Long-term outcome and quality of life in patients with iliac vein compression syndrome after endovascular treatment

Abstract

Purpose

Deep venous thrombosis induced by iliac vein compression syndrome often interferes with patients’ work or daily living. This study aims to investigate the long-term outcome and quality of life in patients with iliac vein compression syndrome after endovascular treatment.

Methods

From October 2011 until June 2016, 28 patients with acute deep venous thrombosis diagnosed as iliac vein compression syndrome by ultrasonography were enrolled in this perspective study. Fifteen patients underwent balloon dilation and stent insertion (group A); 13 patients received anticoagulation treatment, thrombolysis, or balloon dilation without stenting (group B). The Medical Outcomes Study-Short Form-36 was used to assess the quality of life preoperatively and after endovascular treatment. The follow-up of Short Form-36 questionnaire was obtained within 12.13 ± 12.04 months after repair.

Results

There was no operative mortality in two groups, and technical success was achieved in 14 (93.3%) patients in group A. Thirteen (86.7%) patients were cured in group A, which was significantly higher than that of group B (46.2%, p = 0.042). Only one patient showed occlusion of stent in group A, with a secondary patency rate of 93.3%. Except for ‘Role emotion’, all remaining domains were significantly improved in group A when compared with preoperative score (p < 0.01). The scores of ‘Physical functioning’, ‘Role physical’, and ‘General health’ in group A were significantly higher than those of group B (p < 0.05).

Conclusions

Endovascular stenting to treat iliac vein compression syndrome shows beneficial clinical outcome, cumulative patency rate, and quality of life, with high technical success and low complications.

Keywords

Cockett syndrome endovascular treatment deep venous thrombosis iliac stenting quality of life assessment

Introduction

The iliac vein compression syndrome (IVCS), also known as Cockett syndrome, or May–Thurner syndrome, is caused by the compression of the common iliac vein by the overlying artery and associated mechanical trauma, which induce endothelial irritation and result in the formation of venous spurs^1,2 McMurrich³ first reported the presence of web-like intraluminal obstruction in 1908, high prevalence of this lesion was then confirmed by autopsy in asymptomatic general population,^1,4 The spur formation is a risk factor for developing deep venous thrombosis (DVT) of lower extremities.¹ This clinical syndrome is considered to be a contributor of chronic venous disease.⁵

IVCS often presents as sudden pain and limb swelling of lower extremities in young patients after surgery or pregnancy,⁶ which often interferes with patients’ work or daily living, and surgical treatment was the only choice in the past.^7,8 Nowadays, endovascular treatment, including iliac vein balloon dilation and insertion of stent, has made it possible to correct this obstruction.^9–13 Although clinical presentation, stent technique, and results of endovascular treatment were studied,^14–16 little attention has been paid to the quality of life (QoL) assessment, and the impact of other factors, including the possible need for second intervention, on patients’ QoL has not been clearly elucidated yet. This study aims to evaluate the long-term outcome and QoL in patients with IVCS after endovascular treatment.

Methods

Patient selection

This study was approved by the Ethics Committee of our University. From October 2011 until June 2016, 28 patients with acute (<15 days) DVT were diagnosed as IVCS by ultrasonography and were enrolled in this perspective study (Figure 1). According to patients’ choice of stenting or not, these case were divided into two groups. In group A, 15 patients underwent balloon dilation and stent insertion; in group B, 13 patients received anticoagulation treatment, thrombolysis, or balloon dilation without stenting. The Medical Outcomes Study-Short Form-36 (MOS SF-36) was used to assess the QoL preoperatively and after treatment. Patients, who were unable to fill in the questionnaires themselves, for example because of dementia, were excluded from this study. All patients were recorded and were asked to answer SF-36 questionnaires during routine follow-up; two were lost to follow-up. Duplex ultrasound was used to assess stent patency during follow-up (Figure 2).

Figure 1.

Preoperative diagnosis of IVCS. The left common iliac vein and external iliac vein were filled with uneven echo, and no obvious blood flow signal was observed (A). The diameter of the left common iliac vein into the inferior vena cava was about 2 mm, and no obvious blood flow signal was observed (B). IVCS was confirmed by venography during intervention (C). IVCS, iliac vein compression syndrome.

