Latest Review Date: August 2024

Category: Surgery                                                                 

POLICY:

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.

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 treating 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. Type B aortic dissections are classified by acuity (termed as complicated or uncomplicated) and chronicity and are summarized in the table below.

Category	Description
Uncomplicated	No rupture No malperfusion No high risk features
Complicated	Rupture Malperfusion
High risk	Refractory pain Refractory hyperfusion Bloody plural effusion Aortic diameter >40mm Radiographic only malperfusion Readmission Entry tear: lesser curve location False lumen diameter >22mm
Chronicity (time elapsed since the onset of symptoms)	Hyperacute (<24 hours) Acute (1 to 14 days) Subacute (15 to 90 days) Chronic (>90 days)

Treatment

Type A dissections are often 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.

As noted, type A dissections (involving the ascending aorta) are treated surgically. 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. Endovascular intervention has supplanted open repair or medical management alone as first-line treatment for complicated type B aortic dissection as a result of accumulated data indicating reduced morbidity and mortality.

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 July 1, 2024.

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 support the conclusion that TEVAR is a safer procedure in the short term. The likely short-term benefits of TEVAR are mitigated by less favorable longer term outcomes, 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 uncomplicated type B (descending) thoracic aortic dissections who receive endovascular repair, the evidence includes randomized controlled trials (RCTs), systematic reviews, and retrospective cohort studies. Relevant outcomes are OS, morbid events, and treatment-related mortality and morbidity. In the INSTEAD trial there were no statistically significant differences between the endovascular and medical groups for OS at 1 year or at 5 years. At 5 years of follow-up, aorta-specific mortality (7% versus 19%) was significantly lower for endovascular versus medical treatment. In the ADSORB trial, there were significantly fewer events of the composite outcome of incomplete/no false lumen thrombosis, aortic dilation, or aortic rupture in the endovascular group in the per protocol analysis, but the trial had several limitations and was not designed for mortality outcomes. An ongoing RCT is designed to compare 5-year all-cause mortality for best medical therapy alone versus best medical therapy with thoracic endovascular aortic repair for uncomplicated acute type B aortic dissection. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have complicated type B (descending) thoracic aortic dissections who receive endovascular repair, the evidence includes systematic reviews and nonrandomized comparative studies. Relevant outcomes are OS, morbid events, and treatment-related mortality and morbidity. Systematic reviews of the available nonrandomized comparative studies consistently indicate benefits in early morbidity and mortality with TEVAR relative to open repair, as well as similar or superior long-term survival outcomes compared to open repair or medical management alone. Although these studies carry inherent limitations and the interventions carry complication risks that do not completely overlap, the accrued evidence favors use of TEVAR over open repair in suitable patients. The evidence is sufficient 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. Systematic reviews of the available nonrandomized comparative studies consistently indicate benefit in early mortality and similar or superior long-term survival outcomes with TEVAR relative to open repair, with low rates of complications requiring reintervention with long-term follow-up. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

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/American Heart Association

In 2022, the American College of Cardiology and American Heart Association published guidelines for the diagnosis and management of aortic disease. The guideline included the recommendations regarding thoracic aortic disorders below.

American College of Cardiology/American Heart Association 2022 Guideline on Aortic Disease

Recommendation	COR	LOE
In patients without Marfan syndrome, Loeys-Dietz syndrome, or vascular Ehlers-Danlos syndrome, who have a descending TAA that meets criteria for intervention and anatomy suitable for endovascular repair, TEVAR is recommended over open surgery	1	B-NR
In patients with ruptured descending TAA who are anatomic candidates for endovascular repair, TEVAR is recommended over open repair because of decreased perioperative death and morbidity	1	B-NR
In patients with ruptured TAAA requiring intervention, open repair is recommended	1	B-NR
In patients with ruptured TAAA requiring intervention, provided that the patient is hemodynamically stable, endovascular repair may be reasonable in centers with endovascular expertise and access to appropriate endovascular stent grafts	2B	C-LD
In patients with Marfan syndrome, Loeys-Dietz syndrome, or vascular Ehlers-Danlos syndrome and intact TAAA requiring intervention, open repair is recommended over endovascular repair	1	C-LD
In patients with intact degenerative TAAA and suitable anatomy, endovascular repair with fenestrated stent grafts, branched stent grafts, or both may be considered in centers with endovascular expertise and access to appropriate endovascular stent grafts	2B	B-NR
In patients with rupture [of acute type B aortic dissection], in the presence of suitable anatomy, endovascular stent grafting, rather than open surgical repair, is recommended	1	C-EO
In patients with other complications [of acute type B aortic dissection, besides rupture], in the presence of suitable anatomy, the use of endovascular approaches, rather than open surgical repair, is reasonable	2A	C-LD
In patients with uncomplicated acute type B aortic dissection who have high-risk anatomic features, endovascular management may be considereda	2B	B-R
In patients with blunt traumatic thoracic aortic injury who meet indications for repair and with appropriate anatomy, TEVAR is recommended over open repair.	1	B-NR

