Endovascular Aortic Aneurysm Repair Group Research Articles

Nationwide analysis of EVAR explantation outcomes in Korea: A comprehensive dataset study.

Endovascular aortic aneurysm repair (EVAR) is the primary treatment for abdominal aortic aneurysms, constituting 70%-80% of interventions. Despite initial benefits, long-term studies show increased mortality. Using nationwide data, this study assesses outcomes of EVAR, open aortic repair (OAR), and EVAR explantation (EE) in Korea, while exploring characteristics of late open conversion, including the rising EE incidence. Employing the National Health Insurance Service database, covering health-related data for nearly 50 million Koreans, the study spanned from 2002 to 2020. Patients with AAA diagnoses (I71.3 or I71.4) were categorized into OAR, EVAR, and EE groups based on procedural codes. Statistical analyses, including t-tests, Fisher's exact tests, Cox proportional hazard models, and multivariate Cox regression, assessed baseline characteristics, mortality risks, and factors within the EE group. The analysis encompassed 26,195 patients, with 66.19% in the EVAR group, 31.87% in the OAR group, and 1.94% in the EE group. EVAR cases steadily increased from 2002 to 2018. Survival rates favored EVAR, followed by OAR and EE. 30-day survival was lower in EE than EVAR. Multivariate analysis for EE revealed no risk factors for 30-days survival but identified age, chronic kidney disease, high Charlson Comorbidity Index scores, and less than 6months since EVAR as risk factors for overall mortality. Rising EE trends with increased EVAR adoption, particularly evident in the Korean dataset, underscore inferior outcomes. This highlights the critical need for strategic initial treatment decisions and timely interventions to enhance overall results and mitigate the unfavorable EE incidence.

Incidence of endoleak type IA in patients undergoing chimney endovascular aortic repair (ChEVAR) vs. standard endovascular repair.

Almost half of endovascular aortic aneurysm repair (EVAR) procedures are performed in hostile anatomy, increasing the risk of procedure related complications such as type IA endoleaks, which may be prevented with the chimney technique in EVAR (ChEVAR). Our aim is to describe the differential characteristics between EVAR in favorable anatomy and ChEVAR in hostile necks. A cohort of patients with infrarenal abdominal aortic aneurysms (AAA) that were treated with EVAR or ChEVAR were included. The primary outcome was the incidence of type IA endoleak. Secondary outcomes were the rate of chimney occlusion, reintervention, migration, rupture, acute limb ischemia, sac growth, and aneurysm-related mortality during the follow-up period. . With a median follow-up of 11.5 months, 79 patients were treated with EVAR and 21 with ChEVAR. The overall age was 76.49 ± 7.32 years old, and 82% were male. The ChEVAR cohort had a higher prevalence of tobacco use than the EVAR cohort (38.1% vs. 17.7%, p = 0.041), and a shorter neck (7.88 mm ± 5.73 vs 36.28 mm ± 13.73, p<0.001). There were no differences in type IA endoleak incidence between the groups (a single endoleak type IA in the EVAR group, p = 0.309). One patient experienced an asymptomatic chimney occlusion in the ChEVAR group, and another patient required a reintervention due to chimney occlusion. Sac regression and reinterventions were not different between groups. There were no migration, rupture, acute limb ischemia, or aneurysm-related mortality events. . In patients with abdominal aortic aneurysms, ChEVAR in hostile necks had similar event rates to EVAR in favorable necks.

Outcomes and Cost-Analysis of Open Versus Endovascular Abdominal Aortic Aneurysm Repair in a Developing Country: A 15-year Experience at a Tertiary Medical Center

Endovascular aortic aneurysm repair (EVAR) has become the most common procedure for treating abdominal aortic aneurysms based on multiple studies conducted in the western world. The implication of such findings in developing countries is not well demonstrated. The objective of this study was to compare medical outcomes and costs of EVAR and open surgical repair (OSR) in a developing country. This is a retrospective study of all patients undergoing elective abdominal aortic aneurysm repair between 2005 and 2020 at a tertiary medical center in a developing country. Medical records were used to retrieve demographics, comorbidities, and perioperative complications. Medical records were also used to provide data on the need of reintervention, date of last follow-up, and mortality. The study included a total of 164 patients. Median follow-up time was 41months. The mean age was 69.9 +/- 7.84years and 90.24% (n=148) of patients were males. Regarding long-term mortality outcomes, no significant difference was detected between both groups; OSR patients had a survival rate of 91.38% and 74.86% at 5 and 10years, compared to 77.29% and 56.52% in the EVAR group (P value=0.10). Both groups had comparable long-term reintervention rates (P value=0.334). The OSR group was charged significantly less than the EVAR group ($27,666.35 vs. $44,528.04, P value=0.008). OSR and EVAR have comparable survival and reintervention outcomes. Unlike what was reported in developed countries, patients undergoing OSR in countries with low hospital stay costs incur lower treatment costs.

