Rationale and design of the EAGLE Registry: EVAR with Endurant® in challenging anatomy.

AIM: The aim of this study was to collect clinical information on the performance of the Endurant® (II) Stent Graft System for endovascular repair in anatomically challenging infrarenal aneurysms, and to critically assess whether the current instructions for anatomic eligibility for endovascular treatment with this system are still applicable. METHODS: Initiated by doctors, EAGLE is a prospective, non-interventional study, aiming to enrol 250 patients in 20 experienced centres across several countries worldwide. EAGLE focuses on patients with challenging angulation or neck length. To minimize the risk of selection bias and enhance data quality, EAGLE eligibility will be determined by an independent core-lab and efforts will be made to secure consecutive enrolment of challenging cases. The EAGLE database is designed to merge with the on-going ENGAGE database, which enables comparative analysis of cases and results. RESULTS: The primary endpoint is treatment success at 30 days, 12 months and yearly up to 5 years postimplant. CONCLUSION: Separate studies on the performance of EVAR in challenging anatomy are necessary to demonstrate safety and effectiveness of the latest generation stent-grafts, which is essential in making a balanced judgment about the optimal management of AAAs.

Challenging the evidence for pre-emptive coil embolisation of the internal iliac artery during endovascular aneurysm repair.

OBJECTIVES: We retrospectively analysed the results of a strategy in which coverage of the internal iliac artery (IIA) during endovascular aneurysm repair (EVAR) was routinely performed without coil embolisation. METHODS: From January 2010 until May 2012, 32 patients (96.9% men; mean age 73.0 years, range 52-89 years) underwent EVAR with stent grafts extended into the external iliac artery (EIA), all without prior coil embolisation. Aneurysm morphology was determined on preoperative computed tomography (CT) images. During follow-up, patients were interviewed about buttock claudication, and the occurrence of endoleaks and evolution of aneurysm diameter were recorded. RESULTS: At baseline, the mid-common iliac artery (CIA) diameter was 33.5 ± 16.8 mm and seven patients presented with ruptured aneurysms. Mean follow-up was 14.3 ± 7.4 months. There were eight deaths, none related to IIA coverage. Buttock claudication occurred in seven (22.6%) patients, which persisted after 6 months in two cases of bilateral IIA coverage. No Type-I or -II endoleaks occurred related to IIA coverage. Aneurysm growth was not observed. CONCLUSION: Endovascular treatment of aortoiliac and iliac aneurysm without pre-emptive coil embolisation of the IIA appears safe and effective. No IIA-related endoleaks or re-interventions occurred in our series. This approach saves operating time, contrast load and costs and may reduce complications. However, a larger population and longer follow-up is required to confirm our findings.

Targeted screening as a tool for the early detection of chronic Q fever patients after a large outbreak.

In the aftermath of the Dutch Q fever outbreak, an increasing number of patients are being diagnosed with chronic Q fever. Most of these patients are unaware of being infected with Coxiella burnetii, the causative agent of Q fever. To find patients in an earlier, asymptomatic stage, a targeted screening strategy (TSS) for patients with risk factors for chronic Q fever was started in the southeast region of Noord-Brabant. In total, 763 patients were tested using an IgG phase II indirect fluorescent antibody test (IFAT), of which 52 (7 %) patients tested positive. Ten of these 52 patients displayed a chronic Q fever serological profile. All of these 10 patients had a heart valve(s) or (endo-)vascular prosthesis. All except one were asymptomatic. Suggestive signs for chronic infections on positron emission tomography-computed tomography (PET-CT) were demonstrated in 5 (50 %) of these patients. Forty-two out of the 52 patients with a positive screening test showed a past Q fever serological profile. After a year of follow-up (every 3 months), none of these patients showed elevation of antibody titres and no new chronic Q fever patients were found in this group. A targeted screening programme is a useful instrument for detecting patients at risk of developing chronic Q fever.

Early results from the ENGAGE registry: real-world performance of the Endurant Stent Graft for endovascular AAA repair in 1262 patients.

OBJECTIVE: The ENGAGE registry was undertaken to examine the real-world outcome after endovascular abdominal aortic aneurysm (AAA) repair (EVAR) with the Endurant Stent Graft in a large, contemporary, global series of patients. METHODS: From March 2009 to April 2011, 1262 AAA patients (89.6% men; mean age 73.1 years, range 43-93 years) were enrolled from 79 sites in 30 countries and treated with Endurant. Results are described following the reporting standards for EVAR. Follow-up data were tabulated for all 1262 patients at a 30-day follow-up and for the first 500 patients at a 1-year follow-up. RESULTS: Intra-operative technical success was achieved in 99.0% of cases. Within 30 days, adverse events were reported in 3.9% of patients, including a 1.3% mortality rate. Type-I or -III endoleaks were identified in 1.5% of cases. Estimated overall survival, aneurysm-related survival and freedom from secondary interventions at 1 year were 91.6%, 98.6% and 95.1%, respectively. At 1 year, aneurysm size increased ≥ 5 mm in 2.8% and decreased ≥ 5 mm in 41.3% of cases. CONCLUSION: Early results from this real world, global experience are promising and indicate that endovascular AAA repair with the Endurant Stent Graft is safe and effective across different geographies and standards of practice. Longer-term follow-up is necessary to assess durability of these results.

No differences in perioperative outcome between symptomatic and asymptomatic AAAs after EVAR: an analysis from the ENGAGE Registry.

AIM: This study aimed to compare the differences in perioperative outcome after endovascular repair of symptomatic abdominal aneurysms (S-AAAs) and elective non-symptomatic AAAs (E-AAAs). Data from the ENGAGE Registry were used for the analysis. METHODS: Between March 2009 and December 2010, 1200 AAA patients were enrolled from 79 sites in 30 countries and treated with an Endurant Stent Graft. S-AAAs defined as AAAs accompanied by abdominal or back pain, without rupture, were present in 185 (15.4%) patients and E-AAAs in 1015 (84.6%) patients. Multivariate logistic regression was used to compare results. RESULTS: At baseline, E-AAA patients had larger aneurysms on average (P = 0.006) and scored higher ASA classification more often (P = 0.001). Further analyses were corrected for baseline differences. Operation time and technical success were comparable, and S-AAAs were admitted to the Intensive Care Unit (ICU) as often as E-AAAs (35.7% vs. 33.4%, P = 0.479). Post-operative hospitalisation was similar (4.83 ± 5.29 in E-AAAs and 4.37 ± 3.49 in S-AAAs, P = 0.360). No differences in the occurrence of major adverse events, including mortality, within the 30-day post-implantation were seen between S-AAA and E-AAA patients, respectively, 3.2% and 4.2% (P = 0.572). CONCLUSION: With contemporary devices and technical proficiency, there is no difference in outcome between symptomatic AAA and elective non-symptomatic AAA patients if treated with endovascular techniques.