Evaluation of a novel mesh-covered stent for treatment of carotid stenosis in patients at high risk for endarterectomy: 1-year results of the SCAFFOLD trial.

OBJECTIVE: The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year. BACKGROUND: SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy. Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population. METHODS: The rate of DSMI within 30 days plus ipsilateral stroke between 31 days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis (≥80% diameter stenosis by core lab angiography) are reported as Kaplan-Meier (KM) estimates. RESULTS: Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30 days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (p < .00001). The proportion with ipsilateral stroke from 31 to 365 days was 1.2%. The KM estimates of 1-year event probability were 1.6% for CD-TLR and 1.2% for restenosis. CONCLUSIONS: Use of the mesh-covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year. ClinicalTrials.gov Identifier: NCT01901874 (redacted).

Use of a novel embolic filter in carotid artery stenting: 30-Day results from the EMBOLDEN Clinical Study.

OBJECTIVES: The EMBOLDEN study was conducted to test the safety and efficacy of a novel emboli protection filter design for use in carotid artery stenting (CAS) in patients with severe carotid stenosis who were at high risk of operative complications from carotid endarterectomy (CEA). BACKGROUND: General considerations for filter design usually involve trade-offs between trackability/profile and wall apposition/capture efficiency. The GORE® Embolic Filter (GEF) is intended to address these design goals via a hybrid construction. METHODS: Patients at high risk for CEA (N = 250) were treated with CAS using the GEF study device paired with an FDA-approved carotid stent. The primary outcome was death, stroke, and myocardial infarction (MI) at 30 days, compared to a pre-determined performance goal. Neurologic outcomes were judged by an independent assessor and angiographic results evaluated by an independent central core lab. RESULTS: The GEF study device was successfully deployed in 96.4% of procedures. The primary endpoint of 30-day death, stroke, and MI occurred in 4.0% of subjects and was significantly lower than the pre-defined performance goal (P < 0.001). The 30-day rate for death and major stroke was 1.2% and for death and any stroke was 3.6%. The rate of major adverse events was 5.4% among octogenarians and 3.2% among non-octogenarians. CONCLUSION: In patients at high risk for CEA undergoing CAS, the GEF not only showed high rates of successful deployment but also met the primary endpoint of low death, stroke, and MI rates, thus demonstrating safety and effectiveness.

Lambl's Excrescence as an Etiology of Thromboembolism: Case Report and Literature Review.

Lambl's excrescence (LE), a rare thin linear fibrous thread of collagen and elastic fibrous tissue originating at closure margins of heart valve leaflets is considered a rare cause of thromboembolism, causing ischemic stroke, transient ischemic attack (TIA), acute coronary syndrome, or peripheral thromboembolism. The gold standard for diagnosing LE is transesophageal echocardiography (TEE). Due to the rarity of the disease and lack of significant research, no guidelines exist about the management of LE. Twenty-two papers about LE were reviewed, focusing on the management aspect aiming to assist in guideline publication. Articles were retrieved using PubMed database using "Lambl's excrescences" as a keyword. All free full text papers up to 2023 were retrieved. In this report, we present the first publication of a case of a TIA secondary to LE in the United Arab Emirates. A 53-year-old male presented with transient attacks of left monocular blindness with complete recovery 2 days later. Extensive stroke work-up was negative, except for TEE, which showed an echo-dense linear mobile structure attached to the aortic surface of the aortic valve closure margin, suggesting LE. As no guidelines exist on the management of LE, the patient was started on Clopidogrel 75 mg daily and remained asymptomatic for 2 years. After reviewing the literature, we suggest the use of Aspirin for patients with ⩾1 embolic event attributed to LE while not on antiplatelets or anticoagulants, as it is the most used and recommended treatment option and is effective in preventing recurrent thromboembolic events.

Risk Factors for the Development of Carotid Artery In-Stent Restenosis: Multivariable Analysis.

OBJECTIVES: In this study, we evaluated the relationship between certain patient and stent characteristics with regards to their association with the development of restenosis. BACKGROUND: Carotid artery stenosis is a major cause of stroke. Carotid artery stenting is an FDA approved method for the treatment of carotid artery stenosis. However, carotid artery stenting has been fraught with lumen loss and in-stent restenosis. The literature is limited in regard to variables affecting long term patency after carotid artery stenting. METHODS: This is a retrospective chart review study investigating the variables affecting the long term patency in patients who underwent carotid artery stenting. The data was analyzed using a Multivariable logistic regression models. RESULTS: 148 patients were included in the study. 123 patients did not develop signs of restenosis after 1 year, while 25 patients developed restenosis defined on annual follow up carotid duplex ultrasound. The odds ratio of developing restenosis for current/former smokers vs. never smokers was 10.1 (p = 0.018), closed vs. open cell design stents was 12.5 (p = 0.008). The odds ratio of developing restenosis decreases by 50.1% for every 1 mm increase in the diameter (p = 0.021). Data was collected and reanalyzed at 3 years to look for any changes in risk factors that become significant which showed that the chance of developing restenosis increases by 11.2% for every 1 mm increase in the length of the stent. CONCLUSIONS: Our data suggest that the risk of developing restenosis is elevated in those with a history of previous/current tobacco use; those treated with closed-cell as opposed to open-cell design. We also found that restenosis is positively associated with stent length and inversely associated with stent diameter. The aforementioned factors should be considered in the management of carotid artery stenosis.

