CAM 40118

Ovarian and Internal Iliac Vein Endovascular Occlusion as a Treatment of Pelvic Congestion Syndrome

Category:Ob/Gyn/Reproduction   Last Reviewed:January 2020
Department(s):Medical Affairs   Next Review:January 2021
Original Date:April 2004    

Description:
Pelvic congestion syndrome is characterized by chronic pelvic pain that is often aggravated by standing; diagnostic criteria for this condition are not well-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.

For individuals who have pelvic congestion syndrome who receive ovarian and/or internal iliac vein endovascular occlusion, the evidence includes case series and systematic reviews. Relevant outcomes are symptoms and treatment-related morbidity. According to a systematic review of case series data, approximately 80% of patients have reported some degree of symptom relief 12 months after ovarian and/or internal iliac vein endovascular occlusion. It is difficult to draw conclusions from these data because of a lack of a placebo control or comparative data from current alternative interventions. Moreover, definitions of pelvic congestion syndrome vary, making it challenging to define a patient population with symptoms arising from pelvic congestion. Randomized controlled trials using well-defined eligibility criteria are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background
Pelvic Congestion Syndrome 
Pelvic congestion syndrome is a chronic pelvic pain syndrome 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 vascular congestion. Because 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, computed tomography, or contrast venography. However, the syndrome is still not well-defined, and it is unclear whether pelvic congestion syndrome causes chronic pelvic pain.1 Although venous reflux is common, not all women with this condition experience chronic pelvic pain and, conversely, chronic pelvic pain is reported by women without pelvic congestion syndrome.

Treatment 
Initial treatment of pelvic congestion syndrome includes psychotherapy and medical therapy (e.g., nonsteroidal anti-inflammatory drugs) and hormonal therapy. For patients who fail initial therapy, surgical ligation of the ovarian vein may be considered. Embolization therapy of the ovarian and internal iliac veins has been proposed as an alternative to surgical ovarian vein ligation. Vein embolization can be performed using a variety of materials including coils, glue, and gel foam.

Regulatory Status 
Ovarian and internal iliac vein embolization are surgical procedures and, as such, are not subject to regulation by the U.S. Food and Drug Administration.

Various products (eg, coils, vascular plugs, glue, liquid embolic agents, Gelfoam) and/or delivery-assist devices would be used to embolize the vein(s), and they would be subject to Food and Drug Administration regulation. Several products have been cleared for marketing by the Food and Drug Administration through the 510(k) process for uterine fibroid embolization (eg, Embosphere® Microspheres, Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles) and/or embolization of hypervascular tumors and arteriovenous malformations (eg, 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 (eg, ArtVentive Medical Group, Inc. Endoluminal Occlusion System (EOSTM)) or coils (e.g., Cook Incorporated MReye® Flipper®). FDA product code: KRD.

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).

Related Policies:
40111 Occlusion of Uterine Arteries Using Transcatheter Embolization

Policy:
Embolization of the ovarian vein and internal iliac veins is investigational and/or unproven therefore considered NOT MEDICALLY NECESSARY  as a treatment of pelvic congestion syndrome.

Policy Guidelines:
Endovascular occlusion of the ovarian vein may require an overnight hospital stay. Endovascular occlusion of the internal iliac veins has been performed on an outpatient basis.

Benefit Application
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all U.S. Food and Drug Administration (FDA)-approved devices, drugs, biologics, and imaging may not be considered investigational and thus, may be assessed only on the basis of their medical necessity.

Rationale 
This evidence review was created in April 2004 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through May 31, 2019.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function -- including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, two domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical uses of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Pelvic Congestion Syndrome
No randomized controlled trials have been published comparing endovascular occlusion for pelvic congestion syndrome with a relevant alternative comparator or sham/placebo treatment. A randomized, prospective trial comparing embolization with coils vs vascular plugs is discussed. The remaining published evidence consists of case series, most of which were retrospective and conducted outside of the United States. Complicating the literature on this indication is a lack of standardized diagnostic criteria.

Clinical Context and Therapy Purpose
The purpose of ovarian and/or internal iliac vein endovascular occlusion in patients who have pelvic congestion syndrome is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of ovarian and/or internal iliac vein endovascular occlusion improve the net health outcome in patients with pelvic congestion syndrome?

