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 ◽  
...  

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.

2016 ◽  
Vol 24 (1) ◽  
pp. 115-120 ◽  
Author(s):  
Marwan Youssef ◽  
Sebastian Zerwes ◽  
Rudolf Jakob ◽  
Oroa Salem ◽  
Fritz Dünschede ◽  
...  

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.


Vascular ◽  
2021 ◽  
pp. 170853812199259
Author(s):  
Andrés Reyes Valdivia ◽  
Arindam Chaudhuri ◽  
Ross Milner ◽  
Giovanni Pratesi ◽  
Michel MPJ Reijnen ◽  
...  

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.


2018 ◽  
Vol 26 (9) ◽  
pp. 667-676
Author(s):  
Yuk Law ◽  
Yiu Che Chan ◽  
Stephen Wing-Keung Cheng

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.


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

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.


Vascular ◽  
2015 ◽  
Vol 24 (2) ◽  
pp. 177-186 ◽  
Author(s):  
William D Jordan ◽  
Manish Mehta ◽  
Kenneth Ouriel ◽  
Frank R Arko ◽  
David Varnagy ◽  
...  

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.


Vascular ◽  
2018 ◽  
Vol 26 (5) ◽  
pp. 490-497 ◽  
Author(s):  
Daniel Silverberg ◽  
Uri Rimon ◽  
Daniel Raskin ◽  
Avner BarDayan ◽  
Moshe Halak

Background “Chimney” techniques with parallel grafts used in order to extend the landing zones in endovascular aneurysm repair (ch-EVAR) are increasingly being reported. Conflicting data has been reported regarding the success and durability of the repair. We report a single center experience using ch-EVAR in treating complex aortic pathologies. Methods We performed a retrospective review of all patients treated with ch-EVAR in our institution between 2013 and 2017. Data collected included patients demographics, indications for surgery, configuration of parallel grafts, technical success, and perioperative morbidity and mortality. Follow-up data included aortic sac size, reintervention rate, and overall mortality. Results Thirty-five patients underwent treatment of their aneurysms with parallel grafts. Sixty parallel grafts were placed. Mean age was 75 years (range 59–93) and 30 (85%) were male. Technical success was achieved in 32 (91%) patients. Mean follow up was 12 months. Sac size decreased in diameter or remained unchanged in 26 of the 30 (86.6%) patients. Four patients were found to have enlarging aneurysms due to gutter endoleaks. All were treated successfully with endovascular methods. The estimated primary patency was 95% at 12 months. Probability of freedom from intervention was 75% at 12 months. No late aneurysm related mortality occurred. Conclusion The use of ch-EVAR in treating complex aortic aneurysms is technically feasible and safe. Gutter endoleaks are encountered only in a minority of the cases, and can be treated with minimally invasive techniques. Longer term follow up is required to evaluate the patency of these parallel grafts and the durability of the aneurysm exclusion.


Vascular ◽  
2020 ◽  
Vol 28 (3) ◽  
pp. 251-258
Author(s):  
Fabien Lareyre ◽  
Claude Mialhe ◽  
Carine Dommerc ◽  
Aurélie Mbeutcha ◽  
Juliette Raffort

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.


Vascular ◽  
2016 ◽  
Vol 25 (1) ◽  
pp. 92-100 ◽  
Author(s):  
Yang Yaoguo ◽  
Chen Zhong ◽  
Kou Lei ◽  
Xiao Yaowen

Objective We reviewed data pertaining to fenestrated endograft technique and chimney stent repair of complex aortic aneurysm for comparative analysis of the outcomes. Methods A comprehensive search of relevant databases was conducted to identify articles in English, related to the treatment of complex aortic aneurysm with fenestrated endovascular aneurysm repair and chimney stent repair, published until January 2015. Results A total of 42 relevant studies and 2264 patients with aortic aneurysm undergoing fenestrated endovascular aneurysm repair and chimney stent repair were included in our review. A total of 4413 vessels were involved in these processes. The cumulative 30-day mortality was 2.4% and 3.2% ( p = 0.459). The follow-up aneurysm-related mortality was 1.4% and 3.2% ( p = 0.018), and target organ dysfunction was 5.0% and 4.0% in fenestrated endovascular aneurysm repair and chimney stent repair, respectively ( p = 0.27). A total of 156 vessels showed restenosis or occlusion after primary intervention (3.6% and 3.4% in fenestrated endovascular aneurysm repair and chimney stent repair, respectively, p = 0.792). The cumulative type I endoleak was 2.0% (38/1884) after fenestrated endovascular aneurysm repair compared with 3.4% (13/380) after chimney stent repair ( p = 0.092), and the type II endoleak was 5.4% (102/1884) and 5.3% (20/380), respectively ( p = 0.905). Approximately, 1.1% and 1.6% increase in aneurysm was observed following fenestrated endovascular aneurysm repair and chimney stent repair, respectively ( p = 0.437). The re-intervention frequency was 205 and 19 cases after fenestrated endovascular aneurysm repair and chimney stent repair, respectively (11.7%, 5.6%, p = 0.001). Conclusions Fenestrated endovascular aneurysm repair and chimney stent repair are safe and effective in treating patients with complex aortic aneurysm. A higher aneurysm-related mortality was observed in chimney stent repair while fenestrated endovascular aneurysm repair was associated with a higher re-intervention rate.


2018 ◽  
Vol 25 (6) ◽  
pp. 726-734 ◽  
Author(s):  
Raman Uberoi ◽  
Carlo Setacci ◽  
Mario Lescan ◽  
Antonio Lorido ◽  
David Murray ◽  
...  

Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.


2018 ◽  
Vol 25 (4) ◽  
pp. 492-498 ◽  
Author(s):  
Sonia Ronchey ◽  
Stefano Fazzini ◽  
Salvatore Scali ◽  
Giovanni Torsello ◽  
Paul Kubilis ◽  
...  

Purpose: The aim of this retrospective analysis was to evaluate the performance of the chimney (ch) technique in the treatment of type Ia endoleaks after standard endovascular aneurysm repair (EVAR). Methods: Between January 2008 and December 2014, 517 chEVAR procedures were performed in 13 US and European vascular centers (PERICLES registry). Thirty-nine patients (mean age 76.9±7.1 years; 33 men) were treated for persistent type Ia endoleak and had computed tomography angiography or magnetic resonance angiography follow-up at >1 month. Endurant abdominal stent-grafts were used in the 20 cases. Single chimney graft placement was performed in 18 (46%) patients and multiple in 21 (54%). Overall, 70 visceral vessels were targeted for revascularization. Results: Technical success was achieved in 35 (89.7%) cases; 3 persistent type Ia endoleaks and 1 chimney graft occlusion were detected within the first 30 days. Thirty-day mortality was 2.6%. Two other deaths (not aneurysm related) occurred during a mean follow-up of 21.9 months (0.23–71.3). Primary patency of the chimney grafts was 94.3% at 36 months. In a subgroup analysis comparing Endurant to other stent-grafts, no significant differences were observed regarding persistent endoleak [1/20 (5%) vs 2/19 (11%), p=0.6] or reintervention [1/20 (5%) vs 0/19 (0%)]. Conclusion: The present series demonstrates that chEVAR in the treatment of post-EVAR type Ia endoleaks has satisfactory results independent of the abdominal and chimney graft combinations. Midterm results show that chEVAR is an effective method for treating type Ia endoleaks.


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