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…
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…
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…
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…
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…
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”…
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…
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…
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…
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…