Coverage Policy Manual
Policy #: 2000014
Category: Surgery
Initiated: August 2017
Last Review: July 2018
  Uterine Artery Embolization for the Treatment of Leiomyomas or Abnormal Uterine Bleeding

Description:
Transcatheter uterine artery embolization (UAE) is a minimally invasive technique that involves the injection of small particles into the uterine arteries to block the blood supply to the uterus and uterine fibroids. It potentially serves as an alternative to hysterectomy. UAE has also been used to treat other conditions including postpartum hemorrhage (PPH) and cervical ectopic pregnancy.
 
Background
Uterine leiomyomata (i.e., fibroids) are extremely common benign tumors that can be located primarily within the uterine cavity (submucosal fibroids) or on the serosal surface of the uterus. Treatment for uterine fibroids is usually sought when they are associated with menorrhagia, pelvic pain, urinary symptoms (i.e., frequency), or are suspected to be the cause of infertility. Treatment options include medical therapy with gonadotropin agonists or gestagen suppression or various types of surgical therapy. Hysterectomy is considered the definitive surgical treatment for those who no longer wish to maintain fertility. Various types of myomectomy, which describes removal of the fibroid with retention of the uterus, have also been described. Hysteroscopic myomectomy involves removal of submucosal fibroids using either a resectoscope or a laser. Subserosal fibroids can be removed via an open abdominal or laparoscopic approach. Laparoscopic laser coagulation of uterine fibroids is a unique approach in that the fibroid is not physically removed, but instead multiple (up to 75) laparoscopic laser punctures of the uterine fibroids are performed in an effort to devascularize the fibroid and induce atrophy. There is interest in techniques to directly devascularize the uterine fibroid by interrupting the uterine arteries. One technique, uterine artery embolization involves selective catheterization of the uterine arteries with injection of embolization material. UAE has also been used to control bleeding in other situations such as severe postpartum hemorrhage or in the treatment of cervical ectopic pregnancy.
 
Regulatory Status
In April 2000, Embosphere® Microspheres (Biosphere Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for hypervascularized tumors and arteriovenous malformations (AVMs). In November 2002, this product was cleared for marketing specifically for use in uterine fibroid embolization. Since that time, several other devices have been cleared for marketing. In 2003, Contour® Emboli PVA (Boston Scientific) was cleared for the embolization of peripheral hypervascular tumors and peripheral AVMs. In March 2004, the Contour SE™ (Boston Scientific) was cleared by the FDA for treatment of uterine fibroids. In December 2008, Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles received FDA marketing clearance for use in uterine fibroid embolization.
 

Policy/
Coverage:
Effective July 2017
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Uterine artery embolization meets primary coverage criteria for effectiveness and is covered for:
 
    • Emergency control of abnormal uterine bleeding from benign conditions, including postpartum uterine hemorrhage  
    • Treatment of bleeding or bulk related symptoms from uterine fibroids   
 
One repeat transcatheter embolization of uterine arteries to treat documented persistent symptoms of uterine fibroids, such as bleeding or pain, after an initial uterine artery embolization meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Transcatheter embolization for the management of all other indications, including cervical ectopic pregnancy, uterine arteriovenous malformation, and adenomyosis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, transcatheter embolization for the management of all other indications including cervical ectopic pregnancy, uterine arteriovenous malformation, and adenomyosis is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective August 2012
Uterine artery embolization meets primary coverage criteria for effectiveness and is covered for:
 
        • Emergency control of abnormal uterine bleeding from benign conditions, including postpartum uterine hemorrhage
        • Treatment of bleeding or bulk related symptoms from uterine fibroids  
 
One repeat transcatheter embolization of uterine arteries to treat documented persistent symptoms of uterine fibroids, such as bleeding or pain, after an initial uterine artery embolization meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
Transcatheter embolization for the management of cervical ectopic pregnancy does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, transcatheter embolization for the management of cervical ectopic pregnancy is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective, prior to August 2012
Uterine artery embolization meets primary coverage criteria for effectiveness and is covered for:
    • Emergency control of abnormal uterine bleeding from benign conditions,
    • Treatment of bleeding or bulk related symptoms from uterine fibroids
 
Repeat transcatheter embolization of uterine arteries to treat persistent symptoms of uterine fibroids after an initial uterine artery embolization and laparoscopic occlusion of the uterine arteries using bipolar coagulation do not meet Primary Coverage Criteria for effectiveness.
 
For contracts without primary coverage criteria, repeat transcatheter embolization of uterine arteries to treat persistent symptoms of uterine fibroids after an initial uterine artery embolization  and laparoscopic occlusion of the uterine arteries using bipolar coagulation are considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
This policy was initially developed based on a 1999 Arkansas Blue Cross Blue Shield Technology Assessment, which found that uterine artery embolization was investigational.  
 
In 1999, The American College of Obstetrics and Gynecology Committee on Gynecologic Practice determined that this procedure is investigational and should be performed only under the auspices of an institutional review board.
 
2002 Update:
The data on uterine artery embolization for treatment of bleeding is from case series, with no direct comparison to surgical ligation of pelvic vessels or emergency hysterectomy.  However, the information appears promising, and the procedure has been evaluated over 2 decades.  It appears to be accepted in the interventional radiology and obstetrical-gynecological community for the emergency control of bleeding for patients with benign disease of the uterus (postpartum hemorrhage) who have not responded to conventional therapy.  Coverage should be provided when used for this indication.  
 
The data on uterine artery embolization for treatment of uterine fibroids is considerably less established, with all authors indicating further study is indicated.  Uterine artery embolization for treatment of bleeding or pain or both from uterine fibroids is considered investigational.
 