Clinical presentation, operative management, and long-term outcomes of rupture after previous abdominal aortic aneurysm repair

ObjectiveThe aim of the present study was to evaluate the presentation trends, intervention, and survival of patients who had been treated for late abdominal aortic aneurysm rupture (LAR) after open repair (OR) or endovascular aortic aneurysm repair (EVAR). MethodsWe reviewed the clinical data from a single-center, retrospective database for patients treated for LAR from 2000 to 2020. The end points were the 30-day mortality, major postoperative complication, and survival. The outcomes between LAR managed with EVAR (group I) vs OR were compared (group II). ResultsOf 390 patients with infrarenal aortic rupture, 40 (10%) had experienced aortic rupture after prior aortic repair and comprised the LAR cohort (34 men; age 78 ± 8 years). LAR had occurred before EVAR in 30 and before OR in 10 patients. LAR was more common in the second half of the study with 32 patients after 2010. LAR after prior OR was secondary to ruptured para-anastomotic pseudoaneurysms. After initial EVAR, LAR had occurred despite reintervention in 17 patients (42%). The time to LAR was shorter after prior EVAR than after OR (6 ± 4 vs 12 ± 4 years, respectively; P = .003). Treatment for LAR was EVAR for 25 patients (63%; group I) and OR for 15 (37%, group II). LAR after initial OR was managed with endovascular salvage for 8 of 10 patients. Endovascular management was more frequent in the latter half of the study period. In group I, fenestrated repair had been used for seven patients (28%). Salvage for the remaining cases was feasible with EVAR, aortic cuffs, or limb extensions. The incidence of free rupture, time to treatment, 30-day mortality (8% vs 13%; P = .3), complications (32% vs 60%; P = .1), and disposition were similar between the two groups. Those in group I had had less blood loss (660 vs 3000 mL; P < .001) and less need for dialysis (0% vs 33%; P < .001) than those in group II. The median follow-up was 21 months (interquartile range, 6-45 months). The overall 1-, 3-, and 5-year survival was 76%, 52%, and 41%, respectively, and was similar between groups (28 vs 22 months; P = .48). Late mortality was not related to the aorta. ConclusionsLAR after abdominal aortic aneurysm repair has been encountered more frequently in clinical practice, likely driven by the frequency of EVAR. However, most LARs, including those after previous OR, can now be salvaged with endovascular techniques with lower morbidity and mortality.

Endovascular infrarenal aortic aneurysm repair: Perhaps we've gone about it all wrong

Endovascular infrarenal aortic aneurysm repair: Perhaps we've gone about it all wrong

An observational assessment of aortic deformation during infrarenal and complex endovascular aortic aneurysm repair

ObjectiveReal-time aortic deformation during endovascular aortic aneurysm repair (EVAR) has not been reported. Successful EVAR relies on predicting intraoperative aortic-endograft deformation from preoperative imaging. Correct prediction is essential, because malalignment of endografts decreases patient survival. We describe intraoperative aortic deformation during infrarenal EVAR and complex fenestrated/branched EVAR (F/BEVAR), relating deformation to preoperative anatomy and follow-up outcomes. MethodsA multicenter, retrospective cohort of aortic aneurysm patients undergoing operation between January 2019 and February 2021, substratified by repair, infrarenal EVAR (n = 50), F/BEVAR (n = 80), and iliac branch graft with F/B/EVAR (IBG + F/B/EVAR; n = 27), were compared using software-based nonrigid two- and three-dimensional aortic deformational intraoperative assessment (CYDAR). Preoperative computed tomography reconstructions of aortic and iliac tortuosities were assessed against intraoperative deformation, the primary outcome, and related to perioperative and follow-up adverse outcomes. ResultsAll treatment groups had low preoperative visceral aortic tortuosity; the EVAR group had higher iliac tortuosity (1.43 ± 0.05; P = .018). Intraoperative aortic visceral deformation was consistently cranial and anterior; IBG + F/B/EVAR patients had the largest magnitude deformation (superior mesenteric artery, EVAR 5.1 ± 0.9 mm; F/BEVAR 4.4 ± 0.4 mm; IBG 8.3 ± 1.2 mm; P = .004). Celiac artery, superior mesenteric artery, and bilateral renal artery deformations were correlated (R = 0.923-0.983). Iliac deformation was variable in magnitude and direction. Preoperative tortuosity was not correlated with the magnitude of intraoperative deformation nor was deformation magnitude related to endograft instability during follow-up, including endoleak development, reinterventions, or visceral vessel complications. ConclusionsThe aorta deforms consistently during EVAR at the visceral aortic segment but unpredictably at the iliac bifurcation. Aortoiliac deformation is unrelated to adverse perioperative outcomes, branch instability, or reinterventions during short-term follow-up.

