Pipeline Vantage Embolization Device for the treatment of intracranial aneurysms: A systematic review and meta-analysis.

OBJECTIVE: The Pipeline Vantage Embolization Device (PVED) is a novel coated flow diverter with reduced wire diameters to improve neoendothelialization and stent porosity. This systematic review evaluates the safety and efficacy of the PVED based on the current literature. METHODS: Following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, a thorough literature search was conducted using PubMed, EMBASE, and Cochrane. The random effects model was used to calculate estimates with major neurological complications within 30 days of treatment as the primary safety endpoint and ≤1-year complete occlusion rate as the primary efficacy endpoint. RESULTS: Six single-arm studies (5 retrospective, 1 prospective) with 392 patients and 439 aneurysms (6.8% ruptured) were included. Antiplatelet regimens varied, but dual antiplatelet therapy was administered in the majority. The pooled technical success rate was 99.0% (95%CI, 98.0%-100%) with an average of 1.2 devices implanted per procedure. Balloon angioplasty was performed in 17.0% (95%CI, 6.4-27.6%) and adjunctive coiling in 28.0% (95%CI, 17.8-38.2%), with significant heterogeneity for both variables. Pooled estimates for major neurological complications were 3.5% (95%CI, 1.7%-5.2%) with total ischemic events in 4.1% (95% CI, 1.6%-6.6%) and hemorrhagic events in 1.0% (95% CI, 0.0%-1.9%). The rate of complete angiographic occlusion was 75.7% (95%CI, 70.7%-80.6%) at a mean follow-up of 7 months, with in-stent stenoses in 8.1% (95%CI, 4.5%-11.8%). CONCLUSIONS: The safety and efficacy profile of the PVED appears comparable to competing devices, with potentially fewer complications than first-generation flow diverters. Long-term and comparative studies are needed to further confirm these results.

Multicenter Experience with the Pipeline Flex and Vantage with Shield Technology for Intracranial Aneurysm Treatment.

BACKGROUND AND PURPOSE: The Pipeline Embolization Device is a safe and effective treatment option for intracranial aneurysms. The newer Pipeline generations have received structural refinements and a surface modification to improve deliverability, procedural safety, and angiographic outcomes. This multicenter study evaluated the clinical safety and efficacy of the 2 surface-modified Pipeline iterations, Pipeline Vantage and Pipeline Flex with Shield Technology (PFS). MATERIALS AND METHODS: Consecutive patients treated between 2017 and 2023 were retrospectively reviewed for aneurysm characteristics, procedural details, complications, and angiographic outcomes. The safety end point was the rate of procedural and postprocedural major neurologic events occurring during the hospital stay. The efficacy end point was the rate of complete occlusion at last follow-up. RESULTS: One hundred forty-one patients underwent 112 Pipeline Vantage procedures and 32 PFS procedures for 147 aneurysms with a mean size of 8.0 (SD, 5.9) mm (11% ruptured, 16% posterior circulation, 18% nonsaccular morphology). All procedures were technically successful with a mean of 1.2 devices implanted. Balloon angioplasty was required in 20/144 (13.9%) procedures. Major neurologic adverse events occurred in 6/144 (4.2%) procedures (all ischemic stroke), resulting in death in 2 (1.4%) patients. There were no hemorrhagic complications. At a mean of 11 months, complete occlusion was achieved in 85/112 (75.9%) aneurysms, 15/112 (13.4%) had an entry remnant, and 12/112 (10.7%) had an aneurysm remnant. CONCLUSIONS: The results demonstrate high feasibility, procedural safety, and efficacy of the surface-modified Pipeline flow diverters.

Prasugrel Single Antiplatelet Therapy versus Aspirin and Clopidogrel Dual Antiplatelet Therapy for Flow Diverter Treatment for Cerebral Aneurysms: A Retrospective Multicenter Study.

