Onyx™ Cast Fragmentation After Embolization of Endoleaks

Purpose: Endoleaks are common following endovascular aneurysm repair (EVAR), and the liquid embolic material Onyx has been widely used in their treatment. We report our experience of long-term morphological changes of Onyx casts on surveillance imaging. Materials and Methods: We identified 10 patients over 10 years who underwent Onyx embolization in our institution. Morphological changes of Onyx casts were assessed on surveillance radiographs and computed tomography (CT) scans. Relevant outcome data and sequelae were obtained via electronic patient records. Results: Twelve procedures were performed on 10 cases, 9 for type 2, and 1 for a type 1a endoleak. Five cases showed evidence of Onyx fragmentation on follow-up imaging ranging from a single fracture to gross fragmentation with migration of fragments. Of these 5, 3 had achieved primary success but 2 went on to develop recurrence of endoleak. Onyx volume ranged from 4 to 46.5 ml (median 10.5 ml) per patient with larger volumes demonstrating the most marked fragmentation on follow-up. Follow-up ranged from 9 months to 8 years (median 2.25 years). Conclusion: To our knowledge, this is the first report of Onyx fragmentation after endoleak embolization. If long-term morphological stability of the Onyx cast is necessary to maintain aneurysm seal, then Onyx may not offer a permanent solution to some patients with post-EVAR endoleaks. Our study cannot ascertain whether the observed changes were the cause or the effect of ongoing aneurysm growth, persistent endoleak, and/or other forces acting on the solidified polymer, but it raises important questions on the use of Onyx in this setting.

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Systematic Review on the Mid-Term Outcomes of Elective Endovascular Aneurysm Sealing in Comparison to Endovascular Aneurysm Repair

Journal of Endovascular Therapy ◽

10.1177/15266028211047941 ◽

2021 ◽

pp. 152660282110479

Author(s):

Zoethout Aleksandra C ◽

Hochstenbach Iris ◽

van der Laan Maarten J ◽

de Vries Jean-Paul P.M ◽

Reijnen Michel M.P.J. ◽

...

Keyword(s):

Systematic Review ◽

Endovascular Aneurysm Repair ◽

Cochrane Library ◽

Type I ◽

Early Results ◽

Aneurysm Growth ◽

Meta Analyses ◽

Aneurysm Repair

Introduction The Nellix endovascular aneurysm sealing (EVAS) system has been a topic of discussion. Early results were promising but did not deliver on the long-term and the device has been recalled from the market. This study compares literature for EVAS and conventional endovascular aneurysm repair (EVAR). Methods A systematic review and analysis was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. PubMed, Embase, and Cochrane Library were searched and identified the eligible studies. Proportion rates for the outcomes of interest were extracted. Subgroup analyses were performed for EVAS and EVAR. Results A total of 12 studies were included (EVAS n = 4, EVAR n = 8) including 10,255 patients (EVAS n = 784, EVAR n = 9441). The longest duration of follow-up was 3.4 years for EVAS and 5.0 years for EVAR studies. Throughout follow-up the overall all-cause mortality rates were 6% for EVAS and 13% for EVAR, and endoleak of any type was described in 10% of EVAS and 17% of EVAR patients. The migration rate >10 mm was 8% for EVAS and 0% for EVAR and aneurysm growth >5 mm was found in 11% of EVAS and 3% of EVAR cases. Total reintervention rate was 13% for EVAS and 7% for EVAR patients. For all analyzed outcome parameters heterogeneity was >50%. Conclusion There is a tendency toward lower mortality and overall endoleak rates for EVAS compared to EVAR but with a higher rate of migration, aneurysm growth, and reintervention. Despite lower overall endoleak rates there was a tendency toward less type II and more type I endoleaks after EVAS compared to EVAR. Substantial heterogeneity however limits robust statistical analyses, and is probably caused by significant instructions for use breach in EVAS-treated patients. We call for more high-quality and long-term follow-up studies on both EVAS and EVAR in order to confirm the trends found in this study.

