|Subject:||Venous Angioplasty with or without Stent Placement|
|Policy #:||SURG.00122||Current Effective Date:||08/12/2013|
|Status:||Revised||Last Review Date:||08/08/2013|
Venous angioplasty (with or without stent placement) has been used in the treatment of obstructed hemodialysis access grafts, superior vena cava syndrome, Budd-Chiari syndrome and congenital cardiac defects. Venous angioplasty, also known as venoplasty, has been investigated as a method to improve venous flow in a relatively new condition known as chronic cerebrospinal venous insufficiency (CCSVI). CCSVI has been reported in some individuals with multiple sclerosis (MS). Venous angioplasty has also been investigated in the treatment of lower extremity venous congestion. This document addresses the use of venous angioplasty as a treatment modality.
Venous angioplasty (with or without stent placement) is considered medically necessary for treatment of the following conditions:
Investigational and Not Medically Necessary:
Venous angioplasty (with or without stent placement) is considered investigational and not medically necessary for the treatment of multiple sclerosis, chronically occluded iliac veins, ilio-femoral venous thrombosis, and any other conditions not listed above as medically necessary.
Stenotic or Thrombosed Arterio-venous Dialysis Access Grafts
The maintenance of thrombosed dialysis access grafts has been a challenging undertaking for many years. Once a dialysis access graft is thrombosed or stenosed, balloon angioplasty has been shown to effectively restore graft function (Beathard, 1992; Beathard 2003; Kanterman, 1995; Pappas 2002). Van Ha (2004) reported that there has been an evolution in the percutaneous treatment of thrombosed dialysis access grafts during the last 20 years allowing for safe and efficacious restoration of flow in thrombosed grafts.
The National Kidney Foundation (NKF) (2006) guideline update for the treatment of arteriovenous graft complications states in regards to stenosis without thrombosis:
Stenoses that are associated with AVGs should be treated with angioplasty or surgical revision if the lesion causes a greater than 50% decrease in the luminal diameter and is associated with the following clinical/physiological abnormalities:
For treatment of thrombosis or associated thrombosis the NKF states:
Each institution should determine which procedure, percutaneous thrombectomy with angioplasty or surgical thrombectomy with AVG revision, is preferable based upon expediency and physician expertise at that center.
Thrombotic Obstruction of Major Hepatic Veins (Budd-Chiari Syndrome)
Data to support angioplasty with or without stent placement for the treatment of Budd-Chiari syndrome consists of multiple retrospective studies or case series of varying size (Fisher, 1999; Han, 2013; Meng, 2011; Pelage, 2003; Qiao, 2005; Zhang, 2003).
In the largest case series, Meng and colleagues (2011) evaluated endovascular treatment of Budd-Chiari syndrome (BCS) in 903 cases at a single Chinese center. The obstruction in the inferior vena cava (IVC) was carried out first, then obliteration or stenosis in the IVC was opened or dilated and a stent was placed. The procedure was reported to be successful in 821 out of 903 cases. Complications included acute renal failure (eight cases), hepatic coma (two cases), and acute heart failure (43 cases). The authors concluded that endovascular treatment has become the treatment of choice for BCS because of its minimal trauma and fast recovery.
More recently, Han and colleagues (2013) evaluated the long-term outcomes of percutaneous recanalization and predictors of patency and survival in a retrospective case series of individuals with BCS at a single Chinese center. Between July 1999 and August 2010, 177 consecutive cases of primary BCS were treated with percutaneous recanalization and followed up until their last clinical evaluation or death. Percutaneous recanalization was reported as technically successful in 168 of the 177 cases (95%). Fifty-one of the 168 individuals (30%) were treated with percutaneous transluminal angioplasty (PTA) alone and 117 (70%) were treated with a combination of PTA and stent placement. Procedure-related complications occurred in seven of the 168 individuals (4%). The cumulative 1-, 5-, and 10-year primary patency rates were 95%, 77%, and 58%, respectively. Independent predictors of reocclusion included increased white blood cell count and use of PTA alone. The cumulative 1-, 5-, and 10-year secondary patency rates were 97%, 90%, and 86%, respectively. There were 22 deaths during a median follow-up of 30 months (range, 0.25-137 months). The cumulative 1-, 5-, and 10-year survival rates were 96%, 83%, and 73%, respectively. Independent predictors of survival included variceal bleeding, increased alkaline phosphatase and blood urea nitrogen levels, and reocclusion.
Venous Angioplasty for Stenosis or Occlusion associated with Superior Vena Cava Syndrome
Superior vena cava stenting for the treatment of malignant and nonmalignant superior vena cava obstruction is well established (Schindler, 1999; Uberoi, 2006). Venous angioplasty is often necessary prior to stenting to offer safe palliation of potentially fatal complications associated with mediastinal malignant disease and compares very favorably with standard therapies such as chemotherapy and radiotherapy. Superior vena cava syndrome can also be caused by benign occlusion from chronic indwelling catheters resulting in arm or facial swelling, difficulty breathing, or an inability to obtain vital venous access, among others.
