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Endovascular Stent Grafts for Thoracic Aortic Aneurysms or Dissections

Policy Number: MP-637

 

Latest Review Date: June 2021

Category: Surgery                                                                 

Policy Grade: B

POLICY:

Effective for dates of service on and after June 23, 2021:

Endovascular stent grafts using devices approved by U.S. Food and Drug Administration (FDA) may be considered medically necessary for the following conditions:

 

  • Descending thoracic aortic aneurysms when used according to FDA approved specifications 
  • Acute, complicated (organ or limb ischemia or rupture) type B thoracic aortic dissection.
  • Descending thoracic aortic tears or rupture.

 

Endovascular stent grafts are considered investigational for the treatment of descending aortic disorders that do not meet the above criteria.

Endovascular stent grafts are considered investigational for the treatment of ascending aortic disorders, including but not limited to thoracic aortic arch aneurysms.

 

Effective for dates of service prior to June 23, 2021:

Endovascular stent grafts using devices approved by the FDA according to the approved specifications, may be considered medically necessary for the treatment of descending thoracic aortic aneurysms without dissection.

 

Endovascular stent grafts using devices approved by the FDA according to the approved specifications may be considered medically necessary for the treatment of acute, complicated (organ or limb ischemia or rupture) Type B thoracic aortic dissection.

 

Endovascular stent grafts may be considered medically necessary for the treatment of rupture of the descending thoracic aorta.

 

Endovascular stent grafts are considered investigational for the treatment of thoracic lesions not meeting the above criteria, including but not limited to thoracic aortic arch aneurysms, acute, uncomplicated Type B thoracic aortic dissection, and chronic Type B aortic dissection.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Thoracic endovascular aneurysm repair (TEVAR) involves the percutaneous placement of a stent graft in the descending thoracic or thoracoabdominal aorta. It is a less invasive alternative to open surgery for the treatment of thoracic aortic aneurysms, dissections, or rupture, and thus has the potential to reduce the morbidity and mortality of open surgery. Endovascular stenting may also be an alternative treatment to medical therapy for thoracic aortic aneurysms or thoracic aorta dissections.

 

Thoracic Aortic Aneurysms

Aortic aneurysms are arterial dilations that are associated with age, atherosclerosis, and hypertension, as well as some congenital connective tissue disorders. The likelihood of significant sequelae of aortic aneurysm is dependent on location, size, and underlying disease state. Left untreated, these aneurysms tend to enlarge over time, increasing the risk of rupture or dissection. Of greatest concern is the tendency for aortic aneurysms to rupture, with severe consequences including death. Another significant adverse occurrence of aortic aneurysm is aortic dissection, in which an intimal tear permits blood to enter the potential space between the intima and the muscular wall of the aorta. Stable dissections may be managed medically; however, dissections that impinge on the true lumen of the aorta or occlude branching vessels are a surgical emergency.

 

Treatment

Indications for the elective surgical repair of aortic aneurysms are based on estimates of the prognosis of the untreated aneurysm balanced against the morbidity and mortality of the intervention. The prognosis of thoracic aortic aneurysm (TAA) is typically reported in terms of the risk of rupture according to size and location, i.e., the ascending or descending or thoracoabdominal aorta. While several studies have estimated the risk of rupture of untreated aneurysms, these studies have excluded patients who underwent surgical repair; therefore, the true natural history of thoracic aneurysms is unknown. Clouse et al (1998) performed a population-based study of TAA diagnosed in Olmstead County, Minnesota, between 1980 and 1994. A total of 133 patients were identified; the primary clinical end points were cumulative rupture risk, rupture risk as a function of aneurysm size, and survival. The cumulative risk of rupture was 20% after 5 years. The 5-year risk of rupture as a function of aneurysm size at recognition was 0% for aneurysms less than 4 cm in diameter, 16% for those 4 to 5.9 cm, and 31% for aneurysms 6 cm or more. Interestingly, 79% of the ruptures occurred in women. Davies et al (2002) reported on the yearly rupture or dissection rates in 721 patients with TAA.  A total of 304 patients were dissection-free at presentation; their natural history was followed up for rupture, dissection, and death. Patients were excluded from analysis once the operation occurred. Not surprisingly, the authors reported that aneurysm size had a profound impact on outcomes. For example, based on their modeling, a patient with an aneurysm exceeding 6 cm in diameter can expect a yearly rate of rupture or dissection of at least 6.9% and a death rate of 11.8%. In a previous report, the authors suggested surgical intervention of a descending aorta aneurysm if its diameter measured 6.5 cm.

