Predicting Rotation in Fenestrated Endovascular Aneurysm Repair Using Finite Element Analysis.

Fenestrated endovascular aneurysm repair (FEVAR) is a minimally invasive method of abdominal aortic aneurysm (AAA) repair utilized in patients with complex vessel anatomies. Stent grafts (SG) used in this process contain fenestrations within the device that need to be aligned with the visceral arteries upon successful SG deployment. Proper alignment is crucial to maintain blood flow to these arteries and avoid surgical complications. During fenestrated SG deployment, rotation of the SG can occur during the unsheathing process. This leads to misalignment of the vessels, and the fenestrations and is associated with poor clinical outcomes. The aim of this study was to develop a computational model of the FEVAR process to predict SG rotation. Six patient-specific cases are presented and compared with surgical case data. Realistic material properties, frictional effects, deployment methods, and boundary conditions are included in the model. A mean simulation error of 2 deg (range 1-4 deg) was observed. This model was then used to conduct a parameter study of frictional properties to see if rotation could be minimized. This study showed that increasing or decreasing the coefficients of friction (COF) between the sheath and the vessel walls would decrease the amount of rotation observed. Our model accurately predicts the amount of SG rotation observed during FEVAR and can be used as a preoperative planning tool within the surgical workflow.

Prediction of advanced endovascular stent graft rotation and its associated morbidity and mortality.

OBJECTIVE: Advanced endovascular aneurysm repair (EVAR) with fenestrated and branched stent grafts is increasingly being used to repair complex aortic aneurysms; however, these devices can rotate unpredictably during deployment, leading to device misalignment. The objectives of this study were to quantify the short-term clinical outcomes in patients with intraoperative stent graft rotation and to identify quantitative anatomic markers of the arterial geometry that can predict stent graft rotation preoperatively. METHODS: A prospective study evaluating all patients undergoing advanced EVAR was conducted at two university-affiliated hospitals between November 2015 and December 2016. Stent graft rotation (defined as ≥10 degrees) was measured on intraoperative fluoroscopic video of the deployment sequence. Standard preoperative computed tomography angiography imaging was used to calculate the geometric properties of the arterial anatomy. Any in-hospital and 30-day complications were prospectively documented, and a composite outcome of any end-organ ischemia or death was used as the primary end point. RESULTS: Thirty-nine patients undergoing advanced EVAR were enrolled in the study with a mean age of 75 years (interquartile range [IQR], 71-80 years) and a mean aneurysm diameter of 64 mm (IQR, 59-65 mm). The incidence of stent graft rotation was 37% (n = 14), with a mean rotation of 25 degrees (IQR, 21-28 degrees). A nominal logistic regression model identified iliac artery torsion, volume of iliac artery calcification, and stent graft length as the primary predictive factors. The total net torsion and the total volume of calcific plaque were higher in patients with stent graft rotation, 8.9 ± 0.8 mm-1 vs 4.1 ± 0.5 mm-1 (P < .0001) and 1054 ± 144 mm3 vs 525 ± 83 mm3 (P < .01), respectively. The length of the implanted stent grafts was also higher in patients with intraoperative rotation, 172 ± 9 mm vs 156 ± 8 mm (P < .01). The composite outcome of any end-organ ischemia or death was also substantially higher in patients with stent graft rotation (36% vs 0%; P = .004). In addition, patients with stent graft rotation had significantly higher combined rates of type Ib and type III endoleaks (43% vs 8%; P = .03). CONCLUSIONS: Patients with intraoperative stent graft rotation have a significantly higher rate of severe postoperative complications, and this is strongly associated with higher levels of iliac artery torsion, calcification, and stent graft length. These findings suggest that preoperative quantitative analysis of iliac artery torsion and calcification may improve risk stratification of patients before advanced EVAR.

Clinical outcomes and material properties of in situ fenestration of endovascular stent grafts.

OBJECTIVE: In situ fenestration of endovascular stent grafts has been used as a method for branch vessel revascularization in urgent and emergent settings. The objective of this manuscript was to review the clinical and experimental evidence related to this technique. METHODS: PubMed, MEDLINE, and Embase databases were searched for papers published until December 2015 describing in situ fenestration of aortic stent grafts. Benchtop, animal, and human studies were included. RESULTS: The literature review identified 118 articles, of which 28 studies were selected for inclusion. These included 16 clinical papers (2 case series and 14 case reports) reporting in situ fenestration of 46 aortic branch vessels in 44 patients. There were 42 retrograde and 4 antegrade instances of in situ fenestration. The most frequent target vessel for in situ fenestration was the left subclavian artery (72%), and the most frequent indication for stent graft implantation was a degenerative aortic aneurysm (43%). Technical success was reported in 44 of 46 attempted fenestrations (96%). The combined rate of perioperative mortality, stroke, and paralysis was 7%. In situ fenestration was predominantly performed with the Talent (Medtronic, Santa Rosa, Calif) stent graft (54%), followed by the Zenith (Cook Medical, Bloomington, Ind) stent graft (37%) and the TAG (W. L. Gore & Associates, Newark, Del) stent graft (9%). In vitro benchtop evaluations of in situ fenestration showed minimal change in fenestration size after 1 year of pulsatile fatigue testing. The use of energy-based fenestration techniques (radiofrequency or laser) has been associated with less fabric fraying than in needle-based techniques. The larger caliber initial fenestration created by these devices also avoids the need for cutting balloons, which have also been linked with increased fabric tears and fraying of the fibers surrounding the fenestration. In addition, the Zenith stent graft was shown in benchtop testing to be the strongest in postfenestration mechanical testing, but it was also the most resistant to balloon dilation. CONCLUSIONS: In the short to moderate term, in situ fenestration appears to be a reasonable and effective method to extend the proximal landing zone for revascularization of the left subclavian artery. However, longer follow-up is needed to fully assess the long-term durability of this procedure. Based on studies of material properties, an energy-based fenestration technique (radiofrequency or laser) is recommended, along with the avoidance of cutting balloons for dilation of the fenestration.