Latest Review Date:  August 2024

Category:  Surgery                                                                

POLICY:

Endovascular occlusion of the ovarian vein and internal iliac veins for the treatment of pelvic congestion syndrome is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Pelvic congestion syndrome is characterized by chronic pelvic pain that often is aggravated by standing; diagnostic criteria for this condition are not defined. Endovascular occlusion (e.g., embolization, sclerotherapy) of the ovarian and internal iliac veins has been proposed as a treatment for patients who fail medical therapy.

Pelvic Congestion Syndrome

Pelvic congestion syndrome is a condition of chronic pelvic pain of variable location and intensity, which is associated with dyspareunia (possibly aggravated by standing) and symptoms suggestive of a venous origin, such as postcoital ache and tenderness over the ovarian point. Pain is often greater before or during menses. The underlying etiology is thought to be related to varices of the pelvic veins, leading to pelvic congestion.  The lack of clear diagnostic criteria and overlapping clinical presentation of pelvic congestion syndrome with other potentially related pelvic venous disorders has hindered research progress and contributed to underdiagnosis of these disorders as causes of chronic pelvic pain. In 2021, a multidisciplinary, intersociety working group convened by the American Vein and Lymphatic Society published the Symptoms-Varices-Pathophysiology (SVP) classification of pelvic venous disorders which, in conjunction with the established Clinical-Etiologic-Anatomic-Physiologic classification for lower extremity venous disorders when applicable, places patients in homogeneous populations based on standardized definitions of presenting symptoms, involved variceal reservoirs, and underlying pathophysiology (including anatomic, hemodynamic, and etiologic disease features). The term pelvic venous disorder, accompanied by the patient-specific SVP classification, has been proposed to replace pelvic congestion syndrome and other historical nomenclature for related diseases (such as May-Thurner syndrome and nutcracker syndrome). As diagnostic criteria remain lacking, pelvic venous disorder as a cause of chronic pelvic pain amounts to a diagnosis of exclusion. Evaluation of this syndrome may involve a variety of physical assessments, laboratory measurements, and/or imaging studies to eliminate other etiologies of chronic pelvic pain, such as cystitis or gynecologic malignancy.

Treatment

An initial conservative approach to the treatment of pelvic congestion syndrome may involve analgesics (e.g., short-term use of nonsteroidal anti-inflammatory drugs) and hormonal therapy, with or without psychotherapy. The evidence base for medical management consists primarily of 5 clinical trials of hormonal therapy (sample sizes ranging from 22 to 102) in which medroxyprogesterone (in combination with psychotherapy), goserelin, and etonogestrel demonstrated significant improvements in pain scores with up to 13 months of follow-up. Longer-term efficacy of these treatments has not been demonstrated, and the largest trial of medroxyprogesterone indicated rapid recurrence of symptoms with discontinuation. Surgical ligation of pelvic veins may be considered, but is also supported by limited evidence and further limited by need for general anesthesia, duration of hospitalization, recovery time, and associated morbidity. Embolization therapy and/or sclerotherapy of the ovarian and internal iliac veins has been proposed as an alternative to surgical vein ligation. Endovascular occlusion can be performed using a variety of materials including coils, vascular plugs, glue, liquid embolic agents, and gelatin sponge or powder (Gelfoam).

KEY POINTS:

The most recent literature review was updated through June 12, 2024.

