Endovascular Treatment of Anterior Circulation Aneurysms With the p64 Flow Modulation Device: Mid- and Long-Term Results in 617 Aneurysms From a Single Center

Abstract

BACKGROUND Flow diverters have become an important tool in the treatment of intracranial aneurysms, especially when dealing with difficult-to-treat or complex aneurysms. The p64 is the only fully resheathable and mechanically detachable flow diverter available for clinical use. OBJECTIVE To evaluate the safety and effectiveness of p64 for the treatment of intracranial saccular unruptured aneurysms arising from the anterior circulation over a long-term follow-up period. METHODS We retrospectively reviewed our prospectively maintained database to identify all patients who underwent treatment for an intracranial saccular (unruptured or beyond the acute hemorrhage phase) aneurysm arising from the anterior circulation with ≥1 p64 between December 2011 and December 2019. Fusiform aneurysms and dissections were excluded. Aneurysms with prior or concomitant saccular treatment (eg, coiling and clipping) were included. Aneurysms with parent vessel implants other than p64 were excluded. Anatomic features, intraprocedural complications, clinical outcome, as well as clinical and angiographic follow-ups were all recorded. RESULTS In total, 530 patients (388 females; median age 55.9 yr) with 617 intracranial aneurysms met the inclusion criteria. The average number of devices used per aneurysm was 1.1 (range 1-3). Mean aneurysm dome size was 4.8 mm (range 1-27 mm). Treatment-related morbimortality was 2.4%. Early, mid-term, and long-term angiographic follow-up showed complete or near-complete aneurysm occlusion in 76.8%, 89.7%, and 94.5%, respectively. CONCLUSION Treatment of intracranial saccular unruptured aneurysms of the anterior circulation using p64 is a safe and effective treatment option with high rate of occlusion at long-term follow-up and low morbimortality.

First Experience of Three Neurovascular Centers With the p64MW-HPC, a Low-Profile Flow Diverter Designed for Proximal Cerebral Vessels With Antithrombotic Coating

“…After ∼6 months, 65% of the aneurysms treated with the p64MW-HPC were sufficiently isolated from the parent vessel. These findings are largely in accordance with earlier studies investigating the efficacy of nowadays well-established bare-metal FDS, for example, the firstgeneration "classic" p64 or the Pipeline Embolization Device (PED), which demonstrated occlusion rates for proximally located aneurysms between 58.3 and 73.6%, 3-6 months post implantation (29)(30)(31)(32).…”

Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device

“…Several previous publications have looked at the p64 FMD, but these reports have been retrospective with no core laboratory, no CEC, and no source data verification. 6 7 10–12 Aguilar Pérez et al 9 recently published a retrospective, single-center series of 530 patients harboring 617 unruptured saccular aneurysms (or those treated >30 days post-rupture), located in the anterior circulation and treated with at least one p64 FMD. The majority of the aneurysms (562, 91.1%) were <10 mm, with an average aneurysm dome size of 4.8 mm (range 1–27 mm), and the p64 FMD procedure was the first treatment performed for 515 (83.5%) of the aneurysms.…”

“…The device is approved for the treatment of intracranial aneurysms and dissections in Europe, and a growing body of literature supports its longterm efficacy. [5][6][7][8][9][10][11][12] Diversion-p64 was a single-arm, international, multicenter, prospective study to assess the safety and efficacy of the p64 FMD and is the largest prospective study on flow diversion to date.…”

Flow Diversion for Reconstruction of Intradural Vertebral Artery Dissecting Aneurysms Causing Subarachnoid Hemorrhage—A Retrospective Study From Four Neurovascular Centers

“…Subsequently, a thrombus is formed in the aneurysm sac, and neointima formation along the lattice of the flow diverter begins ( 22 ). This concept has been proven to be clinically successful for treating anatomically challenging aneurysms in the anterior circulation, particularly for wide-neck sidewall or complex fusiform aneurysms, and long-term follow-up data after flow diverter implantation substantiate good safety and efficacy ( 23 , 24 ). However, ruptured dissecting aneurysms of the intradural VA are biologically distinct from incidental aneurysms, particularly the anterior circulation, and very little data on the use of flow diverters for treatment of dissecting intracranial VA aneurysms have been made available ( 16 ).…”