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DESCRIPTIONThe traditional standard therapy for thoracic aortic aneurysm (TAA) is open operative repair with graft replacement of the diseased segment. This procedure requires lateral thoracotomy, use of cardiopulmonary bypass, long operation times, and a variety of peri- and postoperative complications, with spinal cord ischemia considered the most devastating. 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 thorabdominal aorta.
In March 2005, the GORE-TAG Thoracic Endoprosthesis was approved by the U.S. Food and Drug Administration (FDA) for endovascular repair of aneurysms of the descending thoracic aorta. Use of this device requires patients have adequate iliac/femoral access; aortic inner diameter in the range of 23-37 mm; and 2 cm non-aneurysmal aorta proximal and distal to the aneurysm.
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 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 October 2012, the FDA granted approval for the Valiant™ Thoracic Stent Graft with the Captivia® Delivery System (Medtronic Vascular, Santa Rosa, CA) 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 diameter is 18-42 mm for aneurysms and penetrating ulcers, and 18-44 mm for blunt traumatic injuries.
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.
POLICY GUIDELINESEndograft 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.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
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.