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Journal of the American Heart... Jun 2022Background Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have been of great interest as an alternative to transvenous implantable... (Meta-Analysis)
Meta-Analysis Review
Background Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have been of great interest as an alternative to transvenous implantable cardioverter-defibrillators (TV-ICDs). No meta-analyses synthesizing data from high-quality studies have yet been published. Methods and Results An electronic literature search was conducted to retrieve randomized controlled trials or propensity score-matched studies comparing S-ICD against TV-ICD in patients with an implantable cardioverter-defibrillator indication. The primary outcomes were device-related complications and lead-related complications. Secondary outcomes were inappropriate shocks, appropriate shock, all-cause mortality, and infection. All outcomes were pooled under random-effects meta-analyses and reported as risk ratios (RRs) and 95% CIs. Kaplan-Meier curves of device-related complications were digitized to retrieve individual patient data and pooled under a 1-stage meta-analysis using Cox models to determine hazard ratios (HRs) of patients undergoing S-ICD versus TV-ICD. A total of 5 studies (2387 patients) were retrieved. S-ICD had a similar rate of device-related complications compared with TV-ICD (RR, 0.59 [95% CI, 0.33-1.04]; =0.070), but a significantly lower lead-related complication rate (RR, 0.14 [95% CI, 0.07-0.29]; <0.0001). The individual patient data-based 1-stage stratified Cox model for device-related complications across 4 studies yielded no significant difference (shared-frailty HR, 0.82 [95% CI, 0.61-1.09]; =0.167), but visual inspection of pooled Kaplan-Meier curves suggested a divergence favoring S-ICD. Secondary outcomes did not differ significantly between both modalities. Conclusions S-ICD is clinically superior to TV-ICD in terms of lead-related complications while demonstrating comparable efficacy and safety. For device-related complications, S-ICD may be beneficial over TV-ICD in the long term. These indicate that S-ICD is likely a suitable substitute for TV-ICD in patients requiring implantable cardioverter-defibrillator implantation without a pacing indication.
Topics: Death, Sudden, Cardiac; Defibrillators, Implantable; Electric Countershock; Humans; Propensity Score; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 35656975
DOI: 10.1161/JAHA.121.024756 -
Pacing and Clinical Electrophysiology :... Jul 2016Every 4-7 years an implantable cardioverter defibrillator (ICD) pulse generator must be replaced surgically. This procedure is not without risk. In some cases, the risk... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Every 4-7 years an implantable cardioverter defibrillator (ICD) pulse generator must be replaced surgically. This procedure is not without risk. In some cases, the risk versus benefit ratio may be against replacement. We aimed to synthesize the evidence on risks, benefits, and costs related to ICD replacement.
METHODS
A systematic review was conducted using electronic databases from 2000 onward. Literature screening, quality appraisal, and data extraction were independently conducted by two reviewers. Outcomes included major and minor complications, ICD therapies, and costs, which were synthesized descriptively.
RESULTS
Of 1,483 citations, 17 nonrandomized studies met criteria. Median rate of major complications was 4.05% (range 0.55-7.37%) and minor complications was 3.50% (range 0.36-7.37%). Without non-ICD control groups, the true risk reduction provided by the ICD following replacement is unknown. Following ICD replacement, annualized rate of appropriate ICD therapy was 10.52% (range 2.42-75.00%). Of these, patients without therapies during their first generator life and those no longer meeting ICD criteria received appropriate therapies at nontrivial rates.
CONCLUSION
Rates of complications associated with ICD replacement are substantial. No study had nonreplacement groups, hence the true risk reduction provided by the ICD following replacement is unknown. Our analysis did not identify a subgroup at low risk of therapies following replacement. Shared discussions should occur with patients about the evidence, healthcare goals, risk tolerances, and feelings about life and death trade-offs to enable high-quality decisions about ICD replacement.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Death, Sudden, Cardiac; Defibrillators, Implantable; Device Removal; Equipment Failure; Female; Humans; Male; Middle Aged; Prosthesis Implantation; Risk Assessment; Survival Rate; Treatment Outcome; Young Adult
PubMed: 26969818
DOI: 10.1111/pace.12850 -
Journal of Interventional Cardiac... Aug 2020Cardiac sarcoidosis is a multisystem inflammatory disorder characterized by ventricular arrhythmias. Implantable cardioverter defibrillator (ICD) is used to prevent... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Cardiac sarcoidosis is a multisystem inflammatory disorder characterized by ventricular arrhythmias. Implantable cardioverter defibrillator (ICD) is used to prevent sudden cardiac death.
