Medical Policy


Subject:  Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome
Policy #:  SURG.00062Current Effective Date:  07/15/2014
Status:ReviewedLast Review Date:  05/15/2014

Description/Scope

Pelvic congestion syndrome (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. This document addresses ovarian and internal iliac vein embolization as a treatment for PCS.

Position Statement

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.

Rationale

The literature regarding the clinical outcomes for embolization therapy for treatment of pelvic congestion syndrome (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, five year results were reported for a prospective, single center case series of 202 women suffering from chronic pelvic pain who were being treated for lower limb varices.  Inclusion criteria were: lower limb varices and chronic pelvic pain 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 (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, 2013; 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 two women the coils inadvertently migrated to the pulmonary circulation where they were retrieved without incident.  Recurrences of varices were noted in three 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.  Ninety-seven women completed long term follow-up (mean 45 months +/- 18).  Eighty-three percent (83%) of these women exhibited clinical improvement at long-term follow-up, 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 five 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).

Background/Overview

Pelvic congestion syndrome (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 for chronic pelvic pain, 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.

Definitions

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.

Coding

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:

CPT 
37241Vascular 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)
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2015]
456.5Varicose veins of other sites, pelvic varices [when indicated as ovarian and internal iliac veins]
625.5Pelvic congestion syndrome
625.9Unspecified symptom associated with female genital organs [when indicated as chronic pelvic pain]
  
ICD-10 Procedure[For dates of service on or after 10/01/2015]
06LY3DZOcclusion of lower vein with intraluminal device, percutaneous approach
06LY4DZOcclusion of lower vein with intraluminal device, percutaneous endoscopic approach
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2015]
I86.2Pelvic varices [when indicated as ovarian and internal iliac vein varices]
I87.2Venous insufficiency [when specified as pelvic venous insufficiency]
N94.89Other specified conditions associated with female genital organs and menstrual cycle [when indicated as chronic pelvic pain, female pelvic congestion]
R10.2Pelvic and perineal pain
  
References

Peer Reviewed Publications:

  1. Asciutto G, Asciutto KC, Mumme A, Geier B. Pelvic venous incompetence: reflux patterns and treatment results.  Eur J Vasc Endovasc Surg. 2009; 38(3):381-386.
  2. Bachar GN, Belenky A, Greif F, et al.  Initial experience with ovarian vein embolization for the treatment of chronic pelvic pain syndrome.  Isr Med Assoc J. 2003; 5(12):843-846.
  3. Ball E, Khan KS, Meads C. Does pelvic congestion syndrome exist and can it be treated? Acta Obstet Gynecol Scand. 2012; 91(5):525-528.
  4. Black C, Thorpe K, Venrbux A, et al.  Research reporting standards for endovascular treatment of pelvic venous insufficiency.  J Vasc Interv Radiol. 2010; 21(6):796–803.
  5. Chung MH, Huh CY. Comparison of treatments for pelvic congestion syndrome.  Tohoku J Exp Med. 2003; 201(3):131-138.
  6. Cordts PR, Eclavea A, Buckley PJ, et al.  Pelvic congestion syndrome: Early clinical results after transcatheter ovarian vein embolization.  J Vasc Surg. 1998; 28(5):862-868.
  7. Creton D, Hennequin L, Kohler F, Allaert FA. Embolisation of symptomatic pelvic veins in women presenting with non-saphenous varicose veins of pelvic origin - three-year follow-up.  Eur J Vasc Endovasc Surg. 2007; 34(1):112-117.
  8. 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):778-784.
  9. Hobbs JT.  Varicose veins arising from the pelvis due to ovarian vein incompetence.  Int J Clin Pract. 2005; 59(10):1195-1203.
  10. Hocquelet A, Le Bras Y, Balian E, et al.  Evaluation of the efficacy of endovascular treatment of pelvic congestion syndrome.  Diagn Interv Imaging. 2013; 95(3):301-306.
  11. Kies DD, Kim HS. Pelvic congestion syndrome:  A review of current diagnostic and minimally invasive treatment modalities.  Phlebology. 2012; 27(Suppl 1):52-57.
  12. 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):289-297.
  13. 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):655-661.
  14. Laborda A, Medrano J, de Blas I, et al. Endovascular treatment of pelvic congestion syndrome: Visual Analog Scale (VAS) long-term follow-up clinical evaluation in 202 patients. Cardiovasc Intervent Radiol. 2013; 36(4):1006-1014.
  15. Maleux G, Stockx L, Wilms G, Marchal G.  Ovarian vein embolization for the treatment of pelvic congestion syndrome: long term technical and clinical results.  J Vasc Interven Radiol. 2000; 11(7):859-864.
  16. Meneses L, Fava M, Diaz P.  Embolization of incompetent pelvic veins for the treatment of recurrent varicose veins in lower limbs and pelvic congestion syndrome. Cardiovasc Intervent Radiol. 2013; 36(1):128-132.
  17. Naoum JJ.  Endovascular therapy for pelvic congestion syndrome. Methodist Debakey Cardiovasc J.  2009; 5(4):36-38.
  18. Nasser F, Cavalcante RN, Affonso BB, et al.  Safety, efficacy, and prognostic factors in endovascular treatment of pelvic congestion syndrome. Int J Gynaecol Obstet. 2014; 125(1):65-68.
  19. Pieri S, Agresti P, Morucci M, de' Medici L. Percutaneous treatment of pelvic congestion syndrome.  Radiol Med (Torino). 2003; 105(1-2):76-82.
  20. Sichlau MJ, Yao JS, Vogelzang RL. Transcatheter embolotherapy for the treatment of pelvic congestion syndrome.  Obstet Gynecol. 1994; 83(5 Pt 2):892-896.
  21. Smith PC.  The outcome of treatment for pelvic congestion syndrome.  Phlebology. 2012; 27 Suppl 1:74-77.
  22. Stones RW.  Pelvic vascular congestion - half a century later.  Clin Obstet Gynecol. 2003; 46(4):831-836.
  23. Tarazov PG, Prozorovakji KV, Ryzhov VK.  Pelvic pain syndrome caused by ovarian varices. Treatment of transcatheter embolization.  Acta Radiol. 1997; 28(6):1023-1025.
  24. 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):332-340.
  25. 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 Vas Inter Radiol. 2002; 13(2 Pt 1):171-178.
  26. Venbrux AC, Lambert DL.  Embolization of the ovarian veins as a treatment for patients with chronic pelvic pain caused by pelvic venous incompetence (pelvic congestion syndrome).  Curr Opin Obstet Gynecol. 1999; 11(4):395-399.

