Con: endovascular stent repair for aortic aneurysm surgery is not associated with lower perioperative risk

Abstract

CONVENTIONAL OPEN operative repair (OR) of abdominal aortic aneurysms (AAAs) has been the gold standard beginning with the initial report in 1951 by Dubost and collaborators.1 The endoluminal approach to the management of AAA repair was reported by Parodi et al2 and Volodos et al3 in 1991 and development of endoluminal grafts has increased exponentially since then. Endoluminal or endovascular AAA repair (ER) has gained astonishing popularity. The early results of ER were extremely promising, showing a reduction in hospital stay, decrease in blood loss, and lower complication rates compared with results of standard OR.4,5 However, mortality rates of ER were not uniformly superior, and sometimes inferior to, OR.6 The opportunity for a less invasive technique to treat a potentially life-threatening disorder, permit more rapid recovery, reduce morbidity, and potentially achieve cost savings by shortened hospitalizations and decreased use of hospital resources is attractive to patients, physicians, hospital administrators, and insurers. The initial enthusiasm for ER was understandably high, although estimates of the number of patients with AAA anatomy suitable for ER varied widely. A recently designed national multicenter ER trial in Great Britain has estimated that 60% of all infrarenal AAAs are amenable to ER treatment.7 Whereas many authorities have suggested that ER could substantially lower the excessive mortality and morbidity associated with ruptured and symptomatic AAAs, Lee and colleagues8 have shown that only about 40% of such patients are eligible for ER treatment because of unfavorable anatomic features. As experience using endoluminal repair of AAAs increased, reports of adverse outcomes became progressively more frequent. For example, the EUROSTAR Project (EUROpean Collaborators on Stent/graft Techniques for Aortic Aneurysm Repair) is essentially a voluntary registry established in 1996.9 To date, nearly 100 European centers of vascular surgery have contributed data on more than 3,000 patients treated with a variety of commercially available endografts. Initially, the perioperative mortality for ER was 3.4%, and the endoleak (persistent flow within the AAA sac) rate was 15.7% after 430 patients had been entered into the database during the first year. However, at 2 years, after 895 patients had been voluntarily registered, the early endoleak rate remained essentially unchanged, but another 18% of patients had developed new endoleaks; moreover, additional problems associated with ER such as late limb occlusions were noted with increasing frequency, and reports began to appear with alarming perioperative mortality rates, as high as 11.3%.9,10 Thus, early unrealistic optimism about ER repair of AAAs has been replaced with a more pragmatic understanding of its benefits and limitations. Randomized, controlled, prospective trials (RCTs) are necessary to establish the most appropriate application of the ER technique compared with established conventional open repair, and, to date, there has been no large-scale randomized controlled trial of OR versus ER for AAAs. Predictably, as shown by many innovations in surgical approaches, there is a pendulum effect. Even the lay press has become involved. The initial media onslaught publicizing unrealistic benefits and successes of ER was closely followed by numerous backlash publications urging caution in the widespread application of ER for AAAs. A front-page story by Julie Appleby12 that appeared in the September 24, 2001 issue of the USA Today newspaper was entitled Debate Follows Development of Medical Device: Smaller Incision Cuts Recovery Time, but Durability Questioned. ER has also been assailed in the medical literature, as reflected in an editorial by Collin and Murie13 entitled Endovascular Treatment of Abdominal Aortic Aneurysms: A Failed Experiment, in which the authors opined that “the gestation period of experimental endovascular aneurysm repair has already been ten years. . .When eventually delivered, it will probably be stillborn. We believe it is dead already.”