Konstantinos Lagios

The Aorfix stent-graft to treat infrarenal abdominal aortic aneurysms with angulated necks and/or tortuous iliac arteries: midterm results.

Purpose: To present performance data on the use of the Aorfix stent-graft in patients with hostile infrarenal abdominal aortic aneurysm (AAA) anatomy. Methods: A study protocol was designed to examine the safety and efficacy of the Aorfix endovascular stent-graft in AAA patients who had a proximal neck diameter between 18 and 30 mm, neck angulation between 60° and 90°, and/or severe iliac artery angulation/tortuosity. Between September 2005 and April 2009, 20 men (mean age 72.4±7.7 years, range 55–89) were enrolled in the study. The mean AAA diameter was 61.8±14.9 mm (range 45.5–102). The mean angulation of the proximal neck was 61.9°±16.5° (range 30°– 90°); in the iliac arteries, the angulation was 59.9°±16.3° (range 30°–85°) for the left and 60.9°±17.6° (range 28°–90°) on the right. Fourteen (70%) patients had >60° proximal neck angulation. Outcome measures were analyzed using life-table analysis. Results: The graft was successfully implanted in all but 1 patient (technical success 95%); failure to cannulate the contralateral iliac limb resulted in conversion to aortomonoiliac stent-graft placement. In 1 patient, bilateral renal artery stent rescue was performed due to severe procedure-related stenosis. Occlusion of an internal iliac artery was noted in 2 patients. Mean follow-up was 26.9 months (range 4.5–43.5). No aneurysm-related rupture or death occurred. Two endoleaks were observed: 1 type I without migration at 3 years and 1 type II at 13 months. Freedom from any type of endoleak was 91.6% at 1 year and 75.9% at 2 years. Freedom from any early or late intervention was 88.8% at 1 year and 76.0% at 2 years. Aneurysm sac shrinkage (>5 mm) was evident in 79% (11/14) of the cases reaching 12-month follow-up. Conclusion: The Aorfix device seems to be safe and reliable in purely complex infrarenal AAA anatomy, demonstrating good short and midterm clinical outcomes. Further larger or multicenter studies are needed to confirm the suitability of the Aorfix stent-graft in hostile infrarenal AAA anatomy.

Primary EndoAnchoring in the Endovascular Repair of Abdominal Aortic Aneurysms With an Unfavorable Neck

Purpose To investigate the feasibility and early results of endoanchoring (endostapling) using a new commercially available device as an adjunctive procedure during endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with an unfavorable proximal neck. Methods Between June 2010 and May 2012, 13 consecutive patients (all men; median age 73 years, range 62–82) were prospectively enrolled in a 2-center registry to follow outcomes of adjunctive primary endoanchoring (Aptus HeliFX Aortic Securement System) of the proximal endograft to enhance proximal graft fixation and sealing during EVAR. Indications for proximal neck endoanchoring included at least one of the following: neck angulation 45° to 90°, length 8 to 15 mm, diameter 29 to 33 mm, conical neck configuration, or an irregularly shaped neck. The median AAA diameter was 56 mm (range 50–98). The Endurant stent-graft was implanted in 4 patients and the Zenith device in 9. Results A median of 4 endoanchors were implanted per patient (range 3–10) in adjunctive procedures that required a median 12 minutes (range 7–20). Intraoperatively, 2 proximal type I endoleaks were present following endoanchor implantation (85% primary technical success); a cuff was deployed in 1 case, which successfully sealed the endoleak (92% assisted primary technical success). The second proximal type I endoleak was minute and sealed spontaneously within 30 days. No further major device-related complications occurred intraoperatively. In the 30-day perioperative period, the only procedure-related complications were 2 type II endoleaks, which required no intervention. Over a median follow-up of 7 months (range 2–17), no further complications occurred apart from an asymptomatic internal iliac artery occlusion and a non-lethal myocardial infarction at 9 months. The type II endoleaks spontaneously sealed. No endograft migration was noticed nor loss of endoanchor integrity. No deaths occurred throughout follow-up. Conclusion Primary endoanchoring using the HeliFX aortic securement system is feasible, and early results were promising in this series.

Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study

Background and purpose The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer. Materials and methods The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes. Results Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period. Conclusions The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods. Clinical trial registration NCT02390037.

Percutaneous endovascular treatment of aortic aneurysms: Clinical evaluation and literature results

Abstract In this study we aimed to evaluate the efficiency of percutaneous endovascular aortic aneurysm repair (p-EVAR). Anatomically selected patients treated with a single 10Fr Perclose Prostar XL vascular closure device (VCD) were examined. Primary success rate and common femoral artery (CFA) open conversion (OC) requirement per sheath size used were recorded. A literature review on p-EVAR results was also performed. One-hundred patients were enrolled. Successful p-EVAR was achieved in 183 of the 196 CFA access sites (93.4%), and was specifically 85.9% and 98.3% for sheaths ≥20Fr and ≤18Fr respectively. There were 13 periprocedural complications (bleeding = 10, arterial dissection and thrombosis = 1, pseudoaneurysm = 2) all leading to OC. Use of ≥20Fr sheaths had significantly higher OC rate (P < .05). Reconstruction was achieved with primary repair (N = 11) and patch angioplasty (N = 2). Mean hospital stay was 1.8 days. The literature review (vascular closure of 2921 CFA access sites) revealed an overall technical success rate of 92.3%. Device related- were more common than patient related-OCs (P < .05). p-EVAR procedures are safe and feasible. Sheath size is a significant predictor of OC rate and more OCs might be expected with very large (≥20Fr) sheath sizes.

