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Patients with an indication for an implantable cardioverter–defibrillator but no indication for pacing were randomly assigned to a subcutaneous or a transvenous ICD. At 49 months, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is a completely extrathoracic device that has recently been FDA approved for the prevention of sudden cardiac death in select populations. Although the transvenous implantable cardioverter defibrillator (TV-ICD) has a proven mortality benefit in multiple patient populations, there are significant risks both with implantation and years after its placement. The S-ICD may help prevent some of these complications. Currently, the S-ICD is typically implanted in patients with prior device infection or at an increased risk for an infection, younger patients with difficult venous access related to either hemodialysis or difficult cardiac anatomy, patients who live active lifestyles, and those who may outlive the TV-ICD leads. There is an absolute contraindication for S-ICD implantations for patients who need pacing either for ventricular tachycardia or bradycardia because this device cannot perform these functions. To date, there are no randomized controlled trial (RCT) data evaluating the safety and efficacy of this relatively new device. Observational studies of both the S-ICD alone and in comparison with the TV-ICD have showed promising results, including a decrease in lead-related and periprocedural complications as well as a high level of effectiveness at terminating ventricular arrhythmias. These analyses over time may have contributed to the evolution and comfortability with the S-ICD system, as physicians are more often referring for and/or implanting this device for patients with appropriate indications. Furthermore, inappropriate shock rates with the S-ICD have decreased over time especially with dual zone programming. This review summarizes the results of a multitude of observational studies with respect to patient selection for the S-ICD, complication rates, appropriate and inappropriate shock rates, and programming. This review also tackles current ongoing randomized trials. Although the results of ongoing trials will be helpful, there is still a continued need to evaluate the efficacy of the S-ICD in broader patient populations including patients with several comorbidities and older patients so that more patients can be considered for this potentially lifesaving device.

In this trial, two new programs for delivering implantable cardioverter–defibrillator therapy resulted in fewer inappropriate interventions (shocks or antitachycardia pacing) and an unexpected reduction in mortality. Improved programming could benefit patients with ICDs. The implantable cardioverter–defibrillator (ICD), either alone or in conjunction with cardiac-resynchronization therapy (CRT), is highly effective in reducing the rate of death due to ventricular tachyarrhythmia among high-risk cardiac patients. 1 – 4 However, inappropriate ICD activations, which are typically caused by supraventricular tachyarrhythmias, are frequent, despite sophisticated device-related detection algorithms that are designed to differentiate supraventricular from ventricular tachyarrhythmias; such activations have potentially life-threatening side effects. 5 , 6 Inappropriate device-delivered therapy, defined as therapy delivered for nonventricular tachyarrhythmias, affects 8 to 40% of patients with ICDs. 5 The best method for programming ICD devices to reduce inappropriate therapy is unknown. 7 We conducted a . . .

Infection is a known complication of the placement of cardiac implantable electronic devices. In this randomized, controlled trial involving 6983 patients undergoing cardiac-device placement, an antibacterial envelope was studied to determine infection prevention. The envelope reduced infection by 40%.

In this trial, patients with atrioventricular block and systolic dysfunction were randomly assigned to receive biventricular or right ventricular pacing. Clinical outcomes were superior with biventricular pacing. These data may extend the use of this pacing mode. Trials of cardiac-resynchronization therapy (CRT) have included patients with advanced systolic heart failure and prolonged QRS duration. 1 These trials have specifically excluded patients with a moderate-to-high degree of atrioventricular block who require ventricular pacing in order to evaluate the effects of CRT independently of the potentially confounding detrimental effects of right ventricular pacing. Whereas right ventricular pacing achieves the primary goal of restoring an adequate heart rate in patients with atrioventricular block, studies suggest that right ventricular apical pacing may lead to progressive left ventricular dysfunction and heart failure in patients with preexisting left ventricular dysfunction, 2 , 3 presumably owing to . . .

In this trial, patients with mild-to-moderate heart failure were randomly assigned to receive an implantable cardioverter–defibrillator (ICD) alone or an ICD plus cardiac-resynchronization therapy. Patients in the latter group had lower rates of death and hospitalization for heart failure. The use of implantable cardioverter–defibrillators (ICDs) improves survival among patients who have New York Heart Association (NYHA) class II or III heart failure with left ventricular systolic dysfunction despite optimal medical therapy. 1 Cardiac-resynchronization therapy (CRT) improves symptoms of heart failure, quality of life, exercise capacity, 2 – 6 and left ventricular function 7 when used in patients with NYHA functional class III or ambulatory class IV heart failure with a wide QRS complex. CRT has also been shown to reduce mortality among patients not receiving an ICD. 8 However, studies have not shown a survival benefit of CRT in patients with NYHA class II . . .