Figure 2.

Ultrasound follow-up after stenting. The stent echo was seen in the left common iliac vein and external iliac vein, with a diameter of 7 mm; the blood flow was patent, and the velocity of the common iliac vein into the inferior vena cava was 21 cm/s.

Technique

The diagnosis of IVCS was obtained by ultrasound and confirmed by venography. After the performance of the diagnostic venogram, a 7F sheath was placed, thrombolysis catheter implantation, angioplasty, or stenting were performed. All patients were heparinized during intervention to maintain an activated clotting time of 200–300 s. In group A, the lesion was pre-dilated with a balloon catheter (8–10 mm) and 1–2 endovascular stents were implanted after an effective thrombolysis. Post-dilation was performed with a balloon catheter if necessary (8–12 mm) and immediate postoperative venography was performed (Figure 3). Technical success was defined as a less than 10% residual stenosis with adequate flow. Clinical efficacy was established as below: patient was cured if resolution of symptoms with a normal QoL; improvement of symptoms with a moderate QoL was considered as improved efficacy; no improvement of symptoms with a low QoL, including death, was considered invalid efficacy. Patients received oral anticoagulation by oral take of warfarin sodium (100 mg/day; international normalized ratio 2–3) for 3–6 months if no contraindications, and dipyridamole (225 mg/day) was used in case of contraindication or resistance to warfarin. Elastic stockings were used if necessary.

Figure 3.

Interventional procedure. IVCS in left common iliac vein was shown by venography (A); the lesion was pre-dilated with a balloon catheter (B) and postdilation was performed with a balloon catheter if necessary (C); the left common iliac vein was patent by second venography (D). IVCS, iliac vein compression syndrome.

Questionnaires and data collection

A Chinese version of the standard MOS SF-36 questionnaire has been validated for a Chinese population.¹⁷ Dataset was acquired using SF-36 QoL questionnaire. The SF-36 questionnaire was gathered and ultrasonography was performed during follow-up.

Statistical analysis

The statistical analysis was performed with Prism 5.0 software (GraphPad Software Inc., San Diego, CA). Statistics are summarized as mean value and one-way analysis of variance was used for continuous variables. Mean values are given with standard deviation (SD) in the form mean ± SD. Measures of dispersion are summarized as standard deviation or range. Chi-square test was used to test percentage scoring. For all tests, bilateral significance was tested and accepted as significant with p < 0.05.

Results

Demographics

There was no significant difference of clinical profiles between group A and group B. One in each group showed carcinoma (p > 0.05); 5 (33.3%) patient had history of traumatism or open surgery in group A, 3 (23.1%) in group B (p > 0.05). Furthermore, there was 1 (7.7%) with Budd–Chiari syndrome in group B (Table 1).

Table 1.

Demographics of patients with DVT.

Variables	Group A	Group B	p
Patients	15	13
Gender, male	4 (26.7%)	4 (30.8%)	ns
Age, mean (years)	53.6 ± 16.6	48.0 ± 19.8	ns
Medical history
Carcinoma	1 (6.7%)	1 (7.7%)	ns
Traumatism/open surgery	5 (33.3%)	3 (23.1%)	ns
Budd–Chiari syndrome	0	1 (7.7%)	ns
Arterial hypertension	1 (6.7%)	2 (15.4%)	ns
Pulmonary thromboembolism	0	0	ns

Note: There were no significant differences between groups. DVT: deep venous thrombosis; ns: not significant.

Operative techniques

There was no operative mortality in both groups, and technical success was achieved in 14 (93.3%) patients in group A. A re-thrombosis of stent occurred after one week in group A. Twenty-two self-expanding stents (Luminexx; Bard, Austin, TX, USA) were used, with a mean length of 104.5 mm (60–120 mm) and a mean diameter of 11.6 mm (8–12 mm). Treatment of DVT consisted of catheter direct thrombolysis, peripheral thrombolysis, balloon dilation, and stenting. Inferior vena cava filter was used if the clot extends into the inferior vena cava. Inferior vena cava filters were implanted in three (20%) patients in group A, three (23.1%) in group B. All patients received anticoagulation treatment, four (30.8%) patients in group B received sole anticoagulation treatment, without thrombolysis, balloon dilation, or stenting. Catheter direct thrombolysis was performed in six (40%) patients in group A, eight (61.5%) in group B; one (7.7%) patient received peripheral thrombolysis in group B. All patients received balloon dilation and stenting in group A, two (15.4%) cases in group B underwent balloon dilation.

