Pelvic Congestion Syndrome: Treatments

Number: 0441

Table Of Contents

Policy Applicable CPT / HCPCS / ICD-10 Codes Background References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses pelvic congestion syndrome: treatments.

1. Medical Necessity

   Aetna considers embolization (e.g., using metallic coils or foam/gel sclerotherapy) of gonadal veins or ovarian veins, with or without the internal iliac veins, medically necessary for the treatment of pelvic congestion syndrome (PCS) when both of the following criteria are met:

   1. The member has had a definitive diagnostic venography, computed tomography (CT) or magnetic resonance imaging (MRI); and
   2. The member has failed a trial of appropriate pharmacotherapy (e.g., analgesics, hormonal therapy).

   Aetna considers gonadal vein or ovarian vein embolization for the treatment of PCS experimental, investigational, or unproven when criteria are not met.

2. Experimental, Investigational, or Unproven

   The following interventions are considered experimental, investigational, or unproven because the effectiveness of these approaches has not been established:

   1. Sacral nerve root neuromodulation for the treatment of chronic pelvic pain;
   2. Median sacral vein embolization for the treatment of PCS because of insufficient evidence;
   3. The use of micronized purified flavonoid fraction for the treatment of pelvic congestion syndrome.

3. Related Policies

   • CPB 0050 – Varicose Veins
   • CPB 0754 – Uterine Nerve Ablation (UNA) and Presacral Neurectomy (PSN)

Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code Code Description

Information in the [brackets] below has been added for clarification purposes. &nbspCodes requiring a 7th character are represented by “+”:

CPT codes covered if selection criteria are met:

36245 Selective catheter placement, arterial system; each first order abdominal, pelvic, or lower extremity artery branch, within a vascular family 36246 initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family 36247 initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family + 36248 additional second order, third order, and beyond, abdominal, pelvic, or lower extremity artery branch, within a vascular family (List in addition to code for initial second or third order vessel as appropriate) 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) [including gonadal vein embolization] [not covered for median sacral vein embolization] 75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation 75898 Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis

CPT codes not covered for indications listed in the CPB:

64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed 64581 Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)

HCPCS codes not covered for indications listed in the CPB:

A4290 Sacral nerve stimulation test lead, each

Other HCPCS codes related to the CPB:

J1110 Injection, dihydroergotamine mesylate, per 1 mg J1950 Injection, leuprolide acetate (for depot suspension), per 3.75 mg J9202 Goserelin acetate implant, per 3.6 mg J9217 Leuprolide acetate (for depot suspension), 7.5 mg J9219 Leuprolide acetate implant, 65 mg S0132 Injection, ganirelix acetate, 250 mcg

ICD-10 codes covered if selection criteria are met:

Xem thêm : Ketchup, Interrupted

N94.89 Other specified conditions associated with female genital organs and menstrual cycle [pelvic congestion syndrome]

Trans-Venous Occlusion:

CPT codes covered if selection criteria are met:

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) [metallic coils or foam/gel sclerotherapy]

ICD-10 codes covered if selection criteria are met:

Xem thêm : Ketchup, Interrupted

N94.89 Other specified conditions associated with female genital organs and menstrual cycle [pelvic congestion syndrome]

Micronized purified flavonoid fraction:

HCPCS codes not covered if selection criteria are met:

Micronized purified flavonoid fraction – no specific code

ICD-10 codes not covered if selection criteria are met:

Xem thêm : Ketchup, Interrupted

N94.89 Other specified conditions associated with female genital organs and menstrual cycle [pelvic congestion syndrome]

Background

Pelvic congestion syndrome (PCS), also called pelvic venous incompetence (PVI), may be one of many causes of chronic pelvic pain (CPP). CPP is described as continuous or intermittent noncyclic pain, localized to the pelvic region, which lasts for six or more months.

