Hum. Reprod. Advance Access originally published online on July 27, 2006
Human Reproduction 2006 21(12):3270-3277; doi:10.1093/humrep/del275
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Uterine artery embolization for symptomatic fibroids: short-term versus mid-term changes in disease-specific symptoms, quality of life and magnetic resonance imaging results
1 Department of Radiology and 2 Department of Obstetrics and Gynecology, Charité Universitätsmedizin Berlin, Berlin, Germany 4 Present Address: German Pelvic Floor Centre, Department of Urogynecology, St. Hedwig Hospital, Große Hamburger Str. 5-11, 10115 Berlin, Germany.
3 To whom correspondence should be addressed at: Schumannstrasse 20/21, Berlin, Germany. E-mail: thomas.kroencke{at}charite.de
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Abstract |
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BACKGROUND: Prospective study to evaluate changes in symptom severity, health-related quality of life (HRQOL) and uterine and leiomyoma volume after uterine artery embolization (UAE). METHODS: Eighty-two women completed a validated uterine fibroid symptom and quality of life (UFS-QOL) questionnaire and underwent magnetic resonance imaging (MRI) before and 3–20 months after UAE. Primary outcome measures were changes in symptom severity and QOL at short-term follow-up [median 5 (range 3–7) months] and mid-term follow-up [median 14 (8–20) months]. Secondary outcome measures included the frequency of additional procedures to control persistent symptoms and changes in dominant fibroid volume (DFV) and uterine volume (UV). RESULTS: Of 82 patients, 71 (86.6%) patients completed follow-up, 7 (8.5%) patients had a second procedure and 4 (4.9%) were lost to follow-up. Symptom severity scores decreased from a median of 43.75 to 21.88 (P < 0.001) in the short-term follow-up group and from a median of 43.75 to 9.38 (P < 0.001) in the mid-term follow-up group. QOL scores increased from a median of 56.90 to 87.93 (P < 0.001) and 66.81 to 96.12 (P < 0.001), respectively. During short-term follow-up, median UV decreased by 27% (95% CI 20.25–33.81, P < 0.001) and median DFV by 62% (95% CI 47.81–71.55, P < 0.001), whereas UV decreased by 36% (95% CI 23.34–55.02, P < 0.001) and DFV by 66% (95% CI 54.28–71.92, P < 0.001) for the mid-term follow-up group. A decrease in UV correlated with change in symptom severity (P < 0.005). CONCLUSIONS: Women report significant improvements in fibroid-specific symptoms and QOL at short- and mid-term follow-ups after UAE.
Key words: fibroids/magnetic resonance imaging/quality of life/uterine artery embolization
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Introduction |
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Since it was first described in 1995 for the treatment of leiomyomas (fibroids) of the uterus, uterine artery embolization (UAE) has been shown in numerous studies to be a highly successful technique that alleviates fibroid-related symptoms such as heavy menstrual bleeding and bulk-related symptoms (Ravina et al., 1995
; Spies et al., 2001, 2005a; Walker and Pelage, 2002; Pron et al., 2003). It was not possible for quite some time to record the specific complaints and interference with the patient’s quality of life (QOL) in a uniform and comparable manner. The uterine fibroid symptom and QOL questionnaire (UFS-QOL) presented by Spies et al. in February 2002 is a practical and validated tool for the objective assessment of disease-specific symptoms, their severity and the impact of leiomyomas on different aspects of the patient’s QOL (Spies et al., 2002a). The UFS-QOL allows the comparison of a patient’s condition before and after treatment by UAE or alternative treatment options. To our knowledge, there have been only three published reports on the use of the UFS-QOL after UAE, with two of them applying the UFS-QOL prospectively (Smith et al., 2004; Spies et al., 2004, 2005b). We undertook this prospective study to analyse the changes of fibroid-related complaints and QOL as well as the changes in the uterus volume (UV) and the dominant fibroid volume (DFV) after UAE at short- versus mid-term follow-ups employing the UFS-QOL and magnetic resonance imaging (MRI). |
Materials and methods |
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Patient population
Between August 2002 and June 2004, 102 patients were referred for UAE. All patients had been advised by referring gynaecologists to undergo surgery (myomectomy and hysterectomy) after >12 months’ duration of leiomyoma-related complaints and failure of conservative treatment. The indication for UAE was established by a gynaecologist and interventional radiologist after clinical examination and confirmation of the diagnosis by transvaginal ultrasound and MRI. Patients with pedunculated subserosal fibroids (stalk <50% of fibroid diameter), intraligamentous fibroids, fibroids >10 cm in diameter or uterine enlargement above the level of the umbilicus or patients wishing to conceive were excluded. Twenty patients were excluded from the study because of adenomyosis (n = 10), a uterus larger than the above-mentioned exclusion criterion (n = 1), the presence of pedunculated subserosal leiomyomas (n = 2), a completely (auto-) infarcted leiomyoma (n = 1) or the absence of uterine leiomyoma (n = 2) based on pre-interventional MRI. Four patients opted not to undergo UAE after the explanation of the planned therapy (UAE) and alternative treatment options. The remaining 82 patients who filled out the UFS-QOL and underwent UAE formed the study population of this trial. Detailed demographics of the study population are summarized in Table I. Patients gave informed written consent and volunteered to participate in the follow-up examinations. Prospective data collection was approved by the institutional review board. Permission to use the UFS-QOL was obtained from its authors and the Society of Interventional Radiology before the study, who provided an official translation of the UFS-QOL into German.
