Abdominal Aortic Aneurysm Stent Graft Research Articles

Two cases of pararenal artery aortic aneurysm treatment after pancreaticoduodenectomy and abdominal aortic aneurysm stent grafting

BackgroundAcute pancreatitis caused by surgical procedures may occur less frequently in surgeries for aortic aneurysm involving the abdominal branch. However, in such cases, the associated mortality rate increases significantly. There have been few reports on abdominal aortic aneurysm surgery after pancreatoduodenectomy; as such the incidence of postoperative pancreatitis remains unclear.Case presentationTwo cases of pararenal artery aortic aneurysm after pancreaticoduodenectomy and endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysm are reported. In the first case, a 74-year-old man was diagnosed with abdominal aortic aneurysm and duodenal cancer 6 years earlier and underwent pancreaticoduodenectomy after EVAR. Subsequently, the abdominal aorta expanded to 58 mm at the level of the renal artery proximal to the EVAR site. Graft replacement was performed through a left thoraco-retroperitoneal incision. However, the patient died from acute pancreatitis, believed to be caused by intraoperative manipulation. Given this initial experience, in the second case, a 77-year-old man had undergone a pancreaticoduodenectomy for a gastrointestinal stromal tumor 17 years earlier and EVAR for an abdominal aortic aneurysm 10 years earlier. The abdominal aorta had expanded to 50 mm immediately below the right renal artery on the proximal side of the EVAR. Subsequently, hematuria was noted, and he was diagnosed with right ureteral cancer. Autologous transplantation of the left kidney and EVAR was performed avoiding manipulation of the area around the pancreas and achieved good results. Combined right renal and ureteral resections were performed 20 days after EVAR.ConclusionsWhile performing aortic surgery after pancreaticoduodenectomy, surgeons should avoid manipulating tissues around the pancreas.

Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study.

Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study. Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory. The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively. In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years. Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.ClinicalTrials.gov Identifier: NCT02477111.

Sex different abdominal artery anatomy may induce different displacement force on stent-graft after endovascular aneurysm repair.

Women with abdominal aortic aneurysm (AAA) have a higher incidence of complications after Endovascular aneurysm repair (EVAR), most of which are related to the migration of stent-graft. The different force acting on the stent-graft after EVAR caused by different abdominal artery anatomy of male and female AAA patients may be the reason for the sex-different complications. This article aims to explore the possible biomechanical mechanisms of sex differences by making a comparison of displacement force acting on the stent graft of male and female AAA patients. To explore the effect of different vascular anatomy on stent-graft migration, the uniformed models were constructed according to the specific vascular anatomy parameters of AAA patients of different sex, which have been measured before. The computational fluid dynamics method was used to quantitate the pulsatile force acting on the stent-graft after EVAR in a cardiac cycle. Then the displacement force was calculated with the pressure and the wall shear stress, and the total and area-weighted average of displacement force acting on the stent-graft were compared respectively. In one cardiac cycle, the wall pressure for the male model is greater than that of the female model (2.7-4.4 vs. 2.2-3.4 N), and the wall shear force for the female model is slightly greater (0-0.0065 vs. 0-0.0055 N). The displacement force is mainly provided by the wall pressure, which is also greater in the male model. However, the area-averaged displacement force is greater for the female model than that for the male model (180-290 vs. 160-250 Pa). Because of the different vascular anatomies, the impact caused by the pulsating aortic blood flow on the AAA stent-graft of women after EVAR was greater than that of men. Women's vascular anatomy leads to greater area-averaged displacement force after stent-graft implantation, resulting in a greater risk of stent-graft migration, which might be one of the reasons why women had a higher incidence of complications after EVAR.