PCS may occur when valves within the pelvic veins weaken and cause blood to flow backward and pool, similar to varicose veins in the legs. Blood pooling in pelvic or ovarian veins may result in engorgement or thrombosis, causing pain and discomfort. Risk factors associated with PCS include congestion of veins in the lower extremities, hormonal imbalance, multiple pregnancies and polycystic ovarian disease. Symptoms of pelvic congestion syndrome include the following:

• Continuous or recurring pain for at least six months
• Initial sensation of fullness or heaviness, which can increase to severe pain, including during or after menstruation or intercourse
• Pelvic pain that worsens toward the end of the day or after long periods of time standing
• Persistent lower back pain
• Vaginal discharge.

Pelvic congestion syndrome is manifested by pelvic pain of variable intensity, that is heightened before or during menses and that is aggravated by prolonged standing, fatigue and intercourse. Laparoscopic and venographic evidence of varicosities confirm the diagnosis of PCS. The traditional therapy for PCS includes both medical approaches (e.g., dihydroergotamine, ovarian suppression, and rheologic agents) and surgical approaches (e.g., hysterectomy, uterine ventro-suspension, ovarian vein ligation, and excision).

Ovarian vein embolization is a minimally invasive treatment alternative for PCS. The technique, usually performed by an interventional radiologist, involves threading a catheter, guided by fluoroscopic X-ray imaging, through the groin to the ovarian veins. If the imaging reveals a cluster of serpentine veins, tiny stainless steel coils and/or absorbable sponges, or liquids such as glue are passed through the catheter into the ovarian vein, forming a clot that subsequently blocks the accumulation of blood in the varices. Careful selection of patients and use of appropriate angiographic and technical skills by the interventional radiologist are requisite for the success of this therapeutic alternative.

Smith (2012) stated that PCS is one of many causes of chronic pelvic pain. It is generally accepted that this is attributable to ovarian and pelvic vein incompetence that may result in varices in the lower limb leading to presentation in varicose vein clinics. However, far more patients have pelvic varices associated with varicose veins in the lower limb than have PCS. Magnetic resonance imaging and computed tomographic venography are usually used in the diagnosis of this condition and criteria have been established to identify pelvic varices. Many different treatments have been used to manage the symptoms of pelvic congestion. Hysterectomy combined with oophrectomy, open surgical ligation of ovarian veins and laparoscopic vein ligation have been used in the past. The most common treatments used currently involve embolization of pelvic and ovarian veins. The results of this treatment have been published in a limited number of clinical series, usually with fairly short follow-up periods. These treatments may be complicated by migration of embolization of coils used to occlude veins. The longest duration of follow-up currently reported is 5 years. Limited clinical evidence supports the use of embolotherapy in the management of PCS.

Mahmoud and associates (2016) described the technique of transcatheter embolization, the complications thereof and the clinical results of the treatment for PCS. These researchers performed a literature search using PubMed, Science Direct, Google Scholar, and Scopus to identify case series on the endovascular treatment of PCS up until the end of November 2014. A total of 20 studies (1,081 patients) were included in the review. There were no randomized trials, and only 1 study included a control group. The immediate technical success rate in the occlusion of the affected veins was 99 %; 17 studies reported the 1- to 3-month clinical success of 641 patients. Of these, 88.1 % reported moderate-to-significant relief in the symptoms, and 11.9 % reported little or no relief. In 17 studies, long-term results were reported, and the follow-up varied between 7.3 months and 5 years. In late follow-up, 86.6 % reported relief of the symptoms and 13.6 % experienced little or no relief. The authors concluded that the immediate success rate for the endovascular treatment of PCS was good and the complication rate low. Most patients reported relief in the symptoms for up to 5 years after the procedure. However, there are no randomized or high-quality controlled trials, and the level of evidence therefore remains at C.

