Clinical UM Guideline
|Subject:||Transcatheter Uterine Artery Embolization|
|Guideline #:||CG-SURG-28||Current Effective Date:||01/05/2016|
|Status:||Revised||Last Review Date:||11/05/2015|
This document addresses the use of transcatheter uterine artery embolization (UAE) as a treatment for fibroid tumors. UAE is a pelvic angiographic procedure used to decrease the symptoms of heavy bleeding and pelvic pain associated with fibroid tumors. Using hemostatic particles, selected vasculature providing the blood supply to the fibroids are occluded. When the blood supply is occluded, the fibroids decrease in size which reduces the symptoms.
Transcatheter UAE has also been used for treatment of other acute pelvic hemorrhagic conditions such as uterine hemorrhage and ectopic pregnancy. Transcatheter uterine artery embolization is a technique performed by an interventional radiologist.
Note: Please see the following related document for additional information:
Not Medically Necessary:
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|37243||Vascular 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|
|37244||Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for arterial or venous hemorrhage or lymphatic extravasation|
|04LE3DT||Occlusion of right uterine artery with intraluminal device, percutaneous approach|
|04LE3ZT||Occlusion of right uterine artery, percutaneous approach|
|04LF3DU||Occlusion of left uterine artery with intraluminal device, percutaneous approach|
|04LF3ZU||Occlusion of left uterine artery, percutaneous approach|
|D25.0-D25.9||Leiomyoma of uterus (fibroids)|
|N92.0-N92.6||Excessive, frequent and irregular menstruation|
|O03.6||Delayed or excessive hemorrhage following complete or unspecified abortion|
|O04.6||Delayed or excessive hemorrhage following (induced) termination of pregnancy|
|O07.1||Delayed or excessive hemorrhage following failed attempted termination of pregnancy|
|O08.1||Delayed or excessive hemorrhage following ectopic and molar pregnancy|
Transcatheter UAE is a radiologic technique that deprives blood flow to fibroids that are present in the uterus. Restricting blood supply to these areas or tissues causes them to shrink and disintegrate. UAE involves inserting a small plastic tube into the arterial blood vessels leading to target lesions and then blocking the blood supply (a process called embolization) with one of several substances. The blockage of blood supply results in atrophy and death of the target tissue (fibroid) over a period of weeks or months. UAE has been reported to have a success rate of 81-100% (American College of Radiology [ACR], 2012).
A study by Moss and colleagues (2011) reported on a randomized comparison of UAE with surgical treatment in individuals with symptomatic uterine fibroids (REST trial). A total of 157 women were randomized in a 2:1 ratio to either UAE (n=106) or surgery (n=51). Quality of life (QOL) was assessed at 5 years using a Short Form General Health Survey (SF-GHS). The participants were followed at 12 months and no significant differences in QOL gain were found between the UAE and the surgery group. At 5 years, a total of 138/157 women were available for follow-up and no significant differences were observed between the 2 groups in 8 components of the survey. Satisfaction level at 5 years was also similar between the 2 groups and remained high at 90% in the UAE group and 87% in the surgery group. The re-intervention rate was higher at 32% in the UAE group as compared with 4% in the surgical group and the overall group size decreased from 200 to 157 due to difficulty in recruitment.
Toor and colleagues (2012) completed a meta-analysis evaluating the complication rates of UAE, adverse events, reintervention, and clinical improvement of UAE for the treatment of symptomatic fibroids. A total of 54 studies were analyzed (8159 women). There were 7 randomized controlled trials comparing UAE with an alternative therapy; 37 prospective observational studies; and 10 retrospective observational series. None of the participants received UAE for adenomyosis only. Follow-up ranged from 3-60 months. No deaths attributable to UAE were reported. A total of 270 women experienced a major complication (2.9%). The passage of fibroid tissue was the most commonly reported adverse event following UAE (326/6858 women [4.7%]). Hysterectomy occurred in 26/4903 women (0.7%). A total of 42 of the reviewed studies provided re-intervention data (from 4682 women). Reinterventions included 81 repeat UAE, 81 myomectomies, and 257 hysterectomies. A total of 30 studies (2930 women) provided clinical symptom improvement data. Clinical follow-up ranged from 0.25 to 2 years. Rates of symptomatic improvement ranged from 77.5% to 90.1% (95% confidence interval [CI]).
