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International Journal of Technology... Apr 2014The objectives of this systematic literature review were to identify all published literature on wearable defibrillators, assess the wearable defibrillator's efficacy... (Review)
Review
OBJECTIVES
The objectives of this systematic literature review were to identify all published literature on wearable defibrillators, assess the wearable defibrillator's efficacy and effectiveness in general and among specific patient groups, including post-myocardial infarction, post coronary artery bypass grafting or percutaneous coronary intervention, non-ischemic cardiomyopathy, and ischemic cardiomyopathy, and to evaluate the quality of evidence.
METHODS
The search and synthesis was informed by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, and the quality of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation and the Newcastle Ottawa Scale.
RESULTS
A total of thirty-six articles and conference abstracts from thirty-three studies were included in the review. It appears that wearable defibrillator use compared with no defibrillator use reduces the chance of ventricular tachycardia and ventricular fibrillation (VT/VF) associated deaths by an absolute risk reduction of approximately 1 percent, achieved by averting approximately 4/5th of all VT/VF associated deaths. The quality of evidence was low to very low quality, such that our confidence in the reported estimates is weak.
CONCLUSIONS
To validate beneficial results, further investigation using robust study designs conducted by independent researchers is warranted.
Topics: Defibrillators; Evidence-Based Medicine; Female; Humans; Male; Middle Aged; Tachycardia, Ventricular; Ventricular Fibrillation
PubMed: 24893969
DOI: 10.1017/S026646231400004X -
Efficacy and safety of the subcutaneous implantable cardioverter defibrillator: a systematic review.Heart (British Cardiac Society) Sep 2017Subcutaneous implantable cardioverter defibrillators (S-ICDs) are considered an alternative to conventional transvenous ICDs (TV-ICDs) in patients not requiring pacing. (Review)
Review
BACKGROUND
Subcutaneous implantable cardioverter defibrillators (S-ICDs) are considered an alternative to conventional transvenous ICDs (TV-ICDs) in patients not requiring pacing.
METHODS
We searched MEDLINE and EMBASE for studies evaluating efficacy and safety outcomes in S-ICD patients. Outcomes were pooled across studies.
RESULTS
Sixteen studies were included with 5380 participants (mean age range 33-56 years). Short-term follow-up data were available for 1670 subjects. The most common complication was pocket infection, affecting 2.7%. Other complications included delayed wound healing (0.6%) and wound discomfort (0.8%). 3.8% of S-ICDs were explanted, most commonly for pocket infection. Mortality rates in hospital (0.4%) and during follow-up (3.4% from 12 studies reporting) were low. Incidence of ventricular arrhythmia varied from 0% to 12%. Overall shock efficacy exceeded 96%. Inappropriate shocks affected 4.3% and was most commonly caused by T-wave oversensing.
CONCLUSIONS
Although long-term randomised data are lacking, observational data suggest similar shock efficacy and short-term complication rates between the S-ICD and TV-ICD.
Topics: Arrhythmias, Cardiac; Death, Sudden, Cardiac; Defibrillators, Implantable; Equipment Design; Humans
PubMed: 28687562
DOI: 10.1136/heartjnl-2016-310852 -
Pacing and Clinical Electrophysiology :... Nov 2018Patients go without pacemaker, defibrillator, and cardiac resynchronization therapies (devices) each year due to the prohibitive costs of devices. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Patients go without pacemaker, defibrillator, and cardiac resynchronization therapies (devices) each year due to the prohibitive costs of devices.
OBJECTIVE
We sought to examine data available from studies regarding contemporary risks of reused devices in comparison with new devices.
METHODS
We searched online indexing sites to identify recent studies. Peer-reviewed manuscripts reporting infection, malfunction, premature battery depletion, and device-related death with reused devices were included. The primary study outcome was the composite risk of infection, malfunction, premature battery depletion, and death. Secondary outcomes were the individual risks.
