The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the costs and non-inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG-IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). DESIGN: Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial. SETTING: General practices and gynaecology departments in the Netherlands. POPULATION: In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child. METHODS: Randomisation to a strategy starting with the LNG-IUS (n = 132) or EA (n = 138). The incremental cost-effectiveness ratio was estimated. MAIN OUTCOME MEASURES: Direct medical costs and (in)direct non-medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)-score (non-inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC-score ≤75 points). RESULTS: Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months, mean PBAC-scores were 64.8 in the LNG-IUS group (n = 115) and 14.2 in the EA group (n = 132); difference 50.5 points (95% CI 4.3-96.7). In the LNG-IUS group, 87% of women had a PBAC-score ≤75 points versus 94% in the EA group (relative risk [RR] 0.93, 95% CI 0.85-1.01). The ICER was €23 (95% CI €5-111) per PBAC-point. CONCLUSIONS: A strategy starting with the LNG-IUS was cheaper than starting with EA, but non-inferiority could not be demonstrated. The LNG-IUS is reversible and less invasive and can be a cost-effective treatment option, depending on the success rate women are willing to accept. TWEETABLE ABSTRACT: Treatment of heavy menstrual bleeding starting with LNG-IUS is cheaper but slightly less effective than endometrial ablation.

Keyhole hysterectomy is effective for women with heavy menstrual bleeding.

The studyCooper K, Breeman S, Scott NW, et al. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial. Lancet 2019;394:1425-36.The study was funded by the NIHR Health Technology Assessment Programme (project number 12/35/23).To read the full NIHR Signal, go to: https://discover.dc.nihr.ac.uk/content/signal-000837/keyhole-hysterectomy-is-effective-for-women-with-heavy-menstrual-bleeding.

Employer-perspective cost comparison of surgical treatments for abnormal uterine bleeding.

Aim: To estimate direct and indirect costs of surgical treatment of abnormal uterine bleeding (AUB) from a self-insured employer's perspective. Methods: Employer-sponsored insurance claims data were analyzed to estimate costs owing to absence and short-term disability 1 year following global endometrial ablation (GEA), outpatient hysterectomy (OPH) and inpatient hysterectomy (IPH). Results: Costs for women who had GEA are substantially less than costs for women who had either OPH or IPH, with the difference ranging from approximately $7700 to approximately $10,000 for direct costs and approximately $4200 to approximately $4600 for indirect costs. Women who had GEA missed 21.8-24.0 fewer works days. Conclusion: Study results suggest lower healthcare costs associated with GEA versus OPH or IPH from a self-insured employer perspective.

Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding: the HEALTH RCT.

