Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome. Original Policy Date

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1 MP Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome Medical Policy Section OB/Gyn/Reproduction Issue 12:2013 Original Policy Date 12:2013 Last Review Status/Date Reviewed with literature search/12:2013 Return to Medical Policy Index Disclaimer Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. Description Pelvic congestion syndrome is characterized by chronic pelvic pain which often is aggravated by standing; diagnostic criteria are not well-defined. Embolization of the ovarian and internal iliac veins has been proposed as a treatment for patients who fail medical therapy with analgesics. Pelvic congestion syndrome is a condition of chronic pelvic pain of variable location and intensity, which is associated with dyspareunia and postcoital pain and aggravated by standing. The syndrome occurs during the reproductive years, and pain is often greater before or during menses. The underlying etiology is thought to be related to varices of the ovarian veins, leading to pelvic congestion. As there are many etiologies of chronic pelvic pain, the pelvic congestion syndrome 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 fail medical therapy with analgesics, surgical ligation of the ovarian vein has been considered. More recently, embolization therapy of the ovarian and internal iliac veins has been proposed. Vein embolization can be performed using a variety of materials including coils, glue and gel foam. Regulatory Status Not applicable. Policy Embolization of the ovarian vein and internal iliac veins is considered investigational as a treatment of pelvic congestion syndrome.

2 Policy Guidelines Embolization of the ovarian vein may require an overnight hospital stay. Embolization of the internal iliac veins has been performed on an outpatient basis. There are no specific CPT codes for this procedure. The following nonspecific CPT codes may be used: 36012: Selective catheter placement, venous system: second order or more selective, branch 37204: Transcatheter occlusion or embolization (e.g., for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method, non-central nervous system, non-head or neck Rationale This policy was created in 2004 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period March 2011 through March Following is a summary of the key literature to date: No randomized controlled trials have been published comparing embolization therapy for pelvic congestion syndrome to an alternative or sham/placebo treatment. Randomized controlled trials are especially needed in situations such as this where the primary symptom is pain, a subjective outcome for which a placebo response to treatment is likely. The published studies consist of case series, most of which were retrospective and conducted outside of the United States. A summary table of the largest case series, (1-6, respectively) identified in review articles by Naoum (7) and Kies and Kim (8) is as follows: Study Location No. of patients Mean follow-up (months) Clinical outcome (improvement in symptoms) Maleux et al., 2000 Belgium Significant: 58.9% (1) Venbrux et al., U.S Significant or partial: 96% 2002 (2) Pieri et al., 2003 (3) Italy Significant: 100% Kim et al., 2006 (4) U.S Significant: 83% Kwon et al., 2007 Korea 67 ~44.8 Significant or partial: 82% (5) Gandini et al., 2008 Italy Significant: 100% (6) In addition to the efficacy of embolization for treating pelvic congestion syndrome, the published literature has addressed the issue of diagnosis of pelvic congestion syndrome and whether it causes pelvic pain. In his 2009 review article, Naoum, a U.S.-based vascular surgeon, stated