 
It should be noted that the impact of UAE on subsequent fertility and completion of pregnancy are unknown. Although successful pregnancy after UAE has been reported anecdotally, this outcome has not been studied in large numbers of patients. Therefore, it is anticipated that all candidates for UAE will either have completed their child bearing, or will be properly informed of the unknown impact of UAE on fertility and pregnancy.
 
2005 Update
A search of the medical literature based on the MEDLINE database was performed for the period 2002 to July of 2005, with a specific focus on repeat uterine artery embolization (UAE) in patients whose symptoms respond incompletely or recur after an initial UAE. There were no articles identified that focus on repeat UAE; therefore, a policy statement is added, indicating that this is an investigational application of UAE.
 
Recent clinical trials continue to assess the positive and negative health outcomes associated with UAE. One study of 538 patients undergoing bilateral UAE assessed fibroid uterine volume reduction, patient reported symptom improvement, symptom life impact, and treatment satisfaction. UAE reduced fibroid uterine volume. Improvements in menorrhagia were unrelated to the pre-UAE uterine size or post-UAE uterine volume reduction. Patient satisfaction with short-term UAE treatment outcomes was high.
 
Complications are procedure-related and are partially attributable to vascular anastomoses of the uterine artery and ovarian artery. In one angiographic study, ovarian artery to uterine artery anastomoses were studied in 76 consecutive patients undergoing UAE. Three types of anastomoses were identified: Type I (33 of 152 arteries: 27.5%), flow from the ovarian artery to the uterus was through anastomoses with the main uterine artery; Type II (6 arteries: 3.9%), the ovarian artery supplied the fibroids directly; and Type III (10 arteries: 6.9%), major blood supply to the ovary was from the uterine artery. The authors suggest that delineation of ovarian artery to uterine artery anastomosis is of practical relevance in avoiding nontarget ovarian embolization, in identification of those who would be at risk of ovarian failure, and in those in whom the ovarian artery can be embolized safely.
 
Women who become pregnant after UAE are at increased risk for pregnancy-related complications. An analysis of 50 published cases of pregnancy after UAE revealed the following types and rates of complications compared to pregnancy complication rates in the general population: malpresentation (17% vs. 5%), small for gestational age (7% vs. 10%), premature delivery (28% vs. 5%-10%), cesarean delivery (58% vs. 22%), and postpartum hemorrhage (13% 4%-6%), and spontaneous abortion rates (22% vs. 10%-15%).
 
One comparative study assessed the long-term outcomes of UAE to myomectomy. Follow-up on 51 of 59 patients treated with UAE and 30 of 38 patients treated with myomectomy ranged from 37-59 months. The study found that 29% of woman treated with UAE and 3% of woman treated with myomectomy had further invasive treatment (surgery or repeat embolization) in the 3-5 years after initial treatment. Among woman who did not need further treatment, satisfaction and relief of symptoms were similar.
 
In 2004, the American College of Obstetrics and Gynecology (AGOG) issued a committee opinion on UAE. The statement offered the following conclusions:
 
"Based on current evidence, it appears that uterine artery embolization, when performed by experienced physicians, provides good short-term relief of bulk-related symptoms as well as a reduction of menstrual flow. Complication rates associated with the procedure are low, but in rare cases can include hysterectomy and death. There is insufficient evidence in the current literature to ensure safety in women desiring to retain their fertility. Furthermore, pregnancy-related outcomes remain understudied. Therefore, the procedure should be considered investigational or relatively contraindicated in women wishing to retain fertility. The use of uterine artery embolization in postmenopausal women is rarely, if ever, indicated. It is strongly recommended that women who wish to undergo uterine artery embolization have a thorough evaluation with an obstetrician-gynecologist to help facilitate optimal collaboration with interventional radiologists and to ensure the appropriateness of this therapy, taking into account the reproductive wishes of the patient. It is also recommended that all patients considering uterine artery embolization be adequately informed about potential complications."
 
The literature search also focused on studies of occlusion of uterine arteries using laparoscopic bipolar coagulation. In comparison to uterine artery embolization, there is minimal published literature consisting of case series, with the largest including 87 patients. One comparative case series compared the outcomes in 24 patients undergoing UAE with 22 undergoing laparoscopic closure with bipolar coagulation. The authors reported that those undergoing laparoscopic closure reported less postoperative pain than the UAE group with comparable effects on symptoms. However, at the present time, there is adequate published data on laparoscopic closure of the uterine arteries to permit scientific conclusions.
 
In 2005 Hehenkamp et al reported results of 81 women treated with UAE and 75 treated with hysterectomy. The unsuccessful bilateral UAE procedure rate of 4.9% is higher than previously reported.  The hospital stay was shorter for UAE patients but this group had a higher rate of minor complications after discharge necessitating readmission and unscheduled visits.  The study was too small to detect differences in major complication rates.  The authors concluded that the question of whether UAE is a good alternative for hysterectomy still remains to be answered.
 
2006 Update
A search of the MEDLINE database was performed from January 2005 to October 2006. This search retrieved 3 ongoing randomized controlled trials on UAE. No studies were found that focused on repeat UAE.
 
A systematic review on UAE by the Cochrane collaboration  concluded that “UAE offers an advantage over hysterectomy with regards to a shorter hospital stay and a quicker return to routine activities. There is no evidence of benefit of UAE compared to surgery (hysterectomy/myomectomy) for satisfaction. The higher minor complications rate after discharge in the UAE group as well as the unscheduled visits and readmission rates require longer follow-up trials to comment on its effectiveness and safety profile.”
 
Complication rates were derived primarily from a multicenter randomized controlled trial (EMMY trial) that compared UAE with hysterectomy in 177 subjects for up to 6 weeks’ post-intervention. Bilateral UAE failure occurred in 4.9% of patients. Hospital stay was reduced compared with hysterectomy (2.5 ± 2.7 days vs. 5.1 ± 1.3 days) with a similar percentage of major complications. Minor complications from discharge to 6 weeks were higher in the UAE group and UAE patients had higher readmission rates (11% vs. 0%).
 
