Balloon-Expandable Venous Stents

Number: 0531

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 balloon-expandable venous stents.

1. Medical Necessity

   Aetna considers placement of balloon-expandable venous stents with or without initial thrombolysis or surgical thrombectomy medically necessary for any of the following indications:

   • Budd-Chiari syndrome (thrombotic obstruction of major hepatic veins); or
   • Chronic iliac vein occlusions; or
   • Chronic ilio-caval vein obstruction; or
   • Ilio-femoral thrombosis secondary to iliac compression syndrome (compression of the left iliac vein between the right iliac artery and the fifth lumbar vertebra); or
   • Ilio-femoral venous obstructive disease; or
   • Post-operative venous narrowing due to repair of sinus venosus atrial septal defect (ASD); or
   • Salvage of thrombosed or stenotic arterio-venous dialysis access grafts; or
   • Superior or inferior vena caval stenosis in a child or adult; or
   • Symptomatic pelvic venous spurs (May-Thurner syndrome) – left deep venous thrombosis or post-thrombotic leg swelling; or
   • Venous obstruction of the superior or inferior limb of an atrial baffle after Mustard or Senning repair of transposition of the great arteries.

   Aetna considers venous stenting medically necessary for the treatment of superior vena cava occlusive disease.

2. Experimental, Investigational, or Unproven

   Aetna considers balloon-expandable venous stents experimental, investigational, or unproven for all other indications (e.g., management of central vein stenosis in hemodialysis individuals, and porto-mesenteric and porto-systemic venous reconstruction; not an all-inclusive list) because of insufficient evidence of effectiveness.

3. Related Policies

   1. CPB 0382 - Intravascular Ultrasound
   2. CPB 0541 - Dialysis
   3. CPB 0621 - Drug-Eluting Stents
   4. CPB 0785 - Endovascular Arterial and Venous Stent Procedures

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
CPT codes covered if selection criteria are met:
Balloon-expandable venous stents with or without initial thrombolysis or surgical thrombectomy - no specific code
37238	Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; initial vein
37239	each additional vein (List separately in addition to code for primary procedure)
37248	Transluminal balloon angioplasty (except dialysis circuit), open or percutaneous, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty within the same vein; initial vein[not covered for porto-mesenteric and porto-systemic venous reconstruction]
37249	each additional vein (List separately in addition to code for primary procedure)[not covered for porto-mesenteric and porto-systemic venous reconstruction]
Other HCPCS codes related to the CPB:
C1874	Stent, coated/covered, with delivery system
C1876	Stent, non-coated/non-covered, with delivery system
C1877	Stent, non-coated/non-covered, without delivery system
C2617	Stent, non-coronary, temporary, without delivery system
C2623	Catheter, transluminal angioplasty, drug-coated, non-laser
C2625	Stent, non-coronary, temporary, with delivery system
ICD-10 codes covered if selection criteria are met:
I80.10 - I80.13	Phlebitis and thrombophlebitis of femoral vein (deep) (superficial) [ilio-femoral thrombosis secondary to iliac compression syndrome]
I80.201 - I80.209 I80.221 - I80.299	Phlebitis and thrombophlebitis of other and unspecified deep vessels of lower extremities [May-Thurner syndrome]
I80.211 - I80.219	Phlebitis and thrombophlebitis of iliac vein [chronic occlusions]
I82.0	Budd-Chiari syndrome
I82.210 – I82.211	Embolism and thrombosis of superior vena cava
I82.411 – I82.419	Acute embolism and thrombosis of femoral vein
I82.421 - I82.429	Acute embolism and thrombosis of iliac vein [iliofemoral thrombosis secondary to iliac compression syndrome]
I82.521 - I82.529	Chronic embolism and thrombosis of iliac vein [chronic iliac vein occlusions]
I87.1	Compression of vein [vena cava syndrome (inferior) (superior)] [chronic ilio-caval vein obstruction][not covered for central vein stenosis in hemodialysis individuals]
Q20.5	Discordant atrioventricular connection [status post Mustard or Senning repair]
Q26.0	Congenital stenosis of vena cava [congenital stenosis of vena cava (inferior) (superior)]
T82.818A - T82.818S	Embolism of vascular prosthetic devices, implants and grafts [arteriovenous dialysis access grafts]
T82.828A - T82.828S	Fibrosis of vascular prosthetic devices, implants and grafts [arteriovenous dialysis access grafts]
T82.858A - T82.858S	Stenosis of vascular prosthetic devices, implants and grafts [arteriovenous dialysis access grafts][not covered for central vein stenosis in hemodialysis individuals]
T82.868A - T82.868S	Thrombosis of vascular prosthetic devices, implants and grafts [arteriovenous dialysis access grafts]
ICD-10 codes not covered for indications listed in the CPB:
Z99.2	Dependence on renal dialysis [central vein stenosis in hemodialysis individuals]

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Background

Endovascular balloon dilation has been proven to be effective in a great majority of patients with stenoses or occlusions of major veins. It is performed to re-establish venous flow and relieve symptomatic venous obstructions secondary to benign disease, malignant disease, and/or radiotherapy, and has been associated with little morbidity and mortality. The addition of balloon-expandable stents to the armamentarium has increased the overall success rate in a variety of clinical scenarios. Stents have been found to be particularly useful in dilatable venous lesions whose intrinsic elasticity results in vessel recoil after balloon dilation alone. Unlike self-expanding stents, balloon-expandable stents provide higher radial force and more precise deployment, making them particularly suited for rigid, calcified, or extrinsically compressed lesions and for anatomic locations requiring exact positioning (Azizi et al., 2020).