Anatomical Feasibility of an Off-the-shelf Single-Renal Scalloped Stent-Graft for Hostile Neck Abdominal Aortic Aneurysm: A Preclinical Study

To evaluate the feasibility of a standardized single-renal scallop stent-graft. Preclinical, single-center, real-world, all-comers, retrospective cohort study. A total of 1347 abdominal aortic aneurysm (AAA) repairs (endovascular and open) performed between 2010 and 2020 were screened for elective treatment and retrievable preoperative high-quality computed tomography angiography (CTA) performed <6 months of the surgical procedure. Six hundred of the included CTAs involved prespecified measurements and a morphological assessment protocol (NCT05150873). The proximal sealing zones suitable for standard stent-graft implantations were further analyzed (N=547). The primary outcome assessed the feasibility of 2 single-renal scallop designs (10×10 mm and 15×10 mm, height × width). The feasibility was the inter-renal length ≥10 mm and ≥15 mm for prototypes #10 and #15, respectively. The secondary outcome quantified hypothetical length and surface improvements comparing those suitable for investigational devices implantation (study group) versus those not (control group). Of the total, 24.7% (n=135) was feasible with prototype #10. The study versus control group sealing zones were shorter (p=0.008), with a smaller surface (p=0.009) and a higher alpha angle (p=0.039). The length and surface area increased by about 25% and 23%, respectively, (both p<0.001) within the study group and became significantly better versus the control group (standard stent-graft; both p<0.001). Of the total, 7.1% (n=39) was suitable for prototype #15. The study versus control group sealing zones were shorter (p=0.148), with a smaller surface (p=0.077) and a higher alpha angle (p=0.027). The length and surface area increased by about 34% and 31%, respectively, (both p<0.001) within the study group and became significantly higher versus the control group (standard stent-graft; both p<0.001). The use of single-renal scalloped stent-graft might be feasible in a considerable number of AAA patients. The breakthrough stands in treating hostile AAAs presenting in mismatched renal arteries, keeping the complexity of the repair as similar as possible to standard endovascular repair with a remarkable improvement in sealing. The anatomic feasibility of a single renal stent graft for the treatment of "hostile" abdominal aortic aneurysm (AAA) with mismatched renal arteries was evaluated. The experimental device could be feasible in a considerable number of patients with AAA, approaching 25%, and demonstrate significant improvements in sealing. As far as we know, this is the first paper to report the prevalence of mismatched renal arteries in a large cohort of AAA patients in the real world, while proposing a dedicated device. The breakthrough is to keep the complexity of the repair as close as possible to standard endovascular repair.

Is there a Relationship Between Endoleak and Antiaggregant Treatments in the Change of the Aneurysm Sac After Endovascular Treatment in Abdominal Aortic Aneurysm?

Aim: It was aimed to determine the prognosis and treatment in relation to the risk factors of the patient group by recording the changes in aneurysm sac, thrombus diameter and thrombus load in the follow-up of patients treated with endovascular stent-graft for abdominal aortic aneurysm (AAA). Material and Methods: Preoperative and postoperative 1st, 3rd, 6th and 12th month CT-A's of 112 patients who were followed up regularly were performed and changes in aneurysm sac diameter, thrombus diameter and thrombus percentage were recorded. Results: When the measurements were evaluated, an increase was detected in the mean thrombus diameter at post-operative month 1 with a gradual reduction over time; however, it was observed to be higher than the pre-operative values even at month 12. These changes were statistically significant (p&lt;0.001). Aneurysm sac diameters of the cases in the pre-operative work-up ranged between 50mm and 108mm with a mean of 65.53±12.08mm. Pre-operative thrombus burden was measured to be 28% minimum and 96% maximum with a mean of 61.8±18.69%. In the post-operative measurements, the mean thrombus burden was 86.0±13.47 at month 1, 85.9±15.46 at month 3, 82.94±14.27 at month 6 and 82.27±13.82 at month 12. Similar to the changes in thrombus diameter, there was an increase at month 1 with a gradual reduction over time; however, the values at month 12 were still higher than the pre-operative values. These changes were also statistically significant (p&lt;0.001). Conclusion: The present study showed that the changes in aneurysm sac diameter and endoleak formation may affect prognosis and single antiaggregant treatment would be more suitable compared to the combination treatment.

