A comprehensive simulation framework for predicting the eCLIPs implant crimping into a catheter and its deployment mechanisms.

Tubular flow diverters (FDs) represent an important subset of the endovascular treatment of cerebral aneurysms (CAs), acting to reduce aneurysm inflow, eventually resulting in aneurysm thrombosis and occlusion. eCLIPs (product of Evasc Neurovascular Enterprises, Vancouver, Canada), an innovative non-tubular implant causes flow diversion by bridging the neck of bifurcation CAs. However, in a small subset of challenging bifurcation aneurysms with fusiform pathology, the currently available eCLIPs models do not provide sufficient neck bridging resulting in a gap created between the device structure and the aneurysm/artery wall.

Role of preliminary registry data in development of a clinical trial for an innovative device: a small but integral piece of a health policy initiative.

Establishing a national health policy at a macro level involves the integration of a series of health initiatives across a spectrum of activities, including clinical care. Evaluation of the safety and efficacy of a new medical device ultimately evolves to testing in humans. The pathway to a formal prospective clinical trial includes a stepwise appreciation of pre-clinical data and detailed analysis of data obtained from preliminary registries, where information about appropriate patient selection and use of the device is obtained.

Physiological remodeling of bifurcation aneurysms: preclinical results of the eCLIPs device.

OBJECTIVE Intracranial bifurcation aneurysms are complex lesions for which current therapy, including simple coiling, balloon- or stent-assisted coiling, coil retention, or intrasaccular devices, is inadequate. Thromboembolic complications due to a large burden of intraluminal metal, impedance of access to side branches, and a high recurrence rate, due largely to the unmitigated high-pressure flow into the aneurysm (water hammer effect), are among the limitations imposed by current therapy. The authors describe herein a novel device, eCLIPs, and its use in a preclinical laboratory study that suggests the device's design and functional features may overcome many of these limitations.

A training paradigm to enhance performance and safe use of an innovative neuroendovascular device.

Training has been important to facilitate the safe use of new devices designed to repair vascular structures. This paper outlines the generic elements of a training program for vascular devices and uses as an example the actual training requirements for a novel device developed for the treatment of bifurcation intracranial aneurysms. Critical elements of the program include awareness of the clinical problem, technical features of device, case selection, and use of a simulator.

Spontaneous coronary artery dissection: association with predisposing arteriopathies and precipitating stressors and cardiovascular outcomes.

Background: Nonatherosclerotic spontaneous coronary artery dissection (NA-SCAD) is underdiagnosed and an important cause of myocardial infarction in young women. The frequency of predisposing and precipitating conditions and cardiovascular outcomes remains poorly described.

Methods And Results: Patients with NA-SCAD prospectively evaluated (retrospectively or prospectively identified) at Vancouver General Hospital were included.

Nonatherosclerotic coronary artery disease in young women.

Background: Nonatherosclerotic coronary artery disease (NACAD) is an important cause of myocardial infarction (MI) in young women but is often missed on coronary angiography, especially spontaneous coronary artery dissection (SCAD). The prevalence of NACAD in young women has not been described.

Methods: We retrospectively reviewed all coronary angiograms of women aged 50 years and younger at Vancouver General Hospital from December 1, 2009 to November 30, 2011.

Spontaneous coronary artery dissection: prevalence of predisposing conditions including fibromuscular dysplasia in a tertiary center cohort.

Objectives: We sought to evaluate the prevalence of fibromuscular dysplasia (FMD) and other predisposing conditions among spontaneous coronary artery dissection (SCAD) patients.

Background: Spontaneous coronary artery dissection is considered rare. However, we observed many young women with SCAD and concomitant FMD.

Perforation during stenting of a coronary artery with morphologic changes of fibromuscular dysplasia: an unrecognized risk with percutaneous intervention.

Fibromuscular dysplasia (FMD) is increasingly recognized as a nonatherosclerotic pathology in young women presenting with acute coronary syndromes. The angiographic appearance of these lesions may mimic typical atherosclerosis, and a high index of suspicion is needed. The pathophysiological changes in the intima and media alter the vessel's elasticity and may adversely affect the lesion's response to balloon dilatation and stenting.

The effects of aspirin and clopidogrel response on myonecrosis after percutaneous coronary intervention: a BRIEF-PCI (Brief Infusion of Intravenous Eptifibatide Following Successful Percutaneous Coronary Intervention) trial substudy.

Objectives: The purpose of this study was to evaluate the effects of aspirin and clopidogrel response on myonecrosis after percutaneous coronary intervention (PCI) with glycoprotein (GP) IIb/IIIa blockade.

Background: Aspirin and clopidogrel resistance is increasingly recognized, but its effects on PCI outcomes with GP IIb/IIIa blockade are unknown.

