Phlebology Forum May-June 2017

MAY - JUNE 2017

COMPARISON OF TREATMENTS FOR PELVIC CONGESTION SYNDROME PAGE 10

ENDOVASCULAR TREATMENT OF PELVIC CONGESTION SYNDROME PAGE 14

may-june ‘17

From the Editor-in-Chief Sherry Scovell, MD

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Contributing Editor/Reviewer: Chieh-Min Fan, MD Associate Editor: Sherry Scovell, MD,

contents

Transvaginal duplex ultrasonography appears to be the gold standard

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The role of duplex ultrasound in the workup of pelvic congestion syndrome

Comparison of treatments for pelvic congestion syndrome

Contributing Editor/Reviewer: Fedor Lurie, MD, PhD

Contributing Editor/Reviewer: Arjun Jayaraj, MD

Associate Editor: Mark Forrestal, MD, FACPh

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Associate Editor: Mark Meissner, MD

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Endovascular treatment of pelvic congestion syndrome Contributing Editor/Reviewer: Javier Leal Monedero, MD Associate Editor: Sherry Scovell, MD

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Sherry Scovell, MD

Phlebology Forum (Editor-In-Chief)

7/31/15

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From the

Editor-in-Chief Dear Readers We welcome you back for our first issue of Phlebology Forum in 2017. For this edition, we chose to highlight the topic of pelvic congestion syndrome (PCS) because, historically, it has been an underdiagnosed cause of chronic pelvic pain due to pelvic venous insufficiency (PVI). As you know, the underlying etiology is incompetence of either the ovarian vein, the internal iliac vein or both. MR venography has played a significant role in the diagnosis, although duplex ultrasound is being employed more as the initial diagnostic test of choice in experienced laboratories.

In this edition, we have focused on the role of duplex ultrasound, especially transvaginal ultrasound, in the diagnosis of PVI, as well as a comparison of the options available for treatment. Our reviewers are experts in this field and include: Dr. Javier Leal Monedero (Madrid, Spain), Fedor Lurie, MD (Toledo, Ohio), Arjun Jayaraj, MD (Jackson, Mississippi), and Chieh-Min Fan, MD (Boston, Massachusetts). We hope that you enjoy this selection of articles and the excellent reviews that accompany them.

On behalf of the associate editors and editorial staff, we are looking forward to seeing you all at the 2017 Annual Congress in Austin, Texas November 2-5, 2017! Please visit acpcongress.org for more information.

Best Regards,

Sherry Scovell, MD Editor-in-Chief

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Transvaginal duplex ultrasonography appears to be the gold standard investigation for the haemodynamic evaluation of pelvic venous reflux in the ovarian and internal iliac veins in women Authors: Whiteley, et al.

Phlebology. 2015 Dec;30(10):706-13. doi: 10.1177/0268355514554638. Epub 2014 Oct 16.

Contributing Editor/Reviewer: Chieh-Min Fan, MD Associate Editor: Sherry Scovell, MD

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ABSTRACT The authors evaluated the utility of transvaginal sonography (TVS) for the detection of pelvic venous reflux though a retrospective analysis of 100 sequential patients who underwent TVS before and after embolization for pelvic congestion syndrome. The rationale for the study stemmed from the observation that embolization of pelvic congestion syndrome based on contrast venography findings often fails to fully eliminate the pelvic venous reflux. In this study, the authors used TVS exclusively to detect and map out pelvic venous reflux in the ovarian, internal iliac, and labial veins. Site specific embolization targeting the refluxing veins was then performed, with follow-up TVS was done by a blinded observer.

Treatment success was defined as anatomic correction of reflux in the TVU-identified incompetent veins or persistent absence of reflux in a vein before and after embolization. Treatment failure was defined as technical failure of embolization, embolization of TVU-proven competent vein (overtreatment), or nonembolization of a TVU-proven incompetent vein (undertreatment). The study specifically did not assess clinical outcome and PCS symptom response to this TVS-guided targeted embolization approach. There were 14/100 treatment failures with residual reflux after treatment, 4 due to technical non-embolizaton of target veins and 10 to persistent

TVS permits quantitative assessment of embolization technical success

reflux despite embolization.