BACKGROUND: Heavy menstrual bleeding (HMB) is a common problem that affects many British women. When initial medical treatment is unsuccessful, the National Institute for Health and Care Excellence recommends surgical options such as endometrial ablation (EA) or hysterectomy. Although clinically and economically more effective than EA, total hysterectomy necessitates a longer hospital stay and is associated with slower recovery and a higher risk of complications. Improvements in endoscopic equipment and training have made laparoscopic supracervical hysterectomy (LASH) accessible to most gynaecologists. This operation could preserve the advantages of total hysterectomy and reduce the risk of complications. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of LASH with second-generation EA in women with HMB. DESIGN: A parallel-group, multicentre, randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). Surgeons and participants were not blinded to the allocated procedure. SETTING: Thirty-one UK secondary and tertiary hospitals. PARTICIPANTS: Women aged < 50 years with HMB. Exclusion criteria included plans to conceive; endometrial atypia; abnormal cytology; uterine cavity size > 11 cm; any fibroids > 3 cm; contraindications to laparoscopic surgery; previous EA; and inability to give informed consent or complete trial paperwork. INTERVENTIONS: LASH compared with second-generation EA. MAIN OUTCOME MEASURES: Co-primary clinical outcome measures were (1) patient satisfaction and (2) Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS) score at 15 months post randomisation. The primary economic outcome was incremental cost (NHS perspective) per quality-adjusted life-year (QALY) gained. RESULTS: A total of 330 participants were randomised to each group (total n = 660). Women randomised to LASH were more likely to be satisfied with their treatment than those randomised to EA (97.1% vs. 87.1%) [adjusted difference in proportions 0.10, 95% confidence interval (CI) 0.05 to 0.15; adjusted odds ratio (OR) from ordinal logistic regression (OLR) 2.53, 95% CI 1.83 to 3.48; p < 0.001]. Women randomised to LASH were also more likely to have the best possible MMAS score of 100 (68.7% vs. 54.5%) (adjusted difference in proportions 0.13, 95% CI 0.04 to 0.23; adjusted OR from OLR 1.87, 95% CI 1.31 to 2.67; p = 0.001). Serious adverse event rates were low and similar in both groups (4.5% vs. 3.6%). There was a significant difference in adjusted mean costs between LASH (£2886) and EA (£1282) at 15 months, but no significant difference in QALYs. Based on an extrapolation of expected differences in cost and QALYs out to 10 years, LASH cost an additional £1362 for an average QALY gain of 0.11, equating to an incremental cost-effectiveness ratio of £12,314 per QALY. Probabilities of cost-effectiveness were 53%, 71% and 80% at cost-effectiveness thresholds of £13,000, £20,000 and £30,000 per QALY gained, respectively. LIMITATIONS: Follow-up data beyond 15 months post randomisation are not available to inform cost-effectiveness. CONCLUSION: LASH is superior to EA in terms of clinical effectiveness. EA is less costly in the short term, but expected higher retreatment rates mean that LASH could be considered cost-effective by 10 years post procedure. FUTURE WORK: Retreatment rates, satisfaction and quality-of-life scores at 10-year follow-up will help to inform long-term cost-effectiveness. TRIAI REGISTRATION: Current Controlled Trials ISRCTN49013893. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 53. See the NIHR Journals Library website for further project information.

Almost 1.5 million women in England and Wales suffer from heavy periods. Initial treatment involves tablets or a medicated coil inserted within the womb. Sometimes these treatments do not work and many women need an operation, either endometrial ablation (EA) (removing the lining of the womb) or a full hysterectomy (complete removal of the womb). Previous studies have shown that a full hysterectomy is better at relieving symptoms, but the risk of complications during surgery is higher and patients take longer to recover fully. A newer operation, laparoscopic (keyhole) supracervical hysterectomy, or 'LASH', removes only the part of the womb that causes periods and preserves the cervix or neck of the womb. Women who have LASH can expect fewer complications, earlier discharge from hospital and quicker recovery time. In this study, we compared EA with LASH by asking women who had either procedure how they felt about it 1 year after their operation. Regardless of which operation they had, most women were very satisfied and felt that their symptoms were better. However, the results were much better for those who had the LASH operation, although these women stayed in hospital for longer and took more time to recover. There was no difference in complications from either surgery, although nearly 1 in 20 women who had an EA returned within 1 year to have their wombs removed in a second operation. Although LASH led to a greater improvement in symptoms and levels of satisfaction, it was more expensive in terms of costs incurred by both the health service and society. Given that some women who had an EA are likely to need a second operation in the future, LASH surgery may provide better value for money in the long term.

Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.

BACKGROUND: Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding. METHODS: In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893. FINDINGS: Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1-14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83-3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8-22·8; adjusted OR 1·87, 95% CI 1·31-2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56-3·02; p=0·54). INTERPRETATION: Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

The case against endometrial ablation for treatment of heavy menstrual bleeding.

PURPOSE OF REVIEW: Endometrial ablation is a common treatment for heavy menstrual bleeding, but serious limitations and long-term complications exist. Our purpose is to summarize the use of endometrial ablation devices, potential short-term and long-term complications, cost effectiveness, and quality of life in relation to alternative treatments. RECENT FINDINGS: There is insufficient evidence to strongly recommend one endometrial ablation device over another. Providers should consider and discuss with their patients, complications including risk of future pregnancy, endometrial cancer, and hysterectomy for continued bleeding or pain. Patient selection is key to reducing postablation pain and failure; patients with a history of tubal ligation and dysmenorrhea should consider alternative treatments. All patients should also be counseled that the levonorgestrel intrauterine device is a cost-effective alternative with higher quality of life and fewer complications. Hysterectomy is definitive treatment with higher quality of life and fewer complications. SUMMARY: Although endometrial ablation can offer adequate symptom control for patients who have failed medical therapy, desire uterine preservation, or who are high-risk surgical candidates, patients should be appropriately selected and counseled regarding the potential for treatment failure and long-term complications.

