Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population.

Background: The extravascular (EV) implantable cardioverter-defibrillator (ICD) includes features to address sensing and arrhythmia detection challenges presented by its substernal lead location.

Objectives: In this study, the authors sought to evaluate sensing and detection performance in 299 patients discharged with an EV-ICD in the global pivotal study.

Methods: We reviewed and adjudicated all induced ventricular fibrillation (VF) episodes and spontaneous device-stored episodes that satisfied rate and duration criteria in a programmed ventricular tachycardia (VT)/VF therapy zone.

Development of a robotic cluster for automated and scalable cell therapy manufacturing.

Background Aims: The production of commercial autologous cell therapies such as chimeric antigen receptor T cells requires complex manual manufacturing processes. Skilled labor costs and challenges in manufacturing scale-out have contributed to high prices for these products.

Methods: We present a robotic system that uses industry-standard cell therapy manufacturing equipment to automate the steps involved in cell therapy manufacturing.

Quantifying Cardiothoracic Variation with Posture and Respiration to Inform Cardiac Device Design.

Purpose: With extravascular implantable cardioverter defibrillator leads placed beneath the sternum, it is important to quantify heart motion relative to the rib cage with postural changes and respiration.

Methods: MRI scans from five males and five females were collected in upright and supine postures at end inspiration [n = 10 each]. Left and right decubitus [n = 8 each] and prone [n = 5] MRIs at end inspiration and supine MRIs at end expiration [n = 5] were collected on a subset.

Long-term, real world experience of ventricular tachycardia and granulomatous cardiomyopathy.

Background: Granulomatous cardiomyopathy (GCM) is relatively uncommon in patients presenting with ventricular tachycardia (VT). Sarcoidosis and tuberculosis are the most common causes of GCM with VT. The aim of study was to evaluate their clinical characteristics and the long-term outcomes.

The extravascular implantable cardioverter-defibrillator: characterization of anatomical parameters impacting substernal implantation and defibrillation efficacy.

Aims: The aim of this study is to provide a thorough, quantified assessment of the substernal space as the site of extravascular implantable cardioverter-defibrillator (ICD) lead placement using computed tomography (CT) scans and summarizing adverse events and defibrillation efficacy across anatomical findings. Subcutaneous ICDs are an alternative to transvenous defibrillators but have limitations related to ICD lead distance from the heart. An alternative extravascular system with substernal lead placement has the potential to provide defibrillation at lower energy and pacing therapies from a single device.

Short-term bone formation is greatest within high strain regions of the human distal radius: a prospective pilot study.

Bone adaptation is understood to be driven by mechanical strains acting on the bone as a result of some mechanical stimuli. Although the strain/adaptation relation has been extensively researched using in vivo animal loading models, it has not been studied in humans,likely due to difficulties in quantifying bone strains and adaptation in living humans. Our purpose was to examine the relationship between bone strain and changes in bone mineral parameters at the local level.

Predicting surface strains at the human distal radius during an in vivo loading task--finite element model validation and application.

Bone strains resulting from physical activity are thought to be a primary driver of bone adaptation, but cannot be directly noninvasively measured. Because bone adapts nonuniformly, physical activity may make an important independent structural contribution to bone strength that is independent of bone mass and density. Our objective was to create and validate methods for subject-specific finite element (FE) model generation that would accurately predict the surface strains experienced by the distal radius during an in vivo loading task, and to apply these methods to a group of 23 women aged 23-35 to examine variations in strain, bone mass and density, and physical activity.

In vivo loading model to examine bone adaptation in humans: a pilot study.

Bone is typically well suited for its habitual loading environment because of its ability to adapt. Although characteristics of the mechanical loading environment predict the bone adaptive response in animals, this has not been prospectively validated in humans. Here, we describe an in vivo loading model in which women apply forces to the radius by leaning onto their hand.