Demetris Yannopoulos1, Rajat Kalra2, Marinos Kosmopoulos2, Emily Walser2, Jason A Bartos2, Thomas A Murray3, John E Connett3, Tom P Aufderheide4. 1. Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN. Electronic address: yanno001@umn.edu. 2. Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN. 3. Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN. 4. Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI.
Abstract
BACKGROUND:Venoarterial extracorporeal membrane oxygenation has emerged as a prominent therapy for patients with refractory cardiac arrest. However, the optimal time of initiation remains unknown. AIM: The aim was to assess the rate of survival to hospital discharge in adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest treated with 1 of 2 local standards of care: (1) earlyvenoarterial extracorporeal membrane oxygenation-facilitated resuscitation for circulatory support and percutaneous coronary intervention, when needed, or (2) standard advanced cardiac life support resuscitation. DESIGN: Phase II, single-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial. POPULATION: Adults (aged 18-75), initial out-of-hospital cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System automated cardiopulmonary resuscitation device, and transfer time of <30 minutes. SETTING: Hospital-based. OUTCOMES: Primary: survival to hospital discharge. Secondary: safety, survival, and functional assessment at hospital discharge and 3 and 6 months, and cost. SAMPLE SIZE: Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients. CONCLUSIONS: The ARREST trial will generate safety/effectiveness data and comparative costs associated with extracorporeal cardiopulmonary resuscitation, informing broader implementation and a definitive Phase III clinical trial.
RCT Entities:
BACKGROUND: Venoarterial extracorporeal membrane oxygenation has emerged as a prominent therapy for patients with refractory cardiac arrest. However, the optimal time of initiation remains unknown. AIM: The aim was to assess the rate of survival to hospital discharge in adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest treated with 1 of 2 local standards of care: (1) early venoarterial extracorporeal membrane oxygenation-facilitated resuscitation for circulatory support and percutaneous coronary intervention, when needed, or (2) standard advanced cardiac life support resuscitation. DESIGN: Phase II, single-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial. POPULATION: Adults (aged 18-75), initial out-of-hospital cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System automated cardiopulmonary resuscitation device, and transfer time of <30 minutes. SETTING: Hospital-based. OUTCOMES: Primary: survival to hospital discharge. Secondary: safety, survival, and functional assessment at hospital discharge and 3 and 6 months, and cost. SAMPLE SIZE: Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients. CONCLUSIONS: The ARREST trial will generate safety/effectiveness data and comparative costs associated with extracorporeal cardiopulmonary resuscitation, informing broader implementation and a definitive Phase III clinical trial.
Authors: Demetris Yannopoulos; Jason Bartos; Ganesh Raveendran; Emily Walser; John Connett; Thomas A Murray; Gary Collins; Lin Zhang; Rajat Kalra; Marinos Kosmopoulos; Ranjit John; Andrew Shaffer; R J Frascone; Keith Wesley; Marc Conterato; Michelle Biros; Jakub Tolar; Tom P Aufderheide Journal: Lancet Date: 2020-11-13 Impact factor: 79.321
Authors: Tom P Aufderheide; Rajat Kalra; Marinos Kosmopoulos; Jason A Bartos; Demetris Yannopoulos Journal: Ann N Y Acad Sci Date: 2021-02-20 Impact factor: 5.691
Authors: Andrew C Read; Stephen Morgan; Claire Reynolds; Jeff Breeding; Sean Scott; David A Lowe; Sally Newman; Rosemary Kennedy; Hergen Buscher Journal: Resusc Plus Date: 2022-04-22