The following PICO was used to select literature to inform this review.

Patients
The relevant population of interest is patients with pelvic congestion syndrome.

Interventions
The therapies being considered are ovarian and internal iliac vein endovascular occlusion.

Comparators
The following therapies are currently being used to make decisions about pelvic congestion syndrome: medical therapy (eg, analgesics, hormonal therapy) and surgical ovarian vein ligation.

Outcomes
The general outcomes of interest are symptom reduction (eg, pain related to varicose veins) and adverse events. Procedural follow-up ranges from 1 to 3 months.

Systematic Reviews
Tu et al (2010) published a systematic review of literature on the diagnosis and management of pelvic congestion syndrome.2, They observed that studies have rarely specified explicit diagnostic criteria for pelvic congestion syndrome and that definitions of pelvic pain have varied widely across studies. Moreover, most studies have not used objective outcome measures.

Two systematic reviews assessing endovascular occlusion for pelvic congestion syndrome were published between 2016 and 2018. Tables 1 and 2 summarize key characteristics and results.

Table 1. Systematic Review Characteristics

Study

Dates

Trials

Participants1

N (Range)

Design

Duration

Brown et al (2018)3, 1997-2014 14

Women with:

  • pelvic congestion syndrome with signs of pelvic vein incompetence on catheter-based venography**

Studies with:

  • percutaneous intervention for pelvic congestion syndrome (eg, sclerosis or embolization)
  • outcomes assessed pre- and post-treatment
828 (NR)

Quasi-randomized trial

Prospective observational studies

Case series*

1-288 months
Mahmoud et al (2016)4, 1997-2014 20

Women with:

  • pelvic congestion syndrome**

Studies with:

  • endovascular treatment of pelvic venous reflux
1,081 (6-218)

Prospective observational studies

Case series

1-72 months

1Key eligibility criteria.

*Study design noted by author not consistent with design type.

**No specific diagnostic criteria specified for pelvic congestion syndrome.

Table 2. Systematic Review Results

Study

Patients with Symptomatic Improvement

Patients with Little to No Symptomatic Improvement

Procedural Complications

Reports of Worsening Symptoms

Brown et al (2018)3,

Overall relief

Overall relief

   

N (Total N)1

697 (762)

57 (697)

36 (944)2

6 (710)

% (Range)

91.5% (68.3 - 100%)

8.2% (0-31.7%)

3.8% (NR)

0.8% (0-4.1%)

Median

95.1

4.6

NR

0

IQRQ3-Q1

17.4

14.2

NR

0

Mahmoud et al (2016)4,

Short-term relief

Long-term relief

Short-term relief

Long-term relief

   

N (Total N)

571 (648)

624 (721)

77 (648)

97 (721)

120 (1041)

NR

% (Range)

88.1% (NR)

86.6% (NR)

11.9% (NR)

13.4% (NR)

11.5% (NR)

NR

Median

NR

NR

NR

NR

NR

NR

IQRQ3-Q1

NR

NR

NR

NR

NR

NR

IQRQ3-Q1: interquartile range. NR: not reported.
1Proportion of patients with outcome from population completing all relevant follow-up.
2Proportion of procedures with outcome from total number of procedures performed.

A systematic review by Mahmoud et al (2016) identified 20 case series (total N=1081 patients) assessing endovascular treatment for pelvic congestion syndrome.4,Reviewers did not require any particular diagnostic criteria for pelvic congestion syndrome. Only a single study used a comparison group, but patients in it received conservative treatment because they were ineligible for vein embolization therapy; as a result, outcomes following the two interventions cannot be compared. The authors included a quality assessment for the included studies - which were deemed to be of poor quality.

Brown et al (2018) evaluated patient outcomes following percutaneous treatment of pelvic congestion syndrome (N=828).3, Study inclusion criteria required symptom(s) of pelvic congestion syndrome and the presence of pelvic venous incompetence on catheter-based venography - criteria which were not specified or defined. This review also includes a randomized trial published by Chung and Huh (2003) that evaluated the efficacy of various treatments for pelvic congestion syndrome that had failed 4-6 months of treatment with medroxyprogesterone acetate (N=106).5, However, this study compared ovarian vein coil embolization to hysterectomy with bilateral or unilateral oophorectomy and was therefore not assessed separately as evidence.

