5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial.

Background: The Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiveness of the Amulet occluder (Abbott) in patients with nonvalvular atrial fibrillation. The Amulet IDE trial is the largest randomized LAAO trial, comparing the Amulet occluder with the Watchman 2.5 device (Boston Scientific).

Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study.

Background: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device.

Objective: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study.

Methods: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated.

DNA methylation signatures of early-life adversity are exposure-dependent in wild baboons.

The early-life environment can profoundly shape the trajectory of an animal's life, even years or decades later. One mechanism proposed to contribute to these early-life effects is DNA methylation. However, the frequency and functional importance of DNA methylation in shaping early-life effects on adult outcomes is poorly understood, especially in natural populations.

3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE).

Background: The Amulet (Abbott) left atrial appendage occluder investigational device exemption trial is the largest randomized trial evaluating the safety and effectiveness of the Amulet left atrial appendage occluder compared with the Watchman 2.5 device (Boston Scientific) through 5 years.

Objectives: This analysis evaluated the device effect on 3-year outcomes in the Amulet investigational device exemption trial.

Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.

Aims: Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs.

DNA methylation signatures of early life adversity are exposure-dependent in wild baboons.

The early life environment can profoundly shape the trajectory of an animal's life, even years or decades later. One mechanism proposed to contribute to these early life effects is DNA methylation. However, the frequency and functional importance of DNA methylation in shaping early life effects on adult outcomes is poorly understood, especially in natural populations.

Incidence, Predictors, and Clinical Outcomes of Device-Related Thrombus in the Amulet IDE Trial.

Background: Device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) can lead to adverse clinical outcomes. DRT rates and outcomes from randomized trials are limited.

Objectives: This analysis investigated the incidence, predictors, and clinical outcomes of DRT following LAAO in the Amulet IDE (AMPLATZER Amulet LAA Occluder Trial) trial.

Sex Differences in Safety and Effectiveness of LAAO: Insights From the Amulet IDE Trial.

Background: Women have higher rates of acute complications after left atrial appendage occlusion (LAAO). However, data on long-term safety and effectiveness are limited.

Objectives: The aim of this study was to examine sex-specific short- and long-term outcomes after LAAO in the Amulet IDE (Amplatzer™ Amulet™ LAA Occluder) trial.

Peridevice Leak After Transcatheter Left Atrial Appendage Occlusion: An Analysis of the Amulet IDE Trial.

Background: Peridevice leak (PDL) is a limitation of left atrial appendage occlusion.

Objectives: The aim of this study was to assess the incidence of and outcomes associated with PDL in the Amulet IDE (AMPLATZER™ Amulet™ LAA Occluder Trial) randomized controlled trial.

Methods: Patients with atrial fibrillation at increased stroke risk were randomly assigned to undergo either Amulet (dual occlusive mechanism) or Watchman 2.

Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion.

Background: Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF.

Selection against admixture and gene regulatory divergence in a long-term primate field study.

Genetic admixture is central to primate evolution. We combined 50 years of field observations of immigration and group demography with genomic data from ~9 generations of hybrid baboons to investigate the consequences of admixture in the wild. Despite no obvious fitness costs to hybrids, we found signatures of selection against admixture similar to those described for archaic hominins.

Distinct gene regulatory signatures of dominance rank and social bond strength in wild baboons.

The social environment is a major determinant of morbidity, mortality and Darwinian fitness in social animals. Recent studies have begun to uncover the molecular processes associated with these relationships, but the degree to which they vary across different dimensions of the social environment remains unclear. Here, we draw on a long-term field study of wild baboons to compare the signatures of affiliative and competitive aspects of the social environment in white blood cell gene regulation, under both immune-stimulated and non-stimulated conditions.

Sparrows and supergenes: Ecological epigenetics in action.

Despite the promise of ecological epigenetics, there remain few cases that clearly link epigenetic variation in wild animal populations to evolutionary change. In this issue of Molecular Ecology, Sun et al. provide such an example in white-throated sparrows-a fascinating system in which a large chromosomal rearrangement generates a "supergene" polymorphism linked to plumage colour, aggression and parenting behaviour.

High social status males experience accelerated epigenetic aging in wild baboons.

Aging, for virtually all life, is inescapable. However, within populations, biological aging rates vary. Understanding sources of variation in this process is central to understanding the biodemography of natural populations.