Iliac Vein Compression Syndrome (for example, May-Thurner Syndrome)
May-Thurner syndrome has been treated with endovascular stent placement for nearly 20 years (O'Sullivan, 2000; Semba, 1994). Endovascular therapy, specifically catheter-directed thrombolysis followed by stent placement, is the current primary intervention for May-Thurner syndrome (Moudgill, 2009). Review of the current literature, primarily case studies and case series, indicates that angioplasty has also been used with mixed results. Peters and colleagues (2012) reports three cases and Zander (2008) reports one case of successful intervention in May-Thurner compression with angioplasty. However, Patel (2000) reports that 10 women with symptomatic May-Thurner syndrome failed an initial course of angioplasty and subsequently progressed to urokinase and stenting. One retrospective case review from a surgical registry included 15 May-Thurner cases in which venous angioplasty with stenting restored and maintained venous flow through the compressed area. Titus and colleagues (2011) described a series of iliofemoral venous angioplasty and stenting occurring over a four-year period. Charts were retrospectively reviewed for individual demographics, the extent of venous system involvement, the time course of the venous pathology, and any underlying cause. The 15 (42%) individuals with a recognized underlying etiology had been diagnosed with May-Thurner syndrome. An etiology was not recognized in nine cases. A total of 36 subjects (40 limbs) were stented from January 2005 through December 2008. Both lower extremities were involved in four subjects. Thrombolysis was performed in 19 cases (52.8%). The mean follow-up time period in the study population was 10.5 months. One stent in the study occluded acutely and required restenting. Primary patency rates at 6, 12, and 24 months were 88%, 78.3%, and 78.3%, respectively. Secondary patency rates for the same time frames were 100%, 95%, and 95%. Better outcomes were seen in stenting for May-Thurner syndrome and idiopathic causes, whereas external compression and thrombophilia seemed to portend less favorable outcomes (P < .001). Symptomatic improvement was reported in 24 of 29 individuals (83%) contacted by telephone follow-up.
Venous Angioplasty for Pulmonary Vein Stenosis
Expert specialty consensus review indicates that venous angioplasty may be used for the treatment of pulmonary vein stenosis. Recently there have been published reports of venous angioplasty being successfully used to treat pulmonary vein stenosis following lung transplant (Loyalka, 2012).
Venous Angioplasty for Congenital Heart Disease:
Angioplasty has long played a role in the treatment of numerous congenital cardiac defects including stenosis or hypoplasia of a pulmonary artery; coarctation of the aorta, transposition of the great arteries, repair of sinus venosus atrial septal defect (ASD); or venous obstruction following Mustard or Senning repair of transposition of the great arteries (Allen, 1998).
Treatment of Multiple Sclerosis
Various reports in the peer reviewed published literature (Zamboni 2009a; Zamboni, 2009b) describe a potential relationship between the abnormal venous circulation termed chronic cerebrospinal venous insufficiency (CCSVI) and MS.
The role of venous angioplasty as a potential treatment option for those with MS and CCSVI has been investigated. Zamboni and colleagues (2009c) evaluated the influence of venous angioplasty on the clinical outcome of CCSVI and MS. The authors characterized CCSVI as multiple stenoses of the principal pathways of extracranial venous drainage, including the internal jugular veins (IJV) and the azygous (AZY) vein with development of insufficient drainage evidenced by cerebral magnetic resonance (MR) perfusion studies. In this study, a total of 65 consecutive participants with CCSVI and MS (35 with relapsing remitting MS [RRMS], 20 with secondary progressive MS [SPMS], and 10 with primary progressive MS [PPMS]), underwent venous angioplasty. Mean follow-up time was 18 months. Reported study results included lower postoperative venous pressure in the IJVs and AZY, a higher risk of restenosis in the IJVs compared with the AZY, improved MS clinical outcomes, and improved mental quality of life outcomes in all types of MS, except SPMS.
Doepp and colleagues (2010) investigated the hypotheses of CCSVI by performing extended extracranial and transcranial color coded sonography studies on 56 participants with MS and 20 controls. Study results demonstrated that blood flow direction in the internal jugular veins (IJVs) and vertebral veins was normal (in all but one person) and IJV stenosis was not present in any participants. The authors concluded that the results of their study did not suggest restricted venous drainage in participants with MS and challenged the hypothesis that CCSVI plays a role in the pathogenesis of MS.
Sundstrom and colleagues (2010) tested the hypothesis of CCSVI on 21 individuals with RRMS and 20 controls. All study participants were examined with magnetic resonance imaging (MRI) and those with RRMS also received contrast enhanced magnetic resonance angiography (MRA). Findings reported to be associated with the MS hypothesis of CCSVI were not able to be reproduced. The authors concluded they found no support for a treatment rationale of endovascular procedures like angioplasty or stenting for the treatment of individuals with CCSVI and MS.
In a larger, more recent controlled and blinded study, Zivadinov and colleagues (2011) performed transcranial and extracranial Doppler imaging on 499 people to determine the prevalence of CCSVI. The participants included 289 people with MS, 163 healthy controls (HC), 26 with other neurological diseases (OND), and 21 with clinically isolated syndrome (CIS) (having a first neurological episode that can often lead to definite MS). Researchers found an increased prevalence of CCSVI in MS, although lower than in earlier reports. In addition, CCSVI was found in non-MS participants. Variable rates were reported depending on whether or not borderline cases were included. When borderline cases were considered not to have CCSVI, the prevalence was 56.1% in MS, 42.3% in OND, 38.1% in CIS and 22.7% in HC. When borderline cases were excluded from calculations, the prevalence of CCSVI was 62.5% in MS, 45.8% in OND, 42.1% in CIS and 25.5% in HC. The researchers reported modest sensitivity and specificity and stated that their findings point against CCSVI as having a primary causative role in MS.
