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Journal of the American College of... Feb 2022Hypertrophic cardiomyopathy (HCM), a relatively common, globally distributed, and often inherited primary cardiac disease, has now transformed into a contemporary highly...
Hypertrophic cardiomyopathy (HCM), a relatively common, globally distributed, and often inherited primary cardiac disease, has now transformed into a contemporary highly treatable condition with effective options that alter natural history along specific personalized adverse pathways at all ages. HCM patients with disease-related complications benefit from: matured risk stratification in which major markers reliably select patients for prophylactic defibrillators and prevention of arrhythmic sudden death; low risk to high benefit surgical myectomy (with percutaneous alcohol ablation a selective alternative) that reverses progressive heart failure caused by outflow obstruction; anticoagulation prophylaxis that prevents atrial fibrillation-related embolic stroke and ablation techniques that decrease the frequency of paroxysmal episodes; and occasionally, heart transplant for end-stage nonobstructive patients. Those innovations have substantially improved outcomes by significantly reducing morbidity and HCM-related mortality to 0.5%/y. Palliative pharmacological strategies with currently available negative inotropic drugs can control symptoms over the short-term in some patients, but generally do not alter long-term clinical course. Notably, a substantial proportion of HCM patients (largely those identified without outflow obstruction) experience a stable/benign course without major interventions. The expert panel has critically appraised all available data and presented management insights and recommendations with concise principles for clinical decision-making.
Topics: Cardiomyopathy, Hypertrophic; Death, Sudden, Cardiac; Humans
PubMed: 35086661
DOI: 10.1016/j.jacc.2021.11.021 -
Circulation Oct 2020
Topics: Advanced Cardiac Life Support; American Heart Association; Cardiology; Cardiology Service, Hospital; Cardiopulmonary Resuscitation; Consensus; Emergencies; Emergency Service, Hospital; Evidence-Based Medicine; Heart Arrest; Humans; Risk Factors; Treatment Outcome; United States
PubMed: 33081529
DOI: 10.1161/CIR.0000000000000916 -
Circulation Mar 2024Device-detected atrial fibrillation (also known as subclinical atrial fibrillation or atrial high-rate episodes) is a common finding in patients with an implanted... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Device-detected atrial fibrillation (also known as subclinical atrial fibrillation or atrial high-rate episodes) is a common finding in patients with an implanted cardiac rhythm device and is associated with an increased risk of ischemic stroke. Whether oral anticoagulation is effective and safe in this patient population is unclear.
METHODS
We performed a systematic review of MEDLINE and Embase for randomized trials comparing oral anticoagulation with antiplatelet or no antithrombotic therapy in adults with device-detected atrial fibrillation recorded by a pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device, or implanted cardiac monitor. We used random-effects models for meta-analysis and rated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework (GRADE). The review was preregistered (PROSPERO CRD42023463212).
RESULTS
From 785 citations, we identified 2 randomized trials with relevant clinical outcome data: NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes; 2536 participants) evaluated edoxaban, and ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation; 4012 participants) evaluated apixaban. Meta-analysis demonstrated that oral anticoagulation with these agents reduced ischemic stroke (relative risk [RR], 0.68 [95% CI, 0.50-0.92]; high-quality evidence). The results from the 2 trials were consistent (I statistic for heterogeneity=0%). Oral anticoagulation also reduced a composite of cardiovascular death, all-cause stroke, peripheral arterial embolism, myocardial infarction, or pulmonary embolism (RR, 0.85 [95% CI, 0.73-0.99]; I=0%; moderate-quality evidence). There was no reduction in cardiovascular death (RR, 0.95 [95% CI, 0.76-1.17]; I=0%; moderate-quality evidence) or all-cause mortality (RR, 1.08 [95% CI, 0.96-1.21]; I=0%; moderate-quality evidence). Oral anticoagulation increased major bleeding (RR, 1.62 [95% CI, 1.05-2.50]; I²=61%; high-quality evidence).
CONCLUSIONS
The results of the NOAH-AFNET 6 and ARTESiA trials are consistent with each other. Meta-analysis of these 2 large randomized trials provides high-quality evidence that oral anticoagulation with edoxaban or apixaban reduces the risk of stroke in patients with device-detected atrial fibrillation and increases the risk of major bleeding.
