Coverage Policy Manual
Policy #: 2004019
Category: Surgery
Initiated: August 2017
Last Review: June 2022
  Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome

Description:
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 MRI, CT scanning or contrast venography. However, the syndrome is still not well-defined, and it is unclear whether pelvic congestion syndrome causes chronic pelvic pain (Ball, 2012). 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.
 
Initial treatment of pelvic congestion syndrome includes psychotherapy and medical therapy (eg, nonsteroidal anti-inflammatory drugs) and hormonal therapy. For those who fail initial therapy, surgical ligation of the ovarian vein has been considered. Embolization therapy and/or sclerotherapy of the ovarian and internal iliac veins has been proposed as an alternative to surgical ovarian 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).
 
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 (FDA).
 
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 FDA regulation. Several products have been cleared for marketing by the FDA 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 (eg, Cook Incorporated MReye® Flipper®). FDA product code: KRD.
 
In November 2004, the sclerosant agent Sotradecol® (sodium tetradecyl sulfate injection) was approved by the FDA for use in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves (ANDA 040541).
 
There are no specific CPT codes for this procedure. The following nonspecific CPT code may be 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.

Policy/
Coverage:
EFFECTIVE JUNE 2021
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Embolization of the ovarian vein and internal iliac veins does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, embolization of the ovarian vein and internal iliac veins is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EFFECTIVE PRIOR TO JUNE 2021
Embolization of the ovarian vein and internal iliac veins is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, embolization of the ovarian vein and internal iliac veins is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
The published data regarding embolization therapy for pelvic congestion syndrome is inadequate to permit scientific conclusions, due to the lack of standardized diagnostic criteria for pelvic congestion and the lack of controlled trials of embolization therapy. While published studies of embolization state that all patients had ovarian varices, the diagnostic criteria are not provided.  For example, Stones (2003) states that pelvic congestion can be identified when dilated uterine and ovarian veins are present with reduced venous clearance of contrast medium. However, the degree of dilatation defining a varix and the definition of reduced venous clearance are not provided.  In two recent case series, the authors do not detail their diagnostic criteria.  For example, in a case series of 31 patients Maleux and colleagues (2000) do not provide any diagnostic criteria. In their review article, Venbrux and colleagues (1999) also comment on the challenges of imaging ovarian varices; for example, patients are typically imaged in the supine position when the varices may collapse and thus may not be detected.
 
The literature regarding the clinical outcomes of embolization therapy is relatively sparse, consisting entirely of case series, with the largest including 56 patients. In this study Venbrux and colleagues (2002) performed bilateral ovarian vein embolization therapy using gel foam and coils as an inpatient procedure (for postoperative pain control), followed 3 to 10 weeks later by embolization of the internal iliac arteries, performed as an outpatient. The second procedure was performed to reduce the risk of recurrence based on the observation that there was free communication between the ovarian venous plexus and the internal iliac vein tributaries. The study endpoints included technical success and pre and postoperative pain assessment using a visual analog scale. The procedures were considered a technical success in all patients, although in 2 patients the coils inadvertently embolized to the pulmonary circulation where they were retrieved without incident. Recurrences of varices were noted in three patients; two underwent repeat internal iliac vein embolization while the third refused further treatment. In terms of pain control, the mean VAS score fell from 7.8 to 2.7 over a 12 month period. The time to pain improvement was very variable among the women.  Based on a questionnaire completed by 24 of the 56 patients, the menstrual cycle was unchanged. Maleux and colleagues (2000) reported on the results of ovarian vein embolization in 41 patients.  Unlike the Venbrux study above, where the patients underwent bilateral ovarian and internal iliac vein embolization, in this study 32 patients underwent unilateral embolization of the left ovarian vein based on the findings at venography, while the remaining 9 patients underwent bilateral embolization therapy. No patient underwent embolization of the internal iliac vein. The authors reported a technical success rate of 98%. Pain relief was assessed via a questionnaire filled out at variable times after the procedure. The questionnaire asked the patient to rate their pain as very painful, painful, bearable or no pain. There was no formal assessment of pain prior to the procedure. A total of 68.3% of patients reported either partial or complete relief. A variety of other smaller case series report pain relief in from 50-80% of patients (Sichiau,1994; Tarazov,1997; Cordis,1996).
 
