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.

Immediate results of the еndovascular aneurysm repair in abdominal aortic aneurysm patients with an unfavorable proximal neck

More than half of the interventions for abdominal aortic aneurysm are performed using endovascular techniques. However, due to the anatomical characteristics of the aorta about 40 % of patients cannot be candidates for еndovascular aneurysm repair (EVAR). Anatomical features that are difficult or unacceptable for stent-graft placement include short or no proximal neck, angular, tapered neck, and vessel diameter that exceeds the existing capabilities of endoprostheses. In cases where traditional surgical correction is not an acceptable option, various technological methods and equipment are used. The observation included 16 consecutive patients with abdominal aortic aneurysm, where EVAR was performed. When analyzing the anatomical characteristics of the aneurysmal sac, 7 (43.7 %) patients were classified as patients with an unfavorable proximal neck of the aneurysm, the so-called «hostile neck». Two EVAR interventions were complex (2 patients with parallel grafts), which made it possible to achieve an increase in the proximal infrarenal zone implantation up to 16–20 mm, and adjuvant or additional endovascular procedures – in our case, implantation of Aptus Heli-FX endoancors in 5 patients. The comparison group consisted of 9 patients with standard aneurysm neck, where standard EVAR procedures were performed. The main anatomical difference in the groups was the length of the aneurysm neck – 9.9 mm and 36.1 mm in groups I and II, respectively (p = 0,0003). EVAR in the groups were carried out without significant complications or fatal cases; in the first group, the duration of the operation (p = 0.01), the amount of contrast (p = 0.03) and the fluoro time (p = 0.01) were significantly increased than in the 2nd group. The postoperative period did not differ between the groups. Conclusions. The use of contemporary technologies allows to significantly expand the indications for EVAR in patients with unfavorable anatomy. Key words: abdominal aortic aneurysm, еndovascular aneurysm repair.

Outcomes of endosutured aneurysm repair with the Heli-FX EndoAnchor implants

Objective Endovascular aneurysm repair has gained field over open surgery for the treatment of abdominal aortic aneurysm. However, type Ia endoleak represents a common complication especially in hostile neck anatomy that is recently faced using endoanchors. We conducted a systematic review and meta-analysis to collect and analyse all the available comparative evidence on the outcomes of the endosuture aneurysm repair in patients with or without hostile neck in standard endovascular aneurysm repair. Methods The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the prospective and retrospective studies reporting primary use of the Heli-FX EndoAnchor implants were considered eligible for inclusion in this study. The main study outcomes (technical success of endoanchor implantation, incidence of type Ia endoleak, aortic stent graft migration and the percentage of patients who presented regression or expansion of aneurysm sac throughout the follow-up) were subsequently expressed as proportions and 95% confidence intervals. Results Eight studies with a total of 968 patients were included in a pooled analysis. The technical success of the primary endoanchor fixation was 97.12% (95%CI: 92.98–99.67). During a mean six months follow-up period, a pooled rate of 6.23% (95%CI: 0.83–15.25) of the patients developed a persistent type Ia endoleak despite the primary implantation. Migration of the main graft was reported in five studies, in which a 0.26% (95%CI = 0.00–1.54) of the patients required an additional proximal aortic cuff. Regression of the aneurysm sac was observed at 68.82% (95%CI: 51.02–84.21). An expansion of the aneurysm sac was found in 1.93% (95%CI: 0.91–3.24) of the participants. The overall survival rate was 93.43% (95%CI: 89.97–96.29) at a mean six months follow-up period. Conclusions Endosuture aneurysm repair with the Heli-FX EndoAnchor implants seems to be technically feasible and safe either for prevention or for repair of intraoperative type Ia endoleak. Despite the primary implants of endoanchors, few cases of persistent type Ia endoleak and migration are still conspicuous. Long-term follow up is needed to determinate the role of this therapeutic option in the treatment of aortic aneurysms.