METHODS
We performed literature search for studies that addressed the outcome and complications of ICD in Cardiac Sarcoidosis (CS). Multiple search sites were reviewed from January 1, 2000 until December 1, 2018. We then performed a meta-analysis using a random effects model. Two investigators independently extracted the data and assessed studies' quality.
RESULTS
Ten studies with 585 patients qualified for the analysis. In the pooled analysis, 57% were male with mean left ventricular ejection fraction (LVEF) of 38.4%. Appropriate and inappropriate ICD treatments (AT and IAT) were reported in 39% and 15% of patients respectively over mean follow-up period of 25 months and mortality rate of 8%. A sub-analysis of four studies indicated that patients with appropriate therapy did not differ from the rest of CS population in LVEF% (mean difference (MD) = - 7.37%, 95% confidence interval (CI) - 16.89 to 2.15, p = 0.12), age (MD = - 3.87 years, 95% CI - 10.19 to 2.46, p = 0.23), primary prevention (range difference (RD) = - 0.11, 95% CI - 0.31 to 0.10, p = 0.31) or secondary prevention indication (RD = 0.09, 95% CI - 0.12 to 0.3, p = 0.37). High degree AV block was more common in patients with AT (RD = 0.07, 95% CI 0.00 to 0.14 p = 0.05).
CONCLUSIONS
ICD placement in CS is associated with high incidence of both appropriate and inappropriate therapy. High degree AV block appears to be predictive of appropriate ICD therapy.
Topics: Death, Sudden, Cardiac; Defibrillators, Implantable; Humans; Infant, Newborn; Male; Risk Factors; Sarcoidosis; Stroke Volume; Treatment Outcome; Ventricular Function, Left
PubMed: 32062788
DOI: 10.1007/s10840-020-00705-1 -
Cardiovascular Digital Health Journal Feb 2022Current implantable cardioverter-defibrillator (ICD) devices are equipped with a device-embedded accelerometer capable of capturing physical activity (PA). In contrast,... (Review)
Review
BACKGROUND
Current implantable cardioverter-defibrillator (ICD) devices are equipped with a device-embedded accelerometer capable of capturing physical activity (PA). In contrast, wearable accelerometer-based methods enable the measurement of physical behavior (PB) that encompasses not only PA but also sleep behavior, sedentary time, and rest-activity patterns.
OBJECTIVE
This systematic review evaluates accelerometer-based methods used in patients carrying an ICD or at high risk of sudden cardiac death.
METHODS
Papers were identified via the OVID MEDLINE and OVID EMBASE databases. PB could be assessed using a wearable accelerometer or an embedded accelerometer in the ICD.
RESULTS
A total of 52 papers were deemed appropriate for this review. Out of these studies, 30 examined device-embedded accelerometry (189,811 patients), 19 examined wearable accelerometry (1601 patients), and 3 validated wearable accelerometry against device-embedded accelerometry (106 patients). The main findings were that a low level of PA after implantation of the ICD and a decline in PA were both associated with an increased risk of mortality, heart failure hospitalization, and appropriate ICD shock. Second, PA was affected by cardiac factors (eg, onset of atrial fibrillation, ICD shocks) and noncardiac factors (eg, seasonal differences, societal factors).
CONCLUSION
This review demonstrated the potential of accelerometer-measured PA as a marker of clinical deterioration and ventricular arrhythmias. Notwithstanding that the evidence of PB assessed using wearable accelerometry was limited, there seems to be potential for accelerometers to improve early warning systems and facilitate preventative and proactive strategies.
