Sex as a Predictor of Outcomes for Symptomatic Carotid Stenosis: A Comparative Analysis between CAS and CEA.

PURPOSE: Reporting gender-related outcomes for symptomatic carotid lesion revascularization after both endarterectomy (CEA) and carotid artery stenting (CAS) procedures in an unselected group of patients treated by Italian Vascular Specialists. MATERIAL AND METHODS: A retrospective study was conducted on patients presenting with recently symptomatic carotid stenosis treated by CAS and by CEA. The primary endpoint was the 30 days any stroke occurrence rate; secondary endpoints were technical success, occurrence of transient ischemic attack (TIA), acute myocardial infarction (AMI) and death. Demographic, clinical and procedural data were all noted in order to identify the outcome's determining factor. RESULTS: A total of 265 patients (193 males and 72 females) were enrolled, and of these 134 (50.5%) underwent CEA and 131 CAS (49.5%). At 30 days, the overall new stroke rate was 3.4% (one fatal), and no TIA, AMI or deaths were observed. Among strokes, seven major and two minor strokes were reported, with six after CEA and three after CAS (p = 0.32; OR: 2; CI95%: 0.48-8.17). The timing of revascularization has been found to be slightly associated with new stroke occurrence: seven out nine strokes were observed in patients treated within 14 days from symptom onset (5.5% vs. 1.4%; p = 0.08, OR: 3.8, CI95%: 0.77-18.56). Lastly, female patients presented a significantly higher risk of post-operative stroke compared to male patients: 6.9% vs. 2.1% (p: 0.05; OR: 3.52; CI95%: 0.91-13.52). CONCLUSIONS: Our experience seems to suggest that both CEA and CAS provide safe and effective results in treating patients presenting with symptomatic carotid stenosis. Regardless of the type of revascularization, female sex is an independent risk factor for stroke recurrence after treatment.

Open Surgical Conversion of Popliteal Endograft Infection: Case Reports and Literature Review.

BACKGROUND: Endovascular treatment of popliteal aneurysms (PA) has increased in the last few years, quickly becoming the main treatment performed in many vascular centers, based on the acceptable and promising outcomes reported in the literature. However, endograft infections after endovascular popliteal aneurysm repair (EPAR) are the most dangerous complications to occur as they involve serious local compromise and usually require open surgical conversion and device explantation to preserve the affected extremity. CASE REPORT: We report two patients who were admitted to the emergency room of our hospital for pain and edema in the lower leg. Both patients had undergone exclusion of a ruptured PA a few years before by endovascular graft. CTA testing showed a significant volume of fluid-corpuscular collection related to perianeurysmal abscess collection in both cases. Blood cultures and drained material cultures were positive for Staphylococcus capitis in the first case and S. aureus in the second. Prophylactic antibiotics were administered for 10 days, then patients underwent an open surgical conversion with the complete explantation of endovascular material and a femoro-popliteal bypass using an autologous vein in the first case and a biological bovine pericardium prosthesis in the second case. The infective department of our hospital had defined a discharged specific antibiotic therapy for each patient, based on intraoperative microbiological samples. Furthermore, we have examined the literature and found six more cases described in case report articles that refer to popliteal graft infections by different microorganisms, mostly presenting acute limb ischemia as the first symptom and suggesting endograft explantation with open conversion and autologous vein bypass as the commonest therapeutic choice. CONCLUSIONS: The open surgical conversion of popliteal endograft infection is the best strategy to manage peripheral infection after an endovascular popliteal aneurysm repair procedure.

Percutaneous gluteal artery access to embolize false lumen of type B aortic dissection in marfan patient.

This case study presents an innovative endovascular approach using percutaneous gluteal artery access for embolizing the false lumen of a type B aortic dissection in a patient with Marfan syndrome. Following multiple complex surgeries, the patient developed an enlarging thoraco-abdominal aneurysm, necessitating an urgent intervention branched endoprosthesis despite persisting false lumen perfusion. Doppler ultrasound-guided percutaneous gluteal access was utilized for spiral-coil embolization of the false lumen. Successful embolization and exclusion of the aneurism, confirmed by follow-up angiography and computed tomography scans, demonstrated the technique's efficacy and safety. This approach underscores the need for innovative solutions addressing complex vascular pathologies in patients with Marfan.