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Embolization technique
Bilateral embolization was performed by an interventional radiologist with >5 years’ experience in embolization procedures using a transfemoral approach. In most patients, both uterine arteries were accessed consecutively via a common femoral artery approach. In 25 of 82 (30.5%) patients, both common femoral arteries were punctured and embolization of the uterine arteries was performed via two catheters placed in the uterine arteries in crossover technique. Catheterization and embolization was performed by using 4F or 5F endhole catheters or coaxially placed microcatheters used at the discretion of the interventional radiologist. The catheter was positioned in the horizontal segment of the uterine artery distal to angiographically visualized cervicovaginal branches. Embolization was achieved by free-flow deployment of trisacryl microspheres [Embosphere® (n = 62), 500–700 and 700–900 µm, Biosphere Medical, Paris, France] or spherical polyvinyl alcohol particles [Contour-SE® (n = 18), 500–700 and 700–900 µm, Boston Scientific, Ratingen, Germany and BeadBlock® (n = 2), 500–700 and 700–900 µm, Biocompatibles, Farnham, UK]. The end-point of embolization was the occlusion of the perifibroid plexus vessels with the elimination of fibroid perfusion and preservation of weak antegrade flow in both uterine arteries. After the procedure, patients received intravenous narcotics and non-steroidal anti-inflammatory drugs for pain control and were admitted for observation.
Clinical assessment
The self-administered UFS-QOL was filled out by all study patients before UAE and at follow-up visits. The questionnaire comprises eight questions pertaining to the type and severity of symptoms and 29 questions on how the disease affects different aspects of the patient’s health-related QOL (HRQOL). The questions refer to the 3 preceding months. The eight symptom items (questions 1–8) are summarized in a symptom severity scale. The 29 HRQOL items are grouped in six subscales pertaining to ‘concern’, ‘activities’, ‘energy/mood’, ‘control’, ‘self-consciousness’ and ‘sexual function’ and together represent the ‘HRQOL total score’. Symptom severity subscale, HRQOL subscales and HRQOL total score result in a total of eight scores. Response options are presented as five-level Likert scales ranging from ‘not at all’ (1) to ‘a very great deal’ (5) in response to ‘how distressed were you by...?’ for the symptom severity items (questions 1–8) and from ‘none of the time’ (1) to ‘all of the time’ (5) in response to the questions about HRQOL (questions 9–37). The questionnaire was administered again at follow-up for comparison with the scores before treatment. If a patient failed to answer a question, the corresponding subscale was excluded from analysis, whereas all other subscale scores were included. The mode of calculation of the scores is described in detail elsewhere (Spies et al., 2002b). The HRQOL and symptom scores are normalized to a 100-point scale, with higher HRQOL indicating improvement in QOL and lower symptom scores indicating improvement in fibroid-related symptoms. Any surgical or radiological intervention to control persistent fibroid-related symptoms was recorded during follow-up, and UAE was regarded as a therapeutic failure in these women. Additional interventions to treat complications after UAE were also noted for each patient. The menstrual status was recorded before and after treatment. For the purposes of this study, the cessation of menses for 
6 months’ duration after UAE was defined as permanent amenorrhoea.
