New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation.

Introduction: A current limitation of single chamber implantable cardioverter defibrillators (ICDs) is the lack of an atrial lead to reliably detect atrial fibrillation (AF) episodes. A novel ventricular based atrial fibrillation (VBAF) detection algorithm was created for single chamber ICDs to assess R-R variability for detection of AF.

Methods: Patients implanted with Visia AF™ ICDs were prospectively enrolled in the Medtronic Product Surveillance Registry from December 15, 2015 to January 23, 2019 and followed with at least 30 days of monitoring with the algorithm.

Risk factors for hematoma in patients undergoing cardiac device procedures: A WRAP-IT trial analysis.

Background: Implant site hematoma is a known complication of cardiac device procedures and can lead to major consequences.

Objectives: To evaluate risk factors for hematoma and further understand the relationship between anticoagulant (AC), antiplatelet (AP) use, and hematoma development.

Methods: We included 6800 patients from the WRAP-IT trial.

Performance evaluation of implantable cardioverter-defibrillators with SmartShock technology in patients with inherited arrhythmogenic diseases.

Background: Patients with inherited arrhythmogenic diseases (IADs) are often prescribed preventative implantable cardioverter-defibrillators (ICDs) to manage their increased sudden cardiac arrest risk. However, it has been suggested that ICDs in IAD patients may come with additional risk. We aimed to leverage the PainFree SmartShock Technology dataset to compare inappropriate therapies, appropriate therapies, mortality, and complications in patients with and without IAD.

Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics.

Background: Implantable cardioverter-defibrillator (ICD) lead monitoring diagnostic alerts facilitate the diagnosis of structural lead failure.

Objective: The purpose of this study was to prospectively study the performance of Medtronic ICD lead monitoring alerts.

Methods: A prespecified ancillary substudy, World-Wide Randomized Antibiotic Envelope Infection Prevention Trial, was conducted in patients with an ICD with all available alerts enabled.

Trends in implantable cardioverter-defibrillator programming practices and its impact on therapies: Insights from a North American Remote Monitoring Registry 2007-2018.

Background: Recent evidence has revealed the utility of prolonged arrhythmia detection duration and increased rate cutoff to reduce implantable cardioverter-defibrillator (ICD) therapies. Data on real-world trends in ICD programming and its impact on outcomes are limited.

Objective: The purpose of this study was to evaluate trends in ICD programming and its impact on ICD therapy using a large remote monitoring database.

Risk Factors for CIED Infection After Secondary Procedures: Insights From the WRAP-IT Trial.

Objectives: This study aimed to identify risk factors for infection after secondary cardiac implantable electronic device (CIED) procedures.

Background: Risk factors for CIED infection are not well defined and techniques to minimize infection lack supportive evidence. WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention trial), a large study that assessed the safety and efficacy of an antibacterial envelope for CIED infection reduction, offers insight into procedural details and infection prevention strategies.

Infectious consequences of hematoma from cardiac implantable electronic device procedures and the role of the antibiotic envelope: A WRAP-IT trial analysis.

Background: Hematoma is a complication of cardiac implantable electronic device (CIED) procedures and may lead to device infection. The TYRX antibacterial envelope reduced major CIED infection by 40% in the randomized WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention Trial) study, but its effectiveness in the presence of hematoma is not well understood.

Objective: The purpose of this study was to evaluate the incidence and infectious consequences of hematoma and the association between envelope use, hematomas, and major CIED infection among WRAP-IT patients.

In vitro modeling accurately predicts cardiac lead fracture at 10 years.

Background: Development of a cardiac lead fracture model has the potential to differentiate well-performing lead designs from poor performing ones and could aid in future lead development.

Objective: The purpose of this study was to demonstrate a predictive model for lead fracture and validate the results generated by the model by comparing them to observed 10-year implantable cardioverter-defibrillator lead fracture-free survival.

Methods: The model presented here uses a combination of in vivo patient data, in vitro conductor fatigue test data, and statistical simulation to predict the fracture-free survival of cardiac leads.

Low-temperature electrocautery reduces adverse effects from secondary cardiac implantable electronic device procedures: Insights from the WRAP-IT trial.

Background: Cardiac device procedures require tissue dissection to free existing device lead(s). Common techniques include blunt dissection, standard electrocautery, and low-temperature electrocautery (PlasmaBlade, Medtronic); however, data on the type of electrosurgical tool used and the development of procedure- or lead-related adverse events are limited.

Objective: The purpose of this study was to determine whether standard or low-temperature electrocautery impacts the development of an adverse event.

Use of healthcare claims to validate the Prevention of Arrhythmia Device Infection Trial cardiac implantable electronic device infection risk score.

Aim: The Prevention of Arrhythmia Device Infection Trial (PADIT) infection risk score, developed based on a large prospectively collected data set, identified five independent predictors of cardiac implantable electronic device (CIED) infection. We performed an independent validation of the risk score in a data set extracted from U.S.

