One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair

Vascular ◽  
2015 ◽  
Vol 24 (2) ◽  
pp. 177-186 ◽  
Author(s):  
William D Jordan ◽  
Manish Mehta ◽  
Kenneth Ouriel ◽  
Frank R Arko ◽  
David Varnagy ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Neck Length ◽  
Aortic Neck ◽  
Hostile Neck ◽  
Type Ia ◽  
Study Population ◽  
Neck Anatomy ◽  
One Year ◽  
Aneurysm Repair

Objectives EndoAnchors have been used to address proximal aortic neck complications including type Ia endoleaks and endograft migration after endovascular aortic aneurysm repair (EVAR). Methods The study population included 100 patients with one-year follow-up in the ANCHOR study. A primary cohort ( N = 73) comprised patients who underwent EndoAnchor implantation at the time of an initial EVAR and a Revision cohort ( N = 27) included patients treated remote from EVAR. A hostile neck was defined for neck length <10 mm, neck diameter >28 mm, angulation >60°, conical configuration or significant mural thrombus or calcium. Results Baseline anatomy included neck length of 17 ± 14 mm, diameter of 27 ± 5 mm, and angulation of 35 ± 18°; 83% of patients had hostile necks. Over 18 ± 4 months of clinical follow-up, six patients (6%) underwent aneurysm-related reinterventions. There were no aneurysm ruptures. Over 13 ± 2 months of imaging follow-up, freedom from type Ia endoleak was 95% in the Primary Arm and 77% in the Revision Arm ( P = .006). Aneurysm sacs regressed > 5 mm within one year in 45% of the Primary cases and in 25% of the Revisions. Aneurysm expansion > 5 mm occurred in one revision patient. Conclusion Despite a high frequency of hostile neck anatomy, proximal neck complications were relatively infrequent after EndoAnchor use.

scholarly journals Midterm Single-Center Results of Endovascular Aneurysm Repair With Additional EndoAnchors

2018 ◽  
Vol 26 (1) ◽  
pp. 90-100 ◽  
Author(s):  
Seline R. Goudeketting ◽  
Jan Wille ◽  
Daniel A. F. van den Heuvel ◽  
Jan-Albert Vos ◽  
Jean-Paul P. M. de Vries
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Late Complications ◽  
Graft Occlusion ◽  
Entire Cohort ◽  
Aortic Neck ◽  
Hostile Neck ◽  
Type Ia ◽  
New Type ◽  
Aneurysm Repair

Purpose: To review midterm clinical outcomes of EndoAnchor placement during or after endovascular aneurysm repair (EVAR) or chimney EVAR (ch-EVAR). Materials and Methods: A retrospective analysis was conducted of 51 consecutive patients [median age 75 years; 38 men] who underwent EVAR/ch-EVAR with EndoAnchor placement between June 2010 and December 2016 to prevent seal failures (31, 61%) or to treat type Ia endoleak and/or migration (20, 39%). Median aortic neck diameter was 27.7 mm and median neck length was 9.0 mm. Thirty-three (65%) had a conical neck; 48 (94%) had at least 1 hostile neck characteristic. Thirty-two (63%) patients had severe comorbidities (ASA score ⩾III). Eight patients had a single ch-EVAR procedure. Baseline patient characteristics, anatomic variables, procedure details, early and late complications, reinterventions, and aneurysm-related and all-cause mortality rates were recorded. Follow-up imaging was performed with computed tomography angiography (CTA) or duplex ultrasonography. Results: Median procedure time was 100 minutes; a median of 6 EndoAnchors were implanted. There were 10 (10%) residual type Ia endoleaks at the end of the procedure; 9 had resolved by the first postoperative CTA. One residual and 2 new type Ia endoleaks were identified at the first postoperative imaging. Median follow-up for the entire cohort was 24.0 months, during which 3 new type Ia endoleaks were identified. Five of the 6 type Ia endoleaks were treated, 1 resolved spontaneously. There was 1 endograft limb occlusion without clinical consequences, 1 chimney graft occlusion without possibilities for a reintervention, 1 rupture after type IV endoleak (a Nellix device was successfully deployed within the main device), and 1 complete graft explantation for infection. There was no new-onset hemodialysis. Kaplan-Meier estimates of freedom from type Ia endoleak, proximal neck–related reinterventions, and aneurysm-related mortality at 2 years were 87.3%, 92.2%, and 94.0%, respectively. Conclusion: EndoAnchors are helpful in the endovascular treatment of unfavorable proximal aortic necks, with fair midterm results.

