Heart Surgery

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May 2024
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New calculator determines likelihood of developing cardiovascular disease

Editor's Note For the first time, researchers have designed a calculator that estimates a person’s risk for developing cardiovascular disease (CVD) over the next 30 years. The news was announced in a statement from the American Heart Association in the journal Circulation on November 10. 1 in 3 U.S. adults…

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By: Brita Belli
November 10, 2023
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Study: Redo TAVR procedures safe, effective

Editor's Note This study by researchers at Cedars-Sinai Medical Center, Los Angeles, finds that redo transcatheter aortic valve replacement (TAVR) procedures are both safe and effective. Of 350,591 patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry who underwent TAVR with balloon-expandable valves between November…

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By: Judy Mathias
September 5, 2023
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FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs

Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…

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By: Judy Mathias
September 5, 2023
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LivaNova receives FDA 510(k) approval for new in-line blood monitor

Editor's Note The Essenz™ In-Line Blood Monitor (ILBM) has received U.S. FDA 510(k) clearance and CE mark, as announced by manufacturer LivaNova on August 30. The new ILBM provides “accurate and continuous measurement of essential blood parameters for perfusionists throughout cardiopulmonary bypass procedures,” and integrates with the company’s Essenz Perfusion…

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By: Lindsay Botts
September 1, 2023
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FDA: Class I recall of labeling for Impella RP Flex with SmartAssist

Editor's Note The Food and Drug Administration (FDA), on August 17, identified the recall by Abiomed of the labeling for its Impella RP Flex with Smart Assist System Catheter as Class I, the most serious. The recall was initiated because the catheters’ instructions for use did not appropriately address precautions…

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By: Judy Mathias
August 21, 2023
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Study: Surgeon communication with patients on innovative procedures

Editor's Note This study from the UK finds that patients are not given sufficient information about innovative surgical procedures and their potential risks and uncertainties. Researchers collected data on seven cases, using preoperative interviews with surgeons, audio-recorded consultations during which innovative procedures were discussed between surgeons and patients, and postoperative…

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By: Judy Mathias
August 15, 2023
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Effect of poverty on surgical care, postop outcomes

Editor's Note This study from the Ohio State University Wexner Medical Center, Columbus, examines the association between long-standing poverty and postoperative outcomes. The analysis included 335, 595 patients who underwent lung resection, colectomy, coronary artery bypass grafting, or lower extremity joint replacement, and who were categorized according to the duration…

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By: Judy Mathias
August 14, 2023
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FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs

Editor's Note The Food and Drug Administration (FDA), on August 10, identified the recall by Datascope/Maquet/Getinge of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because the pumps may shut down unexpectedly due to electrical failures in the Power…

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By: Judy Mathias
August 11, 2023
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FDA: Class I recall of GE HealthCare’s TruSignal SpO2 sensors

Editor's Note The Food and Drug Administration (FDA), on July 28, identified the recall by GE HealthCare of its TruSignal SpO2 [arterial oxygen saturation] sensors as Class I, the most serious. The recall was initiated because of issues that may reduce the amount of energy sent to the heart during…

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By: Judy Mathias
July 31, 2023
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FDA: Class I recall of Abiomed Impella Left Sided Blood Pumps

Editor's Note The Food and Drug Administration (FDA), on July 27, identified the recall by Abiomed of all Impella Left Sided Blood Pumps as Class I, the most serious. Abiomed is recalling the pumps because the instructions for use do not adequately address precautions to take when treating transcatheter aortic…

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By: Judy Mathias
July 27, 2023
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