2007 Update
Searches of the PubMed database for the periods of April 2004 through December 2005 and January 2006 through June 2007 identified only retrospective studies, most from outside of the United States.
In the largest case series to date, Kim and colleagues (2006) reported results for 127 women treated with bilateral embolotherapy. Ninety-seven patients (76%) completed clinical follow-up (mean duration of 45 months + 18); overall pain scores were reduced from 7.6 to 2.9 (10-point scale).
 
2009 Update
A literature search for the period of July 2007 through May 2009 did not identify any publications on treatment of pelvic congestion syndrome using coils. A review article was identified that described radiological criteria for the diagnosis of pelvic congestion syndrome. (Ganeshan, 2007) Transvaginal or transabdominal ultrasound criteria included: 1) tortuous pelvic veins with a diameter of greater than 6 mm; 2) slow blood flow (about 3 cm/sec) or reversed caudal flow; 3) dilated arcuate veins in the myometrium that communicate between bilateral pelvic varicose veins; and 4) sonographic appearances of polycystic changes of the ovaries.
 
Kwon and colleagues (2007) reported follow-up by telephone interview of women who had undergone unilateral ovarian vein coil embolization for pelvic congestion syndrome; 55 of 67 patients (82%) reported being satisfied with the procedure; the remainder reported no improvement or a worsening of symptoms.  Of note, 2 recent case series from Italy reported successful treatment of pelvic congestion syndrome with transcatheter foam sclerotherapy without use of coils. (Gandini, 2008; Tropeano, 2008)  Although these initial case series suggest that beneficial results may be obtained with a less invasive treatment, controlled studies with longer follow-up are needed. Prospective randomized trials on ovarian and internal iliac vein embolization using a coil are also needed. The available scientific evidence does not permit conclusions concerning the effect of this procedure on health outcomes and the coverage statement is unchanged.
 
2010 Update
 
A literature search was conducted through March 2010.  A recent review article, published by Naoum, a U.S.-based vascular surgeon, states that venography is considered the ‘gold standard’ for diagnosing pelvic congestion syndrome but that other types of diagnostic imaging, e.g., ultrasound, computed tomography, are also used (Naoum, 2009). He adds that a diagnostic algorithm to guide patient management still needs to be developed.
 
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.
 
2012 Update
A literature search was conducted using the MEDLINE database. There was no new information that would prompt a change in the coverage statement.
 
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 (Ball, 2012). 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. The authors recommended a systematic review of evidence on the causal link between pelvic congestion syndrome and chronic pelvic pain, and they stated that, if causation is established, well-designed randomized controlled trials evaluating embolization therapy may be needed (Ball, 2012).
 
2013 Update
A literature search was conducted using the MEDLINE database through May 2013. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
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 (Kies, 2012; Monedero, 2012; Naoum, 2009).
 
Longer-term outcomes after coil embolization for pelvic congestion syndrome were reported by Laborda and colleagues in 2013 (LaBorda, 2013). 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 analogue 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 (Tu, 2010). 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.
 
Randomized controlled trials using well-defined diagnostic criteria are still needed to establish the safety and effectiveness of this procedure.
 
2014 Update
A literature search conducted through May 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Literature review identified two additional largest case series published in the previous 10 years that reported the proportion of patients with improvement in symptoms is as follows (Nasser, 2014; Hocquelet, 2014): Nasser and colleagues (2014) reported results for 113 women with a mean follow-up of 12 months with clinical outcomes (at least substantial improvement in symptoms) of 100% (53% complete, 47% partial). Hocquelet and colleagues (2014) reported results for 33 women with a mean follow-up of 26 months with clinical outcomes (at least substantial improvement in symptoms) of 94% (61% complete, 34% partial).
 
