|Subject:||Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome|
|Policy #:||SURG.00062||Current Effective Date:||06/28/2016|
|Status:||Reviewed||Last Review Date:||05/05/2016|
This document addresses ovarian and internal iliac vein embolization as a treatment for pelvic congestion syndrome (PCS). PCS, which is also referred to as pelvic venous incompetence (PVI), is a condition involving chronic pelvic pain (CPP) which is non-cyclic and of variable location and intensity. The CPP is usually aggravated by prolonged standing. The underlying etiology is thought to be related to varices of the ovarian veins, leading to pelvic congestion. As there are many etiologies for CPP, PCS is often a diagnosis of exclusion, with the identification of varices using a variety of imaging methods, such as magnetic resonance imaging (MRI), computed tomography (CT) scanning or contrast venography. For those who do not respond to medical therapy with analgesics, embolization therapy of the ovarian and internal iliac veins has been proposed.
Investigational and Not Medically Necessary:
Embolization of the ovarian vein and internal iliac veins is considered investigational and not medically necessary as a treatment of pelvic congestion syndrome.
The literature regarding the clinical outcomes for embolization therapy for treatment of PCS is limited to primarily case series and one randomized comparative trial. Several older small case series report pain relief in 50-80% of women (Cordis, 1998; Sichlau, 1994; Tarazov, 1997). In 2013, 5-year results were reported for a prospective, single center case series of 202 women suffering from CPP who were being treated for lower limb varices. Inclusion criteria were: lower limb varices and CPP of greater than 6 month duration; greater than 6 mm pelvic venous caliber on ultrasonography; and venous reflux or presence of communicating veins. Both ovarian and hypogastric veins were targeted for embolization. Pain level was assessed before and after embolotherapy and during follow-up using a visual analog scale (VAS). Technical and clinical success and recurrence of leg varices were studied. The study subjects completed a quality questionnaire, and clinical follow-up was performed at 1, 3, and 6 months and every year for 5 years. A total of 179 of 202 women (89%) completed the 5-year follow-up. The primary outcomes were pain improvement and individual post-procedure satisfaction. At baseline, the mean VAS was 7.34 (standard deviation [SD]: 0.7) and at 5 years the mean VAS was 0.78 (SD: 1.2). The decrease in the VAS score over time was statistically significant (p<0.0001). Mean individual satisfaction scores were 7.39 (standard deviation [SD]: 1.5) on a 0 to 9 scale. There were 4 cases of coil migration (2%), which were considered to be a major complication; also groin hematoma occurred in 6 subjects. Post-procedure abdominal pain was reported in 23 subjects, and 24 subjects (12.5%) experienced recurrence of their leg varices within the follow-up period. Notably, this study was limited by the lack of a control group for clinical outcomes comparison and no clearly defined diagnostic criteria for use in trial subject selection (Laborda, 2013).
Additional small retrospective case series and single center chart reviews have reported favorable short-term outcomes (averaging 12-24 months) for embolization therapy related to VAS scores and symptomatic improvements. However, some investigators acknowledge difficulty in assessing subsequent recurrence rates, due to complexities associated with the pathophysiology of venous reflux disease and ongoing debate around the most effective embolic materials and techniques, as well as uncertainties about the most appropriate candidate selection (Hocquelet, 2014; Nasser, 2014).
Additional case series include Venbrux and colleagues who performed bilateral ovarian vein embolization therapy on 56 women, followed 3 to 10 weeks later by embolization of the internal iliac veins. The procedures were considered a technical success in all women, although in 2 women the coils inadvertently migrated to the pulmonary circulation where they were retrieved without incident. Recurrences of varices were noted in 3 women. In terms of pain control, the mean VAS score fell from 7.8 to 2.7 over a 12-month period (Venbrux, 2002).
In another case series of 41 women who underwent ovarian vein embolization, Maleux and colleagues (2000) reported a technical success rate of 98%. Partial or complete pain relief was reported by 68.3% of women. However, there was no formal assessment of pain prior to the procedure.
