Didon Jean-Philippe, Jekova Irena, Frattini Benoît, Ménétré Sarah, Derkenne Clément, Ha Vivien Hong Tuan, Jost Daniel, Krasteva Vessela
Schiller Médical SAS, 4 rue L. Pasteur, 67160 Wissembourg, France.
Institute of Biophysics and Biomedical Engineering, Bulgarian Academy of Sciences, Acad. G. Bonchev Str. Bl 105, 1113 Sofia, Bulgaria.
Resusc Plus. 2024 Aug 5;19:100740. doi: 10.1016/j.resplu.2024.100740. eCollection 2024 Sep.
This study involving automated external defibrillators (AEDs) in early treatment of refibrillation aims to evaluate the performance of a new shock advisory system (SAS) during chest compressions (CC) in out-of-hospital cardiac arrest (OHCA) patients.
This work focuses on AED SAS performance as a secondary outcome of DEFI 2022 clinical prospective study, which included first-analysis shockable OHCA patients. SAS employs the Analyze Whilst Compressing (AWC) algorithm to interact with both cardiopulmonary resuscitation (CPR) and shock advice by conditional operation of two-stage ECG analysis in presence or absence of chest compressions. AWC is triggered by the first-shock recommendation. Then, after 1 min of CPR, ECG analysis during CC decides between two treatment scenarios. For patients with refibrillation, CPR is paused for immediate confirmation analysis and shock advice. For patients with non-shockable rhythms, CPR is continued for 2 min until standard analysis.
Clinical data from 285 OHCA patients with shock recommendation at the first-analysis by AEDs (DEFIGARD TOUCH7, Schiller Médical) consisted of 576 standard analyses, 2011 analyses during CC, 577 confirmation analyses in absence of CC. Global AED SAS performance meets the standard recommendations for arrhythmia analysis sensitivity (94.9%) and specificity (>99.3%). AWC provided innovative treatment of shockable rhythms by stopping CPR earlier than 2 min in most ventricular fibrillations (92.9%), while most non-shockable patients (86.5-95.2%) benefitted from continuous CPR for at least 2 min.
This study provides positive evidence for routine use of AEDs with AWC-integrated algorithm for ECG analysis during CPR by first-responders in early OHCA treatment. Registration number: NCT04691089, trial register: ClinicalTrials.gov.
本研究涉及自动体外除颤器（AED）在早期治疗再发性心室颤动中的应用，旨在评估一种新型电击咨询系统（SAS）在院外心脏骤停（OHCA）患者胸外按压（CC）期间的性能。
本研究聚焦于AED SAS的性能，作为DEFI 2022临床前瞻性研究的次要结果，该研究纳入了首次分析时可电击的OHCA患者。SAS采用边按压边分析（AWC）算法，通过在有或无胸外按压时进行两阶段心电图分析的条件操作，与心肺复苏（CPR）和电击建议相互作用。AWC由首次电击建议触发。然后，在CPR 1分钟后，CC期间的心电图分析决定两种治疗方案。对于再发性心室颤动患者，暂停CPR以进行即时确认分析和电击建议。对于不可电击心律的患者，继续CPR 2分钟直至进行标准分析。
来自285例首次分析时由AED（DEFIGARD TOUCH7，席勒医疗）给出电击建议的OHCA患者的临床数据包括576次标准分析、2011次CC期间分析、577次无CC时的确认分析。AED SAS的整体性能符合心律失常分析敏感性（94.9%）和特异性（>99.3%）的标准建议。AWC通过在大多数心室颤动（92.9%）中比2分钟更早地停止CPR，为可电击心律提供了创新治疗，而大多数不可电击患者（86.5 - 95.2%）受益于至少2分钟的持续CPR。
本研究为急救人员在OHCA早期治疗中常规使用集成AWC算法进行CPR期间心电图分析的AED提供了积极证据。注册号：NCT04691089，试验注册：ClinicalTrials.gov。
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