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Showing papers on "Implantable cardioverter-defibrillator published in 2018"


Journal ArticleDOI
TL;DR: Catheter ablation for atrial fibrillation in patients with heart failure was associated with a significantly lower rate of a composite end point of death from any cause or hospitalization for worsening heart failure than was medical therapy.
Abstract: Background Mortality and morbidity are higher among patients with atrial fibrillation and heart failure than among those with heart failure alone Catheter ablation for atrial fibrillation has been proposed as a means of improving outcomes among patients with heart failure who are otherwise receiving appropriate treatment Methods We randomly assigned patients with symptomatic paroxysmal or persistent atrial fibrillation who did not have a response to antiarrhythmic drugs, had unacceptable side effects, or were unwilling to take these drugs to undergo either catheter ablation (179 patients) or medical therapy (rate or rhythm control) (184 patients) for atrial fibrillation in addition to guidelines-based therapy for heart failure All the patients had New York Heart Association class II, III, or IV heart failure, a left ventricular ejection fraction of 35% or less, and an implanted defibrillator The primary end point was a composite of death from any cause or hospitalization for worsening heart f

1,386 citations


Journal ArticleDOI
TL;DR: Authors/Task Force Members: Michele Brignole* (Chairperson), Angel Moya* (Co-chairperson) (Spain), Frederik J. de Lange (The Netherlands), Jean-Claude Deharo (France), Perry M. Elliott (UK), Alessandra Fanciulli (Austria), Artur Fedorowski (Sweden), Raffaello Furlan (Italy), Rose Anne Kenny (Ireland), Alfonso Mart ın (Spain

1,015 citations



Journal ArticleDOI
01 Nov 2018-Europace
TL;DR: In this article, a position paper was designed to state the art in management of young individuals with Congenital Heart Disease (CHD) and arrhythmias, including pharmacological treatment, catheter ablation, and device therapy.
Abstract: The population of patients with congenital heart disease (CHD) is continuously increasing with more and more patients reaching adulthood. A significant portion of these young adults will suffer from arrhythmias due to the underlying congenital heart defect itself or as a sequela of interventional or surgical treatment. The medical community will encounter an increasing challenge as even most of the individuals with complex congenital heart defects nowadays become young adults. Within the past 20 years, management of patients with arrhythmias has gained remarkable progress including pharmacological treatment, catheter ablation, and device therapy. Catheter ablation in patients with CHD has paralleled the advances of this technology in pediatric and adult patients with structurally normal hearts. Growing experience and introduction of new techniques like the 3D mapping systems into clinical practice have been particularly beneficial for this growing population of patients with abnormal cardiac anatomy and physiology. Finally, device therapies allowing maintanence of chronotropic competence and AV conduction, improving haemodynamics by cardiac resynchronization, and preventing sudden death are increasingly used. For pharmacological therapy, ablation procedures, and device therapy decision making requires a deep understanding of the individual pathological anatomy and physiology as well as detailed knowledge on natural history and long-term prognosis of our patients. Composing expert opinions from cardiology and paediatric cardiology as well as from non-invasive and invasive electrophysiology this position paper was designed to state the art in management of young individuals with congenital heart defects and arrhythmias.

179 citations


Journal ArticleDOI
TL;DR: The risk of sudden cardiac death is significant in cardiac sarcoidosis presenting with high-grade AVB with or without ventricular tachycardia or LV dysfunction, and the consensus recommendation to implant an intracardiac cardioverter defibrillator whenever permanent pacing is needed seems well-founded.
Abstract: Background: Symptomatic high-grade atrioventricular block (AVB) is the most common and often the only presenting manifestation (lone AVB) of cardiac sarcoidosis. Implantation of an intracardiac car...

80 citations


Journal ArticleDOI
TL;DR: The combination of IV amiodarone and oral propranolol is safe, effective, and superior to the combination of ICD patients with implantable cardioverter-defibrillators and oral metoprolol in the management of ES in I CD patients.

70 citations


Journal ArticleDOI
TL;DR: The first randomized data on the efficacy and safety of Percutaneous Coronary Intervention in ICM and has the potential to inform guidelines pertaining to both revascularization and HF is provided.
Abstract: Objectives Evaluate whether PCI in combination with optimal medical therapy (OMT) will reduce all-cause death and hospitalization for HF compared to a strategy of OMT alone. Background Ischemic cardiomyopathy (ICM) is the most common cause of heart failure (HF) and is associated with significant mortality and morbidity. Surgical revascularization has been shown to improve long-term outcomes in some patients, but surgery itself carries a major early hazard. Percutaneous coronary intervention (PCI) may allow a better balance between risk and benefit. Methods REVIVED-BCIS2 is a prospective, multi-center, open-label, randomized controlled trial, funded by the National Institute for Health Research in the United Kingdom. Follow-up will be for at least 2 years from randomization. Secondary outcomes include left ventricular ejection fraction (LVEF), quality of life scores, appropriate implantable cardioverter defibrillator therapy and acute myocardial infarction. Patients with LVEF ≤35%, extensive coronary disease and demonstrable myocardial viability are eligible for inclusion and those with a myocardial infarction within 4 weeks, decompensated HF or sustained ventricular arrhythmias within 72 h are excluded. A trial of 700 patients has more than 85% power to detect a 30% relative reduction in hazard. Results A total of 400 patients have been enrolled to date. Conclusions International guidelines do not provide firm recommendations on the role of PCI in managing severe ICM, because of a lack of robust evidence. REVIVED-BCIS2 will provide the first randomized data on the efficacy and safety of PCI in ICM and has the potential to inform guidelines pertaining to both revascularization and HF. (Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure [REVIVED-BCIS2]; NCT01920048) (REVascularisation for Ischaemic VEntricular Dysfunction; ISRCTN45979711)