 

Surgical morbidity and mortality are typically subdivided into elective versus emergency repair with a focus on the incidence and risk of spinal cord ischemia, considered of the most devastating complications, resulting in paraparesis or paraplegia. The operative mortality of surgical repair of aneurysm of the descending and thoracoabdominal aorta is estimated at 6% to 12% and 10% to 15%, respectively, while mortality associated with emergent repair is considerably higher.  In elective cases, predictors of operative mortality include renal insufficiency, increasing age, symptomatic aneurysm, presence of dissection, and other comorbidities, such as cardiopulmonary or cerebrovascular disease. The risk of paraparesis or paraplegia is estimated at 3% to 15%. Thoracoabdominal aneurysms, larger aneurysms, presence of dissection, and diabetes are predictors of paraplegia.  A number of surgical adjuncts have been explored over the years to reduce the incidence of spinal cord ischemia, including distal aortic perfusion, cerebrospinal fluid drainage, hypothermia with circulatory arrest, and evoked potential monitoring.  However, the optimal protective strategy is still uncertain.

 

This significant morbidity and mortality makes definitive patient selection criteria for repair of thoracic aneurysms difficult. Several authors have recommended an individual approach based on balancing the patients' calculated risk of rupture with their anticipated risk of postoperative death or paraplegia. However, in general, surgical repair is considered in patients with adequate physiologic reserve when the thoracic aneurysm measures from 5.5 to 6 cm in diameter or in patients with smaller symptomatic aneurysms.

 

Thoracic Aortic Dissection

Aortic dissection can be subdivided into Type A, which involves the aortic arch, and Type B, which is confined to the descending aorta. Dissections associated with obstruction and ischemia can also be subdivided into an obstruction caused by an intimal tear at branch vessel orifices, or by compression of the true lumen by the pressurized false lumen.

 

Treatment

Type A dissections (involving the aortic arch) are usually treated surgically, while Type B dissections are usually treated medically, with surgery indicated for serious complications, such as visceral ischemia, impending rupture, intractable pain, or sudden reduction in aortic size. It has been proposed that endovascular therapy can repair the latter group of dissections by redirecting flow into the true lumen. The success of endovascular stent grafts of abdominal aortic aneurysms has created interest in applying the same technology to the aneurysms and dissections of the descending or thoracoabdominal aorta.

 

There is more controversy regarding the optimal treatment of Type B dissections (i.e., limited to the descending aorta). In general, chronic, stable Type B dissections are managed medically, although some surgeons recommend a more aggressive approach for younger patients in otherwise good health. When serious complications arise from a Type B dissection (i.e., shock or visceral ischemia), surgical intervention is usually indicated. Although there is an estimated 50% one-year survival rate in those treated with an open surgical procedure, it is not clear whether that rate is any better or worse for those treated medically.  The advent of stent grafting, with the potential of reducing the morbidity and mortality of an open surgical procedure, may further expand the number of patients considered for surgical intervention.

 

Thoracic Aortic Rupture

Rupture of the thoracic aorta is a life-threatening emergency that is nearly always fatal if untreated. Thoracic artery rupture can result from a number of factors. Aneurysms can rupture due to progressive dilatation and pressure of the aortic wall. Rupture can also result from traumatic injury to the aorta, such as occurs with blunt chest trauma. Penetrating injuries that involve the aorta can also lead to rupture. Penetrating ulcers can occur in widespread atherosclerotic disease and lead to aortic rupture.

 

Treatment

Emergent repair of thoracic artery rupture is indicated in many cases in which there is free bleeding into the mediastinum and/or complete transection of the aortic wall. In some cases of aortic rupture, where the aortic media and adventitia are intact, watchful waiting with delayed surgical intervention is a treatment option. With the advent of thoracic endovascular aneurysm repair (TEVAR), the decision making for intervention may be altered, because there may be a greater tendency to intervene in borderline cases due to the potential for fewer adverse events with TEVAR.

 

Thoracic Endovascular Aneurysm Repair

TEVAR is an alternative to open surgery. TEVAR has been proposed for prophylactic treatment of aneurysms that meet criteria for surgical intervention, as well as for patients in need of emergency surgery for rupture or complications related to dissection. The standard open surgery technique for TAA is open operative repair with graft replacement of the diseased segment. This procedure requires lateral thoracotomy, use of cardiopulmonary bypass, lengthy surgical procedures, and is associated with a variety of peri- and postoperative complications, with spinal cord ischemia considered the most devastating.