Kostecki and colleagues (2011) prospectively evaluated six month follow-up results of endovascular treatment of CCSVI and MS. Thirty-six participants with confirmed MS and CCSVI underwent endovascular treatment by means of a uni- or bilateral jugular vein angioplasty with optional stent placement. Their MS-related disability status and quality of life were evaluated at one, three and six months postoperatively by the following scales: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale (MSIS-29), Epworth Sleepiness Scale (ESS), Heat Intolerance scale (HIS) and Fatigue Severity Scale (FSS). For patency and restenosis rate assessment, the control US duplex Doppler examination was used. Six months after the procedure, restenosis in post-PTA jugular veins was found in 33% of cases. Among 17 individuals who underwent stent implantation into the jugular vein, restenosis or partial in-stent thrombosis was identified in 55% of the cases. At the six month follow-up, there was no significant improvement in the EDSS or the ESS. The endovascular treatment of the CCSVI improved the quality of life according to the MSIS-29 scale but only up to three months after the procedure (with no differences in the six month follow-up assessment). Six months after the jugular vein angioplasty (with or without stent placement), a statistically significant improvement was observed only in the FSS and the HIS. Based on their findings, the researchers concluded that "endovascular treatment in individuals with MS and concomitant CCSVI did not have an influence on the patient's neurological condition; however, in the mid-term follow-up, an improvement concerning some parameters influencing the patient's quality-of-life parameters was observed." They also emphasized that there is an urgent need for a well-designed randomized controlled trial.
Zamboni and colleagues (2012) reported on a small series of eight individuals with ultrasound criteria for CCSVI undergoing immediate venoplasty compared to seven individuals undergoing delayed venoplasty. There were improvements on the EDSS (expanded disability status scale) for both groups following treatment, but no difference between groups in the first six months comparing immediate versus delayed treatment subjects. The relapse rate during the initial six months was 0.12% in the treatment group versus 0.66% in the control group; however this difference did not meet statistical significance. There were also trends toward improvement for the immediate treatment group on magnetic resonance imaging (MRI) scans, such as the number of T2 lesions, but these differences also did not reach statistical significance. No short-term adverse events were reported following the procedure, but the rate of restenosis at one year was 27% in treated individuals.
Van Zuuren and colleagues (2012), in a Cochrane Review, concluded there was no high level evidence to either support or refute the efficacy and safety of angioplasty for CCSVI in people with MS. The authors further noted that additional robust and well designed studies are needed.
There have been various reports of serious adverse and potentially fatal events occurring as a result of venous angioplasty for the treatment of MS (Doepp, 2010; Kahn, 2010; Qui 2010). Khan (2010) states: "Any invasive endovascular procedures including angioplasty and venous stent placement should be discouraged until there is conclusive evidence to justify their indication in MS."
More recently, Mandato and colleagues (2012) evaluated the safety of outpatient endovascular treatment in those with MS and CCSVI. A retrospective analysis was performed to assess complications occurring within 30 days of endovascular treatment of CCSVI. The study was comprised of 240 individuals and 257 procedures performed over eight months. The indication for treatment was symptomatic MS. Primary procedures accounted for 93.0% (239 of 257) of procedures, and repeat interventions accounted for 7% (18 of 257). For individuals treated primarily, 87% (208 of 239) had angioplasty and 11% (26 of 239) had stent placement. Five individuals were not treated. Of those with restenosis, 50% (9 of 18) had angioplasty and 50% (9 of 18) had stent placement. Complications reported in the participants after the procedures included headache in 8.2% (21 of 257) and neck pain in 15.6% (40 of 57); 52.5% (21 of 40) of these individuals underwent stent placement. Three individuals experienced venous thrombosis requiring retreatment within 30 days. Sustained intra-procedural cardiac arrhythmias were observed in three individuals with two requiring hospitalization. The authors reported that the correlation between MS and CCSVI is a new theory and future research is needed in this area to show the effectiveness of endovascular treatment. This particular study demonstrated the risks of angioplasty and did not assess clinical outcomes after endovascular treatment of CCSVI.
The United States Food and Drug Administration (FDA) (2012) issued an alert concerning the potential for adverse events following endovascular interventions for MS. Reports of adverse events obtained by the FDA included death, stroke, detachment and/or migration of stents, vein damage, thrombosis, cranial nerve damage, and abdominal bleeding. This alert cautioned that clinical trials of this procedure require FDA approval and an investigational device exemption due to potential for harms.
The American Academy of Neurology does not currently address venous angioplasty for the treatment of MS or CCSVI in any of their current MS guidelines. The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) (2010) in a commentary on the treatment of CCSVI indicates there is a lack of evidence for the treatment of CCSVI, stresses the need for randomized trials and advises that this treatment should not be offered to those with MS outside of a well-designed clinical trial.