68 citations


Journal ArticleDOI
TL;DR: Pediatric-onset hypertrophic cardiomyopathy is rare and associated with adverse outcomes driven mainly by arrhythmic events, which extends well beyond adolescence, which calls for unchanged clinical surveillance into adulthood.
Abstract: Importance Predictors of lethal arrhythmic events (LAEs) after a pediatric diagnosis of hypertrophic cardiomyopathy (HCM) are unresolved. Existing algorithms for risk stratification are limited to patients older than 16 years because of a lack of data on younger individuals. Objective To describe the long-term outcome of pediatric-onset HCM and identify age-specific arrhythmic risk factors. Design, Setting, and Participants This study assessed patients with pediatric-onset hypertrophic cardiomyopathy diagnosed from 1974 to 2016 in 2 national referral centers for cardiomyopathies in Florence, Italy. Patients with metabolic and syndromic disease were excluded. Exposures Patients were assessed at 1-year intervals, or more often, if their clinical condition required. Main Outcomes and Measures Lethal arrhythmic events (LAEs) and death related to heart failure. Results Of 1644 patients with HCM, 100 (6.1%) were 1 to 16 years old at diagnosis (median [interquartile range], 12.2 [7.3-14.1] years). Of these, 63 (63.0%) were boys. Forty-two of the 100 patients (42.0%) were symptomatic (defined as an New York Heart Association classification higher than 1 or a Ross score greater than 2). The yield of sarcomere gene testing was 55 of 70 patients (79%). During a median of 9.2 years during which a mean of 1229 patients were treated per year, 24 of 100 patients (24.0%) experienced cardiac events (1.9% per year), including 19 LAEs and 5 heart failure–related events (3 deaths and 2 heart transplants). Lethal arrhythmic events occurred at a mean (SD) age of 23.1 (11.5) years. Two survivors of LAEs with symptoms of heart failure experienced recurrent cardiac arrest despite an implantable cardioverter defibrillator. Risk of LAE was associated with symptoms at onset (hazard ratio [HR], 8.2; 95% CI, 1.5-68.4; P = .02) and Troponin I or Troponin T gene mutations (HR, 4.1; 95% CI, 0.9-36.5; P = .06). Adult HCM risk predictors performed poorly in this population. Data analysis occurred from December 2016 to October 2017. Conclusions and Relevance Pediatric-onset HCM is rare and associated with adverse outcomes driven mainly by arrhythmic events. Risk extends well beyond adolescence, which calls for unchanged clinical surveillance into adulthood. In this study, predictors of adverse outcomes differ from those of adult populations with HCM. In secondary prevention, the implantable cardioverter defibrillator did not confer absolute protection in the presence of limiting symptoms of heart failure.

67 citations


Journal ArticleDOI
TL;DR: A review of disease mechanisms, diagnostic strategies, clinical consequences, and state-of-the-art device therapy for chronic incompetence in patients with heart failure can be found in this paper.
Abstract: Chronotropic incompetence (CI) is generally defined as the inability to increase the heart rate (HR) adequately during exercise to match cardiac output to metabolic demands. In patients with heart failure (HF), however, this definition is unsuitable because metabolic demands are unmatched to cardiac output in both conditions. Moreover, HR dynamics in patients with HF differ from those in healthy subjects and may be affected by β-blocking medication. Nevertheless, it has been demonstrated that CI in HF is associated with reduced functional capacity and poor survival. During exercise, the normal heart increases both stroke volume and HR, whereas in the failing heart, contractility reserve is lost, thus rendering increases in cardiac output primarily dependent on cardioacceleration. Consequently, insufficient cardioacceleration because of CI may be considered a major limiting factor in the exercise capacity of patients with HF. Despite the profound effects of CI in this specific population, the issue has drawn limited attention during the past years and is often overlooked in clinical practice. This might partly be caused by a lack of standardized approach to diagnose the disease, further complicated by changes in HR dynamics in the HF population, which render reference values derived from a normal population invalid. Cardiac implantable electronic devices (implantable cardioverter defibrillator; cardiac resynchronization therapy) now offer a unique opportunity to study HR dynamics and provide treatment options for CI by rate-adaptive pacing using an incorporated sensor that measures physical activity. This review provides an overview of disease mechanisms, diagnostic strategies, clinical consequences, and state-of-the-art device therapy for CI in HF.

