Heart Surgery

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FDA: Class I recall of Edwards Lifesciences SAPIEN 3 Ultra Delivery System

Editor's Note The Food and Drug Administration on August 22 identified the recall by Edwards Lifesciences of all lots of its SAPIEN 3 Ultra Delivery System as Class I, the most serious. The delivery system is part of the Edwards SAPIEN 3 Transcatheter Heart Valve System. The recall was initiated…

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By: Judy Mathias
August 22, 2019
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FDA: Class I recall of Ellipse Implantable Cardioverter Defibrillators

Editor's Note The Food & Drug Administration on August 5 identified the recall by Abbott (formerly St Jude Medical Inc) of its Ellipse Implantable Cardioverter Defibrillators as Class I, the most serious. The recall was initiated because electrical failures have been identified that are due to a faulty manufacturing process…

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By: Judy Mathias
August 5, 2019
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US News publishes 2019-2020 top hospitals list

Editor's Note The US News & World Report on July 30 released its 2019-2020 Best Hospitals Honor Roll. The top five are: Mayo Clinic, Rochester, Minn Massachusetts General Hospital, Boston Johns Hopkins Hospital, Baltimore Cleveland Clinic New York-Presbyterian Hospital/Columbia and Cornell, New York City. In the specialty rankings: University of…

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By: Judy Mathias
July 30, 2019
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Study debunks ‘July Effect’ in cardiac surgery

Editor's Note The “July Effect”−the idea that more errors occur in July because of the influx of new interns and residents starting their in-hospital training−does not apply to cardiac surgery, this study finds. For more than 470,000 cardiac procedures analyzed (coronary bypass, aortic valve, mitral valve, thoracic aortic aneurysm), in-hospital…

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By: Judy Mathias
July 25, 2019
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FDA: Class I recall of Getinge’s Maquet/Datascope intra-aortic balloon pumps

Editor's Note The Food & Drug Administration on July 23 identified the recall by Getinge of its Maquet/Datascope intra-aortic balloon pumps (IABPs) as Class I, the most serious. Recall of the Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS 100/100i IABPs was initiated because of reports of the IABP batteries failing…

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By: Judy Mathias
July 24, 2019
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Effect of incentive spirometer patient reminder after CABG

Editor's Note An incentive spirometer reminder after coronary artery bypass grafting (CABG) improved patient adherence and, in turn, improved the atelectasis severity score and multiple subsequent clinical outcomes, this study finds. In this study of 212 patients who had CABG surgery, 145 were randomized by hourly reminder SpiroTimer “bell on”…

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By: Judy Mathias
July 18, 2019
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FDA: Class I recall of Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Device

Editor's Note The Food and Drug Administration on July 1 identified the recall by Edwards Lifesciences (Irvine, California) of its IntraClude Intra-Aortic Occlusion Device as Class I, the most serious. The recall was initiated because of a risk of balloon rupture during use in patients undergoing cardiopulmonary bypass. The company…

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By: Judy Mathias
July 9, 2019
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Study: EHR data limited in capture of patient outcomes, risk factors needed for risk adjustment

Editor's Note Retooling paper-based measures to electronic format for reporting performance measures can help reduce hospitals’ reporting burden. However, in this study by Joint Commission and State University of New York researchers, a simplified risk model using electronic health record (EHR) elements could not capture most risk factors in the…

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By: Judy Mathias
June 26, 2019
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CMS finalizes coverage policy for TAVR

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on June 21 issued final updates to its national coverage policy for Transcatheter Aortic Valve Replacement (TAVR). The update provides more flexibility in how centers meet volume requirements for performing TAVR, while emphasizing the importance of the heart team for…

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By: Judy Mathias
June 26, 2019
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Association of TAVR for bicuspid vs tricuspid aortic stenosis with mortality, stroke

Editor's Note In this study, patients who had transcatheter aortic valve replacement (TAVR) for bicuspid compared with tricuspid aortic stenosis had no significant difference in mortality, but they had a 30-day increased risk of stroke. In this cohort of 2,691 matched pairs of patients having TAVR for bicuspid vs tricuspid…

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By: Judy Mathias
June 12, 2019
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