Immediate procedural outcomes in 44 consecutive Pipeline Flex cases: The first North American single-center series

Background Flow diversion is an established technique for treatment of cerebral aneurysms. The Pipeline embolization device (PED) is the only FDA-approved flow diverting stent in the USA. A second-generation device, PED Flex, has recently been released with modifications to the delivery system. Published reports of experience with this new device are limited. Objective To describe the initial outcomes from the first North American series using the PED Flex-a single-center experience of 44 cases. Methods All patients consecutively treated with the PED Flex embolization device from February 2015 through April 2015 were included in the study. Data were collected for patient demographics, aneurysm characteristics, technical procedural details, and early outcomes. Results PED Flex treatment was attempted in 42 patients (mean 56.6±2.0years) with 44 aneurysms (mean size 6.5±0.6mm), 41/44 (93%) of which were anterior circulation and 3/44 (7%) were posterior circulation. PED Flex was successfully implanted in 43/44 cases (98%). A single device was used in 41/43 cases (95%), with a mean of 1.07±0.05 devices implanted per case. Resheathing was performed in 4/44 cases (9%). Mean postprocedure hospital length of stay was 1.3 ± 0.2days. One significant neurological complication (2.3%) occurred, which was a stroke in a patient non-compliant with the prescribed antiplatelet regimen. Conclusions Pipeline Flex is a second-generation flow diverter with enhanced features compared with the first-generation PED. These modifications allow for more reliable deployment with continued improvements in procedural safety.