 

TEVAR is performed through a small groin incision to access the femoral artery, followed by delivery of catheters across the diseased portion of the aorta. A tubular stent graft composed of fabric and metal is then deployed under fluoroscopic guidance. The stent graft is then fixed to the proximal and distal portions of the aorta. Approximately 15% of patients do not have adequate femoral access; for them, the procedure can be performed using a retroperitoneal approach.

 

Potential complications of TEVAR are bleeding, vascular access site complications, spinal cord injury with paraplegia, renal insufficiency, stroke, and cardiopulmonary complications. Some of these complications are similar to those encountered with open repair (e.g., paraplegia, cardiopulmonary events), and others are unique to TEVAR (e.g., access site complications).

 

Outcome Measures

Controlled trials of specific patient groups treated with specific procedures are required to determine whether endovascular approaches are associated with equivalent or improved outcomes compared with surgical repair. For patients who are candidates for surgery, open surgical resection of the aneurysm with graft replacement is considered the criterion standard for treatment of aneurysms or dissections. Some patients who would not be considered candidates for surgical therapy (due to unacceptable risks) might be considered candidates for an endovascular graft. In this situation, the outcomes of endovascular grafting should be compared with optimal medical management. Comparative mortality rates are of high concern, as are the rates of serious complications such as the incidence of spinal cord ischemia.

 

KEY POINTS:

The most recent literature review was updated through April 1, 2021.

 

Summary of Evidence

For individuals who have type B (descending) thoracic aortic aneurysms who receive endovascular repair, the evidence includes nonrandomized comparative studies and systematic reviews. Relevant outcomes are overall survival, morbid events, treatment-related morbidity, and treatment-related mortality. The available nonrandomized comparative studies consistently report reduced short-term morbidity and mortality compared with surgical repair. Although these types of studies are subject to selection bias and other methodologic limitations, the consistency of the findings of equivalent or reduced short-term mortality and fewer early complications across populations with different characteristics lends support to the conclusion that TEVAR is a safer procedure in the short term. The likely short-term benefits of TEVAR are mitigated by longer term outcomes that are less favorable for TEVAR, but longer term mortality appears to be roughly similar for patients undergoing TEVAR or open surgery. The evidence is sufficient to determine qualitatively that the technology results in an improvement in the net health outcome.

 

For individuals who have Type B aortic dissections who receive endovascular repair, the evidence includes randomized controlled trials (RCTs), systematic reviews and non-randomized comparative studies. Relevant outcomes are overall survival, morbid events, treatment-related morbidity, and treatment-related mortality.

  • For acutely complicated type B dissections, there are no RCTs. Short- and intermediate-term results from a systematic review of observational studies that compared TEVAR with open surgery has suggested a benefit for TEVAR in complicated (organ or limb ischemia or rupture) type B dissection. There is also evidence that suggests TEVAR allows restoration of end-organ perfusion and may allow for favorable reverse remodeling to heal the aorta. The evidence is sufficient to determine the technology results in an improvement in the net health outcome.
  • For acute uncomplicated type B dissections, an RCT has reported short-term improvements in aortic remodeling and a decreased risk of aortic dilation and rupture in patients treated with TEVAR compared with best medical management. However, this trial was underpowered to evaluate mortality differences, and limitations included a high TEVAR failure rate based on imaging follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
  • For chronic type B dissections, evidence from an RCT did not demonstrate short-term outcome benefits associated with TEVAR; however, after more than 5 years of follow-up, TEVAR was associated with a survival benefit beginning two years postprocedure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

 

 

For individuals who have descending aortic tears or rupture who receive endovascular repair, the evidence includes non-randomized comparative studies and systematic reviews. Relevant outcomes are overall survival, morbid events, treatment-related morbidity, and treatment-related mortality. For traumatic thoracic aortic injury and rupture, nonrandomized comparative data have suggested a benefit for TEVAR in reducing periprocedural mortality and morbidity. It is expected that RCTs will be difficult to perform for this indication due to its emergent nature.

