This policy addresses the use of stent grafts placed endovascularly for the treatment of aortic and aortoiliac aneurysms.

Medically Necessary:

The use of FDA approved endovascular/endoluminal stent graft devices is considered medically necessary for patients with the following indications, when the presence of co-morbidities precludes an open approach:

• Abdominal aortic aneurysm (AAA); or
• Aortoiliac aneurysm; or
• Descending thoracic aortic aneurysm.

Investigational/Not Medically Necessary:

The use of non-FDA approved endovascular/endoluminal stent graft devices is considered investigational/not medically necessary.

The use of endovascular/endoluminal stent graft devices for all other indications not noted above is considered investigational/not medically necessary including, but not limited to, the treatment of dissections.

Rationale

Abdominal Aortic Aneurysms (AAA)
The use of an endovascular/endoluminal stent graft for the repair of an abdominal or an aortoiliac aneurysm is considered to be a medically acceptable alternative to surgical repair for some aneurysms.  A variety of devices have received FDA approval, including both straight and bifurcated grafts that extend into the iliac arteries.  Fenestrated grafts have also been investigated.  These grafts are designed with openings in the wall that can be placed across the renal or celiac arteries while still protecting vessel patency.  In addition, extensions can be placed from inside the main endograft body into the visceral arteries to create a hemostatic seal.

The original FDA approval for endovascular grafts for abdominal aneurysms did not require randomized studies.  Randomized studies of straight or bifurcated grafts have now been reported that provide additional information in two categories of patients; those considered to be candidates for an open repair, and those not considered candidates for an open repair, due to comorbidities.  Several devices have received FDA pre-market approval (PMA) for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms, subject to FDA-approved labeling indications.  These include, but are not limited, to: the AneuRx® (Medtronic, Inc., Santa Rosa, CA); the Ancure® System and the Ancure® Aortoiliac System (Guidant Corp., Menlo Park, CA); the Zenith® AAA Endovascular Graft with the H & L-B One-Shot™ Introduction System (Cook, Inc. Bloomington, IN); and the EXCLUDER™ (W. L. Gore & Associates, Inc., Flagstaff, AZ).

Several randomized studies focusing on endovascular repair, as an alternative to open repair, have confirmed that endovascular repair is associated with a decreased operative mortality, although these studies did not report improvement in long term survival. The DREAM (Dutch Randomized Endovascular Aneurysm Management) trial enrolled 351 patients who were randomized to either endovascular or open repair.  The operative mortality was 4.6% in the open repair group and 1.2 % in the endovascular repair group (Blankensteijn, 2005).  However, the cumulative survival rates were 89.6% for open repair and 89.7% for endovascular repair (Prinssen, 2004).  The Endovascular Aneurysm Repair Trial (EVAR) I trial randomized 1,000 patients age 60 years or older with aneurysms at least 5.5 cm in diameter to undergo either open or endovascular repair (EVAR Trial I, 2005).  After four years of follow-up, all-cause mortality was not significantly different between the two patient groups, although aneurysm-related mortality was significantly less in the endovascular repair group, 4% versus 7%.  In contrast, within four years of follow up, endovascular repair was associated with a complication rate of 41%, compared to only 9% in the surgically treated group.  Due to the higher incidence of late complications in those undergoing endovascular repairs, ongoing surveillance is typically recommended.  The results of these trials suggest that fit patients with long life expectancies may benefit more from an open approach (Cronenwett, 2005).

The EVAR 2 trial randomized 338 patients, unfit for open repair, to either endovascular repair or medical management (EVAR Trial 2, 2005).  Endovascular repair was associated with a considerable 30 day operative mortality with no improvement in survival over no intervention.  However, the results of this trial are compromised, since 47 of the patients originally assigned to no intervention crossed over to the medical management arm.  Additionally, endovascular repair was not performed until a median of 57 days after randomization; during this period nine aneurysms ruptured, contributing to the endovascular mortality calculation, biasing results.  Therefore, it is difficult to interpret the reported lack of a survival advantage, associated with endovascular repair.

The Agency for Healthcare Research and Quality (AHRQ) of the U.S. Department of Health and Human Services published an Evidence-Based Practice Center Report that compared endovascular to open surgical repair for abdominal aortic aneurysms (Wilt, 2006).  This report concluded that for aneurysms greater than 5.5 cm in diameter, endovascular intervention improves peri-operative outcomes compared with open surgical repair, although it has not been shown to improve long-term survival or health status compared with open surgery.

Descending Thoracic Aortic Aneurysms (TAA)
Endovascular stent grafting has also been proposed for the repair of descending thoracic aortic aneurysms, and one device received FDA approval for this indication in 2005, the GORE TAG Thoracic Endoprosthesis (W. L. Gore and Associates, Inc., Flagstaff, AZ). Similar to the FDA approval of abdominal aortic stent grafts, the FDA did not require randomized trials for approval of the GORE TAG device.  The FDA based its approval on the results of two comparative case series, using historical and concurrent controls with two different designs of the prosthesis. The results of these studies have not been published in the peer reviewed literature but are summarized in the device manual (FDA, 2005).  In the first case series, TAG 99-01, the results of 140 patients, treated endovascularly, were compared with 94 concurrent and historical controls.  After the device was redesigned, an additional 51 patients underwent endovascular repair in the TAG 03-03 study.  The primary outcomes in both studies were the number of patients who had one or more major adverse events and the number of patients that did not experience device related events 12 months post deployment.  The number of patients in the TAG 99-01 study who experienced > 1 major adverse event (42%) was significantly lower than the surgical repair control group (77%) at one year follow up.  Additionally, four of 140 patients (3%) experienced paraplegia or paraparesis vs. 13 of 94 patients (14%) in the control group.  No major adverse device-related events occurred in the 30-day follow-up of the TAG 03-03 group.

Additional devices are currently under clinical investigation, including the Valiant Thoracic Stent Graft with Xcelerant® Delivery System and the Talent™ Thoracic Stent Graft System (both from Medtronic, Inc., Santa Rosa, CA).  The Zenith® TX2™ TAA Endovascular Graft (Cook, Inc., Bloomington, IN) is to be used in the STARZ-TX2 Trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith® TX2™ TAA Endovascular Graft) and is currently recruiting patients for participation.

A systematic review of endovascular repair in the treatment of thoracic aortic disease commissioned by the National Institute of Clinical Excellence (NICE) concluded that the evidence base for the assessment of safety and efficacy consists primarily of case series of heterogeneous groups with incomplete outcomes data.  However, due to the high mortality rates seen in these patients if left untreated, NICE issued Interventional Procedure Guidance (2005), which indicates that endovascular stent-graft placement in thoracic aortic aneurysms and dissections is a suitable alternative to surgery in appropriately selected patients (NICE, 2005). 

Background/Overview

Description of Aortic Aneurysms
 
An aneurysm is an abnormal "bulging" of a vessel, usually due to a congenital or acquired weakness or thinning of the vessel wall. Aortic aneurysms are commonly classified according to their anatomical location. While thoracic aortic aneurysms (TAA) involve the ascending aorta, arch or descending aorta; abdominal aortic aneurysms (AAA) affect the part of the aorta in the abdominal cavity.

AAA is a relatively common condition in older individuals, with a prevalence of 8% in individuals over 65 years of age. Major complications of abdominal aortic aneurysm include rupture and dissection, or splitting of the walls of the aorta. Thoracic aortic aneurysms (TAA) may be caused by the effects of atherosclerosis, high blood pressure, or in rare cases syphilis or tuberculosis. It can also be inherited via connective tissue disorders, such as Marfans or Ehlers Danlos Syndromes.  While both thoracic and abdominal aneurysms can be surgically repaired using stents and grafts, these open procedures are associated with considerable morbidity and mortality. Endovascular repair was developed to provide a minimally invasive approach, using a catheter inserted through a small groin incision to place the stent/graft across the aneurysm site.  

Definitions

Abdominal Aorta: The portion of the aorta extending from the diaphragm to the iliac arteries in the groin

Aneurysm: a dilating, bulging or ballooning out of a part of the wall of a blood vessel where the wall has weakened, often due to the build-up of plaque

Aortoiliac: pertaining to both the aorta and the iliac arteries

Endovascular or Endoluminal stent graft: is a piece of graft material (fabric tubing), within which metal stents (a framework) have been placed to support and secure the device to the wall of the aorta

Ehlers Danlos syndrome: a group of genetic conditions that have resulted from defects in a collagen molecule which would normally give strength and adhesion to the body's tissues

Marfans syndrome: a genetic disorder of the connective tissues; if the largest artery (the aorta) is affected, the diameter will likely widen or dilate

Perioperative mortality: death from any cause within 30 days of the procedure

Thoracic aorta: the portion of the aorta extending from the heart to the level of the diaphragm  