Topics: Humans; Administration, Oral; Anticoagulants; Atrial Fibrillation; Embolism; Hemorrhage; Ischemic Stroke; Pyridines; Stroke; Thiazoles; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 37952187
DOI: 10.1161/CIRCULATIONAHA.123.067512 -
Circulation Oct 2020
Topics: Advanced Cardiac Life Support; American Heart Association; Cardiology; Cardiology Service, Hospital; Cardiopulmonary Resuscitation; Consensus; Emergencies; Emergency Service, Hospital; Evidence-Based Medicine; Heart Arrest; Humans; Risk Factors; Treatment Outcome; United States
PubMed: 33081530
DOI: 10.1161/CIR.0000000000000918 -
Circulation Oct 2020
Topics: Adolescent; Advanced Cardiac Life Support; Age Factors; American Heart Association; Cardiology; Cardiology Service, Hospital; Cardiopulmonary Resuscitation; Child; Child, Preschool; Consensus; Emergencies; Emergency Service, Hospital; Evidence-Based Medicine; Heart Arrest; Humans; Infant; Pediatrics; Risk Factors; Treatment Outcome; United States
PubMed: 33081526
DOI: 10.1161/CIR.0000000000000901 -
The Journal of Innovations in Cardiac... May 2022Defibrillation threshold (DFT) testing is performed in individuals with higher predicted risks of defibrillation failure. Many strategies have been explored to overcome...
Defibrillation threshold (DFT) testing is performed in individuals with higher predicted risks of defibrillation failure. Many strategies have been explored to overcome the challenge of high DFT, including an insertion of a defibrillator lead into the azygos vein. We performed a systematic review of the literature to evaluate the safety and efficacy of azygos vein implantable cardioverter-defibrillator insertion for high DFT combined with the analysis of a single-center experience of the procedure at our institution. The literature search was performed in PubMed and Embase from database inception to December 2020 to identify all case reports and case series related to azygos vein defibrillator lead insertion. Our search identified 291 records. After excluding duplicate studies and those without DFT thresholds and non-azygos vascular destinations, 12 studies (23 cases) were reviewed from the current database. We also conducted a retrospective analysis of 5 cases performed at our institution, and a total of 28 patients were included in our final analysis. The mean age of the pooled cohort was 47 years (range, 17-88 years). Men composed 92% of the total cases, and the average body mass index was 34 kg/m. The mean ejection fraction (EF) was 25%, with 78% having non-ischemic cardiomyopathy. The left axillary (36%) or subclavian (48%) vein was the common percutaneous access point. The mean duration of azygos vein access and lead delivery was 22 min (range, 13-60 min). The average DFT prior to azygos coil insertion was 35 J (range, 20-45 J). Fifty-seven percent of cases achieved substantial DFT improvement, whereas 18% achieved relative improvement compared to the pre-procedural threshold. No immediate or remote procedure-related complications were reported in 24 cases where data were available. During an average follow-up period of 18 months, 5 patients had ventricular arrhythmic events requiring device therapy and 4 had successful cardioversion from the device. One patient died from cardiac arrest with variable device therapies of both unsuccessful and successful events. In conclusion, azygos vein defibrillator lead insertion has a considerable rate of success, ease of vascular access with minimal procedural time, and lower risks and complications. Larger studies and longer follow-up periods are warranted to establish its efficacy and safety.
PubMed: 35655807
DOI: 10.19102/icrm.2022.130502 -
ESC Heart Failure Apr 2023This systematic review evaluated the clinical effectiveness and safety of subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients at an increased risk of... (Review)
Review
This systematic review evaluated the clinical effectiveness and safety of subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients at an increased risk of sudden cardiac death and with an ICD indication for primary or secondary prevention. A systematic literature search was conducted in four databases (Medline via Ovid, Embase, the Cochrane Library, and HTA-INAHTA). Randomized controlled trials (RCTs) and controlled observational studies with ≥100 S-ICD patients and a low to moderate risk of bias were eligible for inclusion. The studies' quality and the available evidence's strength were assessed using the Cochrane risk of bias tool, the ROBINS-I tool, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. One RCT, a post hoc analysis of the RCT (n = 849) and four controlled observational studies (n = 7149) were included. The quality of the available evidence was graded as low to very low, except for the primary composite endpoint of the RCT, which was rated as moderate quality. After 4 years, the RCT showed that S-ICD was non-inferior to TV-ICD regarding the composite endpoint of inappropriate shocks and device-related complications (68 [15.1%] vs. 68 [15.7%], hazard ratio [HR] 0.99, 95% confidence interval [CI] [0.71, 1.39], non-inferiority margin 1.45, P = 0.001). The RCT and two observational studies reported statistically significantly fewer lead complications in S-ICD patients (after 4 years: 1.4% vs. 6.6%, HR 0.24, 95% CI [0.10, 0.54]; after 3 years: 0.3% vs. 2.3%, P = 0.03; and after 5 years: 0.8% vs. 11.5%, P = 0.03). Identified evidence about appropriate and inappropriate shocks was inconclusive: The RCT detected statistically significantly more appropriate shocks in patients with S-ICD (83 [19.2%] vs. 57 [11.5%], HR 1.52, 95% CI [1.08, 2.12], P = 0.02), whereas one observational study showed a statistically significantly lower rate in the S-ICD group (9.9%, 95% CI [7.0, 13.9], vs. 13.9%, 95% CI [10.8, 17.8], P = 0.003). Regarding inappropriate shocks, one observational study reported statistically significantly higher rates in the S-ICD cohort (11.9% vs. 7.5%, P = 0.007), whereas the RCT and two other observational studies did not detect a statistically significant difference between the treatment groups (P > 0.05). None of the included studies showed a statistically significant difference in overall mortality and shock efficacy between patients with S-ICD and TV-ICD (P > 0.05). The available evidence is insufficient to show the superiority of S-ICD compared with TV-ICD, hindering the widespread use of the technology. Results of the recently completed ATLAS trial are to be awaited, and the anticipated role of the S-ICD needs to be clearly formulated.