Women with Newly Diagnosed Uterine Fibroids: Treatment Patterns and Cost Comparison for Select Treatment Options.

The primary objective of this study was to describe surgical treatment patterns among women with newly diagnosed uterine fibroids (UF). A secondary objective was to estimate the medical costs associated with other common surgical interventions for UF. Claims-based commercial and Medicare data (2011-2016) were used to identify women aged ≥30 years with continuous enrollment for at least 12 months before and after a new diagnosis of UF. Receipt of a surgical or radiologic procedure (hysterectomy, myomectomy, endometrial ablation, uterine artery embolization, and curettage) was the primary outcome. Health care resource utilization and costs were calculated for women with at least 12 months of continuous enrollment following a UF surgical procedure. Among women who met selection criteria, 31.7% of patients underwent a surgical procedure; 20.9% of these underwent hysterectomy. An increase was observed over time in the percentage of women undergoing outpatient hysterectomy (from 27.0% to 40.2%) and hysteroscopic myomectomy (from 8.0% to 11.5%). The cost analysis revealed that total health care costs for hysteroscopic myomectomy ($17,324) were significantly lower (P < 0.001) than those for women who underwent inpatient hysterectomy ($24,027) and those for women undergoing the 3 comparison procedures. Hysterectomy was the most common surgical intervention. Patients undergoing inpatient hysterectomy had the highest health care costs. Although less expensive, minimally invasive approaches are becoming more common; they are performed infrequently in patients with newly diagnosed UF. The results of this study may be useful in guiding decisions regarding the most appropriate and cost-effective surgical treatment for UF.

Economic Evaluation of Global Endometrial Ablation Versus Inpatient and Outpatient Hysterectomy for Treatment of Abnormal Uterine Bleeding: US Commercial and Medicaid Payer Perspectives.

Every year, abnormal uterine bleeding (AUB) exacts a heavy toll on women's health and leads to high costs for the US health care system. The literature shows that endometrial ablation results in fewer complications, shorter recovery and lower costs than more commonly performed hysterectomy procedures. The objective of this study was to model clinical-economic outcomes, budget impact, and cost-effectiveness of global endometrial ablation (GEA) versus outpatient hysterectomy (OPH) and inpatient hysterectomy (IPH) procedures. A decision tree, state-transition (semi-Markov) economic model was developed to simulate 3 hypothetical cohorts of women who received surgical treatment for AUB (GEA, OPH, and IPH) over 1, 2, and 3 years to evaluate clinical and economic outcomes for GEA vs. OPH and GEA vs. IPH. Two versions of the model were created to reflect both commercial health care payer and US Medicaid perspectives, and analyses were conducted for both payer types. Total health care costs in the first year after GEA were substantially lower compared with those for IPH and OPH. Budget impact analysis results showed that increasing GEA utilization yields total annual cost savings of about $906,000 for a million-member commercial health plan and about $152,000 in cost savings for a typical-sized state Medicaid plan with 1.4 million members. Cost-effectiveness analysis results for both perspectives showed GEA as economically dominant (conferring greater benefit at lower cost) over both OPH and IPH in the 1-year commercial scenario. This study demonstrates that, for some patients, GEA may prove to be a safe, uterus-sparing, cost-effective alternative to OPH and IPH for the surgical treatment of AUB.

Endometrial resection and global ablation in the normal uterus.

There are various methods that can be used to destroy the endometrium as a treatment for menorrhagia. This chapter reviews the history, rationale, evidence, indications and long-term safety and efficacy of the current techniques. It also discusses endometrial ablation in the context of its clinical utility in comparison with existing alternative treatments.

Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): A clinical and economic analysis.

BACKGROUND: Radiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB. METHODS: We performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette ®) or Naproxen (Naprosyn®) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients' satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months. RESULTS: Compared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0-4] vs. 15 [0-131], p = 0.003), higher satisfaction rates (96.8%vs.63.2%, p = 0.003) and higher MMAS (median [IQR]: 100 [100-100] vs. 100 [87-100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs.$2,901, 95% confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95% CI of mean difference:-$339, $4,089). CONCLUSION: For women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care. CLINICAL TRIAL REGISTRATION: NCT01165307.