In children, there have been numerous reports of successful balloon dilation with stent placement for systemic venous stenoses, especially in patients who have post-operative narrowing due to repair of sinus venosus atrial septal defect (ASD) or Mustard or Senning operations. Balloon-expandable stents for superior vena caval stenosis, occurring in patients with sclerosing mediastinitis due to malignancy or other causes, are recommended as a preferred alternative to surgery, as operative repair is difficult and somewhat unrewarding. In contrast to the success observed with systemic venous obstruction, the limited experience with pulmonary vein stenosis dilation has been almost uniformly futile. Even when some initial successes were reported, stenosis recurred in virtually every instance.

Balloon-expandable stents have also been used successfully to treat superior or inferior vena caval stenosis in children and adults. Stenting appears to provide excellent short- and intermediate-term relief of such large venous obstructions, which may be associated with the presence of indwelling central venous lines or mediastinal malignancy, either before or after radiation therapy. Superior vena cava syndrome, mainly associated with malignant tumors, is usually resistant to any therapy. Although mechanical dilation of the narrowed lumen is ideal for relief of symptoms, conventional balloon angioplasty has not been effective. Surgical intervention is not a good choice in patients with advanced malignant tumors. Recently developed expandable metallic stents have been adopted for superior vena cava syndrome with good results.

Budd-Chiari syndrome (BCS) is an uncommon form of portal hypertension caused by obstruction of the hepatic venous outflow. Primary BCS requires different therapies depending on the stage of the disease. The fulminant or chronic forms with irreversible hepatic damage require definitive treatment, such as orthotopic liver transplantation. For the acute or subacute forms, characterized by reversible hepatic injury, a porto-systemic shunt represents the most effective treatment. Patients at poor hepatic risk can be treated with balloon-expandable stents. In both cases, preliminary caval stenting is necessary if the syndrome is complicated by significant obstruction of the inferior vena cava.

Iliac vein compression syndrome is a clinical condition that occurs as a result of compression of the left iliac vein between the right iliac artery and the fifth lumbar vertebra. Venous hypertension develops, and patients usually have marked edema of the left leg, sometimes leading to recurrent episodes of left leg cellulitis. Besides surgical repair, stenting has been shown to restore and maintain venous flow through the compressed area, relieving the leg edema.

Chronic Ilio-Caval Venous Occlusion or Obstruction 

Koksoy and associates (2018) noted that the role of cutaneous microvascular dysfunction is well known in the development of chronic venous disease. However, the effects of venous obstruction on microcirculation have not been well investigated. The investigators examined cutaneous microvascular function in patients with ilio-caval venous obstruction (ICVO) before and after venous stent placement. Endothelium-dependent and endothelium-independent vasodilator responses to iontophoretic administration of incremental doses of acetylcholine (ACh) and sodium nitroprusside (SNP) were evaluated using a laser Doppler scanner in the peri-malleolar region in the supine and sitting positions in patients with ICVO (n = 11) and in healthy control subjects (n = 15). Cutaneous microvascular function, the Venous Clinical Severity Score (VCSS), and the Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) clinical class were re-evaluated 3 months after stent placement in patients with ICVO. The vasodilatory responses to ACh and SNP in the cutaneous microcirculation were lower in patients with ICVO than in healthy subjects in the sitting position (p < 0.05). Re-canalization and stent placement were successful in all patients in the evaluation of VCSS and clinical class, and a significant decrease was determined in the signs and symptoms of the venous disease (p < 0.01). Stent placement resulted in a significant increase in the vasodilation response to both ACh and SNP in the supine position, with no improvement in the sitting position in patients with ICVO. The authors concluded that ICVO impaired endothelium-dependent and endothelium-independent vasodilation in the peri-malleolar region, and ilio-caval venous stent placement may recover microvascular dysfunction at different levels.

Tosenovsky (2019) presented results of interventions for ilio-caval obstruction or compression in patients with acute and chronic venous disease. Patients with chronic venous insufficiency (CVI) C3 to C6 (CEAP classification of venous insufficiency) and acute deep venous thrombosis (DVT) were assessed by ultrasound (US) scan, computed tomography (CT), venography, and/or intravascular ultrasound (IVUS), and if an obstruction in their ilio-caval or iliofemoral segments was confirmed, they underwent venoplasty and stenting. Acute DVT cases were treated with pharmaco-mechanical and/or catheter-directed thrombolysis, and residual obstruction was then stented. A total of 118 consecutive limbs were treated between October 2011 and December 2017; 32 limbs had an active ulcer (27%), 27 limbs had healed ulcers or advanced skin changes (23%), 39 limbs had swelling with or without other symptoms of CVI (33%), 15 limbs had acute symptomatic DVT (13%), and the residual 5 iliac vein cases were causing pelvic congestion syndrome (4%). Patency rates of the stents in acute cases were 84.6%, 76.9%, and 76.9%, and in chronic cases (combined thrombotic and non-thrombotic) 93.1%, 91%, and 89.9% at 3, 6, and 12 months, respectively. Relief of symptoms was achieved in 81.5% of limbs at some stage during the first 12 months (most of them within the first 3 months), although at the end of this period only 59.3% remained symptom-free. There was no limb loss and no mortality within 30 days of the intervention. The authors concluded that ilio-caval and iliofemoral venoplasty and stenting in both acute and chronic obstruction cases could be performed safely with good patency rates and reasonable improvement of symptoms of CVI.

