scholarly journals Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm Repair

2019 ◽  
Vol 26 (3) ◽  
pp. 369-377 ◽  
Author(s):  
Kim van Noort ◽  
Jenske J. M. Vermeulen ◽  
Seline R. Goudeketting ◽  
Kenneth Ouriel ◽  
William D. Jordan ◽  
...  
Keyword(s):  
Penetration Depth ◽  
Aortic Wall ◽  
Endovascular Aneurysm Repair ◽  
Therapeutic Use ◽  
Clinical Consequence ◽  
Type Ia ◽  
Good Penetration ◽  
Aneurysm Repair ◽  
Over Time

Purpose: To investigate changes in penetration depths and angles of EndoAnchor implants with initially good penetration after therapeutic use in endovascular aneurysm repair. Materials and Methods: Patients were selected from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR; ClinicalTrials.gov identifier NCT01534819). Inclusion criteria were (1) EndoAnchor implantation to treat intraoperative or late type Ia endoleak and (2) at least 2 postoperative computed tomography angiography (CTA) scans. Exclusion criteria were the use of adjunct procedures. Based on these criteria, 54 patients (44 men) with 360 EndoAnchor implants were eligible for this analysis. Penetration depth of each EndoAnchor implant into the aortic wall was judged as (1) good (≥2-mm penetration), (2) borderline (<2 mm or when there was a gap between the endograft and the aortic wall), or (3) no penetration. The penetration depth and longitudinal angles of EndoAnchors with good penetration were investigated on the last available postprocedure CTA scan. Endoleaks were also analyzed. Results: EndoAnchor penetration on the first postprocedure CTA scan was good in 187 (51.9%), borderline in 69 (19.2%), and missing in 104 (28.9%). On the last CTA scan, 182 (97.4%) of the 187 initially well-positioned EndoAnchors remained good. Five (2.6%) EndoAnchors in 4 patients changed configuration over time (4 became borderline and 1 became nonpenetrating), all without any clinical sequelae. The median orthogonal angles of the EndoAnchor implants with good penetration on the first and last CTA scans were 92° [interquartile range (IQR) 85, 98] and 90° (IQR 84, 97), respectively (p=0.822); for longitudinal angles, medians of 85° (IQR 71, 96) and 84° (IQR 70, 96) were found (p=0.043). Of the 18 (33%) patients who had a type Ia endoleak on the first postprocedure CTA, 6 resolved over time. Median follow-up was 13 months, during which no new type Ia endoleak was found. Conclusion: Despite the small number of EndoAnchors analyzed, this study showed that the sustainability of EndoAnchor implants with initially good penetration is satisfactory at 1-year follow-up. The vast majority of EndoAnchor implants with good penetration initially remained in good position; <3% of implants became borderline or nonpenetrating, without any clinical consequence.

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.

Endovascular Aneurysm Sealing (EVAS) and Chimney EVAS in the Treatment of Failed Endovascular Aneurysm Repairs

2016 ◽  
Vol 24 (1) ◽  
pp. 115-120 ◽  
Author(s):  
Marwan Youssef ◽  
Sebastian Zerwes ◽  
Rudolf Jakob ◽  
Oroa Salem ◽  
Fritz Dünschede ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Multiple Organ ◽  
Aortic Aneurysms ◽  
Technical Success ◽  
Graft Thrombosis ◽  
Type Ia ◽  
Aneurysm Repair ◽  
Chimney Graft ◽  
Bifurcated Graft