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Determinants of Abdominal Aortic Aneurysm Sac Enlargement After Endovascular Aneurysm Repair with a Long-Term Follow-Up to 15 Years

Journal of Vascular Surgery ◽

10.1016/j.jvs.2012.05.019 ◽

2012 ◽

Vol 56 (2) ◽

pp. 579

Author(s):

Carlos E. Donayre ◽

Faidzal Othman ◽

George E. Kopchok ◽

Ali Khoynezhad ◽

Rodney A. White

Keyword(s):

Abdominal Aortic Aneurysm ◽

Aortic Aneurysm ◽

Endovascular Aneurysm Repair ◽

Abdominal Aortic ◽

Long Term Follow Up ◽

Aneurysm Repair

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Postoperative imaging follow-up at two years as a predictor of long-term outcome after endovascular aneurysm repair (EVAR)

Journal of Vascular Surgery ◽

10.1016/j.jvs.2021.05.044 ◽

2021 ◽

Author(s):

Suvi Väärämäki ◽

Ilkka Uurto ◽

Velipekka Suominen

Keyword(s):

Endovascular Aneurysm Repair ◽

Term Outcome ◽

Long Term Outcome ◽

Postoperative Imaging ◽

Aneurysm Repair

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Effects of Abdominal Aortic Aneurysm Size on Mid- and Long-term Mortality After Endovascular Aneurysm Repair

Journal of Endovascular Therapy ◽

10.1177/1526602819829901 ◽

2019 ◽

Vol 26 (2) ◽

pp. 231-237 ◽

Cited By ~ 2

Author(s):

Haekyung Jeon-Slaughter ◽

Harish Krishnamoorthi ◽

David Timaran ◽

Amanda Wall ◽

Bala Ramanan ◽

...

Keyword(s):

Abdominal Aortic Aneurysm ◽

Aortic Aneurysm ◽

Endovascular Aneurysm Repair ◽

Optimal Cutoff ◽

Term Survival ◽

Abdominal Aortic ◽

All Cause Mortality ◽

Aneurysm Repair

Purpose: To investigate the effect of abdominal aortic aneurysm (AAA) size on mid- and long-term survival after endovascular aneurysm repair (EVAR). Materials and Methods: Retrospective data were collected from 325 consecutive patients (mean age 69.7 ± 8.5 years; 323 men) who underwent EVAR for intact AAA at a single institution between January 2003 and December 2013. The primary endpoint was death at 3, 5, and 10 years after EVAR. Optimal cutoff points for AAA size and age were determined using receiver operating characteristics (ROC) curves. Time to event analyses (Kaplan-Meier curves and Cox proportional hazard models) were employed to determine any differences in all-cause mortality outcomes between AAA size groups. Cox models were adjusted for age and other comorbidities (hypertension, hyperlipidemia, coronary artery disease, smoking status, symptomatic status, and creatinine); the outcomes are reported as the hazard ratio (HR) with 95% confidence interval (CI). Results: The cohort was dichotomized according to the ROC analysis, which defined an optimal cutoff point of 5.6 cm for AAA size and >70 years for age. The mean follow-up period post EVAR was 45.5±29.2 months. In total, 134 (41.2%) patients died during the 10-year follow-up. Thirty-day mortality was 1.1% (2/184) in the patients with AAA <5.6 cm and 2.1% (3/141) in patients with AAA ≥5.6 cm (p=0.45). All-cause mortality was not significantly affected by comorbidities. However, AAA size ≥5.6 cm was associated with increased 3-year mortality risk (HR 1.59, 95% CI 1.001 to 2.52, p<0.049) but not 5-year (HR 1.44, 95% CI 0.98 to 2.10, p=0.062) or 10-year mortality (HR 1.28, 95% CI 0.91 to 1.80, p=0.149). After adjusting for comorbidities, AAA size ≥5.6 cm was no longer significantly associated with morality at any time point. Using a larger size cutoff (AAA size ≥6.0 cm) resulted in improved statistical significance in the unadjusted model. In the adjusted Cox model, AAA size ≥6.0 cm was significantly associated with increased risk of mortality at 3 years (HR 1.67, 95% CI 1.01 to 2.77, p<0.047), but not at longer time points. Conclusion: Our study demonstrates that midterm survival after EVAR is significantly and independently associated with AAA size even after correcting for comorbidities. However, in the long term, preoperative AAA size is not an independent predictor of mortality.