McDevitt and co-workers (2019) reported the technical success, adverse events (AEs), clinical outcomes, and long-term stent patency of ilio-caval stent reconstruction for naive, non-inferior vena cava (IVC) filter-related chronic ilio-caval thrombosis. A total of 69 patients, including 47 (68%) males, with a mean age of 36 years (range of 8 to 71 years), underwent first-time ilio-caval stent reconstruction for non-IVC filter-associated ilio-caval thrombosis. The mean number of prothrombotic risk factors was 2.2 (range of 0 to 5), including 30 (43%) patients with IVC atresia. Upon initial presentation, the CEAP classification was C3 in 55 (80%) patients, C4 in 4 (5.8%) patients, C5 in 1 (1.4%) patient, and C6 in 7 (10%) patients. Technical aspects of stent reconstruction, technical success, AEs, 2-week and 6-, 12-, and 24-month clinical response, and 6-, 12-, and 24-month primary, primary-assisted, and secondary stent patency rates were recorded. Technical success was defined as re-canalization and stent deployment; AEs were reported according to the Society of Interventional Radiology classification system. Clinical success was defined as a 1-point decrease in CEAP classification, and stent patency was defined by the Cardiovascular and Interventional Radiological Society guidelines. The technical success rate was 100%. There were 352 venous stents deployed during stent reconstructions; 1 (1.4%) severe, 4 (5.8%) moderate, and 4 (5.8%) minor AEs occurred, and the median post-procedure hospitalization was 1 day (range of 1 to 45 days). Clinical success at 2 weeks and 6, 12, and 24 months was 76%, 85%, 87%, and 100%, respectively. The estimated 6-, 12-, and 24-month primary patency rates were 91%, 88%, and 62%, respectively. The estimated 6-, 12-, and 24-month primary-assisted patency rates were 98%, 95%, and 81%, respectively. The estimated 6-, 12-, and 24-month secondary-assisted patency rates were all 100%. The authors concluded that ilio-caval stent reconstruction was an effective treatment for non-IVC filter-associated chronic ilio-caval thrombosis with high rates of technical success, clinical responses, and stent patency.

Flynn and colleagues (2020) noted that chronic ilio-caval obstruction is challenging to treat. Endovenous ilio-caval stenting is becoming the treatment of choice for central vein stenosis and occlusion. However, outcomes in thrombotic disease have not been as robust as in non-thrombotic disease. These researchers described their experience utilizing covered stents as a novel tool for the management of chronic total occlusions of the ilio-caval veins. They carried out a retrospective review of a prospectively maintained database of all patients undergoing endovenous stenting with a covered stent for chronic occlusive ilio-caval disease over a 3-year period at their institution. Patients were followed clinically and with venous Duplex US scans to examine the feasibility, safety, and outcomes of ilio-caval endovenous stenting with covered stents. A total of 10 patients (8 men and 2 women) underwent ilio-caval stenting with covered stents from July 2015 to May 2018. A total of 20 self-expanding covered stents (SECS) and 13 balloon-expandable covered stents (BECS) were deployed in the central veins of the 10 patients; 6 SECS and 5 BECS were deployed in the inferior vena cava (IVC), 10 SECS and 6 BECS were deployed in the common iliac veins (CIVs) (5 patients had bilateral CIV BECS and 2 patients had bilateral CIV SECS), and 4 SECS and 2 BECS were deployed in the external iliac veins (EIVs) (2 patients had bilateral SECS placed). The median follow-up time was 12.1 months (range of 0.5 to 35.0 months). There were no peri-operative or post-operative complications; 9 (90%) patients maintained primary stent patency during the follow-up time; 1 patient (10%) had re-thrombosis of his stent due to under-treated common femoral vein disease in the setting of a new myeloproliferative neoplasm and an inappropriate cessation of therapeutic anticoagulation. All patients who were symptomatic pre-operatively had improvement in their pain, venous ulceration, and venous claudication; 8 of 9 (89%) patients had improvement of their lower extremity (LE) edema. The authors concluded that covered endovenous stenting of chronically occluded central veins is a safe and promising procedure; their use may improve the short- and long-term outcomes in this challenging patient population.

Chronic Iliofemoral Venous Occlusion or Obstruction

The Society of Interventional Radiology (SIR) position statement recommends endovascular stent placement for chronic iliofemoral venous obstruction in highly selected symptomatic patients with at least moderate life interference, anatomic evidence of significant obstruction (≥50% area reduction by intravascular ultrasound [IVUS] or occlusion), adequate deep venous inflow, and the ability to receive antithrombotic therapy when indicated; the statement acknowledges that the risk-benefit ratio has not been evaluated in well-designed multicenter randomized trials (Level of Evidence C–D) (Vedantham et al., 2023). The 2020 multi-society appropriate use criteria (AVF/SVS/AVLS/SIR) rated iliac vein stenting as appropriate for CEAP C4–C6 disease with ≥50% area reduction, may be appropriate for C3, rarely appropriate for C2, and never appropriate for asymptomatic compression or C1 disease; most supporting evidence consists of case series, and the panelists noted that edema outcomes with stenting are less predictable (Masuda et al., 2020). The evidence base for these indications is predominantly composed of single-center retrospective series and prospective registries, with no completed multicenter randomized controlled trials comparing stenting to conservative management.