COR: class of recommendation; EO: expert opinion; LD: limited data; LOE: level of evidence; NR: non-randomized; R: randomized; TAA: thoracic aortic aneurysm; TAAA: thoracoabdominal aortic aneurysm; TEVAR: thoracic endovascular aortic repair. a High-risk anatomic features include maximal aortic diameter >40 mm, false-lumen diameter >20-22 mm, entry tear >10 mm, entry tear on lesser curvature, increase in total aortic diameter of >5 mm between serial imaging studies, bloody pleural effusion, imaging-only evidence of malperfusion, refractory hypertension despite >3 different classes of antihypertensive medications at maximal recommended or tolerated doses, refractory pain persisting >12 hours despite maximal recommended or tolerated doses, or need for readmission.

Society of Thoracic Surgeons/American Association for Thoracic Surgery

The Society of Thoracic Surgeons and American Association for Thoracic Surgery published a guideline on the management of type B aortic dissection in 2022. The guideline included the recommendations regarding thoracic aortic disorders below.

Society of Thoracic Surgeons/American Association for Thoracic Surgery 2022 Guideline on Type B Aortic Dissection

Recommendation	COR	LOE
TEVAR is indicated for complicated hyperacute, acute, or subacute TBADs with rupture and/or malperfusion and favorable anatomy for TEVAR	1	B-NR
Open surgical repair for complicated hyperacute, acute, or subacute TBADs should be considered for those patients with unsuitable anatomy for TEVAR	2a	B-NR
OMT is the recommended treatment for patients with uncomplicated TBAD	1	B-NR
Prophylactic TEVAR may be considered in patients with uncomplicated TBAD to reduce late aortic-related adverse events and aortic-related death	2b	B-NR
Open surgical repair should be considered for patients with chronic TBAD with indications for intervention, unless comorbidities are prohibitive or anatomy is not suitable for TEVAR	2a	B-NR
TEVAR is reasonable for patients with chronic TBAD with an indication for intervention with suitable anatomy (adequate landing zone, absence of ascending or arch aneurysm) but who are at high risk for complications of open repair due to comorbidities	2a	B-NR
TEVAR alone as sole therapy is not recommended in patients with chronic TBAD who have a large abdominal aortic aneurysm, an inadequate distal landing zone, and/or large distal reentry tears	3	C-LD

COR: class of recommendation; LD: limited data; LOE: level of evidence; NR: non-randomized; OMT: optimal medical therapy; TBAD: type B aortic dissection; TEVAR: thoracic endovascular aortic repair

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).

Device	Manufacturer	Date Approved	PMA No.
GORE TAG® Thoracic Endoprosthesis	W.L. Gore and Associates	Mar 2005	P040043
Zenith TX2® TAA Endovascular Graft	Cook Europe	May 2008	P070016
Zenith Alpha™ Thoracic Endovascular Graft	Cook	Sep 2015	P140016
Talent™ Thoracic Stent Graft System	Medtronic Vascular	Jun 2008	P070007
Relay® Thoracic Stent-Graft with Plus Delivery System	Bolton Medical	Sep 2012	P110038
Valiant™ Thoracic Stent Graft with the Captivia® DeliverySystem	Medtronic Vascular	Apr 2011	P100040

 

The Gore TAG® Thoracic Endoprosthesis is indicated 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 23to 37 mm, and 2 cm or more nonaneurysmal aorta proximal and distal to the aneurysm. In 2012, the FDA expanded the 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 aorta distal and proximal to the lesion.

The Zenith TX2® TAA Endovascular Graft was approved by the FDA through the premarket approval (PMA) process for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta. Indicated aortic inner diameter ranges from 24 to 38 mm.

The Talent™ Thoracic Stent Graft System was approved by the FDA through the PMA process for the endovascular repair of fusiform and saccular aneurysms or penetrating ulcers of the descending thoracic aorta. Indicated aortic inner diameter ranges from 18 to 42 mm. The Talent Thoracic Stent Graft System was discontinued by the manufacturer and replaced with the Valiant™ Thoracic Stent Graft System.

The Relay® Thoracic Stent-Graft with Plus Delivery System was approved by the FDA through the PMA process for the endovascular repair of fusiform aneurysms and saccular aneurysms or penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including:

• Iliac or femoral access vessel morphology compatible with vascular access techniques, devices, and/or accessories
• Nonaneurysmal aortic neck diameter ranging from 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.

The Relay®Pro system is indicated for treatment of all lesions of the descending thoracic aorta, including Type B dissections and traumatic injuries.

