Comparative study between Surgical and Endovascular Management of Chronic Iliofemoral Venous Obstruction

About 50% of leg thrombi resolve spontaneously However, nearly 20%  extend more proximally into the popliteal, femoral, and iliac veins. The
consequences can range from minor leg swelling to severe complications such as chronic debilitating lower limb pain, intractable edema, and venous leg ulceration.

Other symptoms are associated with chronic iliofemoral venous obstruction as leg cramping, pruritus, fatigue, heaviness, venous claudication, paresthesias, and bursting thigh pain with exercise (Yves and oliver et al., 2019).                     

       Chronic venous disorders(CVD) are a spectrum of venous diseases. The lower limb is the most commonly affected. The manifestations include varicose veins, pain, edema, skin changes, and venous ulcerations. The pathophysiology involves increased venous pressure within the deep, superficial, and perforating veins and/or venous obstruction. Lower extremity deep venous thrombosis (DVT) often leads to higher rates of the advanced forms of CVD, with skin changes and ulcerations (Joseph  et al., 2019) .

It is estimated that PTS occurs in 20% to 50% of patients from a few months to 1 to 2 years, following a lower extremity DVT. A high clinical suspicion is vital in selecting patients with chronic venous disease (CVD) who should have further testing for proximal obstruction. On
presentation, patients should be evaluated on the clinical, etiological, anatomical,
and pathophysiological (CEAP)       classification system (O'Donnell et al., 2014). Patient’s history that should prompt further evaluation for a proximal obstructing lesion include history of DVT. Venous duplex ultrasonography is useful in evaluating the lower extremities, and transfemoral venography is the
gold standard to visualize iliofemoral occlusion or stenosis A variety of conservative, surgical and endovascular techniques are now available
for treating chronic lower limb venous obstruction (Jose and peter et al., 2019).

The non-operative approach to patients with chronic venous disease includes prevention, lifestyle modification, compression, and pharmacologic therapies  (Kahn et al., 2016).

Percutaneous endovenous stenting has emerged during the last decade as the “method of choice” for the treatment of chronic obstruction of the iliofemoral venous outflow. The procedure can be performed with low morbidity, no mortality, long-term high patency rate, and low rate of stent restenosis. It has replaced bypass surgery as the primary treatment. Open venous reconstruction for chronic iliofemoral  obstruction should be considered only in cases of unsuccessful or failed endovenous treatment in surgically fit patients with severe symptoms (Garg et al., 2011) .

Endovascular treatment was applied using mid-thigh ipsilateral femoral vein access under local anesthesia and ultrasound guidance. on-table venogram performed for diagnostic and road-mapping purposes.

A hydrophilic guide wire (0.035 inch) was inserted and the cannula replaced by a 9F to 11F sheath, which was accommodated the appropriate balloon and stent sizes. A stiff guide wire and predilation with serial dilators facilitated sheath placement in the case of perivenous fibrosis . In patients with stenosis , the guide wire  passed through the stenosis and into the IVC with ease. An initial contrast-enhanced venogram was then performed.Ballooning dilation   occurred to 24, 18, 16, and 14 mm for IVC, CIV, EIV and CFV segments, respectively. To conserve supplies we used 18 mm balloons for all iliofemoral segments and have not encountered problems. Completion venography was essential to ensure that a recanalized passage of adequate caliber without conduit defects has been established.

The aim of this work was to comparative between surgical and endovascular procedures in the management of chronic iliofemoral venous obstruction.

PATIENT AND METHODS

This prospective randomized controlled study was conducted in the Vascular Surgery Departments Al-Azhar University Hospitals during  the period from December 2016 to December 2018 (24 months). The study included 30 patients (18 females and 12 males) with a ratio of 1.5:1 suffering from chronic ilio-femoral venous obstruction. Their mean age was 40 years “ranging from 19-83 years”. All patients were belonging to CEAP classifications which included  clinical state of venous disease in which there is edema up to active venous ulcer. Patients were divided into two groups: 

1) Endovascular procedure group : Patients with chronic iliofemoral venous obstruction whom were treated by endovenous ballooning and stenting,

2) Open surgery procedure group : patients with chronic iliofemoral venous
obstruction were treated by surgery for graft bypass. The patients of the two groups were followed up for 2 years regarding patency of the stent or graft, detection of failure (thrombosis), and
improvement of patients complain. All patients in this study were classified according to clinical classification into:-
C (clinical score) C3 7 patients (23.3%) ,C4 10 patients (33.3%) , C5 2 patients (6.6%) and C6 11 patients (36.6%).