Clinical Practice Guidelines from the Society of Obstetricians and Gynaecologists of Canada, the Canadian Association of Radiologists, and the Canadian Interventional Radiology Association recommend that uterine fibroid embolization should only be considered for women with symptomatic or problematic fibroids who might otherwise be advised to have surgical treatment; the procedure is contraindicated in women who are unwilling to have a hysterectomy under any circumstances.  No long-term data exist, particularly in regard to future fertility and pregnancy outcomes.
 
A search for laparoscopic uterine artery coagulation retrieved two European cohort studies (n = 21 and n = 114). Both studies are limited due to a lack of appropriate controls. A retrospective evaluation of the complications and recurrence rate from the study of 114 patients found a 7.1% complication rate with a rate of fibroid recurrence of 9%. The recurrence-free survival rate at a median of 23.6 months follow-up was 88.3%. Success and complication rates were similar to those reported for UAE. The authors concluded that additional studies are needed to confirm these results.
 
2007 Update
A search of the MEDLINE database for the period of November 2006 through October 2007 identified a number of controlled trials. One-year results are available from the REST multicenter trial (Randomized Trial of Embolization versus Surgical Treatment for Fibroids).  Patients were assigned in a 2:1 ratio to undergo UAE (n = 106) or surgery (43 hysterectomies and 8 myomectomies). The embolization group had lower postoperative pain (3.0 vs. 4.6) and faster recovery (e.g., 1- vs. 5-day median hospitalization), but a higher rate (20% vs. 0%) of continued or recurrent symptoms requiring an additional intervention. Of 7 identified pregnancies in the UAE group, 2 resulted in successful live births. Investigators from the EMMY trial (UAE compared with hysterectomy) reported that 24% of UAE patients had undergone a hysterectomy at 2-year follow-up.  A retrospective analysis of 221 patients with pre- and postoperative enhanced MRI (of 290 consecutive embolization patients) reported that the cumulative rates of additional intervention at 5-year follow-up were 3% of patients for complete (100%) infarction of fibroids (n = 142); 15% re-intervention for 90%–99% infarction (n = 74); and 20% re-intervention if less than 90% infarction of fibroids (n = 5) had been achieved.  No studies were found that focused on repeat UAE.
 
Hald et al. reported on 56 patients (85% follow-up) who had been randomized to embolization or laparoscopic occlusion of uterine arteries.  Clinical failure was seen in 2 (7%) of the embolization patients and 6 (21%) patients with laparoscopic occlusion; however, additional treatment was required in a similar number of patients in each group (24% and 21%, respectively). Fewer patients in the embolization group complained of heavy bleeding (4% vs. 21%) at 6-month follow-up. Adverse events from laparoscopic occlusion included pulmonary embolism (n = 1), claudication of the buttock (n = 1), and temporary adductor muscle weakness (n = 2). A larger study and longer follow-up are needed to compare these treatments. Therefore, the policy statements remain unchanged.
 
2012 Udpate
 
Repeat UAE to treat recurrent or persistent symptoms
A few retrospective case series on repeat UAE were identified. In 2009, McLucas and colleagues published a study in which the charts of 1,058 women who had undergone initial bilateral UAE at several U.S. centers were reviewed (McLucas, 2009). Forty-two (4%) patients had documentation of persistent symptoms, and they were offered a second bilateral UAE. Thirty-nine patients had repeat procedures, and 34 of these (87%) completed a follow-up questionnaire at least 6 months postembolization. Before the second UAE procedure, 27 of the 34 (79%) women reported severe bleeding, and only 2 (6%) women reported severe bleeding after the procedure. Similarly, the number of women with severe pain decreased from 20 (59%) to 2 (6%), and with severe pressure decreased from 18 (53%) to 2 (6%). A total of 4 individuals experienced severe levels of one or more symptoms after the second UAE. Prospective comparative studies are needed to confirm the findings.
 
In 2006, Yousefi and colleagues reported on 24 patients who underwent repeat embolization for recurrent or persistent symptoms 6-66 months after the initial procedure (Yousefi, 2006). The most common symptoms were pressure and/or bulk symptoms (n=15), recurrent heavy bleeding, (n=12) and pelvic pain or cramping (n=7). Follow-up data were available on 21 of 24 (87.5%) after the second UAE; 19 (90%) reported symptom control.
 
UAE for treatment of postpartum uterine hemorrhage (PPH)
No RCTs or other comparative studies evaluating UAE for treating PPH were identified. Several case series have been published. Representative larger series are described below:
 
In 2011, Ganguli and colleagues published data on 66 women who underwent UAE for the treatment of postpartum hemorrhage (Ganguli, 2011). The clinical success rate, defined as obviation of hysterectomy, was 95%. Three of 66 (5%) women had a subsequent hysterectomy. In addition to the 3 clinical failures, there were 3 (5%) major complications after UAE: one case of lower-extremity deep vein thrombosis, one case of postprocedural pancreatitis, and one admission for intravenous antibiotic treatment for presumed endometritis. Nine pregnancies after UAE were identified; there were 2 spontaneous abortions and 7 viable gestations.
 
In 2009, Kirby and colleagues published a retrospective analysis of data from 43 women who underwent UAE for primary PPH (Kirby, 2009). In this study, clinical success was defined as cessation of bleeding without need for repeat embolization, laparotomy or hysterectomy and without mortality. Eight of 43 (19%) of women had a hysterectomy prior to UAE. Of the remaining 35 women, clinical success was achieved in 29 women (83%). Considering the sample as a whole, the clinical success rate was 29 of 43 (67%). Complications among women who had a UAE without a previous hysterectomy included one case of a groin hematoma, one inadvertent perforation of the left obturator artery during UAE, one bleeding necrotic fibroid tumor, and one case of symptoms consistent with endometritis.
 
