A Prospective Clinical Economic and Quality of Life Analysis of Open Repair, Endovascular Aortic Repair and Best Medical Treatment in High Risk Patients with AAA

Abstract

There is consensus that endovascular aneurysm repair (EVAR) offers several benefits when compared to open repair of abdominal aortic aneurysm (AAA). Although originally introduced for patients considered unfit for major surgery. (Parodi, 1991) EVAR has been used increasingly in patients judged fit for open repair (OR). Results of randomized trials demonstrated that the 30-day mortality in such patients is 2%. (EVAR trial 1 participants, 2005; Prinssen 2004) The results of the EVAR-2 trial stunned the vascular community. The high mortality rates (9% at 30 days and 64% at 4 years) in the EVAR arm elicited trepidation that the minimally invasive approach may afford no benefit compared with the natural history of untreated AAAs in high-risk patients. (EVAR trial 2 participants, 2005) However, subsequent data from the Society for Vascular Surgery (SVS) Lifeline Registry (Sicard, 2006) and the Veterans Affairs National Surgical Quality Improvement Program (Bush, 2007) have shown that EVAR benefits many patients who fulfilled the EVAR-2 high-risk criteria by curtailing perioperative sequelae. All of these published studies used objective endpoints of morbidity and mortality. However, in a high-risk cohort, the issue of quality of life in terms of years gained needs to be addressed, as well as the broader issue of the cost to society. There are also questions as to which patients are going to die from something else before they benefit from the aneurysm repair, which patients should not be treated, and what happens to patients who choose non-interventional management. These are complex issues, so it is necessary to approach optimizing AAA treatment of high-risk patients from a number of perspectives. Clinically, we need to verify the efficacy and safety of each treatment option and identify if a subgroup exists in which repair poses more of a risk than a benefit. Secondly, from the patient’s viewpoint, what price is he/she willing to pay for quality of life? Finally, how much is the healthcare system keen to invest for optimal AAA treatment? The aim of our study was to scrutinize EVAR as a feasible treatment option for high risk patients and elucidate whether it can enhance survival and quality of life in a cost-effective manner.