MRI
All patients underwent MRI on a 1.5-Tesla superconducting scanner (Magnetom Vision®, Magnetom Symphony®, Siemens Medical Systems, Erlangen, Germany) using a torso phased-array coil. After an initial localization scan, sagittal and transaxial T2-weighted turbo spin-echo images (TR 4300–7000 ms, TE 96–115 ms, 512 matrix, slice thickness 5 mm) covering the uterus were taken after intramuscular injection of 20 mg butylscopolamine to reduce bowel motion artefacts. In addition, transaxial, coronal and sagittal breath-hold T2-weighted half-Fourier acquired single-shot turbo spin-echo images (TR/TE, 
/65, flip angle 150°, 128 x 256 matrix, 7 mm slice thickness) were obtained. MRI follow-up was performed approximately 3, 6, 12 and 24 months after UAE. The volume of the uterus and of the dominant leiomyoma (largest tumour before therapy), the number of leiomyomas per patient (single, 2–5, >5) and the localization of the dominant leiomyoma were determined. Based on the location of the centre of the leiomyoma, dominant leiomyomas were defined as being subserosal pedunculated, subserosal, intramural, submucosal or submucosal pedunculated using a modification of the classification of Goodwin et al. (2001). Volumes were determined by measuring the maximum extent of the uterus and dominant leiomyoma in three planes and multiplying the product by 0.5233 (ellipsoid volume formula; Orsini et al., 1984).
Statistical analysis
All patients who completed follow-up were eligible for further analysis. To evaluate outcome in the course of follow-up, the total study population was subdivided into two groups having undergone short-term follow-up (3–7 months, median 5) and mid-term follow-up (8–20 months, median 14) with roughly equal numbers of patients. The age distribution of the two subgroups was compared by Mann–Whitney U-test for unpaired samples to identify any significant differences. Pearson’s chi-square test or Fisher’s exact test for dichotomous variables was used to identify differences between the two follow-up groups with regard to the number of leiomyomas, the localization of the dominant leiomyoma, clinical symptoms and the patient’s menstrual status before treatment. The pre-embolization UV and DFV were compared between both groups using the Mann–Whitney U-test. Wilcoxon’s test for paired samples was applied to test changes in volume after UAE for statistical significance. The percentage volume reduction is given as median and 95% confidence interval. The volume changes from short-term to mid-term follow-up were assessed using the Mann–Whitney U-test for unpaired samples. The results of each UFS-QOL score before and after UAE are given as median with 25 and 75 percentiles and are illustrated graphically. The absolute as well as the proportional changes are given as median with 95% confidence interval. The UFS-QOL was analysed using Wilcoxon’s test for paired samples. Short-term versus mid-term follow-up groups were compared using the Mann–Whitney U-test for unpaired samples to detect differences between both groups before and after UAE.
The Kruskal–Wallis test was applied in a first step to identify possible interactions among the number of leiomyomas, the localization of the dominant leiomyoma, UV and DFV reductions and changes in symptom severity or the seven HRQOL scores. Whenever significant associations between any two of the parameters were identified, the Mann–Whitney U-test was applied in a second step to two categories of that parameter (e.g. single leiomyoma versus more than five leiomyomas) and their interaction with the other parameter (e.g. percentage UV reduction). Spearman’s rank correlation served to identify associations between changes in the symptom severity score or the HRQOL scores, and the percentage UV and DFV reductions. Scatter plots were generated to assess the nature of associations, when appropriate. Statistical significance was accepted at P < 0.05. Statistical analysis was performed using the SPSS software package (SPSS 10.0.7; SPSS Corporation, Chicago, USA).
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Results |
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Both uterine arteries were successfully embolized in 80 of 82 (98%) patients. In 2 of 82 (2%) cases, UAE was performed only unilaterally because of an absent uterine artery in one case and occlusion of the uterine artery by a surgical clip placed before sterilization in another. Of 82 patients, 7 (8.5%) patients with persisting leiomyoma-related symptoms underwent repeat UAE (n = 5) or hysterectomy (n = 2), and initial UAE was regarded as a therapeutic failure. Of 82, 4 (4.9%) patients failed to appear for follow-up. The embolic agents in these failures were gelatine-coated trisacryl microspheres (Embosphere) in five patients and polyvinyl alcohol (PVA) spheres (BeadBlock) in two patients.
Excluding the above-mentioned 11 patients from further analysis who either were lost to follow-up or underwent a second procedure to treat persisting leiomyoma-related symptoms, 71 of 82 (86.6%) patients initially included in the study and followed up for 3–20 months (median 7 months) could be analysed. These 71 patients were assigned to a short-term follow-up group (median 5 months, range 3–7 months, 37 patients) or a mid-term follow-up group (median 14 months, range 8–20 months, 34 patients). Figure 1 shows the number of patients included and the number excluded during the course of the study.
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The two follow-up groups did not differ in terms of age, menstrual status, presenting clinical symptoms, UV and DFV, the localization of the dominant leiomyoma and the total number of leiomyomas detected or HRQOL and symptom severity scores at baseline. During the course of the study, 2 of 71 (3%) patients were admitted to treat symptomatic fibroid expulsion without infection. At follow-up, 3 of 71 (4%) patients aged 44, 49 and 60 at the time of UAE reported permanent amenorrhoea in 18 months, 2 months and directly after UAE, respectively.
Analysis of the UFS-QOL
Table II lists the results of the individual scores before and after UAE as well as the median change, including 95% confidence intervals separately for the two follow-up groups. The symptom severity score of the UFS-QOL decreased significantly (P < 0.001) to a median of 21.88 points (95% CI 6.25–29.69, P < 0.001) in the short-term follow-up group versus 9.38 (95% CI 0.00–18.75, P < 0.001) in the mid-term follow-up group. The HRQOL scores showed a significant increase (P < 0.001) both in the short-term follow-up group (median 87.93, 95% CI 74.14–97.84) and in the mid-term follow-up group (median 96.12, 95% CI 84.70–98.92). Figure 2 shows the results as radial plots for each follow-up group with eight spokes representing the subscales of the questionnaire, and the corresponding scores ranging from zero at the centre to 100 at the outer margin. The radial plots show a pronounced constriction for the symptom severity score represented in the 12 o’clock position, indicating the symptom alleviation after UAE. The HRQOL scores show a uniform expansion of the area covered, corresponding to a significant reduction of the fibroid-related interference with all areas of QOL covered by the questionnaire.
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The most pronounced change in both the short- and the mid-term follow-up groups was seen for the symptom severity score (median decrease at short-term was 25.0 points and at mid-term 28.13 points). Regarding the HRQOL subscales, the energy/mood subscale, which provides information on how much the disease interferes with inner motivation as well as physical and mental energy for daily activities showed the most prominent change during the short-term follow-up (median increase 21.43 points), whereas several subscales showed a marked change from baseline values during the mid-term follow-up. The least changes occurred in the self-consciousness subscale before and after the procedure (median increase at short-term was 8.33 points and at mid-term 16.67 points). The items of this subscale comprise concern about weight gain and appearance (e.g. related to restricted choice of clothing). The results at short- and mid-term follow-ups are compared in Table III. None of the eight subscale scores differed significantly between the two follow-up groups before therapy. Improvement in the activities score between the two follow-up times differs significantly (P = 0.019), whereas the difference in improvement for the symptom severity score approaches significance with P = 0.053. No significant difference was seen between short- and mid-term follow-ups in any of the other subscales.
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Analysis of MRI findings
Table IV presents the MRI findings before the procedure in comparison with the findings at short-term and mid-term follow-ups. A statistically significant reduction in UV and DFV was observed both at short- and at mid-term follow-ups. The measurements at mid-term follow-up showed a more pronounced UV reduction compared with those at short-term follow-up, whereas the DFV reduction differs only slightly between both groups. However, these differences are not statistically significant (P = 0.118 and 0.376, respectively).
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Interactions and correlations
The scores of the eight UFS-QOL subscales were tested for statistical associations with the percentage UV and DFV reductions, the localization of the DF and the number of fibroids. An association was found for the concern subscale, which showed a significant correlation (P = 0.020) with the percentage DFV reduction. The correlation of these two parameters is very weak as suggested by Spearman’s correlation coefficient (
= 0.296). A moderate correlation ( = 0.388; P = 0.002) was found between changes in the symptom severity score and percentage UV reduction (Figure 3). A significant association was found for the number of fibroids and changes in the energy/mood score of the questionnaire (P = 0.015). The Mann–Whitney U-test revealed that patients with one fibroid had a significantly stronger improvement of this score (–31.92 versus –14.46) than patients with two to five fibroids. There was no significant difference between either of these categories and the patients with more than five fibroids.