Improving Endograft Stability by Accommodation onto the Aortic Bifurcation

Purpose: To report the technique for deploying a 3-part endovascular graft onto the native aortic bifurcation for greater stent-graft stability. Technique: The Zenith Composite Endovascular Graft is a 3-part system consisting of a proximal tubular body with an uncovered Gianturco Z stent, a distal bifurcated body, and a contralateral leg. Proximally, 8-mm flexible interstent gaps facilitate precise infrarenal aortic placement, even in angulated necks. Technically, the bifurcated part is deployed first and pulled down to the aortic bifurcation, while the tubular main body and contralateral leg deployment follow. Using this technique to accommodate the graft onto the natural aortic bifurcation, distal stability can be enhanced and graft migration minimized. Conclusion: The Composite configuration can be an alternative to ensure a higher security index in difficult anatomies. It may be beneficial in patients with short (10–15 mm), angulated (>60°), or conical necks and deserves investigation in these patient populations.

O-020 Treatment of intracranial aneurysms with pipelinetm flex embolization device with shield technologytm : angiographic and safety outcomes at 1 year follow-up

Introduction/Purpose The Pipeline™ Embolization Device (PED) is a flow-diverter available for treatment of intracranial aneurysms (IAs). We assessed the long-term safety and angiographic outcomes of a new generation of PED, Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline™ Shield). The Pipeline™ Shield device features the same implant and delivery system as the Pipeline™ Flex Embolization Device, but has been modified to include a surface synthetic biocompatible polymer to reduce the thrombogenicity of the braid surface. Materials and Methods The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. Patients with IA located in the internal carotid artery (ICA) up to the carotid terminus or vertebral artery segment up to and including the posterior inferior cerebellar artery were included. The primary study endpoint was the occurrence of major stroke in the territory supplied by the treated artery or neurological death at 1 year post-procedure. An independent Clinical Events Committee (CEC) adjudicated all adverse events. The study also assessed angiographic outcomes at 1 year post-procedure, and angiographic images in standard and working views that corresponded to the treatment angiograms were interpreted by an independent core radiology laboratory. Results Fifty patients with 50 unruptured target IAs, 49 (98%) saccular and 1 (2%) fusiform, were treated. The mean age was 53.0±13.01 years, and 82% (41/50) of the patients were female. The mean target aneurysm diameter was 8.82±6.15 mm. Twenty-four aneurysms (48%) were small (<7 mm), 14 (28%) were medium (7–12 mm), 11 (22%) were large (13–24 mm), and 1 (2%) was giant (≥25 mm). Forty-seven (94%) aneurysms were located in the internal carotid artery, and 3 (6%) were located in the vertebral artery. Device deployment was successful in all patients. The mean number of Pipeline Shield utilized per aneurysm was 1.1±0.27. Complete wall apposition was achieved immediately post-procedure in 48 (96%) cases. No major strokes or neurological deaths were reported through 1 year post-procedure. There were 3 procedure-related, serious adverse events (headache, diplopia and retroperitoneal hematoma) and 1 device-related serious adverse event (intracranial arterythrombosis) observed through 1 year follow up. Complete aneurysm occlusion was achieved in 83.9% of target aneurysms at 1 year post-procedure. There were no reports of target aneurysm recurrence or retreatment. Conclusions The PFLEX study is the first prospective study to evaluate the use of the Pipeline Shield device. The results from the study are comparable to previously published results with the earlier generation devices, and demonstrate that the Pipeline Shield device is safe and effective for treatment of intracranial aneurysms. Disclosures M. Martínez-galdámez: 2; C; Proctor and consultant for Medtronic. S. Lamin: 2; C; Proctor and consultant for Medtronic. K. Lagios: None. T. Liebig: 2; C; previously consulted and proctored for Covidien, Stryker, and MicroVention, and currently serves as a proctor and consultant for Sequent Medical.. E. Ciceri: None. R. Chapot: None. L. Stockx: None. S. Chavda: None. C. Kabbasch: None. G. Farago: None. H. Nordmeyer: None. T. Boulanger: None. M. Piano: None. E. Boccardi: 2; C; receives honoraria from Medtronic and serves as a consultant for Medtronic.

Thoracic Aortic Injury: Embolization of the Tenth Intercostal Artery and Endovascular Treatment in a Young Woman after Posterior Spinal Instrumentation.

Iatrogenic aortic injuries are rare and well-recognized complications of a variety of procedures, including spinal surgery. The placement of pedicle screws is sometimes associated with devastating consequences. Aortic perforation with rapid hematoma formation and delayed aortic trauma leading to pseudoaneurysm formation have been described in the literature. A case describing a significant time interval between iatrogenic aortic injury and diagnosis in the absence of pseudoaneurysm formation is described in this paper and, according to our knowledge, is unique in the literature. The aortic injury was successfully treated, selecting the appropriate graft and, as a consequence, normal spinal cord blood flow was achieved.

Surviving common carotid rupture caused by a cervical abscess.

Case Report: This article describes the events preceding and following the rupture of the right common carotid artery caused by a cervical abcess. Stent grafting resulted in a good outcome.