The Current Burden of Follow-up of Stage 1A1 Cervical Cancer.

OBJECTIVE: The aim of this study was to assess the current burden and consistency of stage 1A1 cervical cancer follow-up within Greater Glasgow and Clyde Health Board. METHODS: A retrospective review was undertaken of women diagnosed with and treated of, between 2007 and 2011, stage 1A1 cervical cancer in Greater Glasgow and Clyde Health Board. Data were collected on referral cytology, definitive method of treatment, posttreatment cytology, and rate of recurrence. Outcomes included rate of recurrence, abnormal cytology, and number of interventions during follow-up. RESULTS: Of the 78 women diagnosed with stage 1A1 cervical cancer, 43 had a LLETZ (large loop excision of the transformation zone) as definitive treatment. Ninety percent of stage 1A1 cervical cancers were diagnosed following abnormal screening cytology. Almost 86% of all cytology post-LLETZ were negative. Only 1 woman had a recurrence. No posthysterectomy vault smears were low-grade dyskaryosis or worse. CONCLUSIONS: There is a very low rate of abnormal cytology after LLETZ. Vault smears are of limited benefit in the management of women posthysterectomy for stage 1A1 cervical cancer.

Comparison of the levonorgestrel-releasing intrauterine system, hysterectomy, and endometrial ablation for heavy menstrual bleeding in a decision analysis model.

BACKGROUND: A better understanding of the relative risks and benefits of common treatment options for abnormal uterine bleeding (AUB) can help providers and patients to make balanced, evidence-based decisions. OBJECTIVES: To provide comparative estimates of clinical outcomes after placement of levonorgestrel-releasing intrauterine system (LNG-IUS), ablation, or hysterectomy for AUB. SEARCH STRATEGY: A PubMED search was done using combinations of search terms related to abnormal uterine bleeding, LNG-IUS, hysterectomy, endometrial ablation, cost-benefit analysis, cost-effectiveness, and quality-adjusted life years. SELECTION CRITERIA: Full articles published in 2006-2016 available in English comparing at least two treatment modalities of interest among women of reproductive age with AUB were included. DATA COLLECTION AND ANALYSIS: A decision tree was generated to compare clinical outcomes in a hypothetical cohort of 100 000 premenopausal women with nonmalignant AUB. We evaluated complications, mortality, and treatment outcomes over a 5-year period, calculated cumulative quality-adjusted life years (QALYs), and conducted probabilistic sensitivity analysis. MAIN RESULTS: Levonorgestrel-releasing intrauterine system had the highest number of QALYs (406 920), followed by hysterectomy (403 466), non-resectoscopic ablation (399 244), and resectoscopic ablation (395 827). Ablation had more treatment failures and complications than LNG-IUS and hysterectomy. Findings were robust in probabilistic sensitivity analysis. CONCLUSIONS: Levonorgestrel-releasing intrauterine system and hysterectomy outperformed endometrial ablation for treatment of AUB.

Cost-effectiveness of treatments for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding affects up to one third of women in the United States, resulting in a reduced quality of life and significant cost to the health care system. Multiple treatment options exist, offering different potential for symptom control at highly variable initial costs, but the relative value of these treatment options is unknown. OBJECTIVE: The objective of the study was to evaluate the relative cost-effectiveness of 4 treatment options for heavy menstrual bleeding: hysterectomy, resectoscopic endometrial ablation, nonresectoscopic endometrial ablation, and the levonorgestrel-releasing intrauterine system. STUDY DESIGN: We formulated a decision tree evaluating private payer costs and quality-adjusted life years over a 5 year time horizon for premenopausal women with heavy menstrual bleeding and no suspected malignancy. For each treatment option, we used probabilities derived from literature review to estimate frequencies of minor complications, major complications, and treatment failure resulting in the need for additional treatments. Treatments were compared in terms of total average costs, quality-adjusted life years, and incremental cost-effectiveness ratios. Probabilistic sensitivity analysis was conducted to understand the range of possible outcomes if model inputs were varied. RESULTS: The levonorgestrel-releasing intrauterine system had superior quality-of-life outcomes to hysterectomy with lower costs. In a probabilistic sensitivity analysis, levonorgestrel-releasing intrauterine system was cost-effective compared with hysterectomy in the majority of scenarios (90%). Both resectoscopic and nonresectoscopic endometrial ablation were associated with reduced costs compared with hysterectomy but resulted in a lower average quality of life. According to standard willingness-to-pay thresholds, resectoscopic endometrial ablation was considered cost effective compared with hysterectomy in 44% of scenarios, and nonresectoscopic endometrial ablation was considered cost effective compared with hysterectomy in 53% of scenarios. CONCLUSION: Comparing all trade-offs associated with 4 possible treatments of heavy menstrual bleeding, the levonorgestrel-releasing intrauterine system was superior to both hysterectomy and endometrial ablation in terms of cost and quality of life. Hysterectomy is associated with a superior quality of life and fewer complications than either type of ablation but at a higher cost. For women who are unwilling or unable to choose the levonorgestrel-releasing intrauterine system as a first-course treatment for heavy menstrual bleeding, consideration of cost, procedure-specific complications, and patient preferences can guide the decision between hysterectomy and ablation.