Government Agency, Medical Society and Other Authoritative Publications:

  1. Andrews J, Yunker A, Reynolds WS, et al.  Noncyclic Chronic Pelvic Pain Therapies for Women: Comparative Effectiveness. Comparative Effectiveness Review No. 41. (Prepared by the Vanderbilt Evidence-based Practice Center under Contract No. 290-2007-10065-I.) AHRQ Publication No. 11(12)-EHC088-EF. Rockville, MD: Agency for Healthcare Research and Quality. January 2012.  Available at:  http://effectivehealthcare.ahrq.gov/ehc/products/195/808/CER41-Pelvic-Pain_20120112.pdf.  Accessed on April 9, 2014.
  2. Angle JF, Siddiqi NH, Wallace MJ, et al.  Society of Interventional Radiology (SIR) Standards of Practice Committee.  Quality Improvement Guidelines for Percutaneous Transcatheter Embolization.  2010.  Available at:  http://www.sirweb.org/clinical/cpg/QI7.pdf.  Accessed on April 9, 2014.
  3. Centers for Medicare and Medicaid Services. National Coverage Determination for Therapeutic Embolization. NCD #20.28. Effective December 15, 1978. Available at:  http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=52&ncdver=1&DocID=20.28&bc=gAAAAAgAAAAAAA%3d%3d&. Accessed on April 9, 2014.
  4. Cheong YC, Smotra G, Williams ACDC. Non-surgical interventions for the management of chronic pelvic pain. Cochrane Database Syst Rev. 2014;(3):CD008797.  Available at:  http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008797.pub2/abstract.  Accessed on April 9, 2014.
  5. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.  J Vasc Surg. 2011; 53(5 Suppl):2S‐48S.
  6. Society of Interventional Radiology (SIR). Patient Information Sheet on Chronic Pelvic Pain in Women and Pelvic Congestion Syndrome.  2014. Available at: http://www.sirweb.org/patients/chronic-pelvic-pain/.  Accessed on April 9, 2014.
  7. Stones W, Cheong YC, Howard FM, Singh S. Interventions for treating chronic pelvic pain in women. Cochrane Database Syst Rev. 2005;(4):CD000387.  Available at:  http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000387/abstract.  Accessed on April 9, 2014.
Index

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

Document History
StatusDateAction
Reviewed05/15/2014Medical Policy and Technology Assessment Committee (MPTAC) review.  No change in stance. Rationale and References were updated.
 01/01/2014Updated Coding section with 01/01/2014 CPT changes; removed 37204 deleted 12/31/2013, and 75894.
Reviewed05/09/2013MPTAC review.  No change in stance. Rationale, Definitions and References were updated.
Reviewed05/10/2012MPTAC review. Rationale and References updated.
Reviewed05/19/2011MPTAC review. References updated.
Reviewed05/13/2010MPTAC review. References updated.
Reviewed05/21/2009MPTAC review. Rationale and References updated.
Reviewed05/15/2008MPTAC review. Description clarified by removing surgical ligation. References updated.
 02/21/2008The 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.
Reviewed05/17/2007MPTAC review. References updated. 
Reviewed06/08/2006MPTAC review. No change in position. Rationale and References updated. 
 11/22/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised07/14/2005MPTAC review.  Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.  
Pre-Merger OrganizationsLast Review DateDocument NumberTitle

Anthem, Inc.

 

10/28/2004SURG.00062Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome
WellPoint Health Networks, Inc.06/24/20043.09.09Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome