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Purpose: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries.Materials and Methods: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months.Results: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory-adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months.Conclusion: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery. [ABSTRACT FROM AUTHOR]

There is no proven therapy to reduce growth rates of small- to medium-sized abdominal aortic aneurysms (AAAs). Ex vivo and animal studies have demonstrated that a novel stabilizing agent, 1,2,3,4,6-pentagalloyl glucose (PGG), delivered locally to the aneurysm sac, can bind to elastin and collagen to re-establish strength and resist enzymatic degradation. We aimed to demonstrate that a one-time administration of PGG solution to the aneurysm wall is safe and potentially effective to slow the growth of small- to medium-sized AAAs. Patients with small- to medium-sized infrarenal AAAs (maximum diameter <5.5 cm) were recruited. Via transfemoral access, a 14F or 16F dual-balloon delivery catheter was introduced into the aneurysm sac. A single, 3-minute, localized endoluminal infusion of PGG was delivered via a 'weeping' balloon to the aneurysm wall. Independent core laboratory measurements of maximum aneurysm sac diameter and sac volume measurements based on computed tomography angiography (CTA) were used for assessments at 1, 6, 12, 24, and 36 months. The primary endpoints were technical success and safety (major adverse events at 30 days). The secondary endpoint was growth stabilization, defined as freedom from aneurysm sac enlargement (diameter increase >5 mm per year or volume increase of >10% per year). Twenty patients (19 male) were enrolled at five centers from May 2019 to June 2022 (mean age, 67.8 years; range, 50-87 years). All procedures were technically successful. The safety profile was consistent with standard interventional procedures. Four patients demonstrated transient elevations of liver enzymes levels that returned to normal by 30 days with no clinical symptoms. Through November 2022, follow-up CTA data is available on the first 11 patients. The average changes in maximum aneurysm diameter from baseline to 6, 12, 24, and 36 months were 0.2 mm, 1.1 mm, 1.2 mm, and 0.8 mm, respectively, and the average changes in volume were 2.0%, 9.6%, 18.1%, and 11.6%, respectively. At 12 months, none of the aneurysms showed growth >5.0 mm, and three had volume growth >10%. The early results of this first-in-human, small cohort study demonstrated that a single, localized PGG administration to patients with small- to medium-sized infrarenal AAAs is safe. Longer term follow-up on all 20 treated patients is needed to better assess the potential impact on aneurysm growth. [ABSTRACT FROM AUTHOR]