Is the Pictorial Blood Loss Assessment Chart (PBAC) score associated with treatment outcome after endometrial ablation for heavy menstrual bleeding? A cohort study.

OBJECTIVE: The Pictorial Blood Loss Assessment Chart (PBAC) is a validated tool that is used to diagnose heavy menstrual bleeding (HMB). Knowledge of the effect of its score and its relationship with outcome could have implications for using the PBAC as an outcome measurement in future HMB studies, and as a tool to evaluate the treatment effect in research and clinical practice. Our aim was to relate PBAC scores to other measures of success after endometrial ablation for HMB. DESIGN: Analysis of individual patient data (IPD) of randomised controlled trials studying women with HMB. SETTING: Women with HMB consulting their gynecologists. POPULATION OR SAMPLE: Individual patient data (IPD) of randomised controlled trials studying women with HMB. METHODS: We included studies if they had studied second-generation endometrial ablation techniques and had collected PBAC scores for both baseline and follow-up. The effectiveness of treatment was scored as satisfaction or re-intervention (yes/no) 12 months after treatment. We related these outcomes to the PBAC score at 12 months after treatment, and to PBAC decrease between baseline and 12 months of follow-up. RESULTS: We studied data for 900 patients included in nine studies. The median PBAC score at 12 months was 7 (0-2500). The overall satisfaction rate was 89% and the overall re-intervention rate was 7.2%. A clear association was found between absolute PBAC score at the 12-month follow-up and satisfaction (odds ratio, OR 0.16; 95% confidence interval, 95% CI 0.11-0.24) and surgical re-intervention (OR 2.3, 95% CI 1.8-2.8). A change in PBAC score was also associated with satisfaction (OR 2.0, 95% CI 1.7-2.3) and surgical re-intervention (OR 0.69, 95% CI 0.63-0.75). Both the absolute PBAC scores and the changes in score show high accuracy for both treatment outcomes. CONCLUSIONS: PBAC scores at 12 months after treatment are significantly associated with satisfaction and re-intervention rates. We propose to use the PBAC in research as a primary end point in studies on HMB, and in clinical practice as a measure to assess the effectiveness of treatment. TWEETABLE ABSTRACT: PBAC scores 12 months after treatment are significantly associated with satisfaction and reintervention rates.

Levonorgestrel-Releasing Intrauterine System (52 mg) for Idiopathic Heavy Menstrual Bleeding: A Health Technology Assessment.

