The influence of gender and aortic aneurysm size on eligibility for endovascular abdominal aortic aneurysm repair.

The purpose of this study was to compare the eligibility of men and women with infrarenal abdominal aortic aneurysms (AAAs) for on-label endovascular aneurysm repair (EVAR) as part of the clinician-Food & Drug Administration (FDA) collaborative effort, the Characterization of Human Aortic Anatomy Project (CHAP). Computed tomography (CT) scans with 3D reconstruction from a single institution obtained between July 1996 and December 2009, including standardized measurements by a blinded third-party (M2S, West Lebanon, NH) were examined. For inclusion, abdominal aortic aneurysm (AAA) had to be infrarenal, unrepaired, and >5 cm, or 4 cm to 5 cm if the orthogonal sac diameter was more than twice the aortic diameter at the renal level. Scans were included regardless of subsequent EVAR, open repair, or lack of treatment. One thousand sixty-three unique, unrepaired AAAs were analyzed. Neck length, diameter, and angulation differ for women (P < .001) even after adjustment for patient age and AAA size. EVAR eligibility based on device Instructions for Use (IFU) criterion is affected by gender. Neck length <15 mm was found in 47% of men and 63% of women. Neck angulation exceeding 60 degrees was found in 12% of men and 26% of women. Minimum iliac diameter of 6 mm was found in 35% of men and 55% of women. Only 32% of men and 12% of women met all three neck criterion and had iliac lumen diameters >6 mm. Logistic regression modeling shows that older patient age (odds ratio [OR], 0.84 per decade), increased aneurysm diameter (OR, 0.70 per cm), and female gender (OR, 0.4) are each independently associated with decreased odds of meeting all device IFU neck criterion (P < .05). EVAR eligibility by neck criterion does not decline significantly until AAA size exceeds 5.5 cm in women and 6.5 cm in men. Women are significantly less likely to meet device IFU criterion for EVAR. Aortic neck criteria and iliac access are important for men and women, but more women than men fail to meet IFU criterion. Devices that accommodate shorter infrarenal AAA neck length will have the greatest impact on expanding on-label EVAR regardless of gender. Lower profile devices and those that accommodate higher neck angulation are expected to expand EVAR eligibility further for women. EVAR eligibility is unlikely to be lost as AAAs enlarge to 5.5 cm in women and 6.5 cm in men. Observation of small AAAs until they reach the standard threshold size for repair should not compromise EVAR eligibility.

Sweet MP ，Fillinger MF ，Morrison TM ，Abel D ... -  《-》

An analysis of variables affecting aortic neck length with implications for fenestrated endovascular repair of abdominal aortic aneurysm.

A major factor in the selection of patients for endovascular aneurysm repair (EVAR) is the character of the aortic neck, and studies suggest that many patients are treated outside of the instructions for use (IFU) criteria. By analyzing aortic neck morphology, we hope to identify factors that may influence decision making about the use of fenestrated endografts as an alternative to extending the neck limitations of traditional endografts. A retrospective analysis was completed on 111 patients who underwent computed tomography angiography (CTA) scans between May 1, 2009 and January 3, 2011 for the evaluation of abdominal aortic aneurysm (AAA). Individual characteristics of neck and aneurysm morphology were analyzed to establish whether certain factors determined suitability for EVAR with traditional nonfenestrated endografts. In considering augmented neck lengths (ANL), anatomic measurements of distance from the start of aortic dilatation to the lowest renal artery (LRA) and highest renal artery (HRA) were analyzed. Measurements were analyzed using Stata software (version 11.2; StataCorp, College Station, TX). There were 86 men and 25 women in the patient population, with an average age of 72.9 years. In 46 patients, the proximal neck length was <15 mm, with 26 patients having neck lengths <10 mm. There was a negative relationship between AAA maximum diameter and proximal neck length (rs = -0.2237; P = 0.018), indicating that as aneurysm size increases, proximal neck length decreases. There was a significant correlation between proximal neck length and proximal neck diameter (rs = -0.2585; P = 0.006) and between proximal neck length and angle (rs = -0.2355; P = 0.013), and between proximal neck diameter and right iliac maximum diameter (rs = 0.2329; P = 0.014). Using fenestration to place an endograft above the LRA would create an ANL of >15 mm in 20 of 40 patients with aortic necks deemed too short to be eligible for EVAR using conventional infrarenal graft positioning. Extending the graft above the HRA would create an ANL of >15 mm in 36 of 40 patients. In this study, 41% of patients presented with neck lengths outside that of the traditional IFU for most aortic endografts. While there was wide variation from patient to patient, there was a general correlation between increasing AAA size and aneurysms that have shorter, wider, and more angulated proximal necks. Fenestration of even 1 renal artery could substantially increase the ANL. Additional study is warranted to determine if an increase in ANL in patients with otherwise short necks will positively impact long-term EVAR outcomes.

Stark M ，Suresh A ，Alexander J ，Cragg A ... -  《-》

Anatomic feasibility of endovascular treatment of abdominal aortic aneurysms in emergency in the era of the chimney technique: impact on an emergency endovascular kit.