Trans-Venous Occlusion of Pelvic Vein Incompetence

Hansrani et al (2015) stated that chronic pelvic pain (CPP) affects 24 % of women worldwide; the cause cannot be identified in 40 % despite invasive investigations. Dilated, refluxing pelvic veins may be a cause of CPP and treatment by trans-venous occlusion is increasingly performed when gynecological causes are excluded, but is it effective? These investigators performed a systematic review of the literature published between 1966 and July 2014. Two authors independently reviewed potential studies according to a set of eligibility criteria, with a third assessor available as an arbiter. A total of 13 studies including 866 women undergoing trans-venous occlusion of pelvic veins for CPP were identified (Level of evidence: 1 study grade 2b, 12 studies grade 4). Statistical significant improvements in pelvic pain were reported in 9 of the 13 studies. Technical success was reported in 865 of 866 (99.8 %) with low complication rates: coil migration in 14 women (1.6 %), abdominal pain in 10 women (1.2 %) and vein perforation in 5 (0.6 %). In a study on varicose veins of the legs, recurrence was seen in 13 % of 179 women 5-years following coil embolization. Subjective improvements in pain were seen in all 13 studies after treatment by trans-venous occlusion. All 13 studies were of poor methodological quality. Complication rates were low and no fatalities occurred. The authors concluded that well-designed studies are needed to examine if pelvic vein incompetence (PVI) is associated with CPP, and to explore whether trans-venous occlusion of PVI improves quality of life for these women.

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An UpToDate review on “Vulvovaginal varicosities and pelvic congestion syndrome” (Johnson, 2015) states that, in patients with PCS and vulvar varices, the authors suggest treatment of ovarian vein reflux first. This generally leads to reduction in the size of vulvar varicosities. Local sclerotherapy can be performed subsequently, if needed.

Sacral Nerve Root Neuromodulation

An UpToDate review on “Treatment of chronic pelvic pain in women” (Barbieri, 2017) states, regarding sacral nerve root neuromodulation, that “In general, neuromodulation for CPP has not been well-studied. Sacral nerve root neuromodulation for bladder related symptoms and pain is the best studied technique, but all trials are observational. A review of published case series suggests a 40 to 60 % rate of improvement in pelvic pain symptoms after placement of either unilateral or bilateral lead placement [citing Mayer and Howard, 2008). Follow-up has been up to 3 years in some series. There is some information on laparoscopic intra-abdominal placement of a neuroprosthesis for CPP, but this work is still early in development and has not been widely used”.

Embolization of Insufficient Pelvic Veins for Pelvic Congestion Syndrome

Drazic and colleagues (2019) stated that PVI may cause PCS that is characterized by chronic pelvic pain exacerbated by prolonged standing, sexual activity or menstrual cycle. It may be treated by embolizing the dysfunctional pelvic venous drainage and sometimes resecting vulvar, perineal and thigh varices. These researchers evaluated the results of embolization of insufficient pelvic or ovarian veins on PCS. Analysis of 17 women aged 32 to 53 years, who underwent a selective coil embolization of insufficient pelvic and/or ovarian veins via the jugular, basilic or cephalic veins. In the pre-operative period, all patients had a lower extremity venous duplex pelvic ultrasound (US) examination and some had an abdominal and pelvic CT angiogram. The technical success of the procedure was 100 % and no complications were registered. During a 32-month follow-up, no patient had symptoms of PVI or relapse of vulvar or thigh varices. The authors concluded that embolization of insufficient pelvic and ovarian veins was a safe and successful procedure for the treatment of PVI or vulvar varices.

Gonadal Vein Embolization

Whiteley and associates (2018) stated that pelvic vein embolization is increasing in venous practice for the treatment of conditions associated with pelvic venous reflux. In July 2014, these investigators introduced a local anesthetic “walk-in walk-out” pelvic vein embolization service situated in a vein clinic, remote from a hospital. They carried out a prospective audit of all patients undergoing pelvic vein embolization for pelvic venous reflux. All patients had serum urea and electrolytes tested before procedure. Embolization coils used were interlock embolization coils as they can be re-positioned after deployment and before release. These researchers noted the following – complications during or post-procedure; successful abolition of pelvic venous reflux on transvaginal duplex scanning; and the number of veins (territories) treated and number of coils used. In 24 months, a total of 121 patients underwent pelvic vein embolization; 3 men were excluded as transvaginal duplex scanning was impossible and 6 women were excluded due to lack of complete data. None of these 9 excluded subjects had any complications. Of 112 women analyzed (mean age of 45 years; range of 24 to 71), 104 were for leg varices, 48 vulval varices and 20 for PCS (some had more than 1 indication). There were no deaths or serious complications to 30 days; 2 procedures were abandoned, 1 completed subsequently and 1 was technically successful on review; 1 more had transient bradycardia and 1 had a coil removed by snare during the procedure. The mean number of venous territories treated was 2.9 and a mean of 3.3 coils was used per territory. The authors concluded that pelvic vein embolization of gonadal and internal iliac veins under local anesthetic was safe and technically effective in a remote out-patient facility outside of a hospital.