The U.K. National Center for Clinical Excellence (NICE) (2012) issued guidance on the use of percutaneous venoplasty to treat CCSVI in those with MS. The following statements on the diagnosis and treatment of CCSVI were included in this document:
At this time there is insufficient evidence available in the peer-reviewed published literature to support the use of venous angioplasty (with or without stent placement) for the treatment MS. The relationship between CCSVI and MS is not certain, the impact of treating CCSVI on outcomes of MS is not known and the safety and efficacy of this treatment have not been proven. Limitations of recent published studies include small sample size and lack of randomization. Current findings are preliminary and there are studies which demonstrate conflicting results. Results from large randomized controlled clinical trials are needed to further assess this proposed treatment modality.
Venous Angioplasty for Ilio-femoral Venous Thrombosis and Chronically Occluded Iliac Veins
Kurklinsky and colleagues (2012) retrospectively analyzed 30-day, 1-year, and 3-year patency of chronically occluded ilio-femoral venous thrombosis treated with stent placement in a case series from a single institution. Records of 189 consecutive individuals treated by interventional radiology for ilio-femoral venous occlusions between March 1, 2003, and December 1, 2008, were reviewed. A total of 89 cases of chronic iliac or ilio-femoral deep vein thrombosis without involvement of the inferior vena cava met criteria for analysis. All individuals (91 limbs) successfully underwent angioplasty with placement of venous self-expanding stents. Patency rate at discharge was 100%. Following the index procedure, mean pressure gradient across the lesion decreased from 5.63 mm Hg to 0.71 mm. Median follow-up was 11.3 months (range, 0.8-72.4 mo). Follow-up at 30 days demonstrated 90 of 91 limbs to be patent. Primary patency rates of treated limbs at 1 and 3 years were 81% and 71%, respectively. Primary patency was lost in 17 cases (19.1%); interventions to maintain or restore stent patency were performed in 13 cases (14.6%). Primary assisted limb patency rates at 1 and 3 years were 94% and 90%, respectively; secondary patency rate was 95%. The authors concluded that angioplasty with stent placement for treatment of chronically thrombosed ilio-femoral veins is a low-risk procedure with acceptable patency rates for as long as three years.
TORPEDO (Thrombus Obliteration By Rapid Percutaneous Endovenous Intervention In Deep Venous Occlusion) Trial
In a randomized controlled trial, Sharifi and colleagues (2010) compared the safety and efficacy of percutaneous endovenous intervention (PEVI) and anticoagulation with anticoagulation alone in the reduction of venous thromboembolism (VTE) and post-thrombotic syndrome (PTS) in acute proximal deep venous thrombosis (DVT). One hundred eighty three (183) individuals with symptomatic proximal DVT were randomized over a 30 month period beginning in February 2007 to receive either PEVI plus anticoagulation or anticoagulation alone. PEVI consisted of one or more of a combination of thrombectomy, balloon venoplasty, stenting, or local low-dose thrombolytic therapy. In the PEVI group 68 persons received a balloon venoplasty and 47 stents were placed in 27 persons. Anticoagulation consisted of intravenous unfractionated heparin or subcutaneous low-molecular weight heparin plus warfarin. At six months follow-up, recurrent VTE developed in 2 of 88 persons of the PEVI plus anticoagulation group versus 12 of 81 of the anticoagulation-alone group (2.3% vs. 14.8%, P = 0.003). PTS developed in 3 of 88 persons of the PEVI plus anticoagulation group and 22 of 81 of the anticoagulation-alone group (3.4% vs. 27.2%, P < 0.001). The authors concluded that PEVI plus anticoagulation may be superior to anticoagulation alone in the reduction of VTE and PTS at six months and in reducing length of hospital stay and signs and symptoms of DVT.
Follow up results of the TORPEDO trial were reported by Sharifi and colleagues in 2012. Over a mean follow up of 30 + 5 months (range 12-41), three persons were lost to follow up and there were 11 deaths (5 PE, 6 cancer) which left 88 of 91 persons in the PEVI group and 81 of 92 in the control group. PTS developed at a significantly higher rate in the control group compared to the PEVI group [6 (6.8%) of the PEVI + anticoagulation group vs. 24 (29.6%)] of the anticoagulation only group (p<0.001). Recurrent VTE developed in 4 (4.5%) of the 88 PEVI + anticoagulation subjects vs. 13 (16%) of the 81 subjects receiving anticoagulation only. The authors concluded that PEVI in persons with proximal DVT appears to be superior to anticoagulation alone in the reduction of VTE and PTS. This benefit extended to more than 30 months.
Many persons receiving conventional anticoagulant treatment for acute DVT develop post thrombotic syndrome (PTS). In an open-label, randomized controlled trial, Enden and colleagues (2012) examined whether additional treatment with catheter-directed thrombolysis (CDT) using alteplase reduced the development of post-thrombotic syndrome (PTS). A total of 209 persons aged 18-75 years with a first-time iliofemoral DVT were recruited from various Norwegian hospitals. Study subjects were randomized within 21 days from symptom onset to conventional anticoagulant treatment alone or additional CDT. Two co-primary outcomes were assessed: frequency of PTS as assessed by Villalta score at 24 months, and iliofemoral patency after six months. Two hundred and nine participants were randomly assigned to treatment groups (108 control, 101 CDT). At completion of 24 months' follow-up, data for clinical status was available for 189 subjects (90%; 99 control, 90 CDT). At 24 months, 37 (41.1%) subjects allocated additional CDT presented with PTS compared to 55 (55.6%) in the control group. The difference in PTS corresponded to an absolute risk reduction of 14.4%, and the number needed to treat was seven. Iliofemoral patency after six months was reported in 58 subjects (65.9%) on CDT versus 45 (47.4%) on control. CDT improved clinically relevant long-term outcomes after iliofemoral DVT by reducing PTS compared with conventional treatment. Study limitations included possible local differences due to four different centers having performed the interventions as well as the possibility of bias due to the open-label design of the study.
