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Original Research |
1 Department of Cardiovascular and Interventional Radiology, Medical University of Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria.
Received September 17, 2008;
accepted after revision December 19, 2008.
Funded solely by the Department of Cardiovascular and Interventional
Radiology at the Medical University of Vienna.
Abstract
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MATERIALS AND METHODS. A retrospective follow-up cohort study included all patients described in a 2006 publication. Analysis was performed with a questionnaire consisting of 49 questions about six topics. Assessment was focused on comparing symptoms and quality of life in long-term follow-up.
RESULTS. The analysis was based on questionnaires completed by 39 patients. The median follow-up period was 7 years (interquartile range, 1.5 years). Uterine fibroid embolization led to a reduction of bleeding symptoms in 89.7% of the patients, pain in 78.9%, bulk-related symptoms in 89.5%, fatigue in 76.9%, limitations of social life in 92.9%, and depression in 78.6%. The median impairment scores for bleeding and pain decreased significantly from 7 to 0 and from 5 to 0 (both p < 0.001). The general quality-of-life index increased significantly from 4.5 to 9 (p < 0.001). In the long term, there was no significant difference in parameters assessed compared with the midterm follow-up findings. Six patients (15.4%) underwent hysterectomy an average of 32.1 months after intervention. Thirty-two patients (82.1%) continued to be satisfied with the intervention, and 30 patients (76.9%) answered that they would recommend uterine fibroid embolization to other patients.
CONCLUSION. Uterine fibroid embolization seems to lead to notable long-term relief of fibroid-associated symptoms. In comparison with the midterm results, long-term outcome shows a clear continuance of improvement in general quality of life.
Keywords: embolization • fibroids • genitourinary tract imaging • interventional radiology
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Uterine fibroid embolization (UFE) has been reported to be an effective minimally invasive therapeutic alternative and to be associated with high patient satisfaction rates [3-6]. UFE is cost-effective and has a shorter recovery period than surgical techniques [7, 8]. The patient's preference for one therapeutic option over another is affected by the amount and extent of potential complications, the duration of hospital stay, and the recovery period. Physical factors such as bleeding, bulk-related symptoms, pain, urinary and sexual dysfunction, and psychological manifestations in the form of depression, and loss of control of and infringement on one's life play an important role in quality of life (QOL).
The objective of any therapy for nonmalignant disease is to improve the patient's health-related QOL [6]. There is little evidence in the literature addressing the health-related long-term QOL of women who have undergone UFE with a median follow-up of more than 7 years [9-11]. To the best of our knowledge, there have been no reports of studies comparing midterm and long-term results. One registry, however, contains solid information with regard to QOL assessed with validated survey instruments and shorter follow-up periods [12]. A well-documented study [13] with a 2-year follow-up of health-related QOL after UFE and hysterectomy showed UFE to be a good alternative in the treatment of patients with symptomatic uterine fibroids. Although hysterectomy and UFE are considered equal with respect to safety, economic factors render UFE the method of choice [14]. Because most studies have been conducted with differing outcome variables, direct comparison is challenging. To update findings published in 2006 [15], we performed a retrospective long-term follow-up study to assess changes in QOL and general satisfaction among patients treated with UFE.
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We focused our analytic efforts on post-interventional status, satisfaction, and QOL and how the same patient sample assessed her QOL 6-8 years after intervention. All women had primary symptomatic uterine fibroid disease, defined as pain, bleeding, bulk-related symptoms, sexual and urinary dysfunction, or a combination of these symptoms. A comprehensive description of the UFE procedure has been published [9]. The questions were used to identify fibroid-related physical and psychologic symptoms, such as bleeding, pain, bulk-related symptoms, and urinary and sexual function; they also were used to assess QOL, including mood, control of one's life, and daily life activity with respect to fibroid disease. Additional analyses included patient data on necessary hysterectomy, complications associated with the intervention, achieving pregnancy, child-bearing, and the patient's general evaluation of UFE. The institutional ethics committee approved this study, and written informed consent was obtained from each patient.
The analysis was performed with SPSS statistical software (version 16.0, SPSS). All categoric questions had a binary (yes or no) answer structure, and results were recorded as absolute and relative frequencies. The patients' estimation of the severity of bleeding and pain was assessed with a 10-point scale (0, no limitation or pain; 10, strong limitation, extreme pain). The patients' estimation of general QOL also was assessed with a 10-point scale (0, worst imaginable QOL; 10, perfect QOL). Results on these scales are reported as median and interquartile range (IQR). All metric numeric values are stated as mean ± SD with the minimum and maximum in parentheses. Comparison of categoric data before and after intervention is represented as relative frequency reduction (1 - [postinterventional value / pre interventional value]). The nonparametric Wilcoxon's rank sum test was used for comparison of scales. A value of p < 0.05 was considered significant.
