PulseRider-assisted treatment of wide-necked intracranial bifurcation aneurysms: safety and feasibility study

OBJECTIVE The goal of this study was to assess the safety and feasibility of PulseRider, a novel endovascular stent, in the treatment of intracranial bifurcation aneurysms with wide necks. The authors present the initial results of the first 10 cases in which the PulseRider device was used. METHODS Patients whose aneurysms were intended to be treated with the PulseRider device at 2 institutions in the United Kingdom were identified prospectively. Patient demographics, procedural details, immediate neurological and clinical status, and immediate angiographic outcomes and 6-month clinical and imaging follow-up were recorded prospectively. RESULTS At the end of the procedure, all 10 patients showed complete aneurysm occlusion (Raymond Class 1). There were no significant intraprocedural complications except for an occurrence of thromboembolism without clinical sequelae. There was no occurrence of aneurysm rupture or vessel dissection. At 6-month follow-up, 7 and 3 patients had modified Rankin Scale scores of 0 and 1, respectively. All 10 patients had stable aneurysm occlusion (Raymond Class 1) and daughter vessel intraluminal patency on 6-month follow-up catheter angiography. CONCLUSIONS The authors' early experience with the PulseRider device demonstrates that it is a safe and effective adjunct in the treatment of bifurcation aneurysms with wide necks arising at the middle cerebral artery bifurcation, anterior cerebral artery, basilar apex, and carotid terminus. It works by providing a scaffold at the neck of the bifurcation aneurysm, enabling neck remodeling and coil support while maintaining parent vessel intraluminal patency. Early clinical and radiological follow-up showed good functional outcome and stable occlusion rates, respectively. Further data are needed to assess medium- and long-term outcomes with PulseRider.