title: Safety and feasibility of intravenous rt-PA in the Emergency Department without a neurologist-based stroke unit: an observational study.
abstract: Early intravenous thrombolysis has proven to be a safe and effective therapy for selected patients with acute ischemic stroke (AIS). Nowadays, thrombolysis is usually delivered by neurologists in "hub" referral centers. However, only a few among eligible patients actually receive treatment. Barriers to early administration of thrombolysis are represented by delays in presentation to referral centers, in-hospital and transfer delays, as well as changes in symptoms during assessment time. The aim of this study is to evaluate the safety and rate of thrombolysis provided in Emergency Department (ED) of a district hospital without neurological stroke team. Consecutive patients with AIS treated with intravenous thrombolysis were prospectively enrolled in this observational study, conducted between May 2010 and December 2013. The main outcomes evaluated were: mortality, symptomatic intracerebral hemorrhage (ICH), systemic adverse events, and neurological recovery. Secondly, all patients admitted with ischemic stroke were retrospectively screened to assess the reasons for exclusion to treatment and the rate of thrombolysis delivered. During the study period, 43 patients with AIS received intravenous rt-PA treatment. The mortality rate at three months was 9.5 % (4/43; 95 % CI 2.6-22.1) and total ICH at any-time CT scan imaging was 18.6 % (8/43; 8.4-33.4). At seven days or at discharge, 35/43 patients (81.4 %; 66.6-91.6) presented a neurological improvement and 46.5 % (20/43; 31.2-62.3) a complete neurological recovery presenting a normal NIHSS, while 9.5 % of patients remained in steady conditions and other 9.5 % worsened (4/43; 2.6-22.1). Outcomes do not appear to be very different from those reported in SITS-MOST study cohort. Among the overall 732 patients with AIS, 117 (16.0 %; 13.4-18.8) were eligible for age and arrived within the three-hour window of time, and the thrombolysis rate was 5.9 % (43/732; 4.3-7.8). Administration of rt-PA in an ED setting without neurological specialized stroke unit seems to be feasible and safe after adequate training. Thrombolysis rate found seems to be favorably comparable with the national average in specialist stroke units. If such data were confirmed by studies of greater dimension, this may imply the ability to perform thrombolysis even in smaller centers without the neurologist, thus being able to treat a greater number of patients in the times proven effective for thrombolysis.
authors.affiliation: Emergency Department, Ospedale Civile Santa Maria della Scaletta. Imola, Via Montericco 4, Imola (Bologna), 40026, Italy, andrea.tampieri@libero.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Tampieri
authors.forename: Eugenio
authors.initials: E
authors.lastname: Giovannini
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Rusconi
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Cristoni
authors.forename: Daniela
authors.initials: D
authors.lastname: Bendanti
authors.forename: Patrizia
authors.initials: P
authors.lastname: Cenni
authors.forename: Tiziano
authors.initials: T
authors.lastname: Lenzi
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000188:drug therapy; D002543:Cerebral Hemorrhage / Q000209:etiology; D004636:Emergency Service, Hospital; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D009462:Neurology; D012189:Retrospective Studies; D020521:Stroke / Q000188:drug therapy; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000009:adverse effects* / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator