Abstract TP9: Solitaire FR Thrombectomy For Acute Stroke: Real-world Experience After FDA Approval
Background and Purpose: Based on promising results of the Solitaire FR With the Intention for Thrombectomy (SWIFT) trial, Solitaire FR stent retriever device recently received the Food and Drug Administration (FDA) approval for recanalization of cerebral vessels in patients with acute ischemic stroke. Real world experience with this device since its FDA approval in the United States has not been previously described.
Methods: We conducted retrospective analysis of consecutive acute ischemic strokes cases from March 2012 to July 2012 in 10 centers within the United States, where Solitaire FR was used as a single device or in conjunction with other intra-arterial endovascular approaches.
Results: A total of 107 patients were identified (mean age, 64 years; male gender, 51%; mean admission NIHSS score 17). Mean time from symptom onset to angiogram (groin puncture) was 4 hrs 47 min. Intravenous thrombolysis with tissue plasminogen activator (tPA) was administered in 37% of cases. Other endovascular techniques utilized in conjunction with Solitaire FR included intra-arterial thrombolysis with tPA (12% of patients), aspiration thrombectomy with Penumbra system (29%) and stenting (17%). Complete recanalization (TIMI 2-3) was achieved in 88% of patients. The rate of sICH within the first 24 hours was 15%. In-hospital mortality was 24%. 30-day clinical follow up data was available on 82 (77%) patients. Of those, 28 patients (34%) had favorable functional outcome (defined as modified Ranking Scale,mRS≤2) and 22 patients (27%) had excellent functional outcome (mRS≤1) at 30 days. Three or more passes with the Solitaire device was associated with a higher incidence of mortality compared with patients requiring 1 or 2 passes only (43% and 18% respectively, p = 0.011). No statistically significant correlation between clot location or length and outcome was evident. Use of other devices with the Solitaire FR was correlated with worsened outcome (p=0.037).
Conclusions: This is the first study describing real-world experience with Solitaire FR device outside the SWIFT trial in the United States. Out study shows that variety of other endovascular approaches are used in conjunction with Solitaire FR.
- © 2012 by American Heart Association, Inc.