Razavi et al. (2025) noted that there are varying anatomical and mechanical demands of stent placement in the iliofemoral venous segment; the Duo Venous Stent System is designed to address these issues. The purpose of the VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) Trial was to examine the safety and effectiveness of the Duo Venous Stent System for the treatment of patients with non-malignant iliofemoral venous obstructive disease. It was a prospective, international, single-arm, multi-center study that enrolled patients with symptomatic non-thrombotic (NT), post-thrombotic (PTS), or acute DVT (aDVT) iliofemoral venous outflow obstruction. The primary safety endpoint was freedom from major AEs at 30 days after the index procedure. The primary effectiveness endpoint was primary patency of stent-bearing segments at 12 months. Secondary and observational endpoints included symptom relief, primary-assisted patency, secondary patency, and device success. Patients remain in follow-up for 36 months. A total of 162 patients were enrolled at 30 sites in the U.S. and Poland. The primary safety endpoint was attained in 98.7% of patients against a pre-defined performance objective of 89.0% (p < 0.0001). The primary safety endpoint was attained in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary effectiveness endpoint was met in 90.2% compared with the performance objective of 77.3% (p = 0.0002). Primary patency was observed in 95.2% of patients with NT disease, 79.4% of those with PTS, and 86.7% of those with aDVT. No stent fracture, migration, or embolization occurred through 12 months. Patient-reported outcomes (PROs) showed improvements in VCSS, Villalta, EQ-5D-3L, and VEINES-QOL/Sym scores from baseline through 6 and 12 months. The authors concluded that through 12 months, the Duo Venous Stent System was safe and effective for the treatment of non-malignant iliofemoral venous obstructive disease.

Smith et al. (2025) noted that venous stenting has become the standard of care (SOC) for patients with iliofemoral venous stenosis who have failed conservative therapy. Although outcome data following such stenting exist for Wallstents and Wallstent-Zenith (Z) stent combinations, such data for dedicated stents is sparse outside of industry-sponsored trials. These investigators addressed this gap by comparing the outcomes of matched cohorts of limbs that underwent stenting with either the Medtronic Abre stent, the Bard Venovo stent, or Wallstent-Z stent combinations. Contemporaneously entered data on matched cohorts of patients who underwent stenting from 2016 to 2022 for quality of life (QOL)-impairing iliofemoral venous stenosis (not occlusion) after failing conservative therapy was analyzed. The VCSS (0 to 27), grade of swelling (GOS; 0 to 4), visual analog scale (VAS) pain score (0 to 10), and CIVIQ-20 QOL scores were evaluated initially and post-stenting to examine the effects of stenting. Analysis of variance and paired t-tests were used to compare clinical and QOL variables, whereas Kaplan-Meier analysis was used to examine primary, primary-assisted, and secondary stent patencies, with the log-rank test employed to discriminate between different curves. There were a total of 198 limbs that had undergone stenting, including 68 in the Abre, 60 in the Venovo, and 70 in the Wallstent-Z stent groups. The median age for the entire cohort was 65 years (range of 21 to 101 years). The cohort included 141 women and 57 men. Left laterality (112 limbs) was more common than right laterality (86 limbs). Post-thrombotic syndrome was observed in 146 limbs and non-thrombotic iliac vein lesions/May-Thurner syndrome in 52 limbs. The median body mass index (BMI) was 35 kg/m². Median follow-up was 20 months. For the entire cohort, post-stenting, VCSS improved from 6 to 4.5 at 3 months (p < 0.0001), further improved to 4 at 6 months (p < 0.0001), and remained at 4 at 12 months (p < 0.0001) and 24 months (p < 0.0001). GOS for the entire cohort improved from 3 to 1 at 3 months (p < 0.0001) and remained at 1 at 6 months (p < 0.0001), 12 months (p < 0.0001), and 24 months (p < 0.0001). VAS pain score for the entire cohort improved from 8 to 2 at 3 months (p < 0.0001), increased to 3 at 6 months (p < 0.0001) before dropping to 2 at 12 months (p < 0.0001), and remained at 2 at 24 months (p < 0.0001). The CIVIQ-20 score for the entire cohort improved from 61 to 38 (p < 0.0001) over the duration of follow-up. The primary patencies for the Abre, Bard, and Wallstent-Z stent groups at 32 months were 93%, 86%, and 92%, respectively (p = 0.37). Primary assisted patencies for all 3 groups at 32 months were 100% (p = 0.08). There were no stent occlusions in any of the groups. Re-intervention was pursued for QOL-impairing recurrent clinical manifestations in 13 limbs (7%), without a significant difference between groups (p = 0.46). The authors concluded that for patients undergoing stenting for QOL-impairing symptoms of iliofemoral venous stenosis after failing conservative therapy, Abre, Venovo, and Wallstent-Z stent combinations all appeared to provide similar clinical and QOL improvement. A significant difference between stent patencies for the 3 stent types was also not detected. These researchers stated that stent selection for the treatment of stenotic lesions of the iliofemoral venous territory can be based on stent availability and the preference/expertise of the interventionalist.

Huang et al. (2026) stated that endovascular re-canalization with venous stenting is the preferred treatment for iliofemoral venous obstruction. In a retrospective study, these investigators reviewed their experience and mid-term outcomes with endovascular therapy for iliofemoral venous obstruction using the Venovo self-expanding venous stent. Between October 2022 and March 2024, medical records of patients with iliofemoral venous obstruction treated with Venovo self-expanding venous stents were analyzed. Subjects were monitored at 3, 6, and 12 months. The primary endpoint was 12-month primary patency, defined as CT venography-derived stenosis of less than 50% and no target venous re-vascularization. Secondary endpoints included stent intimal hyperplasia and pain VCSSs. These researchers evaluated 51 limbs from 40 patients (mean age of 61.7 ± 10.7 years; 26 women), including 3 acute DVT cases, 6 post-thrombotic syndrome (PTS) cases, and 42 non-thrombotic iliofemoral vein lesion cases. All participants (100%) underwent successful endovascular treatment, with 5 undergoing combined stent deployment. The interventional operation-related complication rate was 1/51 (1.96%). The median follow-up was 14.6 months (range of 12 to 18 months). The primary patency rate at 1 year was 90%. Freedom from stent intimal hyperplasia at 12 months was 74.51% (38/51), and 3.92% (2/51) had in-stent stenosis of greater than 50%, which was reduced after high-pressure balloon dilation at 6 months. The mean VCSS decreased from a baseline of 13.1 ± 3.7 to 3.3 ± 1.6 at 12 months (p < 0.0001). No complications were observed during follow-up. The authors concluded that stenting iliofemoral venous obstruction using the Venovo self-expanding venous stent appeared to be safe and effective, with a high rate of 1-year clinical patency and a low re-intervention rate.