 

For individuals who have ascending aortic disorders who receive endovascular repair, the evidence includes small case series. Relevant outcomes are overall survival, morbid events, treatment-related morbidity, and treatment-related mortality. For patients with ascending aortic pathologies, including dissections, aneurysms, and other disorders, the evidence related to the use of TEVAR is limited to small series that include heterogeneous patient populations. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Practice Guidelines and Position Statements

American College of Cardiology Foundation, American Heart Association, et al

In 2010, a joint task force published guidelines on the diagnosis and management of descending thoracic and thoracoabdominal aortic aneurysms.  The task force consisted of the American College of Cardiology Foundation, American Heart Association, American Association for Thoracic Surgery, American College of Radiology, American Stroke Association, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of Thoracic Surgeons, and Society for Vascular Medicine. The task force offered the following Class I recommendations:

  • For patients with chronic dissection, particularly if associated with a connective tissue disorder, but without significant comorbid disease, and a descending thoracic aortic diameter exceeding 5.5 cm, open repair is recommended (Level of Evidence: B)
  • For patients with degenerative or traumatic aneurysms of the descending thoracic aorta exceeding 5.5 cm, saccular aneurysms, or postoperative pseudoaneurysms, endovascular stent grafting should be strongly considered when feasible (Level of Evidence: B)
  • For patients with thoracoabdominal aneurysms, in whom endovascular stent graft options are limited and surgical morbidity is elevated, elective surgery is recommended if the aortic diameter exceeds 6.0 cm, or less if a connective tissue disorder such as Marfan or Loeys-Dietz syndrome is present (Level of Evidence: C)
  • For patients with thoracoabdominal aneurysms and with end-organ ischemia or significant stenosis from atherosclerotic visceral artery disease, an additional revascularization procedure is recommended. (470) (Level of Evidence: B)

 

Society for Vascular Surgery

In 2021, the Society for Vascular Surgery published guidelines on TEVAR for descending thoracic aortic aneurysms. The guideline included the following recommendations:

 

Society for Vascular Surgery Guidelines on Thoracic Endovascular Aortic Repair for Descending Aortic Aneurysms

Recommendation

LOR

QOE

In patients who could undergo either technique (open repair vs TEVAR) (within the criteria of the device’s instructions for use),we recommend TEVAR as the preferred approach to treat elective DTA aneurysms, given its reduced morbidity and length of stay as well as short-term mortality

1

A

We recommend TEVAR in asymptomatic patients with a descending TAA when the maximum aneurysm diameter exceeds 5.5cm in “low-risk” patients with favorable aortic anatomy

1

B

We suggest using higher aortic diameter thresholds for TEVAR in patients deemed to have a particularly high risk of death, renal failure, or paraplegia from the procedure, where the benefit of treatment is lower than the risk posed by the natural history of the TAA

2

C

We recommend TEVAR in patients with IMH or penetrating aortic ulcer who have persistent symptoms or complications or show evidence of disease progression on follow-up imaging after a period of hypertension control

1

B

We suggest TEVAR in selected cases of asymptomatic penetrating aortic ulcer in patients who have at-risk characteristics for growth or rupture

2

B

We suggest TEVAR for symptomatic mycotic/infected TAA as a temporizing measure, but data demonstrating long-term benefit are lacking

2

C

We recommend TEVAR over open repair for the treatment of ruptured DTA when anatomically feasible

1

B

We recommend contrast-enhanced computed tomography scanning at 1 month and 12 months after TEVAR and then yearly or life, with consideration of more frequent imaging if an endo leak or other abnormality of concern is detected at 1 month

1

B

DTA: descending thoracic aorta; IMH: intramural hematoma; LOR: level of recommendation; QOE: quality of evidence; TAA: thoracic aortic aneurysm; TEVAR: thoracic endovascular aortic repair

 

U.S. Preventive Services Task Force Recommendations

Not applicable

 

KEY WORDS:

Aneurysm, Thoracic Aorta, Endovascular Stent, Stents, Thoracic Aortic Aneurysm, Endovascular Graft, GORE TAG® Thoracic Endoprosthesis, Zenith TX2® TAA Endovascular Graft, Talent™ Thoracic Stent Graft System, TEVAR, thoracic aneurysm, TAA, aortic aneurysm

 

APPROVED BY GOVERNING BODIES:

A number of endovascular grafts are approved for use in thoracic aortic aneurysms (TAAs).

 

In March 2005, the GORE TAG® Thoracic Endoprosthesis (W.L. Gore and Associates, Inc. Flagstaff, AZ) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process for endovascular repair of aneurysms of the descending thoracic aorta. Use of this device requires patients to have adequate iliac/femoral access, aortic inner diameter in the range of 23–37 mm, and equal to or greater than 2 cm non-aneurysmal aorta proximal and distal to the aneurysm. In January 2012, FDA granted an expanded indication for the Gore TAG® system to include isolated lesions of the thoracic aorta. Isolated lesions refer to aneurysms, ruptures, tears, penetrating ulcers, and/or isolated hematomas, but do not include dissections. Indicated aortic inner diameter is 16 to 42 mm, with 20 mm or more of nonaneurysmal aortic distal and proximal to the lesion.