QoL before operative techniques

The distributions of MOS SF-36 domain scores of patients on admission are shown in Table 2, which showed no significant difference in all domains. The worst-scoring domain was ‘Role physical’ in two groups, and the best-scoring domain were ‘Role emotion’ in group A, ‘Mental health’ in group B before interventional procedure. Except for ‘Role emotion’, all remaining domains were significantly improved in group A when compared with preoperative score (p < 0.01). However, ‘Bodily pain’, ‘Role emotion’ and ‘Mental health’ did not improve during follow-up in group B (Table 3). As shown in Table 4, the scores of ‘Physical functioning’, ‘Role physical’, and ‘General health’ in group A were significantly higher than those of group B (p < 0.05). The condition significantly improved in the majority of patients when compared with the condition one year ago in group A (p < 0.001).

Table 2.

Results of the SF-36 questionnaire on admission.

	Group A	Group B	p
Physical functioning	33.33 ± 28.71	25.56 ± 28.11	ns
Role physical	10.42 ± 19.82	2.78 ± 8.33	ns
Bodily pain	59.83 ± 28.99	55.78 ± 40.27	ns
General health	36.25 ± 14.32	42.78 ± 23.60	ns
Vitality	67.50 ± 15.45	62.22 ± 23.6	ns
Social functioning	30.58 ± 29.00	32.00 ± 24.61	ns
Role emotion	77.75 ± 41.06	37.00 ± 42.35	ns
Mental health	74.33 ± 19.03	64.00 ± 26.98	ns

ns: not significant.

Table 3.

QoL change in all groups when compared with previous score.

	Group A	Group B
Physical functioning	<0.001	0.013
Role physical	<0.001	0.001
Bodily pain	0.001	0.069 (ns)
General health	<0.001	0.007
Vitality	<0.001	0.041
Social functioning	<0.001	0.002
Role emotion	0.642 (ns)	0.070 (ns)
Mental health	0.008	0.163 (ns)

ns: not significant.

Table 4.

QoL changes during follow-up.

	Group A	Group B	p
Physical functioning	88.13 ± 7.72	63.33 ± 23.58	<0.05
Role physical	89.06 ± 15.73	54.17 ± 36.67	<0.01
Bodily pain	94.25 ± 12.71	91.33 ± 12.80	ns
General health	85.63 ± 6.02	70.83 ± 23.82	<0.05
Vitality	90.00 ± 5.77	80.42 ± 10.76	ns
Social functioning	83.75 ± 10.54	74.17 ± 19.85	ns
Role emotion	93.81 ± 13.30	72.33 ± 31.26	ns
Mental health	91.00 ± 5.16	82.33 ± 11.11	ns

ns: not significant.

Follow-up

The follow-up of SF-36 questionnaire was obtained within 12.13 ± 12.04 (range 0.8–58.7) months. Thirteen (86.7%) patients were cured in group A, which was significantly higher than that of group B (46.2%, p = 0.042). Also, group A shows a significant low rate of invalid efficacy compared with group B (23.1%, p = 0.049). Little complication occurred in group A, only one patient showed occlusion of stent in group A, with a secondary patency rate of 93.3%. No bleeding was found in both groups. Two (15.4%) patients in group B died of multiple organ failure syndromes due to malignancy tumor (Table 5). These two patients with malignant tumors was probably connected with paraneoplastic hypercoagulation.

Table 5.

Operative techniques of patients with DVT.