Superior and Inferior Vena Cava Stenosis

Barrette et al. (2020) reported the largest series specifically using Palmaz balloon-expandable stents for inferior vena cava (IVC) reconstruction. In 37 patients with symptomatic chronic venous obstruction in the infrarenal (n = 25) and intrahepatic (n = 12) IVC, 68 Palmaz stents were placed. Restoration of caval patency was achieved in all patients, with complications in 5.4%. Kaplan-Meier analysis demonstrated primary and primary-assisted patency of 66% and 84%, respectively, at 24 and 48 months. Risk of stent migration was low.

In a retrospective study, Matthaiou et al. (2020) examined the technical and clinical outcomes of superior vena cava (SVC) stent placement via upper-limb (UL) venous access in malignant SVC syndrome (SVCS) and compared the effectiveness of different nitinol stent types. Between 2006 and 2018, a total of 156 patients (132 men; mean age of 62 years; range of 33 to 81 years) underwent SVC stent placement for malignant obstructions via UL venous access with one of three types of nitinol stents: one venous-dedicated (Sinus-XL stent) and two non-venous-dedicated (E-Luminexx Vascular Stent and Protégé GPS). Cases of common femoral vein access or non-nitinol stents were excluded from further analysis. The mean duration of follow-up was 8 months. Technical success was achieved in 99.3% of cases; one patient died during the procedure as a result of cardiac tamponade. Balloon pre-dilation was carried out in 10 patients and post-dilation in 126. Mean procedural time was 34.4 minutes (range of 18 to 80 minutes). Overall survival (OS) rates were 92.3%, 57.3%, and 26.8%, and overall primary patency rates were 94.5%, 84.8%, and 79.6% at 1, 6, and 12 months, respectively. There were no statistically significant differences in primary patency rates between venous- and non-venous-dedicated stents or among different Stanford SVCS grading groups (p > 0.05). The authors concluded that SVC stent placement via an UL approach was a safe and effective technique. Moreover, there was no evident benefit of venous-dedicated versus non-venous-dedicated stents in the treatment of malignant SVCS.

Uceda et al. (2021) stated that thoracic central vein obstruction (TCVO) in the presence of upper extremity (UE) hemodialysis access can present as SVCS and cause vascular access dysfunction and failure. These investigators reported the techniques and results of endo-revascularization of TCVO in hemodialysis patients, which allowed for long-term functioning vascular access in the UE. From June 2009 to February 2020, a total of 45 hemodialysis patients underwent TCV endo-revascularization. The indications for surgery were TCVO or SVCS that threatened the function of a pre-existing upper arm access or contraindicated placement of a new upper arm access. Conventional endovascular techniques were used when feasible. Patients with unfavorable anatomy were treated using a trans-septal needle to cross difficult intra-thoracic stenosis and occlusions or to facilitate an inside-out central venous access technique. The re-establishment of venous outflow was accomplished with angioplasty, stenting, and/or placement of HeRO conduits. Successful re-vascularization was followed by hemodialysis access revision or a new UE access placement. These investigators recorded the risk factors and procedural outcomes, patency rates, complications, as well as mortality. The mean age of participants was 53 ± 16.3 years, and 51% were women. The most common risk factors were diabetes mellitus (64.2%) and hypertension (56%); and 25 patients (55.5%) had symptoms of SVCS. These symptoms resolved after the TCV procedure in all cases. Crossing of the TCV lesion was successful using a conventional catheter and wire in 26 cases (57.8%) and trans-septal needle in 17 cases (37.8%), including 12 using an inside-out central venous access technique. Treatment of the TCV lesion included a HeRO conduit in 20 cases (44.4%), stenting in 17 (37.7%), and transluminal balloon angioplasty alone in 7 (15.5%). Other veins were treated in 33 cases (73.3%). The overall technical success rate was 95.5%. Two intra-operative complications occurred, including one case of severe hypotension and one of fatal cardiac tamponade. Of the 16 patients with pre-existing UE access, its function was preserved in all 16 (100%). In 24 of 27 patients (85.7%), new arm access was successfully created after the TCV procedure. The overall clinical success rate was 88.9%. The average follow-up was 663.4 days (median of 507 days; range of 0 to 2679 days). During follow-up, 26 patients had undergone 90 procedures to maintain access function, 21 had undergone repeat endovascular interventions, and 17 had undergone open procedures. Eight patients (17.8%) had developed infections, 5 involving HeRO conduits that required excision with loss of access. During the follow-up period, 14 patients (31%) had died of unrelated causes, and 34 patients (75.5%) maintained functional access. The authors concluded that the findings of this trial demonstrated that endo-revascularization of TCVO reconstruction was effective in maintaining function or allowing the creation of UE hemodialysis access, with acceptable complication rates.

