Uterine Artery Embolization for Symptomatic Adenomyosis: 7-Year Clinical Follow-up Using UFS-Qol Questionnaire.
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ABSTRACT:
SUBMITTER: de Bruijn AM
PROVIDER: S-EPMC5541078 | biostudies-other | 2017 Sep
REPOSITORIES: biostudies-other
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Project description:ObjectiveTo examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported.Study designPremenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization.Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance.The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes.Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394.Results254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18-1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27-1.05).ConclusionsMyomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.
| S-EPMC8633559 | biostudies-literature
Project description:BACKGROUND:Adenomyosis is a benign uterine disease characterized by invasion of endometrium into the myometrium resulting in heavy menstrual bleeding and pain (dysmenorrhea). Hysterectomy is established as the final treatment option when conservative treatment fails. Uterine artery embolization (UAE) in patients with symptomatic adenomyosis has demonstrated to reduce symptoms and improve quality of life. However, randomized controlled trials are lacking. OBJECTIVE:With this study, we aim to evaluate the impact of UAE on Health-Related Quality of Life (HRQOL) in a randomized comparison to hysterectomy in patients with symptomatic adenomyosis. METHODS:This is a multicenter non-blinded randomized controlled trial comparing UAE and hysterectomy. Eligible patients are symptomatic premenopausal women without the desire to conceive and who have symptomatic magnetic resonance imaging (MRI)-confirmed pure adenomyosis or dominant adenomyosis accompanied by fibroids. After obtaining informed consent, patients will be randomly allocated to treatment in a 2:1 UAE versus hysterectomy ratio. The primary objective is HRQOL at 6 months following the assigned intervention. Secondary outcomes are technical results, pain management, clinical outcomes, HRQOL, and cost effectiveness during 2 years of follow-up. In addition, transvaginal ultrasound (TVUS) and MRI will be performed at regular intervals after UAE. RESULTS:Patient enrollment started November 2015. The follow-up period will be completed two years after inclusion of the last patient. At the time of submission of this article, data cleaning and analyses have not yet started. CONCLUSIONS:This trial will provide insight for caretakers and future patients about the effect of UAE compared to the gold standard hysterectomy in the treatment of symptomatic adenomyosis and is therefore expected to improve patients' wellbeing and quality of life. TRIAL REGISTRATION:Netherlands Trial Register NTR5615; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5615 (Archived by WebCite at http://www.webcitation.org/6xZRyXeIF).
| S-EPMC5856934 | biostudies-literature
Project description:BackgroundFailing conservative therapies, uterine artery embolisation (UAE) has been proposed as a uterine-sparing option for treatment of symptomatic adenomyosis. UAE appears effective at short-term; however long-term durability is less well established.AimsTo evaluate the long-term clinical efficacy of UAE for treatment of adenomyosis.Materials and methodsOne hundred and four women with initial clinical success following UAE for adenomyosis (results previously published) were further followed with a two-part online survey. Part one inquired about menopause, symptom recurrence, need for further intervention and overall satisfaction. Part two comprised the Uterine Fibroid Symptom and health-related Quality of Life (UFS-QOL) questionnaire. Maintenance of clinical success was defined as remaining 'happy' or 'very happy' with overall outcome, no recurrence of symptoms, or need for further intervention.ResultsOf those women with initial success, 91/104 (88%) participated in this long-term study at mean 52 months following UAE. Maintenance of clinical success was demonstrated in 82/91 (90%) women. For the remaining 9/91 (10%) women, mean time to failure was 31 months. There were 53/91 (58%) women who reached menopause at mean age of 51.5 years, occurring at mean 30 months post-UAE. UFS-QOL demonstrated significant decrease in symptom severity from 58.9 to 20.0 (P < 0.001); and significant increase in QOL from 40.3 to 86.3 (P < 0.001).ConclusionsLong-term durability of UAE for treatment of adenomyosis was demonstrated, with cumulative success rate of 80% at mean 52 months. UAE did not appear to bring forward menopause. UAE should be considered as an alternative to hysterectomy to treat adenomyosis.
