Medical Policy: 02.01.62
Original Effective Date: May 2021
Reviewed: May 2021
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
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. 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. 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 (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 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).
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 relevant population of interest is patients with pelvic congestion syndrome.
The therapies being considered are ovarian and internal iliac vein endovascular occlusion.
The following therapies are currently being used to make decisions about pelvic congestion syndrome: medical therapy (e.g., analgesics, hormonal therapy) and surgical ovarian vein ligation.
The general outcomes of interest are symptom reduction and adverse events. Procedural follow-up ranges from 1 to 3 months.
Mahmoud et. al., in 2016 identified 20 case series (total N=1081 patients) assessing endovascular treatment for pelvic congestion syndrome. 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 2 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). 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 that evaluated the efficacy of various treatments for pelvic congestion syndrome that had failed 4-6 months of treatment with medroxyprogesterone acetate (N=106). However, this study compared ovarian vein coil embolization to hysterectomy with bilateral or unilateral oophorectomy and was therefore not assessed separately as evidence.
Guirola et. al., in 2018 in a randomized, prospective trial compared the safety and efficacy of embolization with vascular plugs (VPs) or fibered platinum coils (FPCs) in women with pelvic congestion syndrome. 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.
In 2020, Gavrilov et. al. in a single-center, retrospective cohort analysis compared the safety and efficacy of embolization with coils (N=67) and endoscopic resection (N=28) in women with pelvic congestion syndrome. 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.
In regard to the treatment of pelvic congestion syndrome, the evidence consists of systematic reviews, randomized studies, comparative studies, and case series. A retrospective analysis comparing coil embolization to endoscopic resection determined that resection is associated with significantly shorter times to postprocedural pain relief and avoidance of postembolization syndrome. Moreover, definitions of pelvic congestion syndrome vary, making it difficult to define a patient population with symptoms arising from pelvic congestion. RCTs with well-defined eligibility criteria and relevant comparators are needed.
For individuals who have pelvic congestion syndrome who receive ovarian and/or internal iliac vein endovascular occlusion, the evidence includes randomized studies, comparative studies, case series and systematic reviews. 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 determined that resection is associated with significantly shorter times to postprocedural pain relief and avoidance of postembolization syndrome. 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 net health outcomes.
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 (e.g., 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 (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®). FDA product code:
Endovascular occlusion of the ovarian vein and internal iliac veins is considered investigational as a treatment of pelvic congestion syndrome because the evidence is insufficient to determine the effects of the technology on net health outcomes.
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