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).

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 study hypothesized that a stent with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates. METHODS: The SCAFFOLD trial, a prospective, multicenter, single-arm clinical trial evaluating the GORE carotid stent (GCS), enrolled patients at increased risk for adverse events from CEA with severe carotid artery stenosis (defined as symptomatic ≥50% or asymptomatic ≥80%). The SCAFFOLD trial screening committee was implemented to determine adherence to the study protocol. Patients were evaluated for the primary endpoint, the composite of death, stroke, and MI through 30 days. RESULTS: A total of 312 patients were enrolled, treated, and reviewed by the SCAFFOLD trial screening committee, of which 265 were included in the primary analysis population. The 30-day rate of death, stroke, or MI was 3.0% (95% confidence interval: 1.3% to 5.9%) and the stroke or death rate was 1.5%. The 30-day stroke rate was 1.1%. The 2 deaths in the study were not stroke related. CONCLUSIONS: Low death, stroke, or MI rates were demonstrated with GCS in patients at high risk for CEA. The 30-day stroke rate of 1.1% suggests that the carotid stent mesh covering may reduce the neurologic events associated with CAS when used in appropriately selected patients.

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. The history of how this innovation was developed is particularly relevant as vascular surgeons adopt new endovascular therapies. It has been more than 15 years since Dr Juan Parodi put together a multidisciplinary team of scientists and clinicians to test the "proximal protection" hypothesis. The goal of this overview was to provide Dr Parodi team's perspective on the development of the proximal protection and flow reversal concept to minimize plaque embolization during carotid stent angioplasty procedures.

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. METHODS: A total of eight common carotid artery sacrifices were performed in fully heparinized pigs under fluoroscopic guidance. A single POD device was deployed within each vessel, and intermittent follow-up angiography was performed to assess flow. RESULTS: Complete carotid occlusion was achieved in all cases with a single POD (time range 2-15 min) without any coil migration or intraprocedural complications. Once the anchor zone was stable, no distal migrations were observed during either proximal soft coil packing or during hand injected angiography. Complete occlusion was verified between 2 and 15 min following POD deployment. CONCLUSIONS: Carotid artery sacrifice using a novel POD device is safe and effective, allowing for reduced radiation and material costs compared with any other described endovascular technique.

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. Subsequent dilation of the basilar artery led to symptoms of pontine compression at 18 months that have resolved at 31 months of follow-up.

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.

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. The stent delivery system tracked well over the filter wire and deployment was precise. The result was satisfactory, with 10% residual stenosis. No neurological events occurred during 6 months of follow-up. CONCLUSION: Initial clinical experience with this new carotid hybrid stent showed satisfactory results, including ease of use, precise deployment, conformability to the wall, and protection against embolization.

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. The endovascular graft program at Montefiore Hospital played a major role in vascular surgery's early recognition of the importance of the endovascular revolution. This article will review the history of this early endovascular graft program and how it influenced the specialty.

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. The distribution of CVOs in central veins was as follows: six subclavian, 29 brachiocephalic, and eight SVC. All patients had a history of central venous catheter placement. Patients were monitored with regular clinical evaluations and central venography after treatment. RESULTS: All 42 patients had successful recanalization of CVOs facilitated by the RF wire technique. There was one complication, which was not directly related to the RF wire: one case of cardiac tamponade attributed to balloon angioplasty after stent placement. Forty of 42 patients (95.2%) had patent stents and were asymptomatic at 6 and 9 months after treatment. CONCLUSIONS: The present results suggest that the RF wire technique is a safe and efficient alternative in the recanalization of symptomatic and chronic CVOs when conventional endovascular techniques have failed.

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. The abdominal aortic aneurysm (AAA) diameter ranged from 4.8 to 12.8 cm. Data were collected on the type of AAA; the type of stent-graft (aortomonoiliac versus bifurcated); the performance of hypogastric artery embolization; the presence, number, diameter, and patency of aortoiliac branches identified on the pre and post-EVAR imaging studies; and the presence and type of EL-II (transient vs. persistent) with the goal of identifying any imaging-based predictive factors for the development of EL-II. RESULTS: Among the 208 cases, 11 patients had endoleaks other than type II and were excluded, leaving 195 patients for analysis. In all, 28 (13.4%) patients were diagnosed with EL-II. All had ≥4 patent lumbar arteries (mean diameter >2.3 mm). Ten patients with a transient EL-II had a mean of 4.3 patent lumbar arteries, which had diameters <2 mm (mean 1.5 mm). In the 18 patients with persistent EL-II, the mean diameter of the 4 lumbar arteries was 2.7 mm; at least 1 of the lumbar arteries was >2 mm. The presence of at least 4 patent lumbar arteries (p<0.001) and at least 1 patent hypogastric artery (p<0.001) were predictive factors for EL-II. At least 1 lumbar artery >2 mm in diameter was a positive predictive factor for the development of persistent EL-II (p<0.001). CONCLUSION: Patent hypogastric and lumbar arteries are significantly associated with a higher risk of developing EL-II. Larger diameter lumbar arteries tend to be associated with persistent EL-IIs, while lumbar arteries <2 mm would more likely be seen with a transient EL-II. If substantiated in larger studies, these angiographic criteria may guide early treatment of EL-II to avoid aneurysm sac expansion and potential rupture.

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. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection. RESULTS: The MAE rate was 4.5% (11 patients; P=0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy. CONCLUSION: The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population.

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. Attention to details is crucial, and it involves having the appropriate wires, catheters, balloons, stents, and cerebral protection devices readily available.

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). For biliary occlusion recanalization, the RF wire may allow the use of percutaneous therapy in the treatment of a subset of individuals who would otherwise have to undergo open surgical intervention.

Bailout percutaneous external shunt to restore carotid flow in a patient with acute type A aortic dissection and carotid occlusion.

PURPOSE: To report the use of an external common femoral to carotid artery shunt in the setting of acute type A aortic dissection associated with carotid occlusion and stroke. TECHNIQUE: The procedure is illustrated in a 52-year-old man who presented with a type A dissection extending into the innominate trunk, with associated occlusion of the right common carotid artery (CCA). Angiography showed no collateral circulation to the right cerebral hemisphere. To re-establish brain perfusion in this setting, a percutaneous external shunt was installed from the common femoral artery to the right CCA. The 5-F femoral sheath used during diagnostic angiography was replaced by an 8-F femoral introducer securely fixed to the skin with silk sutures. Ultrasound-guided percutaneous CCA access was obtained using an 18-G needle and a 6-F introducer, also sutured to the skin. The ICA and intracranial branches showed no evidence of thrombosis at this level. A plastic tube was used to connect the femoral and carotid sheath side arms to restore ICA flow. Transcranial Doppler showed normal flow at the right middle cerebral artery after shunt placement. The patient was immediately transferred to the operating room for aortic surgery, during which an intrapericardially ruptured aorta was found. The ascending aorta and proximal arch were replaced under cardiopulmonary bypass and circulatory arrest, but the patient died during the procedure due to uncontrolled bleeding. CONCLUSION: A temporary percutaneous external femoral-carotid shunt can restore blood flow to the brain whenever the carotid artery is occluded by the dissection flap and adequate collateral flow is absent.