 

In May 2008, the Zenith TX2® TAA Endovascular Graft (Cook Incorporated, Bloomington, IN) was approved by the FDA through the PMA process for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta. Indicated aortic inner diameter is in the range of 24-38 mm.

 

In September 2015, the Zenith Alpha™ Thoracic Endovascular Graft (Cook) was approved by the FDA through the PMA process.

 

In June 2008, the Talent™ Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, CA) was approved by the FDA through the PMA process for the endovascular repair of fusiform and saccular aneurysms/penetrating ulcers of the descending thoracic aorta. Indicated aortic inner diameter is in the range of 18–42 mm. The Talent Thoracic Stent Graft System was discontinued by the manufacturer and replaced with the Valiant™ Thoracic StentGraft System.

 

In September 2012, Relay® Thoracic Stent-Graft with Plus Delivery System (Bolton Medical, Sunrise, FL) was approved by FDA through the PMA process for the endovascular repair of fusiform aneurysms and saccular aneurysms/ penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including:

 

  • Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
  • Nonaneurysmal aortic neck diameter in the range of 19 to 42 mm
  • Nonaneurysmal proximal aortic neck length between 15 and 25 mm and nonaneurysmal distal aortic neck length between 25 and 30 mm depending on the diameter stent graft required.

 

In 2011, the Valiant™ Thoracic Stent Graft with the Captivia® Delivery System (Medtronic Vascular, Santa Rosa, CA) was approved by FDA through the PMA process for isolated lesions of the thoracic aorta. Isolated lesions refer to aneurysms, ruptures, tears, penetrating ulcers, and/or isolated hematomas, but not including dissections. Indicated aortic diameter is 18 to 42 mm for aneurysms and penetrating ulcers, and 18 to 44 mm for blunt traumatic injuries. In January 2014, FDA-approved indications for the Valiant™ Thoracic Stent Graft with the Captivia® Delivery System were expanded to include all lesions of the descending thoracic aorta, including Type B dissections. The Valiant graft is intended for the endovascular repair of all lesions of the descending aorta in patients having appropriate anatomy including:

 

  • Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;
  • Nonaneurysmal aortic diameter in the range of 18 to 42 mm (fusiform and saccular aneurysms/penetrating ulcers), 18 to 44 mm (blunt traumatic aortic injuries), or 20 to 44 mm (dissections) and;
  • Nonaneurysmal aortic proximal and distal neck lengths 20 mm or more (fusiform and saccular aneurysms/penetrating ulcers), and landing zone 20 mm or more proximal to the primary entry tear (BTAI, dissection). The proximal extent of the landing zone must not be dissected.

 

The expanded approval was based on the Medtronic Dissection Trial (NCT01114724), a prospective, nonrandomized study to evaluate the performance of the Valiant stent graft for acute, complicated type B dissection, which included 50 patients enrolled at 16 sites.

 

The Valiant Navion™ is a next generation thoracic stent graft system with a modified design of the Valiant Thoracic Stent Graft with Captivia Delivery System. However, unused Valiant Navion thoracic stent graft systems were voluntarily recalled by the manufacturer (Medtronic) in February 2021 due to endoleaks, stent fractures, and stent ring enlargement. The recall occurred due to results of the Valiant Evo GlobalClinical Trial which found 3 patients with stent fractures, 2 of whom had confirmed type IIIb endoleaks, and 1 patient death. Further investigation by an independent imaging laboratory found 7 of 87 patients with stent ring enlargement. The manufacturer is conducting further analysis.

 

Other devices are under development, and in some situations, physicians have adapted other commercially available stent grafts for use in the thoracic aorta.

