Preclinical evaluation of a third-generation absorbable antibacterial envelope.

Background: The TYRX (Medtronic) absorbable antibacterial envelope has been shown to stabilize implantable cardiac devices and reduce infection. A third-generation envelope was developed to reduce surface roughness with a redesigned multifilament mesh and enhanced form factor but identical polymer coating and antibiotic concentrations as the currently available second-generation envelope.

Objective: The purpose of this study was to compare drug elution, bacterial challenge efficacy, stabilization, and absorption of second- vs third-generation envelopes.

Ambulatory atrioventricular synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study.

Background: Previous studies demonstrated that accelerometer-based, mechanically timed atrioventricular synchrony (AVS) is feasible using a leadless ventricular pacemaker.

Objective: The purpose of this study was to determine the performance of a leadless ventricular pacemaker with accelerometer-based algorithms that provide AVS pacing.

Methods: AccelAV was a prospective, single-arm study to characterize AVS in patients implanted with a Micra AV, which uses the device accelerometer to mechanically detect atrial contractions and promote VDD pacing.

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.

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.

Ventricular tachycardia induced by a backup pacing stimulus in a patient with a dual chamber pacemaker with AutoCapture.

Manufacturers of cardiac implantable electronic devices have incorporated automatic features to allow for remote monitoring, improve device longevity, and additional safety. Algorithms to automatically measure capture threshold and adjust output to preserve battery life are one such feature. Automatic features may occasionally result in unexpected or undesirable clinical outcomes.

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.

Atrial fibrillation post central retinal artery occlusion: Role of implantable loop recorders.

Objective: This study evaluated the risk of subclinical atrial fibrillation (AF) in patients with central retinal artery occlusion (CRAO) compared to those with cryptogenic stroke using implantable loop recorders (ILR).

Methods: We conducted a retrospective analysis of 273 consecutive patients who had ILRs inserted at our institution for either cryptogenic stroke (n = 227) or CRAO (n = 46). Our primary endpoint was a time to event analysis for the new diagnosis of AF by ILR.

Cardiovascular implantable electronic device infections due to enterococcal species: Clinical features, management, and outcomes.

Background: Enterococcal cardiovascular implantable electronic device (CIED) infections are not well characterized.

Methods: Data from the Multicenter Electrophysiologic Device Infection Cohort, a prospective study of CIED infections, were used for descriptive analysis of adults with enterococcal CIED infections.

Results: Of 433 patients, 21 (4.

Impact of Abandoned Leads on Cardiovascular Implantable Electronic Device Infections: A Propensity Matched Analysis of MEDIC (Multicenter Electrophysiologic Device Infection Cohort).

Objectives: This study sought to evaluate the impact of abandoned cardiovascular implantable electronic device (CIED) leads on the presentation and management of device-related infections.

Background: Device infection is a serious consequence of CIEDs and necessitates removal of all hardware for attempted cure. The merits of extracting or retaining presumed sterile but nonfunctioning leads is a subject of ongoing debate.

Clinical presentation of CIED infection following initial implant versus reoperation for generator change or lead addition.

Objective: To explore differences in clinical manifestations and outcomes in those patients who develop infection after undergoing initial implantation versus reoperation.

Methods: We compared cases of cardiac implantable electronic device (CIED) infection based on initial implantation versus reoperation from 11 centres.

Results: There were 432 patients with CIED infection, 178 occurring after initial device placement and 254 after repeat reoperation.

Attempted salvage of infected cardiovascular implantable electronic devices: Are there clinical factors that predict success?

Background: Published guidelines mandate complete device removal in cases of cardiovascular implantable electronic device (CIED) infection. Clinical predictors of successful salvage of infected CIEDs have not been defined.

Methods: Data from the Multicenter Electrophysiologic Device Infection Collaboration, a prospective, observational, multinational cohort study of CIED infection, were used to investigate whether clinical predictors of successful salvage of infected devices could be identified.

Treatment patterns, costs, and mortality among Medicare beneficiaries with CIED infection.

Background: Cardiac implantable electronic device (CIED) infection is a serious adverse event, but there are limited contemporary real-world data on treatment pathways and associated costs in the Medicare population following diagnosis of CIED infection. Hence, this study evaluates postinfection treatment pathways and associated healthcare expenditures and mortality among Medicare fee-for-service beneficiaries with CIED infection.

Methods: Retrospective cohort analysis of 5,401 beneficiaries who developed a device-related infection in the year following implantation/upgraded CIED (1/1/2010-12/31/2012).

Effect of battery longevity on costs and health outcomes associated with cardiac implantable electronic devices: a Markov model-based Monte Carlo simulation.

Introduction: The effects of device and patient characteristics on health and economic outcomes in patients with cardiac implantable electronic devices (CIEDs) are unclear. Modeling can estimate costs and outcomes for patients with CIEDs under a variety of scenarios, varying battery longevity, comorbidities, and care settings. The objective of this analysis was to compare changes in patient outcomes and payer costs attributable to increases in battery life of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D).

Reimplantation and Repeat Infection After Cardiac-Implantable Electronic Device Infections: Experience From the MEDIC (Multicenter Electrophysiologic Device Infection Cohort) Database.

Background: Infection is a serious complication of cardiovascular-implantable electronic device implantation and necessitates removal of all hardware for optimal treatment. Strategies for reimplanting hardware after infection vary widely and have not previously been analyzed using a large, multicenter study.

Methods And Results: The MEDIC (Multicenter Electrophysiologic Device Infection Cohort) prospectively enrolled subjects with cardiovascular-implantable electronic device infections at multiple institutions in the United States and abroad between 2009 and 2012.

Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection: Evidence From a Large US Payer Database 1-Year Post Implantation.

Background: Because of the increasing use of cardiac implantable electronic devices (CIEDs), it is important to estimate the incidence and annual healthcare expenditures associated with CIED infections.

Methods And Results: Patients with a record of an initial or replacement (full implant or generator only) CIED implant during the calendar years 2009 to 2012 in MarketScan Commercial Claims and Medicare Supplemental database were identified. CIED infections were classified into 4 categories: (1) infection not managed by inpatient admission nor implant removal, (2) infection managed by inpatient admission but no implant removal, (3) infection managed by an implant removal either in an inpatient or in an outpatient setting, and (4) infection with severe sepsis and managed in an inpatient setting with implant removal.

Ampere Hour as a Predictor of Cardiac Resynchronization Defibrillator Pulse Generator Battery Longevity: A Multicenter Study.

Background: Cardiac resynchronization defibrillator (CRT-D) devices improve survival for New York Heart Association classes II-IV systolic heart failure patients with QRS > 120 ms and left ventricular ejection fraction < 35%. A limitation of 100% CRT pacing is excess battery depletion and pulse generator (PG) replacement compared to VVI or dual-chamber systems. Ampere hour (Ah) measures PG battery capacity and may predict CRT-D device longevity.

Outcomes of patients with definite and suspected isolated cardiac sarcoidosis treated with an implantable cardiac defibrillator.

Purpose: Cardiac sarcoidosis (CS) patients are at increased risk for sudden death. Isolated CS is rare and can be difficult to diagnose.

Methods: In this multicenter retrospective review, patients with CS and an implantable cardiac defibrillator (ICD) were identified.