Despite promising results, endovascular aortic repair (EVAR) of ruptured/painful abdominal aortic aneurysms (RPAAA) continues to have limited use due to anatomic constraints linked to RPAAA morphology. Currently, EVAR for RPAAA is reserved for patients presenting with a long infrarenal aortic neck, because commercially available fenestrated stent grafts are not available in an emergency setting. Recently, the chimney technique (ChT) has been utilized to treat infrarenal abdominal aortic aneurysms (AAA) with short necks, but this technique requires specific materials. The aim of this study was to determine the rate of RPAAA eligible for EVAR since the advent of the ChT and to ascertain the standard materials needed in this context. We carried out a retrospective study of patients operated on for RPAAA (<24 hours after admission) at our center between 2006 and 2011. Patients' computed tomography (CT) scans were analyzed by two independent operators using 3-dimensional reconstruction software with a centerline of flow. To perform standard EVAR, the anatomic criteria used were those provided by the manufacturer (proximal neck diameter 18-32 mm with length >15 mm, angulation <60°, iliac diameter >7 mm). ChT anatomic feasibility criteria were: (1) a healthy aortic area >15 mm between the renal arteries and celiac trunk; (2) caudal orientation of renal arteries; and (3) a healthy descending thoracic aorta. Patients were classified according to the feasibility or nonfeasibility of standard EVAR and ChT. In total, over the period of study, 55 patients were operated on for RPAAA. In 5 patients (9%), CT scan quality was unsatisfactory and thus 50 patients (mean age 76 years, 75% men) were analyzed. Among them, 35 (70%) had a ruptured aneurysm and 17 (34%) were unstable. Anatomically, 22 (44%) patients were eligible for standard EVAR. Taking the ChT into consideration, an additional 11 (22%) patients were eligible for EVAR. Among these EVAR-eligible patients, mean proximal neck diameter was 23 ± 3 mm and stent grafts with 24-, 28-, and 32-mm diameters could fit in 33% (11 of 33), 51% (17 of 33), and 12% (4 of 33) of the cases, respectively. These results enabled us to determine the material that should be made available in the emergency setting in centers treating RPAAA. Among the 17 patients who were not eligible for EVAR, an iliac pathology (calcifications, stenosis) and a very hostile proximal neck (angulation, thrombus), respectively, were involved in 88% (15 of 17) and 12% (2 of 17) of the cases. The ChT increases EVAR feasibility by 50% in RPAAA. Taking into consideration our results, we recommend continued availability of emergency kits, including suitable aortouni-iliac stent grafts and basic material for performing ChT to allow surgeons to provide EVAR to the greatest number of RPAAA cases.

Brossier J ，Coscas R ，Capdevila C ，Kitzis M ，Coggia M ，Goeau-Brissonniere O ... -  《-》

Influence of age, aneurysm size, and patient fitness on suitability for endovascular aortic aneurysm repair.

Timaran CH ，Rosero EB ，Smith ST ，Modrall JG ，Valentine RJ ，Clagett GP ... -  《-》

One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft.

The Endurant (Medtronic, Minneapolis, Minn) is a new stent graft specifically designed to make more patients anatomically eligible for endovascular aneurysm (EVAR). This study presents the 1-year results of 100 consecutive patients with abdominal aortic aneurysms (AAAs) treated with the Endurant stent graft in real-life practice. All clinical preoperative, operative, postoperative, and 1-year follow-up data of patients with the Endurant stent graft from three tertiary centers were prospectively collected. Patients underwent computed tomographic angiography (CTA) preoperatively, at 1 month, and at 1-year post-EVAR. The first 100 patients with an implantation date at least 1 year before our date of analysis and complete information were included. Clinical data, AAA characteristics, presence of endoleaks, graft migration, and other EVAR-related complications were noted. All values are stated as mean ± SD (range). This study included 100 patients with AAAs (88 men) with a mean age of 73 ± 8 years (47 to 87 years), an AAA size of 61 ± 10 mm (31 to 93 mm), an AAA volume of 210 ± 122 mL (69 to 934 mL), a proximal neck length of 33 ± 14 mm (9 to 82 mm), and an infrarenal angulation of 44 ± 25° (0°-108°). Nineteen of the 100 included patients had at least one anatomic characteristic that was considered a violation of the instructions for use (IFU) of the Endurant stent graft. A primary technical success was achieved in 98% of the patients (one additional stent placement in renal artery was required; one unplanned aorto-uni-iliac device placed), with no primary type I or III endoleaks or conversions. A secondary technical success was achieved in all cases. The 30-day mortality was 2% and the first postoperative CTA documented 16 endoleaks (16%; 16 type II). One-year follow-up showed three iliac limb occlusions (3%), one infected stent graft (causing a type Ia endoleak), and five endovascular reinterventions (5%; three to treat iliac limb occlusions, one proximal extension cuff; and one stent in the renal artery). The 1-year all-cause mortality rate was 12% (12 patients) and the AAA-related mortality was 3%. The mean AAA size was significantly smaller after 1 year (diameter, 54 ± 11.8 [32-80] mm; P < .01; volume, 173 ± 119 [42-1028] mL; P < .01), and one graft migration >5 mm and 13 endoleaks were noted (12 type II, 1 type I [neck dilatation]). The treatment of patients with AAAs with the Endurant stent graft seems to be successful and durable during the first year after EVAR. Despite the wider inclusion criteria for the Endurant, and with 19% of our patients treated outside the IFU, the AAA-related mortality, number of type I or III endoleaks, and reintervention rates are comparable to the results of other stent grafts.

van Keulen JW ，de Vries JP ，Dekker H ，Gonçalves FB ，Moll FL ，Verhagen HJ ，van Herwaarden JA ... -  《-》