 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

 

CODING: 

CPT Codes:

33880

Endovascular repair of descending thoracic aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); involving coverage of left subclavian artery origin, initial endoprosthesis plus descending thoracic aortic extension(s), if required, to level of celiac artery origin

33881

; not involving coverage of left subclavian artery origin, initial endoprosthesis plus descending thoracic aortic extension(s), if required, to level of celiac artery origin

33883

Placement of proximal extension prosthesis for endovascular repair of descending thoracic aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); initial extension

33884

; each additional proximal extension (list separately in addition to code for primary procedure)

33886

Placement of distal extension prosthesis(s) delayed after endovascular repair of descending thoracic aorta

33889

Open subclavian to carotid artery transposition performed in conjunction with endovascular repair of descending thoracic aorta, by neck incision, unilateral

33891

Bypass graft, with other than vein, transcervical retropharyngeal carotid-carotid, performed in conjunction with endovascular repair of descending thoracic aorta, by neck incision

75956

Endovascular repair of descending thoracic aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); involving coverage of left subclavian artery origin, initial endoprosthesis plus descending thoracic aortic extension(s), if required, to level of celiac artery origin, radiological supervision, and interpretation

75957

; not involving coverage of left subclavian artery origin, initial endoprosthesis plus descending thoracic aortic extension(s), if required, to level of celiac artery origin, radiological supervision, and interpretation

75958

Placement of proximal extension prosthesis for endovascular repair of descending thoracic aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption), radiological supervision, and interpretation

75959

Placement of distal extension prosthesis(s) delayed after endovascular repair of descending thoracic aorta, as needed, to level of celiac origin, radiological supervision, and interpretation

 

