| Coverage Policy Manual | |
| Policy #: | 2004019 |
| Category: | Surgery |
| Initiated: | August 2017 |
| Last Review: | September 2024 |
|
|
|
|||||||||||
| 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 (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 (Knuttinen, 2023). 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) (Meissner, 2021). 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 (Knuttinen, 2023).
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 (Borghi, 2016; Bendek, 2020). 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 (Bendek, 2020; Tu, 2010). Longer-term efficacy of these treatments has not been demonstrated, and the largest trial of medroxyprogesterone indicated rapid recurrence of symptoms with discontinuation (Farquhar, 1989). 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 (Antignani, 2019). 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).
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 (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 [EOS]) 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 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.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Tu et al published a systematic review of literature on the diagnosis and management of pelvic congestion syndrome (Tu, 2010). The authors 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.
Emad el din et al performed a randomized trial comparing surgical ovarian vein ligation under spinal or general anesthesia (n=25) with endovascular coil embolization under spinal or local anesthesia (n=25) in patients with pelvic congestion syndrome (criteria included chronic pelvic pain with an ovarian vein diameter greater than 6 mm and moderate to severe congestion of the ovarian plexus) who had not experienced improvement with unspecified (non-surgical/embolization) medical management (Emad El Din, 2023). Patients who were nulliparous, aged >55 years, or deemed unfit for surgery were excluded. Outcomes including VAS pain score (possible responses ranging from 0 to 10) and ultrasound assessment of varicosities and reflux were evaluated. No differences between groups in baseline characteristics were reported; median VAS pain score at pre-operative baseline was 9 in both groups (range, 7-10 in the surgical group, 8-10 in the embolization group; p=.71). At 1 week post-operatively, median VAS pain score was reduced to 2 in the surgical group and 1 in the embolization group (p ≤ .001 for within-group pre-post comparison; p=.006 for between-group comparison). However, although patients were followed for 3 months, subsequent clinical outcomes and complication rates were not reported; the authors stated that no procedural complications were recorded.
A multicenter, retrospective, cohort study by Gavrilov et al compared the efficacy of gonadal vein coil embolization under local anesthesia (n=177) with open or endoscopic (transperitoneal or retroperitoneal) gonadal vein resection under general anesthesia (n=184) in patients with pelvic venous disorder-associated chronic pelvic pain (Gavrilov, 2023). Patients with signs and symptoms of pelvic venous disease (chronic pelvic pain, dyspareunia, discomfort and/or heaviness in the hypogastric region, vulvar varicose veins) and pelvic reflux (>1 second in the gonadal, parametrial, and/or uterine veins on duplex ultrasound) were included. Patients who had ultrasound or venographic evidence of nutcracker syndrome or May-Thurner syndrome or who underwent hybrid interventions on the gonadal and iliac or pelvic veins and organs were excluded. The authors stated that no special criteria dictated choice between resection and embolization for most patients; however, patients with a gonadal vein diameter ≥10 mm only underwent resection. Outcomes included patient-reported relief from chronic pelvic pain and change in post-operative VAS pain scores from pre-operative baseline at various time points, as well as rate of recurrence of signs/symptoms of pelvic venous disorder accompanied by imaging evidence of reflux at the site of intervention. Pre-operative characteristics were similar between groups, with the exception of clinical-etiologic-anatomic-pathophysiologic class 2 to 3 chronic lower extremity venous disease, which was more prevalent in the resection group (22%) than the embolization group (11%; p<.001). The rate of reported relief from chronic pelvic pain at 1 month was higher in the resection group (100%) than the embolization group (74%; p<.001). At 1 month post-operatively, VAS pain score was significantly lower in the resection group (mean 1.1 from baseline 6.1) than in the embolization group (mean 4.1 from baseline 6.3; p<.001 for between-group comparison). The authors attributed the initial differences in chronic pelvic pain relief and VAS pain scores to patients in the embolization group who experienced post-embolization syndrome. At 5 years post-operatively, VAS pain scores were not significantly different between the resection (mean 1.7) and embolization groups (mean 2.1; p=.8). Complications within 30 days of the procedure were reported in 14% of resection patients and consisted primarily of pelvic vein thrombosis (11%), with 2 cases of deep vein thrombosis and 1 case of post-operative ileus reported. In the embolization group, Society of Interventional Radiology class C/D (major) complications were reported in 5%, including pelvic or uterine vein thrombosis, deep vein thrombosis, and coil protrusion; class A/B (minor) complications were reported in 37%. Post-embolization syndrome, characterized by pain over the embolized vein, fever, fatigue, and malaise, was reported in 20% of embolization patients, lasting between 5 and 23 days. Recurrence was reported in 6% of the resection group and 16% of the embolization group over the course of the study (p<.05), with mean time to recurrence of 29.2 months and 17.1 months, respectively.