Methods: This was a prospective, pre-specified substudy of the BRIEF-PCI (Brief Infusion of Intravenous Eptifibatide Following Successful Percutaneous Coronary Intervention) trial, which randomized 624 patients to 18-h or <2-h eptifibatide infusion after uncomplicated PCI.

Abbreviated infusion of eptifibatide after successful coronary intervention The BRIEF-PCI (Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention) randomized trial.

Objectives: The purpose of this study was to assess whether the early discontinuation of eptifibatide infusion in nonemergent percutaneous coronary intervention (PCI) is associated with a higher frequency of periprocedural ischemic myonecrosis.

Background: The recommended regimen for eptifibatide is a double bolus followed by an infusion for 18 h. It is not known whether the infusion can be shortened if the PCI is uncomplicated.

A novel endovascular clip system for the treatment of intracranial aneurysms: technology, concept, and initial experimental results. Laboratory investigation.

Object: The authors describe a novel device for the endovascular treatment of intracranial aneurysms, the endovascular clip system (eCLIPs). Descriptions of the device and its delivery system as well as the results of flow model tests and the treatment of experimental aneurysms are provided.

Methods: The eCLIPs comprises a flexible hybrid implantable device (an anchor and a covered leaf) and a balloon catheter delivery system, designed to be positioned and activated in the parent vessel in such a way that the covered portion will abut the aneurysm neck.

Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis.

Background: Percutaneous aortic valve replacement represents an endovascular alternative to conventional open heart surgery without the need for sternotomy, aortotomy, or cardiopulmonary bypass.

Methods And Results: Transcatheter implantation of a balloon-expandable stent valve using a femoral arterial approach was attempted in 50 symptomatic patients with severe aortic stenosis in whom there was a consensus that the risks of conventional open heart surgery were very high. Valve implantation was successful in 86% of patients.

Redefining the normal angiogram using population-derived ranges for coronary size and shape: validation using intravascular ultrasound and applications in diverse patient cohorts.

Objectives: To develop a method for quantitating coronary angiographic abnormalities of segmental size and shape (tapering) in comparison to gender- and segment-specific, population derived, normal values.

Background: In the absence of obvious focal stenoses, remodeling renders the angiogram insensitive to the presence of atherosclerosis and invalidates use of a "normal reference segment" for calculation of percent diameter stenosis.

Methods: Equations were created for detection of size/shape abnormalities of coronary angiographic segments.

Percutaneous aortic valve implantation: a case report.

The present case demonstrates the percutaneous implantation of a bioprosthetic valve in a patient with severe aortic stenosis. An 85-year-old man with significant comorbidities was determined to be at unacceptable risk with traditional surgical valve replacement. Percutaneous aortic valve implantation was performed, was successful and uncomplicated, with significant clinical and hemodynamic improvement.

Percutaneous aortic valve implantation retrograde from the femoral artery.

Background: Percutaneous aortic valve implantation by an antegrade transvenous approach has been described but is problematic. Retrograde prosthetic aortic valve implantation via the femoral artery has potential advantages. Percutaneous prosthetic aortic valve implantation via the femoral arterial approach is described and the initial experience reported.

Procedural efficacy and complications of X-Sizer thrombectomy in de novo and stented lesions.

Angiographic thrombus is associated with poorer procedural and clinical outcomes. We report our experience with the X-Sizer thrombectomy device (EndiCOR Medical) from March 2001 to December 2002. Indications for use in 44 patients (33 male; mean age, 60) included myocardial infarction (27), unstable angina (6), periprocedural thrombosis (2), acute (< 24 hr) stent thrombosis (1), and subacute (> 24 hr) stent thrombosis (8).

The profile of cardiac patients with renal artery stenosis.

Objectives: We examined the prevalence and severity of renal artery stenosis (RAS) in patients undergoing cardiac catheterization who were deemed at risk for RAS based on clinical or laboratory criteria for study entry, but who had not previously been suspected of having RAS.

Background: The diagnosis of atherosclerotic RAS remains problematic because its clinical manifestations are nonspecific.

Methods: Consecutive patients undergoing non-emergent cardiac catheterization at a single institution during a 12-month period were evaluated using standardized clinical, laboratory, and angiographic criteria.

Six-month angiographic and 12-month clinical follow-up of MultiLink long (25 to 35 mm) stents for long coronary narrowings in patients with angina pectoris.

There are limited prospective angiographic data on stent deployment for long coronary lesions. This multicenter prospective study enrolled 120 patients with a single de novo stenosis >20 mm in length, in a native vessel > or =3 mm diameter, suitable for a MultiLink stent 25 to 35 mm in length with additional stent deployment if required. Quantitative angiography before and immediately after stenting and at 6-month follow-up assessed restenosis for the complete lesion and for 5-mm segments of the stented and adjacent nonstented vessel.