Rate, Time Course, and Predictors of Implantable Cardioverter Defibrillator Infections: An Analysis From the SIMPLE Trial.

Background: The number of implantable cardioverter defibrillator (ICD) infections is increasing due to an increased number of ICD implants, higher-risk patients, and more frequent replacement procedures, which carry a higher risk of infection. Reducing the morbidity, mortality, and cost of ICD-related infections requires an understanding of the current rate of this complication and its predictors.

Methods: The hock ant valuation Trial (SIMPLE) trial randomized 2500 ICD recipients to defibrillation testing or not.

[Interruption of cardiac resynchronization therapy after a ventricular premature beat : What is the mechanism?].

The present case report illustrates a mechanism that can interrupt cardiac resynchronization therapy (CRT) and lead to recurrence of dyspnea during exercise. It points out that CRT requires a regular cardiac history, analysis of device-stored data and profound knowledge about function and especially timing intervals of these systems in order to utilize the full potential of this therapy.

Effectiveness of a percutaneous left ventricular assist device in preventing acute hemodynamic decompensation during catheter ablation of ventricular tachycardia in advanced heart failure patients: A retrospective single-center analysis.

Introduction: Acute hemodynamic decompensation during catheter ablation of ventricular tachycardia is associated with increased mortality. We assessed the effectiveness of mechanical circulatory support using a micro-axial percutaneous assist device in preventing acute hemodynamic decompensation.

Methods And Results: Twenty-six consecutive patients with structural heart disease undergoing 28 ventricular tachycardia ablations between May 2013 and October 2017 were included.

Effectiveness of single- vs dual-coil implantable defibrillator leads: An observational analysis from the SIMPLE study.

Introduction: Dual-coil leads (DC-leads) were the standard of choice since the first nonthoracotomy implantable cardioverter/defibrillator (ICD). We used contemporary data to determine if DC-leads offer any advantage over single-coil leads (SC-leads), in terms of defibrillation efficacy, safety, clinical outcome, and complication rates.

Methods And Results: In the Shockless IMPLant Evaluation study, 2500 patients received a first implanted ICD and were randomized to implantation with or without defibrillation testing.

Sedation strategies for defibrillation threshold testing: safety outcomes with anaesthesiologist compared to proceduralist-directed sedation: an analysis from the SIMPLE study.

Aims: No standard practice exists with respect to anaesthesiologist-directed sedation (ADS) vs. sedation by proceduralist (PDS) for defibrillation threshold (DT) testing. We aimed to evaluate adverse events and safety outcomes with ADS vs.

Implantable cardioverter-defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy.

Background: Patients with hypertrophic cardiomyopathy (HCM) are considered to be at high risk for elevated defibrillation thresholds, periprocedural complications, and failed appropriate shocks.

Objective: The purpose of this study was to determine the value of defibrillation testing (DT) in HCM patients undergoing implantable cardioverter-defibrillator (ICD) insertion.

Methods: Defibrillation thresholds, perioperative complications, and long-term outcomes were compared between patients with HCM and those with ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) enrolled in the SIMPLE (Shockless IMPLant Evaluation) trial (Clinialtrials.

Wound haematoma following defibrillator implantation: incidence and predictors in the Shockless Implant Evaluation (SIMPLE) trial.

Aims: Pocket haematoma is a common complication after defibrillator [implantable cardioverter defibrillator (ICD)] implantation, which is not only painful, but also increases the risk of device-related infection, and possibly embolic events. The present study seeks to evaluate the rate and predictors of clinically significant pocket haematoma.

Methods And Results: This study included 2500 patients receiving an ICD in the SIMPLE trial.

Device malfunction caused by "auto-oversensing" of transthoracic impedance measurement test pulses in a modern minute ventilation dual-chamber pacemaker.

Oversensing of physiologic and non-physiologic electrical signals is a relevant cause of malfunctions in subjects with CIED. Physicians taking care of CIED patients must be aware of the potential causes of oversensing and their pattern in EGMs. The present case describes an uncommon source and unique underlying root cause for oversensing in a modern dual-chamber MV rate-adaptive pacemaker.

Troponin levels after ICD implantation with and without defibrillation testing and their predictive value for outcomes: Insights from the SIMPLE trial.

Background: The Shockless IMPLant Evaluation trial randomized 2500 patients receiving a first implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy-defibrillator device to have either defibrillation testing (DT) or no DT. It demonstrated that DT did not improve shock efficacy or reduce mortality.

Objective: This prospective substudy evaluated the effect of DT on postoperative troponin levels and their predictive value for total and arrhythmic mortality.

Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE).

Background: Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing.

Methods: In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide.

The mismatch between patient life expectancy and the service life of implantable devices in current cardioverter-defibrillator therapy: a call for larger device batteries.

In 2005, Bob Hauser published a paper in the Journal of the American College of Cardiology entitled "The growing mismatch between patient longevity and the service life of Implantable Cardioverter-Defibrillators". Now, nearly a decade later, I would like to perform a second look on the problem of a mismatching between ICD device service life and the survival of ICD recipients. Since 2005, the demographics of the ICD population has changed significantly.

Emergent surgical pulmonary embolectomy in a pregnant woman: case report and literature review.

Acute pulmonary embolism is a leading cause of death during pregnancy and delivery in the United States. We describe the case of a 25-year-old woman who presented in cardiogenic shock in week 38 of her first pregnancy. After the emergent cesarean delivery of a healthy male neonate, the mother underwent immediate surgical pulmonary embolectomy.

The deactivation of implantable cardioverter-defibrillators: medical, ethical, practical, and legal considerations.

Background: Implantable cardioverter-defibrillators (ICDs) cannot prevent death from progressive heart failure or non-cardiac disease. Patients with ICDs may receive defibrillation therapy from their devices in the last days of their lives, when such therapy does not accord with the goal of palliative treatment, but rather lowers these patients' quality of life and compromises their dignity.

Methods: We present a case report and a selective review of pertinent literature retrieved by a PubMed search, including two up-to-date consensus documents.