Five-Year Experience With the Zenith Fenestrated Endovascular Graft for Treatment of Juxtarenal Abdominal Aortic Aneurysms at a Medium Volume Center

The use of fenestrated endovascular aortic repair (FEVAR) to treat abdominal aortic aneurysms involving the visceral arteries has increased worldwide with excellent results. The aim of this study was to evaluate the safety and effectiveness of the Zenith fenestrated endovascular graft (Cook Medical, Bloomington, IN) for the treatment of juxtarenal abdominal aortic aneurysms (AAAs) at a medium volume center. We performed a 5-year (2015-2020) retrospective analysis of all patients who had presented to our institution with juxtarenal AAAs and undergone FEVAR. Custom-made fenestrated stent grafts were designed with one to three fenestrations after analysis of computed tomography data sets. Renal alignment was performed with balloon-expandable stents. Follow-up included clinical examination, laboratory studies, mesenteric-renal duplex ultrasound, abdominal radiography, and computed tomography at hospital discharge, at 1, 6, and 12 months, and annually thereafter for ≤5 years. A total of 25 patients with juxtarenal AAAs had undergone FEVAR during the study period and were included in our analysis. Of the 25 patients, 18 were men and 7 were women, with a mean age of 71 ± 10 years. The mean aneurysm diameter was 60 ± 5 mm. A total of 53 visceral arteries required incorporation with fenestrations. Of these, 51 (96%) fenestrations were aligned by stents. Technical success was 100%. One intraoperative complication occurred. The patient developed bilateral common femoral artery plaque dissection and required common femoral artery endarterectomy. The mean length of hospital stay was 2.8 ± 1.5 days. No aneurysm ruptures or conversions were noted during a mean follow-up of 41 ± 15 months (range, 6-67 months). Of a total of 50 renal arteries targeted by fenestration, one renal artery occlusion (2%) and five cases of stenosis (10%) developed. Five patients (20%) required secondary interventions for renal artery stenosis or occlusion. One type I endoleak developed in 2 patients and one type II endoleak developed in 11 patients. One patient with a type II endoleak had experienced an increase in sac size at 1 year and underwent inferior mesenteric artery ligation. None of the patients died during the follow-up period. Our study has demonstrated that endovascular repair of juxtarenal AAAs with the Zenith fenestrated AAA stent graft at a medium volume center is safe and effective. Mortality and morbidity are low for properly selected patients treated at centers with experience in these procedures.

Late type III endoleaks are common in early generation Endologix AFX stent grafts

ObjectiveEarly generation Endologix AFX endovascular abdominal aortic aneurysm (AAA) stent graft devices are at risk of developing type IIIa (intercomponent/overlap-related) as well as type IIIb (fabric tear) endoleaks over time. Current follow-up studies are limited to short (<24 months) and midterm (24-48 months) reports. The purpose of this study was to identify the incidence of type III endoleaks associated with these endografts over a long-term follow-up (>4 years) period and discuss current management strategies. MethodsA retrospective, single-institution cohort analysis of all Endologix AFX endografts implanted from October 2011 to October 2016 was performed. Patient characteristics, imaging, and follow-up were obtained via chart review. Type III endoleaks were characterized based on computed tomography angiogram/operative findings and confirmed by two surgeons. Statistical analysis was performed with SAS v9.4. ResultsSixty-three patients underwent AFX stent graft implantation for aneurysmal disease. Forty-seven patients comprised the final cohort for analysis after exclusions were made for primary iliac aneurysms as well as off-label use of the device (eg, hypogastric snorkel) or primary occlusive indications. The average age was 73.3 years, with the longest follow-up being 8.7 years (median, 5.2 years). Most AAAs (89.2%) were fusiform, with initial median diameter 5.5 cm. Initial 30-day mortality was 0%. Of the initial cohort, 10 (21.3%) type III endoleaks were treated, of which six (60%) were type IIIa and four (40%) were type IIIb. By time-to-event analysis at latest follow-up, freedom from type III intervention was 48% at 8 years. The median time to type III endoleak discovery was 4.7 years (range, 1.1-7.2 years), an interval that was similar for type IIIa and type IIIb leak types (P = .73). Patients with type III endoleaks had average sac growth of 1.3 cm over the follow-up interval compared with a net decrease for patients without type III endoleaks (P < .0001). Of the 10 patients treated for type III leaks, seven (70%) underwent complete endovascular re-lining, one (10%) had partial re-lining, and two (20.0%) underwent open endograft explant with aortic graft reconstruction. Reintervention 30-day mortality was 0% for all approaches. ConclusionsEarly generation Endologix AFX stent grafts have a high rate of type III endoleaks, with freedom from type III leak <50% at 8-year follow-up. Most of these are not detected until several years (>4.5 years) after initial implantation, beyond the range of the follow-up interval of most published reports. Long-term imaging surveillance is critical, and a low threshold for complete relining should be considered with any sign of sac enlargement, even if endoleak is not clearly demonstrated in patients with early generation Endologix AFX grafts.

