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Background and Purpose: The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer., Materials and Methods: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes., Results: Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period., Conclusions: The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods., Clinical Trial Registration: NCT02390037., Competing Interests: Competing interests: MM-G serves as a proctor and consultant for Medtronic. SML receives honoraria from Medtronic in relation to proctoring, speaking, and consulting. TL previously consulted and proctored for Covidien, Stryker, and MicroVention, and currently serves as a proctor and consultant for Sequent Medical. EPB receives honoraria from Medtronic and serves as a consultant for Medtronic., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Direct exposure and cannulation of the superior ophthalmic vein (SOV) provides an alternative access to reach the cavernous sinus for carotid-cavernous fistula (CCF) embolization, when classic transvenous routes through the inferior petrosal sinus (IPS) or facial vein are not feasible. We have used indocyanine green (ICG)-videoangiography to study intraoperatively the flow inside the SOV in two cases of indirect CCF. In this paper, we report the operative technique and the result of ICG videoangiographic-guided cannulation of the SOV for endovascular treatment of CCF. Two male patients, of 59 and 66 years of age respectively, presented at our Institution with right decreased visual acuity, persistent binocular diplopia and painful ophthalmoplegia, chemosis and proptosis, due to right unilateral indirect CCF fistula. The endovascular transvenous approach failed in one case due to thrombosis of the inferior petrosal sinus (IPS) and the extreme tortuosity of the angular vein. In the other case, it was considered unfeasible due to an unfavourable vascular angioarchitecture. For this reason, an ICG videoangiographic-guided cannulation of the SOV, followed by endovascular obliteration of the CCF, was performed. CCF was cured in both cases with this approach. No additional neurological deficits and no complications due to SOV cannulation were registered during the hospital stay. There were no fistula recurrences during the mean follow-up of 18 months. ICG-videoangiography is a simple, fast and cost-effective technique that can be reliably applied in SOV cannulation for subsequent indirect CCF embolization.