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  32. Huynh TT, Miller CC, Estrera AL, et al. Thoracoabdominal and descending thoracic aortic aneurysm surgery in patients aged 79 years or older. J Vasc Surg 2002; 36(3):469-75.
  33. Iba Y, Minatoya K, Matsuda H, et al. How should aortic arch aneurysms be treated in the endovascular aortic repair era? A risk-adjusted comparison between open and hybrid arch repair using propensity score-matching analysis. Eur J Cardiothorac Surg. Jul 2014; 46(1):32-39.
  34. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  35. Jia X, Guo W, Li TX, et al. The results of stent graft versus medication therapy for chronic type B dissection. J Vasc Surg. Feb 2013; 57(2):406-414.
  36. Jonker FH, Trimarchi S, Verhagen HJ et al. Meta-analysis of open versus endovascular repair for ruptured descending thoracic aortic aneurysm. J Vasc Surg 2010; 51(4):1026-32, 32 e1-32 e2.
  37. Klima DA, Hanna EM, Christmas AB, et al. Endovascular graft repair for blunt traumatic disruption of the thoracic aorta: experience at a nonuniversity hospital. Am Surg. Jun 2013; 79(6):594-600.
  38. Lee WA, Matsumura JS, Mitchell RS et al.  Endovascular repair of traumatic thoracic aortic injury: clinical practice guidelines of the Society for Vascular Surgery. J Vasc Surg 2011; 53(1):187-92.
  39. Makaroun MS, Dillavou ED, Kee ST, et al.  Endovascular treatment of thoracic aortic aneurysms: results of the phase II multicenter trial of the GORE TAG thoracic endoprosthesis.  J Vasc Surg 2005; 41(1):1-9.
  40. Makaroun MS, Dillavou ED, Wheatley GH, et al. Five-year results of endovascular treatment with the Gore TAG device compared with open repair of thoracic aortic aneurysms. J Vasc Surg 2008; 47(5):912-8.
  41. Martinelli O, Malaj A, Gossetti B, et al. Outcomes in the emergency endovascular repair of blunt thoracic aortic injuries. J Vasc Surg. Sep 2013; 58(3):832-835.
  42.  Matsumoto AH, Angle JF, Secic M, et al. Secondary procedures following thoracic aortic stent grafting in the first 3 years of the VALOR test and VALOR II trials. J Vasc Interv Radiol. May 2014; 25(5):685-692 e685.
  43. Matsumura J, Cambria R, Dake M, et al.  International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results.  J Vasc Surg 2008; 47(2):247-57.
  44. Matsumura JS, Melissano G, Cambria RP, et al. Five-year results of thoracic endovascular aortic repair with the Zenith TX2. J Vasc Surg. Mar 14 2014; 60(1):1-10.
  45. Moulakakis KG, Mylonas SN, Dalainas I, et al. Management of complicated and uncomplicated acute type B dissection. A systematic review and meta-analysis. Ann Cardiothorac Surg. May 2014; 3(3):234-246.
  46. National Institute for Clinical Excellence (NICE).  Endovascular stent-graft placement in thoracic aortic aneurysms and dissections.  Available online at:  www.nice.org.uk/IPG127pubicinfo.
  47. Naughton PA, Park MS, Morasch MD, et al. Emergent repair of acute thoracic aortic catastrophes: a comparative analysis. Arch Surg. Mar 2012; 147(3):243-249.
  48. Nienaber CA, Kische S, Akin I, et al. Strategies for subacute/chronic type B aortic dissection: the Investigation of Stent Grafts in Patients with type B Aortic Dissection (INSTEAD) trial 1-year outcome. J Thorac Cardiovasc Surg. Dec 2010; 140(6 Suppl):S101-108; discussion S142-S146.
  49. Nienaber CA, Kische S, Rousseau H, et al. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. Aug 2013; 6(4):407-416.
  50. Nienaber CA, Zannetti S, Barbieri B, et al. INvestigation of STEnt grafts in patients with type B Aortic Dissection: Design of the INSTEAD trial--a prospective, multicenter, European randomized trial. Am Heart J 2005; 149(4):592-9.
  51. Pang D, Hildebrand D, Bachoo P. Thoracic endovascular repair (TEVAR) versus open surgery for blunt traumatic thoracic aortic injury. Cochrane Database Syst Rev. 2015; 9:CD006642.
  52. Piffaretti G, Benedetto F, Menegolo M, et al. Outcomes of endovascular repair for blunt thoracic aortic injury. J Vasc Surg. Dec 2013; 58(6):1483-1489.
  53. Rectenwald JE, Huber TS, Martin TD, et al. Functional outcome after thoracoabdominal aortic aneurysm repair. J Vasc Surg 2002; 35(4):640-7.
  54. Roselli EE, Idrees J, Greenberg RK, et al. Endovascular stent grafting for ascending aorta repair in high-risk patients. J Thorac Cardiovasc Surg. Jan 2015; 149(1):144-151.
  55. Ruan ZB, Zhu L, Chen GC, et al. Early and long-term effect of thoracic endovascular aortic repair for Stanford B aortic dissection. Thorac Cardiovasc Surg. Mar 2015; 63(2):120-125.
  56. Safi HJ, Miller CC, Subramaniam MH, et al. Thoracic and thoracoabdominal aortic aneurysm repair using cardiopulmonary bypass, profound hypothermia, and circulatory arrest via left side of the chest incision. J Vasc Surg 1998; 28(4):591-8.
  57. Scalea TM, Feliciano DV, DuBose JJ, et al. Blunt Thoracic Aortic Injury: Endovascular Repair Is Now the Standard. J Am Coll Surg. Apr 2019; 228(4): 605-610.
  58. Sood V, Patel HJ, Williams DM, et al. Open and endovascular repair of the nontraumatic isolated aortic arch aneurysm. J Vasc Surg. Mar 19 2014; 60(1):57-63. PMID 24655751.
  59. Steuer J, Bjorck M, Sonesson B, et al. Editor's Choice - Durability of endovascular repair in blunt traumatic thoracic aortic injury: long-term outcome from four tertiary referral centers. Eur J Vasc Endovasc Surg. Oct 2015; 50(4):460-465.
  60. Steur J, Eriksson MO, Nyman R et al. Early and long-term outcome after thoracic endovascular aortic repair (TEVAR) for acute complicated type B aortic dissection.  Eur J Vasc Endovasc Surg 2011; 41(3):318-23.
  61. Thrumurthy SG, Karthikesalingam A, Patterson BO, et al. A systematic review of mid-term outcomes of thoracic endovascular repair (TEVAR) of chronic type B aortic dissection. Eur J Vasc Endovasc Surg. Nov 2011; 42(5):632-647.
  62. Ultee KHJ, Zettervall SL, Soden PA, et al. The impact of endovascular repair on management and outcome of ruptured thoracic aortic aneurysms. J Vasc Surg. Aug 2017;66(2):343-352 e341.
  63. Upchurch GR, Escobar GA, Azizzadeh A, et al. Society for Vascular Surgery clinical practice guidelines of thoracicendovascular aortic repair for descending thoracic aortic aneurysms. J Vasc Surg. Jan 2021; 73(1S): 55S-83S.
  64. Vallabhajosyula P, Gottret JP, Bavaria JE, et al. Endovascular repair of the ascending aorta in patients at high risk for open repair. J Thorac Cardiovasc Surg. Feb 2015; 149(2 Suppl):S144-150.
  65. van Bogerijen GH, Patel HJ, Williams DM, et al. Propensity adjusted analysis of open and endovascular thoracic aortic repair for chronic type B dissection: a twenty-year evaluation. Ann Thorac Surg. Apr 2015; 99(4):1260-1266.
  66. Van Bogerijen GH, Williams DM, Patel HJ. TEVAR for complicated acute type B dissection with malperfusion. Ann Cardiothroac Surg. 2014 Jul;3(4):423-427.
  67. Van Dongen EP, Schepens MA, Morshuis WJ, et al. Thoracic and thoracoabdominal aortic aneurysm repair: Use of evoked potential monitoring in 118 patients. J Vasc Surg 2001; 34(6):1035-40.
  68. Webb TH and Williams GM. Thoracoabdominal aneurysm repair. Cardiovasc Surg 1999; 7(6):573-85.
  69. White RA, Miller DC, Criado FJ et al. Report on the results of thoracic endovascular aortic repair for acute, complicated, type B aortic dissection at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee. J Vasc Surg 2011; 53(4):1082-90.
  70. Wiedemann D, Mahr S, Vadehra A, et al. Thoracic endovascular aortic repair in 300 patients: long-term results. Ann Thorac Surg. May 2013; 95(5):1577-1583.
  71. Yamaguchi T, Nakai M, Sumita Y, et al. Editor's Choice - Endovascular Repair Versus Surgical Repair for Japanese Patients With Ruptured Thoracic and Abdominal Aortic Aneurysms: A Nationwide Study. Eur J Vasc Endovasc Surg. Jun 2019; 57(6): 779-786.
  72. Zeeshan A, Woo EY, Bavaria JE et al. Thoracic endovascular aortic repair for acute complicated type B aortic dissection: superiority relative to conventional open surgical and medical therapy. J Thorac Cardiovasc Surg 2010; 140(6 Suppl):S109-15; discussion S142_6.

