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Safety and efficacy of the Pipeline embolization device for treatment of intracranial aneurysms: a pooled analysis of 3 large studies

David F. Kallmes, Waleed Brinjikji, Saruhan Cekirge, David Fiorella, Ricardo A. Hanel, Pascal Jabbour, Demetrius Lopes, Pedro Lylyk, Cameron G. McDougall, and Adnan Siddiqui

majority of previously published studies are small single-institution case series, and their results may not be generalizable to the overall patient population. IntrePED (International Retrospective Study of the Pipeline Embolization Device), PUFS (Pipeline for Uncoilable or Failed Aneurysms Study), and ASPIRe (Aneurysm Study of Pipeline in an Observational Registry) represent large, multicenter studies that followed predefined protocols to fully characterize the safety and efficacy of the PED. These studies include a broad range of aneurysm types, locations, and sizes

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Patency of the ophthalmic artery after flow diversion treatment of paraclinoid aneurysms

Clinical article

Ross C. Puffer, David F. Kallmes, Harry J. Cloft, and Giuseppe Lanzino

Object

In this study the authors determined the patency rate of the ophthalmic artery (OphA) after placement of 1 or more flow diversion devices across the arterial inlet for treatment of proximal internal carotid artery (ICA) aneurysms, and correlated possible risk factors for OphA occlusion.

Methods

Nineteen consecutive patients were identified (mean age 53.9 years, range 23–74 years, all female) who were treated for 20 ICA aneurysms. In all patients a Pipeline Embolization Device (PED) was placed across the ostium of the OphA while treating the target aneurysm. Flow through the OphA after PED placement was determined by immediate angiography as well as follow-up angiograms (mean 8.7 months), compared with the baseline study. Potential risk factors for OphA occlusion, including age, immediate angiographic flow through the ophthalmic branch, status of flow within the aneurysm after placement of PEDs, whether the ophthalmic branch originated from the aneurysm dome, and number of PEDs placed across the ophthalmic branch inlet were correlated with patency rate.

Results

Patients were treated with 1–3 PEDs (3 aneurysms treated with placement of 1 PED, 12 with 2 PEDs, and 5 with 3 PEDs). In 17 (85%) of 20 treated aneurysms, no changes in the OphA flow were noted immediately after placement of the device. Two (10%) of 20 patients had delayed antegrade filling immediately following PED placement and 1 patient (5%) had retrograde flow from collaterals to the OphA immediately after placement of the device. One patient (5%) experienced delayed asymptomatic ICA occlusion; this patient was excluded from analysis at follow-up. At follow-up the OphA remained patent with normal antegrade flow in 13 (68%) of 19 patients, patent but with slow antegrade flow in 2 patients (11%), and was occluded in 4 patients (21%). No visual changes or clinical symptoms developed in patients with OphA flow compromise. The mean number of PEDs in the patients with occluded OphAs or change in flow at angiographic follow-up was 2.4 (SEM 0.2) compared with 1.9 (SEM 0.18) in the patients with no change in OphA flow (p = 0.09). There was no significant difference between the patients with occluded OphAs compared with nonoccluded branches based on patient age, immediate angiographic flow through the ophthalmic branch, status of flow through the aneurysm after placement of PEDs, whether the ophthalmic branch originated from the aneurysm dome, or number of PEDs placed across the ophthalmic branch inlet.

Conclusions

Approximately one-quarter of OphAs will undergo proximal thrombosis when covered with flow diversion devices. Even though these events were well-tolerated clinically, our findings suggest that coverage of branch arteries that have adequate collateral circulation may lead to spontaneous occlusion of those branches.