BACKGROUND: Heavy menstrual bleeding affects as many as one in three women and has negative physical, economic, and psychosocial impacts including activity limitations and reduced quality of life. The goal of treatment is to make menstruation manageable, and options include medical therapy or surgery such as endometrial ablation or hysterectomy. This review examined the evidence of effectiveness and cost-effectiveness of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) as a treatment alternative for idiopathic heavy menstrual bleeding. METHODS: We conducted a systematic review of the clinical and economic evidence comparing LNG-IUS with usual medical therapy, endometrial ablation, or hysterectomy. Medline, EMBASE, Cochrane, and the Centres for Reviews and Dissemination were searched from inception to August 2015. The quality of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also completed an economic evaluation to determine the cost-effectiveness and budget impact of the LNG-IUS compared with endometrial ablation and with hysterectomy. The economic evaluation was conducted from the perspective the Ontario Ministry of Health and Long-Term Care. RESULTS: Relevant systematic reviews (n = 18) returned from the literature search were used to identify eligible randomized controlled trials, and 16 trials were included. The LNG-IUS improved quality of life and reduced menstrual blood loss better than usual medical therapy. There was no evidence of a significant difference in these outcomes compared with the improvements offered by endometrial ablation or hysterectomy. Mild hormonal side effects were the most commonly reported. The quality of the evidence varied from very low to moderate across outcomes. Results from the economic evaluation showed the LNG-IUS was less costly (incremental saving of $372 per person) and more effective providing higher quality-adjusted life years (incremental value of 0.05) compared with endometrial ablation. Similarly, the LNG-IUS costs less (incremental saving of $3,138 per person) and yields higher quality-adjusted life-years (incremental value of 0.04) compared with hysterectomy. Publicly funding LNG-IUS as an alternative to endometrial ablation and hysterectomy would result in annual cost savings of $3 million to $9 million and $0.1 million to $23 million, respectively, over the first 5 years. CONCLUSIONS: The 52-mg LNG-IUS is an effective and cost-effective treatment option for idiopathic heavy menstrual bleeding. It improves quality of life and menstrual blood loss, and is well tolerated compared with endometrial ablation, hysterectomy, or usual medical therapies.

Acute Sinus Node Dysfunction after Atrial Ablation: Incidence, Risk Factors, and Management.

BACKGROUND: Many patients with atrial fibrillation (AF) or atrial flutter (Aflutter) have concomitant sinus node dysfunction (SND). Ablation may result in injury to the sinus node complex or its blood supply resulting in sinus arrest and need for temporary pacing. We sought to characterize patients who develop acute SND (ASND) during/immediately after AF/Aflutter ablation. METHODS: We performed a retrospective analysis of AF/Aflutter ablation patients between January 1, 2010 and February 28, 2015 to characterize those who required temporary pacemaker (TPM) implantation due to ASND (sinus arrest, sinus bradycardia <40 beats/min, or junctional rhythm with hemodynamic compromise) following atrial ablation. RESULTS: Of 2,151 patients, eight patients (<0.5%) with ASND manifesting as sinus arrest (n = 2), severe sinus bradycardia (n = 2), and junctional rhythm with hemodynamic compromise (n = 4) were identified (all male, age 66 ± 9.9 years, 4/8 [50%] persistent AF). AF ablation was performed in four, atypical Aflutter in one, and AF/Aflutter in three patients. The ablation set consisted of: pulmonary vein (PV) isolation (n = 6), roof line ablation (n = 6), mitral annulus-left inferior PV line ablation (n = 5), left atrial appendage-mitral annulus ablation (n = 1), cavotricuspid isthmus ablation (n = 5), and isolation or ablation near the superior vena cava (SVC, n = 4). Patients with peri-SVC ablation were more likely to develop ASND (P = 0.03). All patients received TPM; six received permanent pacemaker before discharge, performed 3.5 days postablation (range 2-6 days). At 3-month device interrogation, all patients were atrially paced >50%. CONCLUSION: ASND is a rare complication of atrial ablation. It may be more common when peri-SVC ablation is performed and may necessitate permanent pacemaker implantation.

Tratamento do sangramento uterino anormal: uma análise sob a perspectiva dos custos no Sistema Único de Saúde e da medicina suplementar / Treatment of abnormal uterine bleeding: an analysis from the perspective of costs in the public health system and supplementary medicine