Behavioral mimicry predicts social favor in adolescent rhesus macaques (Macaca mulatta).

Non-conscious mimicry is a highly conserved component of animal behavior with multifaceted connections to sociality across taxa. One intriguing consequence of this mimicry in primates is that it promotes positive social feedback from the recipient toward the mimicker. This suggests that mimicry in primates may be an important aspect of positive social interaction, but few studies have tracked the consequences of mimicry in naturally occurring complex social conditions.

Broadening primate genomics: new insights into the ecology and evolution of primate gene regulation.

Comparative analyses have played a key role in understanding how gene regulatory evolution contributes to primate phenotypic diversity. Recently, these studies have expanded to include a wider range of species, within-population as well as interspecific analyses, and research on wild as well as captive individuals. This expansion provides context for understanding genetic and environmental effects on gene regulation in humans, including the importance of the pathogen and social environments.

Development of an automated micropipette coating method for drug-coated balloons.

Drug-coated balloons (DCBs) are a recent technology developed to treat peripheral artery disease (PAD). Along with a suitable formulation of antiproliferative drug and excipient, coating method is an important aspect of a DCB as these factors affect coating characteristics and drug delivery to the treatment site. The multiple release tailored medical devices DCB (MR-TMD-DCB), designed to achieve multiple inflations to treat complex PAD, contains paclitaxel (PAT) as the antiproliferative drug and polyethylene oxide (PEO) as the excipient.

Development of drug-coated balloon for the treatment of multiple peripheral artery segments.

Objective: Peripheral artery disease is the second most common cardiovascular disease. It can often occur in complex form when there is a presence of long, diffuse, and multiple lesions. Current treatments use either single long drug-coated balloons (DCBs) or multiple DCBs; however, treatment success is limited.

Determining the cross-talk between smooth muscle cells and macrophages on a cobalt-chromium stent material surface using an in vitro postimplantation coculture model.

Smooth muscle cells (SMCs) and macrophages are important cellular components involved in the development of complications following the implantation of cardiovascular devices. This leads to various disorders such as restenosis, chronic inflammation, and may ultimately result in device failure. In this study, we developed a postimplant stent coculture model using different ratios of SMCs and macrophages seeded on to cobalt-chromium alloy.

In vitro particulate and in vivo drug retention study of a novel polyethylene oxide formulation for drug-coated balloons.

Objective: The purpose of this study was to investigate the newly developed drug-coated balloon (DCB) using polyethylene oxide (PEO) as a platform and to compare it directly with a commercially available DCB in a preclinical experimental setting.

Methods: The PEO balloon was characterized for coating morphology and degree of paclitaxel (PAT) crystallinity. PAT tissue levels were then measured up to 30 days in a healthy porcine model (10 swine, 20 vessels) after treatment with either a PEO balloon or a commercially available DCB.

Polytetrafluoroethylene topographies determine the adhesion, activation, and foreign body giant cell formation of macrophages.

Polytetrafluoroethylene (PTFE) is one of the commonly used materials in making various cardiovascular implants. However, the success rates of these implants in several occasions are hindered by unwanted immune responses from immune cells, such as macrophages. In this study, we investigated the response of macrophages with different structures (flat, expanded, and electrospun) of PTFE having varied surface topographies: smooth planar surface (flat PTFE), node-fibrils (ePTFE), and randomly oriented microfibers (electrospun PTFE).

Macrophage responses to 316L stainless steel and cobalt chromium alloys with different surface topographies.

The surface topography of a biomaterial plays a vital role in determining macrophage interactions and influencing immune response. In this study, we investigated the effect of smooth and microrough topographies of commonly used metallic biomaterials such as 316 L stainless steel (SS) and cobalt-chromium (CoCr) alloys on macrophage interactions. The macrophage adhesion was greater on CoCr compared to SS, irrespective of their topographies.

Responses of endothelial cells, smooth muscle cells, and platelets dependent on the surface topography of polytetrafluoroethylene.

In this study, the effect of different structures (flat, expanded, and electrospun) of polytetrafluoroethylene (PTFE) on the interactions of endothelial cells (ECs), smooth muscle cells (SMCs), and platelets was investigated. In addition, the mechanisms that govern the interactions between ECs, SMCs, and platelets with different structures of PTFE were discussed. The surface characterizations showed that the different structures of PTFE have the same surface chemistry, similar surface wettability and zeta potential, but uniquely different surface topography.