Early Results From the Pivotal Trial Substudy of the GORE® EXCLUDER® Conformable Endoprosthesis in Angulated Necks.

OBJECTIVE OR BACKGROUND: To report the investigational device exemption (IDE) study 1-year clinical outcomes of the high neck angulation (HNA) substudy of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) for treatment of infrarenal abdominal aortic aneurysms (AAA). METHODS: This study is a prospective, multicenter clinical trial conducted in the United States and included core laboratory assessment of imaging and independent event adjudication. Anatomic criteria for enrollment in the HNA substudy included infrarenal aortic neck angulation >60° and ≤90° with aortic neck length ≥10 mm. Primary safety endpoints included blood loss >1000 mL, death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, and thromboembolic events. Primary effectiveness endpoints included technical success, absence from Type I and III endoleak, migration (≥10 mm), sac enlargement (≥5 mm), sac rupture, and conversion to open repair. RESULTS: Between January 2018 and February 2022, 95 patients were enrolled in the HNA substudy across 35 sites. Of the 95 patients, 71 (74.7%) were male and the cohort average age was 74.4 years old. The mean infrarenal proximal aortic neck angle was 71.6° and mean AAA size was 62.9 mm. Overall technical success was achieved in 93 (97.9%) patients. Freedom from a primary safety endpoint through 30 days was 96.7%; 3 (3.3%) patients had blood loss >1000 mL. Freedom from the primary effectiveness at 12 months was achieved in 94.8%. Four (4.3%) patients had Type IA endoleak; intervention after the procedure was not required and no subsequent interventions or sac enlargement were noted in these patients. At 12 months, 29 (39.7%) patients experienced a Type II endoleak and 1 (1.3%) patient experienced AAA sac expansion ≥5mm. Through 12 months, 1 (1.3%) patient had a conversion to open surgical repair. There were no aneurysm-related deaths, ruptures, or migration through 12 months. CONCLUSIONS: The IDE study demonstrates safety and effectiveness of the EXCC device in AAA with highly angulated necks (>60° and ≤90°) are preserved at the 12-month follow-up.

Endovascular Aortic Repair With the E-Tegra Device: Preliminary Outcomes From a Multicenter National Registry.

PURPOSE: Endovascular aortic repair (EVAR) is currently expanding its feasibility thanks to design innovations, but hostile proximal necks and narrow iliac arteries are still a constraint, as expressed by the Instructions for Use (IFU) of most devices. Our aim is to report the preliminary results of the E-Tegra endograft in infrarenal abdominal aortic aneurysms (AAAs) performed in 15 high-volume centers. MATERIALS AND METHODS: The e-Tegra Italian endoGraft REgistry (TIGRE) is a prospectively maintained database of consecutive EVAR with the E-Tegra stent-graft across 15 participating centers between March 2021 and March 2023. The registry records baseline clinical data, anatomic measurements of the abdominal aorta, perioperative and postoperative outcomes, with a scheduled follow-up period of 3 years for all patients. This is a preliminary analysis of the first results updated to January 2024. The primary endpoints are technical and clinical success, perioperative mortality, freedom from endograft rupture, and aortic-related mortality. The secondary endpoints are freedom from reintervention, and any type of endoleak (EL). The results were analyzed in relation with the anatomic characteristics of the AAAs, namely, iliac axes tortuosity and proximal neck hostility. RESULTS: The registry included 147 consecutive EVAR (138 elective and 9 in emergent setting), 7 of which were associated with an iliac branch implantation. Ninety patients had at least 1 criterion of anatomical hostility, and 25 were treated outside the device IFU. Primary technical success was achieved in 146 cases (99.3%) and assisted success in 147 (100%), with no perioperative mortality. After a median follow-up period of 20 months, no aneurysm-related mortality occurred. Reinterventions were 5: 2 for type IB EL and 3 for type II ELs with aneurysm sac increase. Five more type II ELs with aneurysm sac stability are under observation. No differences in terms of reinterventions were noted between aneurysms with standard and hostile anatomy. CONCLUSION: The E-Tegra endograft is safe and effective in treating AAAs with standard and hostile anatomy, with a low rate of complications and reinterventions, although longer-term outcomes and larger numbers are needed to compare its performances related to specific anatomic criteria. CLINICAL IMPACT: This multi-center nationwide Registry reports a real-world experience of EVAR performed with the E-Tegra abdominal endograft across 15 high-volume Centers, providing early- and mid-term device-specific results, which will help vascular surgeons in endograft selection. In particular, this study focuses on clinical results obtained in treating aneurysms with hostile anatomy, analyzing the performances of the E-Tegra endograft in cases of hostile proximal necks and narrow or tortuous iliac axes.

Chimney endovascular aneurysm repair (ChEVAR) for hostile neck complex aneurysm.

