Initial experience with the novel p64MW HPC flow diverter from a cohort study in unruptured anterior circulation aneurysms under dual antiplatelet medication

Abstract

<jats:sec><jats:title>Objective</jats:title><jats:p> p64MW HPC is a new low-profile flow diverter with reduced thrombogenicity due to hydrophilic coating. The purpose of this study was to evaluate its safety and efficacy in Mongolian patients under dual antiplatelet therapy. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Consecutive patients with unruptured anterior circulation aneurysms were prospectively enrolled. All patients received aspirin and clopidogrel before and six months after the procedure, followed by lifelong aspirin medication. High platelet reactivity (VerifyNow) did not trigger further action. The safety and efficacy endpoints were clinical outcome and aneurysm occlusion. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In 29 patients (26 female, median age 57 years), 46 aneurysms (neck width 3.3 mm, fundus diameter 3.7 mm, median) were treated. Dual platelet function inhibition was confirmed in eight patients (28%). The response to Clopidogrel was between 100 and 239 P2Y12 reaction units (VerifyNow) in 13 patients (45%). Non-response to at least one drug was found in 8 of 29 patients (28%). One collapsed p64MW HPC required balloon angioplasty. No other periprocedural thrombus formation occurred. Postprocedural MRI revealed lesions with diffusion restriction in 3 of 29 patients. Digital subtraction angiography after three months for 42 of 46 (91%) aneurysms showed an adequate aneurysm occlusion in 25 (60%). Distal p64MW HPC migration of 3 implants was retreated with another p64MW HPC. Follow-up digital subtraction angiography of 26 of 46 (57%) aneurysms after six months showed adequate aneurysm occlusion in 22 (85%). Significant in-stent stenosis or thrombosis, morbidity or mortality was not encountered. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> p64MW HPC implantation in patients under dual antiplatelet therapy with or without dual platelet function inhibition has a low procedural complication rate. The early aneurysm occlusion rate is high. </jats:p></jats:sec>

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

“…However, the complications in our patients were treated with good outcomes and no patient suffered from severe, permanent device-related morbidity. The rate of clinical complications in our preliminary study on the p64MW-HPC is in line with or below the complication rates of earlier reports ( 20 ).…”

“…Ex vivo testing has demonstrated that platelets in contact with HPC-covered FDS are significantly less activated than platelets in contact with uncoated FDS (16). Additionally, first clinical evidence indicates that applying the HPC technology to FDS allows reduction of DAPT in selected cases of unruptured and even ruptured cerebral aneurysms (17)(18)(19)(20). Whether the HPC technology may delay neo-endothelialization, and thus aneurysm occlusion, remains to be elucidated.…”

First multicenter experience using the Silk Vista flow diverter in 60 consecutive intracranial aneurysms: technical aspects

“…Recently another Nitinol FD with the same 0.021 inch profile has been launched, the P64 MW HPC; however, clinical experience for this device is limited at the moment. 20 In 2018 the third generation device, the SVB, received CE approval for the treatment of aneurysms located in small or distal vessels (1.5-3.5 mm). The device used DFT technology and allowed full radio-opacity of the device.…”

Treatment of Intracranial Aneurysms Using the New Silk Vista Flow Diverter: Safety Outcomes at Short-Term Follow-Up

“…Since the Food and Drug Administration (FDA), in 2011, authorized the use of the first Flow diverter (Pipeline Embolization Device, Medtronic, Dublin, Ireland), flow diverters (FDs) began to be used representing an important option in the treatment of large and long brain aneurysms, obtaining satisfactory results both in the degree of occlusion and in the clinical efficacy (1)(2)(3)(4)(5)(6)(7)(8). The neurovascular community has been progressively increasing their use, developing a new-generation the FDs, with different structures, in order to produce better parent artery reconstruction and improve endothelial cells formation across the aneurysm neck (Silk flow diverter, Balt Extrusion, Montmorency, France; FRED, MicroVention, Tustin, CA; Derivo Embolization Device, Acandis GmbH, Germany; Surpass stent, Stryker Neurovascular, Kalamazoo, MI, USA; p64, Phenox GmbH, Bochum, Germany) (9)(10)(11)(12)(13)(14).…”