The Valiant™ Thoracic Stent Graft with the Captivia® Delivery System was approved by the FDA for isolated lesions of the thoracic aorta. Isolated lesions refer to aneurysms, ruptures, tears, penetrating ulcers, and/or isolated hematomas, but not dissections. Indicated aortic diameter is 18 to 42 mm for aneurysms and penetrating ulcers, and 18 to 44 mm for blunt traumatic injuries. In 2014, the FDA expanded the indication for this graft and delivery system 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 compatible with vascular access techniques, devices, and/or accessories;
• Nonaneurysmal aortic diameter ranging from 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 of 20 mm or more (fusiform and saccular aneurysms/penetrating ulcers), and landing zone of 20 mm or more proximal to the primary entry tear (blunt traumatic aortic injuries, 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 that evaluated 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 Global Clinical 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.  

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

REFERENCES:

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25. Hanna JM, Andersen ND, Ganapathi AM, et al. Five-year results for endovascular repair of acute complicated type B aortic dissection. J Vasc Surg. Jan 2014; 59(1):96-106.
26. Harky A, Bleetman D, Chan JSK, et al. A systematic review and meta-analysis of endovascular versus open surgical repair for the traumatic ruptured thoracic aorta. J Vasc Surg. Jan 2020; 71(1): 270-282.
27. Hossack M, Patel S, Gambardella I, et al. Endovascular vs. Medical Management for Uncomplicated Acute and Sub-acute Type B Aortic Dissection: A Meta-analysis. Eur J Vasc Endovasc Surg. May 2020; 59(5): 794-807.
28. 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.
29. Iannuzzi JC, Stapleton SM, Bababekov YJ, et al. Favorable impact of thoracic endovascular aortic repair on survival of patients with acute uncomplicated type B aortic dissection. J Vasc Surg. Dec 2018; 68(6): 1649-1655.
30. 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.
31. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
32. Isselbacher EM, Preventza O, Hamilton Black Iii J, et al. 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. Dec 13 2022; 80(24): e223-e393.
33. 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.
34. 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.
35. 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.
36. Leshnower BG, Szeto WY, Pochettino A, et al. Thoracic endografting reduces morbidity and remodels the thoracic aorta inDeBakey III aneurysms. Ann Thorac Surg. Mar 2013; 95(3): 914-21.
37. Lombardi JV, Gleason TG, Panneton JM, et al. STABLE II clinical trial on endovascular treatment of acute, complicated type B aortic dissection with a composite device design. J Vasc Surg. Apr 2020; 71(4): 1077-1087.e2
38. MacGillivray TE, Gleason TG, Patel HJ, et al. The Society of Thoracic Surgeons/American Association for Thoracic Surgery clinical practice guidelines on the management of type B aortic dissection. J Thorac Cardiovasc Surg. Apr 2022; 163(4): 1231-1249.
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 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.
44. 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.
45. 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.
46. 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.
47. 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.
48. 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.
49. 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.
50. 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.
51. Rectenwald JE, Huber TS, Martin TD, et al. Functional outcome after thoracoabdominal aortic aneurysm repair. J Vasc Surg 2002; 35(4):640-7.
52. 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.
53. 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.
54. Sá MP, Jacquemyn X, Van den Eynde J, et al. Midterm Outcomes of Endovascular vs. Medical Therapy for Uncomplicated Type B Aortic Dissection: Meta-Analysis of Reconstructed Time to Event Data. Eur J Vasc Endovasc Surg.Nov 2023; 66(5): 609-619.
55. 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.
56. Safi HJ, Subramaniam MH, Miller CC, et al. Progress in the management of type I thoracoabdominal and descending thoracic aortic aneurysms. Ann Vasc Surg. Sep 1999; 13(5): 457-62.
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. 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.
60. 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.
61. 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.
62. 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.
63. 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.
64. 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.
65. 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.
66. Webb TH and Williams GM. Thoracoabdominal aneurysm repair. Cardiovasc Surg 1999; 7(6):573-85.
67. 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.
68. Wilson-Smith AR, Muston B, Kamalanathan H, et al. Endovascular repair of acute complicated type B aorticdissection-systematic review and meta-analysis of long-term survival and reintervention. Ann Cardiothorac Surg.Nov 2021; 10(6): 723-730.
69. Xiang D, Kan X, Liang H, et al. Comparison of mid-term outcomes of endovascular repair and medicalmanagement in patients with acute uncomplicated type B aortic dissection. J Thorac Cardiovasc Surg. Jul 2021;162(1): 26-36.e1.
70. 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.
71. 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

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (4): Updates to Key Points and References.  No change to policy statements.

Medical Policy Panel, October 2023

Medical Policy Group, November 2023 (4): Updates to Description, Key Points, Approved Governing Bodies, Benefit Application, and References.  No change to policy statements.

Medical Policy Panel, August 2024

Medical Policy Group, August 2024 (4): Updates to Policy, Description, Key Points, Approved by Governing Bodies, and References. Removed policy statements effective for dates of service prior to June 23, 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.