Endovascular Stent Grafting for Treatment of Abdominal Aortic Aneurysm and Thoracic Aortic Aneurysm and Dissections
DESCRIPTION
Endovascular stent grafting is a surgical procedure to repair an aneurysm, which is a weakened and enlarged section of an artery. It is an inpatient procedure performed under general or spinal anesthesia. During this procedure, a prosthetic endograft is introduced with radiographic guidance through the femoral artery, iliac artery or the abdominal aorta. The device is advanced to the aneurysm site, deployed and attached to the aorta with a self-expandable stent system.
A thoracic aortic aneurysm (TAA) is a potentially life-threatening disorder involving a structural weakness of the aortic wall. Progressive arterial dilation and possible rupture may occur. Standard treatment for thoracic aortic aneurysms is an open surgical resection and replacement of the diseased aorta with a graft. It has been proposed that endovascular repair may be an option for treatment of TAA.
In contradistinction, aortic dissection occurs when the inner layer of the aorta's artery wall splits open (dissects) causing bleeding into and along the wall of the aorta. Standard treatment for dissection of the aorta includes antihypertensive medications and / or open surgical repair or replacement of the dissected section of aorta. It has been proposed that endovascular repair may be an option for treatment of aortic dissection by redirecting flow into the true lumen of the aorta.
The conventional management of a clinically significant abdominal aortic aneurysm (AAA) consists of surgical excision with placement of a graft. Surgical excision is associated with a perioperative mortality rate of 4%, which may rise to 10% in symptomatic patients. Due to this high mortality rate, endovascular prostheses have been investigated as a minimally invasive, catheter-based alternative to open surgical excision of AAA. These devices, consisting of intraluminal stents lined with vascular graft material, are deployed across the aneurysm such that the aneurysm is effectively "excluded" from the circulation with subsequent restoration of normal blood flow. There are two basic types of grafts - straight grafts, in which both ends are anchored to the infrarenal aorta, and bifurcated grafts, in which the proximal end is anchored to the infrarenal aorta and the distal ends are anchored to the iliac arteries.
POLICY
Endovascular stent grafting as an alternative to open repair for the treatment of descending thoracic aortic aneurysms is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Endovascular stent grafting as an alternative to open repair for the treatment of abdominal aortic aneurysms is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Endovascular stent grafting for the treatment of thoracic aortic arch aneurysm, thoracic aortic dissections or thoracic aneurysm other than descending is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
See also: Wireless Pressure Sensors in Endovascular Aneurysm Repair
MEDICAL APPROPRIATENESS
Endovascular stent grafting is considered medically appropriate if ANY ONE of the following criteria are met :
Treatment of descending thoracic aortic aneurysms with ALL of the following:
Adequate iliac/femoral access
Device complies with the specifications of the U.S. Food and Drug Administration approval
Treatment of abdominal aortic aneurysm with ANY ONE of the following:
Aneurysm diameter greater than 5.0 cm
Aneurysm diameter 4 - 5.0 cm that has increased by 0.5 cm in the last 6 months
Ruptured abdominal aortic aneurysm with ALL of the following:
Individual is sufficiently stable to undergo CT examination for anatomic measurements
Aneurysm is anatomically appropriate for endovascular repair
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
The GORE TAG® endoprosthesis is approved by the U.S. Food and Drug Administration (FDA) for at least 2 cm of 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 of at least 20 mm and non-aneurysmal aortic diameter in the range of 18 - 42 mm. The Zenith T X 2® 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.
There is insufficient evidence, as well as lack of comparison of this technology to conventional therapy, regarding the efficacy of endovascular grafts for the treatment of thoracic aortic arch aneurysms, thoracic aortic dissections, or thoracic aneurysms other than descending.
These procedures require the availability of a specialized endovascular team including the radiologist and experienced surgeon.
To monitor for leaking of the graft, after implantation patients will typically undergo routine imaging with either computed tomography or ultrasonography every 6 to 12 months, or more frequently if perivascular leaks or aneurysm enlargement is detected.
SOURCES
Ballard, D., Fowkes, F., & Powell, J. Surgery for small asymptomatic abdominal aortic aneurysms. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.:CD001835. DOI: 10.1002/14651858.CD001835.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2010). Endovascular grafts for abdominal aortic aneurysms (7.01.67). Retrieved November 18, 2010 from BlueWeb. (36 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2009). Endovascular stent grafts for thoracic aortic aneurysms or dissections (7.01.86). Retrieved November 18, 2010 from BlueWeb. (23 articles and/or guidelines reviewed)
DeBruin, J., Baas, A., Buth, J., Prinssen, M., Verhoeven, E., Cuypers, P., et al. (2010) Long term outcome of open or endovascular repair of abdominal aortic aneurysm. New England Journal of Medicine, 362, (20), 1881-1889. (Level 1 Evidence - Independent)
Dillon M, Cardwell C, Blair PH, Ellis P, Kee F, Harkin DW. Endovascular treatment for ruptured abdominal aortic aneurysm. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD005261. DOI: 10.1002/14651858.CD005261.pub2.
ECRI Institute. Health Technology Information Service. Evidence Reports. (2004, April). Endovascular grafts for prophylactic abdominal aortic aneurysm repair. Retrieved March 3, 2009 from ECRI Institute. (103 articles and/or guidelines reviewed)
Eliason, J. L., & Upchurch, G. R. (2008). Endovascular abdominal aortic aneurysm repair. Circulation, 117, 1738-1744.
Giles, K., Hamdan, A., Pomposelli, F., Wyers, M., Dahlberg, S., & Schermerhorn, M. (2009). Population-based outcomes following endovascular and open repair of ruptured abdominal aortic aneurysms. International Society of Endovascular Specialists, 2009, (16), 554-564. (Level 3 Evidence - Industry sponsored)
Karkos, C., Harkin, d., Giannakou, A., & Garassimidis, T. (2009). Mortality after endovascular repair of ruptured abdominal aortic aneurysm. Archives of Surgery, 144, (8), 770-778. (Level1 Evidence - Independent)
Makaroun, M. S., Dillavou, E. D., Kee, S. T., Sicard, G., Chaikof, E., Bavaria, J., et al. (2005). Endovascular treatment of thoracic aortic aneurysms: Results of the phase II multicenter trial of the GORE TAG® thoracic endoprosthesis. Journal of Vascular Surgery, 41, (1), 1-9. (Level 1 Evidence - Independent study)
Moore, R., Nutley, M., Cina, S. S., Motomedi, M., Faris, P., & Abuznadah, W. (2007). Improved survival after introduction of an emergency endovascular therapy protocol for ruptured abdominal aortic aneurysms. Journal of Vascular Surgery, 45 (3), 443-450. (Level 3 Evidence - Industry sponsored)
National Institute for Health and Clinical Excellence. (NICE). (2009, February). Endovascular stent–grafts for the treatment of abdominal aortic aneurysms. Retrieved March 5, 2009 from http://www.nice.org.uk/nicemedia/pdf/TA167GuidanceWord.doc.
National Institute for Health and Clinical Excellence. (NICE). (2005, June). Endovascular stent–graft placement in thoracic aortic aneurysms and dissections. Retrieved March 5, 2009 from http://www.nice.org.uk/nicemedia/pdf/ip/IPG163guidance.pdf.
Rousseau, H., Dambrin, C., Marcheix, B., Richeux, L., Mazerilles, M., Cron, C., et al. (2005). Acute traumatic aortic rupture: A comparison of surgical and stent-graft repair. The Journal of Thoracic and Cardiovascular Surgery, 129 (5), 1050-1055. (Level 3 Evidence - Independent study)
Stone, D. H., Brewster, D. C., Kwolek, C. J., Lamuraglia, G. M., Conrad, M. F., Chung, T. K., et al. (2006). Stent-graft versus open-surgical repair of the thoracic aorta: Mid-term results. Vascular Surgery, 44 (6), 1188-1197. (Level 3 Evidence - Independent study)
U. S. Food and Drug Administration. (2005, March). Center for Devices and Radiological Health. GORE TAG® thoracic endoprosthesis. P040043. Retrieved March 3, 2009 from http://www.fda.gov/cdrh/pdf4/P040043b.pdf.
U. S. Food and Drug Administration. (2005, March). Center for Devices and Radiological Health. Talent™ thoracic stent graft system. P070007. Retrieved December 7, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070007b.pdf.
U. S. Food and Drug Administration. (2008, May). Center for Devices and Radiological Health. Zenith® T X 2® Thoracic TAA Endovascular Graft with the H&LB One-ShotTM P070016. Retrieved December 8, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070016A.pdf.
Winfred S. Hayes, Inc. Medical Technology Directory. (2007, February; last update search May 27, 2010). Endovascular repair of thoracic aortic aneurysms and dissections. Retrieved December 7, 2010 from https://www.hayesinc.com/subscribers. (95 articles and/or guidelines reviewed)
Winfred S. Hayes, Inc. Medical Technology Directory. (2007, November; last update search June 23, 2010). Endovascular repair, abdominal aortic aneurysms. Retrieved December 7, 2010 from https://www.hayesinc.com/subscribers. (168 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 6/1/2008
MOST RECENT REVIEW DATE: 2/10/2011
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