In a sub analysis of the CaVenT Study, Haig and colleagues (2012) investigated potential markers for early and long-term efficacy of catheter directed thrombolysis (CDT), adverse events, and their interrelationship. Subjects aged 18-75 years (mean, 54 y; 33 women) with first-time proximal DVT and symptoms up to 21 days were included in an open, multicenter, randomized, controlled trial (CaVenT study). The authors reported on the 92 subjects who received CDT procedures after allocation to the CDT arm in the CaVenT study. The DVT diagnosis was verified by ultrasound or by supplementary venography or CT venography. Anticoagulant therapy was initiated with low molecular weight heparin. CDT was initiated the next working day, and low molecular weight heparin was subsequently stopped. Adjunctive balloon angioplasty and stent insertion were performed at the operator's discretion to obtain flow and stenosis of less than 50%. Adjunctive balloon angioplasty was performed in 40 subjects. Five subjects, (three women and two men) were diagnosed with May-Thurner syndrome (iliac vein compression) and treated with adjunctive angioplasty, two with a balloon only and three with stents. A mean clot resolution of 82% ± 25 was achieved in 92 subjects. Successful lysis (≥50%) was obtained in 83 persons. Early efficacy was equal for femoral and iliofemoral thrombus and not related to thrombus load before CDT, symptom duration, or predisposing risk factors. Lower thrombus score at completion of CDT was associated with increased patency at 24 months (P = .040), and increased patency after 6 and 24 months was correlated with reduced development of PTS after 24 months (P<.001). The authors concluded that CDT via popliteal access appeared to safely and effectively remove clots and restore iliofemoral patency. No baseline characteristics were associated with early efficacy or PTS after 24 months.
Treatment of chronically occluded iliac veins has typically consisted of endovenous bypass. Raju and colleagues (2009) reported on 167 post-thrombotic total iliac occlusions which had been treated with percutaneous recanalization. The procedure was reportedly successful in 129 of 167 limbs (83%). During a 48-month follow-up period, 39 out of 139 stented limbs (28%) occluded. Seventeen of these individuals had patency restored but seven later re-occluded. The four-year secondary stent patency was 66%. While the majority of chronic total occlusions were successfully recanalized with very little morbidity, minimal downtime, sustained long-term stent patency, and substantial clinical improvement, one third of the study subjects failed to maintain patency.
Society of Interventional Radiology 2009 position statement on the treatment of acute iliofemoral deep vein thrombosis with use of adjunctive catheter-directed intrathrombus thrombolysis states:
The Society of Interventional Radiology (SIR) supports the use of anticoagulant therapy for DVT and the use of adjunctive CDT or surgical thrombectomy for patients with limb-threatening phlegmasia. SIR is aware of the controversy within the medical community regarding the use of adjunctive CDT for patients with acute DVT who do not exhibit signs of impending circulatory compromise. SIR recognizes the methodologic limitations of the studies supporting CDT and strongly believes that the execution of a multicenter randomized trial to conclusively quantify the risk–benefit ratio of CDT in patients with acute proximal DVT should be considered an important national health care priority. In the meantime, physicians are still obligated to carefully consider the short-term and long-term consequences of DVT and to recommend the best possible overall treatment strategy to patients based on the currently available, albeit imperfect, evidence. Although there are no large randomized trials to mitigate for or against CDT, the preponderance of the available evidence favors the existence of a clinical benefit to adjunctive CDT for the subset of patients with acute iliofemoral DVT.
American Heart Association (2011) Recommendations for Percutaneous Transluminal Venous Angioplasty and Stenting, state:
(Class IIa: Benefit >> risks, Additional studies with focused objectives needed, it is reasonable to perform procedure or administer treatment. Class IIb: Benefit ≥ risks, additional studies with broad objectives needed, additional registry data would be helpful. Procedures/treatment may be considered. Evidence C: very limited populations evaluated, Only consensus opinion of experts, case studies or standards of care.)
Professional guidelines support the use of venous angioplasty with or without stenting, based primarily on expert consensus. Emerging studies may suggest improved patency and decreased post thrombotic complications; however, these studies are limited in not isolating the unique contribution to patency and improved outcomes of angioplasty, instead reporting out improvements with angioplasty as one of several catheter directed therapies.
Venous angioplasty is a procedure which can be performed during a venogram to open or bypass veins. It also can be used for placement of a stent, which keeps the vessel in an open position to allow for improved blood flow.
There are numerous conditions which have been successfully treated with venous angioplasty, including stenotic or thrombosed arterio-venous-dialysis access grafts; Budd-Chiari syndrome, superior vena cava syndrome, iliac vein compression syndrome (for example, May-Thurner syndrome), and congenital heart disease. Venous angioplasty has not been proven to be efficacious in a variety of other conditions, including but not limited to the treatment of MS or CCSVI, chronically occluded iliac veins, and ileo-femoral venous thrombosis.
