablation (thermochoice) procedure for menorrhagia in a day surgery unit

This study was carried out to assess the efficacy, complication rate and acceptability of endometrial thermal balloon ablation in a District General Hospital in the South West of England.     

Feasibility of endometrial assessment after thermal ablation

Objective

To evaluate the feasibility of endometrial assessment after endometrial thermal ablation.

Study design

Prospective observational study. A total of 57 women (age 47–52 years), who had undergone endometrial thermal ablation as a treatment for heavy menstrual bleeding (HMB) 3–10 years (mean 6 years) earlier, were examined with transvaginal ultrasound and saline sonohysterography. Endometrial samples were collected with a Pipelle device. Visualisation of endometrium, access to uterine cavity, change in cavity length, success in outpatient endometrial sampling and success in sonohysterography were evaluated.

Results

Endometrial thickness was 4.5 mm in amenorrhoeic women (n = 17), 5.6 mm in eumenorrhoeic women (n = 37) and 6.6 mm in hypermenorrhoeic women (n = 3). An endometrial sample was successfully taken in 44 (77%) women, and in 13 (23%) women endometrial sample taking failed. The length of the uterine cavity compared to the length measured before endometrial thermal ablation was 0.5–5 cm (mean 2 cm) shorter in 34 women, unchanged in four women and longer in five women. The uterine cavity distended regularly in only nine (16%) women. In 14 (25%) women the cavity distended irregularly or only partly, and in 24 (42%) women the uterine cavity did not distend at all, but appeared as a narrow tube. In 10 (18%) women the sonohysterography catheter did not enter the uterine cavity at all.

Conclusion

Endometrial assessment is compromised after previous endometrial thermal ablation. Both endometrial sampling and sonohysterography fail quite often, causing problems in diagnosis of abnormal bleeding. Intrauterine adhesions may also decrease the reliability of the endometrial sampling.     

Thermablate EAS: a new endometrial ablation system

Objective To report on Thermablate EAS, the newest endometrial thermal balloon ablation system now available.Design Thermablate EAS consists of a light-weight reusable hand-held treatment control unit (TCU) with a single use disposable catheter–balloon–cartridge system. Treatment time is <2.5 min. A 6.0-mm diameter catheter allows it to be used in an office or outpatient setting utilizing minimal anesthesia/analgesia.Results Six-month follow-up data obtained under a Special Access Program for Health Canada in a series of 54 patients showed amenorrhea 20%, spotting 20%, hypomenorrhea 37%, eumenorrhea 16%, and persisting menorrhagia 6%.Conclusion Thermablate EAS is the smallest, most portable, and simplest endometrial ablation presently available. High rates of clinical success and patient satisfaction combined with enthusiastic acceptance by clinicians of this compact device makes it a very attractive endometrial ablation system.D.B. Yackel is coinventor of Thermablate EAS and is a shareholder of MDMI Technologies, Inc.     

Prognostic factors for the success of endometrial ablation in the treatment of menorrhagia with special reference to previous cesarean section

Objective

To assess whether, among other prognostic factors, a history of Cesarean section is associated with endometrial ablation failure in the treatment of menorrhagia.Study design We compared women who had failed ablation to women who had successful ablation for menorrhagia in a case–control study. Failed ablation was defined as the need for hysterectomy due to persistent heavy menstrual bleeding after ablation. Successful ablation was defined as an ablation for menorrhagia not needing hysterectomy and the woman being satisfied with the result. Both cases and controls were identified from the surgery registration in the Máxima Medical Center between January 1999 and January 2009. Cases were women that had an endometrial ablation and a hysterectomy, whereas controls only had an endometrial ablation. From the medical files we collected for each patient clinical history, including the presence of a previous Cesarean section, baseline characteristics at the moment of initial ablation, data of the ablation technique and follow-up status. We used univariable and multivariable logistic regression to estimate the risk of failure of endometrial ablation.