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
A literature search conducted through May 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A systematic review by Mahmoud and colleagues identified 20 case series (total N=1081 patients) who underwent vein embolization for pelvic congestion syndrome (Mahmoud, 2016). The authors did not require any particular diagnostic criteria for pelvic congestion syndrome. The length of follow-up in the studies ranged from 1 month to 6 years. Seventeen studies (n=648 patients) reported the proportion of patients who reported symptom relief. Overall, 571 (88.1%) patients reported short-term symptom relief and 77 (11.9%) reported little or no relief. Seventeen studies (n=721 patients) reported symptom relief at 12 months. A total of 88.6% had symptom improvement and 13.4% reported little or no relief. Only 1 study used a comparison group, but patients in it received conservative treatment because they were ineligible for vein embolization therapy, so outcomes after the 2 interventions cannot be compared.
 
2018 Update
A literature search conducted using the MEDLINE database through May 2018 did not reveal any new information that would prompt a change in the coverage statement.
 
2019 Update
A literature search was conducted through May 2019.  There was no new information identified that would prompt a change in the coverage statement.      
 
2020 Update
A literature search was conducted through May 2020.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A single-center, retrospective cohort analysis by Gavrilov et al in Russia compared the safety and efficacy of embolization with coils (N=67) and endoscopic resection (N=28) in women with pelvic congestion syndrome (Gavrilov, 2020). Effects on pelvic venous pain, pelvic venous reflux, diameter of the pelvic veins, restoration of daily activity, and treatment safety were assessed. Clinical examinations were conducted at 1 day, 10 days, 30 days, and 36 months post-procedure. Pain reduction was observed at 3.6±1.4 days after embolization and 2.5±0.8 days after endoscopic resection (P=0.49). At 1 month post-procedure, complete relief of pelvic pain was reported by 52 (77.6%) patients post-embolization and by 25 (89.3%) patients post-resection (P>0.05). Rates of valvular incompetence decreased from 85% at baseline in both groups to 3% and 0% in the embolization and resection groups at 36 months, respectively. Postembolization syndrome was diagnosed in 13 (19.4%) patients. A 4-fold increased rate of venous thromboembolism was observed in the embolization group. The RR of this complication after embolization compared to resection was 1.4 (95% CI, 1.146 to 1.732). The time to post-embolization pain relief was statistically greater than the time calculated to postoperative pain relief (11.2±1.7 day and 4.7±0.5 days, P=0.0002). Pelvic pain relief was achieved in 95.5% of patients in the embolization group and 100% of patients in the endoscopic resection group at 3 years. The authors note that endoscopic resection is associated with at least similar, and in some cases, superior outcomes, in terms of significantly shorter times to postprocedural pain relief and avoidance of postembolization syndrome. Evidence of selection bias through the use of differing eligibility criteria between groups limits the findings of this study.
 
A study by Liu et al reported a 92% improvement in pain symptoms at 24-36 months following vein embolization (coil) for pelvic congestion syndrome of 12 participants in China (Liu, 2019). 68% reported successful pregnancy following previous infertility.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2022. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
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)

References: Ball E, Khan KS, Meads C.(2012) Does pelvic congestion syndrome exist and can it be treated? Acta Obstet Gynecol Scand 2012 [Epub ahead of print].

Cordis PR, Eclavea A, et al.(1998) Pelvic congestion syndrome: Early clinical results after transcatheter ovarian vein embolization. J Vasc Surg 1998; 28:862-68.

Gandidn R, Chiocchi M, et al.(2008) Transcatheter foam sclerotherapy of symptomatic female varicocele with sodium tetradecyl-sulfate foam. Cardiovasc Intervent Radiol, 2008; 31(4):778-84.2007

Ganeshan A, Upponi S, et al.(2007) Chronic pelvic pain due to pelvic congestion syndrome: the role of diagnostic and interventional radiology. Cardiovasc Intervent Radiol, 2007; 30:1105-11.

