Amplitude Spectrum Area of ventricular fibrillation to guide defibrillation: a small open-label, pseudo-randomized controlled multicenter trialResearch in context
Laura Ruggeri,
Francesca Fumagalli,
Filippo Bernasconi,
Federico Semeraro,
Jennifer M.T.A. Meessen,
Adriana Blanda,
Maurizio Migliari,
Aurora Magliocca,
Giovanni Gordini,
Roberto Fumagalli,
Giuseppe Sechi,
Antonio Pesenti,
Markus B. Skrifvars,
Yongqin Li,
Roberto Latini,
Lars Wik,
Giuseppe Ristagno
Affiliations
Laura Ruggeri
Laboratory of Cardiopulmonary Pathophysiology, Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy
Francesca Fumagalli
Laboratory of Cardiopulmonary Pathophysiology, Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy
UOC Rianimazione-Emergenza Territoriale, Emergency Department, Maggiore hospital, AUSL di Bologna, Italy
Jennifer M.T.A. Meessen
Laboratory of Cardiopulmonary Pathophysiology, Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy
Adriana Blanda
Laboratory of Cardiopulmonary Pathophysiology, Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy
Maurizio Migliari
Agenzia Regionale Emergenza Urgenza, Milan, Italy
Aurora Magliocca
Department of Pathophysiology and Transplantation, University of Milan, Italy
Giovanni Gordini
UOC Rianimazione-Emergenza Territoriale, Emergency Department, Maggiore hospital, AUSL di Bologna, Italy
Department of Pathophysiology and Transplantation, University of Milan, Italy; Department of Anesthesiology, Intensive Care and Emergency Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
Markus B. Skrifvars
Department of Emergency Care and Services, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Yongqin Li
Department of Biomedical Engineering and Imaging Medicine, Army Medical University, Chongqing, China
Roberto Latini
Laboratory of Cardiopulmonary Pathophysiology, Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy
Lars Wik
National Advisory Unit on Prehospital Emergency Medicine, Oslo University Hospital, Oslo, Norway
Giuseppe Ristagno
Department of Pathophysiology and Transplantation, University of Milan, Italy; Department of Anesthesiology, Intensive Care and Emergency Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Corresponding author. Department of Pathophysiology and Transplantation, University of Milan, Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35, 20122, Milan, Italy.
Summary: Background: Ventricular fibrillation (VF) waveform analysis has been proposed as a potential non-invasive guide to optimize timing of defibrillation. Methods: The AMplitude Spectrum Area (AMSA) trial is an open-label, multicenter randomized controlled study reporting the first in-human use of AMSA analysis in out-of-hospital cardiac arrest (OHCA). The primary efficacy endpoint was the termination of VF for an AMSA ≥ 15.5 mV-Hz. Adult shockable OHCAs randomly received either an AMSA-guided cardiopulmonary resuscitation (CPR) or a standard-CPR. Randomization and allocation to trial group were carried out centrally. In the AMSA-guided CPR, an initial AMSA ≥ 15.5 mV-Hz prompted for immediate defibrillation, while lower values favored chest compression (CC). After completion of the first 2-min CPR cycle, an AMSA < 6.5 mV-Hz deferred defibrillation in favor of an additional 2-min CPR cycle. AMSA was measured and displayed in real-time during CC pauses for ventilation with a modified defibrillator. Findings: The trial was early discontinued for low recruitment due to the COVID-19 pandemics. A total of 31 patients were recruited in 3 Italian cities, 19 in AMSA-CPR and 12 in standard-CPR, and included in the data analysis. No difference in primary outcome was observed between the two groups. Termination of VF occurred in 74% of patients in the AMSA-CPR compared to 75% in the standard CPR (OR 0.93 [95% CI 0.18–4.90]). No adverse events were reported. Interpretation: AMSA was used prospectively in human patients during ongoing CPR. In this small trial, an AMSA-guided defibrillation provided no evidence of an improvement in termination of VF. Trial registration: NCT03237910. Funding: European Commission - Horizon 2020; ZOLL Medical Corp., Chelmsford, USA (unrestricted grant); Italian Ministry of Health - Current research IRCCS.