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Discussion |
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Uterine fibroids are clinically apparent in 25% of women of reproductive age, but their prevalence is estimated to be as high as 77% (Cramer and Patel, 1990
; Stewart, 2001). It has been estimated that in the United States 140 000–180 000 hysterectomies are performed for uterine fibroids each year, accounting for one-third of all hysterectomies performed in middle-aged women (Lepine et al., 1997; Myers et al., 2002). In the UK, women have a one in five chance of having a hysterectomy by the age of 55 with 90% being performed for a benign condition, most likely uterine fibroids (Vessey et al., 1992; Edozien, 2005). Although hysterectomy is the definite treatment for uterine leiomyoma, many patients would like to avoid major surgery and look for permanent alleviation of symptoms rather than surgical cure for this benign disease (Nevadunsky et al., 2001). The clinical efficacy of alternative uterine-sparing treatments for leiomyomas cannot be fully described by objective measurements such as changes in UV and DFV, or an alkaline haematin test for the assessment of menstrual blood loss because symptom alleviation is highly subjective (Khaund et al., 2004; Prollius et al., 2004). The analysis of clinical outcome after therapy should therefore include the patient’s perspective as reflected by the subjective improvement in symptoms and associated HRQOL. To obtain comprehensive data on clinical and imaging outcome after UAE for uterine fibroids, we prospectively employed the UFS-QOL as well as MRI in this study.
We assessed the extent of leiomyoma disease at baseline in our patients by MRI according to the recommendations of an expert panel on reporting standards for UAE (Goodwin et al., 2001). This allowed us to obtain comparable baseline and follow-up data, and evaluate possible interactions with the clinical outcome as measured by the UFS-QOL. MRI showed significant volume reductions of both the uterus and the dominant leiomyoma at short-term and mid-term follow-up. Further shrinkage occurred comparing short-term and mid-term follow-up results, but was not statistically significant. Spies et al. (2001) made similar observations in a study population of 200 patients and demonstrated statistical significance for reduction in UV over time. The amount of UV and DFV reductions in our study is in the range reported in other case series (Spies et al., 2001; Walker and Pelage, 2002). In the study of Walker and Pelage (2002), 400 patients were followed up by imaging for a mean interval of 16.7 months. The dominant leiomyoma and the uterus showed a significant decrease in volume by 67 and 54%, respectively. Whereas DFV decreased similarly by 66% at mid-term follow-up, the percentage UV reduction at mid-term follow-up in our study and in the study by Spies et al. is less pronounced with 36 and 38%, respectively. No clear association between baseline UV and DFV and percentage UV and DFV reductions after UAE emerged from the results of previously reported large case series (McLucas et al., 2001; Spies et al., 2001; Pron et al., 2003). Jha et al. (2000) reported a higher rate of shrinkage for submucosal fibroids, but these results could not be confirmed with a longer follow-up in a larger series (Spies et al., 2002b). In this study, likewise no association was found between the number of leiomyomas/the localization of the dominant leiomyoma at baseline MRI and the UV/DFV reduction after UAE. However, clearly, the limitations of our analysis of associations between baseline imaging variables and UV and DFV reductions as well as clinical outcome measures exist, because we did not control for confounding imaging variables. Bearing this in mind, correlations found between imaging variables and the scores of the UFS-QOL must be viewed with caution. However, based on the analysis of imaging variables and clinical results evaluated in this study, neither the size, location or number of fibroids at baseline can be viewed as factors that have a profound negative impact on the alleviation of fibroid-related symptoms and HRQOL nor can UV and DFV reductions after UAE be regarded as a marker for clinical success.
Our prospective study showed for the first time that improvements in symptom severity and HRQOL after UAE, assessed by a validated disease-specific questionnaire, are significant and similar at short- versus mid-term follow-up, indicating the stability of clinical improvement after UAE over time. Smith et al. (2004) presented a study in which the UFS-QOL was used in a patient population of similar size. However, the questionnaire pertaining to the patient’s pretreatment condition was administered retrospectively together with the post-treatment questionnaire at the end of a follow-up period ranging from 6 to 57.5 months, which limits the quality of their results considerably because of a possible recall bias as well as non-uniformity of follow-up data. In a randomized trial comparing two embolic agents for UAE, Spies et al. presented 3-month clinical follow-up results of 100 patients assessed by the UFS-QOL. They showed a mean reduction in the symptom severity score of 26.8–39.2 (±24) and a mean increase in the HRQOL total score of 23.1–36 (±23–25) (Spies et al., 2004). The mean changes in both scores in their study reflecting the dimensions of improvement in both parameters are comparable with our results with the exception that baseline values for symptom severity were lower and HRQOL total scores higher in our study, resulting in even lower symptom severity scores and higher HRQOL total scores for both follow-up groups after treatment. In a recent multicentre study using the Fibroid Registry for Outcomes Data (FIBROID) and the UFS-QOL as outcome measure, similar results regarding reduction in symptom severity and improvement of health HRQOL total scores were reported for 6 and 12 months after UAE (Spies et al., 2005b).