COMMENTARY This article makes a case for designating TVU as the new gold standard for detection of pelvic venous reflux because it enables the detection of reflux real-time in a noninvasive way. The authors state that CT venography and MR venography cannot demonstrate real-time reflux in the truncal veins. This is not a completely accurate statement. In 2010, two publications reported the use of MR venography with time-resolved imaging of contrast to generate dynamic MR angiographic images demonstrating real-time flow characteristics in the gonadal vein. These images correlated well with venographic and sonographic findings of ovarian and pelvic vein reflux, as well as potentially permitting concurrent evaluation for iliac and renal vein compression1,2. Labropoulos et al also recently published a standardized approach for diagnosis of PCS with transabdominal duplex US, which can detect venous compression syndromes as well as gonadal and pelvic vein reflux, and also permits optimal patient positioning even to the degree of standing up during the study.3 Limitations do exist for these other modalities: MR imaging can be degraded by breathing artifact, and transabdominal duplex US can be disrupted by bowel gas. But given that there are actually three modalities (MRV with time resolved imaging, transabdominal duplex US, and TVS) that 1

Dick EA, Burnett C, Anstee A, et al. Time-resolved imaging of contrast kinetics three-dimensional (3D) magnetic resonance venography in patients with pelvic congestion syndrome. Br J Radiology 2010; 83:882-887.

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Pandey R, Shaikh R, Viswamitra S, et al. Use of Time Resolved Magnetic Resonance Imaging in the Diagnosis of Pelvic Congestion Syndrome. J Magnetic Resonance Imaging 2010;32:700-704.

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Labropoulos N, Jasinski P, Adrahtas D, et al. A standardized ultrasound approach to pelvic congestion syndrome. Phlebology. 2016 Oct 31. pii: 0268355516677135

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can provide non-invasive real time reflux assessment, and the other two modalities can concurrently detect central venous compression syndromes that TVS cannot consistently evaluate, it may be premature to claim that TVS is a new gold standard without prospective comparison to these other modalities first, in addition to contrast venography.

In any case, claiming the “gold standard” moniker is not necessary for this study to merit consideration as a significant contribution to the existing literature on PCS. The authors demonstrate conclusively both the utility of TVS for site specific detection of reflux, and its feasibility in daily practice as a useful diagnostic and post treatment adjunct for PCS assessment. Clear advantages of TVS include potential widespread availability, noninvasiveness, no exposure to ionizing radiation, relative limited cost, and detailed localization of reflux sites in the pelvis which can be challenging with retrograde contrast venography.

TVS permits quantitative assessment of embolization technical success, something that has been needed and lacking in the field up to now. In addition to its clinical usefulness, TVS is a valuable investigative tool for correlating pelvic venous reflux to specific symptoms and disease states, determining the prevalence of pelvic venous reflux in the general population, and in refining our understanding of how pelvic venous reflux circuits interact and evolve.

The authors correctly state that the study does not assess clinical outcomes of embolization of PCS and while proposing TVU as a new gold standard for detection of pelvic venous reflux, they do not claim TVU to be the new gold standard for diagnosis of pelvic congestion syndrome. It is important to note this difference, particularly when the study categorizes one case in which all reflux resolved after only some of the indentified sites were embolized as a “failure of diagnostic TVU.” The authors imply that TVU should reliably detect all sites of reflux needing treatment, and resolution of reflux in a vein without embolization would indicate a diagnostic error occurred. This conclusion can be viewed with some skepticism. A guiding principle of venous reflux management is to treat the highest point of reflux first thereby enabling downstream sites of reflux to spontaneously improve, potentially reducing the need for additional site-specific treatment. Delaying intervention on pathological perforators after saphenous vein closure illustrates this principle. In the pelvis with its richly collateralized system of venous plexes, it is conceivable and possibly expected that after embolization geographic redistribution of reflux or regression of downstream reflux may occur. TVU will facilitate our understanding of how reflux circuits in the pelvis respond to treatment, but as yet it is not established fact that every site of reflux detected by TVU requires treatment to achieve therapeutic response, or that the resolution of some of the reflux without site-specific embolization implies misdiagnosis. Even so, most clinicians treating PCS may opt to treat all points of baseline reflux at the initial session with an acceptable risk of slightly higher radiation exposure in exchange for higher likelihood of prompt and sustained therapeutic benefit.

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The role of duplex ultrasound in the workup of pelvic congestion syndrome Authors: Rafael D. Malgor, MD, Demetri Adrahtas, MD, Georgios Spentzouris, MD, Antonios P. Gasparis, MD, Apostolos K. Tassiopoulos, MD, Nicos Labropoulos, RVT, DIC, PhD JAMA. 2013 Oct 9;310(14):1482-9.

Contributing Editor/Reviewer: Fedor Lurie, MD, PhD Associate Editor: Mark Forrestal, MD, FACPh

COMMENTARY The Malgor et al. article reports their experience in the use of duplex ultrasound (DU) in the work up of pelvic congestion syndrome (PCS). 48 patients presenting with PCS were investigated in their vein center and their data analyzed retrospectively.

Their conclusion is that DU has a high sensitivity for the identification of left ovarian vein diameter but greatly reduced sensitivity for the right ovarian vein. Furthermore they recommend computed tomography venography when DU results are equivocal or negative, but they agree that all venography including conventional venography are equally accurate to show the presence of pelvic varices.

...duplex ultrasound has a high sensitivity for the identification of left ovarian vein diameter but greatly reduced sensitivity for the right ovarian vein.

Our comments on this informative article may be influenced by our investigation protocol, which is different.1 In our practice after the usual gynecologic exam to rule out gynecologic causes for signs and symptoms of PCS, the first investigation is tranvaginal ultrasound that allows us to confirm the presence of pelvic varices as well as the presence or absence of compression syndromes identified by non continuous or continuous flow. If the latter is identified compression syndrome is highly probable and consequently either left renal vein compression (LRVC) or more frequently iliac vein compressions (IVC) are investigated by transabdominal DU. We do not routinely use computed tomography venography or magnetic resonance venography to identifying gonadal vein size or reflux.

If PCS treatment is planned, a super selective venography by brachial access is performed that allows us to identify LRVC or IVC, gonadal vein size and competence, pelvic varices as well as reflux feeding lower limb varices. Treatment is performed in the same session for all of these anomalies.

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Leal Monedero J. Zubicoa Ezpeleta S, Perrin M. Pelvic congestion syndrome can be treated operatively with good long term results. Phlebology 2012;27 Suppl 1:65–73

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Comparison of treatments for pelvic congestion syndrome Authors: Chung MH, Huh CY. Tohoku J Exp Med. 2003 Nov;201(3):131-8 Contributing Editor/Reviewer: Arjun Jayaraj, MD Associate Editor: Mark Meissner, MD

REVIEW In their paper Chung and Huh evaluate the efficacy of embolotherapy (Gp I), hysterectomy with bilateral oophorectomy & hormone replacement therapy (Gp II) and hysterectomy with unilateral oophorectomy (Gp III) for pelvic congestion syndrome (PCS) in patients who did not respond to medical (medroxyprogesterone acetate) therapy alone. Patients with PCS confirmed by laparoscopy and venogram who failed medical therapy were randomized to one of the three treatment modalities. Pain scores (visual analog scale [VAS]) and stress scores (revised social readjustment rating scale [SRRS]) were evaluated at three, six and twelve-months post intervention.

Of the 106 patients enrolled in the study (Gp I - 52, Gp II - 27 and Gp III - 27), 98 had unilateral venous congestion, while 8 had bilateral venous congestion on phlebography. Symptoms included lower abdominal and/or pelvic pain (100%), lower back pain (57.6%), urinary frequency (25.1%), dyspareunia (15.0%), and dysmenorrhea (12.8%).

The difference in mean VAS scores at each followup visit when compared with the pretreatment

These studies report clinical improvement in 82% to 96% of subjects treated

score was significantly decreased in Group I (p<0.05), but not in Groups II and III. There were no significant differences in VAS and SRRS scores between the three groups (p>0.05). For patients with typical and moderate stress levels, embolotherapy showed a significant decrease in pain at all follow-up visits compared to other therapies (p<0.05). However, for patients with very high stress levels, embolotherapy showed a significant decrease in pain only at the 6-month follow-up (p<0.05). The authors conclude that ovarian and/or internal iliac vein embolization is a safe, well-tolerated, effective treatment for pelvic congestion syndrome not responding to medical therapy.

COMMENTARY Pelvic congestion syndrome (PCS) refers to the constellation of symptoms and signs occurring in women arising from incompetence of the pelvic veins. The syndrome can present with pain (pelvic, lower abdominal, lower back, hip, and/or dyspareunia), dysmenorrhea, urinary frequency, and/or varicose veins of the vulva, perineum, buttocks and lower extremity in addition to ovarian point tenderness. PCS is one of the major causes for chronic pelvic pain accounting for 10% to 20% of all outpatient gynecological

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consultations. Both gonadal and internal iliac venous systems can contribute to the development of PCS. Diagnosis is made on the basis of size of the gonadal vein (>6mm), presence of para uterine varicosities in addition ovarian vein reflux on imaging studies including pelvic ultrasound, dynamic magnetic resonance imaging or phlebography. Transvaginal ultrasound with Doppler evaluation enables real time appraisal under Valsalva maneuver/erect position besides determining flow patterns. Treatment of PCS is typically multimodal and options includes counseling/psychotherapy, medroxyprogestorone acetate or gonadotropin-releasing hormone analogue goserelin, transcatheter embolization of ovarian/internal iliac veins (TCE) and surgery (hysterectomy with/without oophorectomy). The latter two are typically reserved for failure of medical therapy and have been shown to be successful in controlling pelvic pain and restore normal coital function and daily life.1 2 More recently, TCE has been increasingly utilized as a first line therapy. Comparison of benefits of TCE versus surgery is scarce and authors Chung and Huh deserve to be complimented for shedding light on the topic in their study. Their work represents the first and only randomized study comparing multiple treatment modalities, including TCE, hysterectomy with bilateral oophorectomy & hormone replacement therapy and hysterectomy with unilateral oophorectomy. TCE unlike hysterectomy with or without oophorectomy helps improve VAS pain scores over the short term based on 12 month follow up data. Additionally, patients with typical or moderate stress levels tend to respond better to TCE in terms of symptom relief compared to patients with very high stress level. The clinical improvement reported in their study lends support to earlier and subsequent non randomized studies that have reported improvement following TCE.2,3,4,5,6,7,8,9 These studies report clinical improvement in 82% to 96% of subjects treated. The questions that remain include ideal agent(s) for TCE (coils versus sclerosant versus glue), indications and timing of internal iliac vein embolization and bilateral versus unilateral TCE. Risk of complications with TCE also need to be elucidated further as multiple studies have reported coil migration to the renal vein and lungs. More recent publications have put forth preference for

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Beard RW, Kennedy RG, Gangar KF, Stones RW, Rogers V, Reginald PW, Anderson M. Bilateral oophorectomy and hysterectomy in the treatment of intractable pelvic pain associated with pelvic congestion. Br J Obstet Gynaecol. 1991 Oct;98(10):988-92.

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Kim HS, Malhotra AD, Rowe PC, Lee JM, Venbrux AC. Embolotherapy for pelvic congestion syndrome: long-term results. J Vasc Interv Radiol. 2006 Feb;17(2 Pt 1):289-97.

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Maleux G, Stockx L, Wilms G, Marchal G. Ovarian vein embolization for the treatment of pelvic congestion syndrome: long-term technical and clinical results. J Vasc Interv Radiol. 2000 Jul-Aug;11(7):859-64.

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Venbrux AC, Chang AH, Kim HS, Montague BJ, Hebert JB, Arepally A, Rowe PC, Barron DF, Lambert D, Robinson JC. Pelvic congestion syndrome (pelvic venous incompetence): impact of ovarian and internal iliac vein embolotherapy on menstrual cycle and chronic pelvic pain. J Vasc Interv Radiol. 2002 Feb;13(2 Pt 1):171-8.

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Kwon SH, Oh JH, Ko KR, Park HC, Huh JY. Transcatheter ovarian vein embolization using coils for the treatment of pelvic congestion syndrome. Cardiovasc Intervent Radiol. 2007 Jul-Aug;30(4):655-61.

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

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Laborda A, Medrano J, de Blas I, Urtiaga I, Carnevale FC, de Gregorio MA. Endovascular treatment of pelvic congestion syndrome: visual analog scale (VAS) long-term follow-up clinical evaluation in 202 patients. Cardiovasc Intervent Radiol. 2013 Aug;36(4):1006-14.

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Hocquelet A, Le Bras Y, Balian E, Bouzgarrou M, Meyer M, Rigou G, Grenier N. Evaluation of the efficacy of endovascular treatment of pelvic congestion syndrome. Diagn Interv Imaging. 2014 Mar;95(3):301-6.

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Nasser F, Cavalcante RN, Affonso BB, Messina ML, Carnevale FC, de Gregorio MA. Safety, efficacy, and prognostic factors in endovascular treatment of pelvic congestion syndrome. Int J Gynaecol Obstet. 2014 Apr;125(1):65-8.

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coils, staged embolization of internal iliac veins in setting of absence of improvement of symptoms with TCE of ovarian veins/communication between ovarian venous tributaries & internal iliac vein and bilateral approach. But these criteria are not uniformly pursued and need further clarification. There are obvious advantages of embolotherapy over surgery (hysterectomy +/- oophorectomy), including maintenance of hormonal milieu, avoidance of surgical complications, reduced postoperative pain and cosmesis. Impact of embolotherapy on fertility and ovarian function has been assessed and appears not to be impacted by TCE.2 Overall TCE seems to be a safe and effective modality to treat PCS patients not responding to medical therapy, however, precise role, certain technical aspects of the procedure and recurrence of symptoms following embolization merit further study.

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Endovascular treatment of pelvic congestion syndrome: visual analog scale (VAS) long-term follow-up clinical evaluation in 202 patients Author: Laborda A1, Medrano J, de Blas I, Urtiaga I, Carnevale FC, de Gregorio MA. Cardiovasc Intervent Radiol. 2013 Aug;36(4):1006-14. doi: 10.1007/s00270-013-0586-2. Epub 2013 Mar 2.

Contributing Editor/Reviewer: Javier Leal Monedero, MD Associate Editor: Sherry Scovell, MD

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ABSTRACT Pelvic Congestion Syndrome (PCS) is one of the main causes of chronic pelvic pain. This study presents a prospective study with 5-year follow-up of 202 patients treated by embolization in order to correct PCS. Those patients consulted for lower limb varices and were recruited according to following criteria: chronic pelvic pain of more than 6 months dilated pelvic veins and presence of venous refluxes.

All patients were treated by embolization, using coils, of all insufficient veins (gonadal and internal iliac veins). In detail, 68.3% of patients had embolization of four veins, 23.8% of three veins, and 7.9% of two veins. In 100% of cases, the embolization was technically successful.

Pregnancy is

As a measure of improvement, authors decide to

considered as

use visual analog scale (VAS) that is a subjective, completely patient derived system. Patients were interrogated before the procedure and then after 1, 3, 6 months and then once a year during follow-up.

Using only patients that completed the entire followup period (179), they elaborate a comparative study.

A 33.52% of cases showed a complete disappearance

the trigger in many women who had vascular predisposition...

of symptoms, or a complete clinical success. Also, they found highly significant differences between pre and post-procedural pain, changing from a mean of 7.34 to 0.78 in VAS. In addition, they compare the results considering the initial level of pain of patients, finding that clinical success was not dependent of it. However, a higher initial pain level slightly slowed the recovery time, from 13.5 months in patients with severe initial pain to 9 months until full recovery in patients with moderate initial pain.

