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• If the individual is prepared to assume the burden of continued regular surveillance for the rest of his or her life

In addition to other diagnostic tests, patients undergoing EVAR undergo abdominal aortic and pelvic angiograms with a marking catheter to enhance the precision of the previous tests (e.g., ultrasound). Precise measurements are crucial component of the decision to proceed with EVAR.

Although EVAR does allow treatment inclusion for individuals who may have other underlying medical conditions, there is continued debate regarding the inclusion of elderly people with comorbid conditions. These patients are considered at a higher risk for complications and their survival rate at three years following surgery is 58%. It is estimated that up to 10% of all EVAR surgeries undergo conversion to open repair because of unexpected technical difficulties or complications during the procedure

Studies indicate that EVAR limits the expansion of AAAs in up to 90% of cases and prevents rupture of the aneurysm in up to 98% of individuals undergoing the procedure. The rate of rupture for aneurysms repaired with EVAR is approximately 0.5% at 3 to 4 years post surgery. As more years pass since the initiation of the procedure, longer term results will become available.

FDA Public Health Notification about Endovascular Grafts

In March 2008, the U.S. Food and Drug Administration (FDA) issued a public health notification to re-emphasize the need for continued surveillance of patients treated with endovascular grafts and provided updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent AAA rupture. The FDA's public health notification focused on the AneuRx Stent Graft System because it is the only currently marketed device with a significant number of patients with long-term clinical follow-up at five years.

The FDA had issued two previous public health notifications (2001 and 2003) identifying several serious adverse events, including aneurysm rupture, in patients treated with the AneuRx Stent Graft. Previously, the FDA reported that late aneurysm-related mortality among AneuRx graft patients was about 0.4% per year. More recent longer-term data suggests that aneurysm-related mortality continues to increase after 3 years post-implant, reaching 1.3% by year 4 and 1.5% by year 5. These rates are substantially higher than the mortality rate for open surgical repair of AAA, which averages 0.18% per year (range = 0% to 0.3% per year).

Based on these findings, the FDA recommended that the AneuRx Stent Graft System be used only in select patients who meet the appropriate risk-benefit profile. In determining the risk-benefit profile for patients with AAA disease and the appropriate treatment option, factors that need to be considered include:

• The risk of long-term AAA-related mortality, especially due to AAA rupture - Based on more complete follow-up data, the latest information available suggests that the average risk of late AAA-related mortality associated with AneuRx exceeds that associated with open surgery.

• The experience of the institution or the surgeon - If open surgery or endovascular repair is performed in institutions or by surgeons with little experience with these surgical procedures, the mortality rate may be considerably higher than average for that procedure.