Heart Surgery

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January 2025
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FDA issues Class I recall of certain Medtronic ICDs, CRT-Ds

Editor's Note The Food and Drug Administration (FDA), on April 12, identified the recall of Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of an unexpected and rapid…

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By: Judy Mathias
April 19, 2021
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FDA: Class I recall of Medtronic’s Valiant Navion Thoracic Stent Graft System

Editor's Note The Food & Drug Administration (FDA), on April 9, identified the recall of Medtronic’s Valiant Navion Thoracic Stent Graft System as Class I, the most serious. The recall was initiated because of the risk of stent fractures and endoleak concerns. The system is used to repair lesions of…

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By: Judy Mathias
April 12, 2021
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FDA: Class I recall of Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface

Editor's Note The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious. The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device…

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By: Judy Mathias
March 25, 2021
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FDA: Class I recall of Medtronic's HVAD Pump Implant Kits

Editor's Note The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious. The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood…

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By: Judy Mathias
March 3, 2021
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‘COVID effect’ leads to fewer cardiac surgeries, more deaths

Editor's Note The COVID-19 pandemic has resulted in a substantial decline in cardiac surgery volume and an unexplained increase in deaths after coronary artery bypass grafting (CABG), finds this study presented January 30 at the Annual Meeting of the Society of Thoracic Surgeons (STS). Researchers from the University of California,…

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By: Judy Mathias
February 8, 2021
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American Heart Association warns of cardiovascular risks of marijuana use

Editor's Note In a Scientific Statement, the American Heart Association (AHA) says marijuana use has no cardiovascular benefits and that it has been linked to an increased risk of heart attacks, atrial fibrillation, and heart failure. Though a full understanding of how marijuana use affects the heart and blood vessels…

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By: Judy Mathias
August 10, 2020
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ACS opposes proposed Medicare physician fee schedule

Editor's Note The American College of Surgeons (ACS) on August 4 announced that it is strongly opposed to the Centers for Medicare & Medicaid Services (CMS) Physician Fee Schedule proposed rule for CY 2021. In the fee schedule, which is set to take place January 1, 2021, Medicare payments will…

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By: Judy Mathias
August 6, 2020
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US News publishes 2020-2021 top hospitals list

Editor's Note US News & World Report on July 28 released its 2019-2020 Best Hospitals Honor Roll. The top five are: Mayo Clinic, Rochester, Minnesota Cleveland Clinic Johns Hopkins Hospital, Baltimore New York-Presbyterian Hospital-Columbia and Cornell, New York City, and UCLA Medical Center, Los Angeles (tie) Massachusetts General Hospital, Boston…

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By: Judy Mathias
July 29, 2020
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Study: Response of cardiac surgery units to COVID-19

Editor's Note This study found reduced cardiac surgery activity, redeployed personnel, and curtailed educational and research activities in response to the COVID-19 pandemic. Survey respondents from 60 cardiac surgery centers in 19 countries said they had reduced their cardiac surgical procedures by an average of 50% to 75% in response…

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By: Judy Mathias
June 2, 2020
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ACS issues statement on maintaining emergency care system during COVID-19 pandemic

Editor's Note As hospitals face a surge of COVID-19 patients, the ability for them to care for trauma cases and medical and surgical emergencies is severely compromised. Because of this, the American College of Surgeons (ACS) on April 7 issued a statement calling for strategies to preserve capacity and capability…

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By: Judy Mathias
April 9, 2020
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