Azizi et al. (2020) specifically compared balloon-expandable versus self-expanding stents for SVC syndrome, noting that balloon-expandable stents (e.g., Palmaz) enable precise placement with reduced incidence of migration and higher radial force to overcome recoil, while self-expanding stents conform better to the vessel wall and are resistant to two-point compression. The review noted that a difference in clinical success rates and overall patient mortality has not yet been demonstrated between various types of stents. A systematic review and meta-analysis of 54 studies encompassing 2,249 patients reported pooled technical and clinical success rates of 96.8% and 92.8%, respectively, with patency remaining above 90% at one year; however, the analysis could not differentiate outcomes by stent type (Aung et al., 2022). A more recent systematic review and meta-analysis of 39 studies (1,539 patients) reported primary patency of 81.5% up to one year, declining to 63.2% at 12–24 months, with secondary patency of 76.6% at ≥24 months (Chawla et al., 2025).

An et al. (2024) noted that SVCS is a constellation of symptoms that results from partial or complete SVC obstruction. Endovascular SVC stenting is an effective treatment for SVCS with rapid effectiveness and low risk of complications. In a retrospective study, these researchers examined the technical and clinical outcomes of a cohort of patients with SVCS treated with the Abre self-expanding venous stent. They employed an institutional database to identify patients with SVCS treated with Abre self-expanding venous stent placement between 2021 and 2023. Patient demographic data, technical outcomes, treatment effectiveness, and AEs were obtained from the electronic medical record. A total of 19 patients (mean age of 58.6 years) were included in this trial – 13 interventions were carried out for malignant compression of the SVC, 5 for central venous catheter-related SVC stenosis, and 1 for hemodialysis (HD) fistula-related SVC stenosis refractory to angioplasty. Primary patency was achieved in 93% of patients (17/19); 2 patients (7%) required re-intervention with thrombolysis and angioplasty within 30 days post-stenting. Mean duration of clinical and imaging follow-up were 228.7 ± 52.7 and 258.7 ± 62.1 days, respectively. All patients with clinical follow-up experienced significant improvement in clinical symptoms post-intervention. No stent-related complications were observed post-intervention. The authors concluded that treatment of SVCS with the Abre self-expanding venous stent exhibited high rates of technical and clinical success; and no complications related to stent placement were identified in this study.

In a retrospective study, Maleux et al. (2024) examined the technical and long-term clinical outcome of angioplasty and stenting using the Venovo venous stent for the treatment of malignant and benign SVC occlusive disease. Consecutive patients treated with the Venovo venous stent for SVC occlusive disease were included. SVC obstruction symptoms were classified according to the Kishi score. The Wilcoxon signed-rank test was employed for testing the significance of changes. Technical success, defined as correct placement of the stent, completely covering and re-expanding the obstruction, between groups was tested using the Fisher exact test. Overall survival was calculated using the Kaplan-Meier method. A total of 55 patients underwent stent insertion for symptomatic benign (n = 13; 24%) or malignant (n = 42; 76%) SVC occlusive disease. A significant drop in Kishi score, mean of 3.91 before versus mean of 1.02 following the procedure (p < 0.0001), was observed. In 1 patient (1.8%), an additional balloon-expandable stent was needed to manage incomplete expansion of the nitinol stent. In 1 patient, a procedure-related lung embolic complication was observed. Early thrombotic occlusion of the stent occurred in 1 patient. Late symptomatic re-stenosis occurred in 3 patients. Overall primary stent patency and primary-assisted stent patency were 86% (95% CI: 66% to 95%) and 97% (95% CI: 83% to 100%) at 1-year follow-up, and 98% (95% CI: 87% to 100%) at 2-year follow-up, respectively. The authors concluded that angioplasty and stent placement using the Venovo venous stent was safe and effective for the treatment of both benign and malignant SVC occlusive disease. Re-intervention for symptomatic re-stenosis was rare.

Furthermore, an UpToDate review on “Malignancy-related Superior Vena Cava Syndrome” (Drews et al., 2025) states that “The placement of an endovenous stent restores venous return and provides rapid and sustained symptom palliation in patients with malignant SVC syndrome, even in the absence of severe or life-threatening symptoms. An endovenous stent is particularly appropriate for rapid symptom palliation in patients with tumors for which response to chemotherapy and/or RT is intermediate or poor (i.e., NSCLC and pleural mesothelioma) and for those with recurrent SVC syndrome who have previously received systemic therapy or RT. The technical success rate for endovenous stenting in patients with malignant SVC syndrome is in the range of 95 to 100%, and over 90% of patients report relief of symptoms. Several dedicated venous stents have been developed and are available for clinical use in the United States in diameters up to 20 mm. Venous stents differ from arterial stents with properties better suited for venous placement, including the ability to withstand external compression. Thrombotic occlusion of the SVC is not a contraindication to endovenous stent placement, nor is the presence of thrombus within the area of stenosis. It may be necessary to clear the thrombus before proceeding. For heavily pretreated patients who develop SVC syndrome after having been exposed to most of the active agents for their particular malignancy, alternative forms of therapy (e.g., RT, endovenous stent placement) may be needed for symptom control. Non-small cell lung cancer -- As compared with more chemotherapy-sensitive SCLC, the degree and rapidity of response to chemotherapy are less in NSCLC. Symptom relief in this setting may be more rapidly achieved by the use of an endovenous stent followed by antitumor therapy, even in the absence of life-threatening symptoms. For patients with highly chemotherapy-sensitive malignancies, such as small cell lung cancer (SCLC), NHL, or germ cell cancer (and possibly breast cancer), we suggest systemic chemotherapy rather than RT or an endovenous stent.”