Long-Term Results of Surgical Treatment for Popliteal Artery Entrapment Syndrome.

INTRODUCTION: Popliteal artery entrapment syndrome (PAES) is a rare disease of the lower limbs, mainly affecting young patients, due to extrinsic compression of the neurovascular bundle at the popliteal fossa. The aim of this study was to describe our experience during a median 15-year period. METHODS: Patients treated for PAES in our institution from 1979 to 2024 were included. Preoperative, intraoperative, and postoperative data were analyzed. RESULTS: A total of 47 patients with a total of 78 limbs were treated. Duplex ultrasound with active maneuvers was performed in all limbs (100%). Angiography was performed in almost all patients (97.4%), computed tomography angiography in 56 (71.8%), and magnetic resonance angiography in 22 (28.2%). Concerning surgical treatment, musculotendinous section was performed in 60 limbs (76.9%), and autologous venous bypass was achieved in 18 limbs (23.1%). The rates for freedom from target lesion revascularization-meaning that no significant stenosis or occlusion during follow-up required revascularization-and 15-year primary patency were 92.4% and 98%, respectively. CONCLUSION: Long-term results of surgical treatment for PAES seem to be very satisfying. Myotomy with or without arterial reconstruction using venous bypass can lead to good patency at 15 years of follow-up.

Clinical and Radiological Outcomes of Accessory Renal Artery Exclusion during Endovascular Repair of Abdominal Aortic Aneurysms.

BACKGROUND: Accessory renal arteries (ARAs) frequently coexist with abdominal aortic aneurysms (AAA) and can influence treatment. This study aimed to retrospectively analyze the ARA's exclusion effect on patients undergoing standard endovascular aneurysm repair for AAA. METHODS: The study focused on medium- and long-term outcomes, including type II endoleak, aneurysmal sac changes, mortality, reoperation rates, renal function, and infarction post-operatively. RESULTS: 76 patients treated with EVAR for AAA were included. One hundred and two ARAs were identified: 69 originated from the neck, 30 from the sac, and 3 from the iliac arteries. The ARA treatment was embolization in 15 patients and coverage in 72. Technical success was 100%. One-month post-operative computed tomography angiography (CTA) revealed that 76 ARAs (74.51%) were excluded. Thirty-day complications included renal deterioration in 7 patients (9.21%) and a blood pressure increase in 15 (19.73%). During follow-up, 16 patients (21.05%) died, with three aneurysm-related deaths (3.94%). ARA-related type II endoleak (T2EL) was significantly associated with the ARA's origin in the aneurysmatic sac. Despite reinterventions were not significantly linked to any factor, post-operative renal infarction was correlated with an ARA diameter greater than 3 mm and ARA embolization. CONCLUSION: ARAs can influence EVAR outcomes, with anatomical and procedural factors associated with T2EL and renal infarction. Further studies are needed to optimize the management of ARAs during EVAR.

Editor's Choice - Outcomes of Off the Shelf Outer Branched Versus Inner Branched Endografts in the Treatment of Thoraco-Abdominal Aortic Aneurysm in the B.R.I.O. (BRanched Inner - Outer) Study Group.