In 2006 (reaffirmed in 2008), ACOG issued a practice bulletin (No. 76) on management of postpartum hemorrhage (ACOG, 2006). The bulletin states that UAE may be indicated under the following circumstances: “A patient with stable vital signs and persistent bleeding, especially if the rate of loss is not excessive, may be a candidate for arterial embolization. Radiographic identification of bleeding vessels allows embolization with Gelfoam, coils, or glue. Balloon occlusion is also a technique used in such circumstances. Embolization can be used for bleeding that continues after hysterectomy or can be used as an alternative to hysterectomy to preserve fertility.”
 
UAE for treatment of cervical ectopic pregnancy
No RCTs or other comparative studies evaluating UAE for treating cervical ectopic pregnancy were identified. The published literature consisted of case series with small numbers of patients. Sample sizes ranged from 2 to 20 patients, and most studies had fewer than 10 patients. The largest prospective series was conducted in China by Xiaolin and colleagues (Xiaolin, 2010). Patients underwent UAE and in conjunction with methotrexate injections before, during, and after the UAE procedure. Median follow-up was 12 months (range 1 to 50 months). Two of 20 patients (10%) had recurrent vaginal bleeding; the other 18 had no significant bleeding after UAE. Five patients (25%) had an additional curettage procedure due to bleeding and/or high levels of beta (b)-hCG. The uterus was preserved in all patients, and normal menses resumed after 2 to 4 months. Eight of 16 (50%) women who attempted another pregnancy achieved a normal pregnancy within 1 year. There were 2 miscarriages and 6 live births at term.
 
Summary
Although there are a lack of controlled studies on repeat UAE, case series found a high rate of success after a second UAE for recurrent or persistent symptoms. The policy statement has been changed to allow one repeat UAE with persistent symptoms such as bleeding or pain.
 
There are no controlled studies evaluating UAE for postpartum hemorrhage or cervical ectopic pregnancy. However, due to available evidence from case series and strong support from clinical reviewers, postpartum hemorrhage was added to the coverage statement. In the absence of either controlled studies or strong clinical support, UAE for management of cervical ectopic pregnancy does not meet member primary coverage criteria that there be scientific evidence of effectiveness and is considered investigational.
 
2013 Update
 
UAE for treatment of uterine fibroids
 
Initial UAE procedure
A number of randomized controlled trials (RCTs) evaluating UAE for treatment of uterine fibroids have been published. In addition, there have been several systematic reviews of these RCTs. A 2012 Cochrane review included 5 RCTs comparing UAE to surgery in women with symptomatic uterine fibroids (Gupta, 2012). Pooled analyses did not find statistically significant differences in patient satisfaction with UAE or surgery after 2 years (odds ratio [OR]: 0.69, 95% confidence interval [CI]: 0.40 to 1.21, 5 trials) or 5 years (OR: 0.90, 95% CI: 0.45-1.90, 2 trials). UAE was associated with a lower procedure length, shorter hospital stay, shorter time to resumption of routine activities, and lower likelihood of blood transfusion. There were no significant differences between UAE and surgery in terms of major complications, but there was a higher rate of minor complications and reintervention with UAE.
 
In 2011, van der Kooij and colleagues published a meta-analysis of RCTs comparing UAE and surgery for treating symptomatic uterine fibroids and presented up to 5-year follow-up data (Van dKSM, 2011). The investigators identified 11 articles reporting on 5 RCTs. The overall intra-procedural and early post-procedural complication rates were similar with the 2 procedures. However, length of hospital stay, need for blood transfusion, and febrile morbidity were significantly lower in the UAE group compared to the surgery group. At 12 months, a pooled analysis of 2 studies found a significantly higher reintervention rate in the UAE group compared to the surgery group (odds ratio [OR]: 5.78, 95% confidence interval [CI]: 2.14 to 15.58). Pooled analyses of quality-of-life variables at 12 months did not find significant differences between groups. Results were similar after 5 years. The reintervention rate was significantly higher at 5 years, according to a pooled analysis of 2 trials (OR: 5.41, 95% CI: 2.48 to 11.81).
 
A 2013 systematic review by Martin and colleagues focused on complication and reintervention rates following UAE for symptomatic uterine fibroids (Martin, 2013). Eight RCTs comparing UAE to another intervention were included. Among the 350 UAE cases in the RCTs, the most common complications were discharge and fever (4%), post-embolization syndrome (2.9%), pain (2.9%) and groin complications (2.9%). Six trials also provided data on 346 cases of surgery for uterine fibroids. The most common complications following surgery were urinary stress incontinence (3.8%), pressure symptoms (2.9%) and menorrhagia (2.6%). Three trials presented reintervention data and, in a meta-analysis of these studies, there was a significantly higher risk of reintervention after UAE compared to surgery, but a wide confidence interval indicating imprecision of the risk estimate (OR: 6.04, 95% CI: 2.0 to 18.1).
 
Representative trials are described below:
The Randomized Trial of Embolization versus Surgical Treatment for Fibroids (REST) multicenter trial assigned patients in a 2:1 ratio to undergo UAE (n=106) or surgery (43 hysterectomies and 8 myomectomies) (Edwards, 2007). The embolization group had lower postoperative pain (3.0 vs. 4.6, respectively) and faster recovery (e.g., 1- vs. 5-day median hospitalization, respectively). Of 7 identified pregnancies in the UAE group, 2 resulted in successful live births. Five-year follow-up data from the REST trial were published in 2011 (Moss, 2011). A total of 144 of 157 (92%) randomized patients were included in the 5-year analysis. Quality-of-life and symptom scores were similar in the 2 groups at 5 years. For example, the mean symptom score was 4.5 in the UAE group and 4.8 in the surgery group (scores ranged from 15, markedly worse to 5, markedly better). By the 5-year follow-up, 27 of 106 (25%) in the UAE group and 2 of 51 (4%) in the surgery group had received an additional intervention for continued or recurrent symptoms. The total rate of further intervention for symptoms or adverse events over the 5-year period was 32% in the UAE group and 4% after surgery. In the UAE group, there were 3 technical failures of the procedure, 8 repeat UAEs, and 18 hysterectomies. Note that one woman had both a repeat UAE and a hysterectomy, and 2 women were not embolized after randomization and subsequently underwent surgery.
 
