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.

A First-in-Human Evaluation of a Novel Mesh-Covered Stent for Treatment of Carotid Stenosis in Patients at High Risk for Endarterectomy: 30-Day Results of the SCAFFOLD Trial.

Objectives: The primary purpose of this study was the composite of major adverse events through 30 days post-index procedure or ipsilateral stroke from 30 days to 1 year (365 days). Presented here is the composite of death, stroke, and myocardial infarction (MI) through 30 days.

Background: Rates of minor stroke have been higher with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA).

The history of proximal carotid protection and flow reversal to prevent stent angioplasty embolization.

Innovation in medicine is often driven by the observations of imaginative physicians who are blessed with insatiable curiosity, coupled with the inability to accept technical boundaries, the status quo of patient care, or the acceptance of procedural morbidity. Few examples illustrate this truism better than the physician-originated clinical research that transformed the safety of carotid stent angioplasty over the last 2 decades. Initial clinical application of carotid stenting suggested that proximal protection may be a better approach to prevent embolic stroke during the angioplasty procedure.

Repair of superior mesenteric artery bypass pseudoaneurysm with physician-modified fenestrated aortic endograft.

Aneurysmal degeneration and pseudoaneurysm formation of visceral vein bypass grafts are rare conditions that may be associated with rupture requiring reintervention. This case represents the first report of an enlarging, complex aorta to superior mesenteric artery vein bypass pseudoaneurysm repaired using a physician-modified fenestrated aortic graft with suprarenal fixation.

New technologies for CAS that might overcome the burden of microembolization.

Microembolization during carotid artery stenting (CAS) is the result of embolic events shown by intraprocedural transcranial Doppler (TCD) or postprocedure diffusion-weighted MRI that do not lead to acute neurological deficit. Although the long term clinical outcome of these silent infarcts is not yet well established, there is increasing evidence that these events could be associated with neurological impairments, such as cognitive decline. In order to prevent microembolization due to excessive catheter manipulation at the time of guiding catheter placement in patients with challenging anatomy, a cervical access system with flow reversal protection was developed.

Bypass and embolization for a vertebral artery aneurysm in a patient with Marfan syndrome.

Extracranial vertebral artery aneurysms represent an uncommon presentation of collagen vascular disease. We performed staged proximal embolization of large left vertebral artery aneurysm after distal common carotid-to-vertebral bypass at C2 in a young adult patient with Marfan syndrome and a hypoplastic contralateral vertebral artery. Dilation of the autogenous saphenous vein graft occurred at 1 year with proximal graft stenosis requiring operative revision.

Advantages to Indigo mechanical thrombectomy for ALI: device and technique.

Catheter-directed thrombolysis (CDT) has been used as the first therapeutic option for acute limb ischemia (ALI) due to its less invasive nature; however, recent systematic review showed higher incidence of major complications related to lytic infusion, including hemorrhagic stroke. In this setting, aspiration thrombectomy with Indigo has the greatest advantage of not increasing systemic risk of bleeding. The Indigo™ system from Penumbra® (Alameda, CA, USA) promotes active thrombectomy using a vacuum pump that generates substantial suction, enabling aspiration of clots of varying sizes and lengths.

Carotid sacrifice with a single Penumbra occlusion device: a feasibility study in a swine model.

Introduction: Carotid sacrifice is a valuable tool in the treatment of select vascular lesions. Traditional coil embolization as the primary means of carotid sacrifice can be expensive, with high radiation exposure. We investigated the feasibility of a novel hybrid coil, the Penumbra occlusion device (POD), for carotid sacrifice in a swine model.

First-in-man implantation of a new hybrid carotid stent to prevent periprocedural neurological events during carotid artery stenting.

Purpose: To report the initial clinical experience with a new hybrid stent to prevent neurological events during carotid artery stenting.

Case Report: A 77-year-old asymptomatic man presented with de novo high-grade stenosis (80%) of the right internal carotid artery (ICA) and occlusion of the contralateral ICA. He was referred for right ICA stenting with a 6/8-mm×40-mm Gore Carotid Stent under cerebral protection using the Gore Carotid Filter.

Early endovascular grafts at Montefiore Hospital and their effect on vascular surgery.

Vascular surgery is very fortunate. It recognized the transition from open surgery to endovascular procedures as treatments for vascular disease early enough to adapt as a specialty. As a result, most vascular surgeons in North America became competent with endovascular techniques, and the survival of the specialty was assured.