62 citations


Journal ArticleDOI
TL;DR: History of high-intensity exercise, electrocardiographic T-wave inversions ≥V3, and greater LV mechanical dispersion were strong predictors of life-threatening ventricular arrhythmia and may help to make decisions on primary preventive implantable cardioverter defibrillator (ICD) therapy.
Abstract: Objectives This study aimed to identify clinical, electrocardiographic (ECG) and cardiac imaging predictors of first-time life-threatening ventricular arrhythmia in patients with arrhythmogenic cardiomyopathy (AC). Background The role of clinical, electrocardiographic, and cardiac imaging parameters in risk stratification of patients without ventricular arrhythmia is unclear. Methods We followed consecutive AC probands and mutation-positive family members with no documented ventricular arrhythmia from time of diagnosis to first event. We assessed clinical, electrocardiographic, and cardiac imaging parameters according to Task Force Criteria of 2010 in addition to left ventricular (LV) and strain parameters. High-intensity exercise was defined as >6 metabolic equivalents. Results We included 117 patients (29% probands, 50% female, age 40 ± 17 years). During 4.2 (interquartile range [IQR]: 2.4 to 7.4) years of follow-up, 18 (15%) patients experienced life-threatening ventricular arrhythmias. The 1-, 2-, and 5-year incidence was 6%, 9%, and 22%, respectively. History of high-intensity exercise, T-wave inversions ≥V3, and greater LV mechanical dispersion were the strongest risk markers (adjusted hazard ratio [HR]: 4.7 [95% confidence interval (CI): 1.2 to 17.5]; p = 0.02, 4.7 [95% CI: 1.6 to 13.9]; p = 0.005), and 1.4 [95% CI: 1.2 to 1.6] by 10-ms increments; p Conclusions History of high-intensity exercise, electrocardiographic T-wave inversions ≥V3, and greater LV mechanical dispersion were strong predictors of life-threatening ventricular arrhythmia. Patients without any of these risk factors had minimal risk, whereas ≥2 risk factors increased the risk dramatically. This may help to make decisions on primary preventive implantable cardioverter defibrillator (ICD) therapy.

60 citations


Journal ArticleDOI
TL;DR: In this population with CPVT, ICDs were common and associated with a high burden of shocks and complications, and poor uptake of adjuvant antiarrhythmic therapies, suggests that improved adherence to guideline-directed management could reduce ICD use and harm.

Journal ArticleDOI
01 Apr 2018-Europace
TL;DR: These data support the utilization of catheter ablation in selected CS cases resistant to medical treatment, however, data are derived from observational non-controlled case series, with low-methodological quality.
Abstract: AIMS: Cardiac sarcoidosis (CS) is associated with a poor prognosis. Important features of CS include heart failure, conduction abnormalities, and ventricular arrhythmias. Ventricular tachycardia (VT) is often refractory to antiarrhythmic drugs (AAD) and immunosuppression. Catheter ablation has emerged as a treatment option for recurrent VT. However, data on the efficacy and outcomes of VT ablation in this context are sparse. METHODS AND RESULTS: A systematic search was performed on PubMed, EMBASE, and Cochrane database (from inception to September 2016) with included studies providing a minimum of information on CS patients undergoing VT ablation: age, gender, VT cycle length, CS diagnosis criteria, and baseline medications. Five studies reporting on 83 patients were identified. The mean age of patients was 50 ± 8 years, 53/30 (males/females) with a maximum of 56 patients receiving immunosuppressive therapy, mean ejection fraction was 39.1 ± 3.1% and 94% had an implantable cardioverter defibrillator in situ. The median number of VTs was 3 (2.6–4.9)/patient, mean cycle length of 360 ms (326–400 ms). Hundred percent of VTs received endocardial ablation, and 18% required epicardial ablation. The complication rates were 4.7–6.3%. Relapse occurred in 45 (54.2%) patients with an incidence of relapse 0.33 (95% confidence interval 0.108–0.551, P < 0.004). Employing a less stringent endpoint (i.e. freedom from arrhythmia or reduction of ventricular arrhythmia burden), 61 (88.4%) patients improved following ablation. CONCLUSIONS: These data support the utilization of catheter ablation in selected CS cases resistant to medical treatment. However, data are derived from observational non-controlled case series, with low-methodological quality. Therefore, future well-designed, randomized controlled trials, or large-scale registries are required.

Journal ArticleDOI
TL;DR: In this study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years, and the high rate of reintervention leads to additional complications.
Abstract: Background The transvenous implantable cardioverter‐defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database. Methods and Results Data from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5‐year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications. Conclusions Incidence of mechanical and infectious complications of transvenous ICD leads over long‐term follow‐up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications.