Balloon-Expandable Stent for Repair of Aortic Aneurysms

In a prospective study, Tenorio and associates (2020) examined outcomes of directional branches using self-expandable stent grafts (SESGs) or balloon-expandable stent grafts (BESGs) during fenestrated-branched endovascular aneurysm repair of thoraco-abdominal aortic aneurysms. Patients treated by fenestrated-branched endovascular aneurysm repair were enrolled from 2014 to 2018. These researchers included in the analysis patients who had target vessels incorporated by directional branches using either SESG (Fluency [Bard, Covington, GA] or Gore Viabahn [W. L. Gore & Associates, Flagstaff, AZ]) or BESG (Gore Viabahn balloon-expandable stent [VBX]). Target artery instability (TAI) was defined by a composite of any stent stenosis, separation, or type IC or type IIIC endoleak requiring re-intervention, and stent occlusion, aneurysm rupture, or death due to target artery complications. Endpoints included technical success, target artery patency, freedom from TAI, freedom from type IC or type IIIC endoleak, and freedom from target artery re-intervention. There were 126 patients (61% men; mean age of 73 ± 8 years) included in the study. A total of 335 renal-mesenteric arteries were targeted by directional branches using SESGs in 62 patients and 176 arteries or BESGs in 54 patients and 159 arteries. Patients in both groups had similar thoraco-abdominal aortic aneurysm classification and aneurysm and target artery diameter, but SESG patients had significantly (p < 0.05) shorter stent length (-7 mm) and larger stent diameter (+1 mm) and more often had adjunctive bare-metal stents (72% versus 15%). Technical success was achieved in 99% of patients, with 1 30-day death (0.7%). Mean follow-up was significantly longer among patients treated by SESGs compared with BESGs (23 ± 12 months versus 8 ± 8 months; p < 0.0001); TAI occurred in 27 directional branches (8%), including 11 type IC endoleaks (2 SESGs, 9 BESGs), 10 stenoses (3 SESGs, 7 BESGs), 4 occlusions (3 SESGs, 1 BESG), 4 type IIIC endoleaks (2 SESGs, 2 BESGs), and 1 stent separation (SESG), resulting in 20 target artery re-interventions in 16 patients (5 SESGs and 11 BESGs). At 1 year, SESGs had higher primary patency (97% ± 2% versus 96% ± 2%; p = 0.004), freedom from TAI (96% ± 2% versus 88% ± 3%; p < 0.0001), freedom from type IC or type IIIC endoleaks (98% ± 1% versus 92% ± 3%; p = 0.0004), and freedom from target artery re-interventions (98% ± 1% versus 88% ± 4%; p < 0.0001) compared with BESGs. There was no difference in secondary patency for SESGs and BESGs (98% ± 1% versus 99% ± 1%; p = 0.75). Factors associated with TAI were large stent diameter (odds ratio [OR], 0.6; p < 0.0001) and use of VBX stent graft (OR, 6.5; p < 0.0001). The authors concluded that directional branches were associated with high technical success and low rates of stent occlusion, independent of stent type; however, primary patency, freedom from TAI, and freedom from type IC or type IIIC endoleaks were lower for BESGs compared with SESGs.

Motta and colleagues (2021) compared the performance between the VBX and a covered SES used as bridging stents for directional branches during fenestrated or branched endovascular aneurysm repair of complex aortic aneurysms. Patients with thoraco-abdominal aortic aneurysms (type I to IV) or pararenal aortic aneurysms, either at high risk for open repair or unsuitable for endovascular repair with commercially available devices, were prospectively enrolled in a physician-sponsored investigational device exemption (IDE) trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES, and data were analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage, and continuous variables were expressed as median (inter-quartile range [IQR]). Kaplan-Meier curves were used to estimate long-term results. Groups were compared with the log-rank test; p < 0.05 was considered statistically significant. During the period from July 2012 through June 2019, a total of 263 patients were treated for complex aortic aneurysm (thoraco-abdominal aortic aneurysm) with fenestrated or branched endografts. The devices used were either custom-manufactured devices or off-the-shelf p-Branch or t-Branch devices. The median age was 71 years (IQR, 66 to 79 years); 70% were men, and 81% were white. The most common cardiac risk factors were smoking (92%), hypertension (91%), hyperlipidemia (78%), and chronic obstructive pulmonary disease (52%). The total number of vessels incorporated into the repair was 977, with branches representing 18.4% (179 branches). Among these 179 branches, the celiac artery, superior mesenteric artery, right renal artery, and left renal artery received 54 (30%), 56 (31%), 38 (21%), and 31 (18%) branches, respectively. VBX and SES groups represented 96 (54%) and 81 (46%) of the branches implanted. The celiac artery, superior mesenteric artery, right renal artery, and left renal artery received VBX as a bridging stent in 40%, 46.7%, 33.8%, and 32.2%, respectively. The overall cohort survival rate was 78.5% at 24 months. There was no branch-related rupture or mortality. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, p = 0.95), freedom from endoleak (VBX, 95.6%; SES, 98.6%; log-rank, p = 0.66), freedom from secondary intervention (VBX, 94.7%; SES, 98.1%; log-rank, p = 0.33), and freedom from branch instability (VBX, 95.6%; SES, 97.2%; log-rank, p = 0.77) were similar between groups. The authors concluded that this initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. These findings showed that in a high-volume, experienced aortic center, the VBX stent was a safe and effective bridging stent option during branched endovascular aortic repair. Moreover, these researchers stated that multi-center studies with a larger cohort and longer follow-up are needed to validate these findings.

