Background and Purpose: Timely recanalization in large vessel occlusive disease is essential to achieving good outcomes in patients with AIS. As such, the SWIFT PRIME study design incorporated aggressive time metrics and real time direct feedback. We systemically investigated variables affecting the time spent during discrete patient process steps including patient transport, selection and treatment delivery in patients treated in the SWIFT PRIME trial.
Methods: Data was analyzed from the SWIFT PRIME trial, a global, multi-center, prospective, randomized, open, blinded endpoint (PROBE) IDE study comparing functional outcomes in AIS subjects treated with either IV t-PA alone (93 patients) or IV t-PA in combination with Solitaire device (93 patients). Each patient enrollment was analyzed for workflow and direct feedback was provided to the enrolling site.
Results: The median time from Emergency Department (ED) arrival to groin puncture was 90 minutes (interquartile range [IQR], 69 - 120) and ED arrival to reperfusion time was 139 minutes (IQR, 108 - 169). The median ED to imaging start time was 16 minutes (IQR, 10-23.5), puncture to device deployment was 24 minutes (IQR, 18-33), and device deployment to reperfusion was 8 minutes (IQR, 5-23). The association between time intervals and baseline characteristics of the patient, mode of arrival at the endovascular-capable hospital and procedural characteristics was evaluated with multivariate negative binomial regression using a logarithmic link function (Figure).
Conclusions: Detailed attention to workflow with iterative feedback and aggressive time goals leads to a highly efficient workflow. Future steps for improvement include faster triage and transport of patients to endovascular capable centers as well as advancements in treating patients with difficult anatomical features.