MicroVention's Sofia Plus Catheter Evaluated for Primary Local Aspiration in Acute Stroke Thrombectomy
January 4, 2017—A multicenter European study was conducted to determine the technical feasibility, safety, and functional outcome with a direct aspiration first pass technique (ADAPT) using the large-bore, 6-F Sofia Plus catheter (MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation). The background of the study is that ADAPT has been introduced as a rapid and safe endovascular treatment strategy in patients with ischemic stroke. The findings were published online by Markus A. Möhlenbruch, MD, et al in the Journal of NeuroInterventional Surgery (JNIS).
As summarized in JNIS, the investigators conducted a retrospective analysis of prospectively collected data from six university hospitals in Germany and Austria. They analyzed the following parameters of all acute stroke procedures (from June 2015 to January 2016) using the Sofia Plus catheter: accessibility of the thrombus with the catheter, recanalization success (thrombolysis in cerebral infarction ≥ 2b), time to recanalization, and procedure-related complications. They also recorded National Institutes of Health Stroke Scale (NIHSS) scores at presentation and discharge, as well as the modified Rankin scale (mRS) score at 90 days.
The investigators reported that 85 patients were treated using the Sofia Plus catheter. The occlusion site was the anterior circulation in 94.1% of patients, median baseline NIHSS score was 18, and ADAPT alone was successful after a median procedure time of 21 minutes in 64.7% of patients. With the additional use of stent retrievers in the remaining cases, the recanalization rate was 96.5%.
There were no catheter-related complications, such as dissections. Thrombus migration to a new vascular territory occurred in 4.7% of cases, and symptomatic hemorrhage was seen in 4.7% of patients. After 3 months, mRS scores of 0 to 2 were achieved in 49.4% of patients. The mortality rate was 20%.
The investigators concluded that in the majority of cases, thrombus aspiration using the Sofia Plus catheter resulted in successful recanalization with a short procedure time. With the additional use of stent retrievers, a higher recanalization rate was achieved (96.5%). The complication rate was in line with those of previous publications, noted the investigators in JNIS.