Summary of Evidence

For individuals who have pelvic congestion syndrome who receive ovarian and/or internal iliac vein endovascular occlusion, the evidence includes randomized studies, comparative cohort studies, non-comparative cohort studies, case series and systematic reviews. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. Systematic reviews of prospective and retrospective data, as well as more recently published retrospective cohort studies, indicate consistently high clinical success rates (primarily in the form of significant pain reduction) ranging from 63.7% to 100% after ovarian and/or internal iliac vein endovascular occlusion at short-term, long-term, or overall follow-up. In a randomized trial of embolization with vascular plugs or coils in patients with pelvic congestion syndrome, adverse events were reported in 22% and 10% of patients, respectively. A retrospective analysis comparing coil embolization to endoscopic resection indicated significantly greater improvement in pain 1 month post-procedure with resection, but similar improvements in pain between the procedures at 5-year follow-up. Differences between these procedures, particularly the need for general anesthesia with resection versus local anesthesia with embolization, suggest the possibility of selection bias in this study. Randomized controlled trials using well-defined eligibility criteria and relevant comparators are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Practice Guidelines and Position Statements

International Union of Phlebology

An international consensus document on the diagnosis and treatment of pelvic congestion syndrome (which acknowledged the suboptimal nature of this terminology and noted that new nomenclature was being proposed at the time of publication) was published by a task force of the International Union of Phlebology in 2019. Key consensus statements include:

• Symptomatic (pain-relief) therapies include analgesics, nonsteroidal anti-inflammatory drugs, psychotropic drugs, but the effect of such therapy is transient.
• Hormonal therapy seems to have therapeutic effect, but long-term usage is not recommended because of the high risk of osteoporosis.
• Current surgical treatment includes open or laparoscopic surgery to ligate the insufficient veins. However, these procedures are rarely performed as they are more invasive than endovascular embolization procedures, and require a general anesthetic and a longer recovery period. Surgery of the reproductive organs is not advised as a treatment option.
• Injecting foam or liquid sclerosant could be used for occlusion of gonadal veins and for the treatment of atypical varicose veins of perineal, vulval, gluteal, or posterior thigh localization.
• Transcatheter embolization therapy is the method of choice for the treatment of pelvic congestion syndrome. The aim of embolization is to occlude insufficient venous axes as close as possible to the origin of the leak. In pelvic venous disorders these will be the gonadal axes, pelvic varicose veins, and insufficient tributary branches of the internal iliac veins. However, published evidence of its effect has been criticized for the lack of validated clinical and imaging criteria for the disorders responsible for pelvic venous disease.
• Treatment of choice for pelvic congestion syndrome is pelvic vein embolization, in the absence of obstructions. Serious complications after this kind of treatment are very rare.

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.

Society for Vascular Surgery and American Venous Forum

A clinical practice guideline for the care of patients with varicose veins and related chronic venous disorders was jointly published by the Society for Vascular Surgery and American Venous Forum in 2011. Portions of these guidelines were updated most recently in 2023, although there was no mention of pelvic congestion syndrome.

The guideline included the recommendations below related to treatment of pelvic congestion syndrome. Medical management is not included among recommendations; the guideline states that "Pharmacologic agents to suppress ovarian function, such as medroxyprogesterone or gonadotropin-releasing hormone, may offer short-term pain relief, but their long-term effectiveness has not been proven."

• We suggest treatment of pelvic congestion syndrome and pelvic varices with coil embolization, plugs, or transcatheter sclerotherapy, used alone or together (grade 2B: weak recommendation, moderate quality of evidence).
• If less invasive treatment is not available or has failed, we suggest surgical ligation and excision of ovarian veins to treat reflux (grade 2B: weak recommendation, moderate quality of evidence).

U.S. Preventive Services Task Force Recommendations

Not applicable

KEY WORDS:

Pelvic congestion syndrome (PCS), embolization therapy, ovarian vein, internal iliac vein, pelvic venous incompetence (PVI), Endovascular occlusion, Flipper, Embosphere, Contour, EOS

APPROVED BY GOVERNING BODIES:

Ovarian and internal iliac vein embolization is a surgical procedure and as such is not subject to regulation by FDA.