 

POLICY HISTORY:

Medical Policy Panel, May 2016

Medical Policy Group, February 2017 (4): Newly adopted policy.

Medical Policy Administration Committee, March 2017

Available for comment February 20 – April 5, 2017

Medical Policy Panel, May 2017

Medical Policy Group, June 2017 (4): Updates to Description, Key Points and References.  Policy section updated to allow coverage for ruptured thoracic aneurysms.

Medical Policy Administration Committee Meeting, June 2017

Available for comment June 17 through August 1, 2017

Medical Policy Panel, May 2018

Medical Policy Group, June 2018 (4): Updates to Description, Key Points, Key Words, and References. Added key words thoracic aneurysm, TAA, aortic aneurysm.

Medical Policy Panel, May 2019

Medical Policy Group, May 2019 (4): Updates to Key Points.  No change to policy statements.

Medical Policy Panel, June 2020

Medical Policy Group, June 2020 (4): Updates to Key Points and References.  No change to policy statements. Removed policy statements effective for dates of service prior to June 15, 2017.

Medical Policy Panel, May 2021

Medical Policy Group, June 2021 (4): Updates to Policy, Key Points, Approved by Governing Bodies, and References.  Policy statements updated to remove “without dissection" from 1st criteria point and added coverage for tears. The following references were removed:  Abraha I, Romagnoli C, Montedori A et al.  Thoracic stent graft versus surgery for thoracic aneurysm.  Cochrane Database Syst; Cambria RP, Crawford RS, Cho JS et al. A multicenter clinical trial of endovascular stent graft repair of acute catastrophes of the descending thoracic aorta; Chemelli-Steingruber I, Chemelli A, Strasak A, et al. Endovascular repair or medical treatment of acute type B aortic dissection?; Dick F, Hinder D, Immer FF, et al. Outcome and quality of life after surgical and endovascular treatment of descending aortic lesions; Instructions for use: TAG thoracic endoprosthesis; Nakamura K, Matsuyama M, Yano M, et al.  Open surgery or stent repair for descending aortic diseases; Orandi BJ, Dimick JB, Deeb GM, et al. A population-based analysis of endovascular versus open thoracic aortic aneurysm repair; Safi HJ, Subramaniam MH, Miller CC, et al. Progress in the management of type I thoracoabdominal and descending thoracic aortic aneurysms; Svensson LG, Kouchoukos NT, Miller DC, et al. Expert Consensus Document on the treatment of descending thoracic aortic disease using endovascular stent-grafts;  Umana JP, Miller DC and Mitchell RS. What is the best treatment for patients with acute type B aortic dissections.

Medical Policy Administrative Committee: July 2021

Available for Comment: June 23, 2021 - August 9, 2021

 

 

 

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.