Heart Surgery
FDA authorizes marketing of first AI guided cardiac ultrasound
Editor's Note The Food & Drug Administration (FDA) on February 7 authorized marketing of software to assist in the acquisition of cardiac ultrasound images. The software, named “Caption Guidance,” uses artificial intelligence (AI) to help capture images of a patient’s heart from different angles, which are used to diagnose various…
Association of LVAD vs IABP with mortality, bleeding
Editor's Note The use of an intravascular microaxial left ventricular assist device (LVAD) vs an intra-aortic balloon pump (IABP) in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock was associated with worse in-hospital clinical outcomes in this study. Of 3,360 propensity-matched patients undergoing percutaneous coronary intervention for AMI,…
FDA: Class I recall of Cook Medical’s CrossCath Support Catheters
Editor's Note The Food and Drug Administration (FDA) on December 17 identified the recall by Cook Medical of its CrossCath Support Catheters as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause the radiopaque marker bands on the catheters to dislodge or…
Association of postop MI with high mortality rates after vascular surgery
Editor's Note Despite high rates of patients discharged with cardioprotective medications, the long-term burden of postoperative myocardial infarction (MI) after major vascular surgery is substantial, with a high mortality rate in the following year, this study finds. Of 26,231 vascular surgery patients analyzed, factors linked to an increased risk of postoperative…
FDA updates device failure linked to Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps
Editor's Note The Food and Drug Administration (FDA) on November 19 updated the device failure associated with Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps (IABPs) in a letter to health care providers. Since 2017, the FDA has received more than 75 reports of the IABPs shutting down while running on battery. Five…
FDA: Class I recall of Abbott CentriMag Circulatory Support System
Editor's Note The Food and Drug Administration on November 4 identified the recall by Abbott of its CentriMag Circulatory Support System as Class I, the most serious. The recall was initiated because of a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop,…
FDA clears Heartvista’s AI-assisted cardiac MRI tool
Editor's Note Heartvista (Los Altos, California) has obtained clearance from the Food and Drug Administration (FDA) for its artificial intelligence (AI)-assisted One Click autonomous MRI acquisition software for cardiac ischemia exams, the October 30 BioWorld MedTech reports. Integrated with existing MRI scanners, the software uses AI to guide image acquisition,…
FDA: Class I recall of Medtronic’s 6 French Sherpa NX Active Guide Catheters
Editor's Note The Food & Drug Administration (FDA) on October 8 announced the recall by Medtronic of all models of its 6 French Sherpa NX Active Guide Catheters. Medtronic is recalling the catheters because of the risk of the outer material separating from the device, resulting in detached fragments that…
PCI vs CABG outcomes for left main coronary disease
Editor's Note In this study of patients with left main coronary disease, there was no significant difference in outcomes at 5 years between treatment with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Researchers randomly assigned 1,905 patients with left main coronary artery disease of low or intermediate…
CMS considering reimbursement for coronary interventions at ASCs
Editor's Note In a proposed rule, the Centers for Medicare & Medicaid Services (CMS) is considering whether to reimburse for percutaneous coronary interventions (PCIs) at ambulatory surgical centers (ASCs), the September 20 tctMD reports. As of May 1, 2019, approximately 22 states allowed for coronary interventions to be done outside…
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