The Embolization versus hysterectomy (EMMY) trial from the Netherlands included 177 women with uterine fibroids and heavy menstrual bleeding who were scheduled to undergo hysterectomy. They were randomized to receive UAE (n=88) or hysterectomy (n=89) (Hehenkamp, 2005; Volkers, 2007). By the 2-year follow-up, 19 of the 81 (23%) women who actually received UAE had undergone a hysterectomy. An analysis of health-related quality of life (HRQOL) outcomes at 2 years found similar improvement in both groups overall. The defecation distress inventory (DDI) score improved significantly in only the UAE group starting at 6 months. A report of 5-year outcome data from the EMMY trial was published in 2010 (Van dKSM, 2010). A total of 70 of the 89 (79%) patients originally randomized to the hysterectomy group and 75 of 88 (85%) in the UAE group completed questionnaires at 60 months. In an intention-to-treat (ITT) analysis, 23 of 81 (28.4%) women who had received UAE underwent hysterectomy during the 5 years. Including the hysterectomies, 58 of 81 (71.6%) women in the UAE group no longer had menorrhagia. There were no significant differences between groups in health-related quality of life at 5 years, as assessed by mental and physical components of the Short Form-36 (SF-36). For example, the mean difference in change scores at 60 months on the physical component summary of the SF-36 was 1.26 (95% CI: 2.16 to 4.70). Within the hysterectomy group, there was a statistically significantly worse physical health score at 5 years (mean of 6.87) compared to 2 years (mean of 7.26), p=0.01. The UAE group did not have a significant change in the mean physical health score, which was 6.87 at 5 years and 5.80 at 2 years, p=0.34. There was also not a statistically significant difference in the rate of reported urinary incontinence. Similar to the 2-year finding, the DDI significantly improved over time in the UAE group but not in the group assigned to initial hysterectomy. There was not, however, a statistically significant difference between groups in defecation function at 5 years. The authors did not discuss their level of statistical power to detect between-group differences.
 
In 2012, findings of the Fibroids of the Uterus: Myomectomy versus Embolization (FUME) trial from the U.K. were published (Manyonda, 2012). The investigators randomized women with symptomatic fibroids to UAE (n=82) or myomectomy (n=81). Mean hospital stay was significantly shorter after UAE than surgery (2 vs. 4 days, respectively; p<0.0001). There were no significant differences in minor or major complications. A total of 120 of 163 (74%) were available for the analysis of quality of life, the primary outcome measure. There were no significant differences between groups in change in quality-of-life scores from baseline to 1 year. Nine patients (11%) in the UAE group required additional intervention, and 3 patients (4%) in the myomectomy group later underwent hysterectomy.
 
An RCT by Hald and colleagues in Norway evaluated clinical outcomes in 66 premenopausal women (mean age: 43 years) with symptomatic uterine fibroids who were randomized to treatment with either laparoscopic occlusion of uterine arteries or UAE (Hald, 2007). Women who wanted to bear children in the future, had a large uterus, had undergone multiple previous open abdominal surgeries, and who had bleeding disorders were excluded. The primary outcome was reduction in blood loss at 6 months’ post-intervention, as measured by a pictorial blood loss assessment chart. Fifty-eight women underwent treatment, 29 with UAE and 29 with laparoscopic occlusion. The proportion of women who had a reduction in blood loss after 6 months did not differ between the treatment groups (52% after UAE and 53% after laparoscopy, respectively; p=0.96). An additional publication reported on follow-up data at a median of 48 months after treatment (range: 8-73 months) (Rath, 2012). The cumulative clinical failure and recurrence rate was significantly lower for patients in the UAE group (17%, n=5) compared to the laparoscopy group (48%, n=17), p=0.02. Moreover, fewer patients in the UAE group (7%, n=2) had a hysterectomy than in the laparoscopy group (28%, n=8), p=0.41. The authors concluded that UAE is superior to laparoscopic UAO for treatment of uterine fibroids.
 
Repeat UAE to treat recurrent or persistent symptoms
No RCTs or other comparative studies evaluating UAE for treating PPH were identified. In 2012, Rath and colleagues published a systematic review of literature on second-line treatment of PPH (Rath, 2012). The authors stated that there is a lack of RCTs on arterial embolization for UAE and the emergent and multi-factorial nature of this condition, as well as potential ethical issues, makes it difficult to conduct a randomized trial. The review summarized the success rate of arterial embolization for PPH reported in case series as ranging from 70-100%, and from 60-83% in placenta accreta. The authors noted that UAE should not be performed in patients with excessive bleeding or when the patient is hemodynamically unstable.
 
UAE for treatment of cervical ectopic pregnancy
No RCTs or other comparative studies evaluating UAE for treating cervical ectopic pregnancy were identified. The published literature consisted of case series with small numbers of patients. Sample sizes ranged from 2 to 20 patients, and most studies had fewer than 10 patients. The largest prospective series was conducted in China by Xiaolin and colleagues (Xiaolin, 2010). Patients underwent UAE and in conjunction with methotrexate injections before, during, and after the UAE procedure. Median follow-up was 12 months (range 1 to 50 months). Two of 20 patients (10%) had recurrent vaginal bleeding; the other 18 had no significant bleeding after UAE. Five patients (25%) had an additional curettage procedure due to bleeding and/or high levels of beta (b)-hCG. The uterus was preserved in all patients, and normal menses resumed after 2 to 4 months. Eight of 16 (50%) women who attempted another pregnancy achieved a normal pregnancy within 1 year. There were 2 miscarriages and 6 live births at term.
 