Chung compared the efficacy of embolization (n=52) to that of hysterectomy and bilateral oophorectomy (n=27) or hysterectomy and unilateral oophorectomy (n=27). Women were also stratified according to stress scores into three subgroups with normal, moderate-high and very high stress levels. A significant improvement in pain symptoms was observed in the three treatment groups. Women with normal to moderate-high stress levels who received embolization experienced superior symptom relief, compared to women who underwent hysterectomy with unilateral or bilateral oophorectomy. However, women with very high stress levels did not derive as much treatment benefit as women with normal to moderate-high stress levels (Chung, 2003).
Kim reported outcomes of internal iliac embolotherapy for chronic pelvic pain caused by ovarian and pelvic varices from 1998 to 2003. A total of 97 women completed long-term follow-up (mean 45 months ± 18). Long-term follow-up showed that 83% of these women exhibited clinical improvement, 13% had no significant change, and 4% exhibited worsened condition (Kim, 2006).
Kwon reported findings for 67 women who underwent ovarian vein coil embolization. Evaluation after coil embolization was performed within 3-6 months (n=3), 6 months to 1 year (n=7), 1-2 years (n=13), 2-3 years (n=7), 3-4 years (n=7), 4-5 years (n=13), or 5-6 years (n=17). Outcome analysis showed 82% (55/67) experienced pain reduction after coil embolization, were satisfied with the procedure, and did not pursue any further treatment. Twelve women (18%, 12/67) responded that their pain level had not changed, or had become more severe; 9 women were treated surgically, and the remaining 3 women remained under continuous drug therapy (Kwon, 2007).
In a 2005 Cochrane review, Interventions for Treating Chronic Pelvic Pain in Women, Stones and colleagues found that there is a "Very limited range of interventions that have been tested for the treatment of women with chronic pelvic pain." They concluded that, "Studies are currently needed to include trials of radiological embolization versus surgery for pelvic congestion" (Stones, 2005).
In a review, Smith discussed the current treatments for PCS, citing that the most common treatments used currently involve the embolization of pelvic and ovarian veins. Published outcomes of this treatment are available in a limited number of clinical series, usually with fairly short follow-up periods. The major complication of this treatment is migration of the materials (e.g. coils) used to occlude veins. The longest duration of follow-up currently reported is 5 years. There is insufficient clinical evidence to support the use of embolization (embolotherapy) in the management of PCS (Smith, 2012).
Black commented on the paucity and quality of evidence supporting embolization treatment for PCS. In their publication, the authors outlined the research and reporting standards required to determine clinical efficacy of embolization for the treatment of PCS. The authors further proposed using pelvic venous insufficiency (PVI) to describe PCS because PVI is more specific to the pathophysiology and anatomy involved with compromised pelvic venous flow (Black, 2010).
Champaneria and colleagues (2016) conducted a systematic review for the diagnosis and treatment of pelvic vein incompetence (PVI) and CPP. Regarding treatment with embolization, it was noted that most of the available data were reported in prospective case series. The authors identified limitations of the available data as:
Based on the available data, the authors concluded that the available data are limited and of variable methodological quality. Robust randomized studies are needed to determine whether embolization is an effective treatment for PCS.
PCS is often associated with dyspareunia and postcoital pain and typically affects young multiparous women. The underlying etiology is thought to be related to varices of the ovarian veins, leading to pelvic congestion. Approximately 10-15% of women may have pelvic varicose veins but not all will have symptoms. As there are many etiologies CPP, PCS is often a diagnosis of exclusion, that is confirmed when other conditions have been ruled-out. The presence of pelvic varices associated with the syndrome may be identified using a variety of imaging methods, such as MRI, CT scanning or contrast venography.