Journal ArticleDOI
01 Jun 2018-Europace
TL;DR: It is demonstrated that fewer women than men undergo ICD implantation for primary prevention after multivariate adjustment, women have a significantly lower mortality and receive fewer appropriate ICD shocks.
Abstract: Aims Therapy with an implantable cardioverter defibrillator (ICD) is established for the prevention of sudden cardiac death (SCD) in high risk patients. We aimed to determine the effectiveness of primary prevention ICD therapy by analysing registry data from 14 centres in 11 European countries compiled between 2002 and 2014, with emphasis on outcomes in women who have been underrepresented in all trials. Methods and results Retrospective data of 14 local registries of primary prevention ICD implantations between 2002 and 2014 were compiled in a central database. Predefined primary outcome measures were overall mortality and first appropriate and first inappropriate shocks. A multivariable model enforcing a common hazard ratio for sex category across the centres, but allowing for centre-specific baseline hazards and centre specific effects of other covariates, was adjusted for age, the presence of ischaemic cardiomyopathy or a CRT-D, and left ventricular ejection fraction ≤25%. Of the 5033 patients, 957 (19%) were women. During a median follow-up of 33 months (IQR 16-55 months) 129 women (13%) and 807 men (20%) died (HR 0.65; 95% CI: [0.53, 0.79], P-value < 0.0001). An appropriate ICD shock occurred in 66 women (8%) and 514 men (14%; HR 0.61; 95% CI: 0.47-0.79; P = 0.0002). Conclusion Our retrospective analysis of 14 local registries in 11 European countries demonstrates that fewer women than men undergo ICD implantation for primary prevention. After multivariate adjustment, women have a significantly lower mortality and receive fewer appropriate ICD shocks.

Journal ArticleDOI
TL;DR: Exercise reduction is unlikely to reduce arrhythmia sufficiently in high‐risk patients to alter decision‐making regarding ICD implantation, and exercise restriction should be recommended to all arrhythmogenic right ventricular cardiomyopathy patients with ICDs.
Abstract: Background Prior studies have shown a close link between exercise and development of arrhythmogenic right ventricular cardiomyopathy. How much exercise restriction reduces ventricular arrhythmia (V...

Journal ArticleDOI
TL;DR: In this monocentric study, substrate modification targeting LAVA for post–myocardial infarction VT resulted in a substantial reduction of VT storm and implantable cardioverter defibrillator shocks and up to 49% of patients free from arrhythmia at 5 years after a single procedure.
Abstract: Background: Long-term results of substrate modification for ablation of ventricular tachycardia (VT) have not been reported. We report long-term outcomes of substrate elimination targeting local abnormal ventricular activities (LAVA) for post–myocardial infarction VT. Methods and Results: One hundred fifty-nine consecutive patients undergoing first ablation were included (65±11 years, 92% implantable cardioverter defibrillators, 54% storms, and 73% appropriate shocks). LAVA were identified in 92% and VT was inducible in 73%. Complete LAVA elimination and noninducibility after ablation were achieved in 64% and 85%. During a median follow-up of 47 months (interquartile range, 34–82), single-procedure ventricular arrhythmia (VA)–free survival was 55% (10% storms and 19% shocks). The VA-free survival was 73%, 68%, 61%, 55%, and 49% after 1, 2, 3, 4, and 5 years, respectively. Complete LAVA elimination was associated with improved outcomes: VA-free survival of 82% at 1 year and 61% at 5 years. In the subgroup treated with multielectrode mapping and real-time image integration, VA-free survival was 86% and 65% at 1 year and 4 years, respectively. Including repeat procedures in 18% of pts (1.3±0.6 ablations/pt) outcomes improved to 69% VA-free survival (2% storms and 9% shocks) during median 46-month follow-up. Overall survival was 91% at 1 year and 77% at 5 years of follow-up. Conclusions: In this monocentric study, substrate modification targeting LAVA for post–myocardial infarction VT resulted in a substantial reduction of VT storm and implantable cardioverter defibrillator shocks and up to 49% of patients free from arrhythmia at 5 years after a single procedure. Complete LAVA elimination, multielectrode mapping, and real-time integration were associated with improved VA-free survival.