Randomized Studies
A randomized, prospective trial by Guirola et al (2018) in Spain compared the safety and efficacy of embolization with vascular plugs (VPs) or fibered platinum coils (FPCs) in women with pelvic congestion syndrome.6, Patients were enrolled (N=100) and randomly assigned to each treatment group via block randomization (N=50). Diagnosis of pelvic congestion syndrome was accomplished through a symptom screening questionnaire followed by an ultrasound study. Patients with 3 or more positive symptom responses advanced to the ultrasound screening, and patients with pelvic veins >6 mm in diameter and/or venous reflux or dilated midline communicating veins were advanced to randomization. Follow-up screening occurred at 1, 3, 6, and 12 months. The primary outcome was clinical success assessed subjectively through patient responses regarding relief of symptoms and pain scores assessed with the visual analog scale. Clinical success was achieved in 89.7% of the FPC group and 90.6% of the VP group (p = 0.760). Improvement in visual analog scale pain scores at the end of 12 months was 90.2% overall and improvement was seen in 95.9% of the FPC group and 96% of the VP group (p>0.999). A total of 11 (22%) complications were seen in the FPC group and 5 (10%) in the VP group (p = 0.059). Minor adverse events included access site hematoma and ovarian vein extravasation. Device migrations were considered major complications. A major limitation in the study is the significant difference in age (p = 0.004) and pre-treatment visual analog scale pain score between groups (p = 0.004), both of which were higher in the VP group despite randomization.

Case Series
Tables 3 and 4 summarize the characteristics and results of select case series that have reported on symptom improvements in patients with pelvic congestion syndrome treated with endovascular occlusion.

Table 3. Summary of Key Case Series Characteristics for Pelvic Congestion Syndrome

Study

Country

Participants

Treatment Delivery

Follow-Up, mo

Hocquelet et al (2014)7,

France

33

Vein embolization (foam, coil)

26

Nasser et al (2014)8,

Brazil

113

Vein embolization (coil)

12

Laborda et al (2013)9,

Spain

202

Vein embolization (coil)

60

Gandini et al (2008)10,

Italy

38

Vein embolization (foam)

12

Kwon et al (2007)11,

Korea

67

Vein embolization (coil)

45

Kim et al (2006)12,

U.S.

127

Vein embolization (foam)

45

a Denotes industry-sponsored or cosponsored trial.

Table 4. Summary of Key Case Series Results for Pelvic Congestion Syndrome

Study

Treatment

Clinical Outcome (at Least Substantial Improvement in Symptoms), %

Hocquelet et al (2014)7,

Vein embolization (foam, coil)

94 (61 complete, 33 partial)

Nasser et al (2014)8,

Vein embolization (coil)

100 (53 complete, 47 partial)

Laborda et al (2013)9,

Vein embolization (coil)

94 (34 complete)a

Gandini et al (2008)10,

Vein embolization (foam)

100

Kwon et al (2007)11,

Vein embolization (coil)

82

Kim et al (2006)12,

Vein embolization (foam)

83

Based on 179 patients who completed the 5-year follow-up.

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, case series and systematic reviews. Relevant outcomes are symptoms and treatment-related morbidity. According to systematic reviews of case series data, approximately 86.6%, 88.1%, and 91.5% of patients have reported some degree of symptom relief 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. It is difficult to draw conclusions from these data because of a lack of a placebo control or comparative data from current alternative interventions. Moreover, definitions of pelvic congestion syndrome vary, making it challenging to define a patient population with symptoms arising from pelvic congestion. Randomized controlled trials using well-defined eligibility criteria and relevant comparators are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements
A fact sheet from the Society for Interventional Radiology on chronic pelvic pain in women endorsed ovarian vein embolization as an effective treatment option for pelvic congestion syndrome.13,

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 5.

