Endograft System Research Articles

First-in-Human Clinical Trial of the WeFlow-JAAA Endograft System in Patients With Juxtarenal Abdominal Aortic Aneurysms.

To preliminarily evaluate the safety and efficacy of the WeFlow-JAAA endograft, a novel off-the-shelf device designed for the repair of juxtarenal abdominal aortic aneurysms (JRAAAs) and pararenal abdominal aortic aneurysms (PRAAAs). This prospective single-arm first-in-human clinical trial included patients with JRAAAs (infrarenal necks ≤10 mm) or PRAAAs with at least a 5 mm sealing zone below the superior mesenteric artery (SMA) who underwent endovascular repair using the WeFlow-JAAA endograft system. With this system, the celiac artery was addressed with a wide scallop, the renal arteries (RAs) were addressed with 2 standard inner branches, and the SMA was addressed with a "mini-inner-cuff" reinforced fenestration. The primary efficacy endpoint was the clinical success at 12 months. The primary safety endpoint was the freedom from major adverse events (MAEs) in the first 30 days after surgery. Fifteen patients (all men; mean age 68.5±6.0 years) were enrolled between October 2019 and August 2021. The median infrarenal neck length was 0 mm (IQR, 0-4 mm). Technical success was achieved in all patients. No MAEs occurred in the first 30 days. The mean fluoroscopy time was 73.1±27.8 minutes, and the mean volume of contrast media was 130.7±29.4 mL. Clinical success was maintained in all patients at 12 months. No aortic-related deaths, aneurysm rupture, type I or type III endoleak, or open surgery conversion occurred during the follow-up period. The secondary intervention was required only in 1 patient who developed an occluded right RA stent 14 months after the procedure. The WeFlow-JAAA endograft device appears to be safe and efficacious in selected patients with JRAAAs or PRAAAs with more than 5 mm sealing zone below SMA. Large-scale, multicenter, and prospective studies with long-term follow-ups are ongoing to validate our findings in China. Clinicaltrials.gov identifier: NCT04745546 (URL: Guo's Visceral Arteries Reconstruction: The First in Man Study of WeFlow-JAAA Stent Graft System-Full-Text View-ClinicalTrials.gov). The first-in-human clinical trial of the WeFlow-JAAA endograft system demonstrates promising safety and efficacy in treating juxtarenal abdominal aortic aneurysms (JRAAAs) and partial pararenal abdominal aortic aneurysms (PRAAAs). This innovative off-the-shelf device offers a potential alternative to traditional endovascular aortic repair. The successful outcomes, including technical success in all patients, freedom from major adverse events, and maintenance of clinical success at 12 months, suggest a potential shift in clinical practice towards using the WeFlow-JAAA endograft system for selected patients. This study paves the way for larger-scale, multicenter, prospective studies to further validate its long-term safety and efficacy, offering clinicians a new option for managing complex abdominal aortic aneurysms.

Five-year results of the LEOPARD trial of commercially available endografts

ObjectiveThe LEOPARD (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) trial is a randomized controlled trial comparing the outcomes of endovascular aneurysm repair (EVAR) using commercially available devices in a real-world population. MethodsA prospective, randomized, multi-center trial was performed to compare the anatomically fixated (AF) AFX/AFX2 endograft system (Endologix) with endografts with proximal fixation (PF) (Cook Medical Zenith Flex; Gore Excluder; and Medtronic Endurant II) in patients with infrarenal abdominal aortic aneurysms. The primary endpoint was freedom from aneurysm-related complications (ARCs), a composite endpoint consisting of perioperative death (≤30 days), aneurysm rupture, conversion to open surgical repair, postoperative endoleaks, endograft migration (≥10 mm), aneurysm enlargement (≥5 mm), endograft limb occlusion, and device- or aneurysm-related reintervention. ResultsThe study population was 455 patients enrolled at 56 United States centers: 235 patients were treated with AF devices and 220 with PF devices. The primary endpoint supported noninferiority of the AF cohort at 1 year. The 5-year freedom from ARC Kaplan-Meier estimates were 63.8% for AF patients and 55.5% for PF patients (P = .10). Kaplan-Meier estimates for freedom from aneurysm-related mortality were 98.7% and 97.0% in the AF group and 99.5% and 98.5% in the PF group at 1 and 5 years. There was no difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and type I and type III endoleak between the two cohorts. The type III endoleak rate at 5 years for the AFX cohort was 1.5% and 0.0% for the comparator cohort (P = .11). There was a lower type II endoleak rate in the AF group at 5 years (78.8% vs 68.4%; P = .037). There were zero open surgical conversions (0.0%) in the AF group and four (2.0%) in the PF group. ConclusionsThe 5-year results from the LEOPARD study demonstrated that there was no clinically significant difference in overall aneurysm-related outcomes between patients randomized to the AFX endograft system or commercially available endografts with proximal fixation.

