Endovascular treatment of abdominal aortic aneurysms in high-surgical-risk patients

Abstract

Background: Following the publication of a prospective randomized trial (Endovascular Aneurysm Repair Trial 2 - EVAR2) that questioned the benefits of endovascular repair of abdominal aortic aneurysms (AAA) in high-surgical-risk patients, we decided to analyze our initial and long-term results with endovascular AAA repair in this patient population. Objective: To evaluate the operative mortality, long-term survival, frequency of secondary operations, outcome of the aneurysm sac, primary and secondary patency rates, and rupture rate after aortic stent-graft placement in high-surgical-risk patients. Methods: From April 2002 to February 2008, 40 high-surgical and anesthetic risk patients with an AAA managed by a bifurcated aortic endograft were entered in a prospective registry. Data concerning diagnosis, operative risk, treatment and follow-up were analyzed in all patients Results: Twenty-four Excluder® and 16 Zenith® stent-grafts were successfully implanted. Thirty patients (75%) were classed ASA III and 10 (25%) were ASA IV. Mean aneurysm diameter was 64 mm. Operative mortality was 2.5%. Two patients required reintervention during the mean follow-up of 28.5 months. Survival rate at 3 years was 95%. There were four endoleaks, one case of endotension, and one endograft limb occlusion. Primary and secondary patency rates at 3 years were 97.5 and 100%, respectively. There were no ruptures. Conclusions: Initial and long-term results with endovascular treatment of AAA in high-surgical-risk patients were satisfactory, and appear to justify such approach for this patient population.

Effects of study design and trends for EVAR versus OSR

“…In the 75 observational studies with perioperative outcomes reported (initial 30 days), there were 16,407 and 41,238 patients receiving EVAR and OSR, respectively. Of these observational studies, 16 were categorized as multi-center (Zarins et al 1999; Beebe et al 2001; Criado et al 2003; Matsumura et al 2003; Akkersdijk et al 2004; Anderson et al 2004; Carpenter and Endologix 2004; Greenberg et al 2004; Forbes et al 2005; Hua et al 2005; Leon et al 2005; LREAR 2005; Bush et al 2006; Mendonca et al 2005; Sandridge et al 2006; Wald et al 2006). The other 59 papers were single center evaluations subdivided based on annual surgical volume of 30 cases per year, identified 31 low volume centers (de Virgilio et al 1999; Kahn et al 1999; Seiwert et al 1999; Treharne et al 1999; Becquemin et al 2000; Cohnert et al 2000; Malina et al 2000; Sangiorgi et al 2001; Berman et al 2002; Davies et al 2002; Forbes et al 2002; Ligush et al 2002; Van Sambeek et al 2002; Gawenda et al 2003; Hansman et al 2003; Patel et al 2003; Ting et al 2003; Turnipseed et al 2003; Ballard et al 2004; Garcia-Madrid et al 2004; Zeebregts et al 2004; Aarts et al 2005; Borchard et al 2005; Goueffic et al 2005; Hayter et al 2005; Iannelli et al 2005; Rosenberg et al 2005; de Donato et al 2006; Manis et al 2006; Vogel et al 2005; Parmer et al 2006), and 28 high volume centers (Baxendale et al 1996; Du Toit et al 1998; Ceelen et al 1999; Scharrer-Pamler et al 1999; Clair et al 2000; Galle et al 2000; …”

“…Five studies included information regarding patients that were surgically suitable for either procedure (Becquemin et al 2000; Forbes et al 2002; Dias et al 2003; Gawenda et al 2003; Garcia-Madrid et al 2004), 8 studies specifically examined the efficacy of high-risk patients only (Du Toit et al 1998; Carpenter et al 2002; Forbes et al 2002; Patel et al 2003; Iannelli et al 2005; Mendonca et al 2005; de Donato et al 2006; Parmer et al 2006) Long-term outcomes (>30 days) were reported in 25 observational studies with long term comparative outcomes of up to 3 years mean follow-up (Zarins et al 1999; Becquemin et al 2000; Birch et al 2000; Cohnert et al 2000; Beebe et al 2001; May et al 2001; Sangiorgi et al 2001; Carpenter et al 2002; Arko et al 2003; Criado et al 2003; Dias et al 2003; Kibbe and Matsumura 2003; Ting et al 2003; Ballard et al 2004; Cao et al 2004; Elkouri et al 2004; Garcia-Madrid et al 2004; Greenberg et al 2004; Zeebregts et al 2004; Goueffic et al 2005; LREAR 2005; Mendonca et al 2005; Bush et al 2006; Carpenter 2006; Parmer et al 2006). …”

Results of Open and Endovascular Abdominal Aortic Aneurysm Repair According to the E-PASS Score

“…Nonetheless, this gain represents a significant improvement in surgical mortality, especially in the higher physiologic risk patients. In the Brazilian literature, Saadi et al [ 28 ] presented very good results in their initial experience with EVAR with no mortality in 25 patients operated for AAA, while Mendonça et al [ 29 ] found a operative mortality of 5.45% for OR and 6.55% for EVAR.…”

The Impact of Using Informative Priors in a Bayesian Cost-Effectiveness Analysis

“…All 8 studies provided estimates of 30-day postoperative mortality. Two of the high-risk studies also provided estimates of longer term mortality but not at 1 year (i.e., mean follow-up of 26.8 months for EVAR and 27.6 months for OSR in one study 15 and 15.6 months for EVAR and 19.8 months for OSR in the other study 16 ). In addition to the body of evidence in high-risk patients, the review also contained information from another 8 nonrandomized studies that were not restricted to high-risk patients but measured mortality at 30 days and 1 year after treatment in a mixed population of low- to high-risk patients.…”

“…These conditional probabilities were calculated from 2 sets of evidence. First, the 2 high-risk studies reporting mortality data at around 2 years were used, 15,16 assuming that the 1- and 2-year probabilities of being dead conditional on being alive at 30 days were similar. The second set of evidence consisted of the 8 studies that measured mortality at 30 days and at 1 year in a mixed-risk population.…”