Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial.

BACKGROUND: Among patients with out-of-hospital cardiac arrest (OHCA) and ventricular fibrillation, more than half present with refractory ventricular fibrillation unresponsive to initial standard advanced cardiac life support (ACLS) treatment. We did the first randomised clinical trial in the USA of extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation versus standard ACLS treatment in patients with OHCA and refractory ventricular fibrillation. METHODS: For this phase 2, single centre, open-label, adaptive, safety and efficacy randomised clinical trial, we included adults aged 18-75 years presenting to the University of Minnesota Medical Center (MN, USA) with OHCA and refractory ventricular fibrillation, no return of spontaneous circulation after three shocks, automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System, and estimated transfer time shorter than 30 min. Patients were randomly assigned to early ECMO-facilitated resuscitation or standard ACLS treatment on hospital arrival by use of a secure schedule generated with permuted blocks of randomly varying block sizes. Allocation concealment was achieved by use of a randomisation schedule that required scratching off an opaque layer to reveal assignment. The primary outcome was survival to hospital discharge. Secondary outcomes were safety, survival, and functional assessment at hospital discharge and at 3 months and 6 months after discharge. All analyses were done on an intention-to-treat basis. The study qualified for exception from informed consent (21 Code of Federal Regulations 50.24). The ARREST trial is registered with ClinicalTrials.gov, NCT03880565. FINDINGS: Between Aug 8, 2019, and June 14, 2020, 36 patients were assessed for inclusion. After exclusion of six patients, 30 were randomly assigned to standard ACLS treatment (n=15) or to early ECMO-facilitated resuscitation (n=15). One patient in the ECMO-facilitated resuscitation group withdrew from the study before discharge. The mean age was 59 years (range 36-73), and 25 (83%) of 30 patients were men. Survival to hospital discharge was observed in one (7%) of 15 patients (95% credible interval 1·6-30·2) in the standard ACLS treatment group versus six (43%) of 14 patients (21·3-67·7) in the early ECMO-facilitated resuscitation group (risk difference 36·2%, 3·7-59·2; posterior probability of ECMO superiority 0·9861). The study was terminated at the first preplanned interim analysis by the National Heart, Lung, and Blood Institute after unanimous recommendation from the Data Safety Monitoring Board after enrolling 30 patients because the posterior probability of ECMO superiority exceeded the prespecified monitoring boundary. Cumulative 6-month survival was significantly better in the early ECMO group than in the standard ACLS group. No unanticipated serious adverse events were observed. INTERPRETATION: Early ECMO-facilitated resuscitation for patients with OHCA and refractory ventricular fibrillation significantly improved survival to hospital discharge compared with standard ACLS treatment. FUNDING: National Heart, Lung, and Blood Institute.

Stroke savvy. The accuracy of EMS-reported last known normal times.

We collected EMS-reported "last known normal" (LKN) times for patients brought to the ED with suspected acute stroke and calculated the absolute difference between the neurologist-determined and EMS-reported LKN times (deltaLKN). We determined the rate of inappropriate IV tissue plasminogen activator (tPA) use if the EMS-reported times were used instead of the neurologist-determined times. Of 251 patients, mean and median deltaLKN were 28 and 0 minutes, respectively. deltaLKN was < 15 minutes in 91% of the entire group and < 15 minutes in 80% of patients with a diagnosis of stroke. Of patients who received IV tPA, none would've been incorrectly excluded from IV tPA if the EMS LKN time had been used. Conversely, of patients who didn't receive IV tPA, 6% would have been incorrectly included for IV tPA consideration had the EMS time been used. In patients with wake-up stroke symptoms, EMS underestimated LKN times by an average of 208 minutes. All of the potentially incorrectly included patients would've been wake-up strokes.

STEMI patients. Do prehospital events have an effect on outcome?

BACKGROUND: Little is known about clinically important events and advanced care treatment that patients with ST-segment elevation myocardial infarction (STEMI) encounter in the prehospital setting. OBJECTIVES: We sought to determine the proportion of community patients with STEMI who experienced a clinically important event or received advanced care treatment prior to arrival at a designated percutaneous coronary intervention (PCI) laboratory or emergency department (ED). METHODS: We reviewed 487 consecutive community patients with STEMI between May 2008 and June 2009. All patients were geographically within a single, large "third-service" urban EMS system and were transported by paramedics with an advanced care scope of practice. We recorded predefined clinically important events and advanced care treatment that occurred in patients being transported directly to a PCI laboratory or ED (group 1) or interfacility transfer to a PCI laboratory (group 2). RESULTS: One or more clinically important events occurred in 92 of 342 (26.9%) group 1 patients and nine of 145 (6.2%) group 2 patients. The most common were sinus bradycardia, hypotension and cardiac arrest. Additionally, 33 of 342 (9.6%) group 1 and nine of 145 (6.2%) group 2 patients received one or more advanced care treatments. The most common were administration of morphine and administration of atropine. Eight group 1 patients and three group 2 patients received cardiopulmonary resuscitation (CPR) or defibrillation. CONCLUSIONS: Clinically important events and advanced care treatment are common in community STEMI patients undergoing prehospital transport or interfacility transfer to a PCI center. Several patients required CPR or defibrillation. Further research is needed to define the clinical experience of STEMI patients during the out-of-hospital phase and the scope of practice required of EMS providers to safely manage these patients.