One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms

ObjectiveEndovascular repair of abdominal aortic aneurysms (AAAs) using the INCRAFT AAA Stent Graft System was safe and effective in regulatory approval studies. We herein report on the 1-year results of a real-world clinical study. MethodsThe INSIGHT study is a multi-center, prospective, open label, post-approval study conducted to continually evaluate the safety and performance of the INCRAFT System. Between 2015 and 2016, 150 consecutive patients with AAA at 23 centers in Europe were treated with the device in routine clinical practice. The primary endpoint was freedom from major adverse events (MAEs), namely death, myocardial infarction, cerebrovascular accident, and renal failure, within 30 days of the index procedure. End point data were assessed by a core laboratory. The secondary end points included technical success at the conclusion of the procedure and clinical success. ResultsAll 150 patients studied (mean age, 73.6 ± 8.0 years; 89.3% men) met the primary end point without MAEs at 30-day follow-up. Technical success was achieved in 99.3% of patients without stent fractures at 30 days. Among the 146 patients eligible for 1-year follow-up, the MAE rate was 8.2% (ie, 12 patients suffered 13 MAEs: cerebrovascular accident in 8, myocardial infarction in 1, and 4 died, resulting in a 2.7% all-cause mortality rate). There were no reports of new onset renal failure requiring dialysis. Only 2.7% of patients had type I endoleak, and no type III endoleaks were identified through 1 year. The rate of clinical success at 1 year was 91.8%. ConclusionsThe 1-year results of this multicenter real-world study underscore the safety and effectiveness of endovascular treatment of AAA with the INCRAFT System in routine clinical practice.

A Comparative Study on the Hemodynamic Performance Within Cross and Non-cross Stent-Grafts for Abdominal Aortic Aneurysms With an Angulated Neck.

Objectives: Cross-limb stent grafts for endovascular aneurysm repair (EVAR) are often employed for abdominal aortic aneurysms (AAAs) with significant aortic neck angulation. Neck angulation may be coronal or sagittal; however, previous hemodynamic studies of cross-limb EVAR stent grafts (SGs) primarily utilized simplified planar neck geometries. This study examined the differences in flow patterns and hemodynamic parameters between crossed and non-crossed limb SGs at different spatial neck angulations.Methods: Ideal models consisting of 13 cross and 13 non-cross limbs were established, with coronal and sagittal angles ranging from 0 to 90°. Computational fluid dynamics (CFD) was used to capture the hemodynamic information, and the differences were compared.Results: With regards to the pressure drop index, the maximum difference caused by the configuration and angular direction was 4.6 and 8.0%, respectively, but the difference resulting from the change in aneurysm neck angle can reach 27.1%. With regards to the SAR-TAWSS index, the maximum difference caused by the configuration and angular direction was 7.8 and 9.8%, respectively, but the difference resulting from the change in aneurysm neck angle can reach 26.7%. In addition, when the aneurysm neck angle is lower than 45°, the configuration and angular direction significantly influence the OSI and helical flow intensity index. However, when the aneurysm neck angle is greater than 45°, the hemodynamic differences of each model at the same aneurysm neck angle are reduced.Conclusion: The main factor affecting the hemodynamic index was the angle of the aneurysm neck, while the configuration and angular direction had little effect on the hemodynamics. Furthermore, when the aneurysm neck was greatly angulated, the cross-limb technique did not increase the risk of thrombosis.

