Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry.

OBJECTIVES: We aim to describe real-world outcomes from multicenter data about the efficacy of adjunct Heli-FX EndoAnchor usage in preventing or repairing failures during infrarenal endovascular aneurysm repair (EVAR), so-called EndoSutured-aneurysm-repair (ESAR). METHODS: The current study has been assigned an identifier (NCT04100499) at the US National Library of Medicine (https://ClinicalTrials.gov). It is an observational retrospective study of prospectively collected data from seven vascular surgery departments between June 2010 and December 2019. Patients included in the ANCHOR registry were excluded from this analysis. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. Follow-up imaging was scheduled according to each center's protocol, which necessarily included either abdominal ultrasound or radiography or computed tomographic scan imaging. The main outcomes analyzed were technical success, freedom from type Ia endoleaks (IaEL), all-cause and aneurysm-related mortality, and sac variation and trends evaluated for those with at least six months imaging follow-up. RESULTS: Two hundred and seventy-five patients underwent ESAR in participating centers during the study period. After exclusions, 221 patients (184 males, 37 females, mean age 75 ± 8.3 years) were finally included for analysis. Median follow-up for the cohort was 27 (interquartile range 12-48) months. A median 6 (interquartile range 3) EndoAnchors were deployed at ESAR, 175 (79%) procedures were primary and 46 (21%) revision cases, 40 associated with type IaEL. Technical success at operation (initial), 30-day, and overall success were 89, 95.5, and 96.8%, respectively; the 30-day success was higher due to those with subsequent spontaneous proximal endoleak seal. At two years, freedom from type IaEL was 94% for the whole series; 96% and 86% for the primary and revision groups, respectively; whereas freedom from all-cause mortality, aneurysm-related mortality, and reintervention was 89%, 98%, and 87%, respectively. Sac evolution pre-ESAR was 66 ± 15.1 vs. post ESAR 61 ± 17.5 (p < 0.001) and for 180 patients with at least six-month follow-up, 92.2% of them being in a stable (51%) or regression (41%) situation. CONCLUSIONS: This real-world registry demonstrates that adjunct EndoAnchor usage at EVAR achieves high rates of freedom from type IaEL at mid-term including in a high number of patients with hostile neck anatomy, with positive trends in sac-size evolution. Further data with longer follow-up may help to establish EndoAnchor usage as a routine adjunct to EVAR, especially in hostile necks.

Predictive factors for the development of type II endoleaks.

PURPOSE: To define predictive factors for endoleak type II (EL-II) based on quantifiable factors in the imaging studies of patients undergoing endovascular aneurysm repair (EVAR). METHODS: The data on 208 consecutive patients (137 men; mean age 75.2 years, range 62-84) who underwent EVAR between the years 2003 and 2008 were retrospectively reviewed. The abdominal aortic aneurysm (AAA) diameter ranged from 4.8 to 12.8 cm. Data were collected on the type of AAA; the type of stent-graft (aortomonoiliac versus bifurcated); the performance of hypogastric artery embolization; the presence, number, diameter, and patency of aortoiliac branches identified on the pre and post-EVAR imaging studies; and the presence and type of EL-II (transient vs. persistent) with the goal of identifying any imaging-based predictive factors for the development of EL-II. RESULTS: Among the 208 cases, 11 patients had endoleaks other than type II and were excluded, leaving 195 patients for analysis. In all, 28 (13.4%) patients were diagnosed with EL-II. All had ≥4 patent lumbar arteries (mean diameter >2.3 mm). Ten patients with a transient EL-II had a mean of 4.3 patent lumbar arteries, which had diameters <2 mm (mean 1.5 mm). In the 18 patients with persistent EL-II, the mean diameter of the 4 lumbar arteries was 2.7 mm; at least 1 of the lumbar arteries was >2 mm. The presence of at least 4 patent lumbar arteries (p<0.001) and at least 1 patent hypogastric artery (p<0.001) were predictive factors for EL-II. At least 1 lumbar artery >2 mm in diameter was a positive predictive factor for the development of persistent EL-II (p<0.001). CONCLUSION: Patent hypogastric and lumbar arteries are significantly associated with a higher risk of developing EL-II. Larger diameter lumbar arteries tend to be associated with persistent EL-IIs, while lumbar arteries <2 mm would more likely be seen with a transient EL-II. If substantiated in larger studies, these angiographic criteria may guide early treatment of EL-II to avoid aneurysm sac expansion and potential rupture.

Biomechanical and histologic analysis in aortic endoprosthesis using fibrin glue.

BACKGROUND: The absence of incorporation between endoprosthesis (EP) and the arterial wall may lead to device migration and endoleaks around the stent graft. Alternatives have been tested aiming to improve this incorporation. Fibrin glue is used in many operating procedures promoting adhesion and tissue regeneration; however, its use to improve EP incorporation by arteries is unknown. OBJECTIVE: The objective of this study was to analyze dislodgement forces needed to extract the EPs implanted in pig aorta, compare different oversizing and fibrin glue injections, and to analyze histologic changes among groups. METHODS: Straight EPs were implanted in the thoracic aorta of pigs using 10% oversizing plus fibrin glue in the interface between the EP and the artery (group 1), using 20% oversizing (group 2), and 10% oversizing (group 3). Fourteen days after the implant, the animals were killed to enable biomechanical analysis of the EP and to verify histologic changes of the aortic wall and its interface with the EP. RESULTS: Group 1 showed a dislodgement force of 21.9 ± 5.3 Newton (N) being higher than the other groups and statistically significant when compared to group 3 (15.6 ± 3.6N), P = .003%. Group 2 had a higher dislodgement force and statistically more significant than group 3 (19.5 ± 7.8N). Histologic analysis showed tissue reaction with inflammatory cells and fibroblasts higher in group 1 and group 2 compared to group 3. CONCLUSION: This study reports a large animal survival model of thoracic aortic stent graft placement by testing the impact of fibrin glue on EP incorporation. Compared to oversizing alone, fibrin glue placed between the stent graft and the arterial wall increases EP incorporation. Additional studies are needed to determine the potential utility of fibrin glue in the setting of human arterial endografts.