OBJECTIVE: This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair, namely the E-nside (Artivion) and Zenith t-Branch (Cook Medical) devices. METHODS: This multicentre retrospective study (2020 - 2023) included patients treated by branched endovascular aortic repair (BEVAR) for TAAA using the inner branched E-nside or the outer branched t-Branch. Endpoints were 30 day technical success and major adverse events (MAEs) as well as one year freedom from target vessel instability and main endograft instability. RESULTS: The study included 163 patients: 79 (307 target vessels) treated with E-nside and 84 (325 target vessels) with t-branch. Aneurysm extent was I - III in 91 patients (55.8%; 47% of E-nside and 66% of t-Branch) and IV in 72 patients (44.2%; 53% of E-nside and 34% of t-Branch) (p = .011). An adjunctive proximal thoracic endograft was used in 43% of E-nside vs. 69% of t-Branch (p < .001), with less frequent thoracic endografting (14% vs. 76%; p < .001) and shorter length of coverage (p = .024) in extent IV TAAA treated by E-nside. E-nside cases had shorter renal artery bridging lengths (66 ± 17 mm vs. 76 ± 20 mm; p < .010) and less frequent use of a distal bifurcated endograft (53% vs. 80%; p < .001). Comparing 30 day results, the mortality rate was 1% vs. 2% (p = .62), any MAE occurred in 18% vs. 21% (p = .55), the stroke rate was 3% vs. 0% (p = .23), and the elective spinal cord ischaemia rate was 5% vs. 8% (p = .40) for E-nside and t-Branch, respectively. At one year, freedom from target vessel instability was 96 ± 3% for E-nside and 95 ± 3% for t-Branch (p = .58), and freedom from endograft instability was 98 ± 2% vs. 97 ± 3% (p = .46), respectively. CONCLUSION: Both off the shelf devices provided excellent early and one year results. The E-nside may require shorter thoracic aortic coverage and bridging length for the renal arteries, and less frequent implantation of a concomitant proximal thoracic or distal abdominal bifurcated endograft. However, these aspects did not determine significant differences in clinical outcomes.

High-Grade Infection after Branched Endovascular Aortic Repair in Patient with Recent COVID-19 Hospitalization.

In the context of the COVID-19 pandemic, the global healthcare landscape has undergone significant transformations, particularly impacting the management of complex medical conditions such as aortic aneurysms. This study focuses on a 76-year-old female patient with a history of extensive cardiovascular surgeries, including aortic valve replacement, Bentall operation, and Frozen Elephant Trunk procedure, who presented with a type II thoracoabdominal aortic aneurysm post-COVID-19 recovery. A comprehensive frailty assessment using the Modified Frailty Index and a two-phase endovascular approach for aneurysm treatment, considering the patient's frailty and complex medical history was performed. Upon successful aneurysm management, the patient's postoperative course was complicated by COVID-19 reinfection and Enterococcus faecalis superinfection, highlighting the increased risk of bacterial superinfections and the challenges posed by antimicrobial resistance in COVID-19 patients. The study underscores the necessity of vigilant postoperative surveillance and a multidisciplinary approach in managing such complex cases, highlighting the importance of personalized care strategies, integrating cardiovascular and infectious disease management, and adapting healthcare practices to the unique challenges of the pandemic. This case contributes to the evolution of knowledge on managing aortic aneurysms in the COVID-19 era, advocating for patient-centric treatment approaches and continuous research into long-term patient outcomes.

Isolated Intramural Hematoma of Superior Mesenteric Artery: Case Reports and a Review of Literature.

(1) Background: Spontaneous isolated intramural hematoma of the superior mesenteric artery (SIHSMA) is a rare entity often considered as a subset of spontaneous isolated dissection of the superior mesenteric artery (SIDSMA). It is characterized by a completely thrombosed false lumen with or without an ulcer-like projection with computed tomography (CT) imaging. The recent literature describes few reports with a relatively short-term follow-up. The natural course, prognosis, and treatment options for SIHSMA still lack consensus. We present two cases of acute abdominal pain in a young man due to IMH of the superior mesenteric artery with an extensive literature review. (2) Case report: A 46-year-old male patient was submitted to an urgent CTA for acute abdominal pain, showing the presence of an isolated dissection of the superior mesenteric artery, determining significant stenosis of the vessel with collateral vessel patency. The patient referred to a recent COVID-19 infection, whose course was paucisymptomatic. He was conservatively treated with antiplatelet therapy and corticosteroid treatments, and, after a few days, the symptomatology completely regressed; also, the 2-month-control CTA showed complete IMH regression and the absence of any signs of residual stenosis. The second patient was a 61-year-old male patient who was submitted to an urgent CTA for acute abdominal pain, showing the presence of an isolated dissection of the superior mesenteric artery, not determining significant vessel stenosis. He was conservatively treated with antiplatelet therapy and corticosteroid treatment, and after a few days, the symptomatology completely regressed and the radiological control showed complete dissection regression. (3) Conclusion: SISHSMA is a rare entity of vascular pathology, and conservative management represents the best medical strategy. We propose corticosteroid treatment as one of the most appropriate tools in the conservative treatment of SISHSMA.

