Balloon Guide Catheter Shown to Improve Revascularization With Covidien's Solitaire FR Device

December 3, 2013—An evaluation of the role of balloon guide catheter (BGC) and recanalization success in a substudy of the North American Solitaire Acute Stroke (NASA) registry concluded that use of a BGC with the Solitaire flow restoration (FR) device (Covidien, Mansfield, MA) resulted in superior revascularization results, faster procedure times, decreased need for adjunctive therapy, and improved clinical outcomes. Thanh N. Nguyen, MD, et al published thestudy online ahead of print in Stroke.

In the background of the study, the investigators noted that efficient and timely recanalization is an important goal in endovascular therapy for acute stroke and that several studies demonstrated improved recanalization and clinical outcomes with stent retriever devices compared with the Merci retriever (Stryker Corporation, Kalamazoo, MI). 

In the investigator-initiated NASA registry, 24 clinical sites within North America were recruited to submit demographic, clinical, site-adjudicated angiographic, and clinical outcomes data on consecutive patients treated with the Solitaire FR device. Use of BGC was at the discretion of the treating physicians.

As summarized in Stroke, there were 354 patients included in the NASA registry. BGC data were reported in 338 of 354 patients in this subanalysis, of which, 149 (44%) underwent use of a BGC. The mean patient age was 67.3 ± 15.2 years, and the median National Institutes of Health Stroke Scale score was 18. Patients with BGC versus patients without BGC had more hypertension (82.4% vs 72.5%; P = .05), atrial fibrillation (50.3% vs 32.8%; P = .001), and were more commonly administered tissue plasminogen activator (51.6% vs 38.8%; P = .02). 

The investigators reported that the time from symptom onset to groin puncture and number of passes were similar between the two groups. Procedure times were shorter in patients with BGC (120 ± 28.5 vs 161 ± 35.6 minutes; P = .02), and less adjunctive therapy was used (20% vs 28.6%; P = .05). Thrombolysis in cerebral infarction 3 reperfusion scores were higher in patients with BGC (53.7% vs 32.5%; P < .001). Distal emboli and emboli in new territory were similar between the two groups. The National Institutes of Health Stroke Scale scores at discharge (mean, 12 ± 14.5 vs 17.5 ± 16; P = .002) and clinical outcomes at 3 months were superior in patients with BGC compared with patients without (51.6% vs 35.8%; P = .02). Multivariate analysis demonstrated that the use of BGCs was an independent predictor of good clinical outcomes (odds ratio, 2.5; 95% confidence interval, 1.2–4.9), reported the NASA investigators.