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PC032 Planned Perioperative Adjunctive Maneuvers Make Off-Label Endovascular Aneurysm Repair (EVAR) Comparable to Standard EVAR at a Long-Term Follow-Up

Journal of Vascular Surgery ◽

10.1016/j.jvs.2017.03.280 ◽

2017 ◽

Vol 65 (6) ◽

pp. 148S-149S

Author(s):

Emiliano Chisci ◽

Azzurra Guidotti ◽

Clara Pigozzi ◽

Eugenio Romano ◽

Pierfrancesco Frosini ◽

...

Keyword(s):

Endovascular Aneurysm Repair ◽

Off Label ◽

Long Term Follow Up ◽

Aneurysm Repair

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AA13. Postoperative Imaging Follow-up at Two Years Predicts Long-Term Outcome After Endovascular Aneurysm Repair

Journal of Vascular Surgery ◽

10.1016/j.jvs.2018.08.078 ◽

2018 ◽

Vol 68 (5) ◽

pp. e139-e140

Author(s):

Suvi Väärämäki ◽

Ilkka Uurto ◽

Velipekka Suominen

Keyword(s):

Endovascular Aneurysm Repair ◽

Term Outcome ◽

Long Term Outcome ◽

Postoperative Imaging ◽

Aneurysm Repair

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Ten-year single-centre experience with type II endoleaks: Intervention versus observation

Vascular Medicine ◽

10.1177/1358863x17704315 ◽

2017 ◽

Vol 22 (4) ◽

pp. 316-323 ◽

Cited By ~ 9

Author(s):

Ikram-Ul Haq ◽

Arun Kelay ◽

Meryl Davis ◽

Jocelyn Brookes ◽

Tara M Mastracci ◽

...

Keyword(s):

Endovascular Aneurysm Repair ◽

Time Frame ◽

Type Ii ◽

Risk Of Mortality ◽

Surveillance Imaging ◽

Increased Risk ◽

Significant Difference ◽

Aneurysm Growth ◽

Aneurysm Repair

Our objective was to determine the relative merits of intervention or observation of type II endoleaks (T2Ls). A retrospective analysis was performed on 386 infra-renal endovascular aneurysm repair (IR-EVAR) patients from 2006 to 2015. Annual surveillance imaging of patients undergoing EVAR at our centre were analysed, and all endoleaks were subjected to a multidisciplinary team meeting for consideration and treatment. In the 10-year time frame, 386 patients (79.5±8.7 years) underwent an IR-EVAR. Eighty-one patients (21.0%) developed a T2L and intervention was undertaken in 28 (34.6%): 17 (60.7%) were treated via a transarterial approach (TA) and 11 (39.3%) using the translumbar approach (TL). Fifty-three patients (65.4%) with T2Ls were managed conservatively. Patients who received T2L treatment had a greater proportion of recurrent T2Ls than patients who were conservatively managed ( p=0.032). T2Ls associated with aneurysmal growth were more resistant to treatment than those where there was no change or a decrease in aneurysm size during follow-up (0.033). There was no significant difference in the TA and TL approach with respect to endoleak repair success ( p=0.525). Treatment of a T2L did not confer a survival advantage compared to conservative management ( p=0.449) nor did the choice of either the TA or TL approach ( p=0.148). Our study suggests the development of a T2L associated with aneurysm growth may represent an aggressive phenotype that is resistant to treatment. However, this did not lead to an increased risk of mortality over follow-up. Neither a transarterial nor a translumbar approach to treating a T2L conferred superiority.