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Bleeding
Before intervention, 29 of the 33 patients (87.9%) had bleeding that
included menorrhagia, dysmenorrhea, and metrorrhagia
(Table 1). The median
impairment score for these difficulties was 7 (IQR, 5.4)
(Fig. 1). Data at midterm and
long-term follow-up evaluations were similar in that two and three women,
respectively, continued to experience bleeding. This finding represents
relative frequency reductions of 93.1% for midterm and 89.7% for long-term
follow-up compared with the status before intervention. Symptoms of
menorrhagia were reported to have continued, whereas difficulties with
metrorrhagia had occurred recently. The median impairment score for these
problems was 0 (IQR, 0), 84.8% of patients scoring the symptom 0 in the
midterm and 81.8% scoring it 0 in the long term. This finding denotes
sustained and significant improvement compared with the situation before
intervention (p < 0.001).
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Pain and Bulk-Related Symptoms
Pain and diffuse bulk-related symptoms were reported by 19 patients (57.6%)
before embolization. The foci of pain were the pelvic region, the back, and
the epigastric region (Table
2). The median pain score was 5 (IQR, 7)
(Fig. 2). At midterm and
long-term follow-up, four patients continued to experience pain. This finding
corresponds to a relative frequency reduction of 78.9% for both follow-up
periods. Midterm and long-term follow-up evaluation for symptoms revealed that
one and two patients, respectively, reported that they continued to have
bulk-related symptoms. This finding corresponds to relative frequency
reductions of 94.7% in the midterm and 89.5% in the long-term assessment.
Symptoms of pain and bulk-related problems were reported to continue. The
median pain score for both follow-up periods was 0 (IQRmidterm, 0;
IQRlong term, 1), 29 patients (87.9%) reporting a score of 0 in the
midterm and 21 patients (63.6%) reporting a score of 0 in the long term (both
p < 0.001 compared with the assessment before intervention).
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After intervention, one patient reported that she felt less productive at midterm assessment (relative frequency reduction, 91.7%), and three women reported diminished productivity at long-term follow-up (relative frequency reduction, 75%). One patient (relative frequency reduction, 93.8%) and five patients (relative frequency reduction, 68.8%) reported problems exercising at midterm and long-term follow-up assessments, respectively. At midterm assessment, one patient reported feeling loss of control over her life (relative frequency reduction, 90.0%), and one patient reported feeling restricted in daily life (relative frequency reduction, 93.8%). The long-term evaluation feedback showed that two patients felt likewise regarding loss of control (relative frequency reduction, 80.0%) and the feeling of restriction in daily life (relative frequency reduction, 87.5%). For both patients, the midterm and long-term median QOL scores improved significantly to 9 (IQRmidterm, 1.8; IQRlong-term, 3; p < 0.001).
Reproduction in the Long Term
After intervention, two patients gave birth to healthy infants at term.
Four women continued to have problems conceiving, and one had a miscarriage.
Five patients had amenorrhea. Four of the five were older than 50 years, and
one patient was 42 years old at follow-up.
Long-Term General Satisfaction
Twenty-eight of the total of 39 patients (71.8%) were content with the
intervention, and five (12.8%) were disappointed. Thirty women (76.9%) would
highly recommend UFE to other patients, and four patients would do so under
conditional circumstances. Overall subjective QOL improved significantly in
the midterm and the long term (Figs.
3 and
4).
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In our work, efficient assessment of health-related QOL in the midterm and the long term after treatment was facilitated by use of the same questionnaire for the two evaluation periods. This approach allows appropriate comparison of the same patients' QOL developments over time. The questionnaires described in the literature for QOL evaluations have been varied and are not standardized. Among the most frequently used instruments for assessment of health-related QOL are the short-form health survey (SF-36), the EuroQol five domain (EQ-5D), and the uterine fibroid-specific QOL [20-23]. These questionnaires have been validated. Although in other ways different from our instrument, they are similar to ours in showing that uterine fibroids are greatly symptomatic and that women with fibroids have a clearly reduced QOL [20-23].
To the best of our knowledge, our report is the first to include information on fibroid patients with a median follow-up period of 7.0 years after embolization. The median follow-up periods in the scientific literature range from 2 to 4.6 years in well-documented research detailing, among other variables, QOL after embolization [12-14]. Results of two studies [21, 22] with follow-up periods of up to 5 years indicated continued symptom control after UFE in 73-89.5% of patients. Furthermore, failure rates at 5-year follow-up, defined as the need for repeated embolization, myomectomy, or hysterectomy, range between 12.7% and 20%.