RESULTS
Nine observational studies (published 2009-2017) were identified totaling 2,302 devices (2,017 pacemakers, 285 defibrillators). Five controlled trials were included in meta-analysis (2,114 devices; 1,258 new vs 856 reused). All device reuse protocols employed interrogation to confirm longevity and functionality, disinfectant therapy, and, usually, additional biocidal agents, packaging, and ethylene oxide gas sterilization. Demographic characteristics, indications for pacing, and median follow-up were similar. There were no device-related deaths reported and no statistically significant difference in risk between new versus reused devices for the primary outcome (2.23% vs 3.86% respectively, P = 0.807, odds ratio = 0.76). There were no significant differences seen in the secondary outcomes for the individual risks of infection, malfunction, and premature battery depletion.
CONCLUSIONS
Device reuse utilizing modern protocols did not significantly increase risk of infection, malfunction, premature battery depletion, or device-related death in observational studies. These data provide rationale for proceeding with a prospective multicenter noninferiority randomized control trial.
Topics: Defibrillators, Implantable; Device Removal; Equipment Failure; Equipment Reuse; Humans; Pacemaker, Artificial; Risk Factors
PubMed: 30191580
DOI: 10.1111/pace.13488 -
BMJ Supportive & Palliative Care Dec 2022Implantable cardioverter defibrillators (ICDs) are used to treat life-threatening cardiac arrhythmias and prevent sudden cardiac arrest. As recipients age they may...
BACKGROUND
Implantable cardioverter defibrillators (ICDs) are used to treat life-threatening cardiac arrhythmias and prevent sudden cardiac arrest. As recipients age they may develop greater risk of dying as a result of progressive multimorbidity rather than sudden cardiac death. Defibrillation shocks may prolong an uncomfortable dying process. Deactivation of the defibrillator would prevent this, yet is not always discussed and planned.
AIM
To systematically review published evidence on ICD deactivation discussions and make recommendations on when, how and who should facilitate effective and patient-centred deactivation discussions.
METHODS
Using standard systematic review methods, MEDLINE, EMBASE, CINAHL and PsycInfo were searched for studies published in the English language between 2010 and March 2021. Inclusion criteria were studies of adults (≥18 years) and including discussions on ICD deactivation and/or related communication. Included studies were independently reviewed, data extracted, quality assessed and data synthesised using a deductive approach.
RESULTS
Of the 8893 articles identified, 22 papers met the inclusion criteria. Deductive approach led to identification of five main themes: (1) timing of ICD deactivation discussions, (2) initiation of deactivation discussions, (3) advance directives, (4) barriers to discussions and (5) facilitators of discussions.
CONCLUSIONS
Despite available guidelines, conversations on device deactivation are not being undertaken consistently. Evidence suggests lack of professional awareness of guidelines and limited training in communication skills. To prevent distress and promote comfortable dying, there needs to be a proactive clinical and policy initiative in the education of both professionals and patients and their relatives about device deactivation.
Topics: Adult; Humans; Defibrillators, Implantable; Terminal Care; Advance Directives; Communication
PubMed: 33963003
DOI: 10.1136/bmjspcare-2021-002894 -
Cureus Nov 2023Implantable cardioverter defibrillators (ICD) have been recommended as an effective therapy in treating sudden cardiac deaths. This study evaluates the safety and... (Review)
Review
Implantable cardioverter defibrillators (ICD) have been recommended as an effective therapy in treating sudden cardiac deaths. This study evaluates the safety and efficacies of ICDs in detecting arrhythmias. Different ICDs, such as the transvenous cardioverter defibrillator (TV-ICD) and the subcutaneous implantable cardioverter defibrillator (S-ICD), are used. This systematic review identified Embase, PubMed, Medical Literature Analysis and Retrieval System Online (MEDLINE), and Web of Science as the primary electronic databases for research. Supplementation of the available articles for the review was done using Google Scholar. The population, exposure, control, outcome, and studies (PECOS) criteria were used in this study. The quality of the included studies was assessed using the Critical Appraisal Skills Program (CASP) standard checklist. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used in this systematic review. Two researchers conducted the extraction of data. A pre-designed Excel worksheet (Microsoft, Redmond, Washington) was used in the recording of extracted data. Eight studies were identified for use in this systematic review. Safety of the ICDs was observed with the minimum number of reported inappropriate shocks. Studies conducted identified that women had a lower number of incidences when a long detection setting by sex was conducted. Strategic programming of ICDs was noted as effective in lowering the levels of mortality. Studies claimed that the reduction of inappropriate shocks were important in the reduction of myocardial damage, which resulted in the mortality rate among the patients decreasing. Having high cutoff rates and long intervals for detection in ICD programming was noted to help in reducing ICD therapy intervention among patients. Differences among the male and female populations were inconsequential in the efficacy and safety of ICDs. Their effectiveness in sensitivity, pacing success, and defibrillation success were high and very significant. ICDs were safe in their use in the detection of arrhythmias.