The Altura endograft system for endovascular aneurysm repair: presentation of its unique design with clinical implications

ABSTRACT Introduction The Altura aortic endograft for the treatment of abdominal aortic aneurysms (AAA) consists of two separate components with a proximal double D-shaped design. The braided endoskeleton of the endograft is attached only at the proximal and distal ends of the inner surface of the fabric resulting in adjustable length of the Altura components. To ensure optimal orientation and sealing, the design of Altura permits collapse, readjustment, and deployment of the repositioned D-shaped endografts. Areas covered Since this new endograft design by Lombard presents unique characteristics, the aim of this article is to present its unique structure and deployment method and discuss its applicability, indications and associated concerns. Expert Opinion The Altura endograft revolutionizes the mechanism of infrarenal sealing by containing no main body at all. This feature allows ideal treatment of AAA with considerable offset of the renal arteries and permits also relining in cases of failing endografts or in cases where the short length of existing structures precludes deployment of conventional bifurcated endografts.

A prospective, multicenter, single-arm clinical trial cohort to evaluate the safety and effectiveness of a novel stent graft system (WeFlow-JAAA) for the treatment of juxtarenal abdominal aortic aneurysm: A study protocol.

IntroductionJuxtarenal abdominal aortic aneurysms (JRAAAs) are challenging to cure by traditional endovascular aortic repair (EVAR). Due to the inherent disadvantages of the customized fenestrated and/or branched aortic endografts (such as delayed cycles with a risk of aneurysm rupture, unavailable in emergency or confine operations), several off-the-shelf devices have been developed for the treatment of JRAAA. However, these devices being used in clinical trials have been proven to have a non-negligible risk of reintervention and inadequate anatomic applicability. We have developed a new off-the-shelf aortic endograft system (WeFlow-JAAA) with a mixed design of inner branches and modified fenestrations. The purpose of this cohort study is to assess the safety and effectiveness of the innovative aortic endograft system.Methods and analysisThis is a prospective, multicenter, single-armed clinical trial cohort study. The enrolment will take place in 29 centers in China, and 106 adult patients with JRAAA will be enrolled in total. Clinical information and CT angiography (CTA) images will be collected and recorded. Patients will be followed up for 5 years. The primary safety endpoint is the rate of no major adverse event within 30 days after index EVAR. The primary efficacy endpoint is the rate of immediate technical success and no JRAAA-related reintervention within 12 months after the procedure.

Initial Study of the Extended STABILISE Technique for Complete Remodeling in Aortic Dissection