Predictors of mortality in nonagenarians undergoing abdominal aortic aneurysm repair: Analysis of the National Surgical Quality Improvement Program dataset

BackgroundThe present study used the American College of Surgeons National Surgical Quality Improvement Program dataset to identify the predictors of 30-day mortality for nonagenarians undergoing endovascular aortic aneurysm repair (EVAR) or open surgical repair (OSR). MethodsPatients aged >90 years who had undergone abdominal aortic aneurysm repair from 2005 to 2017 were identified using procedure codes. Those with operative times <15 minutes were excluded. The demographics, preoperative comorbidities, and postoperative complications of those who had died by 30 days were compared with those of the patients alive at 30 days. ResultsA total of 1356 nonagenarians met the criteria: 1229 (90.6%) had undergone EVAR and 127 (9.4%) had undergone OSR. The overall 30-day mortality was 10.4%. The patients who had died within 30 days were significantly more likely to have undergone OSR than EVAR (40.9% vs 7.2%; P < .001). They also had a greater incidence of dependent functional status (22.0% for those who had died vs 8.1% for those alive at 30 days; P < .001), American Society of Anesthesiology (ASA) classification of ≥4 (81.2% vs 18.8%; P < .001), perioperative blood transfusion (59.6% vs 20.3%; P < .001), postoperative pneumonia (12.1% vs 2.9%; P = .001), mechanical ventilation >48 hours (22.7% vs 2.6%; P < .001), and acute renal failure (12.1% vs 0.5%; P < .001). The EVAR group had a 30-day mortality rate of 2.6% in 1008 elective cases and 28.6% in 221 emergent cases. The OSR group had a 30-day mortality rate of 19.1% in 47 elective cases and 53.7% in 80 emergent cases. In the EVAR cohort, the 30-day mortality group had had a significantly greater incidence of dependent functional status (17% for those who had died vs 8% for those alive at 30 days; P = .004), ASA classification of ≥4 (76.4% vs 40.3%; P < .001), perioperative blood transfusion (57% vs 19%; P < .001), emergency surgery (71% vs 14%; P < .001), and longer operative times (150 vs 128 minutes; P = .001). ConclusionsNonagenarians had an incrementally increased, but acceptable, risk of 30-day mortality with EVAR in elective and emergent cases compared with that reported for octogenarians and cohorts of patients not selected for age. We found greater mortality for patients with dependent status, a higher ASA classification, emergent repair, and OSR. These preoperative risk factors could help identify the best surgical candidates. Given these results, consideration for EVAR or OSR might be reasonable for highly selected patients, especially for elective patients with a larger abdominal aortic aneurysm diameter for whom the risk of rupture is higher.

SS03. Results of Fenestrated and Branched Endovascular Aortic Aneurysm Repair After Failed Infrarenal Endovascular Aortic Aneurysm Repair

Failure of infrarenal endovascular aortic aneurysm repair (EVAR) owing to loss of proximal seal is increasingly common. Open surgical conversion is challenging and associated with significant morbidity/mortality. The aim of this study was to evaluate the use of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of patients with prior EVAR failure. Consecutive patients enrolled in six, prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/BEVAR between 2012 and 2018, were included in this study. The cohort was stratified according to whether the F/BEVAR procedure was performed after EVAR failure. Demographics, operative details, perioperative complications, and length of stay were compared between groups. Patient survival, type I or type III endoleak, target artery patency, and reintervention rates were calculated using Kaplan-Meier method and compared between groups. A total of 893 patients underwent F/BEVAR; 161 (18%) were treated after failed EVAR and 732 (82%) were treated without prior EVAR. Patients with failed EVAR were more often men (84% vs 66%; P < .01) with larger aneurysms (6.9 cm vs 6.4 cm; P < .01). There were no differences in aneurysm extent (P = .20) between the groups: 19% juxtarenal, 9.2% suprarenal, and 72% thoracoabdominal. The average number of targeted arteries per patient was 3.6 in both groups. The procedural technical success (99% vs 97%; P = .15) did not differ between groups, but radiation dose (4753 mGy vs 2924 mGy; P = .02), dose area product (154,572 mGy cm2 vs 82,842 mGy cm2; P < .01), and operative time (5.2 hours vs 4.6 hours; P < .01), were significantly higher in the failed EVAR group. Median intensive care length of stay (2.9 days) and total length of stay (6.3 days) did not differ between groups. The 30-day mortality rate (failed EVAR, 2.5%; no EVAR, 1.1%; P = .25) and 30-day major adverse event rate (Fig 1) did not differ between groups. Kaplan-Meier estimates of freedom from death (88.3% vs 92.5%; P = .10; Fig 2), type I or type III endoleak (91.9% vs 92.5%; P = .65), target artery occlusion (97.3% vs 97.0%; P = .91), and reintervention at 1 year (84.7% vs 88.7%; P = .10) did not differ between the failed EVAR and no EVAR group, respectively. In this multicenter study, F/BEVAR was safe and effective in patients with prior failed EVAR, with nearly identical outcomes as compared with patients without prior EVAR. However, differences in procedural metrics indicate higher level of technical challenge when performing F/BEVAR in patients with prior failed EVAR.Fig 2Kaplan-Meier estimates of freedom from death. EVAR, Endovascular aortic aneurysm repair.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Rate of Secondary Intervention After Open Versus Endovascular Abdominal Aortic Aneurysm Repair