Gavrilov and co-workers (2020) examined the effect of various endovascular interventions on the clinical manifestations of PCS caused by May-Thurner syndrome (MTS). A total of 12 female patients with PCS caused by MTS were included in this trial. Patients were examined by duplex US, CT of the pelvic veins, and ovarian and pelvic venography. All 12 patients underwent endovascular stenting of the left common iliac vein (CIV), and 10 of them underwent subsequent endovascular embolization of the left gonadal vein. The indication for stenting was the presence of stenosis (greater than 50 %) of the CIV with clinical symptoms and signs of PCS. Self-expanding stents (Wallstent, 14 to 16 mm × 60 to 90 mm) were used. Patients with persistent symptoms of PCS after stenting underwent gonadal vein embolization with MReye metal coils (diameter, 10 to 15 mm; length, 10 to 20 cm). Technical success of stenting, namely, the restoration of normal patency of the left CIV, was achieved in 12 patients. In 2 patients, a stent was displaced toward the inferior vena cava, which required implantation of a 2nd stent. In another patient, the stent was displaced into the inferior vena cava at 6 months after the intervention, which was not associated with any complication during the follow-up period. The mean venous pelvic pain severity score decreased from 7.7 ± 0.8 at baseline to 4.8 ± 0.3 after 1 month and stayed at this level during the 6-month follow-up period. Complete elimination of PCS symptoms at 6 months after stenting was achieved in 2 patients, and 10 patients underwent embolization of the left gonadal vein 6 months after stenting because of persistent pelvic pain. The authors concluded that endovascular stenting of the left CIV was an effective technique for relieving symptoms of PCS due to MTS in only 16.6 % of patients. Stenting of the left CIV in combination with embolization of gonadal veins resulted in elimination of the signs of PCS in 83.4 % of patients. These researchers stated that probably only gonadal vein embolization can be used in the treatment of MTS-related PCS.

Gavrilov and colleagues (2021) compared the safety and efficacy of endovascular and endoscopic interventions on the gonadal vein in the treatment of patients with PCS. These researchers examined the treatment outcomes in 95 patients with PCS who underwent endovascular embolization of gonadal veins (EEGV) (group 1, n = 67) or endoscopic resection of the gonadal veins (ERGV) (group 2; n = 28). A comparative analysis of the safety and efficacy of EEGV and ERGV in the treatment of PCS included assessments of their effects on pelvic venous pain, pelvic venous reflux, diameter of the pelvic veins, and restoration of daily activity, as well as treatment safety assessment. Clinical examinations and US studies of the pelvic veins were repeated at 1, 10, and 30 days, and 36 months after EEGV and ERGV. Pain was evaluated using a visual analog scale (VAS) and the Von Korff questionnaire. A decrease in pelvic venous pain intensity was observed at 3.6 ± 1.4 days after EEGV and 2.5 ± 0.8 days after ERGV (p = 0.49 between the groups). At 1 month after the intervention, a complete relief of pelvic pain was reported by 52 and 25 patients in the EEGV and ERGV groups, respectively. The rates of valvular incompetence of the uterine veins were decreased from 85 % in both groups at baseline to 3 % in group 1 and 0 % in group 2 at 36 months after the intervention, respectively. In the early post-procedural period, pain in the femoral or jugular vein puncture site was reported by 8 patients (12 %) who underwent EEGV (2.2 ± 0.7 scores). Post-embolization syndrome was diagnosed in 13 patients (19.4 %). After ERGV, all patients experienced pain in the area of the surgical wound, with a severity of 3.9 ± 0.5 scores. Hematoma at the puncture site of the main vein was observed in 6 % of patients after EEGV. Protrusion of coils was identified in 3 patients (4.5 %). The incidence of venous thromboembolism (VTE) was 4 times greater in group 1 versus group 2 (14 versus 3 patients; p < 0.05). The relative risk (RR) of this complication after EEGV was 1.4 (95 % confidence interval [CI]: 1.146 to 1.732). In 2 patients (7.1 %) after the bilateral laparoscopic resection of the gonadal veins, an ileus developed. No complications of anesthesia were observed in either group. The authors concluded that endovascular and endoscopic techniques for decreasing blood flow through the gonadal veins were safe and effective in treating the PCS. The obvious advantages of EEGV were minimal injury and possibility to perform procedure under local anesthesia. The ERGV was associated with at least similar and, in some cases, even superior outcomes, in terms of significantly (p < 0.05) shorter time to the post-procedural pain relief and avoiding post-embolization syndrome.