Prevalence of emerging cardiovascular risk factors in younger individuals with a family history of premature coronary heart disease and low Framingham risk score.

INTRODUCTION: The purpose of this study was to assess the prevalence of emerging cardiac risk factors in individuals with a family history of premature coronary heart disease (CHD) and who were predicted to be low-risk for cardiovascular (CV) disease based on their Framingham risk score. METHODS: We prospectively evaluated 89 younger men and women with a family history of premature CHD and who had a low Framingham risk score. Patients with CHD or CHD equivalents were excluded. All patients were screened for emerging clinical and lipid risk factors. RESULTS: Coronary calcium was present in 38% of patients and C-reactive protein > 3 mg/dl was present in 24% of patients. Low levels of high-density lipoprotein (HDL2) cholesterol were the most prevalent emerging lipid risk factor and was present in 72% of the study group. More individuals had low levels of HDL2 than total HDL (34% versus 71%; p-value =0.001). Triglyceride- (TG)-rich remnant lipoproteins were present in 49% of patients. CONCLUSIONS: The Framingham risk score poorly predicts CV risk in younger healthy persons with a family history of premature CHD. The prevalence of subclinical CHD and emerging clinical and lipid risk factors is high in these patients. The most prevalent lipid risk factor was low levels of HDL2. Individuals with a family history of premature CHD may benefit from screening for emerging risk factors to better assess their CV risk.

Factors affecting cardiovascular and cerebrovascular complications of carotid artery stenting in Northern Michigan: A retrospective study.

BACKGROUND: This study seeks to identify factors associated with periprocedural complications of carotid artery stenting (CAS) to best understand CAS complication rates and optimize patient outcomes. Periprocedural complications include major adverse cardiovascular and cerebrovascular events (MACCE) that include myocardial infarction (MI), stroke, or death. METHODS: We retrospectively analyzed 181 patients from Northern Michigan who underwent CAS. Rates of stroke, MI, and death occurring within 30days post-procedure were examined. Associations of open vs. closed cell stent type, demographics, comorbidities, and symptomatic carotid stenosis were compared to determine significance. All patients had three NIH Stroke Scale (NIHSS) exams: at baseline, 24h post-procedure, and at the one-month visit. Cardiac enzymes were measured twice in all patients, within 24h post-procedure. All patients were treated with dual anti-platelet therapy for at least 6months post-procedure. RESULTS: Three patients (1.66%) experienced a major complication within one-month post-procedure. These complications included one MI (0.55%), one stroke (0.55%), and one death (0.55%). The following variable factors were not associated with the occurrence of MACCE complications within 30days post-procedure: stent design (open vs. closed cell) (p=1.000), age ≥80 (p=0.559), smoking history (p=0.569), hypertension (p=1.000), diabetes (p=1.000), and symptomatic carotid stenosis (p=0.254). CONCLUSIONS: Age of 80years old or above, symptomatic carotid stenosis, open-cell stent design, and history of diabetes, smoking, or hypertension were not found to have an association with MACCE within 1month after CAS. Future studies using a greater sample size will be beneficial to better assess periprocedural complication risks of CAS, while also considering the effect of operator experience and technological advancements on decreasing periprocedural complication rates.

Endovascular treatment of a left carotid artery "bowtie" pseudoaneurysm with a covered Wallgraft stent.

The authors present an unusual case of a young male patient with a large left common carotid artery pseudoaneurysm in a shape similar to that of a bowtie treated with a covered Wallgraft. The Wallgraft is a covered stent originally designed to be used in the treatment of tracheobronchial fistula and peripheral arterial applications. The favorable outcome of this case illustrates its endovascular application in nonsurgical traumatic injuries of the carotid artery.

Use of gadolinium for carotid artery angiography and stenting in patients with renal insufficiency.

Use of iodinated contrast media (ICM) for angiography can result in contrast-induced nephropathy (CIN). Gadolinium-based contrast media (GCM) have been used in angiography with a goal to reduce the incidence of CIN. We performed a retrospective analysis involving 85 patients with renal insufficiency who underwent 97 carotid artery angiography and stenting (CAAS) procedures with a combination of GCM and ICM. The incidence of peri-procedural death, Q wave myocardial infarction (QWMI), stroke and CIN were recorded. Patients in GCM group had worse preprocedure renal function compared to ICM group. There were no peri-procedural deaths or QWMI in both groups. The incidence of stroke was 2.2% in GCM group and 0% in ICM group. The incidence of CIN were similar in GCM and ICM groups (8.5% vs. 10%, respectively, p NS). However, the predicted risk of CIN was 18.5% for GCM group and 10.4% for ICM group. Use of GCM and ICM combination for CAAS resulted in a 50% reduction in the incidence of predicted CIN risk compared to ICM.