Uterine Artery Embolization for Symptomatic Fibroids Uterus in Gaza, A retrospective cohort study
- 1. Department of Cardiology, Alshifa Hospital, Gaza, Palestine
INTRODUCTION
Fibroid Uterus, the most common type of tumor among women of reproductive age, and increases with age [1,2]. This tumor associated with menstrual bleeding, abdominal pain and a reduced quality of life [3]. After failed medical treatment for women who wish to preserve their uterus myomectomy and uterine artery embolization are therapeutic options.
Surgery, either myomectomy or hysterectomy, has traditionally been the primary approach for the management of symptomatic fibroids. Transcatheter uterine artery embolization (UAE) for fibroid uterus treatment was reported by Ravina in 1995 [4]. Uterine-artery embolization is usually performed under local anesthesia, involves occlusion of the bilateral uterine arteries supplying the uterus by the use of biocompatible particles, to cause ischemic infarction of the fibroids. As compared with myomectomy, uterine-artery embolization is associated with a shorter hospital stay and an earlier return to normal activities [5,6]. Several registries and non-randomized clinical trials have supported UAE in symptomatic women with menorrhagia, as an alternative to hysterectomy. The present retrospective clinical trial is the first trial reported in Gaza Strip to document efficacy and safety of UAE for the treatment of symptomatic uterine fibroids.
METHODS
Patient population
A retrospective cohort study between October 2016 and July 2022. The total 32 patients were undergoing of UAE for symptomatic fibroid uterus in Alshifa hospital and al-Hayat hospital in Gaza, Palestine. The indication for UAE was established by a gynecologists after clinical examination and confirmation of the diagnosis by transvaginal ultrasound. MRI diagnosis was done before and 6 months after procedures for all patients.
Embolization technique
A Foley catheter is placed into the bladder before the procedure to prevent discomfort during and post procedure. An Intravenous normal saline with 100 cc/hour to keep open IV line and in order to administer medication when necessary. Local analgesics with Lidocaine 1% should be administered before puncturing the common femoral artery. Bilateral embolization was performed by an interventional cardiologist with experience in embolization procedures using a trans-femoral approach. In most patients, both uterine arteries were accessed consecutively via a common femoral artery approach. Both common femoral arteries were punctured and embolization of the uterine arteries was performed via catheters placed in the uterine arteries in crossover technique. Catheterization and embolization was performed by using 6F right Judkins catheters and coaxially placed microcatheters. The catheter was positioned in the horizontal segment of the uterine artery distal to angiographically visualized cervicovaginal branches. Embolization was achieved by polyvinyl alcohol particles in 31patients (500–700 and 700– 900 μm,) and 1 patient by coils due to uterine AV malformation additionally to fibroid uterus. During embolization patients received intravenous non-steroidal anti-inflammatory drugs or mild conscious sedation with (usually up to 50-100 microgram) fentanyl and (5 mg of) midazolam for pain control and were admitted for observation (6-12 hours) before discharge, at discharge all patients were received anti-inflammatory drugs , antibiotics and proton pump inhibitors for five days.
Outcome Definitions
Primary Outcome (Clinical success): is the resolution or satisfactory improvement of the patients presenting symptoms, such as menorrhagia or bulk-related pain, bloating, urinary urge, or constipation, without additional therapy.
Secondary outcome
- Interventional success: is a complete occlusion in both uterine arteries. Successful embolization of only one uterine artery is considered a interventional failure unless only a single uterine artery is present.
- Reduction of fibroid dimeter: measurement of fibroid diameter before the procedure and after the procedure by MRI.
Complication (Post-embolization syndrome): is the occurrence of pelvic pain, low-grade fever, nausea, vomiting, loss of appetite and malaise in the first few days after UAE.
Statistical analysis
All patients who completed follow-up were eligible for further analysis. The age, fibroid diameter were calculated by mean+ SD. Follow-up of fibroid Diameter before and after 6 months measurement by paired T test. Statistical significance was accepted at P < 0.05. Statistical analysis was performed using the SPSS software package (SPSS 21 version; SPSS Corporation, Chicago, USA).
RESULTS
Thirty -two consecutive patients (mean age, 44.1+7.6 years; range, 28–53 years) underwent uterine artery embolization (Table 1). Embolization was performed with 500–900 μm polyvinyl alcohol particles. A 6-month imaging follow-up by MRI was available in 27 patients and clinical follow-up were between 6-70 months in 30 patients were recorded.
Table 1: Baseline Data of study population.
Demographic characteristics All |
(n = 32) |
Age [mean +SD] |
44.1+7.6 |
Post-menopausal |
2 (6%) |
Presenting symptoms |
|
Menorrhagia |
16 (50%) |
Bulk symptoms |
4(12.5%) |
Both |
12(37.5%) |
Diameter of fibroid |
6.2 ± 2.4 cm |
Number of fibroids |
|
Single |
10(31%) |
Multiple |
22 (69%) |
Location of dominant fibroid |
|
Subserosal |
2 (6 %) |
Intramural |
21(66%) |
Submucosal |
9 (28%) |
Sixteen patients presented with menorrhagia, four had bulkrelated symptoms (abdominal distension, stress incontinence, pelvic pain), and 12 had both. Interventional success for bilateral embolization was in 31 patients 97%. All patients were discharged to home 6–8 hours after the procedure. Complications reported symptoms included pelvic pain/cramping first 24 hours in 47 % (15 of 32), nausea/vomiting in 34.4% (11 of 32), and a no purulent vaginal discharge in 6% (2 of 32). These symptoms were satisfactorily controlled with discharge medications. No patients returned to the hospital or visited an emergency room during the first 48 hours after discharge. One patient undergo surgery hysterectomy on 14 months after UAE related complaints and failure of conservative treatment. was a significant reduction in dominant fibroid diameter was seen after 6 months after UAE. The mean dominant fibroid diameter reduced from 6.2 ± 2.4 cm to 1.7± 1.44 cm (p = 0.001). Only 2 (6%) women become pregnant with live birth following UAE.