Budd-Chiari syndrome: A rare disease characterized by obstruction of outflow from the small hepatic veins to the level of termination of the inferior vena cava.
May-Thurner syndrome: A rarely diagnosed condition caused by compression of the left iliac vein by the right iliac artery, which increases the risk of deep vein thrombosis in the left extremity.
Superior vena cava syndrome: A group of symptoms that occur (most often as a result of cancer) when the superior vena cava is partially blocked. The most common symptoms are coughing, trouble breathing, and swelling in the face, neck, upper body or arms.
Venogram: An X-ray test that takes pictures of blood flow through the veins in a certain area of the body.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services are Medically Necessary:
|35460||Transluminal balloon angioplasty, open; venous|
|35476||Transluminal balloon angioplasty, percutaneous; venous|
|75978||Transluminal balloon angioplasty, venous (eg, subclavian stenosis), radiological supervision and interpretation|
|164.2-164.9||Malignant neoplasm of mediastinum|
|415.11-415.19||Pulmonary embolism and infarction|
|417.8||Other specified diseases of pulmonary circulation [specified as pulmonary vein stenosis]|
|453.2||Venous embolism and thrombosis of inferior vena cava|
|453.77||Chronic venous embolism and thrombosis of other thoracic veins (superior vena cava)|
|453.87||Acute venous embolism and thrombosis of other thoracic veins (superior vena cava)|
|459.2||Compression of vein [specified as superior vena cava syndrome or iliac vein compression]|
|585.6||End stage renal disease|
|585.9||Chronic kidney disease, unspecified|
|745.0-745.9||Bulbus cordis anomalies and anomalies of cardiac septal closure|
|747.0-747.49||Other congenital anomalies of great arteries, great veins|
|789.00||Abdominal pain, unspecified site|
|996.1||Mechanical complication of other vascular device, implant, and graft (arteriovenous fistula/shunt/catheter)|
|996.62||Infection and inflammatory reaction due to vascular device, implant and graft|
|996.73||Other complications due to renal dialysis device, implant or graft|
|ICD-10 Procedure||ICD-10-PCS draft codes; effective 10/01/2014:|
|027Q04Z-027Q4ZZ||Dilation of right pulmonary artery [by approach and with or without device; includes codes 027Q04Z, 027Q0DZ, 027Q0ZZ, 027Q34Z, 027Q3DZ, 027Q3ZZ, 027Q44Z, 027Q4DZ, 027Q4ZZ]|
|027R04Z-027R4ZZ||Dilation of left pulmonary artery [by approach and with or without device; includes codes 027R04Z, 027R0DZ, 027R0ZZ, 027R34Z, 027R3DZ, 027R3ZZ, 027R44Z, 027R4DZ, 027R4ZZ]|
|027S04Z-027S4ZZ||Dilation of right pulmonary vein [by approach and with or without device; includes codes 027S04Z, 027S0DZ, 027S0ZZ, 027S34Z, 027S3DZ, 027S3ZZ, 027S44Z, 027S4DZ, 027S4ZZ]|
|027T04Z-027T4ZZ||Dilation of left pulmonary vein [by approach and with or without device; includes codes 027T04Z , 027T0DZ, 027T0ZZ, 027T34Z, 027T3DZ, 027T3ZZ, 027T44Z, 027T4DZ, 027T4ZZ]|
|027V04Z-027V4ZZ||Dilation of superior vena cava [by approach and with or without device; includes codes 027V04Z, 027V0DZ, 027V0ZZ, 027V34Z, 027V3DZ, 027V3ZZ, 027V44Z, 027V4DZ, 027V4ZZ]|
|05700DZ-05704ZZ||Dilation of azygos vein [by approach and with or without device; includes codes 05700DZ, 05700ZZ, 05703DZ, 05703ZZ, 05704DZ, 05704ZZ]|
|05710DZ-05714ZZ||Dilation of hemiazygos vein [by approach and with or without device, includes codes 05710DZ, 05710ZZ, 05713DZ, 05713ZZ, 05714DZ, 05714ZZ ]|
|05730DZ-05744ZZ||Dilation of innominate vein [right or left, by approach and with or without device, includes codes 05730DZ, 05730ZZ, 05733DZ, 05733ZZ, 05734DZ, 05734ZZ, 05740DZ, 05740ZZ, 05743DZ, 05743ZZ, 05744DZ, 05744ZZ]|
|05750DZ-05764ZZ||Dilation of subclavian vein [right or left, by approach and with or without device, includes codes 05750DZ, 05750ZZ, 05753DZ, 05753ZZ, 05754DZ, 05754ZZ, 05760DZ, 05760ZZ, 05763DZ, 05763ZZ, 05764DZ, 05764ZZ]|