Thoracic endovascular aortic repair (TEVAR) is the standard treatment for acute complicated type B aortic dissection (TBAD). However, long-term results reveal that TEVAR does not achieve a complete aortic remodeling and poses a risk of aneurysmal aortic degeneration. Distal re-entry treatment at the abdominal level seems to be necessary to obtain a complete remodeling in TBAD. Moreover, it is necessary to treat the aortoiliac bifurcation in patients with persistent true lumen collapse or limb ischemia. Between January 2018 and October 2019, 11 patients with acute or sub-acute complicated TBAD or non-A non-B aortic dissection were treated in our institution in an endovascular fashion. We performed the stent-assisted, balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique in all cases, but 2 cases required complementary treatment of the aortoiliac bifurcation with a bifurcated AFX endograft system for limb ischemia due to true lumen collapse. Technical success was obtained in all patients. No procedural complications occurred. No postoperative deaths, stroke, paraplegia, mesenteric, or renal ischemia were observed, and no secondary intervention was necessary. Satisfactory aortic re-modeling was obtained after the follow-up periods with a 57.5% mean true lumen expansion. Our initial experience using the extended STABILISE (e-STABILISE) technique using a bifurcated AFX endograft did not result in any postoperative mortality or complications. Without additional data, this technique should be reserved for specific patients who require revascularization of the aortoiliac bifurcation.

Is Newer Better? Comparison of Two Generations of a Thoracic Endograft System Utilizing the MAUDE Database

The Valiant Navion (VN) Endograft system (Medtronic, Santa Rosa), originally approved in 2018 for use in the United States for minimally invasive repairs of the descending thoracic aorta, was recalled on February 17, 2021 by the company due to stent fractures and stent ring enlargement observed during the clinical follow-up period. Medtronic reported two patients had confirmed Type IIIB endoleaks and one patient has died. Independent lab review indicated that 8% of patients (seven of 87) had stent ring enlargement beyond device specifications.

Long-term results of endovascular intervention with unibody bifurcation endograft for elective abdominal aortic aneurysm management.

Unibody bifurcated endografts have the advantage of reducing the operative time, avoiding migration and iliac limb dislocation in patient with abdominal aortic aneurysm (AAA). We report our long-term experience in patients who underwent endovascular aortic repair (EVAR) due to infrarenal AAA with Endologix AFX® endograft system. Between January 2013-December 2018, 68 patients with infrarenal AAA had EVAR procedure with Endologix AFX® endograft system. Mean follow-up was 40.4 ± 19.5 months, and all patients had computed tomography periodically, with colored Doppler ultrasonography (CDUS) every six months. Mean age was 68.5 ± 7.1 years and, 63 (92.6%) patients were male. Early mortality, renal complications, stent-graft migration and cardiac complications were not seen in early post-operative period. There was no early mortality in the group and no conversion to open repair. In long-term follow-up 12 patients (17.6%) had endoleak (5 with type II, 7 with type III). Overall survival estimated by Kaplan-Meier analysis was 94.1% at 1 year, 85.2% at 2 years, 74.1% at 3 years and 54.0% at 5 years. Freedom from second intervention and conversion was 98.4% at 1 year, 95.3% at 2 years, 93.3% at 3 years and 87.4% at 5 years. Endologix AFX® endograft provides a fast, safe and effective endograft for the early period, therefore it seems more suitable for elderly and comorbid patients. This endograft has low reintervention rates however according to our results, aneurysms larger than 6 cm may have more sideway displacement possibility and by this way type III endoleak. Proper patient selection and sufficient overlap are the key issues. Close monitoring is mandatory at the follow-up period.

Italian COLT Registry: A Multicenter Experience

The objective was to evaluate early and midterm results of elective and urgent endovascular treatment of complex thoracoabdominal aortic diseases with the custom-made multibranched COLT endograft system (JOTEC, Hechingen, Germany).

Initial Experience and Potential Advantages of AFX2 Bifurcated Endograft System: Comparative Case Series.

