Elsevier

Resuscitation

Volume 84, Issue 9, September 2013, Pages 1214-1222
Resuscitation

Clinical paper
Treatment of non-traumatic out-of-hospital cardiac arrest with active compression decompression cardiopulmonary resuscitation plus an impedance threshold device

https://doi.org/10.1016/j.resuscitation.2013.05.002Get rights and content

Abstract

Background

A recent out-of-hospital cardiac arrest (OHCA) clinical trial showed improved survival to hospital discharge (HD) with favorable neurologic function for patients with cardiac arrest of cardiac origin treated with active compression decompression cardiopulmonary resuscitation (CPR) plus an impedance threshold device (ACD + ICD) versus standard (S) CPR. The current analysis examined whether treatment with ACD + ITD is more effective than standard (S-CPR) for all cardiac arrests of non-traumatic origin, regardless of the etiology.

Methods

This is a secondary analysis of data from a randomized, prospective, multicenter, intention-to-treat, OHCA clinical trial. Adults with presumed non-traumatic cardiac arrest were enrolled and followed for one year post arrest. The primary endpoint was survival to hospital discharge (HD) with favorable neurologic function (Modified Rankin Scale score  3).

Results

Between October 2005 and July 2009, 2738 patients were enrolled (S-CPR = 1335; ACD + ITD = 1403). Survival to HD with favorable neurologic function was greater with ACD + ITD compared with S-CPR: 7.9% versus 5.7%, (OR 1.42, 95% CI 1.04, 1.95, p = 0.027). One-year survival was also greater: 7.9% versus 5.7%, (OR 1.43, 95% CI 1.04, 1.96, p = 0.026). Nearly all survivors in both groups had returned to their baseline neurological function by one year. Major adverse event rates were similar between groups.

Conclusions

Treatment of out-of-hospital non-traumatic cardiac arrest patients with ACD + ITD resulted in a significant increase in survival to hospital discharge with favorable neurological function when compared with S-CPR. A significant increase survival rates was observed up to one year after arrest in subjects treated with ACD + ITD, regardless of the etiology of the cardiac arrest.

Introduction

Use of active compression decompression cardiopulmonary resuscitation (CPR) plus an impedance threshold device (ACD + ICD) has been shown in animal studies to increase myocardial and cerebral perfusion and to improve neurological outcome.1 A recent clinical trial called the ResQTrial demonstrated that ACD + ITD improved survival to hospital discharge with favorable neurologic function for subjects with an OHCA of presumed cardiac etiology by 53%, compared with S-CPR.2 This study focused on cardiac arrest of presumed cardiac etiology. After resuscitation efforts were completed, many patients in that trial were found to have had one or more exclusionary criteria, such as a cardiac arrest of non-cardiac etiology.

Given the need to start CPR as soon as possible to optimize chances for survival, widespread implementation of ACD + ITD would require immediate application of this intervention to a wide spectrum of patients with cardiac arrest, often before the cause of the cardiac arrest is known. One of the primary reasons for performing the analysis described in this manuscript was to determine whether rescue personnel should know the etiology of the cardiac arrest before providing ACD + ITD therapy. We know that it is difficult in many cases and impossible in others to know the etiology prior to starting CPR. Thus, the primary objective of this secondary analysis of the ResQTrial study population was to determine whether treatment with ACD + ITD is more effective in returning patients to their baseline neurological function than S-CPR in all randomized study subjects, regardless of the cause of the arrest. The primary outcome measure was survival to hospital discharge with favorable neurological function, as determined by the Modified Rankin Scale.

Section snippets

Methods

The ResQTrial was performed by investigators in seven distinct geographic locations in the United States (US), including 46 emergency medical services (EMS) agencies, encompassing a total population of 2.3 million. The study was conducted under the US Code of Federal Regulations (21 CFR 50.24): Exception from Informed Consent under Emergency Circumstances. Informed consent was required for continued participation in the study, which consisted of medical records review and in-person follow-up

Results

From October 2005 to July 2009, a total of 2738 patients were prospectively enrolled and randomized to treatment with ACD + ITD (N = 1403) or S-CPR (N = 1335) (Fig. 1). Among all survivors to hospital discharge, consent for ongoing participation in the study was obtained in 86.0% (257/299). Known survival outcomes to one year were available for 2669 (97.5%) patients. Baseline demographics and a summary of resuscitation efforts are shown in Table 1. Baseline characteristics were similar and enrollment

Discussion

When EMS providers arrive at the scene of a cardiac arrest, they generally cannot distinguish between non-cardiac and cardiac etiology prior to initiating CPR. Given this limitation, the intent of this analysis was to determine if the observations from patients in cardiac arrest from a presumed cardiac etiology could be generalized to all non-traumatic cardiac arrest patients in need of CPR, regardless of the cause of the arrest. This study demonstrated that survival to HD with favorable

Conclusions

The expanded analysis with 2738 subjects represents one of the largest prospective interventional CPR trials to date evaluating one year survival and neurologic outcomes after non-traumatic cardiac arrest. Patients treated with ACD + ITD had a relative 38% increase in survival to hospital discharge with favorable neurologic function (MRS  3), compared with S-CPR, regardless of the etiology of their cardiac arrest. Survival to one year with favorable neurological function was also increased by a

Conflicts of interest statement

TPA, RJF, MAW, BDM, RAS, RMD, and MLO all received grant funds to their respective institutions for services related to patient enrollment, follow-up and data management for this clinical study; Outside the present study, TPA has board membership for Take Heart America and Citizen CPR Foundation, has consulted for JoLife Medical and Medtronic, Inc., and has received grants/grants pending from the NIH Immediate Trial, NIH Resuscitation Outcomes Consortium, the NIH Neurological Emergency

Funding

US National Institutes of Health grant R44-HL065851-03 Advanced Circulatory Systems, Inc. The investigational plan was approved by the NIH, and a representative of the NIH participated as a member of the Data and Safety Monitoring Board. The study sponsor, Advanced Circulatory Systems, Inc., assisted with designing the study, obtaining government funding, interpreting the data, and in preparing the manuscript. The sponsor was not involved with patient care or assessment of patient neurologic

Acknowledgements

We thank the many first responders, firefighters, emergency medical technicians, and paramedics at all study sites, without whom survival from cardiac arrest would not be possible.

References (16)

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A Spanish translated version of the abstract of this article appears as Appendix in the final online version at http://dx.doi.org/10.1016/j.resuscitation.2013.05.002

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