PubMed: 38074043
DOI: 10.7759/cureus.48471 -
Heart Failure Reviews Jan 2023A subgroup of patients with noncompaction cardiomyopathy (NCCM) is at increased risk of ventricular arrhythmias and sudden cardiac death (SCD). In selected patients with... (Meta-Analysis)
Meta-Analysis Review
A subgroup of patients with noncompaction cardiomyopathy (NCCM) is at increased risk of ventricular arrhythmias and sudden cardiac death (SCD). In selected patients with NCCM, implantable cardioverter-defibrillator (ICD) therapy could be advantageous for preventing SCD. Currently, there is no complete overview of outcome and complications after ICD therapy in patients with NCCM. This study sought to present an overview using pooled data of currently available studies. Embase, MEDLINE, Web of Science, and Cochrane databases were searched and returned 915 studies. After a thorough examination, 12 studies on outcome and complications after ICD therapy in patients with NCCM were included. There were 275 patients (mean age 38.6 years; 47% women) with NCCM and ICD implantation. Most of the patients received an ICD for primary prevention (66%). Pooled analysis demonstrates that the appropriate ICD intervention rate was 11.95 per 100 person-years and the inappropriate ICD intervention rate was 4.8 per 100 person-years. The cardiac mortality rate was 2.37 per 100 person-years. ICD-related complications occurred in 10% of the patients, including lead malfunction and revision (4%), lead displacement (3%), infection (2%), and pneumothorax (2%). Patients with NCCM who are at increased risk of SCD may significantly benefit from ICD therapy, with a high appropriate ICD therapy rate of 11.95 per 100 person-years and a low cardiac mortality rate of 2.37 per 100 person-years. Inappropriate therapy rate of 4.8 per 100 person-years and ICD-related complications were not infrequent and may lead to patient morbidity.
Topics: Humans; Female; Adult; Male; Defibrillators, Implantable; Cardiomyopathies; Arrhythmias, Cardiac; Death, Sudden, Cardiac; Treatment Outcome; Risk Factors
PubMed: 35689132
DOI: 10.1007/s10741-022-10250-w -
Internal and Emergency Medicine Jun 2018Syncope is the common clinical manifestation of different diseases, and this makes it difficult to define what outcomes should be considered in prognostic studies. The... (Review)
Review
Syncope is the common clinical manifestation of different diseases, and this makes it difficult to define what outcomes should be considered in prognostic studies. The aim of this study is to critically analyze the outcomes considered in syncope studies through systematic review and expert consensus. We performed a systematic review of the literature to identify prospective studies enrolling consecutive patients presenting to the Emergency Department with syncope, with data on the characteristics and incidence of short-term outcomes. Then, the strengths and weaknesses of each outcome were discussed by international syncope experts to provide practical advice to improve future selection and assessment. 31 studies met our inclusion criteria. There is a high heterogeneity in both outcome choice and incidence between the included studies. The most commonly considered 7-day outcomes are mortality, dysrhythmias, myocardial infarction, stroke, and rehospitalisation. The most commonly considered 30-day outcomes are mortality, haemorrhage requiring blood transfusion, dysrhythmias, myocardial infarction, pacemaker or implantable defibrillator implantation, stroke, pulmonary embolism, and syncope relapse. We present a critical analysis of the pros and cons of the commonly considered outcomes, and provide possible solutions to improve their choice in ED syncope studies. We also support global initiatives to promote the standardization of patient management and data collection.
