1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System: The IRONGUARD 2 Study.

OBJECTIVES: The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry. BACKGROUND: DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion. RESULTS: At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence. CONCLUSIONS: This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.

VI2TA2 S2C2ORE: a new score system for in hospital mortality in acute aortic dissections.

INTRODUCTION: Aortic dissections classification systems have always been an argument of debate. It is well known that none of the described classifications is complete and easy at the same time. While the more used classification is currently the Stanford classification, it is clear that type A and B dissections prognosis can dramatically vary, depending on many different characteristics that they can present. The aim of this study was to propose a new severity score system that could reflect the risk of in hospital mortality of acute aortic dissections. EVIDENCE ACQUISITION: Through a review of the literature, studies describing significant predictors of in hospital mortality of any type of aortic dissection were searched and selected by predefined selection criteria. EVIDENCE SYNTHESIS: Nine studies met the criteria and were finally analyzed. The Odds Ratios of the reported predictors were the basis to the drawing of the score system. Sixteen main in hospital mortality predictors were found, 14 of which described in more than one study. They were combined into a new severity score system that we named VI2TA2 S2C2ORE. CONCLUSIONS: This is a simple risk score that we propose as a first assessment risk-evaluating tool. We look forward to validate it and to describe specific in hospital mortality risk ranges once it will be adopted.

"Over-SIRIX": A New Method for Sizing Aortic Endografts in Combination with the Chimney Grafts: Early Experience with Aortic Arch Disease.

BACKGROUND: Large gutters after chimney procedures are one of the main causes of type I endoleak (EL-I). This study aims to evaluate a new tailored planning named "Over-SIRIX," based on Osirix Imaging Software, to choose the correct main graft oversizing in order to minimize EL-I incidence. METHODS: From 2008 to 2015, 34 patients were treated with parallel grafts for aortic arch diseases at our institution. The study included 22 patients with single stent and antegrade flow configuration; they were divided into 2 groups (PRE- and POST-"Over-SIRIX"). "Over-SIRIX" was carried out in the retrospective group (PRE-"Over-SIRIX"), and it was used to plan the endovascular procedure in the prospective group (POST-"Over-SIRIX"). Through the multiplanar reconstruction (MPR) of the preoperative computed tomography angiography (CTA), the proximal neck of the chimney grafts was studied. Stent and endograft configurations were drawn in order to minimize the "gutters." To obtain the ideal main graft sizing (I-Size), a formula was used by adding the custom sizing (C-Size) to the disease oversizing (D-Over). The same MPR imaging was evaluated on postoperative CTA to study gutters area and presence of EL-I. RESULTS: The mean I-Size was 41.67 mm that was equivalent to an ideal oversizing of 19.3% (range 10-28%). The gutters area decreased from 7.3 to 1.7 mm2 (PRE/POST) and EL-I rate from 28.5% to 0% (PRE/POST). Gutters area bigger than 7.5 mm2 and planning made without "Over-SIRIX" were significantly associated (P < 0.05) to EL-I. CONCLUSIONS: "Over-SIRIX" appears to be a feasible method to customize planning during chimney technique, reducing the risk of EL-I which is significantly related to the presence and size of the gutters.

Towards an entirely endovascular aortic world: an update of techniques and outcomes for endovascular and open treatment of type I, II, and III endoleaks.

Endovascular aneurysm repair (EVAR) is largely the most adopted strategy for aneurysmal disease of the aorta. Nevertheless, the high incidence of reintervention makes it difficult to identify EVAR as a definitive solution; in particular, the most frequent indication of reintervention is endoleak, which is defined as persistent flow into the aneurysmal sac from different sources. Several treatment strategies are described. A contemporary literature search was performed with the intent of describing techniques and outcomes of endovascular and open strategies to type I, II, and III endoleak. Described techniques and outcomes were organized by indication (type I, II, and III endoleak) and by type of approach (endovascular, open, and laparoscopic) to give an overview of the current status of the treatment for the three most frequent types of endoleak. Several endovascular means are described in the literature for the treatment of endoleak.

Outcomes of 1000 Carotid Wallstent Implantations: Single-Center Experience.