PubMed: 35265934
DOI: 10.1016/j.cvdhj.2021.11.006 -
Clinical Cardiology Dec 2022The implantable cardiac defibrillator (ICD) is common for the management of nonischemic cardiomyopathy (NICM). Mortality is a crucial issue for patients with NICM. We... (Meta-Analysis)
Meta-Analysis Review
The implantable cardiac defibrillator (ICD) is common for the management of nonischemic cardiomyopathy (NICM). Mortality is a crucial issue for patients with NICM. We can understand the mortality events of ICD versus medicine treatment via a systemic review and meta-analysis of randomized clinical trials. The comparison between ICD treatment and medicine treatment was performed to find if the ICD treatment can be associated with lower relative risk and hazard ratio of mortality than the medicine treatment. In addition, the different kinds of mortality events were analyzed for the ICD treatment. After a restricted selection, 9 studies with a total of 4001 NICM patients were enrolled. The focused outcome was the events of all-cause mortality, sudden cardiac death, and cardiovascular death. The results showed that ICD treatment might be associated with lower relative risk and hazard ratio of all-cause mortality and sudden cardiac death. However, the relative risk and hazard ratio of cardiovascular mortality was not significantly different between ICD treatment and medicine treatment. In the current meta-analysis, the ICD treatment might show a lower relative risk and hazard ratio of all-cause mortality and sudden cardiac death when compared with medicine treatment. However, no significant differences were observed in cardiovascular mortality between ICD and medicine treatment.
Topics: Humans; Primary Prevention; Defibrillators, Implantable; Cardiomyopathies; Death, Sudden, Cardiac; Heart
PubMed: 36056632
DOI: 10.1002/clc.23907 -
World Journal of Cardiology May 2017Implantable cardioverter defibrillator (ICD) programming involves several parameters. In recent years antitachycardia pacing (ATP) has gained an increasing importance in... (Review)
Review
Implantable cardioverter defibrillator (ICD) programming involves several parameters. In recent years antitachycardia pacing (ATP) has gained an increasing importance in the treatment of ventricular arrhythmias, whether slow or fast. It reduces the number of unnecessary and inappropriate shocks and improves both patient's quality of life and device longevity. There is no clear indication regarding the type of ATP to be used, except for the treatment of fast ventricular tachycardias (188 bpm-250 bpm) where it has been shown a greater efficacy and safety of burst compared to ramp; 8 impulses in each sequence of ATP appears to be the best programming option in this setting. Beyond ATP use, excellent clinical results were obtained with programming standardization following these principles: extended detection time in ventricular fibrillation (VF) zone; supraventricular discrimination criteria up to 200 bpm; first shock in VF zone at the maximum energy in order to reduce the risk of multiple shocks. The MADIT-RIT trial and some observational registries have also recently demonstrated that programming with a widespread use of ATP, higher cut-off rates or delayed intervention reduces the number of inappropriate and unnecessary therapies and improves the survival of patients during mid-term follow-up.
PubMed: 28603590
DOI: 10.4330/wjc.v9.i5.429 -
Cardiology Journal 2023Recent data regarding the comparison of implantable cardioverter-defibrillator (ICD) therapy and optimal medical treatment in patients with non-ischemic cardiomyopathy... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Recent data regarding the comparison of implantable cardioverter-defibrillator (ICD) therapy and optimal medical treatment in patients with non-ischemic cardiomyopathy has indicated no mortality benefit as a result of ICD therapy. Although the recommendations for ICD implantation did not change, it is worth noting that these findings significantly affected the daily practice of ICD implantation in Europe.
METHODS
To assess the effect of ICD implantation in comparison to pharmacotherapy in the non- -ischemic cardiomyopathy heart failure population through a systematic review and meta-analysis of the available carefully designed prospective randomized controlled trials. Only prospective randomized controlled trials comparing ICD implantation in primary prevention vs. optimal pharmacological therapy or placebo and reporting mortality results were included in the meta-analysis. The authors have chosen to include the following trials: CAT, AMIOVIRT, DEFINITE, and DANISH.