PurposeThe AFX2 endograft is a unibody, bifurcated stent graft that can be used to lower complications in certain patients. In this study, we retrospectively reviewed consecutive cases in which the AFX2 system was used to overcome the challenges of narrow distal aorta, as well as to reduce procedure time and contrast medium dose. Furthermore, we compared the results with matched patients treated using the Endurant II endograft system.Materials and MethodsThis was a retrospective observational study of nine patients with abdominal aortic aneurysm (AAA) who underwent endovascular aneurysm repair (EVAR) using the AFX2 device between June 2017 and April 2018 at Seoul National University Hospital. The patients had narrow distal aorta (n=3), reversed tapered neck (n=1), iliac artery aneurysm (n=2), chronic kidney disease patients (n=2), and impending rupture (n=1). Seven matched patients were treated using the Endurant II graft.ResultsIn the AFX2 group, the mean procedure time was 87.2 minutes, mean blood loss volume was 157.7 mL, and mean volume of contrast medium used was 48.3 mL. In the Endurant II group, the mean procedure time was 140.0 minutes, mean blood loss volume was 175.0 mL, and mean volume of contrast medium used was 119.3 mL.ConclusionOur preliminary experiences with selected AAA patients treated using the AFX2 endovascular repair system showed good outcomes compared with similar patients treated using the Endurant II system. Therefore, the AFX2 may be a good option to perform EVAR in patients of advanced age who have chronic kidney failure or narrow distal aorta.

Distal Extended Endovascular Aortic Repair PETTICOAT: A Modified Technique to Improve False Lumen Remodeling in Acute Type B Aortic Dissection

Data from the literature suggest that in patients with acute, complicated type B aortic dissection (cTBAD), initial successful treatment with thoracic endovascular aneurysm repair (TEVAR) is not necessarily associated with favorable remodeling of the dissected aorta during follow-up, and long-term results indicate that TEVAR failed to completely suppress false lumen patency. Sealing of all relevant distal reentries, infrarenal and/or iliac, seems to be the key issue to induce total false lumen thrombosis in abdominal aorta as well as the iliac arteries, especially in complicated patients presenting with malperfusion or complete true lumen collapse. Of the 34 consecutive patients diagnosed with cTBAD at our hospital from January 2015 to April 2018, 30 had complicated dissections receiving endovascular treatment according to the standard Provisional ExTension To Induce COmplete ATtachment (PETTICOAT) technique and were excluded from this study, whereas 4 patients with radiologic evidence of multiple reentry tears at detached lumbar arteries and iliac bifurcation with complete true lumen collapse and clinical evidence of malperfusion were treated with a modified PETTICOAT technique with distal extension of the aortic stent, balloon expansion of the stented true lumen, and use of the AFX bifurcated endograft system to preserve the natural aortic bifurcation and provide complete distal sealing of reentry tears. Primary technical success was achieved in all patients. No postoperative deaths were observed, but 1 patient experienced an hemorrhagic shock on the second postoperative day. No patient suffered postoperative stroke, paraplegia, paraparesis, or acute renal failure. Using an abdominal aortic bifurcated endograft with PETTICOAT to treat acute cTBAD seems to be a feasible approach in high-risk patients to improve aortic remodeling. The AFX bifurcated endograft system meets the requirements of anatomical fixation and sealing of distal tears.

Initial Clinical Experience Using the Low-Profile Altura Endograft System With Double D-Shaped Proximal Stents for Endovascular Aneurysm Repair

Purpose: To report the initial clinical results of endovascular aneurysm repair (EVAR) using the low-profile (14-F) Altura Endograft System, which features a double “D-shaped” stent design with suprarenal fixation and modular iliac components that are deployed from distal to proximal. Methods: From 2011 to 2015, 90 patients (mean age 72.8±8.3 years; 79 men) with abdominal aortic aneurysm (AAA; mean diameter 53.8±5.7 mm) were treated at 10 clinical sites in 2 prospective, controlled clinical studies using the Altura endograft. Outcomes evaluated included mortality, major adverse events (MAEs: all-cause death, stroke, paraplegia, myocardial infarction, respiratory failure, bowel ischemia, and blood loss ≥1000 mL), and clinical success (freedom from procedure-related death, type I/III endoleak, migration, thrombosis, and reintervention). Results: Endografts were successfully implanted in 89 (99%) patients; the single failure was due to delivery system malfunction before insertion in the early-generation device. One (1%) patient died and 4 patients underwent reinterventions (1 type I endoleak, 2 iliac limb stenoses, and 1 endograft occlusion) within the first 30 days. During a median follow-up of 12.5 months (range 11.5–50.9), there were no aneurysm ruptures, surgical conversions, or AAA-related deaths. The cumulative MAE rates were 3% (3/89) at 6 months and 7% (6/89) at 1 year. Two patients underwent coil embolization of type II endoleaks at 6.5 months and 2.2 years, respectively. Clinical success was 94% (84/89) at 30 days, 98% (85/87) at 6 months, and 99% (82/83) at 1 year. Conclusion: Early results suggest that properly selected AAA patients can be safely treated using the Altura Endograft System with favorable midterm outcome. Thus, further clinical investigation is warranted to evaluate the role of this device in the treatment of AAA.