Gavrilov SG, Sazhin A, Krasavin G, et al.(2020) 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. PMID 32464289

Hocquelet A, Le Bras Y, Balian E et al.(2014) Evaluation of the efficacy of endovascular treatment of pelvic congestion syndrome. Diagn Interv Imaging 2014; 95(3):301-6.

Kies DD, Kim HS.(2012) Pelvic congestion syndrome: a review of current diagnostic and minimally invasive treatment modalities. Phlebology 2012; 27(Suppl 1):52-7.

Kim HS, Malhotra AD, et al.(2006) Embolotherapy for pelvic congestion syndrome: long-term results. J Vasc Interv Radiol, 2006; 17(2 Pt 1):289-97.

Kwon SH, Oh JH, et al.(2007) Transcatheter ovarian vein embolization using coils for the treatment of pelvic congestion syndrome. Cardiovasc Intervent Radiol, 2007; 30(4):655-61.

Laborda A, Medrano J, de Blas I et al.(2013) 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].

Liddle AD, Davies AH.(2007) Pelvic congestion syndrome: chronic pelvic pain caused by ovarian and internal iliac varices. Phlebology, 2007; 22(3):100-4.

Liu J, Han L, Han X.(2019) 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. PMID 30660471

Mahmoud O, Vikatmaa P, Aho P, et al.(2016) Efficacy of endovascular treatment for pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. Jul 2016;4(3):355-370. PMID 27318059

Maleux G, Stockx L, et al.(2000) Ovarian vein embolization for the treatment of pelvic congestion syndrome: Long term technical and clinical results. J Vasc Interven Radiol 2000; 11:859-64.

Monedero JL, Ezpeleta SZ, Perrin M.(2012) Pelvic congestion syndrome can be treated operatively with good long-term results. Phlebology 2012; 27 Suppl 1:65-73.

Naoum JJ.(2009) Endovascular therapy for pelvic congestion syndrome. Methodist Debakey Cardiovasc J 2009; 5(4):36-8.

Nasser F, Cavalcante RN, Affonso BB et al.(2014) Safety, efficacy, and prognostic factors in endovascular treatment of pelvic congestion syndrome. Int J Gynaecol Obstet 2014; 125(1):65-8.

Nicholson T, Basile A.(2006) Pelvic congestion syndrome: who should we treate and how? Tech Vasc Interv Radiol, 2006; 9(1):19-23.

Shokeir T, Amr R, Abdelshaheed M.(2009) The efficacy of Implanon for the treatment of chronic pelvic pain associated with pelvic congestion: 1-year randomized controlled pilot study. Arch Gynecol Obstet, 2009; Feb 4 [Epub ahead of print].

Sichlau MU, Yao JST, et al.(1994) Transcatheter embolotherapy for the tratment of pelvic congestion syndrome. Obstet Gynecol 1994; 83:892-96.

Stones RW.(2003) Pelvic vascular congestion - Half a century later. Clin Obstet Gynecol 2003; 46:831-36.

Tarazov PB, Prozorovakji KV, et al.(1997) Pelvic pain syndrome caused by ovarian varices: treatment of transcatheter embolization. Acta Rad 1997; 98:1023-25.

Tropeano G, Di Stasi C, et al.(2008) Ovarian vein incompetence: a potential cause of chronic pelvic pain in women. Eur J Obstet Gynecol Reprod Biol, 2008; 139(2):215-21.

Tu FF, Hahn D, Steege JF.(2010) Pelvic congestion syndrome-associated pelvic pain: a systematic review of diagnosis and management. Obstet Gynecol Surv 2010; 65(5):332-40.

Venbrux AC, Chang AH, et al.(2002) Pelvic congestion syndrome (pelvic venous incompetence): Impact of ovarian and internal iliac vein embolotherapy on menstrual cycle and chronic pelvic pain. J Vas Inter Radilo 2002; 13:171-78.

Venbrux AC, Lambert DL.(1999) 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; 11:395-99.


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