scholarly journals Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use

2017 ◽  
Vol 24 (2) ◽  
pp. 191-197 ◽  
Author(s):  
Gianmarco de Donato ◽  
Francesco Setacci ◽  
Luciano Bresadola ◽  
Patrizio Castelli ◽  
Roberto Chiesa ◽  
...  
Keyword(s):  
Stent Graft ◽  
Morphological Changes ◽  
Endovascular Aneurysm Repair ◽  
Neck Length ◽  
Off Label ◽  
Aortic Neck ◽  
Type Ia ◽  
Instructions For Use ◽  
Aneurysm Repair

Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24–50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was −0.05±0.8 mm in the IFU group and −0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration–approved changes to the IFU.

Comparing polymer-filled versus self-expanding endografts in Chinese patients

2018 ◽  
Vol 26 (9) ◽  
pp. 667-676
Author(s):  
Yuk Law ◽  
Yiu Che Chan ◽  
Stephen Wing-Keung Cheng
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Aortic Aneurysms ◽  
The Self ◽  
Chinese Patients ◽  
Type Ii ◽  
Mortality And Morbidity ◽  
Type Ia ◽  
One Year ◽  
Aneurysm Repair

Introduction We performed a single-center nonrandomized study on patients who underwent endovascular aneurysm repair using polymer-filled or other self-expanding endografts. Methods Consecutive patients with asymptomatic infrarenal abdominal aortic aneurysms who underwent endovascular repair were retrospectively reviewed. They were divided into a polymer-filled ( n = 20) or self-expanding group ( n = 42). Baseline characteristics, operative mortality and morbidity, and follow-up data were compared. Results Aneurysm diameter, neck and iliac morphologies did not differ between the two groups. Technical success was 100%. The 30-day mortality was 0% and 2.4% in the polymer-filled and self-expanding group, respectively. At a mean follow-up of 17 months, the changes in sac size were −2.1 mm and −5.1 mm ( p = 0.144) at one year, and −3.5 mm and −7.7 mm ( p = 0.287) at 2 years in the polymer-filled and self-expanding group, respectively. The polymer-filled group had 7 (35%) type II endoleaks, and the self-expanding group had 1 (2.4%) type Ia and 13 (31%) type II endoleaks. Neck diameter remained stable in the polymer-filled stent-grafts whereas there was progressive neck degeneration in the self-expanding group. The rates of reintervention and overall survival were similar in both groups. The presence of an endoleak was the only predictor of non-regression of the aneurysm (odds ratio = 17.00, 95% confidence interval: 4.46–64.88, p < 0.001). Conclusion Polymer-filled endografts had similar safety, effectiveness, and durability to other self-expanding endografts. The major advantage is the small iliofemoral access. They also have the potential long-term benefit of a more stable neck.

Determination of Endograft Apposition, Position, and Expansion in the Aortic Neck Predicts Type Ia Endoleak and Migration After Endovascular Aneurysm Repair

2018 ◽  
Vol 25 (3) ◽  
pp. 366-375 ◽  
Author(s):  
Richte C. L. Schuurmann ◽  
Kim van Noort ◽  
Simon P. Overeem ◽  
Ruben van Veen ◽  
Kenneth Ouriel ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Renal Arteries ◽  
Added Value ◽  
Control Group ◽  
Main Body ◽  
Aortic Neck ◽  
Type Ia ◽  
And Migration ◽  
Aneurysm Repair

Purpose: To describe the added value of determining changes in position and apposition on computed tomography angiography (CTA) after endovascular aneurysm repair (EVAR) to detect early caudal displacement of the device and to prevent type Ia endoleak. Methods: Four groups of elective EVAR patients were selected from a dataset purposely enriched with type Ia endoleak and migration (>10 mm) cases. The groups included cases of late type Ia endoleak (n=36), migration (n=9), a type II endoleak (n=16), and controls without post-EVAR complications (n=37). Apposition of the endograft fabric with the aortic neck, shortest distance between the fabric and the renal arteries, expansion of the main body (or dilatation of the aorta in the infrarenal sealing zone), and tilt of the endograft toward the aortic axis were determined on the first postoperative and the last available CTA scan without type Ia endoleak or migration. Differences in these endograft dimensions were compared between the first vs last scan and among the 4 groups. Results: No significant differences in endograft configurations were observed among the groups on the first postoperative CTA scan. On the last CTA scan before a complication arose, the position of the fabric relative to the renal arteries, expansion of the main body, and apposition of the fabric with the aortic neck were significantly different between the type Ia endoleak (median follow-up 15 months) and migration groups (median follow-up 23 months) compared with the control group (median follow-up 19 months). Most endograft dimensions had changed significantly compared with the first postoperative CTA scan for all groups. Apposition had increased in the control group but had decreased significantly in the type Ia endoleak and migration groups. Conclusion: Progressive changes in dimensions of the endograft within the infrarenal neck could be detected on regular CTA scans before the complication became urgent in many patients.