For those who fail medical therapy (for example, analgesics, vasoconstrictors and hormonal therapies), surgical ligation of the ovarian vein may be considered. More recently, catheter-based embolization therapy of the ovarian and internal iliac veins has been proposed. Catheter-based therapies may be performed on an inpatient or outpatient basis depending on the veins that are accessed and the technique that is used. Ovarian and internal iliac vein embolization is a therapy used to block blood flow to the veins that are causing pelvic congestion. It is performed by accessing the venous system via a catheter and injecting or deploying an inert material (for example, coils, solutions, plugs) to obstruct the affected veins. The embolization procedure may require multiple sessions. For example, one method involves use of gel foam and coils for embolization of the ovarian vein(s). This may be followed 3 to 10 weeks later by embolization of the internal iliac veins to reduce the risk of recurrence. Occasionally, the coils may migrate to another internal organ system, such as the pulmonary circulation, necessitating a retrieval procedure.
Dysmenorrhea: Recurrent pelvic pain associated with menses and described as a painful cramping sensation in the lower abdomen, often accompanied by other symptoms, such as sweating, tachycardia, headaches, nausea, vomiting, diarrhea, and tremulousness. Primary dysmenorrhea begins at or shortly after menarche and is usually not accompanied by pelvic pathologic conditions. Secondary dysmenorrhea arises later in life and is usually associated with other pelvic conditions.
Dyspareunia: This term refers to painful sexual intercourse, due to medical or psychological causes. The symptom is significantly more common in women than in men, affecting up to one-fifth of women at some point in their lives. An extreme form, in which the woman's pelvic floor musculature contracts involuntarily, is termed vaginismus.
Embolization:A procedure in which targeted blood vessels are obstructed by delivering inert material (for example, coils, gels, foam) into the circulatory system.
Multiparous:The clinical term used for women with a history of one or more previous live births.
Pelvic congestion syndrome (PCS): A syndrome involving chronic pelvic pain that is generally associated with the veins in the pelvic area (for example, the ovarian veins).
Varices: Enlarged or twisted blood vessels.
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.
When services are Investigational and Not Medically Necessary:
|37241||Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles)|
|06LY3DZ||Occlusion of lower vein with intraluminal device, percutaneous approach|
|06LY4DZ||Occlusion of lower vein with intraluminal device, percutaneous endoscopic approach|
|I86.2||Pelvic varices [when indicated as ovarian and internal iliac vein varices]|
|I87.2||Venous insufficiency [when specified as pelvic venous insufficiency]|
|N94.89||Other specified conditions associated with female genital organs and menstrual cycle [when indicated as chronic pelvic pain, female pelvic congestion]|
|R10.2||Pelvic and perineal pain|
Peer Reviewed Publications:
Government Agency, Medical Society and Other Authoritative Publications:
Embolization Therapy for Pelvic Congestion Syndrome
Internal Iliac and Ovarian Vein Embolization as a Treatment of Pelvic Congestion Syndrome
Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome
Pelvic Congestion Syndrome
Pelvic Pain – Embolization Therapy for Pelvic Congestion Syndrome
Vein Embolization as a Treatment of Pelvic Congestion Syndrome
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Reviewed||05/05/2016||Medical Policy & Technology Assessment Committee (MPTAC) review. Rationale and References were updated. Removed ICD-9 codes from Coding section.|
|Reviewed||05/07/2015||MPTAC review. References were updated.|
|Reviewed||05/15/2014||MPTAC review. The Rationale and References were updated.|
|01/01/2014||Updated Coding section with 01/01/2014 CPT changes; removed 37204 deleted 12/31/2013, and 75894.|
|Reviewed||05/09/2013||MPTAC review. The Rationale, Definitions and References were updated.|
|Reviewed||05/10/2012||MPTAC review. The Rationale and References were updated.|
|Reviewed||05/19/2011||MPTAC review. References were updated.|
|Reviewed||05/13/2010||MPTAC review. References were updated.|
|Reviewed||05/21/2009||MPTAC review. The Rationale and References were updated.|
|Reviewed||05/15/2008||MPTAC review. Description clarified by removing surgical ligation. References updated.|
|02/21/2008||The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.|
|Reviewed||05/17/2007||MPTAC review. References updated.|
|Reviewed||06/08/2006||MPTAC review. The Rationale and References were updated.|
|11/22/2005||Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
|Revised||07/14/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|10/28/2004||SURG.00062||Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome|
|WellPoint Health Networks, Inc.||06/24/2004||3.09.09||Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome|