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DESCRIPTIONThe goal of abdominal aortic aneurysm (AAA) repair is to reduce pressure in the aneurysm sac and thus prevent rupture. Failure to exclude the aneurysm completely from the systemic circulation results in continued pressurization. An endoleak (persistent perfusion of the aneurysmal sac) may be primary (within the first 30 days) or secondary (after 30 days). Endoleaks are reported to vary from 10%– 50% of cases. There are five types of endoleaks. Type I endoleaks result from ineffective fixation at either end of the graft; while these can seal spontaneously, risk of rupture is high and intervention is often indicated. Type II endoleaks result from retrograde filling of the aneurysm mainly from lumbar and/or inferior mesenteric arteries. Risk of rupture is less than with Types I and III, and type II endoleaks can often be monitored when the aneurysm is shrinking. Type III endoleaks are caused by failure of the implanted graft and include development of holes which need to be treated aggressively. Type IV endoleaks are caused by the porosity of the graft fabric. Type V endoleaks are referred to as endotension and correspond to continued aneurysm expansion in the absence of a confirmed endoleak. Endoleaks, particularly type I and III, lead to continued sac pressurization and therefore may be considered technical failures of Endovascular Aneurysm Repair (EVAR).
The completeness of exclusion or absence of endoleaks is evaluated by intraoperative angiography. However, interpretation of images can be problematic and it can also cause patient morbidity due to the dye load from repeated injections of contrast material. Direct measurement of sac pressure provides a physiological assessment of success. Studies have used direct sac pressure measurements with a catheter; the drawback of this approach is the interference by the catheter during endovascular repair and the inability to leave it in place. Since endoleaks may also develop subsequent to the time of surgery, magnetic resonance imaging (MRI), and ultrasound are used in monitoring the aneurysmal sac. Percutaneous catheter-based approaches can also be used to measure intrasac pressures postoperatively.
Several factors determine aneurysm sac pressure after EVAR. These include graft-related factors, such as endoleak, graft porosity, and graft compliance, and anatomic factors, such as patency of aneurysm side branches, aneurysm morphology, and the characteristics of aneurysm thrombus.
Given this situation, wireless implantable pressure-sensing devices are being evaluated to monitor pressure in the aneurysm sac. These implanted devices use various mechanisms to wirelessly transmit pressure readings to devices for measuring and recording pressure. These devices have the potential to improve outcomes for patients who have had endovascular repair. They may change the need for or the frequency of monitoring of the aneurysm sac using contrast-enhanced CT scans. They may improve post-operative monitoring. However, the accuracy of these devices must be determined and potential benefits and risks must be considered and evaluated. At the present time, two types of systems are being evaluated; radiofrequency or ultrasound based systems.
In October 2006, the Food and Drug Administration (FDA) cleared the CardioMEMS EndoSure™ (radiofrequency-based) system through the 510(k) process. The favorable FDA review indicated only that the device was substantially equivalent to legally marketed predicate devices. The FDA labeling indications noted that the device is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm repair. It also noted that it may be used as an adjunctive tool in the detection of intraoperative endoleaks. In March 2007, additional language was added, stating that the CardioMEMS device may be used to measure intrasac pressure during thoracic aortic aneurysm repair.
The ImPressure™ system (ultrasound-based) is in use in Europe and is being used as part of an investigational device exemption (IDE) trial of stent grafts.
POLICYUse of wireless pressure sensors is considered investigational in the management (intra-operative and/or post-operative) of patients having endovascular aneurysm repair.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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 HISTORY4/25/2007: Policy Added
7/19/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
12/19/2007: Coding updated per 2008 CPT/HCPCS revisions
6/30/2008: Policy reviewed, no changes
9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied
12/31/2008: Code Reference section updated per 2009 CPT/HCPCS revisions
04/12/2010: Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Removed HCPCS 0153T and 0154T from the code table as these codes were deleted on 12/31/2007.
12/30/2010: Policy reviewed; no changes.
12/01/2011: Policy reviewed; no changes.
12/13/2012: Policy reviewed; no changes.
03/07/2014: Policy reviewed; no changes.
01/22/2015: Policy description updated. Policy statement unchanged.
08/27/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number added. Investigative definition updated in Policy Guidelines section.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.111
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.