Fenestrated Endografting for Aortic Aneurysm Repair: A 7-Year Experience

2007 ◽  
Vol 14 (5) ◽  
pp. 609-618 ◽  
Author(s):  
Peter Ziegler ◽  
Efthimios D. Avgerinos ◽  
Thomas Umscheid ◽  
Theodosios Perdikides ◽  
Wolf J. Stelter

Purpose: To present a 7-year single-center clinical experience with fenestrated endografts and side branches. Methods: Between April 1999 and August 2006, 63 patients (57 men; mean age 70.5611.6 years, range 25–89) received custom-designed Zenith fenestrated endoprostheses for a variety of aneurysms (59 abdominal, 1 thoracoabdominal, and 3 thoracic). They were all unsuitable for standard EVAR owing to short aortic necks and high risk for open surgery. Results: Nineteen tube grafts and 44 composite bifurcated grafts with a total of 122 fenestrations and 58 side branches were used. Technical success was achieved in 55 (87.3%) patients and in 118 (96.7%) vessels. Treatment success was 93.7%. The mean follow-up was 23±18 months (median 14, range 6–77). Overall, 9 (7.4%) visceral branches were lost: 4 intraoperative, 2 perioperative, and 3 late. There were 12 (19.0%) endoleaks identified: 5 (7.9%: 4 type Ia and 1 fenestration-related type III) primary and 7 (11.1%: 4 type II, 1 type I, and 2 type III) secondary endoleaks; 4 resolved, 4 were treated, and 4 are under observation. At 77 months, 75.3% of patients were free of a reintervention. All reinterventions were performed within the first 14 months. Fourteen cases of renal impairment were seen [6 permanent (only 1 on dialysis) and 8 transient]. One (1.6%) conversion and 1 (1.6%) rupture were recorded; aneurysm-related mortality was 4.8% (3/63). Conclusion: The favorable outcomes in this study, which encompasses the team's learning curve with fenestrated endografts and side branches, support the use of these devices in selected patients.

2020 ◽  
Vol 27 (3) ◽  
pp. 462-467
Author(s):  
Konstantinos Tigkiropoulos ◽  
Kyriakos Stavridis ◽  
Ioannis Lazaridis ◽  
Evangelos Bontinis ◽  
Ioulia Zournatzi ◽  
...  

Purpose: To report outcomes of elective endovascular aneurysm repair (EVAR) using the Anaconda stent-graft in a tertiary vascular center. Materials and Methods: A retrospective study was conducted of 271 patients (mean age 71.5 years; 260 men) who underwent elective EVAR for abdominal aortic aneurysm using the Anaconda stent-graft from January 2006 to January 2017. Median aneurysm diameter was 58 mm (range 50–90). All patients were anatomically suitable for EVAR according to the 2003 version of the instructions for use. Follow-up included computed tomography angiography at 1, 6, and 12 months and yearly thereafter for the first 4 years and then every 2 years. Primary outcomes included technical success and 30-day aneurysm-related mortality and complications; secondary outcomes were overall and aneurysm-related mortality and aneurysm-related morbidity in follow-up. Results: The Anaconda stent-graft was implanted successfully in all patients. Primary and secondary technical success rates were 99.6% and 100%, respectively. Three patients (1.1%) died within 30 days of causes unrelated to the aneurysm, while 15 patients (5.5%) suffered perioperative complications. Median follow-up was 72 months (range 14–141). The overall type I endoleak rate was 4.7% (11 proximal, 2 distal). Late aneurysm-related complications were observed in 48 patients (17.3%); aneurysm-related mortality was 1.4% (n=4). Non-aneurysm-related mortality was 21.0% (n=57). Freedom from reintervention was 95.2% at 1 year, 98% at 2 years, and 90% at 6 years. There was no significant difference in the overall limb graft occlusion rate between the second- and third-generation devices. Conclusion: Results in our cohort study demonstrate that the Anaconda stent-graft has satisfactory early and late results with low aneurysm-related mortality.


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.


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.


2020 ◽  
Vol 27 (6) ◽  
pp. 910-916
Author(s):  
Konstantinos Spanos ◽  
Tilo Kölbel ◽  
Martin Scheerbaum ◽  
Konstantinos P. Donas ◽  
Martin Austermann ◽  
...  