Purpose: To report the results of the ASCEND Registry of cases involving endovascular aneurysm sealing (EVAS) in combination with chimney grafts (chEVAS) for the treatment of para- and juxtarenal aortic aneurysms (AAA).Methods: A retrospective, multicenter registry established in 8 vascular centers between 2013 and 2016 recorded the treatment results and follow-up of chEVAS procedures for nonruptured AAAs; data were analyzed using standardized outcome measures. In the observation period, 154 patients (mean age 72.3±7.7 years; 124 men) underwent elective treatment for de novo juxtarenal and pararenal aneurysms and formed the study group.Results: Sixty-two (40.3%) of the cohort were treated using a single parallel graft, 54 (35.1%) with double chimneys, 27 (17.5%) with triple chimneys, and 11 (7.1%) with 4 chimneys. The 30-day mortality was 2.8%, and there were 4 perioperative strokes (1 fatal). At 1 year, the freedom from all-cause mortality was 89.8% and the freedom from aneurysm-related mortality was 94.3%. There were 3 endoleaks within 90 days of the procedure, one type Ia and 2 type Ib. The freedom from type Ia endoleaks was 95.7% at 1 year. There were no types II or III endoleaks in this series; the freedom from all endoleaks was 94.2% at 1 year. Freedom from reintervention at 1 year was 89.2%. Target vessel patency rates at 1 year were 97.7%, 99.3%, 100%, and 100% for the left renal, right renal, superior mesenteric artery, and celiac axis stents, respectively.Conclusion: The ASCEND Registry supports a proof of concept for the use of polymer technology and EVAS with parallel grafts in managing patients with complex aortic disease. The future role of chEVAS will be defined by studies that assess mid- to long-term durability. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the safety and efficacy of a next-generation balloon-expandable stent-graft for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.Methods: A prospective, multicenter, single-arm safety and efficacy study ( ClinicalTrials.gov identifier: NCT02080871) of the VBX Stent Graft for treatment of de novo or restenotic lesions in the iliac arteries was conducted under an Investigational Device Exemption at 26 US sites and 1 New Zealand center. The study eligibility criteria were established with the aim of enrolling more "real-world" patients compared with previous iliac stent studies supporting Food and Drug Administration approval. The study enrolled 134 patients (mean age 66±9.5 years; 79 men) with 213 iliac lesions. Three-quarters of the population (101, 75.4%) had Rutherford category 3 ischemia, and 43 (32.1%) patients presented with TASC II C/D lesions. The primary endpoint was a composite of device- or procedure-related death within 30 days, myocardial infarction within 30 days, target lesion revascularization (TLR) within 9 months, and amputation above the metatarsals in the treated leg within 9 months.Results: In all, 234 devices were implanted in 213 lesions with 100% technical success; 57 (42.5%) patients received kissing stents at the aortic bifurcation. No devices exhibited a discernable change in length after final deployment as determined by independent core laboratory quantitative angiographic analysis. At 9 months, 3 (2.3%) of 132 patients (1 lost to follow-up, 1 unrelated death) experienced a major adverse event (3 TLRs) related to the primary endpoint. At 9 months, there were no device-related serious adverse events or unanticipated adverse device effects.Conclusion: The next-generation balloon-expandable stent-graft demonstrated notable 9-month safety and efficacy in treating iliac occlusive disease in patients reflecting common clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: To describe the feasibility and technical aspects of a proximal Nellix-in-Nellix extension to treat caudal stent-graft migration after endovascular aneurysm sealing (EVAS) in the in vitro and in vivo settings.Methods: In vitro studies were designed (1) to assess inner diameters of Nellix-in-Nellix extensions after postdilation with 12-mm balloons and (2) to test wall apposition in tubes with different diameters using a Nellix-in-Nellix stent-graft that extended out of the original Nellix stent-graft lumen by 10, 20, 30, and 40 mm. Simulated-use experiments were performed using silicone models in conjunction with a pulsatile flow pump. In the clinical setting, 5 patients (median age 74 years, range 73-83) presented at 2 centers with type Ia endoleak secondary to caudal Nellix stent-graft migration measuring a median 9 mm (range 7-15) on the left and 7 mm (range 0-11) on the right. Median polymer fill volume at the initial EVAS procedure was 42.5 mL (range 25-71). The median time to reintervention with a proximal Nellix extension was 15 months (range 13-32).Results: In vitro, the inner diameters of the Nellix-in-Nellix extensions were consistent after postdilation. Cases with 10 and 20 mm of exposed endobag resulted in a poor seal with endoleak, while cases with 30 and 40 mm of exposed endobag length exhibited angiographic seal. Fill line pressures of the second Nellix were higher than expected. In the 5 clinical cases, chimney grafts were required in each case to create an adequate proximal landing zone. The Nellix-in-Nellix procedure was successful in all patients. There were no procedure-related complications, and no endoleaks were observed during a median 12-month follow-up. Reinterventions were performed in 2 patients because of in-stent stenosis and chimney graft compression, respectively.Conclusion: Proximal Nellix-in-Nellix extension can be used to treat caudally migrated Nellix stent-grafts and to treat the consequent type Ia endoleak, but the technique differs from primary EVAS. The development of dedicated proximal extensions is desirable. [ABSTRACT FROM AUTHOR]

Purpose: To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis.Methods: A prospective, single-center pilot study recruited 30 symptomatic patients (mean age 64 years; 18 men) to evaluate the safety and early efficacy of the new Gore balloon-expandable covered endoprosthesis for the treatment of de novo or restenotic common and/or external iliac artery lesions. According to protocol, up to 2 discrete lesions could be treated with a maximum total treated length ≤110 mm. Follow-up included clinical evaluation with duplex ultrasound at 1, 6, and 12 months. Data are presented through 12-month follow-up. The primary safety endpoint was a composite of device- or procedure-related death, myocardial infarction, or amputation in the treated leg within 30 days of the index procedure. Multiple performance outcomes were also evaluated.Results: The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revascularization, and freedom from target vessel revascularization were 100% at 1 and 6 months and 96.6% at 12 months. Estimates of assisted primary and secondary patency were both 100% at 12 months. Freedom from major adverse events at 12 months was 100%. Most patients experienced improvements in Rutherford category, ankle-brachial index, and functional status that were sustained to 12 months.Conclusion: This positive first-in-human experience with the Gore balloon-expandable covered endoprosthesis suggests this device will have an important role in the management of aortoiliac occlusive disease. [ABSTRACT FROM AUTHOR]

