scholarly journals Influence of patient-specific rehearsal on operative metrics and technical success for endovascular aneurysm repair

Author(s):  
Cecilie Våpenstad ◽  
Siv Marit Lamøy ◽  
Frode Aasgaard ◽  
Frode Manstad-Hulaas ◽  
Petter Aadahl ◽  
...  
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.


Vascular ◽  
2018 ◽  
Vol 27 (1) ◽  
pp. 46-50 ◽  
Author(s):  
Fadi Taher ◽  
Juergen Falkensammer ◽  
Joseph Nguyen ◽  
Miriam Uhlmann ◽  
Edda Skrinjar ◽  
...  

Objective Custom-made fenestrated aortic endografts allow exclusion of pararenal aortic aneurysms while maintaining blood flow to aortic branches. Meticulous device planning and precise deployment of the main body are essential to allow successful cannulation of the fenestrations. This study investigates whether a learning curve can be observed with more reliable cannulation and connection of fenestrations over time at a single department of vascular and endovascular surgery with multiple surgeons trained to use the device. Methods A retrospective analysis of data from all patients undergoing primary fenestrated endovascular aneurysm repair during the study period was performed. Outcome measures included case volume and average number of fenestrations over time, average fluoroscopy dose area product per calendar year and primary unconnected fenestration and 30-day mortality rates. Results Between 1 January 2013 and 31 December 2016, 89 patients with no history of endovascular aneurysm repair underwent fenestrated endovascular aneurysm repair at our institution. The number of fenestrations per case increased over time, averaging 2.6 in 2013 and 3.3 in 2016. Primary unconnected fenestration and 30-day mortality rates were 5.6%. Primary-assisted technical success was 93.3%, secondary-assisted technical success was 94.4%. Fluoroscopy dose area product declined over the study period. Thirty-day mortality and primary unconnected fenestration rates did not significantly change over the study period. Conclusion Albeit the reduction in lethal complications and primary technical success rates were not statistically significant, a lower percentage of unconnected fenestrations and 30-day mortality per calendar year were observed over time. At the same time, an increasing complexity of performed cases, as reflected by an increasing number of fenestrations per case, was observed. Complications associated with this complex endovascular procedure are potentially lethal and remain an unfortunate reality and may not be entirely dependent on overcoming a learning curve. A higher volume of cases performed over the study period and a reduction in fluoroscopy use can be considered a representation of the institutional development and learning curve for the Anaconda fenestrated endograft at a department with prior complex endovascular aortic repair experience, but due to limitations of the current retrospective observation, deserve further consideration in future trials, ideally designed in a prospective fashion.


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.


Author(s):  
A. Duménil ◽  
J. Gindre ◽  
A. Kaladji ◽  
P. Haigron ◽  
D. Perrin ◽  
...  

The endovascular treatment of abdominal aortic aneurysm (EVAR) consists of inserting a delivery system through intravascular pathway and deploying one or several stent-grafts at the aneurysm site in order to exclude it. This procedure has proven to have a high success rate for eligible patient population and benefits in terms of reduced blood loss, intraoperative morbidity and length of hospital stay. As the selection criteria for EVAR extend progressively due to enhancements in the devices and delivery systems, clinicians are confronted with cases becoming increasingly difficult and demanding procedures with steep learning curve (aortic dissection, branched and fenestrated stent-graft, and complex anatomy with high tortuosity or short aortic neck). In this context patient-specific Finite Element Modeling (FEM) could provide a predictive tool to support endovascular device assessment and selection as well as intervention planning. Given the lack of dedicated solutions, the aim of this study was to assess the feasibility of simulating the main steps of EVAR procedure, from guidewire insertion to stent-graft deployment.