OBJECTIVE: Recent guidelines recognize the role of chimney endovascular aneurysm repair (ChEVAR) in the treatment of complex aortic disorders. The optimal configuration and number of visceral vessels that can be incorporated is still controversial. We aim to review outcomes from a multi-institutional decade-long experience with ChEVAR. METHODS: Patients undergoing ChEVAR with multiple (≥2) chimney branches were selected from a prospectively maintained database at the two academic university hospitals. All patients were poorly suited for fenestrated or branched endograft repair (F/BEVAR) and deemed poor-risk for open surgery. RESULTS: Forty-nine multiple ChEVAR were performed in 44 men and 5 women, with complete outcome data at a mean follow-up of 18 months. Overall, 2 patients died during follow-up (4%) with no aneurysm-related mortality and two ruptures after ChEVAR (4.1%) due to a type Ib endoleak from iliac limb pullout and persistent gutter-flow, both repaired with endovascular means. No stroke or spinal cord ischemia was noted during the follow-up period. Reintervention was undertaken in eight patients (16.3%) with five reinterventions for persistent gutter-flow and four chimney graft-associated. Three-vessel ChEVAR was performed in 16 patients, with two-vessel ChEVAR in 33 patients for a total of 114 chimney branches (mean 2.3 chimneys per patient). There were 21 superior mesenteric artery (SMA), 45 right renal, 46 left renal artery (LRA), and two accessory LRA chimneys placed. Antegrade configuration of chimney branches was chosen in 43 patients (88%). There were no significant differences between three-vessel and two-vessel ChEVAR upon univariate analysis in aneurysm size (65.6 vs 60.5 mm; p = 0.059), iliac diameter (7.3 vs 7.1 mm; p = 0.85), or endograft oversizing (30 vs 32.5%; p = 0.43). Three-vessel ChEVAR was associated with a larger aneurysm neck diameter (28.4 vs 25.0 mm; p = 0.021), shorter native infrarenal neck (0.5 vs 3.37 mm; p = 0.002) as well as longer seal zone (36.33 vs 22.67 mm; p = 0.005) compared with two-vessel ChEVAR. At follow-up, there were no significant differences in gutter area between three-vessel and two-vessel ChEVAR (18.9 vs 15.7 mm3; p = 0.73) nor the rate of persistent gutter-flow (12.5 vs 9.1%; p = 0.71). CONCLUSION: Reintervention to multiple chimney grafts and for persistent gutter-flow is higher compared to single chimneys and demands close surveillance. However, based upon this combined transantlantic experience, we believe multiple ChEVAR provides a reasonable and safe option for complex aortic aneurysm repair when open or custom endografts are not available or indicated based on their Instructions For use, even when triple chimney grafts are required. The optimal configuration for multiple ChEVAR still warrants further study, although theoretical preliminary advantages may exist for a combination of antegrade and retrograde chimneys.

Impact of Gender on Outcomes Following Abdominal Aortic Aneurysm Repair.

OBJECTIVE: The purpose of this study is to use a large, nationally representative vascular database to assess differences in patient characteristics, aortic neck anatomy, and outcomes between men and women following open (open aneurysm repair [OAR]) and endovascular (endovascular aneurysm repair [EVAR]) abdominal aortic aneurysm (AAA) repair. METHODS: Patients undergoing AAA repair from 2003 to 2018 in Vascular Quality Initiative were identified and stratified by procedure (EVAR vs OAR). Thirty-day mortality and major in-hospital complications were assessed between genders within each operative cohort. An EVAR subset analysis was performed to assess differences in aortic neck anatomy; hostile neck anatomy was defined as length <15 mm (L < 15), angle >60° (A > 60), and/or diameter >28 mm (D > 28). Standard univariate and multivariable analyses were performed. RESULTS: A total of 50 213 patients were identified: 9263 (19%) OAR and 40 950 (82%) EVAR. In both cohorts, majority of patients were men (OAR 73% and EVAR 81%). Women were more likely to have a hostile neck (31.7% vs 24.1%, P < .001), L < 15 (19.8% vs 11.9%, P < .001), and A > 60 (11.5% vs 5.4%, P < .001). Men had larger aneurysm (mean, 57 vs 55 mm, P < .001) and were more likely to have D > 28 (14.0% vs 10.6%, P < .001). Women undergoing EVAR were more likely to undergo aortic extensions (21.9% vs 16.0%) and receive higher contrast volume. After adjusting for potential confounders, female gender was associated with 86% and 50% increased risk of 30-day mortality in OAR and EVAR, respectively. Women were more likely than men to experience renal, cardiac, and pulmonary complications only in the EVAR cohort. Women had a 2-fold increased odds of developing type 1 endoleak. CONCLUSION: Our study demonstrates unfavorable neck anatomy occurs more frequently in women compared to men. Women were also at an increased risk of developing major complications, particularly following EVAR. Careful patient selection is indicated in all patients to reduce complications, with special attention in women with hostile neck.

Management of a dislocated endovascular aneurysm repair in a challenging giant abdominal aortic aneurysm.

Introduction A case report of a contained rupture of an abdominal aneurysm, treated by endovascular technique (EVAR), but complicated by perioperative endoprosthesis limb dislocation. Case report An 81-year old male presented at the emergency department with a contained rupture of an infrarenal aortic aneurysm and bilateral extensive iliac aneurysmatic disease. Open repair was no option, due to the pulmonary condition. The patient was prepped for an emergency EVAR. After placing a bifurcated endoprosthesis, angiography revealed a type IIIa endoleak, due to a dislocation between two left iliac extensions. We converted to a right-sided aorto-uni-iliac endoprosthesis with a femorofemoral bypass. A postoperative CT-scan showed a complete exclusion of the aneurysm, a patent aorto-uni-iliac endoprosthesis and a femorofemoral bypass without an endoleak. Discussion EVAR is feasible with a hostile neck AAA, even in a ruptured AAA. In large AAA, one should consider an overlap larger than suggested in the instructions for use.