| S-EPMC8248413 | biostudies-literature
Project description:PurposeTo perform an evaluation on safety and efficacy of uterine artery embolization (UAE) in the patients with symptomatic cervical leiomyomata.MethodsPatients with symptomatic cervical leiomyomata who underwent UAE in one specialized hospital were retrospectively analyzed, both clinically and with MR imaging. The 3-month outcomes were assessed with MR imaging and a validated questionnaire. Long-term follow-up was assessed by direct contact or file review. To determine the efficacy of UAE for cervical leiomyomata, the primary objective was to assess the clinical outcome with the UFS-QOL questionnaire, containing the health-related quality of life (HRQOL) and symptom severity score (SSS). To assess safety, the secondary objective included leiomyomata volume reduction, the infarction/complication rate and secondary interventions were needed.ResultsBetween 2006 and 2017, eight of 1180 patients underwent UAE and were eligible for inclusion. All embolizations were technically successful (n?=?8). At 3 months, all patients showed cervical leiomyomata volume reduction with a median reduction of 41.5% (38.8 cm3) compared to baseline (p?=?0.012). No complications occurred. At a median follow-up of 3 months (range 1-7, n?=?7), the HRQOL and SSS improved with a median difference of 13 points (range -?5 to 60, p?=?0.063) and -?13 points (range -?79 to 3, p?=?0.046), respectively. Long-term follow-up showed two secondary interventions (median of 43.5 months). Six patients reported no symptom recurrence.ConclusionUAE in women with symptomatic cervical leiomyomata is effective and safe with significant improvement in symptoms and quality of life. UAE is a valuable option for women seeking a non-surgical solution.
| S-EPMC6373190 | biostudies-literature
Project description:Uterine fibroids (leiomyomas) are the most common benign neoplasm of the female pelvis and have a lifetime prevalence exceeding 80% among African American women and approaching 70% among Caucasian women. Approximately 50% of women with fibroids experience symptoms which may include menorrhagia that may result in anemia, bulk symptoms with bladder and bowel dysfunction and abdominal protrusion, dysmenorrhea, and infertility. Hysterectomy remains the most common treatment option for fibroids and concerns have been raised about the overuse of this procedure. Uterine artery embolization (UAE) is now a well-established uterine preserving and minimally invasive therapy for symptomatic fibroids. Since its introduction, strong evidence for safety and efficacy of UAE has been generated with low rates of complications. This review will discuss UAE for the management of symptomatic uterine fibroids with special focus on emerging technical approaches and novel periprocedural patient care.
| S-EPMC5886769 | biostudies-literature
Project description:BACKGROUND AND PURPOSE:The Dutch national guideline on heavy menstrual bleeding was updated and published in 2013. It recommended (for the first time) that uterine artery embolization (UAE) should be part of counseling of women with symptomatic fibroids. We aimed to evaluate the implementation of UAE for symptomatic uterine fibroids in the Netherlands and to investigate gynecologists preference and other influential factors. METHODS:The primary outcome was to examine the UAE/hysterectomy ratio before and after introduction of the 2013 guideline by the use of annual hospital reports. The secondary outcome assessed factors that could influence implementation by means of a questionnaire to gynecologists. RESULTS:A total of 29/30 (97%) UAE+ hospitals and 36/52 (69%) UAE- hospitals sent their annual reports. The UAE/hysterectomy percentages in 2012, 2013 and 2014 were 7,0%, 7.0% and 6.9%, respectively. Regarding the questionnaire, the response rates were 88% and 91%, respectively. In both groups we observed a high self-perceived tendency for UAE counseling (90% versus 70%, p =?.001). Approximately 50% of gynecologists from UAE- hospitals indicate they have insufficient information about UAE for appropriate counseling and 40% doubts the effectiveness of UAE. Furthermore, in the majority of gynecologists some 'urban myths' about the effectiveness and side-effects of UAE seem to persevere. CONCLUSION:Adding UAE as a treatment option to the national guideline did not change the number of performed UAEs for symptomatic fibroids. It might be useful to develop an option grid in order to offer appropriate, independent counseling and encourage shared decision making.
| S-EPMC6966393 | biostudies-literature
Project description:Genicular artery embolization (GAE) is a novel therapy to treat patients with symptomatic knee osteoarthritis (OA) by reducing synovial arterial hypervascularity. This study evaluates the safety and efficacy of GAE for the treatment of symptomatic knee OA.MethodsA prospective, single-center, open-label U.S. Food and Drug Administration-approved investigational device exemption study was conducted. Patients enrolled in the study were 40 to 80 years old, with moderate or severe knee OA (Kellgren-Lawrence grade 2, 3, or 4), who previously had failure of conservative therapy. Baseline pain (visual analog scale [VAS]) and symptom scores (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) were assessed. After femoral arterial access was achieved, GAE of 1, 2, or 3 genicular arteries supplying the location of the subject's pain, as determined by digital subtraction angiography and cone-beam computed tomography, was performed using 100-μm particles. Adverse events and symptoms scores were assessed at 1 week, 1 month, 3 months, 6 months, and 1 year after GAE.ResultsOver a 10-month period, 40 subjects were enrolled. The median age was 69 years (range, 49 to 80 years). The median body mass index was 29 kg/m2 (range, 19 to 44 kg/m2). Knee OA severity was grade 2 in 18% of the patients, grade 3 in 43%, and grade 