BackgroundAlthough long-term durability and improved perioperative outcome of endovascular abdominal aortic aneurysm (AAA) repair has been demonstrated, some studies have suggested an increased rate of secondary interventions compared with open AAA repair. More recent data suggest that rates between the two modalities may be similar. We investigated the rate of secondary intervention in patients undergoing endovascular aortic aneurysm repair (EVAR) or open AAA repair for intact AAA and the effect of secondary intervention on long-term mortality in these two groups of patients. MethodsA retrospective, single-institution review was conducted between January 2003 and December 2012. Secondary intervention was defined as any intervention within 30 d of the procedure or an AAA repair-related procedure after 30 d, which included repair of endoleaks and incisional hernia repair. Group differences in demographic and baseline characteristics were examined using Cochran-Mantel-Haenszel and Wilcoxon rank sum tests for categorical and continuous variables, respectively. ResultsA total of 342 patients underwent operative repair of intact AAA. Two hundred seventy four patients underwent EVAR and 68 patients underwent open AAA repair. The mean age overall was 68.6 y and was not significantly different between the two repair groups. The overall rate of secondary intervention was significantly lower in the EVAR group compared with the open AAA repair group (11% versus 27%, P = 0.001). In the EVAR group, 30 patients underwent 37 secondary interventions. In the open repair group, 18 patients underwent 20 reinterventions. The most common secondary intervention was repair of type 2 endoleak (n = 13, 4.7% of patients) after EVAR and incisional hernia repair (n = 4, 5.9% of patients) after open AAA repair. Most secondary interventions (15/20) after open AAA repair occurred within 30 d, whereas most secondary intervention (33/37) after EVAR occurred after 30 d. Comparison of late (>30 d) reintervention between the two groups revealed a significantly lower rate of secondary intervention after open AAA repair (27.8% of all reinterventions after open versus 86.7% of all reinterventions after EVAR, P < 0.001). The overall 10-y mortality rate was 39.1%, and not statistically different between the two repair groups. Estimated survival analysis demonstrated no significant effect of secondary intervention on mortality after EVAR (logrank P = 0.45). Secondary intervention after open repair did not significantly affect long-term survival (logrank P = 0.05). ConclusionsThis study highlights the dramatic change in practice pattern in AAA repair over time. In this study, patients treated with EVAR had a significantly lower overall rate of secondary intervention compared with patients treated with open AAA repair. This was likely secondary to increased perioperative morbidity and mortality and a bias toward more complex patients in the open repair group. In the long term, however, there were significantly fewer reinterventions after open AAA repair. Secondary interventions did not affect long-term survival after EVAR.

Early and Late Outcomes of Endovascular Aortic Aneurysm Repair versus Open Surgical Repair of an Abdominal Aortic Aneurysm: A Single-Center Study

The objective of the study was to compare the treatment outcomes and cost of endovascular aortic aneurysm repair (EVAR) and open surgical repair (OSR) in patients with an abdominal aortic aneurysm (AAA) at a single center. Patients treated for an AAA at a single center between January 2007 and December 2012 were retrospectively identified and classified based on the treatment they received (EVAR or OSR). Patient demographics and in-hospital costs were recorded. Long-term survival was calculated using the Kaplan-Meier method. During the study period, 401 patients with AAA were treated at Asan Medical Center. Among these cases, 226 were treated with EVAR (56%) and 175 received OSR (44%). The mean age of the EVAR group was higher than that of the OSR group (71.25±7.026 vs. 61.26±8.175, P<0.001). The need for intraoperative transfusion and total length of in-hospital stay were significantly lower in the EVAR group (P<0.001). The OSR group showed significantly reduced rates of overall mortality (P=0.003), overall reintervention (P=0.001), and long-term survival (63.98±1.86 vs. 99.54±3.17, P<0.001). The OSR group was charged significantly less than the EVAR group ($12,879.21 USD vs. $18,057.78 USD, P<0.001). EVAR has advantages over OSR in terms of short-term mortality, in-hospital length of stay, and rates of perioperative transfusion. However, OSR is associated with better long-term survival, lower reintervention rates, and lower costs.

