当代可穿戴式除颤器中使用的电击波形的除颤效果和安全性：来自动物和人体研究的结果。

Defibrillation effectiveness and safety of the shock waveform used in a contemporary wearable cardioverter defibrillator: Results from animal and human studies.

机构信息

Division of Cardiology, Department of Medicine, Washington University in Saint Louis School of Medicine in Saint Louis, St. Louis, Missouri, United States of America.

Kestra Medical Technologies, Inc., Redmond, Washington, United States of America.

出版信息

PLoS One. 2023 Mar 14;18(3):e0281340. doi: 10.1371/journal.pone.0281340. eCollection 2023.

DOI:10.1371/journal.pone.0281340

PMID:36917566

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10013906/

Abstract

INTRODUCTION

The wearable cardioverter defibrillator (WCD) is used to protect patients at risk for sudden cardiac arrest. We examined defibrillation efficacy and safety of a biphasic truncated exponential waveform designed for use in a contemporary WCD in three animal studies and a human study.

METHODS

Animal (swine) studies: #1: Efficacy comparison of a 170J BTE waveform (SHOCK A) to a 150J BTE waveform (SHOCK B) that approximates another commercially available waveform. Primary endpoint first shock success rate. #2: Efficacy comparison of the two waveforms at attenuated charge voltages in swine at three prespecified impedances. Primary endpoint first shock success rate. #3: Safety comparison of SHOCK A and SHOCK B in swine. Primary endpoint cardiac biomarker level changes baseline to 6 and 24 hours post-shock. Human Study: Efficacy comparison of SHOCK A to prespecified goal and safety evaluation. Primary endpoint cumulative first and second shock success rate. Safety endpoint adverse events.

RESULTS

Animal Studies #1: 120 VF episodes in six swine. First shock success rates for SHOCK A and SHOCK B were 100%; SHOCK A non-inferior to SHOCK B (entire 95% CI of rate difference above -10% margin, p < .001). #2: 2,160 VF episodes in thirty-six swine. Attenuated SHOCK A was non-inferior to attenuated SHOCK B at each impedance (entire 95% CI of rate difference above -10% margin, p < .001). #3: Ten swine, five shocked five times each with SHOCK A, five shocked five times each with SHOCK B. No significant difference in troponin I (p = 0.658) or creatine phosphokinase (p = 0.855) changes from baseline between SHOCK A and SHOCK B. Human Study: Thirteen patients, 100% VF conversion rate. Mild skin irritation from adhesive defibrillation pads in three patients.

CONCLUSIONS

The BTE waveform effectively and safely terminated induced VF in swine and a small sample in humans.

TRIAL REGISTRATION

Human study clinical trial registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04132466.

摘要

简介

可穿戴式除颤器 (WCD) 用于保护有心脏骤停风险的患者。我们在三项动物研究和一项人体研究中，检查了一种为现代 WCD 设计的双相截断指数波的除颤效果和安全性。

方法

动物（猪）研究：#1：比较 170J BTE 波（SHOCK A）和近似另一种商业可用波形的 150J BTE 波（SHOCK B）的疗效。主要终点为首次电击成功率。#2：在三个预设阻抗下，比较两种波形在衰减电荷电压下对猪的疗效。主要终点为首次电击成功率。#3：比较 SHOCK A 和 SHOCK B 在猪体内的安全性。主要终点为电击后 6 小时和 24 小时的心脏生物标志物水平变化。人体研究：比较 SHOCK A 与预设目标的疗效和安全性评估。主要终点为累积首次和第二次电击成功率。安全性终点为不良事件。

结果

动物研究 #1：六头猪中发生 120 个 VF 发作。SHOCK A 和 SHOCK B 的首次电击成功率均为 100%；SHOCK A 非劣效于 SHOCK B（整个率差的 95%置信区间均在-10%界限以上，p<0.001）。#2：三十六头猪中发生 2160 个 VF 发作。在每个阻抗下，衰减的 SHOCK A 均不劣于衰减的 SHOCK B（整个率差的 95%置信区间均在-10%界限以上，p<0.001）。#3：十头猪，每头猪用 SHOCK A 电击五次，每头猪用 SHOCK B 电击五次。SHOCK A 和 SHOCK B 的肌钙蛋白 I（p=0.658）或肌酸磷酸激酶（p=0.855）的基线变化无显著差异。人体研究：十三名患者，VF 转复率为 100%。三名患者因使用粘合除颤片出现轻度皮肤刺激。