Midterm result of custom-made iliac branch device for common iliac aneurysm with and without abdominal aortic aneurysm.

Although commercial iliac branch devices offer a new and valid endovascular approach to treating iliac aneurysm and effectively preserve antegrade flow of the internal iliac artery, their use may not be suited for all types of challenging anatomy, especially isolated common iliac artery aneurysm. Our custom-made iliac bifurcation device has a unique design and excludes both combined and isolated iliac branch aneurysm. This study validated the efficacy and safety of the custom device by comparing clinical outcomes between groups receiving commercial and custom devices. Data of consecutive patients receiving iliac bifurcation device implantation for iliac aneurysm with or without concomitant endovascular repair for abdominal aortic aneurysm from January 2010 to May 2019 were reviewed. Iliac bifurcation device implantation with or without concomitant abdominal aortic aneurysm stent grafting was completed in 46 patients (commercial, n = 35; custom, n = 11). No significant differences were observed regarding postoperative complications, occlusion or endoleak. Comparisons of primary (80.8% vs 85.7%, P = 0.88) and secondary (86.5% vs 85.7%, P = 0.85) patency and freedom from reintervention (88.2% vs 100%, P = 0.33), all-cause mortality (78.6% vs 100%, P = 0.25) and aneurysm-related mortality (100% vs 100%, P = 1.00) also indicated no differences at a 5-year surveillance point. Furthermore, the iliac aneurysms of the groups displayed similar shrinkage 1 year after procedures. For iliac aneurysm, the novel custom-made iliac bifurcation device is an adaptable design not inferior to commercial devices with regard to postoperative complications, bridge occlusion, endoleak and short-term aneurysm remodelling. It provides an alternative for treatment, particularly when certain anatomic challenges are present. 2018-07-050BC, 2017-01-023ACF.

Final 5-year results of the United States Zenith Fenestrated prospective multicenter study for juxtarenal abdominal aortic aneurysms

PurposeTo report 5-year results of the prospective, multicenter study designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (William A. Cook Australia, Brisbane, Australia) for juxtarenal abdominal aortic aneurysms (AAAs). MethodsSixty-seven patients (54 male, mean age 74 ± 8 years) were prospectively enrolled at 14 U.S. centers from 2005 to 2012. Fenestrated stent grafts were used in patients with infrarenal aortic neck lengths of 4 to 14 mm to target 178 renal-mesenteric arteries with a mean of 2.7 vessels per patient. At 5 years, 42 of the 67 patients completed the final study follow-up, with clinical examination obtained in 41 and computed tomography imaging in 39. Outcomes adjudicated by a clinical events committee included all-cause and aneurysm-related mortality, major adverse events, renal stent occlusion/stenosis, renal function changes and renal infarcts, aneurysm sac enlargement (>5 mm), device migration (≥10 mm), type I/III endoleak, and secondary interventions. ResultsMedian follow-up was 59.8 months (range, 0.1-67.5 months). There were seven deaths, including one (1.5%) within 30 days (procedure-related) and six beyond 30 days (not procedure-related in five, indeterminate in one). At 5 years, freedom from all-cause mortality was 88.8 ± 4.2% and freedom from aneurysm-related mortality was 96.8 ± 2.3%. There were no aneurysm ruptures or conversions to open surgery. Of the 129 renal arteries targeted by fenestrations, five (4%) occluded and 14 (11%) developed in-stent stenosis. Treatment included redo stenting/angioplasty in 13 vessels, renal artery bypass in 2 vessels, and failed thrombectomy in 1 vessel. Primary and secondary renal target patency was 82.7 ± 4.1% and 95.7 ± 2.1% at 5 years, respectively. Dialysis was required in one patient who had pre-existing chronic kidney disease. During the 5 years, there was 1 type IA endoleak (1.5%), 1 type IB endoleak (1.5%), 2 device migrations (3%), and 4 aneurysm sac enlargements (6%). Overall, 81% of patients had sac shrinkage at 5 years. Of 20 patients who underwent secondary interventions, 12 were for renal in-stent stenosis or occlusion, 7 were for endoleak, and 1 was for both indications. Freedom from secondary intervention was 63.5 ± 7.2% at 5 years. ConclusionsThese 5-year results confirm the safety and effectiveness of the Zenith Fenestrated AAA stent graft with no late graft- or aneurysm-related deaths. In-stent stenosis of bare metal renal stents was the most frequent indication for secondary intervention. The low rate of type IA endoleak, sac enlargement, and device migration support its use in patients with juxtarenal AAAs.