Topics: Emergency Service, Hospital; Humans; Incidence; Prognosis; Research Design; Risk Assessment; Risk Factors; Syncope
PubMed: 29349639
DOI: 10.1007/s11739-018-1788-z -
Cureus Jun 2022Sudden cardiac death (SCD) is an unexpected death that occurs within one hour of symptom onset. In the United States, sudden cardiac death is considered the leading... (Review)
Review
A Comparative Study Between Amiodarone and Implantable Cardioverter-Defibrillator in Decreasing Mortality From Sudden Cardiac Death in High-Risk Patients: A Systematic Review and Meta-Analysis.
Sudden cardiac death (SCD) is an unexpected death that occurs within one hour of symptom onset. In the United States, sudden cardiac death is considered the leading cause of natural death, accounting for 325,000 adult patients annually. SCD is more common in adult patients (above the mid-30s) and men. The risk factors that predict SCD are categorized into clinical, sociological, genetic, and psychological. To prevent the occurrence of SCD, several treatment options, especially antiarrhythmic drugs and implantable cardioverter-defibrillator (ICD), have been used. A literature search from 2000 to 2022 was conducted on six electronic databases: PubMed, Cochrane Library, Web of Science, Embase, ScienceDirect, and Google Scholar. The search query used Boolean expressions and keywords such as amiodarone, implantable cardioverter-defibrillator, sudden cardiac death, cardiac arrest, arrhythmic death, and all-cause mortality. The articles identified from the literature search were screened using the eligibility criteria, resulting in eight articles relevant for inclusion in the review. A meta-analysis of data from six of the included studies showed that ICD was more effective in the reduction of SCD rates, with an SCD rate of 5.97% (n = 84/1,408) observed in the ICD group compared with an SCD rate of 11.81% (n = 168/1,423) observed in the amiodarone group. The results also show that ICD was more effective in reducing all-cause mortality compared with amiodarone (odds ratio (OR): 1.36; 95% confidence interval (CI): 1.06-1.74; I = 57%; P = 0.03). ICD treatment of high-risk patients was more effective in reducing SCD and all-cause mortality rates compared with amiodarone treatment. There is evidence that amiodarone can be used as an adjuvant treatment option, especially for patients who are not eligible for ICD treatment and those who face more adverse events. Evidence has also shown that using amiodarone with ICD treatment significantly improves survival rates compared to ICD treatment only.
PubMed: 35865418
DOI: 10.7759/cureus.26017 -
The Cochrane Database of Systematic... Aug 2018Mechanical chest compression devices have been proposed to improve the effectiveness of cardiopulmonary resuscitation (CPR).
BACKGROUND
Mechanical chest compression devices have been proposed to improve the effectiveness of cardiopulmonary resuscitation (CPR).
OBJECTIVES
To assess the effectiveness of resuscitation strategies using mechanical chest compressions versus resuscitation strategies using standard manual chest compressions with respect to neurologically intact survival in patients who suffer cardiac arrest.
SEARCH METHODS
On 19 August 2017 we searched the Cochrane Central Register of Controlled Studies (CENTRAL), MEDLINE, Embase, Science Citation Index-Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science databases. Biotechnology and Bioengineering Abstracts and Science Citation abstracts had been searched up to November 2009 for prior versions of this review. We also searched two clinical trials registries for any ongoing trials not captured by our search of databases containing published works: Clinicaltrials.gov (August 2017) and the World Health Organization International Clinical Trials Registry Platform portal (January 2018). We applied no language restrictions. We contacted experts in the field of mechanical chest compression devices and manufacturers.