Objetivos: Comparar os custos diretos e indiretos do sistema intra‐uterino de liberação de levonorgestrel (SIU‐LNG), ablação endometrial com balão térmico (AEBT) e histerectomia no tratamento de mulheres com sangramento uterino anormal (SUA). Métodos: Foram avaliadas retrospectivamente 88 pacientes tratadas para SUA pelo SIU‐LNG (n = 30), AEBT (n = 28) e histerectomia (n = 30). Foram considerados todos os procedimentos, consultas e exames envolvidos no tratamento das pacientes por um período de 5 anos, assim como os custos resultantes das falhas dos tratamentos utilizados. Foram estimados os custos pelo Sistema Único de Saúde (SUS) e sistema de saúde suplementar. As diferenças entre os grupos foram avaliadas pelo teste do t de Student ou ANOVA. Resultados:O custo do tratamento do SUA com AEBT foi significante mais elevado em comparação ao SIU‐LNG e histerectomia após um e cinco anos de seguimento, tanto no SUS quanto na medicina suplementar (p < 0,001). No SUS, o tratamento com o SIU‐LNG foi de 38,2% dos custos da histerectomia no primeiro ano (R$ 769,61 vs. R$ 2.012,21, p < 0,001) e de 45,2% após cinco anos (R$ 927,83 vs. R$ 2.052,21, p < 0,001). Na saúde suplementar essa diferença foi ainda mais expressiva. Nesse contexto, o custo do SIU‐LNG foi de 29,1% dos custos da histerectomia no primeiro ano (R$ 1.551,92 vs. R$5.324,74, p < 0,001) e de 37,4% após cinco anos (R$ 2.069,35 vs. R$ 5.538,74, p < 0,001). Conclusões: O uso do SIU‐LNG resulta em custos diretos e indiretos menores do que a AEBT e histerectomia no tratamento do SUA. A custo‐efetividade do SIU‐LNG aliado à reversibilidade e por ser um procedimento ambulatorial reforçam o seu papel no tratamento de mulheres com SUA tanto na perspectiva do SUS quanto na saúde suplementar.

Objectives: To compare direct and indirect costs of the levonorgestrel‐releasing intrauterine system (LNG‐IUS), thermal balloon endometrial ablation (TBEA) and hysterectomy in the treatment of women with abnormal uterine bleeding (AUB). Methods: 88 patients treated for AUB by LNG‐IUS (n = 30), TBEA (n = 28) and hysterectomy (n = 30) were retrospectively evaluated. All procedures, medical appointments and tests involved in the treatment of patients were considered for a period of five years, as well as all costs arising from failures of the treatments used. The costs for the Unified Health System (SUS) and the private health care system were estimated. Differences between groups were evaluated by the test t of Student or ANOVA. Results: The cost of the treatment of AUB with TBEA was significantly higher versus LNG‐IUS and hysterectomy after a five‐year follow‐up in both SUS and private health care system (p <0.001). In SUS, the treatment with the LNG‐IUS represented 38.2% of the hysterectomy cost in the first year (R$ 769.61 vs. R$ 2,012.21, p <0.001) and 45.2% after five years (R$ 927.83 vs. R$ 2,052.21, p <0.001). As for the private health care system, this difference was even more significant. In this context, the cost of LNG‐IUS represented 29.1% of the hysterectomy cost in the first year (R$ 1,551.92 vs. R$ 5,324.74, p <0.001) and 37.4% after five years (R$ 2,069.35 vs. R$ 5,538.74, p <0.001). Conclusions: The use of LNG‐IUS results in lower direct and indirect costs versus TBEA and hysterectomy in the treatment of women with AUB. The cost‐effectiveness of LNG‐IUS, together with the reversibility and also by this being an outpatient procedure, highlights its role in the treatment of women with AUB, both in SUS perspective as in private health care system's.

A single baseline ultrasound assessment of fibroid presence and size is strongly predictive of future uterine procedure: 8-year follow-up of randomly sampled premenopausal women aged 35-49 years.