Purpose: To assess the technical success and clinical outcome of reinterventions using the Nellix Endovascular Aneurysm Sealing (EVAS) System to treat complications after endovascular aneurysm repair (EVAR). Methods: Fifteen consecutive patients (mean age 79 years; 14 men) with prior EVAR were treated with EVAS between March 2014 and December 2015 at 2 institutions. The failed prior EVARs included 13 bifurcated endografts, 1 bifurcated graft plus fenestrated cuff, and 1 tube endograft. Endoleaks were the predominant indications: type Ia in 10 and type III in 5 (3 type IIIa and 2 type IIIb). All patients presented with progressive aortic aneurysms (median 7.85-cm diameter; range 6.5–11). Eight patients were treated on an urgent or emergency basis (6 symptomatic aneurysms and 2 contained ruptures). All patients underwent Nellix relining of the failed stent-graft; 10 had chimney (Ch) procedures in combination with EVAS (chEVAS) because the proximal landing zones were inadequate. Results: Technical success was 100%. All endoleaks were successfully sealed, and no additional intervention was required. No further endoleak after EVAS or chEVAS was recorded. Endobag protrusion occurred in 1 case without sequelae. One elderly patient with ruptured aneurysm died from multiple organ failure 2 months postoperatively. One renal artery guidewire injury led to nephrectomy because of active bleeding. No reinterventions, aneurysm-related mortalities, graft thrombosis, endoleaks, or chimney graft occlusions were observed during a median follow-up of 8 months (range 3–24). Conclusion: The present preliminary experience demonstrates that the use of EVAS/chEVAS is feasible for treatment of failed EVAR. This technique may be used as bailout or an alternative treatment when other established methods are infeasible or not available.

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 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.

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.

Changes in Target Vessel Anatomy Following Fenestrated Endovascular Aneurysm Repair: Midterm Results

2020 ◽  
Vol 27 (3) ◽  
pp. 445-451
Author(s):  
Paula R. Keschenau ◽  
Christina Sattler ◽  
Tanja Berger ◽  
Drosos Kotelis ◽  
Michael J. Jacobs ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Renal Arteries ◽  
Mesenteric Arteries ◽  
Length Ratio ◽  
Target Vessel ◽  
Stent Grafts ◽  
Curve Length ◽  
Aneurysm Repair ◽  
Over Time

Purpose: To analyze the changes in target vessel (TV) anatomy after fenestrated endovascular aneurysm repair (fEVAR) during midterm follow-up. Materials and Methods: A retrospective single-center study analyzed 56 patients (mean age 71±7 years; 49 men) who underwent fEVAR using custom-made stent-grafts (22 Zenith and 34 Anaconda) between June 2010 and July 2016. Advanta V12 (V12; 74, 53%) and BeGraft (BeG; 66, 47%) stent-grafts were used to bridge to the 140 TVs. Measurements of the TV deviation at the aortic origin, the vessel shift distal to the bridging stent-graft (BSG), and the outer and inner BSG curve lengths were performed after 3-dimensional reconstruction of the serial computed tomography angiography scans. The results of the measurements for the main devices, the TVs, and the bridging stent-grafts were compared using univariable and multivariable analysis. Results: Of the 140 BSGs examined (74 V12s and 66 BeGs), 393 measurements (38 celiac trunks, 102 superior mesenteric arteries, 121 left renal arteries, and 132 right renal arteries) were analyzed. The outer/inner BSG curve length ratio was larger after implantation of Zenith devices compared with Anaconda (p<0.001). The vessel shift distal to the BSG was significantly associated with the interaction of the TV and type of BSG only in the univariable analysis (p=0.001). There were no significant changes of the TV deviation at the aortic origin. Only the outer BSG curve length was significantly associated with TV complications (p=0.033). Median follow-up was 24 months (range 2–61). The BSG curve length ratio showed a significant increase over time (p<0.001) but did not differ between the BeG and V12 (p=0.381). Conclusion: No difference was found between the V12 and the BeG stent-grafts regarding anatomical TV changes during midterm follow-up after fEVAR. Both stent-grafts adapt to the TV anatomy over time, and moderate anatomical changes seem to be tolerated without increasing the risk for TV complications. The type of main device also influences the TV anatomy.

Radiation exposure in patients treated with endovascular aneurysm repair: what is the risk of cancer, and can we justify treating younger patients?

2016 ◽  
Vol 58 (3) ◽  
pp. 323-330 ◽  
Author(s):  
Thomas Nyheim ◽  
Lars E Staxrud ◽  
Jørgen J Jørgensen ◽  
Kristin Jensen ◽  
Hilde M Olerud ◽  
...  
Keyword(s):  
Cancer Risk ◽  
Radiation Exposure ◽  
Endovascular Aneurysm Repair ◽  
Younger Patients ◽  
Aneurysm Repair ◽  
Risk Of Cancer ◽  
The Impact ◽  
Over Time ◽  
Cumulative Radiation Exposure