A multi-center study for instructions for use-compatible elective endovascular abdominal aneurysm repair via Lifetech Ankura™ abdominal aortic aneurysm stent graft

A multi-center study for instructions for use-compatible elective endovascular abdominal aneurysm repair via Lifetech Ankura™ abdominal aortic aneurysm stent graft

Effectiveness and durability of the GORE® EXCLUDER® AAA stentgraft in the treatment of AAA

To report the results of the post-inscription study of the 5-year effectiveness and durability of the current generation of the GORE® EXCLUDER® AAA stentgraft to treat abdominal aortic aneurysms (AAA) requested by the French High Health Authority.

Tailor-made iliac branched device for preserving the internal iliac artery in patients with common iliac artery aneurysm.

Endovascular repair with stent-graft is a treatment option for patient with common iliac artery aneurysm (CIAA). However, the preservation of the internal iliac artery (IIA) is a concern. The commercially available iliac branched device (IBD) requires a common iliac length of at least 5 cm, which is usually too long for Asian people. Here, we report our medium-term results of using tailor-made IBD for patients with short common iliac artery (CIA) with and without abdominal aortic aneurysm (AAA). A selected iliac limb of the AAA stent-graft was unloaded from the delivery system. A 6-mm fenestration hole was made at the length of the CIA from the proximal end. The edge of the hole was reinforced with the soft and radiopaque tip of a 0.014´´ wire. Then, the iliac limb was reloaded into the introduced sheath as the tailor-made IBD. It was inserted from the selected side of the femoral artery and deployed. The ipsilateral IIA was cannulated through the fenestration hole. Then, a balloon-expandable or self-expandable covered stent with an appropriate size was deployed as the bridging stent-graft. Between March 2013 and March 2017, a total of 10 patients received the tailor-made IBDs. One patient died of systemic thromboembolism 2 days after the operation. The bridging stent-grafts remained patent in all patients, except one occluded at 1 year after operation. A tailor-made IBD is an easy-to-apply, alternative option for preserving the IIA perfusion in short CIAA patients with and without AAA.

Overview of the 2018 US Food and Drug Administration Circulatory System Devices Panel meeting on the INCRAFT AAA Stent Graft System.

On June 12, 2018, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to advise on the safety and effectiveness of the INCRAFT® AAA Stent Graft System for the treatment of abdominal aortic aneurysms (AAA) and to consider a premarket approval application sponsored by Cordis, Inc., for Unique identifier: NCT01664078 based on the results of the pivotal INSPIRATION trial (URL: https://clinicaltrials.gov/ct2/show/NCT01664078). The INCRAFT® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. The stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, with the goal of isolating the aneurysmal sac and preventing sac rupture. The multicenter, prospective, non-randomized investigation trial met its primary composite safety and effectiveness endpoints but also showed higher-than-anticipated rates of stent fracture and endoleaks. The committee discussion focused on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile, of the device. While the panel acknowledged the risk of the device, the panel's final vote supported that the benefits of the INCRAFT AAA Stent Graft System outweigh the risks and that a post-marketing study should be mandated. The FDA approved the device for use in complex access anatomies in December 2018.

Type II Endoleak After Endovascular Aortic Aneurysm Repair Using the Endurant Stent Graft System for Abdominal Aortic Aneurysm with Occluded Inferior Mesenteric Artery.