A variety of products including coils, vascular plugs, glue, liquid embolic agents, Gelfoam and/or delivery-assist devices would be used to embolize the vein(s), and those would be subject to FDA regulation.  Several of these products have 510(k) marketing clearance for uterine fibroid embolization (e.g. Embosphere® Microspheres, Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles) and/or embolization of hypervascular tumors and arteriovenous malformations (e.g. Contour® Emboli PVA). Several embolization delivery systems have also been cleared via the 510(k) process for arterial and venous embolization in the peripheral vasculature featuring vascular plugs (e.g., ArtVentive Medical Group, Inc. Endoluminal Occlusion System [EOSTM]) or coils (e.g., Cook Incorporated MReye® Flipper®).

In November 2004, the sclerosant agent Sotradecol® (sodium tetradecyl sulfate injection) was approved by the U.S. Food and Drug Administration for use in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves (ANDA 040541).

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member's benefit plan.

CURRENT CODING:

CPT Codes:

There are no specific CPT codes for this procedure. The following nonspecific CPT codes may be used:

REFERENCES:

1. Antignani PL, Lazarashvili Z, Monedero JL, et al. Diagnosis and treatment of pelvic congestion syndrome: UIP consensusdocument. Int Angiol. Aug 2019; 38(4): 265-283.
2. Ball E, Khan KS, Meads C. Does pelvic congestion syndrome exist and can it be treated? Acta Obstet Gynecol Scand 2012. 91(5):525-8.
3. Bendek B, Afuape N, Banks E, et al. Comprehensive review of pelvic congestion syndrome: causes, symptoms, treatmentoptions. Curr Opin Obstet Gynecol. Aug 2020; 32(4): 237-242.
4. Borghi C, Dell'Atti L. Pelvic congestion syndrome: the current state of the literature. Arch Gynecol Obstet. Feb 2016;293(2): 291-301.
5. Brown C, Rizer M, Alexander R, Sharpe E, Rochon P. Pelvic Congestion Syndrome: Systematic Review of Treatment Success.. Semin Intervent Radiol, 2018 Apr 10;35(1).
6. Chen H, Wu Z, Wu Z, et al. Proximal coil occlusion preceding distal sclerotherapy in patients with pelvic congestionsyndrome: A multicenter, retrospective study. J Vasc Surg Venous Lymphat Disord. Jan 2023; 11(1): 149-155.
7. Chung M, Huh C. Comparison of treatments for pelvic congestion syndrome.. Tohoku J. Exp. Med., 2003 Dec 3;201(3).
8. Emad El Din M, Soliman M, El Kiran Y, et al. Ovarian vein surgical ablation versus endovascular technique for treatmentof pelvic vein incompetence. J Vasc Surg Venous Lymphat Disord. Jul 2023; 11(4): 801-808.
9. Gandini R, Chiocci M, Konda D, et al.  Transcatheter foam sclerotherapy of symptomatic female varicocele with sodium-tetradecyl-sulfate foam.  Cardiovasc Intervent Radiol, July-Aug 2008; 31(4): 778-784.
10. Gavrilov SG, Sazhin AV, Akhmetzianov R, et al. Surgical and endovascular treatment of pelvic venous disorder: Results ofa multicentre retrospective cohort study. J Vasc Surg Venous Lymphat Disord. May 06 2023.
11. Ganeshan A, Upponi S, Hon LQ, Uthappa MD, et al.  Chronic pelvic pain due to pelvic congestion syndrome:  the Role of diagnostic and interventional radiology.  Cardiovasc Intervent Radiol, Nov-Dec 2007; 30(6): 1105-1111. 
12. Gavrilov SG, Sazhin A, Krasavin G, et al. Comparative analysis of the efficacy and safety of endovascular and endoscopic interventions on the gonadal veins in the treatment of pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. May 25 2020.
13. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venousdiseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg.May 2011; 53(5 Suppl): 2S-48S.
14. Gloviczki P, Lawrence PF, Wasan SM, et al. The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine. J Vasc Surg Venous Lymphat Disord. Jan 2024; 12(1): 101670.
15. Guirola J, Sánchez-Ballestin M, Sierre S. A Randomized Trial of Endovascular Embolization Treatment in Pelvic Congestion Syndrome: Fibered Platinum Coils versus Vascular Plugs with 1-Year Clinical Outcomes.. J Vasc Interv Radiol, 2017 Nov 28;29(1).