Outcomes of Percutaneous Access to the First Versus Third Segment of Axillary Artery During Aortic Procedures.

PURPOSE: This article aims at investigating the outcomes of percutaneous access via the first versus third axillary artery (AXA) segments with closure devices during aortic procedures. MATERIALS AND METHODS: All patients receiving percutaneous AXA access closed with Perclose ProGlide device (Abbott, Santa Clara, California) from 2008 to 2021 were included in a retrospective multicenter registry (NCT: 04589962). Efficacy endpoint was the technically successful percutaneous procedure (no open conversion). Safety endpoints were stroke and access complications according to the Valve Academic Research Consortium-3 reporting standards. The first (AXA1) or third (AXA3) axillary puncture sites were compared. RESULTS: A total of 412 percutaneous AXA accesses were included: 172 (42%) in AXA1 and 240 (58%) in AXA3. Left AXA was catheterized in 363 cases (76% of AXA1 vs 97% of AXA3, p<0.001) and 91% of fenestrated/branched endovascular repair (F/BEVAR) procedures were conducted from the left. A ≥12F internal diameter (ID) sheath was used in 49% of procedures. Open conversion rate was 1%, no major vascular complications occurred, and only one major non-vascular complication was recorded. Primary closure failure occurred in 18 AXA1 (11%) and 32 AXA3 accesses (13%), treated by covered (8.3%) or bare-metal (2.7%) stenting. Bailout stent patency was 100% at median follow-up of 12 months, with 6 of 6 stents still patent after >36 months of follow-up. Stroke rate was 4.4%. An introducer sheath >12F was independently associated with both access complications (p<0.001) and stroke (p=0.005), while a right-side access was associated with stroke only (p=0.034). Even after adjustment for covariates, AXA1 versus AXA3 showed an equal success rate (odds ratio [OR]=0.537, 95% confidence interval [CI]=0.011-1.22 for AXA3, p=0.104). The combination of AXA3 and a >10F introducer sheath provided worse outcomes compared with >10F sheaths through AXA1 (OR for success=0.367, 95% CI=0.176-0.767, p=0.008). This was not confirmed for >12F sheaths, associated with similar outcomes (p=0.31 AXA 1 vs AXA 3). CONCLUSION: Major local complications with the percutaneous axillary approach and ≤12F sheaths are infrequent and solvable by complementary endovascular interventions. Stroke risk remains an issue. First and third AXA segments are both amenable for access with good results, but larger sheaths (12F) perform better in AXA1. CLINICAL IMPACT: Percutaneous access with vascular closure devices at the first or third axillary artery (AXA) segments during aortic procedures is burdened by a negligible risk of open conversion. Local complications with the percutaneous axillary approach are infrequent and solvable by complementary endovascular interventions. First and third AXA segments are both amenable to access with excellent results, but larger sheaths (12F) perform better in the wider first AXA segment. In this setting, bailout stenting does not appear to be associated with mid-term stent occlusion.

Symptomatic Popliteal Artery Aneurysms in Recently SARS-CoV-2-Infected Patients: The Microangiopathic Thrombosis That Undermines Treatment.