PC044. Revisiting Endovascular Repair for Ruptured Abdominal Aortic Aneurysms

The management of ruptured abdominal aortic aneurysms (AAAs) has changed over the past several years. There have been numerous studies that have shown conflicting results for the role of endovascular aortic aneurysm repair (EVAR) in ruptured AAA. There has been a mortality benefit in many studies, but it has been thought that the benefit is due to patient selection factors. However, unlike conventional surgical procedures, instrumentation for endovascular intervention, such as access catheters, wires and grafts, is improved constantly by industry. In light of this, we have compared the outcomes from EVAR with those of open repair. We analyzed data from 4133 patients with ruptured AAA treated with open surgery vs EVAR collected from the National Surgical Quality Improvement Program database from 2010 to 2016 using International Classification of Disease, 9th edition and 10th edition, as well as Current Procedural Terminology codes. We used χ2 tests and t tests to compare perioperative mortality between open and endovascular procedures. Logistic regression analysis was then used to correct for preoperative comorbidities. Analysis of strength of our model was performed using Hosmer-Lemeshow goodness-of-fit testing and receiver operator characteristic analysis. The number of endovascular cases in ruptured AAA increased from 30.1% in 2010 and peaked in 2015 at 53.7% (P < .001). Yearly operative mortality ranged from 27.3% to 39.2% in the open group and 18.1% to 26.2% in the EVAR group. Overall mortality was 22.6% for EVAR and 33.2% for open repair (P < .001). After adjusting for comorbidities, there was a 39% reduction in perioperative mortality with EVAR vs open repair (adjusted odds ratio [aOR], 0.61; 95% confidence interval [CI], 0.52-0.71; P < .001). Perioperative mortality in ruptured AAA was 46% greater in women as compared with men (aOR, 1.46; 95% CI, 1.23-1.73; P < .001), there was no difference between the EVAR and open groups. In addition, smoking status (aOR, 1.67; 95% CI, 1.43-1.95; P < .001), ventilator dependence (aOR, 3.69; 95% CI, 2.94-4.63; P < .001), preoperative transfusion of 1 or more units of packed red blood cells (aOR, 1.64; 95% CI, 1.40-1.96; P < .001), and functional status before surgery (aOR, 1.21; 95% CI, 1.14-1.29; P < .001) all had a statistically significant impact on perioperative mortality. EVAR is becoming an increasingly popular strategy for the treatment of AAA. As surgeon experience has increased, a greater percentage of ruptured AAA are being treated by EVAR. Retrospective analysis of outcomes from a national database portends a significant benefit even after adjustment for patient factors, to managing AAA with EVAR versus open surgery.

Mid-term Results of Endovascular Aortic Aneurysm Repair in the Young

To compare the mid-term outcome and secondary intervention rate following elective open and endovascular aortic aneurysm repair (EVAR) in patients aged 65 years and younger. A retrospective analysis of patients aged 65 years and younger who had elective abdominal aortic aneurysm repair (AAA) between 1994 and 2012. One hundred and sixty-five patients under the age of 65 years (mean age: 61 years ± 4; 8 women) had elective abdominal aneurysm repair (97 EVAR and 68 open). The overall 30-day mortality rate was 3.7% (2.1% EVAR and 5.9% open). Forty per cent of patients had died at a median follow up of 77 months (interquartile range, 36-140). Most deaths were not related to aneurysm. There was no difference in the long-term mortality between the EVAR and open groups (hazard ratio [HR] = 1.22; 95% confidence interval [CI] 0.75-1.98, p = .43), but there was a trend of better outcomes with the use of commercially made endografts over open repair (HR = 2.9; 95% CI 0.9-10.0, p = .08) and custom-made endografts (HR = 3.1, 95% CI 0.9-10.3; p = .07). Eleven per cent of patients who had EVAR required a further procedure compared with 13% who had open repair. All but one of the re-interventions in the EVAR group was performed on patients who had custom-made endografts. Young patients with AAA have significant comorbidities and do not necessarily have long lifespans. In the less fit younger patients with AAA, the results with EVAR are comparable with fit patients who had open AAA repair. The management of fitter young patients with AAA remains controversial, but improving results with EVAR over time may increase the role of EVAR in this group.

Quality of Life in Patients with Small Abdominal Aortic Aneurysm: The Effect of Early Endovascular Repair Versus Surveillance in the CAESAR Trial