To evaluate the incidence of type II endoleak (EL-II) and aneurysm enlargement after endovascular aneurysm repair (EVAR) using the Endurant stent graft in patients with abdominal aortic aneurysm (AAA) with occluded inferior mesenteric artery (IMA). Between 2012 and 2017, 103 patients who underwent EVAR using the Endurant stent graft for AAA with occluded IMA (50 patients with prophylactic embolized IMA and 53 with spontaneous occluded IMA) were retrospectively reviewed. The incidence of EL-II and aneurysm enlargement was evaluated. Predictive factors for persistent EL-II were evaluated based on patient characteristics, preprocedural anatomical characteristics, intraprocedural details, and postprocedural complications. Incidence rates of early EL-II and persistent EL-II were 6.8% (7/103 patients) and 4.9% (5/103 patients), respectively. Aneurysm enlargement was found in 10 patients (9.7%), including all 5 patients with persistent EL-II, 3 with de novo EL-II, and 2 with no EL-II. The rates of freedom from aneurysm enlargement at 1, 2, and 3years were 98.7%, 97.0%, and 93.1% for the group without persistent EL-II, and 80.0%, 60.0%, and 20.0% for the group with persistent EL-II (p < 0.001), respectively. The maximum aneurysm diameter (odds ratio (OR), 1.16; 95% confidence interval (CI), 1.01-1.34; p = 0.0362) and the number of patent lumbar arteries (OR, 2.72; 95% CI, 1.07-6.90; p = 0.0357) were predictive of persistent EL-II. The incidence of EL-II after EVAR using the Endurant stent graft for AAA with occluded IMA was low, but most early EL-II persisted and resulted in aneurysm enlargement. Level of Evidence Level 4, Case Series.

Early outcomes with a single-sided access endovascular stent

ObjectiveThe objective of this study was to report the 1-year follow-up study results of the new Horizon stent graft (Endospan, Herzliya, Israel) from two different prospective consecutive trials. The Horizon abdominal aortic aneurysm stent graft system is a 14F profile system requiring only a single access site. It consists of three modules, introduced separately: base limb (iliac to iliac limb); distal aortic limb; and proximal aortic limb with a bare suprarenal crown and active fixation. MethodsData from the first in man (FIM) clinical study with 10 patients enrolled and the pivotal study with 30 patients were analyzed. Outcomes measured were freedom from major adverse events (MAEs) including all-cause mortality, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, bowel ischemia, and procedural blood loss ≥1000 mL. Performance end points included successful delivery and deployment of the device, freedom from aneurysm growth ≥5 mm, type I or type III endoleak, stent graft occlusion, conversion to open surgery, rupture, and stent graft migration. ResultsIn the FIM study, one conversion to open surgery with >1000 mL of blood loss was registered perioperatively. In the pivotal study, no perioperative MAE was registered. Overall, at 1-year follow-up, two deaths and one aneurysm growth unrelated to endoleak were registered. ConclusionsThe results of both the FIM and pivotal studies demonstrated that 39 of 40 procedures were successful for delivery and deployment of the Horizon stent graft. No MAE was registered during the follow-up. The primary safety and performance end points were met in both studies.

Clinical Outcomes of Endovascular Aneurysm Repair with the Kilt Technique for Abdominal Aortic Aneurysms with Hostile Aneurysm Neck Anatomy: A Korean Multicenter Retrospective Study.

We aimed to evaluate the clinical efficacy and short-term clinical outcomes of Kilt technique-based endovascular aneurysm repair (EVAR) with Seal® stent-grafts for abdominal aortic aneurysms (AAAs) with hostile neck anatomy (angle>60°). We retrospectively evaluated the pre-EVAR and follow-up computed tomography angiography findings of 24 patients (mean age 71±11years; age range 32-87years; mean follow-up 50±12months) with hostile neck AAAs treated between 2010 and 2015. Serial change in aneurysmal neck angle was calculated using a standardized protocol. Relationships between clinical variables and outcomes were evaluated using univariate and multivariate Cox analyses and mixed-model regression. In addition, the Kaplan-Meier method was used to assess the cumulative rates of survival, endoleak, and reintervention. The primary technical success rate (success within 24h after EVAR) was 100% (24/24). The survival rate was 96±8% at 1month, 6months, 1year, and 3years, and 87±18% at 5years. Endoleaks occurred in three patients. Four reinterventions were performed in three patients; no surgical revisions were required. Causes of post-EVAR mortality included intracerebral hemorrhage at 14days and rhabdomyolysis at 32months. The most remarkable change after Kilt-based EVAR was an acute decrease in the neck angle, which was observed between the pre-EVAR and first follow-up visits (at 1month) (P=0.001). Kilt-based EVAR with Seal® stent-grafts for AAAs with a severely angulated neck (angle>60°) provided high technical success, low mortality, and low complication rates during short-term follow-up.