Topics: Humans; Defibrillators, Implantable; Death, Sudden, Cardiac; Treatment Outcome; Observational Studies as Topic
PubMed: 36444868
DOI: 10.1002/ehf2.14249 -
The Canadian Journal of Cardiology Mar 2015It is unknown whether implantable cardioverter-defibrillator (ICD) discharges actively contribute to a worse prognosis independent of the underlying arrhythmia. There is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
It is unknown whether implantable cardioverter-defibrillator (ICD) discharges actively contribute to a worse prognosis independent of the underlying arrhythmia. There is considerable variability in the reported risk of mortality after appropriate and inappropriate ICD shocks. The aim of our systematic review was to provide a reliable effect size of the association between ICD shock and mortality for both types of therapies.
METHODS
On the basis of a systematic literature search, 10 studies were considered eligible for inclusion in the analysis, and data on the hazard ratio (HR) of mortality after ICD shock were extracted from each study.
RESULTS
On pooled analysis, a substantial difference was detected in the risk for subsequent mortality between appropriate and inappropriate shocks. Among patients receiving an appropriate ICD shock, the HR for cardiac death was 2.95 (95% confidence interval [CI], 2.12-4.11; P < 0.001) compared with an HR of 1.71 (95% CI, 1.45-2.02) for those receiving an inappropriate shock. Clinical variables like ejection fraction, New York Heart Association class, and length of follow-up did not affect the HRs in our meta-regression models.
CONCLUSIONS
Our analysis showed a significant association between appropriate and inappropriate ICD shocks and mortality, with a stronger association for appropriate shocks. Previous trials of ICD therapy reduction programming have shown a significant reduction of inappropriate shocks. The management of appropriate shocks is more challenging and may be optimized by the assessment and treatment of the underlying ventricular arrhythmias. The role of therapies aimed at modifying the arrhythmic substrate and the potential impact on ICD shocks and mortality requires further investigation.
Topics: Arrhythmias, Cardiac; Defibrillators, Implantable; Heart Failure; Humans; Randomized Controlled Trials as Topic; Risk Factors; Survival Analysis
PubMed: 25746019
DOI: 10.1016/j.cjca.2014.11.023 -
Journal of Arrhythmia Feb 2018The evidence to support implantable cardioverter defibrillator (ICD) in subjects with nonischemic cardiomyopathy (NICM) for primary prevention of sudden cardiac death... (Review)
Review
The evidence to support implantable cardioverter defibrillator (ICD) in subjects with nonischemic cardiomyopathy (NICM) for primary prevention of sudden cardiac death (SCD) is not robust. This meta-analysis intends to assess the impact of routine ICD implantation for primary prevention of mortality due to SCD in NICM based on all the published randomized clinical trials (RCTs). Six RCTs were selected using PubMed/Medline, EMBASE, and CENTRAL from inception to December 2016. Outcomes were calculated as random-effects relative risk (RR) and risk difference (RD) with 95% confidence interval (CI). Patients were randomized to ICD arm and control arm (usual care, medical treatment, and anti-arrhythmic drugs). ICD significantly reduced all-cause mortality in NICM patients (RR, 0.74, 95% CI, 0.56-0.97, = .03, I = 40). Mortality benefit was achieved due to a significant reduction in sudden cardiac death (SCD) (RR, 0.47, 95% CI, 0.30-0.73, < .001, I = 0). There were no statistical differences between two groups with regard to risk of noncardiac mortality, non-SCD, cardiac arrest, cardiac transplant, sustained ventricular tachycardia (VT), and VT requiring medical treatment. Our results support efficacy of ICDs at reducing all-cause mortality due to a reduction in SCD.
PubMed: 29721108
DOI: 10.1002/joa3.12017 -
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