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The New England Journal of Medicine Nov 2022Despite advances in defibrillation technology, shock-refractory ventricular fibrillation remains common during out-of-hospital cardiac arrest. Double sequential external... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Despite advances in defibrillation technology, shock-refractory ventricular fibrillation remains common during out-of-hospital cardiac arrest. Double sequential external defibrillation (DSED; rapid sequential shocks from two defibrillators) and vector-change (VC) defibrillation (switching defibrillation pads to an anterior-posterior position) have been proposed as defibrillation strategies to improve outcomes in patients with refractory ventricular fibrillation.
METHODS
We conducted a cluster-randomized trial with crossover among six Canadian paramedic services to evaluate DSED and VC defibrillation as compared with standard defibrillation in adult patients with refractory ventricular fibrillation during out-of-hospital cardiac arrest. Patients were treated with one of these three techniques according to the strategy that was randomly assigned to the paramedic service. The primary outcome was survival to hospital discharge. Secondary outcomes included termination of ventricular fibrillation, return of spontaneous circulation, and a good neurologic outcome, defined as a modified Rankin scale score of 2 or lower (indicating no symptoms to slight disability) at hospital discharge.
RESULTS
A total of 405 patients were enrolled before the data and safety monitoring board stopped the trial because of the coronavirus disease 2019 pandemic. A total of 136 patients (33.6%) were assigned to receive standard defibrillation, 144 (35.6%) to receive VC defibrillation, and 125 (30.9%) to receive DSED. Survival to hospital discharge was more common in the DSED group than in the standard group (30.4% vs. 13.3%; relative risk, 2.21; 95% confidence interval [CI], 1.33 to 3.67) and more common in the VC group than in the standard group (21.7% vs. 13.3%; relative risk, 1.71; 95% CI, 1.01 to 2.88). DSED but not VC defibrillation was associated with a higher percentage of patients having a good neurologic outcome than standard defibrillation (relative risk, 2.21 [95% CI, 1.26 to 3.88] and 1.48 [95% CI, 0.81 to 2.71], respectively).
CONCLUSIONS
Among patients with refractory ventricular fibrillation, survival to hospital discharge occurred more frequently among those who received DSED or VC defibrillation than among those who received standard defibrillation. (Funded by the Heart and Stroke Foundation of Canada; DOSE VF ClinicalTrials.gov number, NCT04080986.).
Topics: Adult; Humans; Canada; Defibrillators; Electric Countershock; Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation; Cross-Over Studies; Cluster Analysis
PubMed: 36342151
DOI: 10.1056/NEJMoa2207304 -
Archives of Cardiovascular Diseases Mar 2019Out-of-hospital sudden cardiac arrest (OHCA) is a major public health issue, with a survival rate at hospital discharge that remains below 10% in most cities, despite... (Review)
Review
Out-of-hospital sudden cardiac arrest (OHCA) is a major public health issue, with a survival rate at hospital discharge that remains below 10% in most cities, despite huge investments in this domain. Early basic life support (BLS) and early defibrillation using automated external defibrillators (AEDs) stand as key elements for improving OHCA survival rate. Nevertheless, the use of AEDs in OHCA remains low, for a variety of reasons, including the number, accessibility and ease of locating AEDs, as well as bystanders' awareness of BLS manœuvres and of the need to use AEDs. Several measures have been proposed to improve the rate of AED use, including optimization of AED deployment strategies as well as the use of drones to bring the AEDs to the OHCA scene and of mobile applications to locate the nearest AED. If they are to be effective, these measures should be combined with large communication campaigns on OHCA, and wide-scale education of the public in BLS and AEDs, to reduce the burden of OHCA.
Topics: Defibrillators; Electric Countershock; Health Knowledge, Attitudes, Practice; Health Promotion; Health Services Accessibility; Humans; Out-of-Hospital Cardiac Arrest; Outcome and Process Assessment, Health Care; Time-to-Treatment; Treatment Outcome
PubMed: 30594573
DOI: 10.1016/j.acvd.2018.11.001 -
The New England Journal of Medicine Oct 2022The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and... (Clinical Trial)
Clinical Trial
BACKGROUND
The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known.
METHODS
We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%.
RESULTS
A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period.
CONCLUSIONS
In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).
Topics: Arrhythmias, Cardiac; Defibrillators, Implantable; Electric Countershock; Humans; Prospective Studies; Treatment Outcome
PubMed: 36036522
DOI: 10.1056/NEJMoa2206485 -
Expert Review of Medical Devices Dec 2021Wearable cardioverter-defibrillator (WCD) is a novel tool that may be of interest in situations with atransient risk of sudden cardiac death. It offers a temporary and... (Review)
Review
INTRODUCTION
Wearable cardioverter-defibrillator (WCD) is a novel tool that may be of interest in situations with atransient risk of sudden cardiac death. It offers a temporary and easy to remove protection against malignant ventricular arrhythmias. In this review, the authors describe evidence in literature and different international guidelines and consensus.
AREAS COVERED
The authors searched PubMed, Cochrane Central Register of controlled trials, and Google Scholar for relevant studies and comments.
EXPERT OPINION
If a WCD is indicated, the observance must be as perfect as possible. Thus, patients need proper education in wearing the WCD.The temporary use of a WCD is reasonable in patients with a high risk for SCD, even with a low level of evidence with only one randomized clinical trial (VEST), as its disadvantages are limited to a transitory impairment in quality of life and a low risk of inappropriate shock.Indications are now well accepted: ischemic cardiomyopathy with LVEF below 35% before reassessment, recent onset of NICM or presumed myocarditis with LVEF ≤35% before reassessment, after ICD explant until reimplantation (e.g. infection), and bridge to transplant.Future guidelines on WCD in the prevention of SCD may be warranted to harmonize clinical practice especially in debated indications..