Stenting of the iliofemoral veinin this study after significant stenosis has been diagnosed. It is predilated by an
appropriately sized balloon . mentioned before Predilation of the  tract  over  the wire with 4 to 6 mm balloons was generally required when an occlusion has been recanalized to allow the passage of larger balloons. using large-caliber (16 to 18
mm) high-pressure balloons (14 to 16 atm) was a routine. Because of the fibrous nature of iliac vein lesions, we used large-caliber stents approximating the normal size of the iliofemoral segments . The use of undersized stents was among the most common causes of iatrogenic stenosis.

Surgical treatment  was applied using some technical varieties according to site of occlusion. 1- Saphenopopliteal bypass which was designed for chronic occlusion of the femoral or the proximal popliteal vein. 2- Cross-pubic venous bypass (Palma Procedure) at which the contralateral great saphenous vein was used in cross pubic femoro-femoral vein bypass.

Mean age of surgery patients were 40 years old (ranging from 23 to 70 years old) Number of male patients in Endovascular was 10 (33.33%) while number of female patients was 5(16.66%). Number of male patients in Sugery was 8 (26.66%) while number of female patients was 7(23.33%) (Table 1).

     Our study was carried out on 30 consecutive patients were randomized to receive patients for endovascular and  surgical treatment The patients enrolled in this study were 18 males (60%) and 12 females (40 %) with a mean age of 50 years old (ranging from 19 to 83 years old).

In this study, the hospital stay for endovascular patients was around (1-3) days. And for surgical patients was around (1-10) days. In this study endovascular procedures were done under local anaethesia. Open surgery procedures were done under general anesthesia.

Post endovascular approach during the first 24 hours was one (6.67% )
access site hematoma . Also, post surgical approach during the first 24 hours were two (13.33% ) developed scrotal swelling.

One (6.67 % ) developed hematoma , 1 (6.67%) developed hematoma which was infected and lead to rupture of the anastomosis, and 1 patient (6.67%) developed post operatve occlusion graft.

As a final result, percentage of patency in both endovascular and surgery
procedure were 73.33% (11 patients in Endovascular) and 7 (46.66%) patients in surgery) . Anethesia postponeded patients in 13.33% (0 in endovascular and 2 in open surgery) and they refused to come again.

Procedure failure occurred 6.67% (only 1 at endovascular ) , failure (thrombosis) in  1 (6.67%) in endovascular , 4(26.67%) in
surgery), stenosis in  2 (13.33%)  patient at endovascular), and no death occurred. Missed follow up (2 (13.33%)  patients at open surgery ) .

Open surgery procedures included suprapubic (femoro–femoral crossover bypass) in 53.3 %, iliofemoral bypass in 26.7% and iliac vein release in 6.7%. (Blanch et al., 2014) suggested that  femoral vein was used in 85% and popliteal vein in 15%. Arteriovenous fistula for open surgery venous bypass were used in
patients with higher chance of graft failure due to poor inflow and use of prothetic graft bypass. It was used only for 20 % in our study. AV fistula was used for 26% in the study of (Garg et al., 2011).

In our study, the left lower limb was the most frequently affected. The
left lower limbs were (60%), and right lower limbs were (40%). with left/right limbs ratio of 3:2 . this result was founded in the study of ( Blanch et al., 2014) that left/right limb is a ratio, 2.7:1. Occlusive lesions were founded in 63% and stenotic lesions were founded in 37%. with occlusive lesions / stenotic lesion was 1.7 :1. Same results were founded in the study of (Garg et al., 2011) thatocclusive lesions / stenotic lesion was 1.7:1. Endovascular procedure was done through femoral vein in 86.7% and popliteal vein in 13.3 %.

