Solitaire Flow Restoration Thrombectomy for Acute Ischemic Stroke: Retrospective Multicenter Analysis of Early Postmarket Experience After FDA Approval

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Abstract

BACKGROUND:

The promising results of the Solitaire Flow Restoration (FR) With the Intention for Thrombectomy (SWIFT) trial recently led to Food and Drug Administration (FDA) approval of the Solitaire FR stent retriever device for recanalization of cerebral vessels in patients with acute ischemic stroke.

OBJECTIVE:

To report the early postmarket experience with this device since its FDA approval in the United States, which has not been previously described.

METHODS:

We conducted a retrospective analysis of consecutive acute ischemic strokes cases treated between March 2012 and July 2012 at 10 United States centers where the Solitaire FR was used as a single device or in conjunction with other intraarterial endovascular approaches.

RESULTS:

A total of 101 patients were identified (mean age, 64.7 years; mean admission National Institutes of Health Stroke Scale [NIHSS] score, 17.6). Intravenous thrombolysis was administered in 39% of cases; other endovascular techniques were utilized in conjunction with the Solitaire FR in 52%. Successful recanalization (Thrombolysis in Myocardial Infarction 2/3) was achieved in 88%. The rate of symptomatic intracranial hemorrhage within the first 24 hours was 15%. In-hospital mortality was 26%. At 30 days, 38% of patients had favorable functional outcome (modified Rankin scale score ≤2). Severity of NIHSS score on admission was a strong predictor of poor outcome.

CONCLUSION:

Our study shows that a variety of other endovascular approaches are used in conjunction with Solitaire FR in actual practice in the United States. Early postmarket results suggest that Solitaire FR is an effective tool for endovascular treatment of acute ischemic stroke.

ABBREVIATIONS:

ASPECTS, Alberta Stroke Program Early CT score

ABBREVIATIONS:

ECASS, European-Australasian Acute Stroke Study

ABBREVIATIONS:

FDA, Food and Drug Administration

ABBREVIATIONS:

ICH, intracranial hemorrhage

ABBREVIATIONS:

IV, intravenous

ABBREVIATIONS:

mRS, modified Rankin Scale

ABBREVIATIONS:

NIHSS, National Institutes of Health Stroke Scale Score

ABBREVIATIONS:

sICH, symptomatic intracranial hemorrhage

ABBREVIATIONS:

SWIFT, Solitaire FR With the Intention for Thrombectomy

ABBREVIATIONS:

TIMI, Thrombolysis in Myocardial Infarction

ABBREVIATIONS:

tPA, tissue plasminogen activator

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