Editor's Note The opioid epidemic has expanded the pool of overdose-death donors (ODDs) for heart transplantation. Even though ODDs have higher rates of hepatitis C, cardiac allograft quality indices are favorable, and recipient outcomes are similar to those with non-ODD hearts, this study finds. Of 15,904 heart transplant donors analyzed,…
Editor's Note The Food & Drug Administration on May 30 identified the recall by Terumo Medical Corporation (Somerset, New Jersey) of its SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System as Class I, the most serious. The recall was initiated because the tip could dislodge from the outer…
Editor's Note The Joint Commission on May 29 announced performance measures for two newly developed advanced Disease-Specific Care Certification programs−Acute Heart Attack Ready and Primary Heart Attack Center. The measures will go into effect July 1, 2019, for critical access hospitals and hospitals (including freestanding emergency departments) pursuing these certifications.…
Editor's Note Targeting a patient’s mean arterial pressure (MAP) during cardiopulmonary bypass (CPB) by monitoring cerebral blood flow autoregulation may reduce the incidence of delirium after cardiac surgery in older patients, this Johns Hopkins study finds. In this analysis of 199 patients, the incidence of delirium was significantly greater in…
Editor's Note The Food and Drug Administration (FDA) on May 21 released a letter to healthcare professionals about the most recent, interim post-approval study (PAS) results for the Abiomed Impella RP System, a percutaneous heart pump for right heart support. The latest interim results show a lower survival rate…
Editor's Note This multicenter study demonstrated an association between intraoperative staff movements and door openings with risk of surgical site infections (SSIs). In this study of 13 ORs in 10 hospitals, performing cardiac and total hip or knee replacement surgery, door openings were assessed by sensors fixed on the doors.…
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…
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…
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…
Editor's Note The Food & Drug Administration on March 21 issued a Safety Communication on cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. Medtronic (Dublin, Ireland) is working on updates to address the vulnerabilities and recommends that healthcare…