Chen et al performed a retrospective cohort study of patients with pelvic congestion syndrome (based on symptom screening and transvaginal ultrasound or computed tomography venography demonstrating pelvic vein diameter > 6 mm and/or venous reflux or communicating veins) who underwent proximal coil occlusion of the refluxing vein followed by distal foam sclerotherapy (PCODS; n=94) vs standard coil embolization technique (control; n=53), both under local anesthesia, at 2 centers (Chen, 2023). The primary endpoint was clinical remission (defined as relief of dysmenorrhea, dyspareunia, and/or urinary urgency, and a decrease in VAS pain score of ≥4 points from baseline) at 12 months post-procedure. The authors' per-protocol analysis (which excluded 3 and 2 patients who were lost to follow-up prior to 12 months in the PCODS and control groups, respectively) is reported for this review based on the small difference in sample size compared to the intention-to-treat analysis (N=147 vs 152), similar reported results between analyses, and a lack of description of how missing data were treated in the intention-to-treat analysis. No significant differences were identified in baseline characteristics between groups. At 12 months post-operatively, clinical remission rates in the PCODS and control groups were 86.2% and 71.7%, respectively (p=.032). The authors reported coil migration that did not require intervention in 2 patients in the control group; no other safety outcomes were reported.
Shahat et al reported a single-center, retrospective study of patients with pelvic congestion syndrome (N=40) treated via ovarian vein foam embolization under local anesthesia between 2019 and 2021 (Shahat, 2023). Premenopausal patients with chronic pelvic pain attributed to pelvic congestion syndrome (based on relation to menses, sexual intercourse, prolonged sitting/standing, and relief when lying down, as well as venographic evidence of ovarian vein incompetency) were included. Endpoints included pre- and post-operative VAS pain scores for 6 domains (up to 12 months) and pelvic congestion syndrome recurrence (defined as ultrasound evidence of pelvic varices and/or return of VAS pain score to pre-operative baseline). Compared to pre-operative baseline, statistically significant reductions in VAS pain score for pelvic and leg pain (both scored separately when lying and standing), dyspareunia, and pain with menses were noted at 12 months (specific p-values not reported); significant changes were noted as early as 1 month for most pain domains, except for pelvic pain when lying and leg pain when lying. One recurrence was reported during 12-month follow-up. Complications were reported in 20%, including post-procedural pain (15%), contrast allergy (2.5%), and segmental and subsegmental pulmonary embolism (2.5%).
Sozutok et al reported a single-center, retrospective study of patients with chronic pelvic pain with imaging evidence of pelvic congestion syndrome (enlarged [>6 mm] pelvic veins and/or significant reflux on abdominal computed tomography, or pelvic venous dilatation and/or reflux on diagnostic angiography; N=144) who underwent ovarian vein embolization via coil (n=47) with or without other materials (VP and/or foam; n=97) between 2012 and 2020 (Sozutok, 2022). The study endpoint was change from pre-operative baseline in VAS pain scores up to 12 months, defined as unsuccessful (<50% reduction from baseline), successful (50-80% reduction from baseline), or very successful (>80% reduction from baseline). Baseline mean VAS pain score (possible scores ranging from 0-100) was 35.46; at 3-month follow-up (n=131), mean VAS pain score was 14.68, corresponding to rates of successful and very successful pain management of 38.1% and 25.6%, respectively. At 12-month follow-up (n=84), mean VAS pain score was 14.14, but success rates were not reported at this timepoint. The authors found that patients who underwent coil embolization alone were significantly more likely to achieve successful pain reduction than those undergoing procedures involving additional embolization materials (p=.036). Complication rates were not reported.
Jambon et al reported a single-center, prospective study of patients with imaging diagnoses of non-compressive (non-nutcracker or Crockett syndrome) pelvic venous disorders (N=73) who underwent foam embolization of incompetent pelvic veins (defined by reflux and dilatation with diameter >5 mm) (Jambon, 2022). Endpoints included clinical efficacy, defined as partial (VAS global impairment score improvement by ≥50% from pre-operative baseline to a score <40 out of 100) or complete improvement (VAS impairment score of 0) at 3-month follow-up, and improvement in VAS global impairment score from baseline at the end of follow-up. Median duration of follow-up was 28 months (range, 18.1 to 34.5 months). At 3 months post-operatively, clinical efficacy was achieved in 95.9%, with complete and partial improvement in 30.1% and 65.8%, respectively. Mean VAS global impairment score at the end of follow-up was significantly improved compared to pre-operative baseline (6.52 vs 37.93; p<.0001). Significant improvements were also noted in mean VAS score at the end of follow-up compared to baseline for chronic pelvic pain (1.01 vs 6.07; p<.0001) and dyspareunia (0.81 vs 3.84; p<.0001). No complications were reported during the procedure, while 4 mild complications (3 patients with post-embolization syndrome lasting up to 1 month and 1 case of transitory radiculalgia) were reported post-operatively; no major post-operative complications occurred.
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 (Antignani, 2019). Key consensus statements include:
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 (Gloviczki, 2011). 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."
Additional 2024 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Portions of the 2011 Society for Vascular Surgery and American Venous Forum guidelines were updated most recently in 2023, although there was no mention of pelvic congestion syndrome (Gloviczki, 2024).
|
|
|
|
| CPT/HCPCS: | |
|
|
|
| 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. |
|
|
|
|
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
|