Objective: To evaluate and compare changes over time in health-related quality of life reported by patients with small (4.1–5.4 cm) abdominal aortic aneurysms (AAAs) undergoing endovascular aortic aneurysm repair (EVAR) or surveillance. Methods: Participants were randomly assigned to receive either early EVAR or surveillance within a multicentre, randomised clinical trial on small AAA (Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair, CAESAR). Patient-reported health-related quality of life was assessed before randomisation, at 6 months and yearly thereafter using the Short Form 36 (SF-36) Health Survey. Results: Between 2004 and 2008, 360 patients (345 males, mean age 68.9 years) were randomised, 182 to early EVAR and 178 to surveillance. There was one perioperative death. Mean follow-up was 31.8 months. No significant difference in survival was found. At baseline, comparable quality of life scores were recorded in both treatment groups: Total SF-36: 73.0 versus 75.5 (p = 0.18), Physical domain: 71.4 versus 73.3 (p = 0.33); Mental health domain: 70.9 versus 72.7 (p = 0.33), in the EVAR arm versus the surveillance arm, respectively. Six months after randomisation, Total SF-36 and Physical and Mental domain scores were all significantly higher with respect to baseline in the EVAR group, while patients of the surveillance group scored lower. The differences between EVAR and surveillance arms in score changes at 6 months were significant and in favour of EVAR: Total score: difference 5.4; p = 0.0017; Physical: difference 3.8; p = 0.02; and Mental: difference 6.0; p = 0.0005. Differences between EVAR and surveillance diminished over time. At the last assessment, patients in both groups had decreased scores with a significant drop with respect to the baseline (−3.9 in EVAR, −6.3 in surveillance). There were no significant differences between the EVAR and surveillance arms: Total score: p = 0.25; Physical: p = 0.47; and Mental: p = 0.38. Conclusions: Patients with small AAA under surveillance compared with early EVAR had significant impaired functional health at 6 months after assignment. After a mean of 31.8 months, SF-36 health-related quality of life in patients allocated to early EVAR and surveillance was similar.

Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR): Results from a Randomised Trial

Background: Randomised trials have failed to demonstrate benefit from early surgical repair of small abdominal aortic aneurysm (AAA) compared with surveillance. This study aimed to compare results after endovascular aortic aneurysm repair (EVAR) or surveillance in AAA <5.5 cm. Methods: Patients (50–79 years) with AAA of 4.1–5.4 cm were randomly assigned, in a 1:1 ratio, to receive immediate EVAR or surveillance by ultrasound and computed tomography (CT) and repair only after a defined threshold (diameter ≥5.5 cm, enlargement >1 cm /year, symptoms) was achieved. The main end point was all-cause mortality. Recruitment is closed; results at a median follow-up of 32.4 months are here reported. Results: Between 2004 and 2008, 360 patients (early EVAR = 182; surveillance = 178) were enrolled. One perioperative death after EVAR and two late ruptures (both in the surveillance group) occurred. At 54 months, there was no significant difference in the main end-point rate [hazard ratio (HR) 0.76; 95% confidence interval (CI) 0.30–1.93; p = 0.6] with Kaplan–Meier estimates of all-cause mortality of 14.5% in the EVAR and 10.1% in the surveillance group. Aneurysm-related mortality, aneurysm rupture and major morbidity rates were similar. Kaplan–Meier estimates of aneurysms growth ≥5 mm at 36 months were 8.4% in the EVAR group and 67.5% in the surveillance group (HR 10.49; 95% CI 6.88–15.96; p < 0.01). For aneurysms under surveillance, the probability of delayed repair was 59.7% at 36 months (84.5% at 54 months). The probability of receiving open repair at 36 months for EVAR feasibility loss was 16.4%. Conclusion: Mortality and rupture rates in AAA <5.5 cm are low and no clear advantage was shown between early or delayed EVAR strategy. However, within 36 months, three out of every five small aneurysms under surveillance might grow to require repair and one out of every six might lose feasibility for EVAR. Surveillance is safe for small AAA if close supervision is applied. Long-term data are needed to confirm these results. Clinical Trial Registration Information: This study is registered, NCT Identifier: NCT00118573.

Quality of Life in Patients with Small Abdominal Aortic Aneurysm: The Effect of Early Endovascular Repair Versus Surveillance in the CAESAR Trial

Objective To evaluate and compare changes over time in health-related quality of life reported by patients with small (4.1–5.4 cm) abdominal aortic aneurysms (AAAs) undergoing endovascular aortic aneurysm repair (EVAR) or surveillance. Methods Participants were randomly assigned to receive either early EVAR or surveillance within a multicentre, randomised clinical trial on small AAA (Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair, CAESAR). Patient-reported health-related quality of life was assessed before randomisation, at 6 months and yearly thereafter using the Short Form 36 (SF-36) Health Survey. Results Between 2004 and 2008, 360 patients (345 males, mean age 68.9 years) were randomised, 182 to early EVAR and 178 to surveillance. There was one perioperative death. Mean follow-up was 31.8 months. No significant difference in survival was found. At baseline, comparable quality of life scores were recorded in both treatment groups: Total SF-36: 73.0 versus 75.5 ( p = 0.18), Physical domain: 71.4 versus 73.3 ( p = 0.33); Mental health domain: 70.9 versus 72.7 ( p = 0.33), in the EVAR arm versus the surveillance arm, respectively. Six months after randomisation, Total SF-36 and Physical and Mental domain scores were all significantly higher with respect to baseline in the EVAR group, while patients of the surveillance group scored lower. The differences between EVAR and surveillance arms in score changes at 6 months were significant and in favour of EVAR: Total score: difference 5.4; p = 0.0017; Physical: difference 3.8; p = 0.02; and Mental: difference 6.0; p = 0.0005. Differences between EVAR and surveillance diminished over time. At the last assessment, patients in both groups had decreased scores with a significant drop with respect to the baseline (−3.9 in EVAR, −6.3 in surveillance). There were no significant differences between the EVAR and surveillance arms: Total score: p = 0.25; Physical: p = 0.47; and Mental: p = 0.38. Conclusions Patients with small AAA under surveillance compared with early EVAR had significant impaired functional health at 6 months after assignment. After a mean of 31.8 months, SF-36 health-related quality of life in patients allocated to early EVAR and surveillance was similar.

Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR): Results from a Randomised Trial

Background Randomised trials have failed to demonstrate benefit from early surgical repair of small abdominal aortic aneurysm (AAA) compared with surveillance. This study aimed to compare results after endovascular aortic aneurysm repair (EVAR) or surveillance in AAA <5.5 cm. Methods Patients (50–79 years) with AAA of 4.1–5.4 cm were randomly assigned, in a 1:1 ratio, to receive immediate EVAR or surveillance by ultrasound and computed tomography (CT) and repair only after a defined threshold (diameter ≥5.5 cm, enlargement >1 cm /year, symptoms) was achieved. The main end point was all-cause mortality. Recruitment is closed; results at a median follow-up of 32.4 months are here reported. Results Between 2004 and 2008, 360 patients (early EVAR = 182; surveillance = 178) were enrolled. One perioperative death after EVAR and two late ruptures (both in the surveillance group) occurred. At 54 months, there was no significant difference in the main end-point rate [hazard ratio (HR) 0.76; 95% confidence interval (CI) 0.30–1.93; p = 0.6] with Kaplan–Meier estimates of all-cause mortality of 14.5% in the EVAR and 10.1% in the surveillance group. Aneurysm-related mortality, aneurysm rupture and major morbidity rates were similar. Kaplan–Meier estimates of aneurysms growth ≥5 mm at 36 months were 8.4% in the EVAR group and 67.5% in the surveillance group (HR 10.49; 95% CI 6.88–15.96; p < 0.01). For aneurysms under surveillance, the probability of delayed repair was 59.7% at 36 months (84.5% at 54 months). The probability of receiving open repair at 36 months for EVAR feasibility loss was 16.4%. Conclusion Mortality and rupture rates in AAA <5.5 cm are low and no clear advantage was shown between early or delayed EVAR strategy. However, within 36 months, three out of every five small aneurysms under surveillance might grow to require repair and one out of every six might lose feasibility for EVAR. Surveillance is safe for small AAA if close supervision is applied. Long-term data are needed to confirm these results. Clinical Trial Registration Information This study is registered, NCT Identifier: NCT00118573.

Renal Artery Interventions During Infrarenal Endovascular Aortic Repair: A Greater Potential of Subsequent Failure?

To determine the anatomic and functional outcomes of renal artery interventions during endovascular aortic aneurysm repair (EVAR) and compare them with renal artery interventions without EVAR. A renal artery revascularization database (1987-2007) was reviewed to identify patients who underwent renal intervention during EVAR and those who had an intervention in the absence of EVAR. Outcomes were analyzed with respect to patient comorbidities, renal anatomy and function, procedural events, and postoperative complications. A total of 413 patients (239 men; 58%) underwent 589 renal artery revascularizations (51 with EVAR and 362 without). Mean age was 70 years +/- 10. Mean follow-up was 3.5 years (range, 1-13 y). Primary indications for renal intervention were hypertension (63%) and elevated creatinine level (27%). The EVAR group was more likely to incur an increased creatinine level at 1 month after intervention (33% vs 18%; P = .007). Freedom from restenosis was similar (P = .501), but arterial occlusion rate was higher in the EVAR group (96% +/- 3% vs 100% +/- 10% cumulative patency at 3 y; P = .005). At 3 years, freedom from recurrent symptoms (P = .26), freedom from adverse renal events (P = .12), and survival (85% +/- 8% vs 75% +/- 2%; P = .83) were not significantly different. Renal artery revascularization during EVAR should be considered higher risk because of the high incidence of procedural complications, early functional injury, and early occlusion rates. However, the long-term sequelae and benefits of such a procedure are similar to those of a renal revascularization procedure in the absence of EVAR.

