nitinol and Brain-Ischemia

This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR).. The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016).. Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.

Topics: Aged; Aged, 80 and over; Alloys; Aortic Valve; Aortic Valve Stenosis; Brain Ischemia; Brazil; Cardiac Catheterization; Cognition; Cognition Disorders; Diffusion Magnetic Resonance Imaging; Embolic Protection Devices; Europe; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Intracranial Embolism; Male; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Severity of Illness Index; Stroke; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Transcranial

To describe our initial experience with the Versi Retriever for mechanical thrombectomy in patients with acute ischemic stroke.. This study is a single-center, single-arm, first-in-man registry under institutional review board control to evaluate the efficacy and safety of the new stent retriever, the Versi Retriever. Patients with acute ischemic stroke were consecutively enrolled between September and November 2017. The clinical and procedural data were retrospectively analyzed. The angiographic result after the procedure was self-graded based on the Thrombolysis in Cerebral Infarction (TICI) scale by each operator.. Eleven patients with a mean age of 69.4 years were treated with the Versi Retriever. Median National Institutes of Health Stroke Scale score on admission was 16 (IQR 10-34). The occluded vessel was located in the anterior circulation in 81.8%. Revascularization rates of TICI 2b-3 and TICI 3 at final angiogram were achieved in 100% and 63.6%, respectively. A favorable functional outcome (modified Rankin Scale 0-2) at 90 days was obtained in 72.7%. No symptomatic intracranial hemorrhage occurred and no procedure-related complication was observed.. Our initial experience suggests that the Versi Retriever is a safe and effective stent retriever for mechanical thrombectomy in patients with acute ischemic stroke.. NCT03366818.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angiography; Brain Ischemia; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Registries; Retrospective Studies; Stroke; Thrombectomy; Treatment Outcome; Young Adult

Mechanical thrombectomy (MTB) is a treatment of reference for acute ischemic stroke due to large brain vessel occlusion but some concerns remain about its use in small distal branches. In the present study, we assessed the efficacy and the safety of distal MTB using the Catch Mini (CM) stent retriever.. We retrospectively reviewed a prospectively maintained database of all consecutive patients who underwent MTB for a distal intracranial occlusion with the Catch Mini device at our hospital.. Forty-one patient underwent MTB for distal intracranial occlusions using the CM stent retriever. Good capillary reperfusion (TICT≥2b) was observed in 32 out of 41 patients (78%). Focal ischemia within the territory vascularized by the artery addressed by the CM was observed in 8 patients (19.5%). Post-procedural vasospasm was observed in 8 patients, all responding rapidly to vasodilatator administration. Two asymptomatic hemorrhages (4.9%) were noted on follow-up imaging (one patechial hemorrhage and one parenchymal hematoma) in patients with M2 occlusions. No vessel rupture were observed. Overall, good neurological outcome at three months (mRS≤2) was observed in 28 (out of 34 patients followed; 82.4%) of patients.. Our single-center experience shows that the CM stent retriever is safe and effective for the recanalization of small diameter distal branches feeding eloquent brain areas.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alloys; Brain Ischemia; Device Removal; Female; Humans; Male; Middle Aged; Radiography, Interventional; Retrospective Studies; Stents; Stroke; Thrombectomy; Treatment Outcome

Several randomized trials of patients with carotid stenosis show increased adverse neurological events with stenting versus endarterectomy in the 30-day post-procedure. This study examines the incidence of new ischaemic lesions in patients treated in our centre using the new Roadsaver stent.. Between September 2015 and January 2016, 23 consecutive patients (age 74.3 ± 7.3 years, 17.4 % female) underwent carotid artery stenting with the Roadsaver stent, a nitinol double-layer micromesh device. A distal protection device was used in all cases. Diffusion-weighted magnetic resonance imaging was performed 24 h before, and 24 h and 30 days after the procedure. The 24-h post-procedure imaging showed 15 new ipsilateral ischaemic lesions in 7 (30.4 %) patients: median volume 0.076 cm. Protected stenting with micromesh Roadsaver stent showed good safety and efficacy in the treatment of carotid stenosis, with a low incidence of delayed embolic events and new ipsilateral ischaemic brain lesions. These preliminary results are encouraging, but need to be confirmed with larger populations.