In the Sudden Cardiac Death in Heart Failure Trial, 811 patients were randomly assigned to receive implantable cardioverter–defibrillators (ICDs). Of these patients, 269 (33.2%) received at least one ICD shock over a median follow-up period of 45.5 months. The occurrence of ICD shocks, whether appropriate or inappropriate, was associated with a significant increase in the subsequent risk of death from all causes. The occurrence of ICD shocks, whether appropriate or inappropriate, was associated with a significant increase in the subsequent risk of death from all causes. The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) (ClinicalTrials.gov number, NCT00000609) and the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) both showed that therapy with implantable cardioverter–defibrillators (ICDs) improves survival among patients who are at risk for sudden cardiac death but who have not previously had a sustained ventricular arrhythmia. 1 – 3 On the basis of these data, recent clinical guidelines consider the implantation of an ICD for “primary prevention” (i.e., prevention of a first life-threatening arrhythmic event) to be standard high-quality care for patients who meet the entry criteria for these trials. 4 One result of this broader use . . .

Implantation of a defibrillator early after myocardial infarction (MI) in high-risk patients reduced the risk of sudden cardiac death, but there was a reciprocal increase in the risk of nonsudden cardiac death. Overall mortality was not affected by early defibrillator implantation, and therefore this intervention cannot be recommended after MI in high-risk patients. Early after MI Implantation of a defibrillator early after myocardial infarction (MI) in high-risk patients reduced the risk of sudden cardiac death, but there was a reciprocal increase in the risk of nonsudden cardiac death. Despite the general improvement in outcomes among survivors of acute myocardial infarction the rate of death, including sudden cardiac death, remains highest in the weeks after the event. 1 , 2 Sudden cardiac death due to ventricular tachyarrhythmias accounts for approximately 20 to 50% of all deaths in this population. 3 – 5 Therefore, prevention of sudden cardiac death after myocardial infarction remains an important goal. With the exception of beta-blockers, antiarrhythmic drugs do not reduce this risk. Several randomized trials have shown that an implantable cardioverter–defibrillator (ICD) can reduce mortality both among patients who have had sustained ventricular tachyarrhythmias 6 and among selected patients . . .

Implantable-cardioverter defibrillators (ICD) detect and terminate life-threatening ventricular tachyarrhythmia with electric shocks after they occur. This puts patients at risk if they are driving or in a situation where they can fall. ICD's shocks are also very painful and affect a patient's quality of life. It would be ideal if ICDs can accurately predict the occurrence of ventricular tachyarrhythmia and then issue a warning or provide preventive therapy. Our study explores the use of ICD data to automatically predict ventricular arrhythmia using heart rate variability (HRV). A 5 minute and a 10 second warning system are both developed and compared. The participants for this study consist of 788 patients who were enrolled in the ICD arm of the Sudden Cardiac Death-Heart Failure Trial (SCD-HeFT). Two groups of patient rhythms, regular heart rhythms and pre-ventricular-tachyarrhythmic rhythms, are analyzed and different HRV features are extracted. Machine learning algorithms, including random forests (RF) and support vector machines (SVM), are trained on these features to classify the two groups of rhythms in a subset of the data comprising the training set. These algorithms are then used to classify rhythms in a separate test set. This performance is quantified by the area under the curve (AUC) of the ROC curve. Both RF and SVM methods achieve a mean AUC of 0.81 for 5-minute prediction and mean AUC of 0.87-0.88 for 10-second prediction; an AUC over 0.8 typically warrants further clinical investigation. Our work shows that moderate classification accuracy can be achieved to predict ventricular tachyarrhythmia with machine learning algorithms using HRV features from ICD data. These results provide a realistic view of the practical challenges facing implementation of machine learning algorithms to predict ventricular tachyarrhythmia using HRV data, motivating continued research on improved algorithms and additional features with higher predictive power.

Pocket hematoma is a common and serious complication following cardiac implantable electronic device (CIED) implantation, contributing to significant morbidity and mortality. This study aimed to evaluate the efficacy of a novel pocket compression device in reducing pocket hematoma occurrence. We enrolled 242 patients undergoing CIED implantation, randomly assigning them to receive either the novel compression vest with a pressure cuff or conventional sandbag compression. Pocket hematomas were categorized as grade 1 (mild), grade 2 (moderate), or grade 3 (severe, requiring intervention or prolonged hospitalization). The primary endpoint, incidence of pocket hematoma 24 h post-procedure, did not significantly differ between the two groups (26.7% vs. 19.7%, p  = 0.224). Rates of grade 2 hematoma were similarly low and comparable (2.5% vs. 0.8%, p  = 0.368), with no grade 3 hematomas observed. Skin reactions and patient comfort were similar between groups. The sole predictor for hematoma occurrence was current oral anticoagulation use. In conclusion, our study found a low incidence of clinically significant pocket hematomas. The novel pocket compression device showed comparable efficacy to conventional methods, suggesting it as a viable alternative for reducing post-procedural complications without additional adverse effects. Trial registration number : The study was registered in the Thai Clinical Trials Registry (TCTR) at https://www.thaiclinicaltrials.org/ , with the identification number TCTR20230913005, date of first trial registration 13/09/2023.