Purpose: To compare the outcomes of iliac branch devices (IBD) used in combination with standard endovascular aneurysm repair (EVAR) vs with fenestrated/branched EVAR (f/bEVAR) to treat complex aortoiliac aneurysms. Materials and Methods: The pELVIS Registry database containing the outcomes of IBD use at 8 European centers was interrogated to identify all IBD procedures that were combined with either standard EVAR or f/bEVAR. Among 669 patients extracted from the database, 629 (mean age 72.1±8.8 years; 597 men) had received an IBD combined with standard EVAR vs 40 (mean age 71.1±8.0 years; 40 men) who underwent f/bEVAR with an IBD. The mean aortic aneurysm diameters were 46.4±13.3 mm in the f/bEVAR patients vs 45.0±15.5 mm in the standard EVAR cases. The groups were similar in terms of baseline clinical characteristics and aneurysm morphology. The Kaplan-Meier method was used to compare patient survival, IBD occlusion, type III endoleak, and aneurysm-related reinterventions in follow-up. The estimates are presented with the 95% confidence interval (CI). Results: Technical success was 100% in the f/bEVAR+IBD group and 99% in the EVAR+IBD group (p=0.85). The 30-day mortality was 0% vs 0.5%, respectively (p=0.66), while the 30-day reintervention rates were 7.5% vs 4.1% (p=0.31). The mean follow-up was 32.1±21.3 months for f/bEVAR+IBD patients (n=30) and 35.5±26.8 months for EVAR+IBD patients (n=571; p=0.41). The 12-month survival estimates were 93.4% (95% CI 93.2% to 93.6%) in the EVAR+IBD group vs 93.6% (95% CI 93.3% to 93.9%) for the f/bEVAR+IBD group (p=0.93). There were no occlusions or type III endoleaks in the f/bEVAR+IBD group at 12 months, while the estimates for freedom from occlusion and from type III endoleak in the EVAR+IBD group were 97% (95% CI 96.8% to 97.2%) and 98.5% (95% CI 98.4% to 98.6%), respectively. The 12-month estimates for freedom for aneurysm-related reintervention were 93% (95% CI 92.7% to 93.3%) in the EVAR+IBD group vs 86.4% (95% CI 85.9% to 86.9%) in the f/bEVAR+IBD patients (p=0.046). Conclusion: Treatment of complex aortoiliac disease with f/bEVAR+IBD can achieve equally good early and 1-year outcomes compared to treatment with IBDs and standard bifurcated stent-grafts, except for a somewhat higher reintervention rate in f/bEVAR patients.


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.


2020 ◽  
Vol 30 (12) ◽  
pp. 1772-1782
Author(s):  
Mehmet Akif Onalan ◽  
Ender Odemis ◽  
Murat Saygi ◽  
Bahar Temur ◽  
Selim Aydin ◽  
...  

AbstractObjective:We aimed to determine the early and midterm outcomes of ductal stenting in neonates with ductal-dependent pulmonary blood flow.Methods:Between January, 2014 and July, 2018, 102 patients who underwent 115 cardiac catheterisation procedures for ductal stent implantation in our department were retrospectively reviewed. The age of the neonates ranged from 3 to 30 days (median: 11 days) and their weights ranged from 1.8 to 5.8 kg (mean, 2.8 ± 0.53 kg). Fifty-two patients had functional single ventricle and 50 had biventricular physiology. Thirty-one patients’ weights were <2,500 g (30.3%). The patent ductus arteriosus was vertical in 60 patients (58.8%). The mean ductal length was 12.4 ± 4.1 mm (range, 7.8–23 mm), and the mean narrowest ductal diameter was 2.1 ± 0.7 mm (range, 1.2–3.4 mm).Results:The technical success rate was 85.2%. Procedure-related mortality occurred in three patients (2.9%). After the procedure, the aortic oxygen saturation increased from a mean of 73.1 ± 6.2% to a mean of 90.4 ± 4.3% (p < 0.001), and the ductus diameter increased from a mean of 2.1 ± 0.7 mm to a mean of 4.2 ± 0.9 mm (p < 0.001). Either transcatheter or surgical reinterventions were required in 35 patients (34.3%) during the follow-up period after a median of 101 days (2–356 days). Thirty-three patients (32.3%) were bridged to surgical repair after a median of 288 days (163–650 days). The median duration of palliation with ductal stents was 210 days (range, 2–525 days).Conclusion:Ductus arteriosus stenting may be a reasonable and effective alternative to surgery for the initial palliation procedure in neonates with ductus-dependent pulmonary flow.


2021 ◽  
pp. 152660282110319
Author(s):  
Aleksandra C. Zoethout ◽  
Shirley Ketting ◽  
Clark J. Zeebregts ◽  
Dimitri Apostolou ◽  
Barend M.E. Mees ◽  
...  

