Introduction
Heavy menstrual bleeding is defined as excessive menstrual blood loss of 80 mL per cycle, for more than 7 days which interferes with a woman’s physical, social, emotional and/or quality of life1,2and affects approximately 10%–30% of all women worldwide once in their lifetime3,4. FIGO defined a new terminology for normal and abnormal uterine bleeding (AUB) in the reproductive years and for classification cases with PALM-COEIN5. The causes of dysfunctional uterine bleeding are now defined by O,E,N (Ovulatory dysfunctional, Endometrial, Not otherwise classified). The causes defined by C (Coagulopathology) and I (Iatrogenic) have no indication for surgical treatment. Medical treatment is usually the first intent treatment. Except for curettage, surgical interventions are recommended for women with severe AUB-O,E,N who do not wish to become pregnant6,7. In this case, different surgical interventions are routinely performed for treatment, the choices include second-generation (2G) endometrial ablation techniques (thermal balloon, microwave, cryoablation, radiofrequency) and first-generation (1G) techniques (endometrectomy, roller-ball and laser ablation), whereas a first-line curettage or hysterectomy is no longer recommended in France7. Hysterectomy is effective but has more complications than endometrial ablation; endometrial ablation techniques are less invasive but could ultimately lead to hysterectomy in 20% of cases within 5 years 8. 2G procedures seem to be as effective as 1G procedures and present with fewer complications, like operating time decrease, and can be used more often with local anesthesia 9–11. In 2019, the HEALTH randomized controlled trial 12 compared laparoscopic supracervical hysterectomy versus endometrial ablation (2G or 1G) for surgical treatment of heavy menstrual bleeding for 660 patients. Hysterectomy showed to be superior in terms of clinical effectiveness, with similar rate of complications but takes longer time in operating room, a longer hospital stay and longer recovery time, then increasing the cost of the radical procedure.
Regarding the economic evidence of surgical procedures, a French retrospective study showed that hysterectomy was the most effective but also the most expensive strategy in 2003, as compared to 2G techniques13. The recent economic analysis of the HEALTH trial in UK confirmed that hysterectomy expenses is higher of £1604 at 15 months14. Two trial-based cost-utility analyses demonstrated that 2G endometrial ablation were more cost-effective than 1G devices15,16, but their external validities was questionable regarding limitations in available data to build the model. In real conditions, an economic analysis based on the German health claims database showed that a 2G technique (radiofrequency ablation) was associated with fewer recurrences, lower rates of subsequent surgical treatments and lower costs than other ablation techniques 17. The replicability of this study was however questionable, as it only concerned 88 patients. The most complete economic study was done by Miller et al in 2015 in the US context 18, who performed a semi-Markov model at 1, 3 and 5-years using the data of 63,482 patients from three large medical claims databases in real-conditions to compare Novasureversus other ablation modalities and hysterectomy. To date, there is no similar cost-effectiveness analysis comparing surgical strategies of AUB, that used only data from a hospital claim database, reflecting real-life practice in the European context.
Since the introduction of a DRG-based prospective payment system in France in 2005, the PMSI-MCO database has been used as the basis for the funding of services in all hospitals. Indeed, its high exhaustiveness and the quality of its information allow using this database for epidemiologic, burden of disease, or economic analyses in real-life conditions. As individual patients can be tracked across multiple hospitalizations over time through a unique anonymous patient identifier (with the patient’s social security number, date of birth and gender) which is kept unchanged until the patient dies, a patient can be followed-up during many years. Several years after the implementation of recommendations for the management of menorrhagia in France7, there is a need to compare the different surgical techniques in real life conditions, by comparing both their respective efficacy (expressed in terms of the absence of failure and/or complication) and their associated hospitalizations costs along time. In the present study, the French PMSI-MCO database was used to perform a cost-effectiveness analysis, comparing 2G endometrial ablative techniques to 1G techniques, curettage and hysterectomy for treating AUB-O,E,N.