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.     

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.     

子宫内膜切除术治疗月经过多100例

目的探讨宫腔镜子宫内膜切除术治疗月经过多的手术指征、手术方法及预后。方法2004年8月至2007年3月应用连续灌流宫腔电切镜。对100例手术指征为保守治疗无效的月经过多，无生育要求，合并粘膜下肌瘤≤5．0cm的患者行子宫内膜切除术。15例同时行子宫粘膜下肌瘤切除术，术后随访3个月至3年。结果除5例因异常子宫出血第二次手术切除子宫外。其余95例月经均有所改变。手术成功率95．0％。术后95例无月经，5例为月经点滴状。14例痛经明显改善。结论子宫内膜切除术可减少或停止月经，切除子宫内膜的同时切除子宫肌瘤。疗效满意。     

微波子宫内膜消除术治疗9例严重内科疾病伴月经过多

目的　探讨微波子宫内膜消除术 (microwaveendometrialablation ,MEA)对严重内科疾病伴月经过多的急救治疗价值及应用研究。方法　对 9例严重内科疾病伴月经过多患者在经期大出血时施行MEA进行急救治疗 ,并进行 1～ 12个月随访。结果　 9例中 6例术中、术后均无阴道出血 ,3例术后出现周期性点滴状出血 ,1例死于原有内科疾病 ,所有各例均达到即时止血目的 ,无一例出现术中、术后并发症 ,使病人生活质量明显改善。结论　MEA是一种安全、快速、高效治疗月经过多的新技术 ,对有严重内科疾病伴月经过多病人急性失血的急救有重要应用价值     

Treatment of Menorrhagia with Tranexamic Acid

Objective: to evaluate the efficacy of tranexamic acid for essential menorrhagia.Subjects: women 18 to 45 years of age with a complaint of heavy menstrual bleeding.Design: two pre-treatment baseline cycles were compared to three consecutive treatment cycles of tranexamic acid (one g taken orally every six hours throughout days one to three of each menstrual period).Main outcome measurements: menstrual blood loss using the pictorial blood loss assessment chart (PBAC) and blood haemoglobin (g/L).Results: all eleven patients recruited into the study had objective evidence of menorrhagia, defined as an average PBAC score of greater than or equal to 100 over two pre-treatment cycles. The median difference between baseline and treatment PBAC scores of 96.8 was statistically significant (p = 0.003, Wilcoxon Signed Ranks Test, Range = 32.8 to 432.8). This represented a median 47.4 percent decrease in menstrual blood flow. Four patients recorded a mean PBAC score of less than 100 for the three treatment cycles, indicating a return to normal menstrual flow of less than 80 mL. Three patients were anaemic upon entry into the study as defined by WHO (haemoglobin < 120 g/L). The mean difference (post trial minus pretrial) in haemoglobin concentrations of 9.5 g/L was statistically significant (P = 0.014, paired t test; 95% Confidence Interval = 3.2 to 10.6) and represented a 7.7 percent increase. Three of the women were dissatisfied with their menstrual flow during each of the three treatment cycles. No major side effects were reported.Conclusions: Tranexamic acid is an effective, well-tolerated medication for the treatment of essential menorrhagia and may be utilitized as a first line therapy.     

Diagnosis and Management of Formerly Called “Dysfunctional Uterine Bleeding” According to PALM-COEIN FIGO Classification and the New Guidelines

In 2011, the FIGO classification system (PALM-COEIN) was published to standardize terminology, diagnostic and investigations of causes of abnormal uterine bleeding (AUB). According to FIGO new classification, in the absence of structural etiology, the formerly called “dysfunctional uterine bleeding” should be avoided and clinicians should state if AUB are caused by coagulation disorders (AUB-C), ovulation disorder (AUB-O), or endometrial primary dysfunction (AUB-E). Since this publication, some societies have released or revised their guidelines for the diagnosis and the management of the formerly called “dysfunctional uterine bleeding” according new FIGO classification. In this review, we summarize the most relevant new guidelines for the diagnosis and the management of AUB-C, AUB-O, and AUB-E.     

Novasure as a Mechanical Endometrial Preparation Agent in Large Uteri

Objective:

We evaluated Novasure ablation as a mechanical endometrial preparation agent before Roller Ball endometrial ablation in lieu of GnRH agonists in large uteri.

Methods:

A retrospective chart review of 20 consecutive patients undergoing Novasure ablation for mechanical endometrial preparation before Roller Ball ablation (RB-Novasure group) was conducted and the results compared to that of 23 consecutive patients who received GnRH agonist (Leuprolide acetate) as a medical endometrial preparation before Roller Ball ablation (RB-Lupron group). The postoperative follow-up time frame was divided into immediate (3 mo), intermediate (3 to 12 mo) and long-term (12 to 32 mo). Rates of amenorrhea, heavy bleeding, cramping, and failure (repeat ablation or hysterectomy for heavy bleeding or persistent pain) were compared between the 2 groups.

