Surgery Section - Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION

Pelvic congestion syndrome is a condition of chronic pelvic pain which is thought to be associated with vascular engorgement of the uterus and the vessels of the broad ligament and lateral pelvic walls.  Embolization therapy involves the occlusion of blood flow through the ovarian veins with coils, foam or a chemical sclerosant. The internal iliac veins may be treated  at the same time or a later date to prevent recurrence.

POLICY/CRITERIA

Embolization of the ovarian vein and internal iliac veins is considered investigational as a treatment of pelvic congestion syndrome.

POSITION SUMMARY

Available evidence is not sufficient to determine whether embolization of the ovarian and internal iliac veins is effective as a treatment of pelvic congestion syndrome.

• There is a lack of data in the published literature concerning diagnostic criteria for pelvic congestion syndrome, so patient selection criteria for this procedure are uncertain.
• Long term safety and effectiveness are uncertain as there are a lack of data on treatment outcomes related to embolization therapy.

Effectiveness

There are no prospective, randomized trials comparing embolization to other therapies for pelvic congestion syndrome. The literature regarding the clinical outcomes of embolization therapy consists entirely of case series.  (2-11)  Collectively, conclusions concerning safety and effectiveness cannot be reached from these studies due to significant limitations in the data, including:

• Lack of established diagnostic criteria for pelvic congestion syndrome
  
  Without consistent criteria for patient selection, it is unknown which patients are most likely to benefit — or not — from treatment.  It is unknown how results from the various case series can be applied to the overall population of patients with this condition.
  
  
• Retrospective design and failure to control for other treatments
  
  Retrospective study designs do not allow for control of co-treatments or confounding factors that may influence results.  This design may also introduce bias to interpretation of results.  Control for additional factors, such as other medical therapies, is necessary to isolate treatment response to embolization therapy.
  
  
• Failure to define relevant study endpoints
  
  Bias may also be introduced by failure to define study endpoints and treatment success prior to commencement of the study.
  
  
• Lack of comparison group and randomization
  
  Failure to randomize patients to different treatment groups may introduce bias in favor of the new technology on the part of both the study participant and researcher. For pain treatments, a comparator (preferably sham treatment) is necessary, in order to guard against this bias and to distinguish treatment from placebo effects.

Safety

The following adverse events associated with embolization of the uterine and internal iliac veins have been reported in the literature (2,9):

• Embolization of coils to the pulmonary circulation
• Accidental embolization of glue fragments
• Perforations of the ovarian vein with extravasation of contrast
• Transient cardiac arrhythmia

REFERENCES

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 4.01.18
2. 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
3. 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
4. Sichlau MJ, Yao JS, Vogelzang RL. Transcatheter embolotherapy for the treatment of pelvic congestion syndrome. Obstet Gynecol 1994;83(5 pt 2):892-6
5. 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):395-9
6. Tarazov PG, Prozorovskij KV, Ryzhkov VK. Pelvic pain syndrome caused by ovarian varices: treatment by transcatheter embolization. Acta Radiol 1997;38(6):1023-5
7. 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):862-8
8. 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
9. Kwon SH, Oh JS, Ko DR et al. Transcatheter ovarian vein embolization using coils for the treatment of pelvic congestion syndrome. Cardiovasc Intervent Radiol 2007 30(4):655-61
10. Creton D, Hennequin L, Kohler F et al.  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):112-7
11. 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):778-84
12. Tropeano G, Di Stasi C, Amoroso S et al. Ovarian vein incompetence: a potential cause of chronic pelvic pain in women. Eur J Obstet Gynecol Reprod Biol 139(2):215-21

Cross References

None

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