DISCUSSION
Uterine fibroids are clinically apparent in 25% of women of reproductive age, myomectomy or hysterectomy, has traditionally been the primary approach for the management of symptomatic fibroids, many patients would like to avoid major surgery and look for permanent alleviation of symptoms rather than surgical cure for this benign disease. In our trial The overall incidence of complications associated with UAE was low, the median length of hospital stay was less than 1 day with uterineartery embolization.
In our trial interventional success for bilateral embolization was 97%. Ana all patients were discharged to home 6–8 hours after the procedure, only one patient undergo surgery hysterectomy on 14 months after UAE related complaints and failure of conservative treatment. Significant reduction was seen in the mean dominant fibroid diameter, no mortality was reported.
Our review found pooled rates of pregnancy of 39.4%, live birth of 69.2% and miscarriage of 22% following UAE
Most of the studies included in our trial suggested the use of UAE as an important tool in the treatment of fibroid uterus. The procedure is effective therapy for women with heavy menstrual bleeding who were resistant to other conservative therapies.
The REST study: Randomized comparison of UAE versus surgery (myomectomy and hysterectomy) in 157 women with symptomatic fibroid uterus. The randomization was 2:1 (106 UAE and 51 surgery) and a long follow-up of 5 years. The improvement in quality of life was similar in both groups [7].
The FUME study [8], fibroid uterus for Myomectomy versus Embolization, the quality of life in patients following UAE or myomectomy performed for uterine fibroids in a prospective cohort trial . The outcomes during a follow-up period of 5 years showed similar results regarding significant improvement in quality of life.
The EMMY study: Embolization vs. Hysterectomy was a multicentric randomized controlled trial conducted between 2002 and 2004 which included 177 patients with symptomatic fibroid uterus. The study population was randomized to 81 UAE and 75 hysterectomies with the goal of comparing the outcomes and quality of life 10 years after the procedure [9,10]. In this trial UAE is a well-documented valuable treatment alternative for surgery in the treatment of patients with symptomatic fibroids in terms of quality of life
In FEMME trial [11], Perioperative and postoperative complications was occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterineartery embolization group but patients underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization.
In recent published review [12], found pooled rates of pregnancy of 39.4%, live birth of 69.2% and miscarriage of 22% following UAE. In our trial 6% women was pregnant with live birth.
CONCLUSIONS
After failed medical treatment for women with fibroid uterus who wish to preserve their uterus UAE is alternative to myomectomy. A 3 % hysterectomy rate has to be expected during follow-up after successful embolization. In the shortterm, UAE had lower blood loss, shorter hospital stay and quicker resumption of work. Every symptomatic patient with uterine myoma’s should be offered UAE as alternative treatment to myomectomy.
REFERENCES
- Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG. 2017; 124: 1501-1512.
- Lurie S, Piper I, Woliovitch I, Glezerman M. Age-related prevalence of sonographicaly confirmed uterine myomas. J Obstet Gynaecol. 2005; 25: 42-44.
- Drayer SM, Catherino WH. Prevalence, morbidity, and current medical management of uterine leiomyomas. Int J Gynaecol Obstet. 2015; 131: 117-122.
- Ravina JH, Ciraru-Vigneron N, Bouret JM, Herbreteau D, Houdart E, Aymard A, et al. Arterial embolisation to treat uterine myomata. The Lancet. 1995; 346: 671-672.
- Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008; 31: 73-85.
- Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli A-M. Uterine artery embolization versus myomectomy: impact on quality of life — results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol. 2012; 35: 530-536.
- Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, Craig LE, Lumsden MA. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. BJOG. 2011; 118: 936-944.
- Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli AM. Uterine artery embolization versus myomectomy: impact on quality of life – results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol. 2012; 35: 530-536.
- de Bruijn AM, Ankum WM, Reekers JA, Birnie E, van der Kooij SM, Volkers NA, Hehenkamp WJ. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 10-year outcomes from the randomized EMMY trial. Am J Obstet Gynecol. 2016; 215: 745.e1-745.e12.
- van der Kooij SM, Hehenkamp WJ, Volkers NA, Birnie E, Ankum WM, Reekers JA. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial. Am J Obstet Gynecol. 2010; 203: 105.e1-13.
- Manyonda I, Belli AM, Lumsden MA, Moss J, McKinnon W. Uterine-Artery Embolization or Myomectomy for Uterine Fibroids. N Engl J Med, 2020; 383: 440-451.
- Leto Mailli, Shyamal Patel, Raj Das, Chun JY, Renani S, Das S, et al. Uterine artery embolisation: fertility, adenomyosis and size – what is the evidence? CVIR Endovascular. 2023; 6: 8.