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MP 4.01.18 Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome

Medical Policy    
Section
OB/Gyn/Reproduction 
Original Policy Date
4/16/04
Last Review Status/Date
Reviewed with literature search/5:2013
Issue
5:2013
  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 that often is aggravated by standing; diagnostic criteria for this condition 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.

Background

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. 


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

Beginning in 2014:

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 (e.g., congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles)

Prior to 2014, the following code was used:

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 


Benefit Application
BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs, biologics and imaging may not be considered investigational and thus may be only assessed on their basis of their medical necessity.


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 2012 through March 28, 2013. 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. Case series have been discussed in several review articles, most recently in 2012. (1-3)

A summary table of the largest case series reporting the proportion of patients with improvement in symptoms (4-9) is as follows:

Study   Location   No. of patients   Mean follow-up (months)   Clinical outcome (improvement in symptoms)  
Maleux et al., 2000      Belgium   41   19.9   Significant: 58.9%  
Venbrux et al., 2002      U.S.   56   22.1   Significant or partial: 96%  
Pieri et al., 2003     Italy   33   12   Significant: 100%  
Kim et al., 2006   U.S.   127   45   Significant: 83%  
Kwon et al., 2007   Korea   67   ~44.8   Significant or partial: 82%  
Gandini et al., 2008  Italy   38   12   Significant: 100%  

Longer-term outcomes after coil embolization for pelvic congestion syndrome were reported by Laborda and colleagues in 2013. (10) The study included patients who were referred by a vascular surgeon. There were no clearly defined diagnostic criteria. A total of 179 of 202 women (89%) completed a 5-year follow-up. Mean age at baseline was 43.5 years. The primary outcomes were pain improvement and patient satisfaction. Pain improvement was measured on a 10-point visual analog scale (VAS) with 0 defined as no pain at all and 10 defined as the worst pain imaginable. At baseline, mean VAS was 7.34 (standard deviation [SD]: 0.7) and at 5 years mean VAS was 0.78 (SD: 1.2). The decrease in the VAS score over time was statistically significant (p<0.0001). Mean patient satisfaction was 7.39 (SD: 1.5) on a 0 to 9 scale. There were 4 cases of coil migration (2%) and these were considered major complications. As with the other case series discussed above, this study is limited by the lack a control group with which to compare outcomes.

Another limitation in the literature on embolization therapy for the treatment of pelvic congestion syndrome is lack of standardization regarding diagnostic criteria. In 2010, Tu and colleagues published a systematic review of literature on the diagnosis and management of pelvic congestion syndrome. (11) 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. (12) 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.

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

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. (13)

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.

Medicare National Coverage

No national coverage determination.

References:

  1. Kies DD, Kim HS. Pelvic congestion syndrome: a review of current diagnostic and minimally invasive treatment modalities. Phlebology 2012; 27(Suppl 1):52-7.
  2. Monedero JL, Ezpeleta SZ, Perrin M. Pelvic congestion syndrome can be treated operatively with good long-term results. Phlebology 2012; 27 Suppl 1:65-73.
  3. Naoum JJ. Endovascular therapy for pelvic congestion syndrome. Methodist Debakey Cardiovasc J 2009; 5(4):36-8.
  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-Jan):778-84.
  5. 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):289-97.
  6. 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):655-61.
  7. 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):859-64.
  8. Pieri S, Agresti P, Morucci M et al. Percutaneous treatment of pelvic congestion syndrome. Radiol Med 2003; 105(2-Jan):76-82.
  9. 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):171-8.
  10. 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 [Epub ahead of print].
  11. 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):332-40.
  12. Ball E, Khan KS, Meads C. Does pelvic venous congestion syndrome exist and can it be treated? Acta Obstet Gynecol Scand 2012; 91(5):525-8.
  13. Society of Interventional Radiology (SIR). Pelvic Congestion Syndrome - Chronic Pelvic Pain in Women (Patient information). Available online at: http://www.sirweb.org/patients/chronic-pelvic-pain/. Last accessed March, 2013.

 

Codes

Number

Description

CPT 

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 (deleted 12/31/13)

  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 (e.g., congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles) (new code 1/1/14)
ICD-9 Procedure 99.29 Injection or infusion of other therapeutic or prophylactic substance

ICD-9 Diagnosis

 

Investigational for all relevant diagnoses 

  625.5

Pelvic congestion syndrome 

ICD-10-CM (effective 10/1/14)    Investigational for all relevant diagnoses
   N94.89 Other specified conditions associated with female genital organs and menstrual cycle.
ICD-10-PCS (effective 10/1/14)    ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.
   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
 


Policy History

Date Action Reason
04/16/04 Add policy to OB/Gyn section New policy
11/9/04 Replace policy Coding updated. CPT code 37204 for embolization added
03/7/06 Replace policy Policy updated; no additional literature identified; policy statement unchanged
08/14/08 Replace policy  Policy updated with literature search; rationale edited; references 8, 11 and 12 added; policy statement unchanged.
05/14/09 Replace policy Policy reviewed with literature search from April 2008 through April 2009. The policy statement is unchanged; new reference number 13 added.
05/13/10 Replace policy Policy reviewed with literature search from May 2009 through March 2010. The policy statement is unchanged. Rationale re-written; reference numbers 3, 4, 7 and 10 added; other references re-numbered/removed.
5/12/11 Replace policy Policy reviewed with literature search from March 2010 through March 2011. The policy statement is unchanged. Reference number 10 added and numbering of other references was adjusted accordingly.
5/10/12 Replace policy Policy reviewed with literature search through March 2012. The policy statement is unchanged. Reference numbers 6, 8 and 10 added; other references re-numbered or removed.
05/09/13 Replace policy Policy reviewed with literature search through March 28, 2013. The policy statement is unchanged. Reference numbers 2 and 10 added; other references re-numbered or removed.
10/10/13 Replace policy - coding update only New embolization code 37241 added and deletion of code 37204 noted.