Variables	Group A	Group B
Patients	15	13
Loss of follow-up	0	0
Clinical efficacy
Cured efficacy	13 (86.7%)	6 (46.2%)
Improved efficacy	2 (13.3%)	4 (30.8%)
Invalid efficacy	0	3 (23.1%)
Complications
Occlusion of vein or stent	1 (6.7%)	–
Peripheral bleeding	0	0
Death of carcinoma	0	2 (15.4%)
Death of hematencephalon	0	0
Treatments
Anticoagulation	15	13 (30.8%)
Catheter direct thrombolysis	6 (40%)	8 (61.5%)
Peripheral thrombolysis	0	1 (7.7%)
Balloon dilation	15 (100%)	2 (15.4%)
Stent implantation	15 (100%)	0
Filter insertion/retrieval	3 (20%)	3 (23.1%)

DVT: deep venous thrombosis.

Discussion

McMurrich³ first observed the compression of the left common iliac vein in 1908. May and Thurner¹ had similar finding in 1957. Most of the patients with DVT have more than one risk factor;¹⁸ substantial compression of iliac vein was considered a probable risk factor or a contributing factor. Symptomatic DVT occurs predominantly in young women of 20–40 years, especially during pregnancy.¹⁹ Surgical reconstruction usually requires lengthy postoperative care and presents a risk of postoperative hemorrhage during anticoagulation. Endovascular treatment offers a less invasive alternative.^9–13 Catheter-directed thrombolysis with or without stenting has been reported to be an effective treatment of DVT induced by IVCS, with a primary patency rates of 79%–100% within two years.^6,13,20–22 The prevalence of IVCS ranged from 18% to 49% in patients with a left-sided lower extremity DVT,¹³ with a recurrence rate of 73%, if obstruction was not treated with stenting.²³ Therefore, stent placement in the left common iliac vein is recommended for IVCS to overcome the underlying mechanical obstruction and prevent recurrences.

In this study, possible stent implantation was considered in patients who failed conservative therapy and had severe symptoms interfering with work or daily living. It is reported that iliac vein was balloon dilated and stented with Wallstent of 14–16 mm;^14,16 however, Luminexx stents of 10–12 mm were used in our study. The patency rate during follow-up of 12.13 ± 12.04 months was 93.3% in group A, which was similar as previous reports.^6,9 After stenting, 13 (86.7%) patients in group A had excellent clinical efficacy with resolution of symptoms of lower extremity swelling and pain. The MOS SF-36 scores showed no significant difference in all domains on admission. However, all domains, except for ‘Role emotion’, were significantly improved in group A when compared with preoperative score. Additionally, ‘Bodily pain’, ‘Role emotion’, and ‘Mental health’ did not improve during follow-up in group B. The scores of ‘Physical functioning’, ‘Role physical’, and ‘General health’ in group A were significantly higher than those of group B; the majority of patients said that their condition significantly improved when compared with the condition one year ago in group A.

This promising result indicates stent implantation can improve the QoL in patients with IVCS. However, our study is limited by several factors. First, it is a small, single-center study, there was a big bias for patient selection. Second, follow-up of stent patency with ultrasound can be inaccurate in evaluating iliac venous obstruction. Third, the long-term patency of iliocaval venous stents was not evaluated in this study. Besides, selection of patients was done by ultrasound, which may be affected by the interference of the intestinal contents and the anatomical conditions of the patient as well as by the experience of the operator. Non-ultrasonographic diagnostic methods will be helpful to evaluate with objectivity the effectiveness of the treatments and the differences in the two groups.

Conclusion

This study demonstrates that endovascular stenting to treat IVCS shows beneficial clinical outcome, cumulative patency rate, and QoL, with high technical success and low complications.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was funded by the National Natural Science Foundation of China (Grant No. 81501569). The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.

Ethical approval

This study was approved by the Ethics Committee of our University.

Guarantor

XH.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Contributorship

YB and ZY researched the literature and conceived the study. XH was involved in protocol development, gaining ethical approval and data analysis. YB and ZY wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript.

Acknowledgement

We would like to thank our colleague for the assistance and guidance in this research.

References

May

Thurner

The cause of the predominantly sinistral occurrence of thrombosis of the pelvic veins.

Angiology 1957; 8: 419–427.

Oguzkurt

Ozkan

Ulusan

, et al. Compression of the left common iliac vein in asymptomatic subjects and patients with left iliofemoral deep vein thrombosis. J Vasc Interv Radiol 2008; 19: 366–370.