|05770DZ-05784ZZ||Dilation of axillary vein [right or left, by approach and with or without device, includes codes 05770DZ, 05770ZZ, 05773DZ, 05773ZZ, 05774DZ, 05774ZZ, 05780DZ, 05780ZZ, 05783DZ, 05783ZZ, 05784DZ, 05784ZZ]|
|05790DZ-057A4ZZ||Dilation of brachial vein [right or left, by approach and with or without device, includes codes 05790DZ, 05790ZZ, 05793DZ, 05793ZZ, 05794DZ, 05794ZZ, 057A0DZ, 057A0ZZ, 057A3DZ, 057A3ZZ, 057A4DZ, 057A4ZZ]|
|057B0DZ-057C4ZZ||Dilation of basilic vein [right or left, by approach and with or without device, includes 057B0DZ, 057B0ZZ, 057B3DZ, 057B3ZZ, 057B4DZ, 057B4ZZ, 057C0DZ, 057C0ZZ, 057C3DZ, 057C3ZZ, 057C4DZ, 057C4ZZ]|
|057D0DZ-057F4ZZ||Dilation of cephalic vein [right or left, by approach and with or without device, includes codes 057D0DZ, 057D0ZZ, 057D3DZ, 057D3ZZ, 057D4DZ, 057D4ZZ, 057F0DZ, 057F0ZZ, 057F3DZ, 057F3ZZ, 057F4DZ, 057F4ZZ]|
|057G0DZ-057H4ZZ||Dilation of hand vein [right or left, by approach and with or without device, includes codes 057G0DZ, 057G0ZZ, 057G3DZ, 057G3ZZ, 057G4DZ, 057G4ZZ, 057H0DZ, 057H0ZZ, 057H3DZ, 057H3ZZ, 057H4DZ, 057H4ZZ]|
|057L0DZ-057L4ZZ||Dilation of intracranial vein [by approach & with or without device, includes codes 057L0DZ, 057L0ZZ, 057L3DZ, 057L3ZZ, 057L4DZ, 057L4ZZ]|
|057M0DZ-057N4ZZ||Dilation of internal jugular vein [right or left, by approach and with or without device; includes codes 057M0DZ, 057M0ZZ, 057M3DZ, 057M3ZZ, 057M4DZ, 057M4ZZ, 057N0DZ, 057N0ZZ, 057N3DZ, 057N3ZZ, 057N4DZ, 057N4ZZ]|
|057P0DZ-057Q4ZZ||Dilation of external jugular vein [right or left, by approach and with or without device; includes codes 057P0DZ, 057P0ZZ, 057P3DZ, 057P3ZZ, 057P4DZ, 057P4ZZ, 057Q0DZ, 057Q0ZZ, 057Q3DZ, 057Q3ZZ, 057Q4DZ, 057Q4ZZ]|
|057R0DZ-057S4ZZ||Dilation of vertebral vein [right or left, by approach and with or without device; includes codes 057R0DZ, 057R0ZZ, 057R3DZ, 057R3ZZ, 057R4DZ, 057R4ZZ, 057S0DZ, 057S0ZZ, 057S3DZ, 057S3ZZ, 057S4DZ, 057S4ZZ]|
|057T0DZ-057V4ZZ||Dilation of face vein [right or left, by approach and with or without device; includes codes 057T0DZ, 057T0ZZ, 057T3DZ, 057T3ZZ, 057T4DZ, 057T4ZZ, 057V0DZ, 057V0ZZ, 057V3DZ, 057V3ZZ, 057V4DZ, 057V4ZZ]|
|057Y0DZ-057Y4ZZ||Dilation of upper vein [by approach and with or without device; includes codes 057Y0DZ, 057Y0ZZ, 057Y3DZ, 057Y3ZZ, 057Y4DZ, 057Y4ZZ]|
|06700DZ-06704ZZ||Dilation of inferior vena cava [by approach and with or without device; includes codes 06700DZ, 06700ZZ, 06703DZ, 06703ZZ, 06704DZ, 06704ZZ]|
|06710DZ-06714ZZ||Dilation of splenic vein [by approach and with or without device; includes codes 06710DZ, 06710ZZ, 06713DZ, 06713ZZ, 06714DZ, 06714ZZ]|
|06720DZ-06724ZZ||Dilation of gastric vein [by approach and with or without device; includes codes 06720DZ, 06720ZZ, 06723DZ, 06723ZZ, 06724DZ, 06724ZZ]|
|06730DZ-06734ZZ||Dilation of esophageal vein [by approach and with or without device; includes codes 06730DZ, 06730ZZ, 06733DZ, 06733ZZ, 06734DZ, 06734ZZ]|
|06740DZ-06744ZZ||Dilation of hepatic vein [by approach and with or without device; includes codes 06740DZ, 06740ZZ, 06743DZ, 06743ZZ, 06744DZ, 06744ZZ]|
|06750DZ-06754ZZ||Dilation of superior mesenteric vein [by approach and with or without device; includes codes 06750DZ, 06750ZZ, 06753DZ, 06753ZZ, 06754DZ, 06754ZZ]|
|06760DZ-06764ZZ||Dilation of inferior mesenteric vein [by approach and with or without device; includes codes 06760DZ, 06760ZZ, 06763DZ, 06763ZZ, 06764DZ, 06764ZZ]|
|06770DZ-06774ZZ||Dilation of colic vein [by approach and with or without device; includes codes 06770DZ, 06770ZZ, 06773DZ, 06773ZZ, 06774DZ, 06774ZZ]|
|06780DZ-06784ZZ||Dilation of portal vein [by approach and with or without device; includes codes 06780DZ, 06780ZZ, 06783DZ, 06783ZZ, 06784DZ, 06784ZZ]|
|06790DZ-067B4ZZ||Dilation of renal vein [right or left, by approach and with or without device; includes codes 06790DZ, 06790ZZ, 06793DZ, 06793ZZ, 06794DZ, 06794ZZ, 067B0DZ, 067B0ZZ, 067B3DZ, 067B3ZZ, 067B4DZ, 067B4ZZ]|