Impact of UAE treatment on fertility and pregnancy outcomes
A 2013 systematic review by Mohan and colleagues identified 21 studies reporting pregnancy outcomes and/or pregnancy complications after UAE for treatment of uterine fibroids or postpartum hemorrhage (Mohan, 2013). The authors reported that the cumulative pregnancy and miscarriage rates among women trying to conceive following UAE for uterine fibroids was 59% and 28%, respectively and the cumulative live birth rate was 65%. The term delivery rate was 61%. In the studies on UAE for PPH, the cumulative pregnancy rate, based on a small number of pregnancies, was 87.2%. Rates of miscarriage and live births were not reported following UAE for PPH. Most of the studies included in the systematic review were observational and had no or inadequate controls. There was only one RCT. This study, by Mara and colleagues in Czech Republic, randomized 121 women with uterine fibroids who desired future pregnancies to UAE or myomectomy (Mara, 2008). Participants were followed-up for a mean of 25 months; they were advised to wait for at least 6 months after the procedure before they attempted pregnancy. At final follow-up, 13 of 26 women (50%) in the UAE group who tried to conceive became pregnant compared to 31 of 40 (76%) in the myomectomy group; the difference between groups was not statistically significant. Among women in the UAE group who became pregnant, the abortion rate was 64% and the delivery rate was 19%. In the myomectomy group, the abortion rate was 23%, and the delivery rate was 48%.
 
Ongoing Clinical Trials
The FIRSST: Comparing MRgFUS (MR guided Focused Ultrasound) versus UAE (Uterine Artery Embolization) (NCT00995878): This is an RCT comparing MRgFUS to UAE in premenopausal women at least 25 years of age who have symptomatic uterine fibroids. The primary outcome is reduction in symptoms, including pain, as assessed by validated instruments. The expected enrollment is 180 participants and the expected date of study completion is December 2015.
 
Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Uterine Fibroids (NCT01834703): This RCT is testing the safety and efficacy of HIFU compared to UAE in women aged 30 to 47 with uterine fibroids. The primary outcome is the treatment success rate after 6 months. The investigators plan to enroll 200 women and the estimated study completion date is May 2014.
 
Practice Guidelines and Position Statements
2010 Quality Improvement Guidelines from the Society of interventional Radiology stated that uterine artery embolization is indicated in women with uterine leiomyomas that are causing significant symptoms (Stokes, 2010). Absolute contraindications to UAE are viable pregnancy, active infection, and suspected uterine, cervical, or adnexal malignancy (unless the procedure is being performed for palliation or in conjunction with surgery). A desire to maintain fertility is a relative contraindication.
 
In 2008 ACOG reaffirmed a practice bulletin (No. 76) on management of postpartum hemorrhage (ACOG, 2008). The bulletin states that UAE may be indicated under the following circumstances:
 
“A patient with stable vital signs and persistent bleeding, especially if the rate of loss is not excessive, may be a candidate for arterial embolization. Radiographic identification of bleeding vessels allows embolization with Gelfoam, coils, or glue. Balloon occlusion is also a technique used in such circumstances. Embolization can be used for bleeding that continues after hysterectomy or can be used as an alternative to hysterectomy to preserve fertility.”
 
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Comparison of products used in UAE
A 2013 meta-analysis by Das et al identified 10 studies comparing the efficacy of 1 embolic agent used in UAE to another intervention or comparing 2 embolic agents with one another (Das, 2013). Five of the studies were RCTs and 5 were nonrandomized controlled trials. Embosphere microspheres were used in all of the RCTs. In a pooled analysis of data from 2 studies comparing Embosphere to spherical polyvinyl alcohol (PVA) for treatment of uterine fibroids, there was not a statistically significantly between-group difference in outcomes (uterine volume reduction and dominant fibroid volume reduction). Data from other studies were not pooled, but a qualitative analysis of study findings did not suggest that any agent was clearly superior or inferior to any other agent.
 
As a recent example, a 2014 RCT by Shlansky-Goldberg et al randomized 60 women with symptomatic uterine fibroids to UAE using either Embosphere microspheres (n=30) or spherical PVA (n=30). The study was funded by the manufacturer of the spherical PVA product. The primary study outcome was complete or near-complete infarction of the dominant tumor (an infarction rate of at least 91%), as measured by magnetic resonance imaging 24 hours after UAE. The primary end point was achieved in 29 of 29 (100%) cases in the spherical PVA group and 28 of 30 (93%) cases in the Embosphere group; the difference between groups was not statistically significant. One patient was excluded from the analysis. Similarly, at 3 months, there was not a statistically significant difference in the rate of complete or near-complete infarction rates between groups.
 
The available evidence from multiple RCTs does not suggest that any embolization agent is clearly superior to any other agent.
 
A representative larger case series is 2013, Kim et al evaluated data on 60 women who underwent UAE for treatment of postpartum hemorrhage at a single center in Korea  (Kim, 2013). The clinical success rate (which was not explicitly defined) was reported as 96%. Eleven patients treated with UAE experienced transient fever after the procedure, and there was 1 case of ovarian failure. During the time of data collection for this study, another 61 patients at the same center underwent cesarean hysterectomy for treatment of postpartum hemorrhage; the success rate associated with that procedure was 93%.
 
