PulseRider for Treatment of Wide-Neck Bifurcation Intracranial Aneurysms: 6-Month Results

Background/objective: PulseRider is a new endovascular stent dedicated to treat bifurcation intracranial aneurysms with a wide neck. Our purpose was to evaluate 6-month clinical and anatomic results of the device when used to facilitate endovascular coiling of wide-neck bifurcation aneurysms.

Methods: Unruptured intracranial aneurysms coiled with PulseRider, in 6 European centers and 1 U.S. center, were retrospectively reviewed from June 2014 to October 2015. Immediate and 6-month results were evaluated independently by using the Raymond classification scale. Recanalization was defined as worsening, and progressive thrombosis was defined as improvement on the Raymond scale.

Results: Nineteen patients (10 women, 9 men; mean age, 63 years) harboring 19 bifurcation aneurysms (mean dome size, 8.8 mm; mean neck size, 5.8 mm) were included. Immediate angiographic outcome showed 11 complete aneurysm occlusions, 6 neck remnants, and 2 residual aneurysms. Follow-up at 6 months, obtained in all patients, included 12 complete aneurysm occlusions (63.1%), 6 neck remnants (31.6%), and 1 residual aneurysm (5.3%). Adequate occlusion (defined as complete occlusion and neck remnant combined) was observed in 94.7%. Progressive thrombosis was observed in 2 cases (10.6%) and recanalization in 1 case (5.3%). There was no in-stent stenosis or jailed branch occlusion. No bleeding was observed during the follow-up period. Permanent morbidity rate was 5.3% (1/19), and the mortality rate was 0% at 6 months.

Conclusions: The PulseRider allows endovascular treatment of wide-neck bifurcation intracranial aneurysms. Larger series are needed to confirm our preliminary results.