Balloon-Expandable Venous Stents

Number: 0531

Table Of Contents

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


Policy

  1. 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
    • Post-operative venous narrowing due to repair of sinus venosus atrial septal defect (ASD); or
    • Pulmonary artery stenosis and/or hypoplasia in a child; 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.
  2. Aetna considers balloon-expandable venous stents experimental and investigational 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.


Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code Code Description

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

CPT codes covered if selection criteria are met:

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 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; 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
I82.421 - 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]
Q25.6 Stenosis of pulmonary artery
Q25.79 Other congenital malformation of pulmonary artery [hypoplasia of pulmonary artery]
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]

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.

In children, there have been numerous reports of successful balloon dilation with stent placement of 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 operation.  Balloon-expandable stents for superior vena caval stenosis, occurring in patients with sclerosing mediastinitis due to malignancy or other causes, is 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 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 to the 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.  The patients at poor hepatic risk can be treated by 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 Vein Occlusion

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 micro-circulation have not been well-investigated.  The se 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 micro-circulation 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 vasodilation response to both ACh and SNP in the supine position and 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 patient 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 intra-vascular US (IVUS), and if an obstruction in their ilio-caval or ilio-femoral segments were 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 ulcer 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 %, 76.9 %, and in chronic cases (combined thrombotic and non-thrombotic) 93.1 %, 91 %, and 89.9 % in 3, 6, and 12 months, respectively.  A 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 from the intervention.  The authors concluded that ilio-caval and ilio-femoral 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 %) male, with a mean age of 36 years (range of 8 to 71 years), underwent 1st-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 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 a challenging to treat.  Endo-venous 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 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 data-base of all patients undergoing endo-venous 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 endo-venous 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 CIVs 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).  Median follow-up time was 12.1 (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 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 anti-coagulation.  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 endo-venous 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.

Furthermore, an UpToDate review on “Overview of iliocaval venous obstruction” (Mousa, 2020) states that “Endovenous technique – Balloon angioplasty is performed using a non-compliant balloon (e.g., 6 x 40 mm) prior to angioplasty to facilitate stent placement, typically with stainless steel stents (e.g., Gianturco Z stent, Wallstent, balloon-expandable Palmaz stent).  Post-stent ballooning is carefully performed to achieve proper iliocaval venous dilation.  The balloon is undersized and slowly inflated.  Overdilation or rapid inflation can cause caval rupture.  Following stenting, a completion venogram as well as IVUS exam confirms adequate angioplasty / stenting and rules out any extravasation or venous webbing”.

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 complication.  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 BESGs), 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 was 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 had data 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 TV; 4,797 renal arteries (50.2 %), 4,174 visceral arteries (43.6 %), and undefined TV (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 % and undefined stents in 36.3 %.  The included studies had quality assessment scores ranging between 11/15 and 15/15, with 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 complication 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 complication was 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 (2021) 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.


References

The above policy is based on the following references:

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