SELECTION CRITERIA
We included randomised controlled trials (RCTs), cluster-RCTs and quasi-randomised studies comparing mechanical chest compressions versus manual chest compressions during CPR for patients with cardiac arrest.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included five new studies in this update. In total, we included 11 trials in the review, including data from 12,944 adult participants, who suffered either out-of-hospital cardiac arrest (OHCA) or in-hospital cardiac arrest (IHCA). We excluded studies explicitly including patients with cardiac arrest caused by trauma, drowning, hypothermia and toxic substances. These conditions are routinely excluded from cardiac arrest intervention studies because they have a different underlying pathophysiology, require a variety of interventions specific to the underlying condition and are known to have a prognosis different from that of cardiac arrest with no obvious cause. The exclusions were meant to reduce heterogeneity in the population while maintaining generalisability to most patients with sudden cardiac death.The overall quality of evidence for the outcomes of included studies was moderate to low due to considerable risk of bias. Three studies (N = 7587) reported on the designated primary outcome of survival to hospital discharge with good neurologic function (defined as a Cerebral Performance Category (CPC) score of one or two), which had moderate quality evidence. One study showed no difference with mechanical chest compressions (risk ratio (RR) 1.07, 95% confidence interval (CI) 0.82 to 1.39), one study demonstrated equivalence (RR 0.79, 95% CI 0.60 to 1.04), and one study demonstrated reduced survival (RR 0.41, CI 0.21 to 0.79). Two other secondary outcomes, survival to hospital admission (N = 7224) and survival to hospital discharge (N = 8067), also had moderate quality level of evidence. No studies reported a difference in survival to hospital admission. For survival to hospital discharge, two studies showed benefit, four studies showed no difference, and one study showed harm associated with mechanical compressions. No studies demonstrated a difference in adverse events or injury patterns between comparison groups but the quality of data was low. Marked clinical and statistical heterogeneity between studies precluded any pooled estimates of effect.
AUTHORS' CONCLUSIONS
The evidence does not suggest that CPR protocols involving mechanical chest compression devices are superior to conventional therapy involving manual chest compressions only. We conclude on the balance of evidence that mechanical chest compression devices used by trained individuals are a reasonable alternative to manual chest compressions in settings where consistent, high-quality manual chest compressions are not possible or dangerous for the provider (eg, limited rescuers available, prolonged CPR, during hypothermic cardiac arrest, in a moving ambulance, in the angiography suite, during preparation for extracorporeal CPR [ECPR], etc.). Systems choosing to incorporate mechanical chest compression devices should be closely monitored because some data identified in this review suggested harm. Special attention should be paid to minimising time without compressions and delays to defibrillation during device deployment.
Topics: Blood Circulation; Cardiopulmonary Resuscitation; Heart Arrest; Heart Massage; Hospitalization; Humans; Patient Discharge; Randomized Controlled Trials as Topic
PubMed: 30125048
DOI: 10.1002/14651858.CD007260.pub4 -
Annals of Cardiothoracic Surgery Jul 2017Since the introduction of the implantable cardioverter-defibrillator (ICD) in patients with hypertrophic cardiomyopathy (HCM), the incidence of sudden cardiac death... (Review)
Review
BACKGROUND
Since the introduction of the implantable cardioverter-defibrillator (ICD) in patients with hypertrophic cardiomyopathy (HCM), the incidence of sudden cardiac death (SCD) has been significantly reduced. Given its widespread use, it is important to identify the outcomes associated with ICD use in patients with HCM. The present paper is a systematic review and meta-analysis of the rates of appropriate and inappropriate interventions, mortality, and device complications in HCM patients with an ICD.
METHODS
We conducted a systematic review and meta-analysis on 27 studies reporting outcomes and complications after ICD implantation in patients with HCM. ICD interventions, device complications, and mortality were extracted for analysis.
RESULTS
A total of 3,797 patients with HCM and ICD implantation were included (mean age, 44.5 years; 63% male), of which 83% of patients had an ICD for primary prevention of SCD. The cardiac mortality was 0.9% (95% CI: 0.7-1.3) per year and non-cardiac mortality was 0.8% (95% CI: 0.6-1.2) per year. Annualized appropriate intervention rate was 4.8% and annualized inappropriate intervention was 4.9%. The annual incidence of lead malfunction, lead displacement and infection was 1.4%, 1.3%, and 1.1%, respectively.
CONCLUSIONS
ICD use in patients with HCM produces low rates of cardiac and non-cardiac mortality, and an appropriate intervention rate of 4.8% per year. However, moderate rates of inappropriate intervention and device complications warrant careful patient selection in order to optimize the risk to benefit ratio in this select group of patients.
PubMed: 28944170
DOI: 10.21037/acs.2017.07.05