16. Guirola JA, Sanchez-Ballestin M, Sierre S, et al. A Randomized Trial of Endovascular Embolization Treatment in Pelvic Congestion Syndrome: Fibered Platinum Coils versus Vascular Plugs with 1-Year Clinical Outcomes. J Vasc Interv Radiol. Jan 2018; 29(1): 45-53.
17. Hocquelet A, Le Bras Y, Balian E et al. Evaluation of the efficacy of endovascular treatment of pelvic congestion syndrome. Diagn Interv Imaging 2014; 95(3):301-6.
18. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
19. Jambon E, Le Bras Y, Coussy A, et al. Embolization in pelvic venous disorders using ethylene vinyl alcohol copolymer(Onyx®) and Aetoxysclerol: a prospective evaluation of safety and long-term efficacy. Eur Radiol. Jul 2022; 32(7): 4679-4686.
20. Kies DD, Kim HS. Pelvic congestion syndrome: a review of current diagnostic and minimally invasive treatment modalities. Phlebology 2012; 27(Suppl 1):52-7.
21. Kim HS, Malhotra AD, et al.  Embolotherapy for pelvic congestion syndrome:  Long-term results.  J Vasc Interv Radiol, February 2006; 17(2 Pt 1): 289-297.
22. Knuttinen MG, Machan L, Khilnani NM, et al. Diagnosis and Management of Pelvic Venous Disorders: AJR Expert PanelNarrative Review. AJR Am J Roentgenol. Apr 05 2023.
23. Kwon SH, Oh JH, Ko KR, et al.  Transcatheter ovarian vein embolization using coils for the treatment of pelvic congestion syndrome.  Cardiovasc Intervent Radiol, Jul-Aug 2007; 30(4): 655-661.
24. 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, Aug 2013; 36(4):1006-1014.
25. Liu J, Han L, Han X. The Effect of a Subsequent Pregnancy After Ovarian Vein Embolization in Patients with Infertility Caused by Pelvic Congestion Syndrome. Acad Radiol. Oct 2019; 26(10): 1373-1377.
26. Mahmoud O, Vikatmaa P, Aho P, et al. Efficacy of endovascular treatment for pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. Jul 2016;4(3):355-370.
27. Meissner MH, Khilnani NM, Labropoulos N, et al. The Symptoms-Varices-Pathophysiology classification of pelvic venousdisorders: A report of the American Vein Lymphatic Society International Working Group on Pelvic Venous Disorders. JVasc Surg Venous Lymphat Disord. May 2021; 9(3): 568-584.
28. 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.
29. Naoum JJ.  Endovascular therapy for pelvic congestion syndrome.  Methodist Debakey Cardiovasc J 2009; 5(4): 36-38.
30. 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):65-8.
31. Shahat M, Hussein RS, Ahmed AKS. Foam Sclerotherapy in Pelvic Congestion Syndrome. Vasc Endovascular Surg. Jul2023; 57(5): 456-462.
32. Society of Interventional Radiology (SIR). Pelvic Congestion Syndrome - Chronic Pelvic Pain in Women (Patient information). Available online at: www.sirweb.org/patients/chronic-pelvic-pain/. Accessed July 3, 2023.
33. Society of Interventional Radiology (SIR). Diseases and conditions: Pelvic venous disease (pelvic congestion syndrome orchronic pelvic pain) [Patient Center]. n.d.; https://www.sirweb.org/patient-center/pelvic-venous-disease/https://www.sirweb.org/patient-center/conditions-and-treatments/pelvic-venous-disease/. Accessed July 3, 2023.
34. Sozutok S, Piskin FC, Balli HT, et al. Efficacy of the endovascular ovarian vein embolization technique in pelvic venouscongestion syndrome. Pol J Radiol. 2022; 87: e510-e515.
35. Stones RW. Pelvic vascular congestion - half a century later. Clin Obstet Gynecol 2003; 46(4): 831-6.
36. Tropeano G, Di Stasi C, Amoroso S, Cina A and Scambia G.  Ovarian vein incompetence:  A potential cause of chronic pelvic pain in women.  Eur J Obstet Gynecol Reprod Biol, August 2008; 139(2): 215-221.
37. Tu FF, Hahn D, Steege JR. Pelvic congestion syndrome-associated pelvic pain: a systemic review of diagnosis and management. Obstet Gynecology Surgery 2010; 65(5):332-40.
38. 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.