Furthermore, an UpToDate review on “Vulvovaginal varicosities and pelvic congestion syndrome” (Johnson, 2021) states that “The nutcracker syndrome results from compression of the left renal vein at the origin of the superior mesenteric artery. This entrapment can cause symptoms of pelvic venous congestion with retrograde venous flow and a dilated gonadal vein. Treatment can be targeted at the renal vein, gonadal vein, or both. Options include embolization of the gonadal veins, laparoscopic gonadal vein ligation, and/or treatment of the renal vein compression”.

Median Sacral Vein Embolization

Hasjim and colleagues (2020) stated that PCS is defined as non-cyclical pelvic pain or discomfort caused by dilated para-uterine, para-ovarian, and vaginal veins; and is characterized by ovarian venous incompetence that may be due to pelvic venous valvular insufficiency, hormonal factors, or mechanical venous obstruction. These investigators described the case of a 38-year old multi-parous woman with a history of pelvic pressure, vulvar varices, and dyspareunia. She underwent left gonadal vein coil embolization in 2014 for PCS that resulted in symptomatic relief of her pain. Four years later, the patient returned for recurrent symptoms, and magnetic resonance venography (MRV) demonstrated dilated pelvic varices. The previously embolized left gonadal vein remained thrombosed, and there was no evidence of right gonadal vein insufficiency; however, catheter-based venography revealed a large, dilated, and incompetent median sacral vein. Pelvic venography demonstrated left gonadal vein embolization without any evidence of reflux. The right gonadal vein was also non-dilated without reflux. Internal iliac venography showed large cross-pelvic collaterals and retrograde flow via a large, dilated median sacral vein. Coil embolization of the median sacral vein resulted in a dramatic reduction of pelvic venous reflux and resolution of symptoms. The authors concluded that recurrence of PCS could occur after ovarian vein embolization via other tributaries in the venous network. The median sacral vein is a rare cause of PCS.

Furthermore, an UpToDate review on “Vulvovaginal varicosities and pelvic congestion syndrome” (Johnson, 2021) does not mention median sacral vein embolization as a management / therapeutic option.