Femoral Arterial Haemostasis Using an Anchored Collagen Plug after Percutaneous EVAR with an Ultra-Low Profile Device: Prospective Audit of an Evolving “Post-Close” Technique

To present an audit of a successful "post-close" haemostatic technique using the Angio-Seal VIP vascular closure device (VCD) after percutaneous endovascular aneurysm repair (p-EVAR) using an ultra-low profile (ULP) device. Thirty patients underwent EVAR using the Ovation device, of which 26 procedures were totally percutaneous. Data including patient habitus, procedural details, number of VCDs deployed including use of the double wire approach, and technical success/complications were prospectively recorded. Numerical/statistical analyses were undertaken using Microsoft Excel 2007 and Minitab for Windows. Thirty consecutive patients (27 male, 3 female; age range 70-85 years [mean 76.1, SD 6.5]) underwent EVAR for an infrarenal AAA (mean size 61mm, SD 9.7) between March 2014 and August 2016 using the Ovation endograft system. In a few patients open ipsilateral femoral access was used (n=4); the remainder underwent p-EVAR (n=26), and these results are presented hereafter. Ipsilateral sheath sizes used varied between 14F (n=22), 15F (n=3), and 16F (n=1), and were closed using a single 8F Angio-Seal (n=7), a combination of 8F/6F Angio-Seal VCDs (n=18), or two 8F Angio-Seal VCDs (n=1) with prior double wire set up. Contralateral punctures were closed mostly with a single 8F Angio-Seal (n=24) or combination of 8F/6F Angio-Seal VCDs (n=2) to seal defects downsized to 12F. The overall immediate haemostasis success rate was 100%. Mean length of stay in the p-EVAR cohort was 2 days (SD 1.5). All patients had a post-EVAR computed tomography angiogram (n=24) or duplex ultrasound (n=2) which did not reveal any stenoses or seromas; two patients developed an ipsilateral femoral pseudoaneurysm successfully treated by thrombin injection. A "post-close" technique can be employed successfully for haemostasis after p-EVAR using an ULP device. An 8F Angio-Seal is usually effective in closing a 12F femoral arterial defect. This represents a viable option for femoral arterial closure in this scenario.

Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

PurposeThe newly designed unibody AFX endograft system for endovascular aortic aneurysm repair is the only graft with anatomical fixation to the aortic bifurcation in comparison to most other grafts that use the infrarenal neck as the main fixation point. The aim of this study was to assess the preliminary results of the AFX stent-graft system used with infrarenal aortic component and compare them with those obtained in patients treated with a well established endograft of the same material and pure infrarenal fixation as the Gore Excluder.Materials and MethodsA retrospective analysis of prospectively collected data from March 2014 to December 2014 identified 10 elective abdominal aortic aneurysm patients treated with the AFX endograft, in comparison to a matched group of 20 patients treated with the Excluder stent-graft. Endpoints included technical and clinical success, freedom from any secondary intervention, any type of endoleak and aneurysm related death.ResultsPrimary technical success was achieved in all patients and no 30-day device related complications or deaths were occurred. The two groups were similar in terms of radiation burden, contrast media, duration of the procedure, post implantation syndrome and in-hospital stay. During a median follow-up period of 23 months (range, 18–26 months) there were no differences in clinical success, freedom from reintervention and aneurysm related death. No type I endoleak was observed in either group. Five of the 6 type II endoleaks (1 in the AFX and 4 in the Excluder group) spontaneously resolved, while in only one patient (Excluder) the endoleak remained without however any change in aneurysm sac diameter (log rank=0.34).ConclusionThe initial experience with the AFX stent graft system is promising, with successful aneurysm exclusion and good short-term results. Further and larger studies are needed to fully evaluate the sort as well as the long-term results.