In our study, the endovascular procedure was successful 93.3% similar to the study of (Hartung., 2012) who reported that successful rate was 98%. The net result of open surgery was that 46.6% had patent graft during 24 months, 26.7% had thrombosed graft and 13.3% missed follow up nearly to the study of (Ignatyev et al., 2017) who reported that patency rates was 70%. Clinical improvement was observed despite that deep venous system reflux was not corrected.In this study, about 65% of patients had cummulative improvement in pain and 40% had cummulative improvement of edema . Active ulcer wounds healed in 70%, recurrence of ulcer was not observed during follow up period  (Murphy et al., 2017) stated complete healing of ulcers in 78%, 66% had improvement of pain, and 41% had improvement of swelling, (Kaichuang et al,. (2012)  showed that edema relieved in 89% and ulcer healing in 82% of cases.

All post operative ( endovascular or open surgery ) thrombotic events occurred in occluded veins (post thrombotic ) unlike stenotic veins that did not present complication . In our study, for endovascular and open surgery approach, there was no peroperative pulmonary embolism, morbidity and mortality were 0%  (Murphy et al., 2017).

Conclusion

Endovascular treatment for iliofemoral venous obstruction had progressed rapidly, venous stenting was the primary choice as the stent placement was safe, effective and minimally invasive. However, surgical treatment remains an excellent option in cases in which endovascular techniques had failed or were not possible. Progress in endovascular techniques reduced the number of patients who Candidated for open surgical intervention. Open venous reconstruction was strongly considered in surgically fit patients with severe symptoms but it was inferior to endovascular intervention due to its complications as anesthesia exposure, hematoma, infection and susceptibility of graft thrombosis. 

clinical improvement post endovascular and surgical intervention had success rate including relieved edema (swelling), pain and healed venous ulcer. Good perioperative anticoagulation increase patency of the stents and grafts also restrict regular follow up and scanning by duplex ultrasound or venography identified early thrombosis or stenosis which should be managed directly to avoid stent or graft occlusion.

Blanch A, Luis M, Marta R  and  Isabel L. (2014): Study of endovascular treatment of iliofemoral veinous obstruction Journal of  Vascular Surgery Venous Disorders,  2 (1) ;2-7.

Garg N, Gloviczki P and Karimi KM. (2011): Factors affecting outcome of open and hybrid reconstructions for nonmalignant obstruction of iliofemoral veins and inferior vena cava. J Vasc Surg., 53:383–393.

Hartung O (2012): Endovascular management of chronic disabling iliocaval obstructive lesions: long-term results. Eur J Vasc Endovasc Surg., 38:118–124.

Ignatyev IM, Pokovsky AV and Gradusov EG. (2017): long-term outcomes of veno-venous bypass operations in post-thrombotic syndrome. J Phlebol Lymphol., 10(1) 5-9.

Jose A. and Peter K. (2019): Rutherford's Vascular Surgery and Endovascular Therapy 9th Edition Chapter 9 Venous Pathophysiology,494.

Joseph D, Raffetto, Robert T and Eberhard T. (2019): Postthrombotic Syndrome, Natural History, Pathophysiology, and Etiology Rutherford's Vascular Surgery and Endovascular Therapy, 9^th Edition, Chapter 156 : 6698-6703 .

.

Kahn SR, Galanaud JP, Vedantham S and  Ginsberg JS. (2016): Guidance for the prevention and treatment of the post-thrombotic syndrome. J Thromb Thrombolysis, 41:144-53.

Kaichuang Ye , Xinwu Lu , Weimin Li , Ying Huang , Xintian Huang , Min Lu  and Mier Jiang (2012): Long term outcomes of stent placement for symptomtic Nonthrombotic iliac vein compression lesions in chronic venous disease Journal of Vascular and Interventional Radiology, 23 (4 ) :497-502.

Murphy EH, Johns B, Varney E, Buck W, Jayaraj A and  Raju S. (2017): Deep venous thrombosis associated with caval extension of iliac stents. J Vasc Surg Venous Lymphat Disord., 5(1):8– 17.

O'Donnell TF, Passman MA and Marston WA. (2014): Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF). J Vasc Surg., 60(2 suppl) : :3S–59S.

Yves A and Oliver H. (2019): Iliocaval Venous Obstruction: Surgical Treatment In Rutherford’s 8th Edition 61: 929-950.