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.