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

Vascular ◽  
2020 ◽  
Vol 28 (5) ◽  
pp. 568-576
Author(s):  
Georgios Karaolanis ◽  
Constantine N Antonopoulos ◽  
Stylianos Koutsias ◽  
George A Antoniou ◽  
Efthymios Beropoulis ◽  
...  
Keyword(s):  
Therapeutic Option ◽  
Meta Analysis ◽  
Endovascular Aneurysm Repair ◽  
Pooled Analysis ◽  
Aortic Aneurysms ◽  
Technical Success ◽  
Hostile Neck ◽  
Type Ia ◽  
Aneurysm Repair

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.

scholarly journals Hostile Neck Anatomy Is Associated With Higher Perioperative Type IA Endoleaks and Lower Long-term Survival After Elective Endovascular Aneurysm Repair

2019 ◽  
Vol 70 (3) ◽  
pp. e45
Author(s):  
Livia de Guerre ◽  
Thomas O'Donnell ◽  
Rens Varkevisser ◽  
Nicholas Swerdlow ◽  
Chun Li ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Term Survival ◽  
Long Term Survival ◽  
Hostile Neck ◽  
Type Ia ◽  
Neck Anatomy ◽  
Aneurysm Repair

Impact of Gender on Outcomes Following Abdominal Aortic Aneurysm Repair

2019 ◽  
Vol 53 (8) ◽  
pp. 636-643 ◽  
Author(s):  
Satinderjit Locham ◽  
Abdelrahman Shaaban ◽  
Linda Wang ◽  
Dennis Bandyk ◽  
Marc Schermerhorn ◽  
...  
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Endovascular Aneurysm Repair ◽  
Pulmonary Complications ◽  
Aortic Neck ◽  
Abdominal Aortic ◽  
Increased Risk ◽  
Hostile Neck ◽  
Neck Anatomy ◽  
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.

Endovascular repair with chimney technique of abdominal aortic aneurysm with hostile aortic neck

Vascular ◽  
2013 ◽  
Vol 21 (5) ◽  
pp. 323-329
Author(s):  
Jang Yong Kim ◽  
Jae Young Park ◽  
Soon Gu Cho ◽  
Chan Ik Jin ◽  
W. Anthony Lee ◽  
...  
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Endovascular Aneurysm Repair ◽  
Type I ◽  
Chimney Technique ◽  
Aortic Neck ◽  
Abdominal Aortic ◽  
Hostile Neck ◽  
One Year

Abdominal aortic aneurysm (AAA) with hostile aortic neck is not a good candidate for conventional endovascular aneurysm repair (EVAR), and a recent paper showed that EVAR with chimney technique (Ch-EVAR) yielded reasonable outcome. We report here a case of successful Ch-EVAR treatment of AAA with hostile neck. An 81-year-old man presented with a 71-mm AAA during evaluation of a gastric ulcer. Aortic neck was 30 mm in diameter, 10–15 mm in length and angulated by 100°. EVAR was performed with chimney stenting to both renal arteries, and the patient recovered after transient hematuria. At one-year follow-up, AAA had increased by 7 mm with delayed type I endoleak control without renal insufficiency. The patient needed close follow-up.

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

Vascular ◽  
2021 ◽  
pp. 170853812199259
Author(s):  
Andrés Reyes Valdivia ◽  
Arindam Chaudhuri ◽  
Ross Milner ◽  
Giovanni Pratesi ◽  
Michel MPJ Reijnen ◽  
...  
Keyword(s):  
Real World ◽  
Endovascular Aneurysm Repair ◽  
Abdominal Ultrasound ◽  
Interquartile Range ◽  
Technical Success ◽  
Number Of Patients ◽  
Hostile Neck ◽  
Aneurysm Repair ◽  
Related Mortality

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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