2019 ◽  
Vol 26 (6) ◽  
pp. 797-804
Author(s):  
Sean A. Crawford ◽  
Matthew G. Doyle ◽  
Cristina H. Amon ◽  
Thomas L. Forbes

Purpose: To develop a mechanically realistic aortoiliac model to evaluate anatomic variables associated with stent-graft rotation and to assess common deployment techniques that may contribute to rotation. Materials and Methods: Idealized aortoiliac geometries were constructed either through direct 3-dimensional (3D) printing (rigid) or through casting with polyvinyl alcohol using 3D-printed molds (flexible). Flexible model bending rigidity was controlled by altering wall thickness. Three flexible patient-specific models were also created based on the preoperative computed tomography angiograms. Zenith infrarenal and fenestrated devices were used in this study. The models were pressurized to 100 mm Hg with normal saline. Deployments were performed under fluoroscopy at 37°C. Rotation was calculated by tracking the change in position of gold markers affixed to the devices. Results: In the rigid idealized models, stent-graft rotation increased with increasing torsion; torsion levels of 1.6, 2.6, and 3.6 mm−1 had mean rotations of 5.2°±0.03°, 11.2°±4.8°, and 27.6°±13.0°, respectively (p<0.001). In the flexible models, the highest rotation (58°±3.0°) was observed in models with high torsion and high rigidity (7.5 mm−1 net torsion and 254 N·m2 flexural rigidity). No rotation was observed in the absence of torsion. Applying torque to the device during insertion significantly increased stent-graft rotation by an average of 28° across all levels of torsion (p<0.01). Multiple device insertions prior to deployment did not change the observed device rotation. The patient-specific models accurately predicted the degree of rotation seen intraoperatively to within 5°. Conclusion: Insertion technique plays an important role in the degree of stent-graft rotation during deployment. Our model suggests that in vivo correction of device orientation can increase the observed rotation and supports the concept of fully removing the device, adjusting the orientation, and subsequently reinserting. Additionally, increasing iliac artery torsion in the presence of increased vessel rigidity results in stent-graft rotation.


2017 ◽  
Vol 24 (2) ◽  
pp. 246-253 ◽  
Author(s):  
Zhanjiang Cao ◽  
Weiwei Wu ◽  
Keqiang Zhao ◽  
Junlai Zhao ◽  
Yu Yang ◽  
...  

Purpose: To compare the safety and efficacy of percutaneous (PEVAR) vs open femoral access (OFA) techniques for endovascular aneurysm repair (EVAR). Methods: A systematic review of English-language articles (Medline, EMBASE, and Cochrane databases) between January 1999 and August 2016 returned 11 studies including 1650 patients with 2500 groin accesses eligible for the meta-analysis. Data extracted from each study were synthesized to evaluate technical success rates, procedure time, and complications for the 2 access approaches. Data are presented as the odds ratio (OR) or mean difference (MD) with 95% confidence intervals (CI). The quality of individual studies was evaluated based on the Newcastle-Ottawa scale. Results: The mean technical success rate in the PEVAR group was 94.5% (785/831). The overall OR was 0.38 (95% CI 0.12 to 1.18, p=0.09), indicating no significant difference between the methods. The procedure time in PEVAR was shorter than OFA (mean difference −24.52, 95% CI −46.45 to −22.60, p<0.001). Overall, the total complication rate was 15.3% in the OFA group vs 7.8% in the PEVAR group (OR 0.52, 95% CI 0.37 to 0.73, p<0.001). The meta-analysis identified significant differences between groups for all complications (p<0.001) and the following individual adverse events: wound infection (OR 0.28, 95% CI 0.10 to 0.81, p=0.02), pseudoaneurysm (OR 8.07, 95% CI 1.54 to 42.32, p=0.01), seroma (OR 0.10, 95% CI 0.02 to 0.55, p=0.008), and lymphocele or lymph leak (OR 0.19, 95% CI 0.04 to 0.92, p=0.04). Conclusion: PEVAR had a similar technical success rate, shorter procedure time, and lower complication rate compared with OFA. Thus, percutaneous access appears to be the preferential approach for EVAR. However, larger and randomized studies are needed to draw definitive conclusions.


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