Results

We compared 76 cases to 76 controls. Among the cases, 12 women had had a previous Cesarean section versus 15 in the control group (15.8% versus 19.7%; odds ratio (OR) 0.76; 95% CI 0.3–1.8). Factors predictive for failure of ablation were dysmenorrhea (OR 3.0; 95% CI 1.5–6.1), having a submucous myoma (OR 3.2; 95% CI 1.5–6.8) and uterine depth (per cm OR 1.3; 95% CI 1.0–1.6). Presence of intermenstrual bleeding, sterilization and age were not associated with failure of ablation.

Conclusion

A previous Cesarean delivery is not associated with an increased risk of failure of endometrial ablation, but dysmenorrhea, a submucous myoma and longer uterine depth are. This should be incorporated in the counseling of women considering endometrial ablation.     

Beware: pregnancy and second-generation endometrial ablation

With the promotion of second-generation endometrial ablative techniques—namely thermal balloon endometrial ablation and microwave endometrial ablation—as alternatives to hysterectomy for dysfunctional uterine bleeding, with phrases like three-minute hysterectomy, some women become complacent about contraception after ablation. Some even assume that hysterectomy, as widely used in the popular press, means no more children. Pregnancy after endometrial ablation does not represent a failure of the technique. The failure is due to poor counselling or to women not taking the advice to use appropriate contraception after the procedure.     

Microwave endometrial ablation and pregnancies: case series

Microwave endometrial ablation (MEA) is the most commonly used new generation ablative technique in the UK. It is one of the new generation techniques recommended for management of menorrhagia by NICE. They are favoured over Tran cervical resection or ablation because of the ease of use and equitable effectiveness. Ablative technique usage has increase over the last few years with a reduction in hysterectomy performed for menorrhagia (RCOG). It is offered to women who have completed their family. Adverse complication has been described in pregnancy and endometrial resection and ablation, but there is limited evidence about newer techniques and pregnancy outcome. We found four pregnancies in three women. Three pregnancies were terminated at less than 12 weeks gestation. One pregnancy leads to a successful live birth with no complication in the pregnancy.     

Second generation endometrial ablation techniques: an audit of clinical practice

Objective(s)  To audit the practice and effectiveness of second generation endometrial ablation techniques (microwave and thermal balloon ablation). Design and methods  An audit of microwave and balloon endometrial ablation procedures was completed and performed during a 2-year period, in two district hospitals of Calderdale and Huddersfield NHS Trust, UK. Patients were followed up with for a maximum of 1 year postoperatively, or were referred again from their GPs, with symptoms. A questionnaire was also completed to evaluate patient satisfaction. Results  About 136 and 59 women underwent balloon and microwave endometrial ablation, respectively (Total = 195), for heavy periods. By the end of year 1, 16% of patients were amenorrhoeic and 60% had lighter periods. About 15% of women did not have any relief of symptoms and needed a hysterectomy by 3 years. There were no statistically significant differences in the endometrial ablation techniques. There was no significant effect of age, body mass index, utero-cervical length, or the ablation technique on the results or the hysterectomy rates. A satisfaction survey showed that 75% of women felt better after the procedure and would recommend it to a close friend. Conclusions  Second generation ablation techniques are safe and effective methods of treating dysfunctional uterine bleeding, and are easy to use. They have reduced the incidence of hysterectomies and also have financial implications for healthcare providers.     

Microwave endometrial ablation for menorrhagia in patients with systemic disorders.