Journal ArticleDOI
TL;DR: In patients with CS and VT, temporal change in FDG uptake evaluated by a quantitative approach is associated with parallel change in systolic function, and reduction inFDG uptake is strongly associated with fewer MACE at long-term follow-up.
Abstract: Positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) has shown to be useful in diagnosis, staging and monitoring of cardiac sarcoidosis (CS) but its interpretation is not standardized. We sought to investigate the clinical impact of serial quantitative FDG uptake analysis in patients with CS presenting with ventricular tachycardia (VT) treated by catheter ablation (CA). We followed 20 patients (51 ± 9 years, 70% males) with CS and VT who underwent CA, with 92 serial FDG-PET scans (3–10 per patient). Myocardial FDG-avid lesions were quantified using three parameters: maximum standardized uptake value (SUVmax), partial-volume corrected mean standardized uptake value (SUVmean) and partial-volume corrected volume-intensity product [lesion metabolic activity (LMA)]. The volume-intensity product of the entire heart [global cardiac metabolic activity (gCMA)] and the background cardiac metabolic activity (bCMA: difference between gCMA and LMA) were also calculated. The primary end-point was the occurrence of major adverse cardiac events (MACE), including death, heart transplant, hospitalization for heart failure and implantable cardioverter defibrillator (ICD) appropriate interventions. Evolution of echocardiographic parameters over follow-up was also assessed. During a median follow-up of 35 (20–66) months, 18 MACE (1 death, 2 heart transplants, 12 ICD appropriate interventions, 3 hospitalizations) occurred in 12 (60%) patients. At univariable analysis, lack of PET improvement (defined by decrease in LMA of at least 25%) was the only variable associated with cardiac events during follow-up. In particular, non-responders had a 20-fold higher risk of MACE at follow-up (HR 18.96, 95% CI 2.26–159.27; p = 0.007). Moreover, a significant linear inverse relationship was observed between changes in LMA and changes in left ventricular ejection fraction over follow-up (β = −20.11; p = 0.003). In patients with CS and VT, temporal change in FDG uptake evaluated by a quantitative approach is associated with parallel change in systolic function. Moreover, reduction in FDG uptake is strongly associated with fewer MACE at long-term follow-up.

Journal ArticleDOI
TL;DR: ICD therapy is an effective strategy in young patients with symptomatic Brugada syndrome, treating potentially lethal arrhythmias in >25% of patients during follow-up, and Appropriate shocks were significantly associated with previously aborted sudden cardiac death and spontaneous type I electrocardiograms.

Journal ArticleDOI
01 Jul 2018-Europace
TL;DR: S-ICD screening failure occurs in up to 13% of patients with inherited primary arrhythmia syndromes, and patients with BrS present a higher rate of screening failure as compared with other cardiac channelopathies.
Abstract: Aims: Subcutaneous implantable cardioverter-defibrillator (S-ICD) can avoid important complications associated with transvenous leads in patients with inherited primary arrhythmia syndromes, who do not need pacing therapy. Few data are available on the percentage of patients with inherited arrhythmia syndromes eligible for S-ICD implantation. Aim of this study was to analyse the eligibility for S-ICD in a series of patients with Brugada syndrome (BrS), and to compare it with patients with other channelopathies. Methods and results: Patients presenting with BrS, long-QT syndrome (LQTS), early repolarization syndrome (ERS), and idiopathic ventricular fibrillation (IVF) were considered eligible for this study. ECG screening was performed by analysis of QRS complex and T wave morphology recorded in standing and supine position. Eligibility was defined when ≥1 sense vector was acceptable in both supine and standing position. A total of 100 patients (72 males; mean age: 46 ± 17 years) underwent S-ICD sensing screening. Sixty-one patients presented with BrS, 21 with LQTS, 14 with IVF, and 4 with ERS. Thirty-four patients with BrS (56%) presented with spontaneous type 1 ECG. In the other 27 patients (44%), type 1 ECG was unmasked by ajmaline. Overall, rate of screening failure was 13%. Patients with BrS had a higher rate of inappropriate morphology analysis as compared with other channelopathies (18% vs. 5%, P = 0.07) and had a lower number of suitable sensing vectors (49.6% vs. 84.7% vs. P < 0.001). Ajmaline challenge unmasked sensing failure in 14.8% of drug-induced BrS patients previously considered eligible. In all patients, the reason for sensing inappropriateness was due to the presence of high T wave voltages. Conclusion: S-ICD screening failure occurs in up to 13% of patients with inherited primary arrhythmia syndromes. Patients with BrS present a higher rate of screening failure as compared with other cardiac channelopathies.

Journal ArticleDOI
TL;DR: In high-risk ICD patients, treatment with ranolazine did not significantly reduce the incidence of the first VT or VF, or death, and the study was underpowered to detect a difference in the primary endpoint.