BACKGROUND: Arterial and venous thrombosis are complications in SARS-CoV-2-infected patients. The microangiopathic thrombosis in affected patients can compromise results in urgent limb revascularizations. Aim of our study is to report on the incidence of symptoms development in patients affected by popliteal artery aneurysm (PAA) and to analyze the effect of COVID-19 infection on outcomes. METHODS: Data on patients surgically treated for PAA from the massive widespread of COVID-19 vaccine (March 2021) to March 2022 were prospectively collected. Factors considered for analysis were: presence of symptoms, aneurysm diameter and length, time from symptom onset and hospital referral, ongoing or recently COVID-19 infection. Outcomes measures were: death, amputation, and neurological deficit. RESULTS: Between March 2021 and March 2022, 35 patients were surgically treated for PAA. Among them 15 referred to our hospital for symptomatic PAA and were urgently treated. Urgent treatments included both endovascular procedures and open surgeries. Nine out of 15 symptomatic patients had an ongoing or recently recovered COVID-19 infection. COVID-19 infection was strongly associated to symptoms development in patients affected by PAA and to surgical failure in those patients (OR 40, 95% CI 2.01-794.31, p = 0.005). CONCLUSION: In our series, presence of COVID-19 infection was strongly associated to ischemic symptoms onset and to complications after urgent treatment in symptomatic patients.

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.

Could Gender Impact on Immediate and Long-term Carotid Artery Stenting Outcome? Insight from an Italian Single Center Experience.

BACKGROUND: Carotid artery stenting (CAS) has become a valid alternative to carotid endarterectomy in stroke prevention. However, female gender is still considered as an independent risk factor for CAS procedures, potentially limiting immediate and long-term benefits. Aim of present study was to evaluate gender differences in CAS submitted patients from an Italian high-volume center. MATERIAL AND METHODS: a retrospective monocentric study has been conducted on 568 patients (366 males and 202 females), submitted to CAS, between January 2000 and December 2019. Besides gender sex, clinical anatomical, and procedural data were collected as possible factors determining the outcome, when associated to sex gender itself. Primary endpoint of this study consisted in evaluating the technical and procedural success ratio, and the incidence of major and minor stroke, transient ischemic attack, acute myocardial infarction (AMI) peri-procedurally and at medium and long term, between the male and the female population. Secondary endpoint of this study consisted in evaluating the percentage ratio of minor complications happening peri-procedurally in both genders. RESULTS: Male patients were more likely to be octogenarians, clinical history of coronary artery disease, and smokers, while diabetes was more frequent in female patients. Anatomical and plaque morphology features were not different between the two groups. Technical success was obtained in all but two patients (99,6%), while procedural success was 95% (538/566 patients). During the peri-procedural time, no major stroke, 16 minor strokes (2,81%, 2,45% males vs. 3,45% females, P= 0,48), and 11 transient ischemic attack (2,18% males vs. 1,48% females, P= 0,56) were recorded. At a medium follow-up 57 months, 32 stroke (8 major strokes, 24 minor strokes) episodes (5,6%, males 5,7% vs. females 5,4%, P= 0,88), 24 AMIs (4,2%, males 4,6% vs. females 3,46%, P= 0,5;), 13 restenosis (2,8%, males 2,4% vs. females 1,9%, P= 0,71) and 223 deaths (39,2%, males 34,9% vs. females 47%, P= 0,0048) were noted. CONCLUSIONS: Our results showed no differences in immediate, and long-term CAS outcomes between gender. Larger, prospective studies are required to assess the real importance and significance of gender in determining CAS procedures' benefit and outcome.

Comparison of Outcomes Following EVAR Based on Aneurysm Diameter and Volume and Their Postoperative Variations.