A French comparative monocentric study of reimboursed stent-grafts for abdominal aortic aneurysms

A French comparative monocentric study of reimboursed stent-grafts for abdominal aortic aneurysms

Progress in Endovascular Aortic Repair for Women.

The diagnosed prevalence of abdominal aortic aneurysm (AAA) in women is approximately 20% of that in men.1–3 Therefore, women are underrepresented in epidemiologic studies and trials in which screening and therapeutic methods are evaluated. Consequently, central issues related to AAA in women have not been fully investigated.First, screening recommendations provide inadequate guidance for women. The United States Preventive Services Task Force has concluded that insufficient evidence exists for screening women with a history of smoking and has advised against screening women who have never smoked.4 The only prospective studies of ultrasound screening in women yielded no difference in mortality rates at 10 years.3,5 Subsequent efforts to identify women at high risk of AAA have been more promising.6,7Female sex is associated with a more rapid aneurysmal growth rate and earlier rupture.8,9 These findings suggest that women might benefit more from earlier AAA repair than do men. In addition, AAAs in women are more likely to have complex features.10 The median infrarenal aortic neck length in women is 12 mm, compared with 16 mm in men. The degree of neck angulation is greater in women (45° vs 36°), and iliac vessel caliber is smaller (11 vs 14 mm). Thus, approximately 60% of women are not eligible for endovascular aortic repair (EVAR) with use of conventional devices.11Recent advances in device design, including smaller delivery systems and modifications to accommodate shorter neck lengths and greater angulation, can be expected to increase EVAR eligibility in women. For instance, the Endurant® II AAA Stent Graft System (Medtronic, Inc.; Minneapolis, Minn) and the TriVascular Ovation Prime® device (TriVascular, an Endologix company; Santa Rosa, Calif) can accommodate neck lengths as short as 10 mm and 7 mm, respectively. The Zenith® Fenestrated AAA Endovascular Graft (Cook Medical Inc.; Bloomington, Ind), which is uniquely manufactured to conform to patients' aortic anatomy, can be used in necks as short as 4 mm. Extreme neck angulation is accommodated by the Aorfix™ Endovascular Stent Graft (Lombard Medical, Inc.; Irvine, Calif). These devices can also be used in patients who have iliac vessel diameters as narrow as 8 mm and as wide as 25 mm. The TriVascular Ovation® provides the lowest-profile delivery system at 14F.The ongoing LIFE Study seeks to show benefits associated with the low-profile TriVascular Ovation Prime device in conjunction with the Fast-Track EVAR Protocol, which includes percutaneous access, conscious sedation, and next-day discharge from the hospital.12 Thirty-day results include low rates of adverse events, high procedural success rates, freedom from endoleak, and hospital readmission rates 5 times lower than those in contemporary EVAR reports (1.6% vs 8.2%).13 Patients assigned to the fast-track approach showed a trend toward more greatly improved quality of life. Whether the predicted benefits of the Ovation Prime device will specifically translate into improved outcomes in female patients will be determined in the forthcoming LUCY Study.14The underrepresentation of women in clinical trials related to AAA has resulted in a lack of guidance for patients and physicians in the central issues of natural history, screening, and treatment threshold. Technical advances in stent-grafts, which are now lower-profile and more compatible with complex aneurysmal features, are likely to increase eligibility for EVAR in women. In addition to procedural advances, future study should focus on improved screening algorithms and defining the optimal treatment threshold in women.