Journal ArticleDOI
Neal A. Chatterjee1, M. Vinayaga Moorthy1, Julie Pester1, Andi Schaecter2  +154 moreInstitutions (53)
TL;DR: In a contemporary population of patients with coronary heart disease without severe systolic dysfunction, SAD accounts for a significant proportion of overall mortality and both Absolute and proportional risk of SAD varied significantly across clinical subgroups, and both will need to be maximized in future risk stratification efforts.
Abstract: Importance The majority of sudden and/or arrhythmic deaths (SAD) in patients with coronary heart disease occur in those without severe systolic dysfunction, for whom strategies for sudden death prevention are lacking. Objective To provide contemporary estimates of SAD vs other competing causes of death in patients with coronary heart disease without severe systolic dysfunction to search for high-risk subgroups that might be targeted in future trials of SAD prevention. Design, Setting, and Participants This prospective observational cohort study included 135 clinical sites in the United States and Canada. A total of 5761 participants with coronary heart disease who did not qualify for primary prevention implantable cardioverter defibrillator therapy based on left ventricular ejection fraction (LVEF) of more than 35% or New York Heart Association (NYHA) heart failure class (LVEF >30%, NYHA I). Exposures Clinical risk factors measured at baseline including age, LVEF, and NYHA heart failure class. Main Outcomes and Measures Primary outcome of SAD, which is a composite of SAD and resuscitated ventricular fibrillation arrest. Results The mean (SD) age of the cohort was 64 (11) years. During a median of 3.9 years, the cumulative incidence of SAD and non-SAD was 2.1% and 7.7%, respectively. Sudden and/or arrhythmic death was the most common mode of cardiovascular death accounting for 114 of 202 cardiac deaths (56%), although noncardiac death was the primary mode of death in this population. The 4-year cumulative incidence of SAD was lowest in those with an LVEF of more than 60% (1.0%) and highest among those with LVEF of 30% to 40% (4.9%) and class III/IV heart failure (5.1%); however, the cumulative incidence of non-SAD was similarly elevated in these latter high-risk subgroups. Patients with a moderately reduced LVEF (40%-49%) were more likely to die of SAD, whereas those with class II heart failure and advancing age were more likely to die of non-SAD. The proportion of deaths due to SAD varied widely, from 14% (18 of 131 deaths) in patients with NYHA II to 49% (37 of 76 deaths) in those younger than 60 years. Conclusions and Relevance In a contemporary population of patients with coronary heart disease without severe systolic dysfunction, SAD accounts for a significant proportion of overall mortality. Moderately reduced LVEF, age, and NYHA class distinguished SAD and non-SAD, whereas other markers were equally associated with both modes of death. Absolute and proportional risk of SAD varied significantly across clinical subgroups, and both will need to be maximized in future risk stratification efforts.

Journal ArticleDOI
TL;DR: The data suggest detailed sudden cardiac death risk stratification in nonobstructive HCM and monitoring with less aggressive management in labile HCM.
Abstract: Background Hypertrophic cardiomyopathy (HCM) is a common inherited cardiac disease characterized by varying degrees of left ventricular outflow tract obstruction. In a large cohort, we compare the outcomes among 3 different hemodynamic groups. Methods and Results We prospectively enrolled patients fulfilling standard diagnostic criteria for HCM from January 2005 to June 2015. Detailed phenotypic characterization, including peak left ventricular outflow tract pressure gradients at rest and after provocation, was measured by echocardiography. The primary outcome was a composite cardiovascular end point, which included new‐onset atrial fibrillation, new sustained ventricular tachycardia/ventricular fibrillation, new or worsening heart failure, and death. The mean follow‐up was 3.4±2.8 years. Among the 705 patients with HCM (mean age, 52±15 years; 62% men), 230 with obstructive HCM were older and had a higher body mass index and New York Heart Association class. The 214 patients with nonobstructive HCM were more likely to have a history of sustained ventricular tachycardia/ventricular fibrillation and implantable cardioverter defibrillator implantation. During follow‐up, 121 patients experienced a composite cardiovascular end point. Atrial fibrillation occurred most frequently in the obstructive group. Patients with nonobstructive HCM had more frequent sustained ventricular tachycardia/ventricular fibrillation events. In multivariate analysis, obstructive (hazard ratio, 2.80; 95% confidence interval, 1.64–4.80) and nonobstructive (hazard ratio, 1.94; 95% confidence interval, 1.09–3.45) HCM were associated with more adverse events compared with labile HCM. Conclusions Nonobstructive HCM carries notable morbidity, including a higher arrhythmic risk than the other HCM groups. Patients with labile HCM have a relatively benign clinical course. Our data suggest detailed sudden cardiac death risk stratification in nonobstructive HCM and monitoring with less aggressive management in labile HCM.

