Vanguard Study: Initial experience with the new fourth generation Pipeline Vantage Flow Diverter (PVFD): 6-month results, technical and clinical considerations

de Villiers, Laetitia; Carraro do Nascimento, Vinicius; Domitrovic, Luis; Dhillon, Permesh Singh; Rice, Hal

doi:10.1136/jnis-2023-021182

Cited by 11 publications

(1 citation statement)

References 23 publications

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“…[8][9][10][11][12][13] Numerous new FDs with differing construction and configuration have entered the market, frequently with the focus on simplified deployment. Based on recent observations, 14 15 some interventionalists hypothesized that newer-generation FDs develop [15][16][17] braid changes in follow-up images more frequently than expected from previous experience. 14 15 However, actual data supporting this claim are limited.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN

Fiehler,

Ortega-Gutierrez,

Anagnostakou

et al. 2024

J NeuroIntervent Surg

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BackgroundMultiple studies and meta-analyses have described the technical and clinical outcomes in large cohorts of aneurysm patients treated with flow diverters (FDs). Variations in evaluation methodology complicate making comparisons among studies, hinder understanding of the device behavior, and pose an obstacle in the assessment of further advances in FD therapy.MethodsA multidisciplinary panel of neurointerventionalists, imaging experts, and neuroradiologists convened with the goal of establishing consensus recommendations for the standardization of image analyses in FD studies.ResultsA standardized methodology is proposed for evaluating and reporting radiological outcomes of FD treatment of intracranial aneurysms. The recommendations include general imaging considerations for clinical studies and evaluations of longitudinal changes, such as neointimal lining and stenosis. They cover standards for classification of aneurysm location, morphology, measurements, as well as the assessment of aneurysm occlusion, wall apposition, and neck coverage. These reporting standards further define four specific braid deformation patterns: foreshortening, fish-mouthing, braid bump deformation, and braid collapse, collectively termed ‘F2B2’.ConclusionsWhen widely applied, standardization of methods of measuring and reporting outcomes will help to harmonize the assessment of treatment outcomes in clinical studies, help facilitate communication of results among specialists, and help enable research and development to focus on specific aspects of FD techniques and technology.

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Section: Introductionmentioning

confidence: 99%

Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN

Fiehler,

Ortega-Gutierrez,

Anagnostakou

et al. 2024

J NeuroIntervent Surg

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The DERIVO 2 Heal Embolization Device in the Treatment of Ruptured and Unruptured Intracranial Aneurysms: a Retrospective Multicenter Study

Schwab,

Kabbasch,

Goertz

et al. 2024

Clin Neuroradiol

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Backround The use of flow diverting stents in the treatment of intracranial aneurysms is associated with a risk of neurological morbidity due to their thrombogenicity. To reduce this risk different surface modifications have been developed. The Derivo 2 Embolization Device (Acandis, Pforzheim, Germany) has proven to be a safe and effective flow diverter. To overcome the risk of thrombo-embolism, the device was modified by adding an anti-thrombogenic fibrin-heparin coating. We aimed to assess the safety and effectiveness of the Derivo 2 heal Embolization Device. Methods Retrospective multicenter data from nine German neurovascular centers between February 2022 until December 2023 were used. Patients treated with the Derivo 2 heal Embolization Device for unruptured or ruptured intracranial aneurysms were included. Peri- and postprocedural adverse events, clinical outcomes, and angiographic follow-up results were evaluated. Results 84 patients (73.8% female; mean age 58.7 years) with 89 aneurysms (mean size 9.8 mm) were included. 87.6% were located in the anterior circulation. Most of them were sidewall aneurysms (88.8%). 96 flow diverters were used. 99.0% were successfully implanted. An in-stent balloon angioplasty was performed in 6.0% of the cases. An additional coiling was performed in 28.6%. Technical difficulties were present in 12.0% of the cases. Thrombotic events occurred in 4.8% with no neurological sequelae. Mortality and morbidity were 0 and 1.2% respectively. Adequate aneurysm occlusion was achieved in 80.7% with a mean follow-up time of 6.6 months. Conclusion The Derivo 2 heal Embolization Device showed a satisfying aneurysm occlusion and safety with a low rate of neurological morbidity.

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

Goertz,

Hohenstatt,

Vollherbst

et al. 2024

J NeuroIntervent Surg

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BackgroundThis multicenter study evaluated the safety and efficacy of coated flow diverters (cFDs) for the treatment of ruptured intracranial aneurysms.MethodsConsecutive 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.ResultsThe 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.ConclusionsTreatment of ruptured aneurysms with cFDs was reasonably safe and efficient and thus represents a valid treatment option, especially for complex cases.

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Vanguard Study: Initial experience with the new fourth generation Pipeline Vantage Flow Diverter (PVFD): 6-month results, technical and clinical considerations

Cited by 11 publications

References 23 publications

Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN

Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN

The DERIVO 2 Heal Embolization Device in the Treatment of Ruptured and Unruptured Intracranial Aneurysms: a Retrospective Multicenter Study

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

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