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Medically Necessary:

CPT

ICD-9 Procedure

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above with the following diagnoses:

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

CPT

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. Blankensteijn JD, de Jong SECA, Prinssen M, et al. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Eng J Med. 2005; 352(23):2398-2405.
2. Brewster DC, Jones JE, Chung TK, et al.  Long-term outcomes after endovascular abdominal aortic aneurysm repair:  the First Decade.  Ann Surg. 2006; 244(3):426-438.
3. Chuter TAM, Howell BA.  Suprarenal stents and other advances in endovascular aneurysm repair.  Surg Clin N Am. 2004; 84:1319-1335.
4. Cronenwett JL.  Endovascular aneurysm repair.  Important midterm results.  Lancet. 2005; 365:2156-2158.
5. Dillavou ED, Muluk SC, Makaroun MS.  Improving aneurysm-related outcomes: nationwide benefits of endovascular repair.  J Vasc Surg. 2006; 43(3):446-451; Discussion: 451-452.
6. EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomized controlled trial. Lancet. 2005; 365(9478):2179-2186.
7. EVAR trial participants. Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2): randomized controlled trial. Lancet. 2005; 365(9478):2187-2192.
8. Haro LH, Krajicek M, Lobl JK.  Challenges, controversies and advances in aortic catastrophes.  Emerg Med Clin N Am. 2005; 23:1159-1177.
9. Prinssen M, Verhoeven EL, Buth J, et al. Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group.  A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004; 14;351;1607-1618.
10. Soulez G, Therasse E, Monfared AA, et al. Pain and quality of life assessment after endovascular versus open repair of abdominal aortic aneurysms in patients at low risk.  J Vasc Interv Radiol. 2005; 16(8):1093-1100.
11. Wilt TJ, Lederle FA, MacDonald R, et al.  Agency for Healthcare Research and Quality.  Comparison of endovascular and open surgical repairs for abdominal aortic aneurysm.  Evidence Report/Technology Assessment No. 144. AHRQ Publication No. 06-E017.  August 2006.  Available at:    http://www.ahrq.gov/clinic/tp/aaareptp.htm.  Accessed on April 2, 2007.
12. Zarins CK, Crabtree T, Arko FR, et al. Endovascular repair or surveillance of patients with small AAA. Eur J Vasc Endovasc Surg. 2005; 29(5):496-503; Discussion: 504.  

Government Agency, Medical Society, and Other Authoritative Publications:

1. Bettmann MA, Dake MD, Hopkins LN, et al. Atherosclerotic Vascular Disease Conference: Writing Group VI: Revascularization. Circulation. 2004; 109(21):2643-2650.
2. Blue Cross Blue Shield Association.  Endovascular Repair of Abdominal Aortic Aneurysm.  TEC Assessment, 2001; 16(2).
3. Brewster DC, Cronenwett JI, Hallett JW, et al.  Guidelines for the treatment of abdominal aortic aneurysms.  Report of a subcommittee of the Joint Council of the American Association for Vascular Surgery and Society for Vascular Surgery.  J Vasc Surg.  2003; 37(5):1106-1117.
4. Department of Veterans Affairs.  Open versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms.  NLM Identifier:  NCT00094575.  Last updated February 2007.  Available at:    http://clinicaltrials.gov/show/NCT00094575.  Accessed on April 2, 2007.
5. Eastern Association for the Surgery of Trauma. Guidelines for the Diagnosis and Management of Blunt Aortic Injury. 2002. Available at  www.east.org. Accessed on April 2, 2007.
6. Geller SC. Imaging guidelines for abdominal aortic aneurysm repair with endovascular stent grafts. J Vasc Interv Radiol. 2003; 14(9 pt 2):S263-S264.
7. Hayes Inc. Hayes Medical Technology Directory. Endovascular Repair of Thoracic Aortic Aneurysms and Dissections.  Lansdale, PA: Hayes, Inc; February 19, 2007.
8. Hayes Inc. Hayes Medical Technology Directory.  Endovascular Repair, Abdominal Aortic Aneurysms.  Lansdale, PA: October 6, 2004.  Search updated November 19, 2006.
9. Health Services Research and Development Service (HSR&D) Technology Assessment program. Endovascularly Placed Grafts for Infrarenal Abdominal Aortic Aneurysms. A systematic review of published studies of effectiveness. May 1998.
10. Hirsh AT, Haskal ZJ, Hertzer NR, et al.  ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine and Biology, and the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.  J Am Coll Cardiol. 2006; 47(6):1239-1312.  Available at:    http://content.onlinejacc.org/cgi/reprint/47/6/1239.  Accessed on April 2, 2007.
11. National Institute for Clinical Excellence (NICE).  Interventional Procedures Programme.  A systematic review of the recent evidence for the efficacy and safety relating to the use of endovascular stent-graft (ESG) placement in the treatment of thoracic aortic disease.  London, UK: NICE; 2005.  Available at:  www.nice.org.uk/  Accessed on April 2, 2007.
12. National Institute for Clinical Excellence (NICE).  Endovascular stent-graft placement in thoracic aortic aneurysms and dissections.  Interventional Procedures Guidance 127.  London, UK: NICE; 2005.  Available at:    www.nice.org.uk/  Accessed on  April 2, 2007.
13. National Institute for Health and Clinical Excellence (NICE).  A systematic review update of the recent evidence for the safety and efficacy of elective endovascular repair in the management of infrarenal abdominal aortic aneurysms.  London, UK; 2005.  Available at:    www.nice.org.uk/ip026overview.  Accessed on April 2, 2007.
14. National Institute for Health and Clinical Excellence (NICE).  Stent-graft placement in abdominal aortic aneurysm.  Interventional Procedures Guidance 163.  London, UK:NICE; 2006.  Available at:  www.nice.org.uk/Accessed on April 2, 2007.
15. Preventive Services Task Force.  Screening for abdominal aortic aneurysm:  recommendation statement.  Ann Intern Med. 2005; 142(3):198-202.
16. Society of Interventional Radiology. Imaging Guidelines for Abdominal Aortic Aneurysm Repair with Endovascular Stent Grafts. J Vasc Interv Radiol. 2003; 14:S263-S264.
17. United States Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH): GORE TAG Thoracic Endoprosthesis, W.L. Gore and Associates. - Summary of Safety and Effectiveness. No. P040043. Rockville, MD:FDA. March 23, 2005. Available at:  http://www.fda.gov/cdrh/pdf4/p040043.html. Accessed on April 2, 2007.
18. United States Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH): Ancure® Aortoiliac System, Guidant Corporation. Summary of Safety and Effectiveness. No. 990017/S030. Rockville, MD:FDA. April 24, 2002. Available at:  http://www.fda.gov/cdrh/pdf/p990017S030a.pdf.  Accessed on April 2, 2007.
19. United States Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH): Endologix PowerLink® System, Endologix, Inc. Summary of Safety and Effectiveness. No. P040002. Rockville, MD:FDA. October 29, 2004. Available at:  http://www.fda.gov/cdrh/pdf4/P040002a.pdf.  Accessed on April 2, 2007.
20. United States Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH): Zenith® AAA Endovascular Graft, Cook, Inc. Summary of Safety and Effectiveness. No. PO20018. Rockville, MD:FDA. May 23, 2003. Available at:  http://www.fda.gov/cdrh/pdf2/p020018a.pdf.  Accessed on April 2, 2007.
21. Veith FJ, Ohki T, Lipsitz EC, et al. Endovascular grafts and other catheter-directed techniques in the management of ruptured abdominal aortic aneurysms. Semin Vasc Surg. 2003; 16(4):326-331.

Web Sites for Additional Information

1. Cook, Inc. Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2 Endovascular Graft.  NLM Identifier:  NCT00111176. Last updated July 2006.  Available at:    http://clinicaltrials.gov/show/NCT00111176. Accessed on April 2, 2007.
2. National Library of Medicine.  Medical Encyclopedia- AorticAmeurysms. Available at:  http://www.nlm.nih.gov/medlineplus/ency/imagepages/18072.htm. Accessed on April 2, 2007.
3. Society of Thoracic Surgeons. Aortic Aneurysms. Available at:  http://www.sts.org/doc/9440. Accessed on April 2, 2007.
4. Society for Vascular Surgery. Aortic Aneurysms - Abdominal Aortic Aneurysms (AAA).   Patient and Family Health Information.  Available at:  http://www.vascularweb.org/_CONTRIBUTION_PAGES/Patient_Information/
   3_Most_Common_AVA/AorticAneurysms_AVA.html. Accessed on April 2, 2007.
   

Index

Abdominal Aortic Aneurysm
ANCURE® Aortoiliac System
ANCURE® Endograft System
AneuRx® Stent Graft System
Endovascular Stents
Excluder^TM
Zenith^TM

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association