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Occurrence and outcomes of type 3 endoleaks in endovascular aortic repair within the Vascular Quality Initiative database

BMJ Surgery, Interventions, & Health Technologies ◽

10.1136/bmjsit-2020-000054 ◽

2020 ◽

Vol 2 (1) ◽

pp. e000054

Author(s):

Juliet Blakeslee-Carter ◽

Adam Beck ◽

Emily Spangler

Keyword(s):

Endovascular Aneurysm Repair ◽

Index Hospitalization ◽

Procedural Information ◽

Kaplan Meier ◽

Long Term Follow Up ◽

Clinical Consequences ◽

Aneurysm Repair ◽

Type 3

ObjectivesType 3 endoleaks (T3ELs) represent a lack of aneurysm protection from systemic pressure. Previous studies have found a ~2% incidence of T3EL after standard infrarenal endovascular aneurysm repair (EVAR); however, no prior studies with new-generation devices have been able to determine an association between T3EL and clinical outcomes. Here we examine T3EL within the Society for Vascular Surgery Vascular Quality Initiative (VQI) to define rates of occurrence, rates and modes of reintervention, and clinical consequences of these endoleaks.Design and settingParticipants receiving infrarenal EVAR in the VQI from January 2003 to September 2018 were analyzed in a retrospective cohort study.ParticipantsOf 42 246 entries in the EVAR procedural registry, 41 604 had complete procedural information and were included in analysis. Of these, 36 082 had long-term follow-up, and 26 422 had follow-up (9–21 months per VQI reporting standards) with complete endoleak data recorded.InterventionsAll patients included in this study underwent an infrarenal EVAR.ResultsWithin the VQI database, the rate of T3EL in infrarenal EVAR during index hospitalization was 0.37% (n=157/41 604), of which 85% were due to midgraft separation and 15% were due to fabric disruptions. Out of the 157 index hospitalization T3ELs, 4.5% (n=7) received procedural reintervention during that hospitalization, which accounted for 1% of all index hospitalization reinterventions. During the 21-month follow-up, the rate of incident T3EL was 0.7% (n=205/26 422), which accounted for 5% of all endoleaks seen during follow-up. Reinterventions for incident T3EL at follow-up were done in 30 patients (rate 0.1%), which accounted for 9% of endoleak reinterventions and 3.3% of all reinterventions. The presence of incident T3EL found during follow-up was associated with a significant decrease in 5-year survival (74% vs 80%, respectively; p=0.041) in Kaplan-Meier analysis.ConclusionT3ELs rates at placement and follow-up remain low; however, the majority reported in long-term follow-up are incident and these incident endoleaks are associated with decreased survival in EVAR.

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Crossover ilio-iliac bypass and removal of femoro-femoral graft as first treatment for the infection of crossover bypass in aortouniiliac endovascular aneurysm repair

Vascular ◽

10.1258/vasc.2011.tn0018 ◽

2012 ◽

Vol 20 (6) ◽

pp. 306-310 ◽

Cited By ~ 2

Author(s):

Stefano Bonardelli ◽

Franco Nodari ◽

Maurizio De Lucia ◽

Edoardo Cervi ◽

Stefano Maria Giulini

Keyword(s):

Endovascular Aneurysm Repair ◽

Femoral Prosthesis ◽

Autologous Tissue ◽

Long Term Follow Up ◽

Crossover Bypass ◽

Aneurysm Repair ◽

Femoral Graft

The crossover femoro-femoral bypass, classically used for the treatment of unilateral iliac arterial obstruction, has recently become an integral part of aortouniiliac endovascular aneurysm repair. We therefore, reconsider the therapeutic problems related to thrombosis and in particular to infection of the femoro-femoral prosthesis, when many attempts have been made to preserve the bypass and treat the infection. Showing a case treated and well eight months later, we put forward the old technique of crossover ilio-iliac bypass, followed by the removal of the infected femoro-femoral graft. In our opinion, this technique circumvents the need for autologous tissue and allows for the use of prosthetics in a new, sterile, uncontaminated field. As this approach for these cases has so far not been reported in the literature, further cases and long-term follow-up are needed.

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