Topics: Aged; Aged, 80 and over; Alloys; Brain Ischemia; Carotid Stenosis; Diffusion Magnetic Resonance Imaging; Equipment Design; Female; Humans; Incidence; Male; Middle Aged; Prospective Studies; Recurrence; Stents; Stroke; Treatment Outcome

Intracranial atherosclerosis may be the underlying pathology in up to 15% of ischemic strokes, but may account for about 40% of strokes in some populations. After an ischemic event determined by intracranial atherosclerosis, patients have a 12% annual risk of stroke recurrence, mostly during the first year.. To evaluate procedural safety, clinical outcome and restenosis rate of Wingspan stent placement.. Twenty-one caucasoid patients were enrolled. Target patients were affected by high-grade, symptomatic, intracranial atherosclerotic lesions, were on antithrombotic therapy and at high stroke risk. All patients were treated with the Wingspan stent system.. Technical success resulted 100%, with all target lesions being reduced to <50%. No stroke or death were observed at 30. The mean percent of stenosis was reduced from a middle value of 84% to a middle value of 17% after stent placement. Medium follow-up was 19.5months (range 6-36months). No stroke or death occurred in any patient. None of the patients presented a <50% stent patency rate at follow-up.. The short-term results and follow up analysis provide evidence demonstrating the safety of the Wingspan system when used in high-risk patient population. Due to concerns regarding long-term stent patency and ischemic events occurrence emerged from clinical trials such as the SAMMPRIS, intracranial angioplasty and stent with the Wingspan system should be considered only for high risk patients in which it may be considered the only viable therapeutic option.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Brain Ischemia; Cerebral Angiography; Constriction, Pathologic; Endpoint Determination; Female; Fibrinolytic Agents; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Magnetic Resonance Angiography; Male; Middle Aged; Plaque, Atherosclerotic; Platelet Aggregation Inhibitors; Recurrence; Stents; Stroke; Survival Rate; Tomography, X-Ray Computed; Treatment Outcome

Although extracranial carotid dissection with stroke is common, intracranial dissection with stroke is rare. Stenting has been used to treat extracranial carotid dissections. Intracranially, however, it is only recently that stents have become a feasible option for this disease. We present a case of a spontaneous intracranial CAD with progressive symptoms despite medical management treated with a self-expanding intracranial micronitinol stent.. A 47-year-old, right-handed woman presented to the emergency department after noticing left-sided face and arm weakness and numbness, along with slurred speech. The patient was started on aspirin 325 mg/d orally and lovenox 40 mg/d subcutaneously. On hospital day 2, the patient was noted to have repeated episodes of weakness and numbness on the left side and MRI evidence of a new stroke. A diagnostic cerebral angiogram from a selective right internal carotid injection revealed a flow-limiting stenosis secondary to a dissection of the supraclinoid internal carotid artery with severe flow limitation to the hemisphere. Endovascular management was decided on, and a Neuroform stent measuring 4.5 x 20 mm (Boston Scientific Corporation, Natick, Mass) was deployed across the dissection with significant improvement of flow to that hemisphere on the poststent angiogram.. This case illustrates the successful off-label use of a self-expanding intracranial nitinol stent to treat a symptomatic intracranial internal CAD in the setting of failure of traditional medical management. This is a promising application of novel endovascular technology.

Topics: Alloys; Anticoagulants; Brain; Brain Ischemia; Carotid Artery, Internal; Carotid Artery, Internal, Dissection; Cerebral Angiography; Female; Humans; Magnetic Resonance Angiography; Magnetic Resonance Imaging; Middle Aged; Platelet Aggregation Inhibitors; Stents; Stroke; Treatment Outcome; Vascular Surgical Procedures