OBJECTIVE: To evaluate the effectiveness of microwave endometrial ablation (MEA) in the treatment of menorrhagia in patients with severe systemic disease or medical conditions. METHODS: Forty-two menorrhagic women undergoing systemic disorders with failure of medical management were treated with MEA under local or general anesthesia, and were followed-up for 1 year. RESULTS: The women had a mean age of 39.4 years (range, 17-49). The procedure was successfully completed in all patients, and no intraoperative complications occurred. Two cases died of their primary severe medical diseases within 2 months of treatment but these cases were not associated with MEA. Among the remaining 40 patients, 24 (60.0%) had amenorrhea within 12 months. The duration of hospitalization and the amount of blood transfusion were significantly reduced after treatment, and the quality of life of these patients was improved significantly. CONCLUSIONS: MEA is a safe and effective treatment for the management of severe menorrhagia in patients undergoing systemic illness or severe medical conditions.     

Microwave endometrial ablation (MEA) and bowel injury

Microwave endometrial ablation (MEA) is regarded as an effective nonsurgical option for managing dysfunctional uterine bleeding (DUB). It is believed to be safe, quick, and easy to perform. To our knowledge, there has been only one reported case of a serious complication of a bowel injury during MEA. We report another similar case of accidental uterine perforation and bowel injury.This paper was accepted as an oral communication in the 13th Annual Congress of the European Society of Gynaecological Endoscopy at Cagliari, Sardinia, Italy, 14–18 October 2004.     

Cervical ectopic pregnancy after endometrial ablation: a case report

Case report A 44-year-old woman, with prior endometrial ablation, complaining of heavy vaginal bleeding was diagnosed with cervical ectopic pregnancy. Two doses of intramuscular methotrexate were administered as conservative treatment of the cervical pregnancy. Close follow-up in a dedicated early pregnancy unit allowed successful management on an outpatient basis. Conclusion The urine pregnancy test maintains a crucial role in the investigation of abnormal vaginal bleeding in a sexually active patient. Conservative management of a cervical pregnancy can reduce the potential morbidity and mortality associated with the surgical treatment option.     

Cost-minimisation analysis of endometrial thermal ablation in a day case or outpatient setting under different anaesthesia regimens

Objective

To evaluate the cost difference between a daycase endometrial thermal ablation performed under general anaesthesia and an outpatient endometrial ablation using local anaesthetic.

Study design

Calculations using real reported resource use in 20 daycase procedures and 16 outpatient procedures.

Results

The costs were 1865 euros for daycase procedure versus 1065 euros for outpatient procedure.

Conclusion

The cost of endometrial thermal ablation can be considerably minimised by taking the procedure out of the theatre and performing it under local anaesthetic instead of general anaesthesia. This setting makes endometrial thermal ablation cost-effective.     

Response to an exercise intervention after endometrial cancer: Differences between obese and non-obese survivors

Objective

The objective of this paper is to describe baseline differences between obese and non-obese endometrial cancer survivor in anthropometrics, exercise behavior, fitness, heart rate and blood pressure, and quality of life, and to analyze whether the effect of a home-based exercise intervention on these outcomes differed for obese and non-obese participants.

Methods

One hundred post-treatment Stage I–IIIa endometrial cancer survivors participated in a single arm 6 month study in which they received a home-based exercise intervention. Cardiorespiratory fitness, anthropometrics, and exercise behavior were measured every two months, and quality of life (QOL) and psychological distress were measured at baseline and 6 months.

Results

Adjusting for potential confounders, at baseline obese survivors had poorer cardiorespiratory fitness (p = .002), higher systolic blood pressure (p = .018), and lower physical functioning (p < .001) and ratings of general health (p = .002), and more pain (p = .037) and somatization (.002). Significant improvements were seen in exercise behavior, resting heart rate, systolic blood pressure, and multiple QOL domains over the course of the intervention. Obese survivors had less improvement in exercise behavior and cardiorespiratory fitness than non-obese survivors, but there were no differences with regard to improvements in QOL and stress.

Conclusions

Home based exercise interventions are beneficial to endometrial cancer survivors, including those whose BMI is in the obese range. While obese survivors have lower levels of physical activity and fitness, they experienced similar activity, fitness, quality of life and mental health benefits. Exercise should be encouraged in endometrial cancer survivors, including those who are obese.