In Search of the Optimal Endosutured Aneurysm Repair

Valdivia, Andrés Reyes; Chaudhuri, Arindam

doi:10.1177/1526602819876266

Cited by 4 publications

(4 citation statements)

References 11 publications

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“…Some interesting in vitro studies analyze mechanical forces related to EndoAnchor placements. 26,27 Moreover, the importance of proper use may be related to the economic gain in terms of less neck-related reinterventions during follow-up, 28 but an economic assessment was outside the scope of this study.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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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.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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“…7 Other techniques demonstrate outcomes that are considered acceptable and valid for AAA treatment (Chimney [Ch]-EVAR, fenestrated (F) EVAR) [8][9][10] in such cases. 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.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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Purpose: To analyze sac evolution patterns in matched patients with hostile neck anatomy (HNA) treated with standard endovascular aneurysm repair (sEVAR) and endosutured aneurysm repair (ESAR). Methods: Observational retrospective study using prospectively collected data between June 2010 and December 2019. ESAR group data were extracted from the primary arm of the PERU registry with an assigned identifier (NCT04100499) at 8 centers and those from the sEVAR came from 4 centers. Suitability for inclusion required: no proximal endograft adjuncts (besides EndoAnchor use), ≤15 mm neck length and minimum of 12-months follow-up imaging. Bubble-shaped neck (noncylindrical short neck with discontinuous seal) aspect was analyzed. Both groups were analyzed using propensity score matching (PSM) for aortic neck length, width, angulation, and device fixation type. Main outcome assessed was sac evolution patterns (sac expansion and regression were defined as >5mm increase or decrease, of the maximum sac diameter respectively; all AAAs within this ±5 mm range in diameter change were considered stable) and secondary outcomes were type-Ia endoleaks; other endoleaks and mortality. A power analysis calculation >80% was confirmed for sac regression evaluation. Results: After exclusions, PSM resulted in 96 ESAR and 96 sEVAR patients. Mean imaging follow-up (months) was 44.4±21.3 versus 43.0±19.6 (p=0.643), respectively. The overall number of patients achieving sac regression was higher in the ESAR group ( n=57, 59.4% vs n=31, 32.3%; p<0.001) and the cumulative sac regression achieved at 5 years was 65% versus 38% (p=0.003) in favor of the ESAR group. There were no statistically significant differences in type-Ia endoleak and/or other endoleaks. Univariate analysis for sac regression patients in the sEVAR and ESAR group individually showed the bubble-shape neck as a predictor of sac regression failure. There were no statistical differences in overall and aneurysm-related mortality. Conclusion: Endosutured aneurysm repair provided improved rates of sac regression for patients with AAA and HNA when compared with sEVAR at midterm and up to 5 years, despite similar rates of type-Ia endoleaks, and the need to consider some important limitations. The presence of bubble-shaped neck was a predictor of sac regression failure for both groups equally. Clinical Impact The use of EndoAnchors aids and improves EVAR treatment in hostile neck anatomies by an increased rate of sac regression when compared to EVAR treatment alone in up to 5 year analysis. Moreover, a trend to reduced number of type Ia endoleaks is also achieved, although not significant in the present study. This data, adds to current and growing evidence on the usefulness of EndoAnchors for AAA endovascular treatment.

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“…NT-based endografts and its effect on AND cannot be quantified as tissue incorporation of aortic endoprostheses itself is unpredictable, and not robust enough to prevent migration, thus reinforcing the need for basic fixation adjuncts as a part of aortic endograft design. 2 Endostapling is a recognised technique for reinforcing fixation and seal, 5 with terminology such as endosuture(d) aneurysm repair 6,7 recently used. This study therefore compares AND rates focusing on device skeleton types as there is evidence that endostapling using the Heli-FX EndoAnchor (EA) System (Medtronic Ltd., Minneapolis, USA) can attenuate or protect against the effects of neck dilatation.…”

Section: Introductionmentioning

confidence: 99%

“…Endostapling is a recognised technique for reinforcing fixation and seal, 5 with terminology such as endosuture(d) aneurysm repair 6,7 recently used. This study therefore compares AND rates focusing on device skeleton types as there is evidence that endostapling using the Heli-FX EndoAnchor (EA) System (Medtronic Ltd., Minneapolis, USA) can attenuate or protect against the effects of neck dilatation.…”

Section: Introductionmentioning

confidence: 99%

Endograft platform does not influence aortic neck dilatation after infrarenal endovascular aneurysm repair with primary endostapling

Chaudhuri

Badawy

2020

Vascular

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Objectives Aortic endografts used for endovascular aneurysm repair (EVAR) are based on varying skeletal platforms such as stainless steel or nitinol stents, using radial force applied to seal at the aneurysm neck, and varying proximal fixation methods, applying either suprarenal or infrarenal fixation. This study assesses whether varying skeleton/fixation platforms affect neck-related outcomes after primary endostapling with Heli-FX EndoAnchors at EVAR. Methods Retrospective analysis of a prospective database of infrarenal EVAR undertaken at a single centre. Chimney-EVAR, secondary cases were excluded. Primary outcomes analysed included neck diameter evolution from pre-EVAR to latest imaging follow-up, including a comparison of stent platforms to see if there was any outcome difference between those using stainless steel or nitinol, as also freedom from type I endoleakage and migration. Secondary outcomes assessed included average number of EndoAnchors, and sac size patterns before and after EVAR. Results A total of 101 patients underwent endostapled infrarenal EVAR between September 2013 and March 2020. After exclusion of ineligible patients, 84 patients (76 male, 8 female, age 73.7 ± 7.8 years) were available for analysis. 57/27 endografts used suprarenal/infrarenal fixation, whilst 16/68 devices were based on stainless steel/nitinol platforms, respectively. Mean oversizing was higher for stainless steel/suprarenal fixation endografts ( p = 0.02). A total of 582 EndoAnchors were deployed, averaging 7 ± 2 per patient. Median neck diameter was 25 mm (IQR 22–31) with 22 necks having non-parallel morphology (conical, tapered or bubble). Median follow-up period was 28.5 (IQR 12–43) months. Neck evolution studies suggested aortic neck dilatation of 5 ± 4 mm ( p <0.001, paired T-test), independent of platforms employed ( p = NS, ANOVA). There was no endograft migration; one immediate post-EVAR endoleak settled by eight weeks. There was a mean 5.7 ± 8.2 mm sac size reduction ( p < 0.001, paired T-test). Conclusion Aortic neck dilatation occurs after EVAR with primary endostapling, but the process may be independent of stainless steel/nitinol platforms, possibly due to the attenuating effect of EndoAnchors. Adjunct aneurysm neck fixation by primary endostapling prevents migration regardless of whether suprarenal/infrarenal fixation is the primary fixative method. Device platform choice therefore may be left to the operator discretion if primary endostapling is applied at EVAR. Freedom from complications such as migration and endoleakage in the intermediate term suggests a higher level of ‘tolerance’ to aortic neck dilatation with primary endostapling. We would therefore suggest routine usage of EndoAnchors at EVAR when not otherwise contraindicated.

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In Search of the Optimal Endosutured Aneurysm Repair

Cited by 4 publications

References 11 publications

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

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

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

Endograft platform does not influence aortic neck dilatation after infrarenal endovascular aneurysm repair with primary endostapling

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