RESULTS
A meta-analysis of pooled hazard ratios (HR) from all trials conducted on a total of 1789 patients found that ICD therapy decreased all-cause mortality in comparison to optimal pharmacological treatment, with a HR of 0.48 (95% confidence interval [CI] 0.67-1.01); p = 0.06. The data from the AMIOVIRT, DANISH, and DEFINITE trials, with a total of 1677 participants, showed a significant reduction of sudden cardiac deaths as a result of ICD implantation, with a HR of 0.48 (95% CI 0.31-0.67); p < 0.001.
CONCLUSIONS
In comparison with optimal medical treatment, ICD implantation in patients with heart failure improves the long-term prognosis in terms of sudden cardiac death, with a strong tendency towards all-cause mortality reduction.
Topics: Humans; Defibrillators, Implantable; Cardiomyopathies; Prospective Studies; Primary Prevention; Heart Failure; Myocardial Ischemia; Death, Sudden, Cardiac
PubMed: 33843044
DOI: 10.5603/CJ.a2021.0041 -
Frontiers in Cardiovascular Medicine 2022Catheter ablation (CA) for ventricular tachycardia (VT) can improve outcomes in patients with ischemic cardiomyopathy. Data on patients with non-ischemic cardiomyopathy...
Outcomes of early catheter ablation for ventricular tachycardia in adult patients with structural heart disease and implantable cardioverter-defibrillator: An updated systematic review and meta-analysis of randomized trials.
AIMS
Catheter ablation (CA) for ventricular tachycardia (VT) can improve outcomes in patients with ischemic cardiomyopathy. Data on patients with non-ischemic cardiomyopathy are scarce. The purpose of this systematic review and meta-analysis is to compare early CA for VT to deferred or no ablation in patients with ischemic or non-ischemic cardiomyopathy.
METHODS AND RESULTS
Studies were selected according to the following PICOS criteria: patients with structural heart disease and an implantable cardioverter-defibrillator (ICD) for VT, regardless of the antiarrhythmic drug treatment; intervention-early CA; comparison-no or deferred CA; outcomes-any appropriate ICD therapy, appropriate ICD shocks, all-cause mortality, VT storm, cardiovascular mortality, cardiovascular hospitalizations, complications, quality of life; published randomized trials with follow-up ≥12 months. Random-effect meta-analysis was performed. Outcomes were assessed using aggregate study-level data and reported as odds ratio (OR) or mean difference with 95% confidence intervals (CIs). Stratification by left ventricular ejection fraction (LVEF) was also done. Eight trials ( = 1,076) met the criteria. Early ablation was associated with reduced incidence of ICD therapy (OR 0.53, 95% CI 0.33-0.83, = 0.005), shocks (OR 0.52, 95% CI 0.35-0.77, = 0.001), VT storm (OR 0.58, 95% CI 0.39-0.85, = 0.006), and cardiovascular hospitalizations (OR 0.67, 95% CI 0.49-0.92, = 0.01). All-cause and cardiovascular mortality, complications, and quality of life were not different. Stratification by LVEF showed a reduction of ICD therapy only with higher EF (high EF OR 0.40, 95% CI 0.20-0.80, = 0.01 vs. low EF OR 0.62, 95% CI 0.34-1.12, = 0.11), while ICD shocks (high EF OR 0.54, 95% CI 0.25-1.15, = 0.11 vs. low EF OR 0.50, 95% CI 0.30-0.83, = 0.008) and hospitalizations (high EF OR 0.95, 95% CI 0.58-1.58, = 0.85 vs. low EF OR 0.58, 95% CI 0.40-0.82, = 0.002) were reduced only in patients with lower EF.
CONCLUSION
Early CA for VT in patients with structural heart disease is associated with reduced incidence of ICD therapy and shocks, VT storm, and hospitalizations. There is no impact on mortality, complications, and quality of life. (The review protocol was registered with INPLASY on June 19, 2022, #202260080).
SYSTEMATIC REVIEW REGISTRATION
[https://inplasy.com/], identifier [202260080].
PubMed: 36531738
DOI: 10.3389/fcvm.2022.1063147 -
International Journal of Cardiology.... Aug 2022Sarcoidosis is a chronic inflammatory disorder of unknown etiology associated with high morbidity and mortality. Its association with cardiovascular outcomes is...