Carotid stenting in asymptomatic patients: how to identify patients without symptoms and at high risk for neurologic events.

During the last 20 years, asymptomatic patients with high-grade carotid stenosis have been treated with carotid endarterectomy and more recently with carotid artery stenting in order to prevent stroke. New, best medical treatment including statins, beta-blockers, antiplatelet therapies, and better diabetes and blood pressure control might reduce the incidence of stroke in this patient population making invasive treatment unnecessary. However, patients with asymptomatic carotid stenosis cannot be considered a homogenous population, and therefore, the therapeutic approach should take into consideration a subgroup of patients with greater risk of cerebrovascular event.

Flow control technique to prevent distal embolization during mechanical thrombectomy.

In an era of increasing emphasis on minimally invasive surgery, distal embolization remains a concern in the absence of distal flow control. We present a case using an endovascular flow control technique that can be used for reducing distal embolic events during endovascular recanalization of aortoiliac occlusive disease. This technique has been used in four patients so far (two with native anatomy and two with aorto-bi-iliac grafts) with no evidence of angiographic or clinical embolic complications.

Radiofrequency wire for the recanalization of central vein occlusions that have failed conventional endovascular techniques.

Purpose: To report the technique and acute technical results associated with the PowerWire Radiofrequency (RF) Guidewire used to recanalize central vein occlusions (CVOs) after the failure of conventional endovascular techniques.

Materials And Methods: A retrospective study was conducted from January 2008 to December 2011, which identified all patients with CVOs who underwent treatment with a novel RF guide wire. Forty-two symptomatic patients (with swollen arm or superior vena cava [SVC] syndrome) underwent RF wire recanalization of 43 CVOs, which were then implanted with stents.

Predictive factors for the development of type II endoleaks.

Purpose: To define predictive factors for endoleak type II (EL-II) based on quantifiable factors in the imaging studies of patients undergoing endovascular aneurysm repair (EVAR).

Methods: The data on 208 consecutive patients (137 men; mean age 75.2 years, range 62-84) who underwent EVAR between the years 2003 and 2008 were retrospectively reviewed.

Impact of stent design on the outcome of intervention for carotid bifurcation stenosis.

Over the past several years, there has been continued significant interest in refinement of patient selection, devices, procedures and protocols in an effort to optimize the outcome of percutaneous intervention for carotid bifurcation stenosis, including: ongoing National Institutes of Health and manufacturer trials and registries; the further refinement of existing devices and emergence of new platforms to attain distal embolic protection; ongoing study of what really constitutes a high-risk carotid surgery or stenting patient; and attention to device characteristics and patient-device matching. Within the latter area, considerable interest has focused on stent characteristics that have the potential to impact short and long-term outcome when compared with other stent design strategies when studied in large series. The stent in carotid artery intervention occupies a unique role in that after the embolic protection system has been removed, it is the main line of defense (in concert with aggressive dual antiplatelet therapy) from embolic and thromboembolic complications that may arise from the newly remodeled plaque after post-stent angioplasty.

Minimizing complications of carotid stenting.

Results of carotid artery stenting (CAS) are directly related to the experience and skills of the operator. The most dreadful complication of CAS is stroke. Analyzing the complications during the authors' own procedures, they came to the conclusion that most, if not all, of the complications are preventable.

Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30-day outcomes in the EMPiRE Clinical Study.

Background: Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single-arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain.

Methods: The study evaluated 30-day outcomes in 245 pivotal high-surgical-risk patients (mean age, 70 years; 32% symptomatic; 16% ≥80-years old) with carotid stenosis who underwent CAS using the flow reversal system.

Successful recanalization of bile duct occlusion with a radiofrequency puncture wire technique.

A radiofrequency (RF) wire puncture technique was used in the recanalization of biliary anastomotic occlusions in five patients. The technical success of recanalization, which was defined as successful puncture and crossing of the obstruction followed by balloon cholangioplasty and internal-external biliary drainage without evidence of complications, was 100%. The average follow-up was 13 months (range, 11-16 months).

Endovascular repair of a tracheoinnominate fistula with a stent graft.

Massive bleeding from a tracheostomy developed in a 65-year-old woman with stroke after successful conservative management of a minor tracheostomy bleeding episode. Temporary hemostasis was achieved, and angiography showed a tracheoinnominate fistula (TIF), a rare complication of tracheostomy. Open surgery was contraindicated in this patient, so endovascular repair using a stent graft was performed.