Micronized Purified Flavonoid Fraction

Akhmetzianov and Bredikhin (2021) noted that PCS may be effectively managed with conservative treatment in certain patients. Treatment with veno-active drugs is common, but supportive data are limited. In a single-blind, placebo-controlled study, these researchers examined the effectiveness of micronized purified flavonoid fraction (MPFF), a veno-active agent, in women with PCS. This trial included women with Duplex US diagnosis of pelvic varicose veins (PVV) and PCS were randomized to MPFF 1,000 mg once-daily or placebo for 2 months. Clinical manifestations of PCS were assessed at baseline and end of treatment (M2) using 3 assessment tools: disease-specific quality of life (QOL), Pelvic Varicose Vein Questionnaire (PVVQ), Pelvic Venous Clinical Severity Score (PVCSS), and the VAS for the main symptoms of the disease. A total of 83 women were included, 42 received MPFF and 41 received placebo. In the MPFF group, the mean global PVVQ QOL index decreased significantly from 45.1 ± 14.7 at baseline to 36.6 ± 10.6 at M2 (mean change of 8.2 ± 10.4); no significant change was observed in the control group (mean change of – 0.3 ± 4.0). The between-group difference was statistically significant (p < 0.001). Compared with control, significant improvements were observed in all 4 QOL parameters (pain, physical, social, psychological, all p < 0.001). The mean PVCSS summary score decreased significantly by 3.4 ± 3.4 in the MPFF group (p < 0.001) compared with a non-significant change of – 0.2 ± 1.6 in the control group (between-group difference p < 0.001). In the MPFF group, improvements were statistically significant for 6 out of 10 clinical manifestations of PCS measured using the PVCSS, including pain (mean change from baseline: 0.5 ± 0.7), heaviness (0.4 ± 0.7), discomfort (0.6 ± 0.7) and tenderness (0.3 ± 0.5). No significant improvements were observed in the control group. When measured by VAS, between-group differences were statistically significant for the overall summary score (p < 0.001) and for 8 out of 10 PCS symptoms, including: pain (mean MPFF change from baseline: 2.0 ± 2.2), heaviness (1.3 ± 2.1), discomfort (1.5 ± 2.0), tenderness (0.9 ± 1.9), and edema (1.3 ± 2.1). The authors concluded that in women with PCS, conservative treatment with MPFF was associated with improved QOL and reduced symptom severity. These researchers stated that MPFF may be considered a safe and effective therapeutic option for PCS in routine clinical practice.

The authors stated that although limited by its small sample size and single-blind design, this randomized, placebo-controlled study provided valuable information on the safety and effectiveness of MPFF in real-life practice in a cohort of women with PCS who were well-matched at baseline in terms of clinical and demographic characteristics. Unlike most previous studies, the current analysis was not limited to assessment of painful complaints; but evaluated the effectiveness of treatment on the full range of PCS symptoms and included women with anatomical and morphological signs of PCS in the absence of pain symptoms. Thus, this study added to the limited existing body of literature on the management of PCS symptoms in women.

Furthermore, an UpToDate review on “Vulvovaginal varicosities and pelvic congestion syndrome” (Johnson, 2022) does not mention micronized purified flavonoid fraction as a management / therapeutic option.

Proximal Coil Occlusion Preceding Distal Sclerotherapy for the Treatment of Pelvic Congestion Syndrome

In a retrospective, cohort, multi-center study Chen et al (2023) examined the feasibility, safety and effectiveness of proximal coil occlusion preceding distal sclerotherapy (PCODS) for patients with PCS. Subjects were 94 patients with PCS who had undergone PCODS and 53 patients who had undergone standard endovascular embolization (control group) between June 2014 and April 2020. The primary endpoint was the clinical remission rate; and the secondary endpoints were the operative time, total fluoroscopy time, radiation dose, overall length of coils used per case, and adverse events (AEs). Subjects were followed-up at 1, 3, 6, and 12 months. PCODS was successfully performed in 94 patients (100 %). The clinical remission rates were significantly higher in the PCODS group than in the control group at 1, 6, and 12 months (p = 0.036, p = 0.032, and p = 0.032). The operative time and total fluoroscopy time were shorter for the PCODS group than for the control group (48.3 ± 5.2 mins and 37.7 ± 4.4 mins versus 53.9 ± 4.8 mins and 42.6 ± 4.1 mins, respectively; p < 0.001 for both). The radiation dose was significantly lower in the PCODS group than in the control group (362,634.69 ± 41,533.13 mGy·cm2 versus 421,578.30 ± 49,517.93 mGy·cm2; p < 0.001). The overall length of coils used per case was 19.8 ± 6.0 cm in the PCODS group and 31.7 ± 8.5 cm in the control group (p < 0.001). Migration of n-butyl cyanoacrylate to the renal vein occurred in 2 patients in the control group. The authors found PCODS was feasible with a higher clinical remission rate and mild AEs in patients with PCS.

References

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