|067C0DZ-067D4ZZ||Dilation of common iliac vein [right or left, by approach and with or without device; includes codes 067C0DZ, 067C0ZZ, 067C3DZ, 067C3ZZ, 067C4DZ, 067C4ZZ, 067D0DZ, 067D0ZZ, 067D3DZ, 067D3ZZ, 067D4DZ, 067D4ZZ]|
|067F0DZ-067G4ZZ||Dilation of external iliac vein [right or left, by approach and with or without device; includes codes 067F0DZ, 067F0ZZ, 067F3DZ, 067F3ZZ, 067F4DZ, 067F4ZZ, 067G0DZ, 067G0ZZ, 067G3DZ, 067G3ZZ, 067G4DZ, 067G4ZZ]|
|067H0DZ-067J4ZZ||Dilation of hypogastric vein [right or left, by approach and with or without device; includes codes 067H0DZ, 067H0ZZ, 067H3DZ, 067H3ZZ, ,067H4DZ, 067H4ZZ, 067J0DZ, 067J0ZZ, 067J3DZ, ,067J3ZZ, 067J4DZ, 067J4ZZ]|
|067M0DZ-067N4ZZ||Dilation of femoral vein [right or left, by approach and with or without device; includes codes 067M0DZ, 067M0ZZ, 067M3DZ, 067M3ZZ, 067M4DZ, 067M4ZZ, 067N0DZ, 067N0ZZ, 067N3DZ, 067N3ZZ, 067N4DZ, 067N4ZZ]|
|067P0DZ-067Q4ZZ||Dilation of greater saphenous vein [right or left, by approach and with or without device; includes codes 067P0DZ, 067P0ZZ, 067P3DZ, 067P3ZZ, 067P4DZ, 067P4ZZ, 067Q0DZ, 067Q0ZZ, 067Q3DZ, 067Q3ZZ, 067Q4DZ, 067Q4ZZ]|
|067R0DZ-067S4ZZ||Dilation of lesser saphenous vein [right or left, by approach and with or without device; includes codes 067R0DZ, 067R0ZZ, 067R3DZ, 067R3ZZ, 067R4DZ, 067R4ZZ, 067S0DZ, 067S0ZZ, 067S3DZ, 067S3ZZ, 067S4DZ, 067S4ZZ]|
|067T0DZ-067V4ZZ||Dilation of foot vein [right or left, by approach and with or without device; includes codes 067T0DZ, 067T0ZZ, 067T3DZ, 067T3ZZ, 067T4DZ, 067T4ZZ, 067V0DZ, 067V0ZZ, 067V3DZ, 067V3ZZ, 067V4DZ, 067V4ZZ]|
|067Y0DZ-067Y4ZZ||Dilation of lower vein [by approach and with or without device; includes codes 067Y0DZ, 067Y0ZZ, 067Y3DZ, 067Y3ZZ, 067Y4DZ, 067Y4ZZ]|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014:|
|C38.1-C38.3||Malignant neoplasm of mediastinum|
|C38.8||Malignant neoplasm of overlapping sites of heart, mediastinum and pleura|
|I28.8||Other diseases of pulmonary vessels [specified as pulmonary vein stenosis]|
|I82.210-I82.211||Embolism and thrombosis of superior vena cava|
|I82.220-I82.221||Embolism and thrombosis of inferior vena cava|
|I87.1||Compression of vein [specified as superior vena cava syndrome]|
|N18.6||End stage renal disease|
|N18.9||Chronic kidney disease, unspecified|
|Q20.0-Q20.9||Congenital malformations of cardiac chambers and connections|
|Q21.0-Q21.9||Congenital malformations of cardiac septa|
|Q25.0-Q25.9||Congenital malformations of great arteries|
|Q26.0-Q26.9||Congenital malformations of great veins|
|R10.84||Generalized abdominal pain|
|R16.0||Hepatomegaly, not elsewhere classified|
|T82.590A-T82.591S||Other mechanical complication of surgically created arteriovenous fistula, arteriovenous shunt|
|T82.7XXA-T82.7XXS||Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts|
|T82.818A-T82.818S||Embolism of vascular prosthetic devices, implants and grafts|
|T82.858A-T82.858S||Stenosis of vascular prosthetic devices, implants and grafts|
|T82.868A-T82.868S||Thrombosis of vascular prosthetic devices, implants and grafts|
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Web Sites for Additional Information|
Percutaneous Transluminal Angioplasty (PTA)
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Revised||08/08/2013||Medical Policy & Technology Assessment Committee (MPTAC) review. Position statement updated to consider May-Thurner syndrome as medically necessary. Rationale, Coding and Reference sections updated.|
|Revised||05/09/2013||MPTAC review. Position statement updated with additional indications. Description, Rationale, Background, Coding and Reference sections updated.|
|Reviewed||02/14/2013||MPTAC review. Description, Rationale and Reference sections updated.|
|Reviewed||02/16/2012||MPTAC review. Description, Rationale, Background, References and Index sections updated.|
|New||02/17/2011||MPTAC review. Initial document development.|