Spies et al. (2002b) originally validated their questionnaire in a patient population with uterine leiomyomas in comparison with a healthy control group. The baseline symptom severity and HRQOL scores in their patient population correspond to those observed in our patients before UAE. Interestingly, the comparison of our post-treatment results with those of the control group without leiomyomas of the uterus in the study by Spies et al. [symptom severity score 22.5 (SD 21.1); HRQOL total 86.4 (SD 17.7)] shows that the scores at short-term follow-up after UAE in our patient cohort are similar to those of healthy women. The comparison of short- versus mid-term results in this study showed improvements for all HRQOL subscale scores as well as marked further improvement in the symptom severity score. However, these observations were only statistically significant for the ‘activities’ subscale and approached significance for the symptom severity score. The marked change in the ‘activities’ score, which showed the most pronounced improvement compared with baseline values and continuing improvement from short- to mid-term follow-up, highlights that patients having undergone UAE return to a normal level of daily and professional activities shortly after the procedure. The observed moderate improvement of the self-consciousness score may be due to the fact that this score was already high before treatment (68.89 versus 74.74). In the study by Spies et al. (2002b), self-consciousness was more strongly impaired in patients with leiomyomas [score of 57.2 (25.5)]. This may be related to the median UVs of patients treated in our study that were smaller than those in other studies due to the exclusion of patients with fibroids >10 cm in diameter and uterine enlargement above the level of the umbilicus, which in turn may explain that a less pronounced effect on the self-consciousness score summarizing questions regarding the body perception of patients (e.g. weight gain, size of clothing and abdominal wall distortion) was observed.
The frequency of readmission for complications after UAE was low with two patients admitted to treat fibroid expulsion. Fibroid expulsion is seen in 2–10% of cases according to large case series (Spies et al., 2001; Walker and Pelage, 2002). In most cases spontaneous expulsion occurs, and no further treatment of this condition is necessary (Kroencke et al., 2003). It has been argued that simple fibroid expulsion after UAE should be regarded as ‘cure not complication’ of therapy because fibroid tissue is effectively eliminated (Hehenkamp et al., 2004). However, fibroid expulsion may be complicated by infection, or fibroid tissue may be too large to be passed transvaginally albeit necessitating extraction as in two patients of our study. Only 3 of 71 patients experienced permanent amenorrhoea after UAE, with two of them >45 years. This observation mirrors the results of other studies, which showed an increased incidence of amenorrhoea after UAE in perimenopausal women as opposed to women >40 years (Ahmad et al., 2002; Tropeano et al., 2004). However, also studies reporting no effect on ovarian function have been published (Healey et al., 2004). Non-target embolization of the ovaries during UAE or diminished blood flow via utero-ovarian anastomoses may account for these effects (Payne et al., 2002; Tulandi et al., 2002). In women undergoing hysterectomy, an earlier onset of menopause has been observed and attributed likewise to a reduced blood supply to the ovary after surgery with loss in ovarian reserve (Stone et al., 1975; Janson and Jansson, 1977; Siddle et al., 1987; Farquhar et al., 2005).
The incidence of repeat interventions after UAE for therapeutic failure is reported to range from 5 to 8% in larger series with a follow-up of up to 12 months (Spies et al., 2001; Walker and Pelage, 2002). In our study, 9% of patients with clinical failure after UAE underwent a second invasive intervention, and either hysterectomy or repeat UAE was performed within 12 months after initial UAE for persistent symptoms (primary failure). Calculating also patients who were lost to follow-up as failures, the overall failure rate of 13% appears low. Few studies have reported clinical follow-up data beyond 2 years and reported an incidence of additional therapy ranging from 20 to 29% (Broder et al., 2002; Marret et al., 2003; Spies et al., 2005b). However, most of these studies did not differentiate if additional therapy was performed for primary clinical failure of UAE or secondary failure due to the recurrence of fibroids. The recurrence of initially improved symptoms was not observed in our study. Clearly, additional studies are needed to establish the incidence and causes of primary failure versus clinical recurrence.
We conclude that patients with symptomatic leiomyomas treated by UAE experience significant reductions in UV and DFV as well as a significant alleviation of fibroid-related symptoms and increase in HRQOL. Although limited, our data suggest that these changes are stable over time. However, long-term studies are needed to confirm these results.
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Submitted on November 24, 2005; resubmitted on February 17, 2006; resubmitted on May 3, 2006; accepted on June 14, 2006.
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