McMurrich

The occurrence of congenital adhesions in the common iliac veins and their relation to the thrombosis of the femoral and iliac veins. Am J Med Sci 1908; 135: 342–346.

Negus

Fletcher

Cockett

, et al. Compression and band formation at the mouth of the left common iliac vein. Br J Surg 1968; 55: 369–374.

Kibbe

Ujiki

Goodwin

, et al. Iliac vein compression in an asymptomatic patient population. J Vasc Surg 2004; 39: 937–943.

Hurst

Forauer

Bloom

, et al. Diagnosis and endovascular treatment of iliocaval compression syndrome. J Vasc Surg 2001; 34: 106–113.

Taheri

Williams

Powell

, et al. Iliocaval compression syndrome. Am J Surg 1987; 154: 169–172.

Alimi

DiMauro

Fabre

, et al. Iliac vein reconstructions to treat acute and chronic venous occlusive disease. J Vasc Surg 1997; 25: 673–681.

Binkert

Schoch

Stuckmann

, et al. Treatment of pelvic venous spur (May–Thurner syndrome) with self-expanding metallic endoprostheses. Cardiovasc Intervent Radiol 1998; 21: 22–26.

10.

Vorwerk

Guenther

Wendt

, et al. Iliocaval stenosis and iliac venous thrombosis in retroperitoneal fibrosis: percutaneous treatment by use of hydrodynamic thrombectomy and stenting. Cardiovasc Intervent Radiol 1996; 19: 40–42.

11.

Nazarian

Bjarnason

Dietz

Jr , et al. Iliofemoral venous stenoses: effectiveness of treatment with metallic endovascular stents. Radiology 1996; 200: 193–199.

12.

Carlson

Nazarian

Hartenbach

, et al. Management of pelvic venous stenosis with intravascular stainless steel stents. Gynecol Oncol 1995; 56: 362–369.

13.

O’Sullivan

Semba

Bittner

, et al. Endovascular management of iliac vein compression (May–Thurner) syndrome. J Vasc Interv Radiol 2000; 11: 823–836.

14.

Neglen

Berry

Raju

Endovascular surgery in the treatment of chronic primary and post-thrombotic iliac vein obstruction.

Eur J Vasc Endovasc Surg 2000; 20: 560–571.

15.

Raju

Owen

Jr Neglen

The clinical impact of iliac venous stents in the management of chronic venous insufficiency.

J Vasc Surg 2002; 35: 8–15.

16.

Neglen

Raju

Balloon dilation and stenting of chronic iliac vein obstruction: technical aspects and early clinical outcome.

J Endovasc Ther 2000; 7: 79–91.

17.

Song

Chen

Song

YL.

The free thigh flap: a new free flap concept based on the septocutaneous artery.

Br J Plast Surg 1984; 37: 149–159.

18.

Baglin

Luddington

Brown

, et al. Incidence of recurrent venous thromboembolism in relation to clinical and thrombophilic risk factors: prospective cohort study. Lancet 2003; 362: 523–526.

19.

Ginsberg

Brill-Edwards

Burrows

, et al. Venous thrombosis during pregnancy: leg and trimester of presentation. Thromb Haemost 1992; 67: 519–520.

20.

Patel

Stookey

Ketcham

, et al. Endovascular management of acute extensive iliofemoral deep venous thrombosis caused by May–Thurner syndrome. J Vasc Interv Radiol 2000; 11: 1297–1302.

21.

Lamont

Pearl

Patetsios

, et al. Prospective evaluation of endoluminal venous stents in the treatment of the May–Thurner syndrome. Ann Vasc Surg 2002; 16: 61–64.

22.

Kwak

Han

Lee

, et al. Stents in common iliac vein obstruction with acute ipsilateral deep venous thrombosis: early and late results. J Vasc Interv Radiol 2005; 16: 815–822.

23.

Mickley

Schwagierek

Rilinger

, et al. Left iliac venous thrombosis caused by venous spur: treatment with thrombectomy and stent implantation. J Vasc Surg 1998; 28: 492–497.