Purpose: To show feasibility of the covered endovascular repair of the aortic bifurcation (CERAB) technique in conjunction with chimney grafts in aortic side branches for complex aortoiliac occlusive disease.Methods: Two European centers and one facility located in New Zealand participated in a retrospective observational study that enrolled 14 consecutive patients (mean age 61.2±8.9 years; 11 men) treated with CERAB in conjunction with chimney graft(s) between December 2012 and May 2015. Indications for treatment included disabling claudication in 9 and critical limb ischemia in 5. Lesions were classified as TransAtlantic Inter-Society Consensus II B (n=1), C (n=1), or D (n=12).Results: A total of 15 chimney grafts were used to perfuse the inferior mesenteric artery (n=8), the right renal artery (n=4), and the left renal artery (n=3). Technical success was achieved in all cases. Procedural complications included 5 unintended dissections and 1 vessel thrombosis, all of which were successfully treated intraoperatively. Five patients developed access-site hematoma/ecchymosis (3 at the brachial access). Mean follow-up was 12 months (range 6-24) without death or loss to follow-up. One patient suffered occlusion of a CERAB limb and an IMA chimney graft; the former was recanalized, but the IMA graft was not; there were no signs of bowel ischemia. Ankle-brachial indices significantly increased from 0.54 (range 0.47-0.60) preoperatively to 0.97 (range 0.90-1.00) in 11 patients examined at 12 months, and all patients had an improvement in the Rutherford category. All CERAB limbs, including the one recanalized, were patent at the most recent follow-up, as were 14 of 15 chimney grafts.Conclusion: Chimney-CERAB is technically feasible and may offer an alternative to open surgery for complex aortoiliac occlusive disease. Further prospective studies are needed to confirm these findings. [ABSTRACT FROM AUTHOR]

To our knowledge this is the first reported case of AUF following endovascular stent graft treatment. Common stent graft complications include endoleak, stent graft migration, wireform fracture, limb thrombosis, limb stenosis/kink and stent graft infection.[3] Although AUF has been documented post open aortic rupture repair in the literature, this has not been a reported complication post endovascular aneurysm therapies.[4] The mechanism for the development of AUF in our case remains unclear. [Extracted from the article]

Purpose: To report the early and 12-month results of a global registry of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic aneurysms (AAAs).Methods: The EVAS FORWARD Global Registry was a postmarket, multicenter, open-label, single-arm registry that enrolled 277 patients (mean age 75 years; 228 men) treated with the Nellix EVAS system for nonruptured AAAs at 18 sites over a 1-year period. The cohort had challenging aortic anatomy, with 17% having a proximal aortic neck length <10 mm, 8% a neck angulation >60°, and 20% an iliac diameter >25 mm. Baseline and follow-up computed tomography images were assessed by an independent core laboratory, and major adverse events were reviewed by an independent safety committee.Results: Three patients died within 30 days of the procedure (none device-related). There were 13 endoleaks recorded in this time frame: 8 type Ia, 1 type Ib, and 5 type II. Root cause analysis demonstrated that the majority of type Ia endoleaks were due to technical error (low device placement and underfilling of the endobags). Between 30 days and 1 year, there were 4 new type Ia endoleaks; all were treated. There was also 1 type III endoleak between a Nellix device and a distal extension limb. At 1 year, the persistent endoleak rate was 0.7% (1 type Ia and 1 type II). The Kaplan-Meier estimates of freedom from types I and II endoleak at 12-month follow-up were 96% and 98%, respectively. The estimate of freedom from open conversion (n=7) was 98% at 12 months and the rate of freedom from any reintervention was 92%. The need for secondary intervention was associated with aortic morphology; for patients meeting the requirements of the instructions for use (IFU), the freedom from reintervention at 12 months was 98% compared with 86% when the implant was outside the IFU (p=0.009). At 1 year, the estimates of freedom from aortic-related and all-cause mortality were 98% and 95%, respectively.Conclusion: The EVAS FORWARD Global Registry documents the 12-month outcome of EVAS in an unselected group of patients with challenging aortic morphology. The results at present appear acceptable with regard to perioperative outcomes and complications. The type II endoleak rate is low. The place of EVAS in the armamentarium of techniques to treat AAAs will be defined by durability data in the longer term. [ABSTRACT FROM AUTHOR]

Endovascular repair of abdominal aortic aneurysms (EVAR) is now an established treatment modality for suitable patients presenting with aneurysm rupture. EVAR for ruptured aneurysms reduces transfusion, mechanical ventilation, intensive care. and hospital stay when compared with open surgery. In the emergency setting, however, EVAR is limited by low applicability due to adverse clinical or anatomical characteristics and increased need for reintervention. In addition, ongoing bleeding from aortic side branches post-EVAR can cause hemodynamic instability, larger hematomas, and abdominal compartment syndrome. Endovascular aneurysm sealing, based on polymer filling of the aneurysm, has the potential to overcome some of the limitations of EVAR for ruptured aneurysms and to improve outcomes. Recent literature suggests that endovascular aneurysm sealing can be performed with early mortality similar to that of EVAR for ruptured aortic aneurysms, but experience is limited to a few centers and a small number of patients. The addition of chimney grafts can increase the applicability of endovascular aneurysm sealing in order to treat short-neck and juxtarenal aneurysms as an alternative to fenestrated endografts. Further evaluation of the technique, with larger longitudinal studies, is necessary before advocating wider implementation of endovascular aneurysm sealing in the emergency setting. [ABSTRACT FROM AUTHOR]

