Surgery/Specialties

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FDA issues alert on premature battery depletion in certain Medtronic pacemakers

Editor's Note The Food & Drug Administration (FDA) on May 7 issued a Safety Alert on the risk for premature battery depletion in nearly 132,000 biventricular and conventional cardiac resynchronization therapy implantable pacemakers by Medtronic. The FDA is aware of three patients in which a battery fully drained because of…

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By: Judy Mathias
May 9, 2019
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Patient, surgeon outcomes reporting app helps predict success of ventral hernia repair

Editor's Note Researchers have developed an online app that patients and surgeons can use to guide preoperative planning and provide predictive data for how a patient’s ventral hernia repair will turn out. The basis of the app is a tool named the “Outcomes Reporting App for CLinical and Patient Engagement”…

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By: Judy Mathias
May 8, 2019
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FDA: Class I recall of Neuro Omega System

Editor's Note The Food and Drug Administration (FDA) on May 6 identified the recall my Alpha Omega Engineering of its Neuro Omega System, including the Drive Headstage unit, as Class I, the most serious. The recall was initiated because a design flaw in the device may connect two separate electrode…

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By: Judy Mathias
May 8, 2019
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Intervention to reduce low-value preop tests before cataract surgery

Editor's Note Reducing low-value testing before cataract surgery was associated with cost savings for financially capitated healthcare systems, but it was also associated with losses for fee-for-service healthcare systems, which could be a barrier to eliminating low-value care, this study finds. Of 1,054 patients (469 intervention, 585 controls) included in…

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By: Judy Mathias
May 7, 2019
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Use of TAVR in low-risk patients

Editor's Note In this study of low-risk patients with severe aortic stenosis, outcomes were significantly better at 1 year follow-up with transcatheter aortic-valve replacement (TAVR) than surgical aortic-valve replacement. In 1,000 patients at 71 centers who were randomized to undergo either TAVR or surgical aortic-valve replacement, the rate of the…

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By: Judy Mathias
May 2, 2019
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Trends, factors linked to physician burnout

Editor's Note Physician burnout has reached a critically high level, fueled by regulatory, compliance, and technology demands, but health system leaders at the Massachusetts General Hospital in Boston are working to address and relieve burnout and bring the joy back to the practice of medicine with centrally and locally designed…

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By: Judy Mathias
April 30, 2019
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FDA: Class I recall of Miller and Fogarty Atrioseptostomy Dilation Catheters

Editor's Note The Food & Drug Administration (FDA) on April 26 identified the recall of Edwards Lifesciences' Miller and Fogarty Atrioseptostomy Dilation Catheters as Class I, the most serious. The recall was initiated because of reports of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or…

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By: Judy Mathias
April 30, 2019
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FDA issues Safety Communication for Stryker Wingspan Stent System

Editor's Note The Food and Drug Administration (FDA) on April 25 issued a Safety Communication on use of the Stryker Wingspan Stent System outside of approved indications. The Wingspan Stent System is used to open narrowed arteries in the brains of patients with intracranial stenosis who are experiencing repeated strokes.…

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By: Judy Mathias
April 29, 2019
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Transplanting hearts, lungs from HCV-infected donors into recipients without HCV infection

Editor's Note In patients without HCV infection who received a heart or lung transplant from HCV-infected donors, treatment with a 4-week antiviral regimen prevented establishment of HCV infection, this study finds. Of 44 patients enrolled in the study, 36 received lung transplants and 8 received heart transplants. All of the…

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By: Judy Mathias
April 25, 2019
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Increased duration of surgical antimicrobial prophylaxis linked to adverse events

Editor's Note In this multi-center study, longer durations of surgical prophylaxis did not result in further reductions in surgical site infections (SSIs) but were associated with increasing adverse events. Of 79,058 surgical patients in the VA healthcare system, SSI was not associated with duration of prophylaxis, but odds of acute…

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By: Judy Mathias
April 25, 2019
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