Another meta-analysis by Martin (2013) reported on the use, efficacy, and complications of UAE for the treatment of symptomatic uterine fibroids compared to surgery. Eight randomized, controlled trials were reviewed (350 cases of UAE and 346 cases of surgery). For those women who had UAE the most common complications were bilateral UAE failure, discharge and fever, and postembolization syndrome. Of the women who had surgery, the most common complications were urinary stress incontinence, pressure symptoms, and menorrhagia. A total of 76 non-randomized studies were reviewed (11,195 cases of UAE). The most common complications were amenorrhea, pain, and discharge and fever. The total rate of complication was 24.86%. A total of 41 case studies were reviewed (83 cases of UAE) which showed the most common complications were discharge and fever, fibroid expulsion, and fibroid amenorrhea. The total rate of complications was 0.550%. The authors note that the data must be interpreted with caution as the sample sizes were fairly limited and success rates and complication rates of UAE were related to operator experience. In a large trial with many surgeons, the efficacy and complication rate may be worse than in studies where a single or few surgeons performed the procedure. Much of the reviewed literature did not publish the rates of reintervention. Study authors emphasized that the benefits of UAE (minimally invasive procedure) should be weighed against increased reintervention rates.
Based on evaluation of the existing peer-reviewed medical literature, there is adequate evidence to support the use of UAE for the treatment of acute pelvic and obstetric hemorrhage, ectopic pregnancy, and symptomatic uterine fibroids. For the treatment of pelvic and obstetric hemorrhage, UAE has been shown to be a safe and effective method to control bleeding when compared with alternative methods, such as surgical intervention. For ectopic pregnancy, it has been illustrated that UAE is a safe and effective adjunct to methotrexate treatment, decreasing the need for surgical interventions following drug-only treatment methods that are often unsuccessful.
The presence of pedunculated fibroids has been considered a contraindication for UAE due to the fact if a pedunculated fibroid becomes septic after embolization, a hysterectomy is needed. Review of the peer-reviewed literature suggests that UAE for pedunculated fibroids may be safer than previously believed. Katsumori and colleagues (2005) reported on a retrospective study of 196 women with symptomatic uterine fibroids who were treated with UAE. A total of 12 of the 196 women were found to have pedunculated subserosal uterine fibroids (a total of 15 tumors). The follow-up period was 5 to 51 months. During follow-up, no minor or major complications were reported. One week following UAE, magnetic resonance imaging (MRI) showed complete devascularization in 11/15 of the tumors. Subsequent MRI performed at 4 months and 1 year following UAE showed no tumor regrowth. The study is limited by the short follow-up period, small sample size, and retrospective study design. Another retrospective review by Smeets and colleagues (2009) reported on 716 women with symptomatic uterine fibroids treated with UAE. A total of 29 women were noted to have pedunculated fibroids (a total of 31 fibroids). With a mean follow-up of 33 months, no early or late complications occurred. A total of 4 of the 29 women required hysterectomy following UAE due to persistent symptoms, but the pedunculated fibroids were not the dominant reason and were infarcted. Despite their small sample size, these studies suggest that women with symptomatic fibroids with a pedunculated subserosal fibroid may be safely treated with UAE.
The Society of Obstetricians and Gynaecologists of Canada (SOGC) Clinical Practice Guidelines for uterine artery fibroid embolization (2005) cite contraindications to embolization which include pregnancy, genitourinary infection and malignancy. Andrews and colleagues (2004) also cite contraindications for uterine artery embolization to include pregnancy, infection, malignancy, coagulopathy and prior pelvic irradiation. SOGC stated in an updated guideline entitled "The management of uterine leiomyomas" the following recommendations regarding UAE:
Uterine artery occlusion by embolization or surgical methods may be offered to selected women with symptomatic uterine fibroids who wish to preserve their uterus. Women choosing uterine artery occlusion for the treatment of fibroids should be counselled regarding possible risks, including the likelihood that fecundity and pregnancy may be impacted.
An increase in uterine size due to fibroid volume is a consideration prior to UAE. A study by Choi (2013) evaluated the safety, effectiveness, and rate of complications of UAE in women with large uterine fibroids. A total of 323 women without adenomyosis underwent UAE for symptomatic uterine fibroids. The women were divided into 2 groups: group 1 (treatment group) included 63 women with a large tumor of at least 10cm in size or a uterine volume of at least 700cm and group 2 (260 women) was the control group. Group 1 demonstrated a 46.5% tumor volume reduction compared with 52% in group 2. Group 1 had a 40.7% uterine volume reduction compared with 36.3% in group 2. There were no reported significant differences in satisfaction or the presence of procedure-related complications.