UAE for treatment of bleeding uterine arteriovenous malformation
No RCTs or other comparative studies evaluating UAE for treating uterine arteriovenous malformation were identified. The published literature consists of case reports and a small case series. The series, published in 2014 by Kim et al in Korea, retrospectively reviewed data from a single center on 19 patients who underwent UAE as first-line treatment of bleeding uterine arteriovenous malformation (Kim, 2014). All patients presented with intermittent or progressive vaginal bleeding after gynecologic procedures or obstetric events. The UAE procedures were bilateral, and a variety of embolization agents were used. A total of 17 of 19 patients (89.5%) had immediate clinical success following the UAE. Clinical success was defined as cessation of bleeding without symptom recurrence and resolution of the uterine arteriovenous malformation on postoperative imaging studies.
 
The available limited noncomparative evidence is insufficient to determine the effect of UAE on health outcomes in patients with bleeding uterine arteriovenous malformation.
 
Impact of UAE treatment on fertility and pregnancy outcomes
Several systematic reviews have been published. In 2014, Doumouchtis et al identified 17 studies with a total of 675 participants reporting on fertility outcomes after UAE for postpartum hemorrhage (Doumouchtis, 2014). To be included in the review, studies needed to report on a minimum of 5 cases. None of the studies identified were RCTs. A total of 168 of the 675 patients (25%) wanted a pregnancy following UAE, and 126 of the 168 (75%) women who desired pregnancy achieved conception. There were a total of 136 term live births and 30 cases of pregnancy loss (ectopic pregnancy, miscarriage, elective abortion).
 
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
UAE for Treatment of Uterine Fibroids
Initial UAE Procedure
A number of randomized controlled trials (RCTs) evaluating UAE for treatment of uterine fibroids have been published. In addition, there have been several systematic reviews of these RCTs. A 2014
Cochrane review included 7 RCTs comparing UAE to other surgical interventions in women with symptomatic uterine fibroids (Gupta, 2014). Four of the RCTs excluded women who desired pregnancy in the future. The comparison intervention was hysterectomy in 3 trials, hysterectomy or myomectomy in 2 trials, and myomectomy in 2 trials. The review’s primary outcomes were patient satisfaction and live birth rates (the latter analysis limited to studies where the comparison intervention was a uterine-sparing procedure). Pooled analyses did not find statistically significant differences in patient satisfaction with UAE or other interventions after 2 years (6 trials; odds ratio [OR], 094; 95% confidence interval [CI], 0.59 to 1.48) or 5 years (2 trials; OR=0.90; 95% CI, 0.45 to 1.80). Only 1 study reported live birth rate so meta-analysis was not possible UAE was associated with a higher rate of minor complications at 1 year (OR: 1.99, 95% CI: 1.41 to 2.81, 6 trials) and there was not a statistically significant difference between groups in the rate of major complications. Moreover, the UAE group was significantly less likely to require a blood transfusion than the surgery group (OR: 0.07, 95% CI: 0.01 to 0.52, 2 trials). The rate of further surgical interventions within 2 years was significantly increased in the UAE group (OR: 3.72, 95% CI: 2.28 to 6.04, 6 trials).
 
Ongoing Clinical Trials
 
(ISRCTN70772394) Randomized trial of Treating Fibroids with Embolization or Myomectomy to Measure the Quality of Life Among Women Wishing to Avoid Hysterectomy (the FEMME study); planned enrollment 216; projected completion date not listed.
 
Practice Guidelines and Position Statements
In 2013, ACOG issued a committee opinion on the management of acute abnormal uterine bleeding in non-pregnant reproductive aged women (McPherson, 2014). The committee listed UAE among the surgical options for acute abnormal uterine bleeding and stated that the need for surgical treatment, including UAE, is based on the clinical stability of the patient, the severity of bleeding, contraindications to medical management, the patient’s lack of response to medical management, and the underlying medical condition of the patient.
 
In 2015, the Society of Obstetricians and Gynecologists of Canada published a clinical practice guideline on management of uterine leiomyomas (Vilos, 2015).  The guideline stated, “Of the conservative interventional treatments currently available, uterine artery embolization has the longest track record and has been shown to be effective in properly selected patients.”
 
July 2017 Update
A literature search was conducted using the MEDLINE database through June 2016. A systematic review and case series evaluating UAE for treating adenomyosis were identified.
   
A 2011 systematic review by Popovic et al evaluated literature on UAE for patients with adenomyosis, alone or in conjunction with uterine fibroids (Popovic, 2011). The reviewers identified 8 case series reporting short-term follow-up in patients with adenomyosis alone. After a median follow-up of 9.4 months (range, 3-12 months), 85 (83%) of 102 patients had marked or complete improvement in clinical symptoms. Six case series reported long-term follow-up (median, 40.6 months; range, 17-60 months). Marked or complete improvement occurred in 135 (65%) of 208 patients, suggesting recurrence of symptoms over time in some patients. No deaths or serious adverse events were reported.
 
Case Series
Additional case series have been published after the Popovic systematic review. In 2016, Wang et al prospectively reported on 117 premenopausal patients with adenomyosis who underwent UAE (Wang, 2016). A total of 115 (98%) of 117 patients who successfully underwent bilateral UAE were included in the analysis. At 12 months, patients were queried about change in dysmenorrhea symptoms. Thirteen (11.3%) patients reported slight symptom improvement, 64 (55.7%) reported moderate improvement, and 31 (27.0%) reported marked improvement. Seven (6%) patients reported no change. In 2015, Bae et al retrospectively reviewed outcomes in 50 women who underwent UAE for symptomatic adenomyosis and were followed for at least 18 months (Bae, 2015). At baseline, 41 (82%) of 50 women had both heavy menstrual bleeding and dysmenorrhea; the remainder reported only 1 of these 2 symptoms. The extent of necrosis of adenomyosis was significantly associated with the likelihood of experiencing symptoms at follow-up. In receiver operating characteristic curve analysis, a cutoff of 34.3% necrosis was the most predictive of symptom recurrence (area under the curve, 0.721; 95% CI, 0.577 to 0.839; p=0.004). Among 12 patients with less than 34.3% necrosis, 58% were symptom-free at 18 months; among 40 patients with greater than 34.3% necrosis, 94% were symptom-free at 18 months.
 