Journal ArticleDOI
TL;DR: The aim of this study was to determine whether delayed RV LGE with cardiovascular magnetic resonance would be predictive of adverse events in addition to LV LGE during the long‐term follow-up of pulmonary sarcoidosis patients.
Abstract: textAims: Cardiac involvement is the main determinant of poor outcomes in sarcoidosis. Right ventricular (RV) dysfunction and left ventricular (LV) late gadolinium enhancement (LGE) have been reported to be predictive of adverse outcome in non-ischaemic cardiomyopathies. The aim of our study was to determine whether delayed RV LGE with cardiovascular magnetic resonance would be predictive of adverse events in addition to LV LGE during the long-term follow-up of pulmonary sarcoidosis patients. Methods and results: Eighty-four consecutive biopsy-proven pulmonary sarcoidosis patients were followed for a median of 56 months [38–74] after baseline delayed contrast-enhanced cardiac magnetic resonance. The composite primary endpoint consisted of admission for congestive heart failure, sustained ventricular tachycardia, appropriate implantable cardioverter defibrillator therapy, pacemaker implantation for high degree atrio-ventricular block, or cardiac death. The composite secondary endpoint included all-cause mortality in addition to the primary endpoint. RV and LV LGE were demonstrated in respectively 12 and 27 patients. Five of 10 events included in the primary endpoint occurred in the group with RV LGE. RV LGE, LV, or biventricular LGE yielded Cox hazard ratios of 8.71 [95% confidence interval (CI) 1.90–23.81], 9.22 (95% CI 1.96–43.45), and 12.09 (95% CI 3.43–42.68) for the composite primary endpoint. In a multivariate model, the predictive value of biventricular LGE for the composite primary and secondary endpoints was strongest. Kaplan–Meier event-free survival curves were most significant for RV LGE and biventricular LGE (log rank with P < 0.001). Conclusions: Biventricular LGE at presentation is the strongest, independent predictor of adverse outcome during long-term follow-up. Asymptomatic myocardial scar <8% of LV mass carried a favourable long-term outcome.

Journal ArticleDOI
TL;DR: While it is common practice to implant ICDs in patients with LVADs and a history of ventricular arrhythmias, the efficacy behind this practice at preventing sudden death in this population is unknown.

Journal ArticleDOI
TL;DR: In this paper, a review of the impact of atrial fibrillation on overall survival, left ventricular function, thromboembolic stroke and quality of life is discussed.
Abstract: Atrial fibrillation is common in hypertrophic cardiomyopathy with a prevalence of 22-32 %. The impact of atrial fibrillation on overall survival, left ventricular function, thromboembolic stroke and quality of life is crucial. This review enlightens incidence, pathophysiology, and clinical symptoms. Early recognition of atrial fibrillation is essential. Monitoring methods for early detection are described. Finally effective therapy options are discussed including oral anticoagulation and the role of interventional catheter-based ablation in the treatment of atrial fibrillation in HCM patients.

Journal ArticleDOI
TL;DR: Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT) implantable cardioverter‐defibrillator (ICD) and with permanent atrial fibrillation (AF) has a positive impact on ICD shocks and hospitalizations compared with rate‐slowing drugs.
Abstract: Aims: We sought to determine whether atrioventricular junction ablation (AVJA) in patients with cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillator (ICD) and with permanent atrial fibrillation (AF) has a positive impact on ICD shocks and hospitalizations compared with rate-slowing drugs. Methods and results: This is a pooled analysis of data from 179 international centres participating in two randomized trials and one prospective observational research. The co-primary endpoints were all-cause ICD shocks and all-cause hospitalizations. Out of 3358 CRT-ICD patients (2720 male, 66.6years), 2694 (80%) were in sinus rhythm (SR) and 664 (20%) had permanent AF-262 (8%) treated with AVJA (AF+AVJA) and 402 (12%) treated with rate-slowing drugs (AF+Drugs). Median follow-up was 18months. The mean (95% confidence intervals) annual rate of all-cause ICD shocks per 100 patient years was 8.0 (5.3-11.9) in AF+AVJA, 43.6 (37.7-50.4) in AF+Drugs, and 34.4 (32.5-36.5) in SR patients, resulting in incidence rate ratio (IRR) reductions of 0.18 (0.10-0.32) for AF+AVJA vs. AF+Drugs (P<0.001) and 0.48 (0.35-0.66) for AF+AVJA vs. SR (P<0.001). These reductions were driven by significant reductions in both appropriate ICD shocks [IRR 0.23 (0.13-0.40), P<0.001, vs. AF+Drugs] and inappropriate ICD shocks [IRR 0.09 (0.04-0.21), P<0.001, vs. AF+Drugs]. Annual rate of all-cause hospitalizations was significantly lower in AF+AVJA vs. AF+Drugs [IRR 0.57 (0.41-0.79), P<0.001] and SR [IRR 0.85 (073-0.98), P=0.027]. Conclusion: In AF patients treated with CRT, AVJA results in a lower incidence and burden of all-cause, appropriate and inappropriate ICD shocks, as well as to fewer all-cause and heart failure hospitalizations.