As did the patients described in the published data, our patient cohort reported a reduction in bleeding, pain, and bulk-related symptoms of 86.6%; 84.6% of women treated with UFE retained their uterus and avoided repeated intervention and surgical repair. Before intervention, five of 39 patients (12.8%) had not been able to conceive, and six (15.4%) had reported problems in a previous pregnancy, including two women with spontaneous abortions and five with miscarriages. After intervention, three women continued to have problems conceiving, and one woman had a miscarriage. There were two successful pregnancies (6.2%) among the 33 patients in our study. In the literature, successful pregnancy after UFE occurs in 3.5-11% of patients [23-28]. Although the American College of Obstetrics and Gynecology [29] has advised against UFE for women who plan future pregnancies, data published on ovarian failure in UFE patients younger than 40 years suggest negligible risk [27-31].
In our study, six of 39 women (15.4%) underwent hysterectomy as the definitive treatment. Data collected from the scientific literature suggest a need for repeated intervention due to recurrence of symptoms and a rate of conversion to hysterectomy after UFE of 8-23% [14, 16, 30-33]. Our six patients who underwent hysterectomy were split on their sentiments regarding UFE. Three of these women would still recommend embolization to other patients with fibroids.
Although repeated intervention or hysterectomy may become necessary, the safety-related and economic advantages of UFE are well documented. Major and severe complications are less common for UFE than for hysterectomy [14]. Cost analyses performed in two major studies [14, 31] have shown the fiscal effectiveness of UFE. With complications and the possibility of the need for reintervention taken into account, UFE has proved more cost-effective than hysterectomy and myomectomy. Although the health outcomes are similar for UFE and hysterectomy, the total cost of treatment with UFE is 37% lower. A large portion of this reduction is due to the difference in time lost from work [31].
In the assessment of long-term general satisfaction with UFE, we found that 82.1% of respondents judged the intervention very satisfactory and 56.4% regarded the results as excellent. Only two patients would not recommend UFE to other patients. These results are in accordance with published findings of satisfaction rates of 78-98% [3, 6]. In 2007, Hehenkamp et al. [32] found that after UFE, sexual function and body image scores improved significantly. In a study involving 144 women with symptomatic uterine fibroids, Voogt et al. [33] found significant improvement in psychologic well-being and sexual function 3 months after embolization. In another study, in which the investigators compared findings after UFE with those after hysterectomy among 177 patients with fibroids, at the 2-year follow-up assessment, Hehenkamp et al. [13] found somewhat higher health-related satisfaction among patients who had undergone hysterectomy. In our study, parameters of well-being and contentment improved significantly. The relative frequency reduction of fibroid-associated symptoms was assessed to be 72-98%.
Results of comparisons of UFE and myomectomy [34, 35] suggest that UFE is as safe as myomectomy and less invasive. Furthermore, improvements in sustained symptom control and health-related QOL and a lower rate of complications suggest preference for UFE over myomectomy.
There were several limitations concerning interpretation of the results of our study. First, the baseline questionnaire was administered after intervention. This practice can influence memory or the interpretation of memory and therefore render the data subject to recall bias. Although patients tend to curtail their negative recollection of symptoms and experiences when asked about them in a remote recall situation, intrapatient correspondence between midterm and long-term data is superior. This sort of recall bias would tend to minimize the apparent therapeutic benefit of UFE on the follow-up questionnaire. Second, general QOL items might have been answered by patients without direct relation to fibroids, even though the questionnaire and study invitation letter asked that every aspect of life quality be assessed only in connection with fibroid disease. Third, although the development of our survey instrument took considerable effort, time, and input from numerous qualified and experienced sources, not all aspects of definitive instrument validation in the strictest statistical sense were obtained. Fourth, lack of participation presented a potential source of bias in the retrospective study design. That 14 patients were lost to follow-up and six women underwent hysterectomy reduced the total number of analyzed responses to 33 and further limited and possibly skewed interpretation. Finally, women who decided on UFE as their therapeutic regimen may not represent all women with symptomatic fibroids.
We conclude that UFE seems to significantly improve women's health-related QOL and appears to lead to impressive long-term relief of physical and psychologic leiomyoma-associated symptoms and improvement in well-being. The direct comparison of midterm and long-term results shows, above all, sustained, subjective improvement in QOL in our patient sample. More study is needed to support our findings. Our cohort assessment showed that the UFE approach seems to result in high overall patient satisfaction and health-related QOL even after a median postintervention period of 7 years.
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