There is a lack of RCTs or other controlled studies on repeat UAE for treatment of cervical ectopic pregnancy. Several case series and a systematic review are available. The systematic review found short-term symptom improvement in 83% of patients and long-term improvement in 65% of patients. Additional data from controlled trials are needed, especially on long-term efficacy and recurrence rates.
 
2018 Update
 
UAE FOR TREATMENT OF UTERINE FIBROIDS
 
UAE vs Focused Ultrasound
Barnard et al published an RCT and a cohort study comparing the use of UAE with magnetic resonance imaging guided focused ultrasound surgery (MRgFUS) for the treatment of uterine fibroids (Barnard, 2017). Premenopausal women with symptomatic uterine fibroids were randomized to MRgFUS (n=27) or UAE (n=22). Women who declined randomization were enrolled in a nonrandomized cohort study; 43 underwent MRgFUS, and 40 underwent UAE. The outcome of interest was recovery during the first 6 weeks post procedure, captured in symptom diaries that included information on return to work, return to normal activities, medication use, symptoms, and adverse events. Separate multivariate analyses of the RCT and the cohort populations found similar conclusions: opioid use was significantly higher in the UAE group, and length of time to first day fully back to work and first day back to normal activities were also significantly longer for patients treated with UAE. Treatment time was significantly longer in the MRgFUS group.
 
UAE FOR CERVICAL ECTOPIC PREGNANCY
 
No RCTs or other comparative studies evaluating UAE for treating cervical ectopic pregnancy were identified. The published literature consisted of small case series. Sample sizes ranged from 2 to 20 patients, and most studies had fewer than 10 patients.
 
Kwon et al retrospectively reviewed the charts of 13 women who had ectopic pregnancies that
were refractory to systemic methotrexate who were then treated with UAE (Kwon, 2017). Locations of the ectopic implantation were: cesarean scar (n=6), cervix (n=5), fallopian tube (n=1), and uterine cornua (n=1). Outcomes were technical success, clinical success, and complications. Results were reported for all patients, regardless of the ectopic implantation site. Mean gestational age at the time of diagnosis was 8.5 weeks (range, 3-14 weeks). Median follow-up was 25 weeks (range, 4-85 weeks). Technical success was 100%. Clinical success was achieved in 10 (77%) patients. Three patients experienced recurrent vaginal bleeding (2 instances of which occurred in patients who had cervical ectopic pregnancies) and underwent repeat embolizations. The uteri of all 13 patients were preserved.
 
Hu et al retrospectively reviewed the charts of 19 women who had cervical pregnancies and were treated with UAE followed by curettage (Hu, 2016). The median gestational age of the fetuses at the time of UAE was 7.4 weeks (standard deviation, 1.6). One procedure was deemed an emergency due to profuse bleeding; the remaining 18 were non-emergency procedures. There were no reports of further vaginal bleeding following UAE. None of the patients underwent a hysterectomy due to the cervical pregnancy. Nine patients were followed for up to 39 months. Eight of the nine resumed normal menstruation. Only one attempted to conceive, and she had an uncomplicated pregnancy and a vaginal delivery.
 
UAE FOR UTERINE ARTERIOVENOUS MALFORMATION
 
The following case series were published since the Yoon systematic review. Barral et al described using ethylene vinyl alcohol copolymer (Onyx) as the embolic agent for UAE in the treatment of uterine AVMs (Barral, 2017). Records from 12 women, mean age 33 years, were reviewed. After a mean follow-up of 29 months, 11 of the 12 women achieved clinical success, defined as the absence of bleeding at 1 month following embolization.
 
UAE FOR ADENOMYOSIS
 
Additional case series have been published since the Popovic systematic review. In 2017, de Bruijn et al provided 7-year QOL data on 28 women with adenomyosis treated with UAE (de Brujin, 2017). Outcomes were Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire and Symptom Severity Score (SSS). A higher UFS-QOL score indicates a better QOL and a lower SSS indicates an improvement in symptoms. Patients were considered asymptomatic if their SSS was less than 20 and their UFS-QOL score was greater than 80. At 7 years posttreatment, 3 women had undergone a second UAE, and 5 women had undergone a secondary hysterectomy. Median SSS at baseline was 72 (range, 23-100) and improved to 17 (range, 0-44). Median UFS-QOL score at baseline was 31 (range, 20-88) and improved to 98 (range, 9-100).
 
Zhou et al evaluated short- (12-month) and long-term (5-year) outcomes for 252 women following UAE treatment for adenomyosis (Zhou, 2016). Outcomes of interest were dysmenorrhea and menorrhagia. Subgroup analyses were conducted by lesion vascularity: (1) blood supply equality of the uterus (“equal” if left and right uterine arteries supplied blood equally, otherwise “unequal”) and (2) vascularity degree (“hypervascular” if vessels abundant at margin and center of lesions, “isovascular” if vessels abundant at margin but not core, and “hypovascular” if vessels lacking at margin and core). Following UAE, both short- and long-term rates of dysmenorrhea improvement and menorrhagia improvement were statistically similar among the equal and unequal blood supply groups, with improvement rates reported between 68% and 77%. However, improvement rates in dysmenorrhea and menorrhagia differed statistically among the vascularity groups, with patients in the hypervascular group experiencing higher rates of improvement than the other groups.
  

CPT/HCPCS:
36245Selective catheter placement, arterial system; each first order abdominal, pelvic, or lower extremity artery branch, within a vascular family
36246Selective catheter placement, arterial system; initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family
36247Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family
37243Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction
75894Transcatheter therapy, embolization, any method, radiological supervision and interpretation

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