Journal ArticleDOI
01 Sep 2018-Europace
TL;DR: The earliest experience of the S- ICD demonstrates similar outcomes as contemporary TV-ICD therapy in a matched comparison with predominately single-chamber devices at 3 years follow-up.
Abstract: Aims: Comparison of outcomes between subcutaneous and transvenous implantable cardioverter-defibrillator (S-ICD and TV-ICD) therapy is hampered by varying patient characteristics and complication definitions. The aim of this analysis is to compare clinical outcomes of S-ICD and TV-ICD therapy in a matched cohort. // Methods and results: Patients implanted with de novo implantable cardioverter-defibrillators without need for pacing were selected from two studies: SIMPLE (n = 1091 single and n = 553 dual chamber TV-ICDs) and EFFORTLESS (n = 798 S-ICDs). Subcutaneous implantable cardioverter-defibrillator patients were 1:1 matched on propensity score to TV-ICD patients. Propensity scores were calculated using 15 baseline characteristics including diagnosis. The Kaplan–Meier estimates for complications requiring invasive intervention, appropriate shocks, and inappropriate shocks were calculated at 3 years follow-up. The primary analysis yielded 391 patients pairs with balanced baseline characteristics, with mean age 55 ± 14 years, 49% ischaemic cardiomyopathy, mean left ventricular ejection fraction 40%, 71% primary prevention, and 89% of TV-ICDs were single chamber. Follow-up was mean 2.9 years in the S-ICD arm vs. 3.3 in the TV-ICD arm. All-cause complications occurred in 9.0% of S-ICD vs. 6.5% of TV-ICD patients, P = 0.29. Appropriate shocks occurred in 9.9% of S-ICD vs. 13.8% in TV-ICD patients, P = 0.03 and inappropriate shocks in 11.9% in S-ICD vs. 8.9% in TV-ICD patients (P = 0.07). Total shock burden (20 vs. 31, P = 0.05) and appropriate shock burden per 100 patients years (9 vs. 18, P = 0.02) were lower for S-ICD patients, while inappropriate shock burden was equal (11 vs. 13, P = 0.56). // Conclusion: The earliest experience of the S-ICD demonstrates similar outcomes as contemporary TV-ICD therapy in a matched comparison with predominately single-chamber devices at 3 years follow-up.

Journal ArticleDOI
TL;DR: A systematic review and meta-analysis demonstrates a statistically significant increased risk of SCD with AF in the general population and in those with previous myocardial infarction, coronary artery disease, heart failure, HCM, Brugada syndrome, and an implanted rhythm device.
Abstract: Recent studies suggest that atrial fibrillation (AF) is associated with increased cardiovascular risk and mortality including sudden cardiac death (SCD). According to the Cardiovascular Heath Study cohort, the incident rate of SCD was higher in the AF population (2.9 per 1000 per year) compared with non-AF controls (1.3 per 1000 per year). In this study, we performed a systematic review and meta-analysis to explore the association between AF and SCD. We comprehensively searched the databases of MEDLINE and EMBASE from inception to January 2017. Included studies were published prospective or retrospective cohort studies that compared the risk of developing SCD, defined by World Health Organization’s criteria, in AF patients versus non-AF patients. Data from each study were combined using the random-effects, generic inverse variance method of DerSimonian and Laird to calculate the risk ratios and 95% confidence intervals. Twenty-seven studies from January 1991 to February 2017 involving 8401 AF patients and 67,608 non-AF controls were included in this meta-analysis. Compared with controls, AF patients had a significantly higher risk of SCD in overall analysis (pooled risk ratio = 2.04, 95% confidence interval: 1.77–2.35, p < 0.01, I2 = 42.66) as well as subgroups of general population studies, previous myocardial infarction or coronary artery disease, heart failure, hypertrophic cardiomyopathy (HCM), Brugada syndrome, and patients with either a pacemaker or implantable cardioverter defibrillator (ICD). In subgroup analysis of multivariate-adjusted studies, AF also had a significantly higher risk of SCD (pooled risk ratio = 2.22, 95% confidence interval = 1.59–3.09, p < 0.01, I2 = 73.95). Incident rate of SCD in AF was 2-fold higher than controls but not statistically significant (pooled rate ratio = 2.06, 95% confidence interval = 0.66–7.53, p = 0.292, I2 = 88.58). Our meta-analysis demonstrates a statistically significant increased risk of SCD with AF in the general population and in those with previous myocardial infarction, coronary artery disease, heart failure, HCM, Brugada syndrome, and an implanted rhythm device.

Journal ArticleDOI
TL;DR: Prospective trials that evaluate the performance of risk stratification schema to determine ICD use are necessary for cost-effective reduction of the incidence of SCD after MI.
Abstract: Sudden cardiac death (SCD) accounts for ∼50% of mortality after myocardial infarction (MI). Most SCDs result from ventricular tachyarrhythmias, and the tachycardias that precipitate cardiac arrest result from multiple mechanisms. As a result, it is highly unlikely that any single test will identify all patients at risk for SCD. Current guidelines for use of implantable cardioverter-defibrillators (ICDs) to prevent SCD are based primarily on measurement of left ventricular ejection fraction (LVEF). Although reduced LVEF is associated with increased total cardiac mortality after MI, the focus of current guidelines on LVEF omits ∼50% of patients who die suddenly. In addition, there is no evidence of a mechanistic link between reduced LVEF and arrhythmias. Thus, LVEF is neither sensitive nor specific as a tool for post-MI risk stratification. Newer tests to screen for predisposition to ventricular arrhythmias and SCD examine abnormalities of ventricular repolarization, autonomic nervous system function, and e...