Background Endovascular aneurysm repair (EVAR) is becoming the mainstay treatment of abdominal aortic aneurisms (AAA). The postoperative follow-up regime includes a lifelong series of CT angiograms (CTAs) at different intervals in addition to EVAR, which will confer significant cumulative radiation exposure over time. Purpose To examine the impact of age and follow-up regime over time on cumulative radiation exposure and attributable cancer risk after EVAR. Material and Methods We calculated a mean effective dose (ED) for the EVAR procedure, CTA, and plain abdominal X-rays (PAX). Cumulative ED was calculated for standard, complex, and simplified surveillance over 5, 10, and 15 years for different age groups. Results For EVAR, the mean ED was 34 mSv (range, 12–75 mSv) per procedure. For PAX, the ED was 1.1 mSv (range, 0.3–4.4 mSv), and for CTA it was 8.0 mSv (range, 2–20 mSv). For a 55-year-old man, an attributable cancer risk (ACR) in standard surveillance at 5 and 15 years of follow-up was 0.35% and 0.65%, respectively. The corresponding values were 0.22% and 0.37% for a 75-year-old man. When using a simplified follow-up, the ACRs for a 55-year-old at 5 and 15 years were 0.30% and 0.37%, respectively. These values were 0.18% and 0.21% for a 75-year-old man. A complex follow-up with half-yearly CTA over similar age and time span doubled the ACR. Conclusion Treating younger patients with EVAR poses a low ACR of 0.65% (15-year standard surveillance) compared to a lifetime cancer risk of 44%. A simplified surveillance should be used if treating younger patients, which will halve the ACR over 15 years.

scholarly journals Influence of aortic neck characteristics on successful aortic wall penetration of EndoAnchors in therapeutic use during endovascular aneurysm repair

2018 ◽  
Vol 68 (4) ◽  
pp. 1007-1016 ◽  
Author(s):  
Seline R. Goudeketting ◽  
Kim van Noort ◽  
Kenneth Ouriel ◽  
William D. Jordan ◽  
Jean M. Panneton ◽  
...  
Keyword(s):  
Aortic Wall ◽  
Endovascular Aneurysm Repair ◽  
Therapeutic Use ◽  
Aortic Neck ◽  
Aneurysm Repair

Endovascular aneurysm sealing as an alternative for the treatment of failed endovascular aneurysm repair

Vascular ◽  
2020 ◽  
Vol 28 (3) ◽  
pp. 251-258
Author(s):  
Fabien Lareyre ◽  
Claude Mialhe ◽  
Carine Dommerc ◽  
Aurélie Mbeutcha ◽  
Juliette Raffort
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Postoperative Outcomes ◽  
Technical Success ◽  
Technical Success Rate ◽  
Type Iiia ◽  
Type Iiib ◽  
Novel Approach ◽  
Type Ia ◽  
Aneurysm Repair

Objective The Nellix EndoVascular Aneurysm Sealing (EVAS) system has offered a novel approach in the treatment of abdominal aortic aneurysm (AAA). While it is currently indicated as a primary procedure in patients with infrarenal AAA with suitable anatomy according to the indications for use, a few studies aimed to address its potential interest in failed endovascular aneurysm repair (EVAR). The aim of this systematic review was to analyze the postoperative outcomes of patients with prior EVAR who underwent EVAS. Design of the study A literature search was performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines in May 2019 and included patients with prior EVAR who underwent EVAS. The publications had to report at least one of the basic postoperative outcomes (technical success rate, all-cause complications, mortality, length of in-hospital stay, length of stay in intensive care unit, the need of re-intervention). Results Eleven studies fulfilled the inclusion criteria, for a total of 46 patients. EVAS was used to treat endoleaks in 45 cases (97.8%): 29 type Ia endoleaks (63%), 6 type IIIa endoleaks (13%), and 10 type IIIb endoleaks (21.7%). Standard EVAS procedure was performed in 21 patients (45.7%), and 25 patients (54.3%) had chimney-EVAS. The technical success was achieved in all the studies. Two patients (4.9%) died during the 30-day postoperative period, but no aneurysm-related mortality was reported. The presence of endoleaks was reported in five patients (9.8%) during the follow-up. Conclusion The results suggest the safety and the efficiency of EVAS in the treatment of complications following EVAR including type Ia, type IIIa, and type IIIb endoleaks. Further studies on larger cohorts and longer follow-up periods are required to confirm the interest of EVAS in the endovascular management of failed EVAR.

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