Using the same batch of patients, they also investigate the recurrence of lower limb varicose veins, finding 12.5% of patients with recidivation during follow-up. The recurrence was independent of the initial pain level or the number of embolized veins.

As they conclude, coil embolization is a very effective procedure, and the use of VAS is a very helpful tool to evaluate the success rate subjectively by patients.

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COMMENTARY This is a very interesting report, with many important aspects of PCS diagnosis and treatment.

Laborda et al work is one of the largest populationâ&#x20AC;&#x2122;s series in the literature, with one of the longest follow-up period. It presents a very successful algorithm to treat PCS. It is very important to remark on the influence of pregnancies in the development of PCS. In this study, all patients were multiparous women. Pregnancy is considered as the trigger in many women who had vascular predisposition, and is one of the most common aggravating circumstances in PCS, due to the hormonal changes, the increase in blood flow in pelvic veins (mainly in gonadal axis) and also the increase in blood pressure. Also, after multiple pregnancies it is very common to suffer from debilitation of pelvic floor, which could be the origin of pelvic originated leak points to lower limbs.

The article of Laborda et al gives us a reminder of the high rate of technical success of embolization. It is a safe procedure, with very low number of complications associated. Also, as it can be assessed asking the patients, it is a very satisfactory procedure for them. Also, it remarks the relevance of assessing refluxes in the four main axes in pelvic insufficiency (both gonadal veins and, also, both internal iliac veins). Many authors rely in investigating and treating only the gonadal veins. However, in a high number of cases, if there is incompetence in the internal iliac veins, recidivation may appear. This will lead to further interventions, with the consequent disturbance and additional cost for the patients. As it is done in this work, the assessment and correction of internal iliac veins possible insufficiency in the initial procedure avoid a high number of recidivation. Also, in many cases, the use of Valsalva maneuver is essential, to manifest those insufficiencies that could remain undetected in the venography.

As the author highlights, an important aspect in the follow-up is the performance of Doppler US exams. These investigations are essential in the study and finding of recurrences and lower limb varices presence. However, many patients may be reluctant to continue with the medical consults, if they are not aware of the relevance of recidivation.

One of the complications that the authors reflect, the migration of coils, could be avoided using controlled release coils. This type of devices allows relocating if there is any problem in the first release. So, there is a safer choice that could minimize this issue.

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Concerning technical aspects of embolization, in this work, authors rely on coils only to obtain the occlusion. Other authors, however, defend the use of a combination of coils and sclerosants, such as ethoxisclerol. Both approaches have pros and cons that need to be evaluated in every case. With the combination of coils and sclerosants, it is possible to occlude small caliber veins with effectiveness and also reduce the amount of coils used, minimizing the cost of procedure.

The performance of this type of series, studying a high number of patients and with the longest period of follow up as possible, allow us to deepen more and more in the knowledge of pelvic pathologies. It is essential to correctly understand and, so on, treat not only pelvic pathologies but also lower limb derived varices.

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1

Kim, HS; Malhotra, AD; Rowe, PC; Lee, JM; Venbrux, AC. Embolotherapy for pelvic congestion syndrome: Long-term results. J. Vasc. Interv. Radiol. 2006; 17: 289-297

2

Tessari, L; Cavezzi, A; Frullini, A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Deramtol Surg. 2001; 27(1):58-60.

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Leal Monedero, J; Zubicoa Ezpeleta, S; Grimberg, M; Vergara Correa, L; Perrin, M. Subdiaphragmatic Venous Insufficiency. Embolization treatment using mixed technique (coils and foam). Phlebolymphology. 2004; 45:269-275.

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Hartung O. Embolization is essential in the treatment of leg varicosities due to pelvic venous insufficiency. Phlebology. 2015 Mar; 30 (1 Suppl):81-5.

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