Results:

The mean rates of amenorrhea for the patients not lost to follow-up at 3 mo, 3 to 12 mo, and 12 to 32 mo visits were 45.5%, 58.8%, and 44.4% for the RB-Lupron group, and 80%, 86.7%, and 100% for the RB-Novasure group (P = .02, P = .08, and P = .02). Failure rates were 4.8%, 6.2%, and 55.6% for the RB-Lupron group; and 0 (0/20), 12.5% (2/16) and 0 (0/8) for the RB-Novasure group (P = .51, P = .50, and P = .02). The RB-Novasure group had a significantly lower rate of heavy bleeding and cramping. 86.4%, 58.8%, and 33.3% patients reported satisfaction with their treatment in the RB-Lupron group and 100%, 87.5%, and 75% in RB-Novasure group (P = .13, P = .07, and P = .11).

Conclusion:

Novasure ablation, for mechanical endometrial preparation before Roller Ball ablation, appears to be a superior alternative to medical preparation with GnRH agonists in patients with large uteri.     

宫腔镜下滚球电极去除子宫内膜治疗月经过多合并严重内科疾病35例临床分析

目的探讨宫腔镜下滚球电极去除子宫内膜治疗月经过多合并严重内科疾病的疗效。方法收集2010年10月至2012年6月孝感市中心医院收治的因月经过多合并严重内科疾病行宫腔镜滚球电极电凝去除子宫内膜治疗的患者共35例,观察手术情况及术后疗效。结果所有患者手术顺利,合并的内科病情无加重,随访1年,月经改善有效率为97%,贫血纠正率为100%。结论宫腔镜下滚球电极去除子宫内膜治疗月经过多操作相对简单、安全,临床效果显著,对月经过多合并严重内科疾病患者具有重要的临床应用价值。     

Long-Term Patient Satisfaction with Thermal Balloon Ablation for Abnormal Uterine Bleeding

Background and Objective:

Thermal balloon ablation is a minimally invasive surgical technique that can be used to treat abnormal uterine bleeding/heavy menstrual bleeding (AUB/HMB). Most published studies to date provide information on short-term patient satisfaction and outcomes. The purpose of this study was to determine long-term patient satisfaction after thermal balloon endometrial ablation 7 to 10 years postoperatively in a population previously surveyed at the Penn State Milton S. Hershey Medical Center at 1 to 5 years postoperatively.

Methods:

Two-hundred fourteen patients were identified who underwent thermal balloon ablation at our institution between January 1, 2001 and December 31, 2004. These patients were mailed a 2-page survey asking for information on demographics, patient satisfaction, postoperative bleeding patterns, and the need for subsequent surgery. Satisfaction rates, amenorrhea rates, and the rates of women who required hysterectomy were calculated as percentages.

Results:

Ninety-seven patients returned completed surveys. The survey response rate was 62%, excluding 57 surveys that were returned as undeliverable. The follow-up interval was 93 to 129 months. Eighty-seven percent of respondents were satisfied with the results of their procedure compared with 88% in the original study. Subsequent hysterectomy was required in 21.6% of women after 7 to 10 years compared with 9% after the 1- to 5-year follow-up period. Of the 76 women who did not undergo hysterectomy, 58% reported amenorrhea and 35.5% reported minimal to light bleeding.

Conclusion:

This study demonstrates a consistently high patient satisfaction rate with thermal balloon ablation at our institution at 7 to 11 years postoperatively compared with 1 to 5 years postoperatively. The hysterectomy rate, however, was 2.4 times greater in the long-term follow-up period.     

Single-Center Experience of von Willebrand Disease (vWD) Among Patients with Menorrhagia: A Diagnosis which could be Missed

Menorrhagia is one of the gynecological complaints, seen in women of reproductive age. In majority of cases no organic pathology is found. To date there is no consensus on application of von Willebrand disease (vWD) testing as part of the routine investigations in menorrhagia. Diagnosis of vWD is challenging. It is complicated by intra-individual variations in von Willebrand antigen, activity, and factor VIII levels due to fluctuation of these factor levels during the menstrual cycle or hormonal therapy. The aim of this study is to detect vWD presenting with menorrhagia among Malays attending gynecology clinic by using a standard panel of haemostatic profiles. Thirty Malay patients attending gynecology clinic with unexplained menorrhagia were included in this study. Haemostatic profile such as platelet count, prothrombin time, activated partial thromboplastin time (APTT), factor VIII assay, von Willebrand factor antigen, and von Willebrand factor activity, and collagen binding assay were measured in all patients. Pre- and post hormonal haemostatic profiles were also performed in the patients diagnosed as vWD. All patients had normal APTT. Based on von Willebrand factor work-up, vWD was diagnosed in four patients (13.3%). Three of them were Type 1 and the other one was Type 2M. Investigation for vWD is essential in patients with menorrhagia and thus the laboratories performing vWD testing should provide a complete panel of diagnostic work-up in order to reduce the interpretation error. Screening for vWD should be performed before hormonal treatment as haemostatic profile post treatment could mask the diagnosis.