Mezzetto and co-workers (2021) noted that concern exists regarding the durability of stent grafts used to bridge aortic grafts to visceral and renal arteries during fenestrated and branched endovascular aneurysm repair (F/B-EVAR). There are no guidelines regarding the ideal technique for joining target vessels (TVs). In a systematic review, these researchers examined data published from 2014 to 2019 using PRISMA guidelines and PICO models. Keywords were searched in Medline, Embase, and Cochrane Library. All articles were screened by 2 authors (a 3rd author in case of discrepancies). Only original articles regarding F/B-EVAR in complex aortic aneurysm, reporting the number and type of TVs mated, the onset of bridging stent complications, and re-interventions on TVs were included. Analysis included quality assessment scoring, types of stent grafts, and complications related to bridging stents. A total of 19 studies were included with 2,796 patients and 9,556 TVs; 4,797 renal arteries (50.2%), 4,174 visceral arteries (43.6%), and undefined TVs (n = 585; 6.1%) were bridged. Balloon-expandable stent-grafts (B-EXP) were used in 40.9% and self-expandable (S-EXP) in 22.7%, with undefined stents in 36.3%. The included studies had quality assessment scores ranging between 11/15 and 15/15, with a high grade of accordance on reporting general results, but a low grade of accordance on reporting detailed data. Despite study heterogeneity, high-volume analysis confirmed a higher rate of complications in renal arteries than visceral arteries, 6% (95% CI: 4 to 8) versus 2% (95% CI: 1 to 3), respectively. The rate of re-interventions was similar, 3% (95% CI: 2 to 4) and 2% (95% CI: 1 to 3). S-EXP versus B-EXP stent complications were 4% (95% CI: 2 to 7) versus 3% (95% CI: 2 to 5), respectively. The authors concluded that this systematic review underlined the low grade of accordance in reporting detailed data of bridging stents in F/B-EVAR. Renal TVs were more prone to complications, with an equivalent re-intervention rate to visceral TVs. As to B-EVAR, the choice of B-EXP over S-EXP is still uncertain.

Management of Central Vein Stenosis in Hemodialysis Patients

Jones et al. (2022) described the use of a VBX balloon expandable stent-graft (WL Gore, Flagstaff, AZ) to treat a right brachio-cephalic vein stenosis in a hemodialysis patient before ipsilateral upper limb arterio-venous (AV) fistula formation. Balloon expandable stent-grafts are unsuitable for treating peripheral fistula stenoses due to their susceptibility of being crushed. The right brachio-cephalic vein is both relatively short in comparison to the left and is less susceptible to extrinsic compression and the use of such a device to treat stenosis here allowed for very accurate placement and restoration of luminal diameter. The advantages and disadvantages of using these devices in hemodialysis access circuits were also discussed, in what these researchers believed to be the 1st report of the use of a dedicated commercially available balloon expandable stent graft in a hemodialysis patient. Moreover, these investigators stated that further experience with larger series that also examine longer term outcomes is needed to determine the exact role of these devices in the management of central vein stenosis within the hemodialysis population.

Porto-Mesenteric and Porto-Systemic Venous Reconstruction

Parra et al. (2022) noted that porto-mesenteric and porto-systemic venous occlusive disease may lead to porto-mesenteric hypertension, variceal bleeding, ascites and hypersplenism. Data regarding endovascular reconstructive strategies in children, however, are limited. These investigators reported technical success, outcome and patency of porto-mesenteric and porto-systemic venous reconstruction using VIABAHN VBX balloon-expandable endoprostheses in pediatric patients. A total of 5 pediatric patients (median age of 15 years, range of 4 to 18 years), including 3 (60%) boys and 2 (40%) girls, with porto-mesenteric or porto-systemic venous occlusion or recurrent stenosis, underwent balloon-expandable stent graft reconstruction. Presenting symptoms included acute variceal bleeding, without (n = 2, 40%) or with (n = 1, 20%) splenomegaly, and transfusion-dependent chronic melena (n = 1, 20%); 1 patient was asymptomatic (n = 1, 20%).  Pre-procedural imaging included Doppler US and contrast-enhanced CT in all patients. Initial imaging showed 4 (80%) occlusions and 1 (20%) recurrent stenosis of greater than 50%. Technical aspects of the reconstructions, technical successes, clinical outcomes and adverse events were recorded. Technical success was defined as completion of stent graft reconstruction; AEs were categorized according to Society of Interventional Radiology criteria. Clinical success was defined as resolution of the presenting symptoms and/or prevention of portal hypertensive sequela. Venous reconstruction was technically successful in all 5 patients. Stent graft locations included the main portal vein in 2 (40%), the superior mesenteric vein in 1 (20%), autologous Meso-Rex shunt in 1 (20%) and spleno-caval shunt in 1 (20%); 6 stent grafts were placed (2 stent grafts placed in a single patient). Stent grafts had a median diameter of 7 mm (range of 6 to 10 mm) and a median length of 59 mm (range of 19 to 79 mm). Median fluoroscopy time was 36.6 mins (range of 13.4 to 95.8 mins) and median air kerma was 301.0 mGy (range of 218.0 to 1,148.2 mGy); no AEs occurred. Median clinical follow-up was 18 months (range of 6 to 29 months). Median imaging follow-up was 17 months (range of 2 to 29 months). Clinical success was achieved in all patients and maintained during the follow-up period; 1 patient required follow-up intervention with superior mesenteric vein side extension with a self-expanding bare metal stent due to peri-graft stenosis detected on CT 3 months after stent placement. There were no stent graft occlusions. The authors concluded that porto-mesenteric and porto-systemic venous reconstruction using balloon-expandable stent grafts in pediatric patients was feasible and clinically successful in this preliminary experience. Moreover, these researchers stated that additional studies are needed.

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References