Table 5. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

     

NCT03794466

Quantification of Pain Relief With Gonadal Vein Embolization for Pelvic Congestion Syndrome

30

Sep 2020 (recruiting)

NCT03165214

Effectiveness of Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome

52

Sep 2019 (recruiting)

NCT01909024a

Pelvic Embolisation to Reduce Recurrent Varicose Veins - Recurrent

270

Dec 2018 (unknown)

NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.

References: 

  1. Ball E, Khan KS, Meads C. Does pelvic venous congestion syndrome exist and can it be treated? Acta Obstet Gynecol Scand. May 2012;91(5):525-528. PMID 22268663.
  2. Tu FF, Hahn D, Steege JF. Pelvic congestion syndrome-associated pelvic pain: a systematic review of diagnosis and management. Obstet Gynecol Surv. May 2010;65(5):332-340. PMID 20591203.
  3. Brown, CC, Rizer, MM, Alexander, RR, Sharpe, EE, Rochon, PP. Pelvic Congestion Syndrome: Systematic Review of Treatment Success. Semin Intervent Radiol, 2018 Apr 10;35(1). PMID 29628614.
  4. 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. PMID 27318059.
  5. Chung, MM, Huh, CC. Comparison of treatments for pelvic congestion syndrome. Tohoku J. Exp. Med., 2003 Dec 3;201(3). PMID 14649734.
  6. Guirola, JJ, Sánchez-Ballestin, MM, Sierre, SS. 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). PMID 29174618.
  7. Hocquelet A, Le Bras Y, Balian E, et al. Evaluation of the efficacy of endovascular treatment of pelvic congestion syndrome. Diagn Interv Imaging. Mar 2014;95(3):301-306. PMID 24183954.
  8. Nasser F, Cavalcante RN, Affonso BB, et al. Safety, efficacy, and prognostic factors in endovascular treatment of pelvic congestion syndrome. Int J Gynaecol Obstet. Apr 2014;125(1):65-68. PMID 24486124.
  9. 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. PMID 23456353.
  10. Gandini R, Chiocchi M, Konda D, et al. Transcatheter foam sclerotherapy of symptomatic female varicocele with sodium-tetradecyl-sulfate foam. Cardiovasc Intervent Radiol. Jul-Aug 2008;31(4):778-784. PMID 18172712.
  11. 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. PMID 17468903.
  12. Kim HS, Malhotra AD, Rowe PC, et al. Embolotherapy for pelvic congestion syndrome: long-term results. J Vasc Interv Radiol. Feb 2006;17(2 Pt 1):289-297. PMID 16517774.
  13. Society of Interventional Radiology (SIR). Diseases and conditions: Chronic pelvic pain (pelvic congestion syndrome) [Patient Center]. n.d.; https://www.sirweb.org/patients/pelvic-congestion-syndrome--chronic-pelvic- pain/. Accessed July 5, 2019.

Coding Section 

Codes Number Description
CPT 36012 Selective catheter placement, venous system: second order or more selective, branch
  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 01/01/14)
ICD-9 Diagnosis   Investigational for all relevant diagnoses
  625.5 Pelvic congestion syndrome
ICD-9 Procedure 99.29 Injection or infusion of other therapeutic or prophylactic substance
ICD-10-CM (effective 10/01/15)   Investigational for all relevant diagnoses
  N94.89 other specified conditions associated with female genital organs and menstrual cycle.
ICD-10-PCS (effective 10/01/15)   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)
Type of Service    
Place of Service    

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2013 Forward     

01/07/2020 

Annual review, updating title and language to address both embolization and sclerotherapy treatment strategies. Entire policy being updated to encompass that. 

01/15/2019 

Annual review,no change to policy intent. Updating background, rationale and references. 

02/07/2018 

Annual review, no change to policy intent. Updating rationale. 

01/04/2017 

Annual review, no change to policy intent.Updating background, description, regulatory status, rationale and references. 

01/20/2016 

Annual review, no change to policy intent. Updating background, description, guidelines, rationale, references and coding. Add regulatory status. Deleted index. 

01/22/2015 

Annual review, no change to policy intent. Updated guidelines, rationale and references. Added coding.

01/13/2014

Annual review. Added related policies and guidelines. Updated rationale and references. No change to policy intent.

 


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