3 that venography is considered the gold standard for diagnosing pelvic congestion syndrome but that other types of diagnostic imaging, e.g., ultrasound, computed tomography (CT) scan, are also used. (7) He added that a diagnostic algorithm to guide patient management still needs to be developed. Similarly, in 2010, Tu and colleagues published a systematic review of literature on the diagnosis and management of pelvic congestion syndrome. (9) The authors commented that studies have rarely specified explicit diagnostic criteria for pelvic congestion syndrome and that definitions of pelvic pain have varied widely among studies. Moreover, most studies have not used objective outcome measures. A 2012 review article by Ball and colleagues stated that the issue of whether pelvic congestion syndrome causes chronic pelvic pain is still a matter of debate. (10) The authors noted that although venous reflux is common, not all women with this condition experience chronic pelvic pain and, additionally, chronic pelvic pain is reported by women without pelvic congestion syndrome. The authors recommended a systematic review of evidence on the causal link between pelvic congestion syndrome and chronic pelvic pain, and they stated that, if causation is established, well-designed randomized controlled trials evaluating embolization therapy may be needed. Summary Randomized controlled studies using well-defined diagnostic criteria are required to establish the safety and efficacy of this procedure. The available literature regarding embolization therapy for the treatment of pelvic congestion syndrome is inadequate to draw clinical conclusions; thus the treatment is considered investigational. Practice Guidelines and Position Statements American College of Obstetricians and Gynecologists (ACOG): No relevant policy positions on embolization for treating pelvic congestion syndrome were identified on the organization s website. Society of Interventional Radiology (SIR): A fact sheet on chronic pelvic pain in women endorsed coil embolization as an effective treatment option for pelvic congestion syndrome. (11) Medicare National Coverage No national coverage determination. References: 1. Maleux G, Stockx L, Wilms G et al. Ovarian vein embolization for the treatment of pelvic congestion syndrome: long-term technical and clinical results. J Vasc Interv Radiol 2000; 11(7): Venbrux AC, Chang AH, Kim HS et al. Pelvic congestion syndrome (pelvic venous incompetence): impact of ovarian and internal iliac vein embolotherapy on menstrual cycle and chronic pelvic pain. J Vasc Interv Radiol 2002; 13(2 pt 1): Pieri S, Agresti P, Morucci M et al. Percutaneous treatment of pelvic congestion syndrome. Radiol Med 2003; 105(1-2): Kim HS, Malhotra AD, Rowe PC et al. Embolotherapy for pelvic congestion syndrome: long-term results. J Vasc Interv Radiol 2006; 17(2 pt 1):

4 5. Kwon SH, Oh JH, Ko KR et al. Transcatheter ovarian vein embolization using coils for the treatment of pelvic congestion syndrome. Cardiovasc Intervent Radiol 2007; 30(4): Gandini R, Chiocchi M, Konda D et al. Transcatheter foam sclerotherapy of symptomatic female varicocele with sodium-tetradecyl-sulfate foam. Cardiovasc Intervent Radiol 2008; 31(4): Naoum JJ. Endovascular therapy for pelvic congestion syndrome. Methodist Debakey Cardiovasc J 2009; 5(4): Kies DD, Kim HS. Pelvic congestion syndrome: a review of current diagnostic and minimally invasive treatment modalities. Phlebology 2012; 27(Suppl 1): Tu FF, Hahn D, Steege JF. Pelvic congestion syndrome-associated pelvic pain: a systematic review of diagnosis and management. Obstet Gynecol Surv 2010; 65(5): Ball E, Khan KS, Meads C. Does pelvic congestion syndrome exist and can it be treated? Acta Obstet Gynecol Scand 2012 [Epub ahead of print]. 11. Society of Interventional Radiology (SIR). Patient Information Sheet on Pelvic Congestion Syndrome. Available online at: Last accessed April Codes Number Description CPT ICD-9 Procedure ICD-9 Diagnosis Selective catheter placement, venous system: second order or more selective, branch Transcatheter occlusion or embolization (e.g., for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method, non-central nervous system, non-head or neck Injection or infusion of other therapeutic or prophylactic substance Investigational for all relevant diagnoses Pelvic congestion syndrome ICD-10-CM (effective 10/1/13) ICD-10-PCS (effective 10/1/13) N94.89 Investigational for all relevant diagnoses Other specified conditions associated with female genital organs and menstrual cycle. ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.

5 3E033GC, 3E043GC Administration, physiological systems and anatomical regions, introduction, percutaneous, other therapeutic substance, code by body part (peripheral vein or central vein) Index Embolization Therapy, Ovarian Vein, for Pelvic Congestion Syndrome Pelvic Congestion Syndrome, Embolization Therapy Positron Emission Tomography