POLICY HISTORY:

Medical Policy Group, June 2004 (4)

Medical Policy Administration Committee, July 2004

Available for comment July 12-August 25, 2004

Medical Policy Group, June 2005 (1)

Medical Policy Group, June 2006 (1)

Medical Policy Group, June 2007 (1)

Medical Policy Group, June 2009 (1)

Medical Policy Group, June 2010 (1)

Medical Policy Group, June 2011 (3): Updated Key Points and References; no change to policy statement

Medical Policy Group, June 2012 (4): Updated Key Points and References; no change to policy statement

Medical Policy Panel, May 2013

Medical Policy Group, September 2013 (1): Update to Key Points and References; no change to policy statement

Medical Policy Group, January 2014 (1): 2014 Coding Update: added new code 37241, effective 01/01/2014; moved deleted code 37204 to previous coding section, effective 01/01/2014

Medical Policy Panel, June 2014

Medical Policy Group, June 2014 (1): Update to Key Points and References; no change to policy statement.

Medical Policy Panel, June 2014

Medical Policy Group, June 2014 (4):  Update to Key Points and Approved Governing Bodies.  No change to policy statement.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (4):  Update to Key Points and References.  No change to policy statement.

Medical Policy Panel, August 2017

Medical Policy Group, August 2017 (4): Updates to Key Points. No change to policy statement.

Medical Policy Panel, August 2019

Medical Policy Group, August 2019 (4): Updates to Description, Key Points, Key Words, Approved by Governing Bodies, and References. Policy Title updated to Ovarian and Internal Iliac Vein Endovascular Occlusion as Treatment of Pelvic Congestion Syndrome. No change to policy statement updated to reflect change in title; Embolization changed to Endovascular occlusion. No change in Policy intent. Removed Previous Coding section, cpt code 37204 deleted in 2014.

Medical Policy Panel, August 2020

Medical Policy Group, August 2020 (4): Updates to Description, Key Points, Key Words and References.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (4): Updates to Key Points and References. Policy statement updated to remove “investigational,” no change to policy intent. Removed the following references:  Capasso P, Simons C, Trotteur G, et al.  Treatment of symptomatic pelvic varices by ovarian vein embolization, Cordts PR, Eclavea A, Buckley PJ, et al. Pelvic congestion syndrome: early clinical results after transcatheter ovarian vein embolization, Maleux G, Stockx L, Wilms G, et al. Ovarian vein embolization for the treatment of pelvic congestion syndrome: long-term technical and clinical results, Pieri S. Percutaneous treatment of pelvic congestion syndrome, Tarazov PG, Prozorovskij KV, and Ryzhkov VK. Pelvic pain syndrome caused by ovarian varices: treatment by transcatheter embolization, Sichlau MJ, Yao JS, Vogelzang RL.  Transcatheter embolotherapy for the treatment of pelvic congestion syndrome, 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).

Medical Policy Panel, August 2022

Medical Policy Group, August 2022 (4): Updates to Description.  No change to policy statement. 

Medical Policy Panel, September 2023

Medical Policy Group, September 2023 (4):  Updates to Description, Key Points, Benefit Application, and References.

Medical Policy Panel, August 2024

Medical Policy Group, August 2024 (4): Updates to Policy, Description, Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.