Clinical Presentation, Timing, and Microbiology of CIED Infections: An Analysis of the WRAP-IT Trial.

Objectives: This study characterized the microbiology of major cardiac implantable electronic device (CIED) infections that occurred during the WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) study.

Background: The WRAP-IT study offers a unique opportunity for further understanding of the pathogens involved in major CIED infections in a prospective dataset, with implications for clinical practice and infection management.

Methods: A total of 6,800 patients randomized 1:1 to receive an antibacterial envelope or not (control subjects) were included in this analysis.

Correction: Chronic Alcohol Ingestion Increases Mortality and Organ Injury in a Murine Model of Septic Peritonitis.

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Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.

Background: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system.

Characteristics of ventricular tachyarrhythmias and their susceptibility to antitachycardia pacing termination in patients with ischemic and nonischemic cardiomyopathy: A patient-level meta-analysis of three large clinical trials.

Background: Implantable cardioverter defibrillators (ICDs) reduce all-cause mortality among cardiomyopathy patients. Whether or not antitachycardia pacing (ATP) is equally effective in ischemic (ICM) and nonischemic (NICM) cardiomyopathy patients remains poorly understood. We describe the distribution of monomorphic (MVT) and non-monomorphic (polymorphic ventricular tachycardia/ventricular fibrillation [PVT/VF]) ventricular tachyarrhythmias among ICM and NICM primary prevention patients.

Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial.

Background: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system.

Methods: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs.

SVT discrimination algorithms significantly reduce the rate of inappropriate therapy in the setting of modern-day delayed high-rate detection programming.

Background: Contemporary implantable cardioverter-defibrillator (ICD) programming involving delayed high-rate detection and use of supraventricular tachycardia (SVT) discriminators has significantly reduced the rate of inappropriate shocks. The extent to which SVT algorithms alone reduce inappropriate therapies is poorly understood.

Methods And Results: PainFree SST enrolled 2770 patients with a single- or dual-chamber ICD or cardiac resynchronization defibrillator.

Utilization of implantable cardioverter-defibrillators for the prevention of sudden cardiac death in emerging countries: Improve SCA clinical trial.

Background: Implantable cardioverter-defibrillators (ICDs) are underutilized in Asia, Latin America, Eastern Europe, the Middle East, and Africa. The Improve SCA Study is the largest prospective study to evaluate the benefit of ICD therapy in underrepresented geographies. This analysis reports the primary objective of the study.

Antibacterial Envelope to Prevent Cardiac Implantable Device Infection.

Background: Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections.

Methods: We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations.

Therapy From a Novel Substernal Lead: The ASD2 Study.

Objectives: The ASD2 (Acute Extravascular Defibrillation, Pacing, and Electrogram) study evaluated the ability to adequately sense, pace, and defibrillate patients with a novel implantable cardioverter-defibrillator (ICD) lead implanted in the substernal space.

Background: Subcutaneous ICDs are an alternative to a transvenous defibrillator system when transvenous implantation is not possible or desired. An alternative extravascular system placing a lead under the sternum has the potential to reduce defibrillation energy and the ability to deliver pacing therapies.

Estimating the incidence of atrial fibrillation in single-chamber implantable cardioverter defibrillator patients.

Background: Atrial arrhythmias are associated with major adverse cardiovascular events. Recent reports among implantable cardioverter defibrillator (ICD) patients have demonstrated a high prevalence of atrial fibrillation (AF), predominantly in dual-chamber recipients. AF incidence among patients with single-chamber systems (approximately 50% of all ICDs) is currently unknown.

Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement: Results of the Citadel and Centurion Studies.

Objectives: This study sought to determine whether the nonabsorbable TYRX Antibacterial Envelope (TYRX) reduces major cardiovascular implantable electronic device (CIED) infections 12 months after implant.

Background: TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time. There are limited data on its ability to reduce CIED infections.

Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT).

Background: Cardiac implantable electronic device (CIED) infection is a major complication that is associated with significant morbidity and mortality. The aim of this study is to determine whether Medtronic TYRX absorbable envelope reduces the risk of CIED infection through 12 months of follow-up post procedure.

Methods: WRAP-IT is a randomized, prospective, multi center, international, single-blinded study.

Metabolomic analysis of survival in carbohydrate pre-fed pigs subjected to shock and polytrauma.

Hemorrhagic shock, a result of extensive blood loss, is a dominant factor in battlefield morbidity and mortality. Early rodent studies in hemorrhagic shock reported carbohydrate feeding prior to the induction of hemorrhagic shock decreased mortality. When repeated in our laboratory with a porcine model, carbohydrate pre-feed resulted in a 60% increase in death rate following hemorrhagic shock with trauma when compared to fasted animals (15/32 or 47% vs.