Pipeline shield with single antiplatelet therapy in aneurysmal subarachnoid haemorrhage: multicentre experience

Abstract

BackgroundThe Pipeline Embolisation Device with Shield technology (PED-Shield) is suggested to have reduced thrombogenicity. This reduced thrombogenicity may make it possible to use safely in the acute treatment of aneurysmal subarachnoid haemorrhage (aSAH) on single antiplatelet therapy (SAPT).ObjectiveTo evaluate the safety and efficacy of the off-label use of PED-Shield with SAPT for the acute treatment of aSAH.MethodsPatients who underwent acute treatment of ruptured intracranial aneurysms with the PED-Shield with SAPT were retrospectively identified from prospectively maintained databases at three Australian neurointerventional centres. Patient demographics, aneurysm characteristics, clinical and imaging outcomes were reviewed.ResultsFourteen patients were identified (12 women), median age 64 (IQR 21.5) years. Aneurysm morphology was saccular in seven, fusiform in five, and blister in two. Aneurysms arose from the anterior circulation in eight patients (57.1%). Six (42.9%) patients were poor grade (World Federation of Neurological Societies grade ≥IV) SAH. Median time to treatment was 1 (IQR 0.5) day. Complete or near complete aneurysm occlusion (Raymond-Roy <3) was achieved in 12 (85.7%) patients at the end of early-acute follow-up (median day 7 after SAH). Permanent, treatment-related morbidity occurred in one (7.1%) patient and one (7.1%) treatment-related death occurred. The use of a postoperative heparin infusion (n=5) was associated with a higher rate of all complications (80.0% vs 11.1%, p=0.023) and symptomatic complications (60% vs 0.0%, p=0.028). No symptomatic ischaemic or haemorrhagic complications were observed in the patients who did not receive a post-operative heparin infusion. Nine (64.3%) patients were functionally independent on discharge from the treatment centre.ConclusionThe PED-Shield may be safe to use in the acute treatment of ruptured intracranial aneurysms with SAPT. Further investigation with a formal treatment registry is needed.

The p48 Flow Modulation Device with Hydrophilic Polymer Coating (HPC) for the Treatment of Acutely Ruptured Aneurysms: Early Clinical Experience Using Single Antiplatelet Therapy

“…Recent advances in polymer coating technology have led to FDS with reduced thrombogenicity becoming available (e.g., PED Shield; Medtronic). Maning et al [9] used the PED Shield under SAPT to treat 14 patients with aSAH and reported no difference in the rate of acute stent thrombosis, permanent morbidity, or mortality compared with the meta-analysis performed by Cagnazzo et al [8].…”

The p48_HPC antithrombogenic flow diverter: initial human experience using single antiplatelet therapy

“…[21][22][23] Furthermore, the concept of enhanced platelet recovery was recently discussed in relation to the PED Shield. 6 Although aspirin could be used in conjunction with coated devices, such as the p48_HPC, the potential for inadequate antiplatelet activity was considered too great especially because these were the first cases evaluated in human patients. For these reasons, aspirin is not currently considered to be the optimal antiplatelet agent in these patients.…”

Flow Diversion for Treatment of Acutely Ruptured Intracranial Aneurysms

“…Its rapid onset of action and short half-life make it an attractive alternative to the oral thienopyridine agents in the acute phase of SAH, but the clinical experience is still minimal, and the high price is a significant disadvantage [26]. A promising recent advancement has been the surface modification to reduce the inherent thrombogenicity of FDS [27][28][29]. Manning et al used the PED with shield technology under single antiplatelet therapy in treating 14 patients with ruptured intracranial aneurysms and reported no hemorrhagic or thromboembolic complications in the subgroup that did not receive postinterventional heparin infusion [29].…”

“…A promising recent advancement has been the surface modification to reduce the inherent thrombogenicity of FDS [27][28][29]. Manning et al used the PED with shield technology under single antiplatelet therapy in treating 14 patients with ruptured intracranial aneurysms and reported no hemorrhagic or thromboembolic complications in the subgroup that did not receive postinterventional heparin infusion [29]. Until establishing the efficacy and safety of such coatings in a large clinical trial, the use of FDS will remain limited by the need for DAPT.…”