BACKGROUND AND PURPOSE: The optimal antiplatelet regimen after flow diverter treatment of cerebral aneurysms is still a matter of debate. A single antiplatelet therapy might be advantageous in determined clinical scenarios. This study evaluated the efficacy and safety of prasugrel single antiplatelet therapy versus aspirin and clopidogrel dual antiplatelet therapy. MATERIALS AND METHODS: We performed a post hoc analysis of 4 retrospective multicenter studies including ruptured and unruptured aneurysms treated with flow diversion using either prasugrel single antiplatelet therapy or dual antiplatelet therapy. Primary end points were the occurrence of any kind of procedure- or device-related thromboembolic complications and complete aneurysm occlusion at the latest radiologic follow-up (mean, 18 months). Dichotomized comparisons of outcomes were performed between single antiplatelet therapy and dual antiplatelet therapy. Additionally, the influence of various patient- and aneurysm-related variables on the occurrence of thromboembolic complications was investigated using multivariable backward logistic regression. RESULTS: A total of 222 patients with 251 aneurysms were included, 90 (40.5%) in the single antiplatelet therapy and 132 (59.5%) in the dual antiplatelet therapy group. The primary outcome-procedure- or device-related thromboembolic complications-occurred in 6 patients (6.6%) of the single antiplatelet therapy and in 12 patients (9.0%) of the dual antiplatelet therapy group (P = .62; OR, 0.712; 95% CI, 0.260-1.930). The primary treatment efficacy end point was reached in 82 patients (80.4%) of the single antiplatelet therapy and in 115 patients (78.2%) of the dual antiplatelet therapy group (P = .752; OR, 1.141; 95% CI, 0.599-2.101). Logistic regression showed that non-surface-modified flow diverters (P = .014) and fusiform aneurysm morphology (P = .004) significantly increased the probability of thromboembolic complications. CONCLUSIONS: Prasugrel single antiplatelet therapy after flow diverter treatment may be as safe and effective as dual antiplatelet therapy and could, therefore, be a valid alternative in selected patients. Further prospective comparative studies are required to validate our findings.

Safety and efficacy of coated flow diverters in the treatment of ruptured intracranial aneurysms: a retrospective multicenter study.

BACKGROUND: This multicenter study evaluated the safety and efficacy of coated flow diverters (cFDs) for the treatment of ruptured intracranial aneurysms. METHODS: Consecutive patients treated with different cFDs for ruptured aneurysms under tirofiban at eight neurovascular centers between 2016 and 2023 were retrospectively analyzed. The majority of patients were loaded with dual antiplatelet therapy after the treatment. Aneurysm occlusion was determined using the O'Kelly-Marotta (OKM) grading scale. Primary outcome measures were major procedural complications and aneurysmal rebleeding during hospitalization. RESULTS: The study included 60 aneurysms (posterior circulation: 28 (47%)) with a mean size of 5.8±4.7 mm. Aneurysm morphology was saccular in 28 (47%), blister-like in 12 (20%), dissecting in 13 (22%), and fusiform in 7 (12%). Technical success was 100% with a mean of 1.1 cFDs implanted per aneurysm. Adjunctive coiling was performed in 11 (18%) aneurysms. Immediate contrast retention was observed in 45 (75%) aneurysms. There was 1 (2%) major procedural complication (a major stroke, eventually leading to death) and no aneurysmal rebleeding. A good outcome (modified Rankin Scale 0-2) was achieved in 40 (67%) patients. At a mean follow-up of 6 months, 27/34 (79%) aneurysms were completely occluded (OKM D), 3/34 (9%) had an entry remnant (OKM C), and 4/34 (12%) had residual filling (OKM A or B). There was 1 (3%) severe in-stent stenosis during follow-up that was treated with balloon angioplasty. CONCLUSIONS: Treatment of ruptured aneurysms with cFDs was reasonably safe and efficient and thus represents a valid treatment option, especially for complex cases.