Search

Background The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. Methods and results The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). Conclusion This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.

Aims This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation. Methods and results We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1–2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0–3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality. Conclusion Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed.

Objective: Evaluation of the relation between clinical characteristics and incidence of recurrent ventricular arrhythmias (VAs) or death during long-term follow-up in a cohort of 300 consecutive ischemic heart disease (IHD) patients who had survived an episode of sudden cardiac arrest (SCA). Background: Survivors of life-threatening VA are at high risk for recurrent events. Methods: A total of 300 consecutive survivors of SCA with IHD were included in a standardized screening and evaluation protocol. Multivariable Cox regression analysis was performed to determine the relation between clinical variables at baseline and the incidence of recurrent VA, all-cause mortality and the composite of both (composite endpoint). Results: The presenting arrhythmia was VT in 156 (52%) patients and VF in 144 (48%) patients. Revascularization was performed in 78 (26%) patients and an ICD was implanted in 216 (72%) patients. During follow-up (mean 30 ± 21 months) 37 (12%) patients died and 88 (29%) patients experienced a recurrence. Advanced age (adjusted hazard ratio (HR) 2.0; 1.2–3.3), history of heart failure (HR 1.8; 1.2–2.6), and amiodarone use (HR 3.1; 2.1–4.6) were independent predictors for the composite endpoint. VT as presenting arrhythmia was an independent predictor for all-cause mortality only (HR 2.4; 1.2–4.8). A decreased risk of recurrences was determined by beta-blocker use (HR 0.5; 0.4–0.8) and coronary revascularization (HR 0.3; 0.2–0.6). Conclusion: In a cohort of 300 consecutive survivors of SCA the incidence of recurrent VA and death is dependant on patient age, history of heart failure, and use of amiodarone. In contrast, use of beta-blockers and aggressive coronary revascularization improve the outcome.

Survivors of cardiac arrest due to ventricular arrhythmias are at risk for recurrent events. The role of revascularization in secondary prevention for survivors of cardiac arrest has been addressed in various studies with conflicting results. A total of 142 survivors of cardiac arrest with coronary artery disease were evaluated according to a standardized protocol, including 2-dimensional echocardiography, myocardial perfusion scintigraphy, coronary angiography, and electrophysiologic testing. Revascularization of scintigraphically documented ischemic myocardial regions was performed in 44 patients (31%). Final therapy was based on the results of electrophysiologic testing. Four-year survival rates were 100% for revascularized noninducible patients, 84% for revascularized inducible patients, 91% for nonrevascularized noninducible patients, and 72% for nonrevascularized inducible patients. Only 1 patient (

Background— Survivors of aborted sudden death attributable to ventricular arrhythmias in the presence of coronary artery disease are at risk for recurrences. The substrate underlying these arrhythmias is not clear, and therefore the relation between ischemia, viability, scar tissue (and revascularization), and the incidence of ventricular arrhythmias (and survival) was studied over up to 3 years. Methods and Results— One hundred fifty-three survivors of sudden death underwent stress-rest perfusion imaging. Patients with ischemic/viable myocardium (n=73) were revascularized if possible. Final antiarrhythmic therapy was based on the outcome of electrophysiological testing or left ventricular ejection fraction (LVEF). Implantation of a defibrillator was performed in 112 (72%) patients. During 3-year follow-up, 15 cardiac deaths occurred and 42 (29%) patients had recurrent ventricular arrhythmias. Patients with events (death or recurrence) exhibited more often a severely depressed LVEF (≤30%), more extensive scar tissue, and less ischemic/viable myocardium on perfusion imaging and less frequently underwent revascularization. Multivariate analysis identified extensive scar tissue and LVEF ≤30% as the only predictors of death/recurrent ventricular arrhythmias. Conclusions— In patients with aborted sudden death, extensive scar tissue and severely depressed LVEF are the only predictors of death or recurrent ventricular arrhythmias. These patients should be considered for implantation of a defibrillator.

Aims To assess the long-term rate of mortality and the recurrence of potentially life-threatening ventricular arrhythmias in secondary prevention implantable cardioverter defibrillator (ICD) patients and to construct a model for baseline risk stratification. Methods and results Since 1996, all patients with ischaemic heart disease, receiving ICD therapy for secondary prevention of sudden death, were included in the current study. Patients were evaluated at implantation and during long-term follow-up. A total of 456 patients were included in the analysis and followed for 54 ± 35 months. During follow-up, 100 (22%) patients died and ICD therapy was noted in 216 (47%) patients, of which 138 (30%) for fast, potentially life-threatening ventricular arrhythmia. Multivariate analysis revealed a history of atrial fibrillation or flutter (AF), ventricular tachycardia as presenting arrhythmia, and wide QRS and poor left ventricular ejection fraction as independent predictors of life-threatening ventricular arrhythmias. The strongest predictor was AF with a hazard ratio of 2.1 (95% confidence interval 1.3–3.2). On the basis of the available clinical data, it was not possible to identify a group which exhibited no risk on recurrence of potentially life-threatening ventricular arrhythmias. Conclusion Ischaemic secondary prevention ICD recipients exhibit a high recurrence rate of potentially life-threatening ventricular arrhythmias. Factors that increase risk can be identified but, even with these factors, it was not possible to distinguish a recurrence-free group.

The aim of this study was to evaluate the effect of a systematic screening/treatment protocol on outcome in patients after aborted sudden death.Patients after aborted sudden death are at high risk for recurrent events. In this regard, systematic screening is mandatory to reveal the underlying etiology, to detect and subsequently treat reversible causes, and to establish patient-tailored antiarrhythmic treatment.A total of 417 consecutive patients after aborted sudden death due to ventricular arrhythmias underwent echocardiography and coronary angiography. In the presence of coronary artery disease and myocardial ischemia, using stress-rest myocardial perfusion imaging/exercise testing, subsequent revascularization was performed. Patients without ischemic heart disease were further evaluated with magnetic resonance imaging, contrast echocardiography, right ventricular angiography and/or flecainide/ergonovine testing. After these diagnostic steps, final antiarrhythmic therapy was based on the outcome of electrophysiologic testing.The majority of patients had ischemic heart disease (n = 300, 72%). After screening, 78 (78 of 300, 26%) patients underwent revascularization. In 69% of patients, ventricular arrhythmias were inducible during electrophysiologic testing. Therapy consisted of implantable defibrillators in 301 (72%) patients, antiarrhythmic drugs in 239 (57%) patients, and catheter ablation in 58 (14%) patients. During 5-year follow-up, only 3 (1%) patients died suddenly. The 5-year survival rate was 82%; of 39 deaths, 10 (26%) patients died due to non-cardiac disease and 26 (67%) due to heart failure.Screening and treatment of patients after aborted sudden death according to a standardized protocol resulted in1% arrhythmic deaths during 5-year follow-up. The majority of patients died of heart failure, stressing the importance of optimizing medical and surgical therapy and screening.