Re-Rupture of Abdominal Aortic Aneurysm after Endovascular Repair from Infected Endograft

Introduction: Successful endovascular aortic aneurysm repair (EVAR) aims to prevent catastrophic rupture, however despite technical excellence at index operation, long term follow up remainsm and atory. This is due to the fact that delayed aortic rupture may occur in certain patients after EVAR. We present a technically challenging case which illustrates this concern. Case report: An 82 year old man underwent successful EVAR using a redesigned, clinical trial graft (Medtronic, Minneapolis, MN), five years prior to presentation. He was lost to follow after the initial procedure. At presentation to us, he demonstrated a 13.5cm, ruptured infrarenal aortic aneurysm due to proximal aortic neck enlargement and endograft slippage. Emergency repair included a proximal supra-renal endograft extension (Endologix, Irvine, CA), femoralfemoral bypass (PTFE), and open abdomen with negative-pressure therapy (Abthera, KCI, San Antonio, TX) He survived and was discharged with close follow-up. He re-presented six months later with flank pain and a WBC 22,000. A CT Scan was concerning for a new contained aortic rupture (16cm) and a recurrent proximal endograft slip. High clinical suspicion resulted in a return to operating room for axillary to femoralfemoral artery bypass (PTFE), followed by explantation of the endograft system, aortic sac resection, and omental flap coverage. Operative cultures yielded Staphylococcus epidermis. He survived again and was discharged on a plan for long term antibiotics on postoperative day 10. Conclusion: Long term follow up after EVAR may help to identify patients at high risk for endo-graft failures. Aortic neck enlargement leading to rupture may result from primary aneurysm growth, however infection can be an important cause. Time honored open aortic surgical techniques remain an important tool for every vascular surgeon.

Externalized Guidewires to Facilitate Fenestrated Endograft Deployment in the Aortic Arch

Purpose: To describe a precannulated fenestrated endograft system utilizing externalized guidewires to facilitate aortic arch endovascular repair and to report its use in 2 patients with challenging anatomy. Technique: For distal arch repair, a fenestration for the left subclavian artery (LSA) is made onsite in a standard thoracic endograft tailored to the patient anatomy; it is precannulated with a nitinol guidewire (NGw), which is passed from the femoral artery and externalized from the left brachial artery prior to endograft delivery system introduction over a parallel stiff guidewire. Steps are then taken to remove guidewire intertwining, prevent NGw wrapping around the delivery system, and orient the LSA fenestration superiorly when the delivery system moves into the arch. Gentle traction on the ends of the NGw during endograft deployment facilitates proper fenestration alignment. A covered stent is deployed in the LSA fenestration. The technique is illustrated in a patient with congenital coarctation of the aorta and descending aortic aneurysm. For total arch repair, endograft fenestrations are made for all 3 arch branches; the left common carotid artery (LCCA) and LSA fenestrations are each cannulated with NGws, which travel together from the femoral artery, pass through a LSA snare loop, and are exteriorized from the LCCA. After endograft deployment, the innominate artery fenestration is separately cannulated using right brachial access. Placement of a parallel externalized hydrophilic guidewire passing through the LCCA fenestration (but not the LSA snare loop) and removal of the LCCA fenestration NGw allows exteriorization of the LSA fenestration NGw from the left brachial artery by pulling the LSA snare. Covered stents are deployed in all 3 fenestrations. The technique is presented in a patient with type B aortic dissection. Conclusion: Use of the precannulated fenestrated endograft system described is feasible and has the potential to make aortic arch endovascular repair simpler, more reliable, and safer.

Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system

Endovascular treatment of abdominal aortic aneurysm (AAA) is associated with benefits over open surgery, yet limitations remain with current endovascular devices. This study was performed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors (Aptus Endosystems, Sunnyvale, Calif). This prospective, multicenter, single-arm investigational device exemption trial was conducted at 25 sites in the United States. A total of 155 patients were enrolled in the trial (mean age, 73 ± 8 years; male, 93.5%; mean AAA diameter, 53.6 ± 7.9 mm). The Aptus endograft is a two-component system: a multilumen, modular endograft with two docking limbs (Aptus Endograft System) and the Heli-FX Aortic Securement System comprising an electronically controlled applier (Heli-FX Applier) with helical EndoAnchors provided in a cassette and a deflectable sheath (Heli-FX Guide) designed for delivery of the applier to the target location for EndoAnchor implantation. The main eligibility criteria included proximal neck length of ≥12 mm, diameter of 19 to 29 mm, and infrarenal angulation of ≤60 degrees. The primary safety end point was freedom from major adverse events at 30 days, and the primary effectiveness end point was successful aneurysm treatment at 12 months. Thrombus-related events (TRE) were defined as limb occlusion or thromboembolism from the endograft. Subjects were observed for a median of 4.2 years, with imaging end points analyzed by a core laboratory and adverse events adjudicated by a clinical events committee. Among 155 enrolled subjects, 153 (98.7%) underwent successful implantation of the Aptus endograft and a median of five EndoAnchors; two subjects were converted to open surgical repair during the initial procedure. Overall, the primary safety and effectiveness end points were met in 98.1% and 97.4% of the subjects, respectively. Aneurysm-related mortality was 0.6%, with one postdischarge cardiac death 18 days after implantation. There were no AAA ruptures. There were no fractures of stents or EndoAnchors. There was one type I endoleak and one type III endoleak. Stent graft migration was noted in five subjects, none associated with sac enlargement, type I endoleak, or EndoAnchor dislocation from the endograft. AAA sac shrinkage of ≥5 mm at 1, 2, and 3 years was observed in 60.3%, 72.9%, and 81.7%, respectively. Sixty-one subjects (39.4%) experienced 113 TRE, associated with 80 reinterventions (in 58 subjects) unassociated with limb loss or death. A root cause analysis of TRE identified small, out-of-specification docking limbs with graft infolding and high local shear, resulting in thrombus formation within the endograft with subsequent distal embolization in some cases. Early results of the Aptus endograft trial met its safety and effectiveness end points; however, a high rate of TRE was observed because of manufacturing discrepancies. The findings confirm a low rate of type I and type III endoleaks, migration, and non-TRE reintervention with a high rate of aneurysm sac regression during midterm follow-up.

Early experience with ovation endograft system in abdominal aortic disease

ObjectiveWe describe our initial experience with the use of the TriVascular Ovation endograft system for the treatment of abdominal aortic aneurysms (AAA).MethodsWe retrospectively reviewed data from patients treated for AAA using the Ovation endograft at two institutions from January 2011 to September 2012. Main outcomes included primary success, survival, complications, and device-related events. The mean follow-up period was 10 months (range 1–22 months).ResultsThirty-seven patients (male: 95%, mean age: 76 yr) were treated for AAA (mean diameter: 54 mm) with the Ovation endograft. Local or regional anesthesia was used in 86.5% of cases. Percutaneous access was utilized in 73% of cases. Primary success was 89.2% (33/37). Four adjunctive procedures were required including two distal extensions (type 1b endoleak and iliac limb disconnection resulting in type III endoleak) and two bypass surgeries (limb graft occlusion and gate cannulation failure). No deaths or major complications were reported during the procedure or in follow-up. No type I, III, or IV endoleak, AAA enlargement, AAA rupture, stent fracture, migration, or endovascular or surgical reintervention were reported during the follow-up period. Type II endoleak was observed in two patients. Asymptomatic narrowing of both iliac limbs was observed in one patient at 6 months.ConclusionsOur initial experience with the Ovation endograft demonstrated encouraging results in patients with AAA.

