13 results match your criteria: "Vanderbilt Heart Institute[Affiliation]"
J Am Coll Cardiol
November 2024
University Hospital of Bern, Bern, Switzerland.
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).
View Article and Find Full Text PDFHeart Rhythm
November 2024
Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kansas.
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.
JACC Cardiovasc Interv
January 2024
Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kansas, USA.
Background: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial.
Objectives: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry.
Methods: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included.
JACC Cardiovasc Interv
August 2023
Inselspital, University of Bern, Bern, Switzerland.
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.
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.
View Article and Find Full Text PDFJACC Clin Electrophysiol
January 2023
Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kansas, USA.
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.
JACC Cardiovasc Interv
November 2022
Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kansas, USA.
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.
Heart Rhythm O2
October 2022
Inselspital, University of Bern, Bern, Switzerland.
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.
View Article and Find Full Text PDFCirculation
November 2021
Inselspital, University of Bern, Switzerland (S.W.).
Background: Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device.
Methods: Patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device.
J Am Coll Cardiol
July 2016
Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai Cardiovascular Institute, New York, New York; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York.
Background: Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels. HCR is increasingly used to treat multivessel coronary artery disease that includes stenoses in the proximal left anterior descending artery and at least 1 other vessel, but its effectiveness has not been rigorously evaluated.
Objectives: This National Institutes of Health-funded, multicenter, observational study was conducted to explore the characteristics and outcomes of patients undergoing clinically indicated HCR and multivessel PCI for hybrid-eligible coronary artery disease, to inform the design of a confirmatory comparative effectiveness trial.
J R Army Med Corps
June 2014
Cardiac Surgery, Vanderbilt University Medical Center, Vanderbilt Heart Institute, Nashville, Tennessee, USA.
Background: Primary blast lung injury (PBLI) is defined as lung contusion from barotrauma following an explosive mechanism of injury (MOI). Military data have focused on PBLI characteristics following evacuation from the combat theatre; less is known about its immediate management and epidemiology in the deployed setting. We conducted a quality improvement project to describe the prevalence, clinical characteristics, management strategies and evacuation techniques for PBLI patients prior to evacuation.
View Article and Find Full Text PDFJ Extra Corpor Technol
September 2010
Vanderbilt Heart Institute, Vanderbilt University Medical Center, Nashville, Tennessee 37232, USA.
Unlabelled: Concepts of cardiopulmonary support (CPS), extracorporeal membrane oxygenation (ECMO), and ventricular support (VS) have been thoroughly studied and refined. These perfusion adjuncts often require multiple devices, skill sets, and significant financial burden to purchase, maintain, deploy, and use. We describe a novel system that is rapidly deployable, user-friendly, portable, safe, and economical.
View Article and Find Full Text PDFJ Extra Corpor Technol
June 2008
Vanderbilt Heart Institute, Division of Perfusion Services, Vanderbilt University Medical Center, Nashville, Tennessee 37232, USA.
Heparin-induced thrombocytopenia paradoxically is a transient pro-thrombotic disorder triggered by heparin exposure. If not treated appropriately, it can be life threatening because of its related thromboembolic complications. In particular, it presents a unique challenge in patients needing extracorporeal life support, because anticoagulation is essential for safe management.
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