4 in 40%. Technical success was achieved in 100% of the subjects. Transient skin discoloration and transient mild knee pain after the procedure were common and expected. Treatment-related adverse events included a groin hematoma requiring overnight observation in 1 subject, self-resolving focal skin ulceration in 7 subjects, and an asymptomatic small bone infarct on magnetic resonance imaging at 3 months in 2 subjects. The WOMAC total and VAS pain scores decreased by 61% and 67% at 12 months from a median baseline of 52 (of 96) and 8 (of 10), respectively. Twenty-seven patients (68%) had a reduction of ≥50% in both WOMAC total and VAS pain scores.ConclusionsThis prospective trial demonstrates that GAE is effective and durable in reducing pain symptoms from moderate or severe knee OA that is refractory to other conservative therapy, with an acceptable safety profile.Level of evidenceTherapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
| S-EPMC8542160 | biostudies-literature
Project description:Uterine artery embolization has Level A data supporting excellent safety and efficacy in treating symptomatic uterine leiomyomata. However, there is a perception that either postprocedural pain is severe or poorly managed by the physician performing these procedures. This has led some primary care physicians to omit this procedure from the patients' options or to steer patients away from this procedure. A few simple techniques (pruning of the vascular tree and embolizing to 5-10 beat stasis) and fastidious pre-, intra-, and post-procedural management can nearly eliminate significant pain associated with embolization. Specifically, early implementation of long-acting low-dose narcotics, antiemetics and anti-inflammatory medications is critical. Finally, the use of a superior hypogastric nerve block, which takes minutes to perform and carries a very low risk, significantly reduces pain and diminishes the need for narcotics; when this technique was used in a prospective study, all patients were able to be discharged the day of the procedure. In the authors' experience, patients treated in this manner largely recover completely within 5 days and have a far less traumatic experience than patients traditionally treated with only midazolam (Versed) and fentanyl citrate (fentanyl) intraprocedurally, and narcotics and nonsteroidal antiinflammatory drugs postprocedurally.
| S-EPMC3835579 | biostudies-other
Project description:To evaluate the clinical feasibility and diagnostic accuracy of three-dimensional (3D) quantitative magnetic resonance (MR) imaging for the assessment of total lesion volume (TLV) and enhancing lesion volume (ELV) before and after uterine artery embolization (UAE).This retrospective study included 25 patients with uterine fibroids who underwent UAE and received contrast-enhanced MR imaging before and after the procedure. TLV was calculated using a semiautomated 3D segmentation of the dominant lesion on contrast-enhanced MR imaging, and ELV was defined as voxels within TLV where the enhancement exceeded the value of a region of interest placed in hypoenhancing soft tissue (left psoas muscle). ELV was expressed in relative (% of TLV) and absolute (in cm(3)) metrics. Results were compared with manual measurements and correlated with symptomatic outcome using a linear regression model.Although 3D quantitative measurements of TLV demonstrated a strong correlation with the manual technique (R(2) = 0.93), measurements of ELV after UAE showed significant disagreement between techniques (R(2) = 0.72; residual standard error, 15.8). Six patients (24%) remained symptomatic and were classified as nonresponders. When stratified according to response, no difference in % ELV between responders and nonresponders was observed. When assessed using cm(3) ELV, responders showed a significantly lower mean ELV compared with nonresponders (4.1 cm(3) [range, 0.3-19.8 cm(3)] vs 77 cm(3) [range, 11.91-296 cm(3)]; P < .01).The use of segmentation-based 3D quantification of lesion enhancement is feasible and diagnostically accurate and could be considered as an MR imaging response marker for clinical outcome after UAE.
| S-EPMC4414730 | biostudies-literature
Project description:Background and Purpose:Angioplasty and stenting of the subclavian artery have been reported with high technical and clinical success rates, low complication rates, and good midterm patency rates. Different antegrade or retrograde endovascular catheter-based approaches are used. Nowadays, endovascular therapy has taken over open surgical techniques in subclavian artery disease. The purpose of this study was to determine safety, efficacy, and midterm clinical and radiological outcome of the endovascular treatment with special focus on the different technical approaches in subclavian artery disease. Materials and Methods:Between 2014 and 2017, 11 patients (10 men, 1 woman) with symptomatic high-grade stenosis (90%-100%) of the subclavian artery were treated with endovascular treatment. Their mean age was 51.3 years (range, 32-61 years). Mean angiographic and clinical follow-up was 22.5 months (range, 5-44 months). Clinical follow-up was performed at hospital discharge and routine follow-up was performed at 1, 3, 12 months, and 6 monthly thereafter. In all 11 patients, a percutaneous approach was used successfully. In eight patients, the lesions were accessed retrogradely through a brachial artery puncture. Results:Acute success rate was 100%. There were no significant peri-procedure complications. At the latest clinical follow-up (mean of 22.5 months), all patients showed a good outcome with a restenosis rate of 18.2% including a patient with Takayasu arteritis. Conclusion:Percutaneous antegrade and retrograde stenting of high-grade subclavian artery stenosis is a viable less invasive alternative to open bypass surgery with good midterm clinical results and patency rates.
| S-EPMC6791090 | biostudies-other