Early postmarket results with PulseRider for treatment of wide-necked intracranial aneurysms: a multicenter experience

Abstract

<jats:sec><jats:title>OBJECTIVE</jats:title><jats:p>Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device.</jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p>This study was a prospective registry of patients treated with PulseRider at 13 American neurointerventional centers following FDA approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (&gt; 30 days after the procedure) complications.</jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p>A total of 54 aneurysms were treated, with the same number of PulseRider devices, across 13 centers. Fourteen cases were in off-label locations (7 anterior communicating artery, 6 middle cerebral artery, and 1 A<jats:sub>1</jats:sub> segment anterior cerebral artery aneurysms). The average dome/neck ratio was 1.2. Technical success was achieved in 52 cases (96.2%). Major complications included the following: 3 procedure-related posterior cerebral artery strokes, a device-related intraoperative aneurysm rupture, and a delayed device thrombosis. Immediately postoperative Raymond-Roy occlusion classification (RROC) class 1 was achieved in 21 cases (40.3%), class 2 in 15 (28.8%), and class 3 in 16 cases (30.7%). Additional devices were used in 3 aneurysms. For those patients with 3- or 6-month angiographic follow-up (28 patients), 18 aneurysms (64.2%) were RROC class 1 and 8 (28.5%) were RROC class 2.</jats:p></jats:sec><jats:sec><jats:title>CONCLUSIONS</jats:title><jats:p>PulseRider is being used in both on- and off-label cases following FDA approval. The clinical and radiographic outcomes are comparable in real-world experience to the outcomes observed in earlier studies. Further experience is needed with the device to determine its role in the neurointerventionalist’s armamentarium, especially with regard to its off-label use.</jats:p></jats:sec>

Advances in endovascular aneurysm management: coiling and adjunctive devices

“…A total of 63 aneurysms were treated and although it seems ‘safe and probably effective’ for treating intracranial bifurcation aneurysms, a bigger sample size is needed to support this statement 23. More recently, Srinivasan et al 24 reported early postmarket results across 13 centres in the USA for the treatment of 54 aneurysms. Both clinical and radiographic outcomes were comparable with early studies with technical success in 52 cases (96.2%), major complications in three cases and immediate Raymond I or II occlusion in 69.1%.…”

PulseRider Treated Aneurysm with Significant Artifact on Postoperative Magnetic Resonance Angiography: A Case Report and Literature Review

“…Large multicenter studies have allowed for the treating surgeon to follow with their imaging modality of choice. 2,3 This case report implies that MRA is appropriate for follow-up aneurysms but not necessarily the parent vessel.…”

“…Endovascular treatment of widenecked cerebral aneurysms with the PulseRider has a high technical success rate, and there is complete occlusion of approximately two-thirds of aneurysms at one-year after treatment and adequate occlusion of 90% at one-year. 2,3 Additionally, the PulseRider is composed of less metal than a traditional stent with larger fenestrations, which may allow for easier coiling.…”

Efficacy and safety of PulseRider for treatment of wide-necked intracranial aneurysm—A systematic review and meta-analysis

“…We included six studies in the qualitative and quantitative syntheses (Figure 1). There were a total of 157 subjects from six studies 4,5,7–10 (Table 1). Out of these studies, one was a retrospective cohort study, two were single-arm registries, one was a single-arm clinical trial, and two were case series.…”

“…The scaffolding like-function of this device prevents the protrusion of endovascular coils even in the wide-necked anatomy and thus facilitating thrombus formation. 4 This device is also easier to deploy and requires fewer steps compared to Y-stent. Pulserider is a versatile device and can be positioned within the wings of daughter branches, this device also has a lower metal-to-artery ratio, which prevents jailing of daughter branches.…”