STUDY QUESTION: How well can a single baseline ultrasound assessment of fibroid burden (presence or absence of fibroids and size of largest, if present) predict future probability of having a major uterine procedure? SUMMARY ANSWER: During an 8-year follow-up period, the risk of having a major uterine procedure was 2% for those without fibroids and increased with fibroid size for those with fibroids, reaching 47% for those with fibroids ≥ 4 cm in diameter at baseline. WHAT IS KNOWN ALREADY: Uterine fibroids are a leading indication for hysterectomy. However, when fibroids are found, there are few available data to help clinicians advise patients about disease progression. STUDY DESIGN, SIZE, DURATION: Women who were 35-49 years old were randomly selected from the membership of a large urban health plan; 80% of those determined to be eligible were enrolled and screened with ultrasound for fibroids ≥ 0.5 cm in diameter. African-American and white premenopausal participants who responded to at least one follow-up interview (N = 964, 85% of those eligible) constituted the study cohort. During follow-up (5822 person-years), participants self-reported any major uterine procedure (67% hysterectomies). Life-table analyses and Cox regression (with censoring for menopause) were used to estimate the risk of having a uterine procedure for women with no fibroids, small (<2 cm in diameter), medium (2-3.9 cm), and large fibroids (≥ 4 cm). Differences between African-American and white women, importance of a clinical diagnosis of fibroids prior to study enrollment, and the impact of submucosal fibroids on risk were investigated. PARTICIPANTS/MATERIALS, SETTING, METHODS: There was a greater loss to follow-up for African-Americans than whites (19 versus 11%). For those with follow-up data, 64% had fibroids at baseline, 33% of whom had had a prior diagnosis. Of those with fibroids, 27% had small fibroids (<2 cm in diameter), 46% had medium (largest fibroid 2-3.9 cm in diameter), and 27% had large fibroids (largest ≥ 4 cm in diameter). Twenty-one percent had at least one submucosal fibroid. MAIN RESULTS AND THE ROLE OF CHANCE: Major uterine procedures were reported by 115 women during follow-up. The estimated risk of having a procedure in any given year of follow-up for those with fibroids compared with those without fibroids increased markedly with fibroid-size category (from 4-fold, confidence interval (CI) (1.4-11.1) for the small fibroids to 10-fold, CI (4.4-24.8) for the medium fibroids, to 27-fold, CI (11.5-65.2) for the large fibroids). This influence of fibroid size on risk did not differ between African-Americans and whites (P-value for interaction = 0.88). Once fibroid size at enrollment was accounted for, having a prior diagnosis at the time of ultrasound screening was not predictive of having a procedure. Exclusion of women with a submucosal fibroid had little influence on the results. The 8-year risk of a procedure based on lifetable analyses was 2% for women with no fibroids, 8, 23, and 47%, respectively, for women who had small, medium or large fibroids at enrollment. Given the strong association of fibroid size with subsequent risk of a procedure, these findings are unlikely to be due to chance. LIMITATIONS, REASONS FOR CAUTION: Despite a large sample size, the number of women having procedures during follow-up was relatively small. Thus, covariates such as BMI, which were not important in our analyses, may have associations that were too small to detect with our sample size. Another limitation is that the medical procedures were self-reported. However, we attempted to retrieve medical records when participants agreed, and 77% of the total procedures reported were verified. Our findings are likely to be generalizable to other African-American and white premenopausal women in their late 30s and 40s, but other ethnic groups have not been studied. WIDER IMPLICATIONS OF THE FINDINGS: Though further studies are needed to confirm and extend the results, our findings provide an initial estimate of disease progression that will be helpful to clinicians and their patients.

The incidence of hysterectomy, uterus-preserving procedures and recurrent treatment in the management of uterine fibroids.

OBJECTIVE: To determine the incidence of hysterectomy and uterus-preserving procedures (UPPs) among women with uterine fibroids (UFs) and the incidence of further procedures after a UPP. STUDY DESIGN: This was an observational study using a primary care database, The Health Improvement Network (THIN). Women in THIN with UFs aged 15-54 years between January 2000 and December 2009 were eligible for study. The UPPs examined were myomectomy, endometrial ablation (EA) and uterine artery embolization (UAE). Using Read codes, women were followed up until one of the following was met: there was a record of hysterectomy or UPPs, they died or the study ended (end of 2010). RESULTS: The cumulative incidence of hysterectomy or UPPs was 23.6% at 1 year, and 40.9% after the follow-up period (median 3.6 years). At the end of the follow-up period, the cumulative incidences of hysterectomy, myomectomy, EA and UAE were 33.0%, 3.9%, 6.4% and 1.9%, respectively. For women initially treated with a UPP, the cumulative incidence of second procedures was 11.5% at 1 year. At the end of the follow-up period (median 2.7 years), the cumulative incidence of further procedures was 26.1%, and the cumulative incidences of women undergoing hysterectomy, myomectomy, EA and UAE were 19.0%, 4.3%, 3.4% and 1.4%, respectively. CONCLUSIONS: Women considering UPPs for the management of UFs should be made aware that the incidence of further treatments is high, with hysterectomy being the most frequent procedure undergone.