Topics: Death, Sudden, Cardiac; Defibrillators, Implantable; Electric Countershock; Humans; Quality of Life; Randomized Controlled Trials as Topic; Wearable Electronic Devices
PubMed: 34913789
DOI: 10.1080/17434440.2021.2019013 -
Resuscitation May 2023
Topics: Humans; Electric Countershock; Heart Arrest; Defibrillators
PubMed: 37003512
DOI: 10.1016/j.resuscitation.2023.109782 -
Europace : European Pacing,... May 2015The totally transvenous implantable defibrillator lead, conceived by Mirowski and Mower 45 years ago, is irrevocably related to the wide acceptance of this therapy. It... (Review)
Review
The totally transvenous implantable defibrillator lead, conceived by Mirowski and Mower 45 years ago, is irrevocably related to the wide acceptance of this therapy. It paved the way for the era for non-thoracotomy implantation. This paper covers the most important details of the evolution--over this 45-year period--of the original (ENDOTAK) transvenous ICD lead and subsequent iterations. Over that time period, there have been over 800 000 patients implanted with this family of leads. The 'story' addresses the multiple problems encountered, technological improvements in materials, design, and testing to overcome them. And, the need for continued close collaboration between physicians and industry focused on reliability and longevity of this critical component of these life-saving systems.
Topics: Animals; Arrhythmias, Cardiac; Cooperative Behavior; Death, Sudden, Cardiac; Defibrillators, Implantable; Diffusion of Innovation; Electric Countershock; History, 20th Century; History, 21st Century; Humans; Interdisciplinary Communication; Prosthesis Design; Treatment Outcome
PubMed: 25755290
DOI: 10.1093/europace/euu391 -
Cardiology Clinics Aug 2018Ventricular fibrillation (VF) is the most commonly encountered arrhythmia following out-of-hospital cardiac arrest. Previous studies have demonstrated early... (Review)
Review
Ventricular fibrillation (VF) is the most commonly encountered arrhythmia following out-of-hospital cardiac arrest. Previous studies have demonstrated early defibrillation and bystander cardiopulmonary resuscitation as essential in reducing patient mortality. What remains a clinical concern, however, is the treatment of patients experiencing VF refractory to defibrillation. Although current guidelines advocate pharmacotherapy for the management of shock-refractory VF, double sequential defibrillation has become a popular topic of discussion. This article provides a discourse regarding refractory VF, and a review of double sequential defibrillation literature. Further study is required before the recommendation for widespread implementation of this defibrillation technique.
Topics: Cardiopulmonary Resuscitation; Defibrillators; Electric Countershock; Emergency Medical Services; Humans; Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation
PubMed: 30293605
DOI: 10.1016/j.ccl.2018.03.006 -
European Journal of Medical Research Mar 2022To provide an economical and practical defibrillator for first aid teaching and training, to reduce the cost of teaching and training, increase teaching and training...
BACKGROUND
To provide an economical and practical defibrillator for first aid teaching and training, to reduce the cost of teaching and training, increase teaching and training equipment, provide trainees with more hands-on training sessions, and improve first aid capabilities.
METHODS
Developing a special teaching defibrillator with the same structure and operation configuration as the clinical medical emergency defibrillator. The appearance, structure and operating accessories of the two defibrillators are the same. The difference between the defibrillator and the clinical medical emergency defibrillator are as follows: the clinical medical emergency defibrillator can be energized, and there are expensive electronic accessories and defibrillation accessories for charging and discharging in the machine. When discharging, the electrode plate has current discharged into the human body; the power plug of the "special defibrillator for teaching and training" is a fake plug. When the power is plugged in, no current enters the body and the machine. There are no expensive electronic accessories and defibrillation accessories for charging and discharging, and no current is discharged during discharge. Then compare the teaching effect of the special defibrillator for teaching and training and the clinical medical emergency defibrillator (including operation score and attitude after training).
RESULTS
The scores of defibrillator operation in the experimental group of junior college students (87.77 ± 4.11 vs. 83.30 ± 4.56, P < 0.001) and the experimental group of undergraduate students (90.40 ± 3.67 vs. 89.12 ± 3.68, P = 0.011) were higher than those in the corresponding control group; The attitude of junior college students in the experimental group and undergraduate students in the experimental group after training was more positive than that of the corresponding control group (P < 0.05).
CONCLUSIONS
The special defibrillator for teaching and training can save the purchase cost of teaching equipment, increase teaching and training resources, and improve the trainee's defibrillation ability, defibrillation confidence and defibrillation security.
Topics: Adolescent; Adult; Cardiology; Defibrillators; Education, Medical; Electric Countershock; Female; Humans; Male; Students, Medical; Teaching; Young Adult
PubMed: 35236410
DOI: 10.1186/s40001-022-00657-4 -
Journal of Cardiovascular... Feb 2022
Topics: Defibrillators, Implantable; Electric Countershock; Humans
PubMed: 34911152
DOI: 10.1111/jce.15327 -
JACC. Clinical Electrophysiology Aug 2023
Topics: Humans; Arrhythmias, Cardiac; Defibrillators; Electric Countershock; Wearable Electronic Devices
PubMed: 37558290
DOI: 10.1016/j.jacep.2023.01.019