Print Endovascular Grafts for Abdominal Aortic Aneurysms

Endovascular Grafts for Abdominal Aortic Aneurysms

 

DESCRIPTION

The conventional management of a clinically significant abdominal aortic aneurysm consists of surgical excision with placement of a sutured woven 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 abdominal aortic aneurysms. These devices are deployed across the aneurysm such that the aneurysm is effectively “excluded” from the circulation, with subsequent restoration of normal blood flow.

There are several types of graft currently under investigation—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. Recently, 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 through these critical arteries. In addition, extensions can be placed from inside the main endograft body into the visceral arteries to create a hemostatic seal.

In 1999, the U.S. Food and Drug Administration (FDA) approved 2 endovascular grafts for use in the abdominal aorta: the EBT Abdominal Aortic Endovascular Grafting System (Guidant Endovascular Technologies) and the AneuRx® Prosthesis System (now called AneuRX® AAAdvantage Stent Graft - Medtronic, Inc.). In the Guidant system, the endograft is placed in the aorta and expanded using balloon dilation. The graft is anchored to the vessel wall using sutureless hooks at its superior and inferior ends. The AneuRx® system consists of a woven polyester interior surface with a self-expanding nitinol exoskeleton. The radial force of the expanding stent embeds the exoskeleton into the aneurysm wall, and thus constitutes the attachment mechanism. In April 2002, the FDA approved an additional Guidant device, the Ancure Aortoiliac System. The Ancure device consists of a woven polyester graft that is housed within a long flexible delivery tube (catheter) for use in patients whose anatomy is not suited for the use of the single tube or bifurcated endograft device. This version is identical to the earlier Guidant Endovascular Grafting System except that the aortoiliac Ancure grafts have suture loops on the superior and inferior attachment systems. Several other grafts have been subsequently approved, including the Gore Excluder (2002), the Zenith AAA Endovascular Graft (2003- now called Zenith Flex® AAA Endovascular Graft), and the Endologix Powerlink (2004) and the Medtronic Talent TM Abdominal Stent Graft System (2008). 

Grafts that extend across the visceral arteries are currently under development, but are not FDA approved. For example, the Zenith® Fenestrated AAA Endovascular Graft is currently under investigation as part of the FDA approval process.

Note: This policy addresses abdominal aortic aneurysms only. For discussion of endoprostheses for the treatment of thoracic aortic aneurysms, please see Endovascular Stent Grafts for Thoracic Aortic Aneurysms policy. 

 

POLICY

The use of FDA-approved endoprostheses as a treatment of abdominal aortic aneurysms may be considered medically necessary as a treatment of abdominal aortic aneurysms in any of the following clinical situations:
  • an aneurysmal diameter greater than 5.0 cm
  • an aneurysmal diameter of 4–5.0 cm that has increased in size by 0.5 cm in the last 6 months
  • an aneurysmal diameter that measures twice the size of the normal infrarenal aorta.
  • a ruptured abdominal aortic aneurysm (See Policy Guidelines)

The use of endoprostheses approved by the FDA as a treatment of abdominal aortic aneurysms is considered investigational for the following clinical situations:

  • Treatment of smaller aneurysms that do not meet the current recommended threshold for surgery
  • Treatment of aneurysms that do meet the recommended threshold for surgery in patients who are ineligible for open repair due to physical limitations or other factors

 

POLICY EXCEPTIONS

None

 

POLICY GUIDELINES

For treatment of ruptured abdominal aortic aneurysm with endoprostheses, several factors must be considered including the following:
  • The patient must be sufficiently stable to undergo detailed CT examination for anatomic measurements,
  • The aneurysm should be anatomically appropriate for endovascular repair, and
  • Specialized personnel should be available.

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.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

 

POLICY HISTORY

1/20/2009: Policy added.

6/04/2010: Description section revised to add more common name for abdominal graft systems such as AneuRX® AAAdvantage; Zenith Flex®  AAA Endovascular and Medtronic TalentTM System.  Policy statement revised to include a ruptured abdominal aortic aneurysm as a clinical situation that the use of FDA-approved endoprostheses may be considered medically necessary. Policy statement regarding the use of endoprostheses as a treatment of ruptured abdominal aortic aneurysm is investigational was removed.  Policy Guidelines section was revised to include factors to be considered when treating ruptured abdominal aortic aneurysms with endoprostheses and the use of monitoring for leaking of the graft after implantation. ICD-9 Diagnosis codes 441.3 and 441.4 were added to Covered Codes Table.

06/21/2011: Policy reviewed; no changes.

05/09/2012: Added the following policy statement: The use of endoprostheses approved by the FDA as a treatment of abdominal aortic aneurysms is considered investigational for the following clinical situations: treatment of smaller aneurysms that do not meet the current recommended threshold for surgery or treatment of aneurysms that do meet the recommended threshold for surgery in patients who are ineligible for open repair due to physical limitations or other factors.

08/07/2013: Policy reviewed; no changes.

 

SOURCES

Blue Cross Blue Shield Association Policy # 7.01.67 

 

CODE REFERENCE

This 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. 

Covered Codes      

Code Number

Description

CPT

34812Open femoral artery exposure for delivery of endovascular prosthesis, by groin incision; unilateral
34820Open iliac artery exposure for delivery of endovascular prosthesis or iliac occlusion during endovascular therapy, by abdominal retroperitoneal incision; unilateral
34800Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using aorto-aortic tube prosthesis
34802Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using modular bifurcated prosthesis (one docking limb)
34803Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using modular bifurcated prosthesis (two docking limbs)
34804Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using unibody bifurcated prosthesis
34805Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using aorto-uniliac or aorta-unifemoral prosthesis
34825Placement of proximal or distal extension prothesis for endovascualr repair of infrarenal abdominal aortic aneurysm; initial vessel
34826Placement of proximal or distal extension prothesis for endovascualr repair of infrarenal abdominal aortic aneurysm;  each additional vessel
75952Endovascular repair of infrarenal abdominal aortic aneurysm or dissection, radiological supervision and interpretation
75953Placement of proximal or distal extension prothesis for endovascular repair of infrarenal abdominal aortic aneurysm, radiologic supervision, and interpretation

ICD-9 Procedure

 

 

ICD-9 Diagnosis

441.3

Abdominal aneurysm, ruptured

441.4

Abdominal aneurysm without mention of rupture

 

 

HCPCS

 

 

 

 

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