Other therapies for symptomatic uterine fibroids include hysterectomy, myomectomy, hormonal therapy with gonadotropin-releasing hormone (GnRH) analogues and luteinizing-hormone releasing hormone (LHRH) analogues, and endurance until menopause when fibroids often regress.
The current published literature does not support the use of UAE for adenomyosis. A review by Popovic (2011) evaluated 15 studies in which 511 women received UAE for adenomyosis. Although 387 of the 511 women reported symptomatic relief, the authors of the review concluded that the evidence is insufficient to establish UAE as a potential first-line treatment for adenomyosis. Larger, randomized trials with sufficient follow-up periods are necessary to determine true value of UAE. In 2012, the ACR revised its Appropriateness Criteria® for the Radiologic Management of Uterine Leiomyomas and concluded that "UAE has shown early success in controlling the symptoms of bleeding with adenomyosis." However, there is a recurrence rate of approximately 40%-50% at 2 years and the long-term durability of UAE is questionable.
A retrospective study by Smeets (2012) reported on 40 women with adenomyosis who were treated with UAE. Mean clinical follow-up was 65 months. A total of 8 women required additional therapy due to insufficient symptom relief (7 hysterectomies and 1 repeat UAE). Follow-up consisted of the use of uterine fibroid symptom relief and QOL questionnaires. Of the 33 women with a preserved uterus who responded to QOL questionnaires, 29 had scores indicating they were asymptomatic, and 4 women had scores indicating substantial clinical symptoms despite embolization. This study is limited by its small sample size and retrospective design.
The current literature does not support a repeat uterine artery embolization for treatment of persistent symptoms of uterine fibroids after an initial uterine artery embolization.
Adenomyosis: A benign uterine disease in which the endometrium invades the myometrium resulting in enlargement of the uterus, menorrhagia and dysmenorrhea.
Ectopic pregnancy: A pregnancy which occurs when a fertilized egg becomes implanted outside the uterus in locations such as the fallopian tubes, cervix, ovaries or in the pelvic or abdominal space.
Embolization: The insertion of a substance through a catheter into a blood vessel to prevent the flow of blood.
Myomectomy: Procedure in which uterine fibroids are surgically removed from the uterus.
Uterine fibroids: Common and benign (non-cancerous) tumors of the uterus (also known as leiomyomata).
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Embolization of Uterine Artery for Treatment of Fibroid Tumors
Fibroid Tumors, Uterine Artery Embolization for the Treatment of
Uterine Artery Embolization for Treatment of Fibroid Tumors
|Revised||11/05/2015||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated formatting in Criteria. Updated Discussion/General Information and Reference sections. Removed ICD-9 codes from Coding section.|
|Reviewed||11/13/2014||MPTAC review. Updated Discussion/General Information and Reference sections.|
|Revised||11/14/2013||MPTAC review. Removed list of contraindications from Not Medically Necessary statement and clarified Not Medically Necessary statement. Updated Discussion/General Information, Definitions, and References. Updated Coding section with 01/01/2014 CPT changes; removed CPT 37204, 37210 deleted 12/31/2013, and 75894 (no longer applicable).|
|Revised||11/08/2012||MPTAC review. Added adenomyosis to Not Medically Necessary Clinical Indications. Updated Discussion/General Information and References.|
|Reviewed||02/16/2012||MPTAC review. Updated Discussion/General Information, Definitions, and References.|
|10/01/2011||Updated Coding section with 10/01/2011 ICD-9 changes.|
|Reviewed||02/17/2011||MPTAC review. Updated References.|
|Reviewed||02/25/2010||MPTAC review. Discussion and References updated.|
|Reviewed||02/26/2009||MPTAC review. Place of Service removed. References updated.|
|Revised||02/21/2008||MPTAC review. Medically necessary criteria clarified. Discussion and References updated.|
|New||03/08/2007||MPTAC review. Initial guideline development. SURG.00018 Transcatheter Uterine Artery Embolization transferred to CG-SURG- 28 Transcatheter Uterine Artery Embolization. References updated.|