Pelvic congestion syndrome is characterized by chronic pelvic pain that is often aggravated by standing; diagnostic criteria for this condition are not clearly defined. Endovascular occlusion (eg, 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 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. These data support guideline and international consensus recommendations for endovascular occlusion in this setting. 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 outcome.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Endovascular occlusion of the ovarian vein and internal iliac veins is considered investigational as a treatment of pelvic congestion syndrome.
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CPT |
36012 |
Selective catheter placement, venous system: second order or more selective, branch |
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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 (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles) |
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ICD-10-PCS |
ICD-10-PCS codes are only used for inpatient services. |
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06L00ZZ, 06L03ZZ, 06L04ZZ, 06LB0ZZ, 06LB3ZZ, 06LB4ZZ |
Medical and surgical occlusion of the lower veins (right and left ovarian vein, open, percutaneous, percutaneous endoscopic no device) |
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06LH0ZZ, 06LH3ZZ, 06LH4ZZ |
Medical and surgical occlusion of the lower veins (internal iliac vein, open, percutaneous, percutaneous endoscopic no device) |
| ICD-10-CM | Investigational for all relevant diagnoses | |
| N94.89 | Other specified conditions associated with female genital organs and menstrual cycle |
Endovascular occlusion of the internal iliac and ovarian veins has been performed on an outpatient basis but may require an overnight hospital stay.
Pelvic congestion syndrome is a chronic pelvic pain syndrome of variable location and intensity, which is associated with dyspareunia (which may be aggravated by standing) and symptoms suggestive of a venous origin, such as postcoital ache and tenderness over the ovarian point. The syndrome usually occurs before menopause, and 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 vascular 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.1, 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).2, 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 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.1,
An initial conservative approach to the treatment of pelvic congestion syndrome may involve analgesics (eg, short-term use of nonsteroidal anti-inflammatory drugs) and hormonal therapy, with or without psychotherapy.3,4, 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.4,5, Longer-term efficacy of these treatments has not been demonstrated, and the largest trial of medroxyprogesterone indicated rapid recurrence of symptoms with discontinuation.6, 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.7, 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).
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™ PVA Embolization particles). 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).