PP66. Endoluminal Infrarenal Aortic Aneurysm Repair: A Costly Endeavor for Low Risk Patients

Since the FDA approval of endovascular aortic aneurysm repair (EVAR) devices, there has been a gradual transition from a physiologic to an anatomic criteria case selection. The economic implications of this evolving selection criteria have not been widely studied. The objective of this study is to investigate the cost-effectiveness of elective EVAR compared to OPEN abdominal aortic aneurysm (AAA) repair, in low and high risk patients. A retrospective analysis was performed reviewing all patients who underwent an elective AAA repair between 2004 and 2007. Clinical endpoints included postoperative stay, postoperative complications and 30-day mortality. Total hospital cost associated with the index procedure was obtained. The study population was divided into high (SVS score ≥ 8)and low risk (SVS score <8) surgical groups based on the SVS/AAVS medical comorbidity grading system. P < 0.05 was significant. During the study period, a total of 401 cases were identified, 43% (n = 173, SVS score 7.7 ± 0.25) EVAR and 57% (n = 228, SVS score 6.7 ± 0.32) OPEN. With the exception of ESRD (5.2%, n = 9 EVAR, 0% n = 0 OPEN, P < 0.01), the patient co-morbid profiles were not statistically different. Postoperative stay was less for EVAR (2.1 ± 0.2 days EVAR, 7.6 ± 0.4 days OPEN, P < 0.0001). For high risk patients (EVAR n = 88, OPEN n = 96), there was a trend towards higher 30-day mortality (1.1% EVAR vs 4.2% OPEN, P = 0.20) and a significantly higher complication rate (4.5% EVAR vs 15.6% OPEN, P = 0.013). The total hospital cost was significantly higher in the EVAR group ($35,903 ± 1156 EVAR vs $21,998 ± 1487 OPEN, P < 0.01). For the low risk cohort, there was no difference in morbidity and mortality despite higher total cost with EVAR ($33,758 ± 1120 EVAR vs $20,041 ± 1480 OPEN, P < 0.001). High risk OPEN AAA patients have a higher postoperative complication rate and show a trend in increased 30-day mortality compared to high risk EVAR patients. Low risk AAA repair patients exhibit a negligible difference between EVAR and OPEN regarding postoperative complications and mortality, which does not justify the significant healthcare cost difference between treatment groups. Based on these data, the policy of EVAR in low risk patients cannot be supported by clinical outcomes or financial measures.

Aortoiliac Aneurysm Repair in Kidney Transplant Recipients

A potential problem during endovascular aortic aneurysm repair (EVAR) or open repair in renal allograft patients is ischemia of the transplanted kidney. In this study, kidney transplant patients who underwent aortic aneurysm repair in our institution were added to similar cases extracted from the literature to represent the basis of this work. Comparisons between patients treated with open surgery versus EVAR were performed in terms of renal function. In the EVAR group, most aneurysms were infrarenal, and 84% were treated with modular bifurcated devices. Protective kidney allograft perfusion measures were not used. The pre- and postoperative Cr was 1.69 and 1.73 mg/dL, respectively (P = .412). All EVAR patients had good outcomes. Complications included 8 endoleaks and 1 limb ischemia case. Three patients died from aortic repair-unrelated reasons. In the open group, the pre-and postoperative Cr was 1.45 and 1.37 mg/dL, respectively (P = .055). Most cases were infrarenal and mostly treated by aortobiiliac bypasses. In 16%, no adjuvant allograft perfusion was provided. In the rest, temporary axillofemoral bypasses were used most often. Most outcomes were favorable (57%). Reported procedural-related complications included arterial embolism, wound infection, and pneumonia. Deaths were reported in 5 occasions (none allograft failure dependent). No differences in Cr between EVAR and open techniques (P = .13) were seen. Aneurysm repair in kidney transplant recipients is associated with excellent renal preservation. Adverse outcomes were all allograft failure independent in both groups. EVAR without special allograft protection measures seems to be equally effective as open surgery with or without adjuvant kidney transplant perfusion.

Endovascular Aortic Aneurysm Repair (EVAR) Has Significantly Lower Perioperative Mortality in Comparison to Open Repair: A Systematic Review

Objective The objective of this meta-analysis was to evaluate the effectiveness of endovascular abdominal aortic aneurysm repair (EVAR) in reducing inhospital mortality against open graft replace-ment for aortic aneurysm. Methods Generic terms including EVAR, endovascular aneurysm repair and aortic endografting were used to search a variety of electronic databases. Based on selection criteria, decisions regarding inclusion and exclusion of primary studies were made. Results A total of three randomized controlled trials on 1,468 patients were included. In the EVAR group, 12 of 759 (1.5%) patients died, compared to 33 of 709 (4.6%) patients who died in the open surgery group. In both the fixed and random effect models, EVAR was associated with statistically significantly lower perioperative mortality when compared to open surgical repair of aortic aneurysm. The risk ratio of 0.33 indicates that mortality is 3.3 times more likely in the open surgery group compared to the EVAR group. Conclusion EVAR carries a threefold lower risk of perioperative death in comparison to open repair of abdominal aortic aneurysm. This early advantage must be offset against the increased need for later re-intervention and probable equivalence of long-term outcome. In older and high operative risk patients, EVAR should be the treatment of choice.