Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support.

Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented.

Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has shown favorable outcomes in large registries with broad inclusion criteria. The cohorts reported had less heart disease and fewer comorbidities than standard ICD populations.

Objective: The purpose of this study is to characterize acute performance for primary prevention patients with a left ventricular ejection fraction (LVEF) ≤35% (primary prevention ≤35%).

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.

Defibrillation testing and clinical outcomes after implantable cardioverter-defibrillator implantation in patients in atrial fibrillation at the time of implant: An analysis from the SIMPLE trial.

Background: The Shockless IMPLant Evaluation (SIMPLE) trial showed that defibrillation testing (DT) at the time of implantable cardioverter-defibrillator (ICD) implant did not improve shock efficacy or reduce mortality. There are no data regarding the risk of complications, including stroke, among patients with atrial fibrillation (AF) who undergo DT.

Objective: The purpose of this prospectively planned substudy of SIMPLE was to evaluate the effect of DT vs no DT on clinical outcomes among patients with AF.

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.

Apical versus Non-Apical Lead: Is ICD Lead Position Important for Successful Defibrillation?

Introduction: We aim to compare the acute and long-term success of defibrillation between non-apical and apical ICD lead position.

Methods And Results: The position of the ventricular lead was recorded by the implanting physician for 2,475 of 2,500 subjects in the Shockless IMPLant Evaluation (SIMPLE) trial, and subjects were grouped accordingly as non-apical or apical. The success of intra-operative defibrillation testing and of subsequent clinical shocks were compared.

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 rationale and design of the Shockless IMPLant Evaluation (SIMPLE) trial: a randomized, controlled trial of defibrillation testing at the time of defibrillator implantation.

Defibrillation testing (DT) has been an integral part of defibrillator (implantable cardioverter defibrillator [ICD]) implantation; however, there is little evidence that it improves outcomes. Surveys show a trend toward ICD implantation without DT, which now exceeds 30% to 60% in some regions. Because there is no evidence to support dramatic shift in practice, a randomized trial is urgently needed.

Frequency of atrial tachyarrhythmias in patients treated by cardiac resynchronization (from the Prospective, Multicenter Mona Lisa Study).

The continuous measurement of sustained atrial tachyarrhythmia (AT) is now possible with some permanently implanted devices. Data on this subject remain controversial. The aim of this study was to evaluate the incidence of sustained AT in patients treated with cardiac resynchronization therapy using pacemakers without backup defibrillators (CRT-P), within the first year after implantation, using strict definition criteria for sustained AT and a systematic review of all high-quality electrographically recorded episodes.