Management of Complex Type Iiia Endoleak by Brachio-femoral Realignment and Interposition Stent Graft and Review of the Literature

EVAR has emerged as procedure of choice for morphologically suitable AAAs. Due to direct perfusion of aneurysm sac at systemic blood pressure, types I & III endoleaks are indicated for interventions even when patients are asymptomatic or have stable aneurysm size. Disconnection of components of modular endograft system and defect in the stent-covering graft fabric has been classified as type III a & b endoleaks respectively. Due to an overall smaller incidence, descriptive management of Type III endoleaks has been limited to very few case reports and needs to be individualized. We present a case of complex Type III a endoleak, 2 years following EVAR, where complete disjunction of main body and contralateral limb occurred with increase in aneurysm sac diameter. It was managed by brachio-femoral realignment and interposition stent graft. We also review the current literature on type III endoleak, its classification , risk factors and their management in current practice.

Clinical Ramifications of an Extended Proximal Seal Zone with a Novel Endograft System: First Report of 108 Consecutive Cases

Clinical Ramifications of an Extended Proximal Seal Zone with a Novel Endograft System: First Report of 108 Consecutive Cases

Early results of the Endurant endograft system in patients with friendly and hostile infrarenal abdominal aortic aneurysm anatomy

To evaluate and compare the outcome after endovascular abdominal aortic aneurysm repair (EVAR) with the newly released Endurant endograft system in patients with different aortoiliac anatomic characteristics. We conducted a prospective observational study assigning patients with infrarenal abdominal aortic aneurysm (AAA) treated with the Endurant endoprosthesis from February 2009 to March 2010. Two groups were studied, according to the presence of a friendly (group I [GI] = 43) or hostile (group II [GII] = 34) infrarenal aortoiliac anatomy. Hostile profile was defined as any (or combination) of the following measurements: 5 mm ≤ proximal neck length (Lpr) ≤ 12 mm, 60° < proximal neck angle (A°pr) ≤ 90° and 60° < any iliac axis angle (A°iliac) ≤ 90°. Primary end points included technical and clinical success, freedom from early or late secondary interventions, any type of endoleak, and aneurysm-related death. All outcome measures were calculated using the Kaplan-Meier method and the log rank test was applied for comparisons between the groups. The mean comorbid severity scoring was higher in GII (P = .018). The mean follow-up period in GI and GII was 12.9 ± 3.9 months (± SD, range: 6.4-19.8) and 12.4 ± 4 months (range: 4.2-19.6), respectively. Two unplanned conversions to aortouniiliac configurations were required in GI. The technical success rate in GI and GII was 95.4% and 100%, respectively. The requirement for intentional occlusion of the internal iliac artery, the requirement for cross-limb technique, the necessity of troubleshooting techniques, the procedure and radiation times, the frequency of postimplantation syndrome, and mean hospital stay were significantly higher in GII (P = .028, P = .013, P = .005, P = .037, P < .001, P = .032, P = .021, respectively). Two patients of GI died in the early postoperative period (one aneurysm but not device-related death), whereas no deaths in GII were recorded, yielding an overall 30-day mortality rate of 2.3%. No type I/III endoleaks were recorded up to the end of the study. Freedom from any type of endoleak, early or late secondary interventions, and aneurysm-related death at 12 months were found in 93.2%, 87.1%, and 93.3% of GI patients; respective values for GII were 86% (P = .21), 93.4% (P = .066), and 93.4%. The clinical success rate was 82.1% and 100% at 12 months for GI and GII, respectively. Early (12 months) results suggest similar clinical performance of the Endurant stent graft system in endovascular treatment of AAAs with friendly and hostile anatomies, however, demonstrating more intra- and perioperative adversities for the last group. Larger prospective studies or even randomized trials comparing different new generation graft models are required to evaluate the comparable long-term results and possible expansion of EVAR indications for this specific endograft in adverse anatomies.