PURPOSE: to evaluate the impact of bi- and 3-dimensional preoperative aortic morphological features and their immediate postoperative variations on the outcome of abdominal aortic aneurysms (AAA) treated by endovascular exclusion with standard devices (EVAR). MATERIALS AND METHODS: Double centre retrospective analysis of prospectively collected registry data of EVAR patients. For all patients, preoperative and 30-day computed tomographic angiography images (CTA) were reviewed. Preoperative maximum AAA diameter >59 mm and volume >159 cm3, and any 30-day postoperative increasing at CTA, were considered as potentially influencing the outcome. The outcome measures were: primary technical success; 30-day, 1-year, and mean follow-up reintervention, all-cause and AAA-related mortality rates, and also endoleak-related reinterventions. RESULTS: Three hundred and thrity-three patients were enrolled. Mean preoperative and 30-day AAA diameter and volume were 50.4 mm ± 11.8 vs. 49.1 mm ± 12.1, and 112.9 cm3 ± 79.5 vs. 112.1 cm3 ± 80.5, respectively. Primary technical success was achieved in all cases. At 34.9 months follow-up, cumulative reintervention rate was 12.0%, mortality rates 7.2%, without AAA-related deaths. Endoleak-related reintervention rate was 7.5%. At uni- and multi-variate analysis, preoperative AAA diameter >59 mm, and AAA volume >159 cm3 were significantly associated to reintervention (P = 0.012; P = 0.002), and reintervention and death (P = 0.002; P = 0.001) during follow-up. Additionally, any increase in postoperative AAA diameter or volume was significantly associated with reintervention (P = 0.001, P = 0.001) and reintervention and death (P = 0.006, P = 0.001). Endoleak-related reintervention were also significantly associated with all of the analysed morphological parameters (P = 0.019, P = 0.005, P = 0.005, and P = 0.002, respectively). CONCLUSIONS: Patients with larger baseline AAA size and volume as well as unfavourable early remodelling of the sac are associated to worse long-term EVAR outcome.

Endovascular aortic repair in patients with challenging anatomies: the EXTREME study.

AIMS: The aim of this study was to report the 30-day technical and clinical success with endovascular repair using the ultra-low-profile Ovation stent graft in patients judged to be outside the instructions for use (IFU) for conventional endografts, while amenable to treatment within the IFU for Ovation. METHODS AND RESULTS: One hundred and twenty-two patients (78.65±7.67 years; 111 male) were enrolled. Patients were evaluated as being outside the IFU for standard endografts because of the absence of a suitable proximal aortic neck in 109 cases (89.3%), of inadequate access vessels in 13 (10.7%), or both in 111 (90.9%). Mean aneurysm (abdominal aortic aneurysm [AAA]) diameter was 52.96±10.1 mm; mean aortic neck length was 7.75±6.05 mm. Technical success (98.4%) was achieved in all but two patients due to a type Ia endoleak. At completion angiography, 15 (12.3%) patients presented a type II endoleak. All patients underwent 30-day follow-up. Primary clinical success at one month was 96.8%, assisted clinical success 98.4%. There were no type I endoleaks, while 12 (9.8%) type II endoleaks were still evident, in the absence of sac expansions. Two patients (1.6%) presented an asymptomatic limb occlusion. CONCLUSIONS: Our experience suggests that, in a selected population of patients with challenging anatomy outside the IFU for conventional endografts, endovascular aneurysm repair (EVAR) using the Ovation stent graft can be performed safely with satisfactory immediate outcomes.

Unibody bifurcated aortic endograft: device description, review of the literature and future perspectives.

The unibody (Powerlink/AFX/AFX2) Endovascular AAA device (Endologix Inc., CA, USA) presents a unique design with its long main body and two innate limbs. The device is designed to be deployed and sits on the native aortoiliac bifurcation and represents the only one-piece bifurcated endograft designed to use anatomical fixation for endograft stabilization. According to published literature, the unibody device seems to represent a valid choice in the treatment of abdominal aortic aneurysms. This particular device would seem to satisfactorily perform even in the treatment of more compressed aneurysms (also in off-label association with parallel grafts) and in occlusive pathologies. Ongoing studies will provide new real-life data in a large and unselected patient population to better understand the device's advantages and limitations.

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

OBJECTIVES: This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice. BACKGROUND: When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems. 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 in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates. RESULTS: Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%. CONCLUSIONS: This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.

Use of Dual-Layered Stents for Carotid Artery Angioplasty: 1-Year Results of a Patient-Based Meta-Analysis.

OBJECTIVES: This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS). BACKGROUND: Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published. METHODS: The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year. RESULTS: Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis. CONCLUSIONS: This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate.

Correction: Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study.

[This corrects the article DOI: 10.2196/16959.].