Editor's Note The Food and Drug Administration (FDA) on March 18 issued a Safety Alert for Abbott Vascular’s (Santa Clara, California) Absorb GT1 Bioresorbable Vascular Scaffold (BVS). The alert was issued to inform healthcare providers of an increased rate of major adverse cardiac events in patients receiving the BVS, when…

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Editor's Note In this study, the composite outcomes of death, stroke, myocardial infarction, renal failure, or repeat revascularization at 5 year follow-up were similar for patients who had off-pump and on-pump coronary artery bypass grafting (CABG) procedures. The researchers also found no significant difference in cost or quality of life…

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Editor's Note Surgical site infection (SSI) risk for coronary artery bypass graft (CABG) and hip arthroplasty patients is highest in hospitals with low annual procedure volumes, yet these hospitals are excluded from quality reporting, this study finds. Even for high-volume hospitals, year-to-year variation in SSI rates makes past performance an…

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Editor's Note The Joint Commission on December 7 announced that it is offering a new Comprehensive Cardiac Center Certification, starting January 1. The voluntary program has been developed to recognize accredited hospitals that demonstrate excellence in delivering cardiac care through a combination of standards compliance, performance on targeted metrics, and…

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Editor's Note A global outbreak of Mycobacterium chimaera has been linked to heater-cooler devices used in cardiac surgery, this study finds. Investigators found M chimaera in heater-cooler device water circuits and air samples while the devices were running, suggesting airborne transmission from the device to the surgical site. New heater-cooler…

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Editor's Note On-pump and off-pump coronary artery bypass grafting (CABG) are equally safe and effective, this study finds. At 5 years there was no significant difference between on-pump and off-pump CABG in combined rates of death, stroke, myocardial infarction, renal failure, or subsequent revascularization procedures (23.6% vs 23.1%). There also…

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Editor's Note Harvard researchers have created the first 3-D printed heart-on-a-chip capable of collecting data on how reliably a heart is beating, and how a heart responds to drugs and toxins, the October 25 Gizmodo reports. The 3-D printed organ is made of synthetic material designed to mimic the structure…

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Editor's Note The Food and Drug Administration on October 24 categorized HeartWare Inc’s recall of its HeartWare Ventricular Assist Device Pumps as Class I, the most serious. The recall is because of a design problem with the driveline connector that connects the pump to the external controller and power source.…

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Editor's Note The Food and Drug Administration (FDA) on October 13 updated its Safety Alert on the Stӧckert 3T Heater-Cooler System by LivaNova to provide new information from the Centers for Disease Control and Prevention (CDC) about Mycobacterium chimaera infections associated with the use of the system in US patients…

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Editor's Note The Food and Drug Administration on October 11 issued a Safety Alert for implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) by St Jude Medical (Little Canada, Minnesota). In some cases, full battery drainage can occur in a day to a few weeks after the patient…

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