BACKGROUND
Sarcoidosis is a chronic inflammatory disorder of unknown etiology associated with high morbidity and mortality. Its association with cardiovascular outcomes is under-documented.
AIM
The aim of this study was to assess the adverse cardiovascular outcomes in patients with sarcoidosis compared with that of non-sarcoidosis.
METHODOLOGY
Online databases including PubMed, Embase and Scopus were queried from inception until March 2022. The outcomes assessed included all-cause mortality (ACM) and incidence of ventricular tachycardia (VT), heart failure (HF) and atrial arrhythmias (AA).
RESULT
A total of 6 studies with 22,539,096 participants (42,763 Sarcoidosis, 22,496,354 Non-Sarcoidosis) were included in this analysis. The pooled prevalence of sarcoidosis was 13.1% (95% CI 1% to 70%). The overall mean age was 47 years. The most common comorbidities were hypertension (12.7% vs 12.5%), and diabetes mellitus (5.5% vs 4%) respectively. The pooled analysis of primary endpoints showed that all-cause mortality (RR, 2.08; 95% CI: 1.17 to 3.08; p = 0.01) was significantly increased in sarcoidosis patients. The pooled analysis of secondary endpoints showed that the incidence of VT (RR, 15.3; 95% CI: 5.39 to 43.42); p < 0.001), HF (RR, 4.96; 95% CI: 2.02 to 12.14; p < 0.001) and AA (RR, 2.55; 95% CI: 1.47 to 4.44); p = 0.01) were significantly higher with sarcoidosis respectively compared to non-sarcoidosis.
CONCLUSION
Incidence of VT, HF and AA was significantly higher in patients with CS. Clinicians should be aware of these adverse cardiovascular events associated with sarcoidosis.
PubMed: 35800042
DOI: 10.1016/j.ijcha.2022.101073 -
Circulation. Heart Failure Sep 2012Previous observational studies demonstrated that patients with hypertrophic cardiomyopathy at risk for sudden cardiac death (SCD) may benefit from implantable... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Previous observational studies demonstrated that patients with hypertrophic cardiomyopathy at risk for sudden cardiac death (SCD) may benefit from implantable cardioverter defibrillator (ICD) therapy. A complete overview of outcome and complications after ICD therapy is currently not available. This study pools data from published studies on outcome and complications after ICD therapy in patients with hypertrophic cardiomyopathy.
METHODS AND RESULTS
A PubMed database search returned 27 studies on 16 cohorts reporting outcome and complications after ICD therapy in patients with hypertrophic cardiomyopathy. In case of >1 publications on a particular cohort, the publication with the largest number of patients was included in the meta-analysis. ICD interventions, complications, and mortality rates were extracted, pooled, and analyzed. There were 2190 patients (mean age, 42 years; 38% women), most of whom (83%) received an ICD for primary prevention of SCD. Risk factors for SCD were left ventricular wall thickness ≥30 mm (20%), family history of SCD (43%), nonsustained ventricular tachycardia (46%), syncope (41%), and abnormal blood pressure response (25%). During the 3.7-year follow-up, the annualized cardiac mortality rate was 0.6%, the noncardiac mortality rate was 0.4%, and the appropriate ICD intervention rate was 3.3%. The annualized inappropriate ICD intervention rate was 4.8% and the annualized ICD-related complication rate was 3.4%.
CONCLUSIONS
This meta-analysis demonstrates a low cardiac and noncardiac mortality rate after ICD therapy in patients with hypertrophic cardiomyopathy. Appropriate ICD intervention occurred at a rate of 3.3%/year, thereby, most probably, preventing SCD. Inappropriate ICD intervention and complications are not uncommon.
Topics: Adolescent; Adult; Cardiomyopathy, Hypertrophic; Cause of Death; Death, Sudden, Cardiac; Defibrillators, Implantable; Electric Countershock; Female; Humans; Male; Middle Aged; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Young Adult
PubMed: 22821634
DOI: 10.1161/CIRCHEARTFAILURE.112.969626