Introduction: Type III endoleaks post-endovascular aortic aneurysm repair (EVAR) warrant treatment because they increase pressure within the aneurysm sac leading to increased rupture risk. The treatment may be difficult with regular endovascular devices. Endovascular aneurysm sealing (EVAS) might provide a treatment option for type III endoleaks, especially if located near the flow divider. This study aims to analyze clinical outcomes of EVAS for type III endoleaks after EVAR. Methods: This is an international, retrospective, observational cohort study including data from 8 European institutions. Results: A total of 20 patients were identified of which 80% had a type IIIb endoleak and the remainder (20%) a type IIIa endoleak. The median time between EVAR and EVAS was 49.5 months (28.5–89). Mean AAA diameter prior to EVAS revision was 76.6±19.9 mm. Technical success was achieved in 95%, 1 patient had technical failure due to a postoperative myocardial infarction resulting in death. Mean follow-up was 22.8±15.2 months. During follow-up 1 patient had a type Ia endoleak, and 1 patient had a new type IIIa endoleak at an untreated location. There were 5 patients with aneurysm growth. Five patients underwent AAA-related reinterventions indications being: growth with type II endoleak (n=3), type Ia endoleak (n=1), and iliac aneurysm (n=1). At 1-year follow-up, the freedom from clinical failure was 77.5%, freedom from all-cause mortality 94.7%, freedom from aneurysm-related mortality 95%, and freedom from aneurysm-related reinterventions 93.8%. Conclusion: The EVAS relining can be safely performed to treat type III endoleaks with an acceptable technical success rate, a low 30-day mortality rate and no secondary ruptures at short-term follow-up. The relatively low clinical success rates, related to reinterventions and AAA enlargement, highlight the need for prolonged follow-up.


2007 ◽  
Vol 14 (4) ◽  
pp. 513-519 ◽  
Author(s):  
Peter Ziegler ◽  
Theodossios P. Perdikides ◽  
Efthimios D. Avgerinos ◽  
Thomas Umscheid ◽  
Wolf J. Stelter

Purpose: To investigate the use of fenestration and branch artery stenting during endovascular stent-graft repair of para-anastomotic aneurysms (PAA). Methods: A retrospective review was conducted of 9 patients (all men; mean age 71 years, range 60–80) who received custom-designed fenestrated endoprostheses for PAA repair. Eight tubular fenestrated devices and 1 composite device (fenestrated tube plus modular bifurcated body) with a total of 31 fenestrations were used. Results: The mean operating time was 318±93 minutes (range 220–485); the mean fluoroscopy time was 77±38 minutes (range 39–158), during which a mean 121±81 mL (range 33–300) of contrast was used. Technical success was achieved in all cases. Over a mean follow-up of 12±5.5 months (range 6–24), 1 secondary intervention was carried out due to a break in a side branch stent-graft; 2 transient renal impairments and 1 permanent renal insufficiency unrelated to renal artery patency were observed. So far, no vessel loss has emerged. Conclusion: Conventional repair of PAA has been a standard procedure for many years, though it carries high surgical risk as well as perioperative mortality. Fenestrated endografts may be a promising alternative in selected patients.


Vascular ◽  
2018 ◽  
Vol 27 (2) ◽  
pp. 175-180 ◽  
Author(s):  
Konstantinos P Donas ◽  
Marco V Usai ◽  
Gergana T Taneva ◽  
Frank J Criado ◽  
Giovanni B Torsello ◽  
...  

Objective Chimney endovascular aortic aneurysm repair is gaining ever greater acceptance. However, persistent gutters leading to type IA endoleaks represent an unsolved issue. The aim of the current study was to analyze the impact of abdominal endograft oversizing to the occurrence of this phenomenon. Methods The PERformance of the snorkel/chImney endovascular teChnique in the treatment of compLex aortic PathologiesES registry includes the largest experience with chimney endovascular aortic aneurysm repair from 13 vascular centers in Europe and the U.S. Prospectively collected data from centers with standard use of the Endurant stent-graft and balloon-expandable covered stents as chimney grafts only were included in the present analysis. The parameter which varied was the degree of oversizing of the aortic stent-graft classifying the cohort in two groups, group A (20% and less oversizing) and group B (>20% of oversizing). The primary endpoint was the incidence of persistent type IA endoleak needed reintervention. Secondary endpoints were all-cause mortality and freedom from reintervention. Results Group A included 21 patients while group B 144. The mean preoperative pathology’s neck length and diameter was 5.8 mm (±4.4) versus 4.9 mm (±3.8) and 27.6 mm (±4.7) versus 24.9 mm (±3.7) for group A and group B, respectively. The mean length of the new sealing zone after chimney graft placement was similar for both groups (group A versus group B; 17.9 mm versus 18.3 mm, respectively, P = .21). The percentage of oversizing of the aortic stent-graft ranged between 13.8 and 20% versus 22.2 and 30%, for group A and group B, respectively. Patients of group A had more type 1A endoleaks, (14.3%) versus patients of group B (2.1%) based on the first follow-up imaging, P = .02. The incidence of persistent type IA endoleaks needing a reintervention was 14.3 and 1.4% for the group A and group B, respectively, P = .01. The mean volume of contrast medium used was greater in group A versus group B with 239 ml versus150 ml, P = .05. Additionally, 14.3% of patients of group A experienced acute renal failure compared to those in group B which was 1.0%, P = .01. Conclusions Oversizing of ideally 30% of the Endurant stent-graft is associated with significant lower incidence of type IA endoleaks requiring reintervention for patients treated by chimney endovascular aortic aneurysm repair.


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