PURPOSE: To evaluate the outcomes of carotid artery stenting (CAS) with Wallstents in a single-center experience. METHODS: From January 2003 to December 2013, 1000 carotid artery lesions were treated with Carotid Wallstents under cerebral protection in 877 patients (mean age 71.7 ± 8 years; 621 men). Indications for treatment were de novo lesions (>70% asymptomatic and >60% symptomatic); stenoses following carotid endarterectomy, radiation, or neck surgery; contralateral laryngeal nerve palsy; and high surgical risk. All the patients underwent duplex ultrasound and clinical evaluation during follow-up; radiography was performed when fracture or stent migration was suggested by ultrasound. RESULTS: Procedure success was achieved in 99.3% of patients. Major and minor 30-day adverse events occurred in 2.1% of patients, including stroke (1.8%: 1.3% minor, 0.5% major), myocardial infarction (0.1%), and death (0.2%). Plaque morphology, nature of stenosis, and symptomatic status were significantly associated with the risk of postoperative neurologic events. Restenosis occurred in 3.2% at a mean 45.5-month follow-up and was significantly associated with diabetes, smoking, symptomatic stenosis, de novo stenosis, and calcification (plaque III/IV). No fracture or migration was registered during follow-up. CONCLUSION: CAS is a valid method for treating carotid artery disease, with very low rates of major adverse events and neurologic complications. The Carotid Wallstent seems to have excellent results, even with complex plaque morphology, and a low incidence of restenosis at follow-up.

Spontaneous dissection of the extracranial vertebral artery: indications and long-term outcome of surgical treatment.

Spontaneous dissection of the vertebral artery (VA) is usually managed medically. The objective of this report was to describe 10 patients treated surgically for spontaneous dissection of the VA. Seven men and three women with a mean age of 52.5 +/- 11.3 years were treated between December 1978 and January 2001. In eight cases the presenting symptom was neck pain. Transient ischemic attack or completed stroke in the vertebrobasilar distribution followed in nine cases. In the remaining case, symptoms resulted from irritation of the superior roots of the brachial plexus. Dissection was located in one segment of the VA in seven cases and two contiguous segments in three cases. Lesions involved aneurysm in seven cases, tight stenosis in two, and occlusion in one. The decision to perform surgery was made because of either continued symptoms despite maximal anticoagulation therapy or the presence of an aneurysm causing recurrent thromboembolism or threatening rupture. In eight cases the revascularization procedure consisted of bypass from the carotid artery to the distal VA. In the remaining two cases revascularization was achieved by transposition of the VA directly onto the common or internal carotid artery. Postoperative recovery was uneventful in all cases. No further neurological events were observed in any patient at a mean follow-up of 96.9 +/- 66 months (range, 12-216 months). Long-term resolution of vertebrobasilar symptoms was achieved in all cases, including one patient whose bypass occluded at 6 months. From these results we conclude that surgical treatment is the method of choice for spontaneous dissection of the extracranial VA associated with continued vertebrobasilar symptoms despite maximal medical therapy or with an expanding aneurysm. The most useful technique is bypass to the distal VA. Morbidity is low and long-term outcome is excellent.

Distal vertebral artery reconstruction: long-term outcome.

PURPOSE: The purpose of this article was to report our long-term results of distal vertebral artery (DVA) reconstruction. METHOD: From 1978 to 2001 we performed 352 DVA reconstructions on 323 patients (177 men, 148 women; mean age, 60.0 +/- 12.1 years). Symptoms of vertebrobasilar insufficiency were present in 332 cases (94.3%). Bypass grafting using mostly saphenous vein graft was performed in 240 cases (68.2%). In 102 cases (29.0%) the DVA was transposed into the internal carotid artery (ICA). Other techniques were used in 10 cases. RESULTS: Stroke caused all 7 deaths (2.0%) in the early postoperative period. There were 5 nonfatal strokes (1.4%). Strokes were hemispheric in 7 cases (6 ipsilateral, 1 contralateral) and vertebrobasilar in 5 cases. There were 6 strokes (2.3%) in the subgroup of 264 isolated DVA reconstruction and 6 strokes (6.8%) in the subgroup of 88 procedures involving combined ICA and DVA reconstruction (P <.04). Temporary paralysis of the spinal accessory nerve occurred in 26 cases (7.4%). Intraoperative or early postoperative angiography findings were available in 341 of 345 cases (98.8%). Early postoperative occlusion occurred after 25 procedures (7.1%). Complete clinical follow-up was available for 313 (99.1%) of the postoperative survivors. Mean duration of follow-up was 99.5 +/- 62.5 months. Assessment of late patency was performed in 343 (99.4%) of 345 cases by angiography (21.2%) or duplex scanning (78.8%). A total of 65 (23.7%) patients died during follow-up. No deaths resulted from vertebrobasilar or hemispheric stroke. Cumulative Kaplan-Meier survival rate was 89.0% +/- 3.9% at 5 years and 75.4% +/- 7.1% at 10 years. Significant vertebrobasilar symptom-free rate was 94.0% +/- 3.5% at 5 years and 92.8% +/- 3.8% at 10 years. Primary patency rate was 89.3% +/- 3.6% at 5 years and 88.1% +/- 4.0% at 10 years. CONCLUSIONS: This study clearly establishes the excellent long-term results of DVA reconstruction for the treatment of extracranial lesions of the vertebral artery. However, every effort should be made to reduce the rate of early postoperative occlusions. The subgroup of patients involving combined ICA and DVA reconstruction remains at high risk of postoperative stroke.