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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 than 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 which impinge on the true lumen of the aorta, or occlude branching vessels are a surgical emergency.
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, ie, 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 and colleagues 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 and colleagues 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 one 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. Type A dissections 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. 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. 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 (ie, limited to the descending aorta). In general, chronic, stable type B dissections are managed medically, although some surgeons recommended a more aggressive approach for younger patients in otherwise good health. When serious complications arise from a type B dissection, ie, shock or visceral ischemia, surgical intervention is usually indicated. However, although there is an estimated 50% 1-year survival rate in those treated with an open surgical procedure, it is not clear whether that rate is any better or worse than 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.
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 TEVAR, the decision making for intervention may be altered, as 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 (eg, paraplegia, cardiopulmonary events), and others are unique to TEVAR (eg, access site complications).
A number of endovascular grafts are approved for use in TAAs.
In March 2005, the Gore TAG® Thoracic Endoprosthesis (W.L. Gore and Associates, 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 2 cm or more 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 Inc., 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 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 - 42mm.
In September 2012, Relay® Thoracic Stent-Graft with Plus Delivery System (Bolton Medical, Sunrise, FL) was approved by the 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:
In 2012, the Valiant™ Thoracic Stent Graft with the Captivia® Delivery System (Medtronic Vascular, Santa Rosa, CA) was approved by the 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 do not include dissections. Indicated aortic diameter is 18-42 mm for aneurysms and penetrating ulcers, and 18-44 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:
The expanded approval was based on the Medtronic Dissection Trial, 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.
Other devices are under development, and in some situations, physicians have adapted other commercially available stent grafts for use in the thoracic aorta.
POLICYEndovascular stent grafts using devices approved by the U.S. Food and Drug Administration may be considered medically necessary in the following situations:
Endovascular stent grafts are considered investigational for the treatment of thoracic aortic lesions that do not meet the above criteria, including but not limited to thoracic aortic arch aneurysms.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Endograft placement relies on non-aneurysmal aortic segments proximal and distal to the aneurysm and/or dissection for anchoring, and a maximal graft diameter that varies by device. The Gore TAG® endoprosthesis is approved by the U.S. Food and Drug Administration (FDA) for “≥2 cm non-aneurysmal aorta proximal and distal to the aneurysm" and an “aortic inner diameter of 23–37 mm.” The Talent™ Thoracic Stent Graft System is approved by the FDA for “non-aneurysmal aortic proximal and distal neck lengths ≥20mm” and “non-aneurysmal aortic diameter in the range of 18–42 mm.” The Zenith TX2® device is approved by the FDA for non-aneurysmal aortic segments “of at least 25 mm in length” and “diameter measured outer wall to outer wall of no greater than 38 mm and no less than 24 mm.”
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY7/2003: Approved by Medical Policy Advisory Committee (MPAC)
4/20/2005: Hyperlink to Endovascular Grafts for Abdominal Aortic Aneurysms deleted
3/23/2006: Coding updated. CPT4 2006 revisions added to policy
5/18/2006: Policy revised. Revisions approved by Medical Policy Advisory Committee (MPAC)
6/22/2006: Code reference section updated, all CPT codes moved from non-covered table to covered table. CPT code 33891 added to covered table. ICD-9 procedure code 39.73 added to covered table.
8/19/2009: Policy reviewed, no changes
05/09/2011: Policy description revised to add additional FDA-approved devices: Zenith 2X2® device and Talent™ Thoracic Stent Graft System. The first policy statement was revised to indicate that endovascular stent grafts may be considered medically necessary for the treatment of descending thoracic aortic aneurysms using devices approved by the U.S. Food and Drug Administration for their approved specifications. The approved specifications for each device were added to the Policy Guidelines section.
09/23/2011: Policy statement revised to indicate that thoracic endovascular aneurysm repair may be considered medically necessary for complicated Type B dissections.
09/25/2012: Policy reviewed; no changes.
10/14/2013: Treatment of rupture of the descending thoracic aorta added as medically necessary. Investigational policy statement expanded to include any thoracic aortic lesions that do not meet the above criteria, including but not limited to thoracic aortic arch aneurysms. Deleted outdated references from the Sources section.
08/25/2014: Policy titled changed from "Endovascular Stent Grafts for Thoracic Aortic Aneurysms" to "Endovascular Stent Grafts for Disorders of the Thoracic Aorta." Policy description updated regarding thoracic aortic aneurysms, thoracic aortic dissection, thoracic aortic rupture, TEVAR, and available devices. Policy statement unchanged. Policy guidelines updated.
08/25/2015: Code Reference section updated to add ICD-10 codes. Added ICD-9 diagnosis codes 441.01 and 441.03.
11/03/2015: Policy description updated. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.
05/31/2016: Policy number added.
08/17/2016: Policy description updated. Policy statements unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.86
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.