The published evidence on clinical outcomes of Nellix Endovascular Aneurysm Sealing for elective abdominal aortic aneurysm repair has confirmed low procedural morbidity and reintervention rate. This early clinical experience with Nellix is encouraging, despite the device and procedural steps being in evolution, and patients being treated outside of the recommended instructions for use. The long-term follow-up of a treated patient cohort is now available and demonstrates low aneurysm-related mortality and morbidity. The initial experience with the commercially available Nellix device was captured in a multicenter report involving 171 patients and two independently monitored, company-sponsored device registries (EVAS Forward Global Trial and Forward US Investigational Device Exemption Trial). All three clinical studies report a 99% procedural technical success, low mortality, and persistent endoleak rate with re-intervention rates comparable to conventional EVR device registries. Nellix EVAS is applicable to a range of aneurysm anatomies, including patients with isolated of concomitant iliac artery aneurysms. The post-procedural imaging appearances after Nellix EVAS are unique due to the AAA sac polymer, change with time, but are now well understood. [ABSTRACT FROM AUTHOR]

Purpose: To assess the feasibility and safety of the endovascular aneurysm sealing (EVAS) technique in the treatment of acute abdominal aortic aneurysm (AAA).Methods: A retrospective, multicenter, observational study was conducted at 8 centers (7 European and 1 in New Zealand) experienced with EVAS in the elective setting. From February 2013 to April 2015, 58 patients (mean age 74±9 years; 46 men) with an acute AAA were treated (28 ruptured and 30 symptomatic). The primary endpoint of the study was 30-day mortality; secondary endpoints included endoleak, reinterventions, and 30-day morbidity.Results: The overall intensive care unit and hospital stays were 2.2±6.6 days and 9.7±11.4 days, respectively. Thirty-day mortality rates were 32% (9/28) for the ruptured group and 7% (2/30) for the symptomatic group, with morbidity rates of 57% and 17%, respectively. Early endoleak was present in only 2 (3%) patients, one in each group; both leaks were type Ia. Reinterventions within 30 days were performed in 8 patients in the ruptured group; in the symptomatic patients, the only perioperative reintervention was embolization a type Ia endoleak. The mean follow-up was 9.3±3.1 months in the ruptured group and 12.4±5.4 months in the symptomatic group. The mean aneurysm diameter at 30-day follow-up was 71.8±16.0 mm compared with 74.7±15.7 mm preoperatively in the ruptured group and 66.1±13.5 mm compared with 65.8±13.0 mm in the symptomatic group.Conclusion: EVAS in the acute setting appears safe and feasible and concordant with the literature for endovascular aneurysm repair. More robust prospective and comparative data are required to establish the position of the technique in the treatment algorithm of acute AAA. [ABSTRACT FROM AUTHOR]

Endovascular aneurysm sealing (EVAS) using the Nellix system is a new and different method of abdominal aortic aneurysm repair. Normal postoperative imaging has unique appearances that change with time; complications also have different and specific appearances. This consensus document on the imaging findings after Nellix EVAS is based on the collective experience of the sites involved in the Nellix EVAS Global Forward Registry and the US Investigational Device Exemption Trial. The normal findings on computed tomography (CT), duplex ultrasound, magnetic resonance imaging, and plain radiography are described. With time, endobag appearances change on CT due to contrast migration to the margins of the hydrogel polymer within the endobag. Air within the endobag also has unique appearances that change over time. Among the complications after Nellix EVAS, type I endoleak usually presents as a curvilinear area of flow between the endobag and aortic wall, while type II endoleak is typically small and usually occurs where an aortic branch artery lies adjacent to an irregular aortic blood lumen that is not completely filled by the endobag. Procedural aortic injury is an uncommon but important complication that occurs as a result of overfilling of the endobags during Nellix EVAS. The optimum imaging surveillance algorithm after Nellix EVAS has yet to be defined but is largely CT-based, especially in the first year postprocedure. However, duplex ultrasound also appears to be a sensitive modality in identifying normal appearances and complications. [ABSTRACT FROM AUTHOR]