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

Abstract

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.

Anesthetic, Sedation, and Analgesic Technique for Successful Local Anesthetic EndoSuture Aneurysm Repair

“…Anesthetic, Sedation, and Analgesic Technique for Successful Local Anesthetic EndoSuture Aneurysm Repair www.vsijournal.org tions would be unsuitable for conventional EVAR; therefore, EVAR with EA (also known as EndoSuture aneurysm repair [ESAR]) can expand the indications for infrarenal EVAR [5].…”

“…Current evidence comes mainly from case series, cohort studies, and registry data, and the surrogate endpoint of sac regression is widely used [ 4 ]. Significant proportion of the abdominal aortic aneurysms (AAAs) in these publications would be unsuitable for conventional EVAR; therefore, EVAR with EA (also known as EndoSuture aneurysm repair [ESAR]) can expand the indications for infrarenal EVAR [ 5 ].…”

The Effect of EndoAnchors on Aneurysm Sac Regression for Patients Treated With Infrarenal Endovascular Repair With Hostile Neck Anatomies: A Propensity Scored Analysis

“…gov). 15 Patients included in the standard EVAR group (controls) were extracted from databases of 4 participating centers and were more likely to be treated before the introduction of EndoAnchor usage at each center. Despite this, the generation of endografts for suprarenal and infrarenal fixation were the same.…”

“…The use of Heli-FX EndoAnchors (Medtronic Ltd., Minneapolis, USA) during EVAR—which has created the newer phrase, the Endosutured aneurysm repair (ESAR) 11 is under continued evaluation, 12 mostly from data originating from the ongoing industry-controlled Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) registry, where the literature demonstrates a theoretical benefit regarding improved sac regression up to 2 years when compared with standard EVAR (sEVAR) 13 and potential protection in the context of aortic neck dilatation. 14 Currently, a nonsponsored registry 15 collecting consecutive data from patients with the ESAR technique, evaluates their outcomes; mainly, type Ia endoleaks rates and sac evolution, as described in greater detail in the following sections. Recent literature emphasizes the importance of achieving sac regression as a marker of EVAR success 16 with even a possible link to improved survival and reduced reintervention rates.…”

Az endocsavarozás hatékony lehet a juxtarenalis aortaaneurysmák endovascularis kezelésében

“…A Heli-FX rendszer használatát vizsgáló legnagyobb nemzetközi regiszter (PERU regiszter) adatain alapuló, közelmúltban megjelent tanulmány szerint a módszer középtávon is biztató eredményt mutat a technikai sikerarány (95,5%) és az Ia endoleak mentesség (96%) vonatkozásában is [14]. A PERU regiszter számára történő adatgyűjtésben centrumunk is részt vesz, hosszú távú eredményeink elemzése jövőre várható.…”