Dataset Information

Amplitude Spectrum Area of ventricular fibrillation to guide defibrillation: a small open-label, pseudo-randomized controlled multicenter trial.

ABSTRACT:

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.

SUBMITTER: Ruggeri L

PROVIDER: S-EPMC10060104 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Amplitude Spectrum Area of ventricular fibrillation to guide defibrillation: a small open-label, pseudo-randomized controlled multicenter trial.

Ruggeri Laura L Fumagalli Francesca F Bernasconi Filippo F Semeraro Federico F Meessen Jennifer M T A JMTA Blanda Adriana A Migliari Maurizio M Magliocca Aurora A Gordini Giovanni G Fumagalli Roberto R Sechi Giuseppe G Pesenti Antonio A Skrifvars Markus B MB Li Yongqin Y Latini Roberto R Wik Lars L Ristagno Giuseppe G

EBioMedicine 20230326

<h4>Background</h4>Ventricular fibrillation (VF) waveform analysis has been proposed as a potential non-invasive guide to optimize timing of defibrillation.<h4>Methods</h4>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- ...[more]

PMID: 36977371

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Project description:BackgroundEvidence of the association between AMplitude Spectral Area (AMSA) of ventricular fibrillation and outcome after out-of-hospital cardiac arrest (OHCA) is limited to short-term follow-up. In this study, we assess whether AMSA can stratify the risk of death or poor neurological outcome at 30 days and 1 year after OHCA in patients with an initial shockable rhythm or with an initial non-shockable rhythm converted to a shockable one.MethodsThis is a multicentre retrospective study of prospectively collected data in two European Utstein-based OHCA registries. We included all cases of OHCAs with at least one manual defibrillation. AMSA values were calculated after data extraction from the monitors/defibrillators used in the field by using a 2-s pre-shock electrocardiogram interval. The first detected AMSA value, the maximum value, the average value, and the minimum value were computed, and their outcome prediction accuracy was compared. Multivariable Cox regression models were run for both 30-day and 1-year deaths or poor neurological outcomes. Neurological cerebral performance category 1-2 was considered a good neurological outcome.ResultsOut of the 578 patients included, 494 (85%) died and 10 (2%) had a poor neurological outcome at 30 days. All the AMSA values considered (first value, maximum, average, and minimum) were significantly higher in survivors with good neurological outcome at 30 days. The average AMSA showed the highest area under the receiver operating characteristic curve (0.778, 95% CI: 0.7-0.8, p < 0.001). After correction for confounders, the highest tertiles of average AMSA (T3 and T2) were significantly associated with a lower risk of death or poor neurological outcome compared with T1 both at 30 days (T2: HR 0.6, 95% CI: 0.4-0.9, p = 0.01; T3: HR 0.6, 95% CI: 0.4-0.9, p = 0.02) and at 1 year (T2: HR 0.6, 95% CI: 0.4-0.9, p = 0.01; T3: HR 0.6, 95% CI: 0.4-0.9, p = 0.01). Among survivors at 30 days, a higher AMSA was associated with a lower risk of mortality or poor neurological outcome at 1 year (T3: HR 0.03, 95% CI: 0-0.3, p = 0.02).DiscussionLower AMSA values were significantly and independently associated with the risk of death or poor neurological outcome at 30 days and at 1 year in OHCA patients with either an initial shockable rhythm or a conversion rhythm from non-shockable to shockable. The average AMSA value had the strongest association with prognosis.

Project description:BackgroundDespite high-quality cardiopulmonary resuscitation (CPR), early defibrillation, and antiarrhythmic medications, some patients remain in refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. These patients have worse outcomes compared to patients who respond to initial treatment. Double sequential external defibrillation (DSED) and vector change (VC) defibrillation have been proposed as viable options for patients in refractory VF. However, the evidence supporting the use of novel defibrillation strategies is inconclusive. The objective of this study is to compare two novel therapeutic defibrillation strategies (DSED and VC) against standard defibrillation for patients with treatment refractory VF or pulseless ventricular tachycardia (pVT) during out-of-hospital cardiac arrest.Research questionAmong adult (≥ 18 years) patients presenting in refractory VF or pulseless ventricular tachycardia (pVT) during out-of-hospital cardiac arrest, does DSED or VC defibrillation result in greater rates of survival to hospital discharge compared to standard defibrillation?MethodsThis will be a three-arm, cluster randomized trial with repeated crossover conducted in six regions of Ontario, Canada (Peel, Halton, Toronto, Simcoe, London, and Ottawa), over 3 years. All adult (≥ 18 years) patients presenting in refractory VF (defined as patients presenting in VF/pVT and remaining in VF/pVT after three consecutive standard defibrillation attempts during out-of-hospital cardiac arrest of presumed cardiac etiology will be treated by one of three strategies: (1) continued resuscitation using standard defibrillation, (2) resuscitation involving DSED, or (3) resuscitation involving VC (change of defibrillation pads from anterior-lateral to anterior-posterior pad position) defibrillation. The primary outcome will be survival to hospital discharge. Secondary outcomes will include return of spontaneous circulation (ROSC), VF termination after the first interventional shock, VF termination inclusive of all interventional shocks, and number of defibrillation attempts to obtain ROSC. We will also perform an a priori subgroup analysis comparing rates of survival for those who receive "early DSED," or first DSED shock is shock 4-6, to those who receive "late DSED," or first DSED shock is shock 7 or later.DiscussionA well-designed randomized controlled trial employing a standardized approach to alternative defibrillation strategies early in the treatment of refractory VF is urgently required to determine if the treatments of DSED or VC defibrillation impact clinical outcomes.Trial registrationClinicalTrials.gov NCT04080986 . Registered on 6 September 2019.

Dataset Information

Amplitude Spectrum Area of ventricular fibrillation to guide defibrillation: a small open-label, pseudo-randomized controlled multicenter trial.

Background

Methods

Findings

Interpretation

Trial registration

Funding

Publications

Amplitude Spectrum Area of ventricular fibrillation to guide defibrillation: a small open-label, pseudo-randomized controlled multicenter trial.

Similar Datasets

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