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A research team led by Cleveland Clinic Hospital has found that using an antibiotic-containing, absorbent envelope could reduce the rate of serious infections that can affect patients when implanting cardiac devices in their bodies, such as than pacemakers and cardiac defibrillators, 40 percent.
The results of the study were presented at the sixty-eighth annual scientific conference organized by the American College of Cardiology, then at the European Heartbeat Association Conference 2019, and then published simultaneously in the New England Journal of Medicine.
Each year, 1.7 million patients worldwide are transplanted to cardiac electronic devices. These devices are used to correct arrhythmias, including pacemakers and electric shock devices. Although the devices themselves are safe, the patient remains at risk of infection, particularly after a replacement or minor surgery.
Dr. Khaldoun Tarqji, Associate Head of the Department of Cardiac Epidemiology at Cleveland Clinic Hospital and lead author of the study, said the risk of serious infections was "very low, but that it could have serious consequences if it happened. " "The use of antibiotics just before heart transplantation is the first intervention of a large randomized clinical trial that significantly reduces the risk of infection," he said.
The envelope consists of a tissue consisting of a suction mesh covering the cardiovascular system and designed to stabilize the device when it is implanted in the body, as well as two antibiotics, monocycline and rifampin, which are kept in the device pocket for at least seven days. The envelope is fully absorbed within nine weeks.
The global trial involved 6,983 patients in 181 medical centers in 25 countries that will be implanted with new cardiac defibrillators for cardiac arrhythmias or undergoing specific interventions on their implanted cardiac devices, including pouch modifications, replacement generators and device updates. A number of patients were randomly assigned to receive the envelope and were followed for at least 12 months. All patients received preventive antibiotics before undergoing surgery to reduce the risk of infection. The study found that 1.2% of patients in the control group (42 patients) had a significant infection compared to 0.7% (25 patients) of the group of the envelope, a difference of 40% . The main infections included 17 cases of cardiomyopathy (endocardial infarction), 50 infections of the organ pouches and fewer sinus infections in the group of the envelope.
Dr. Bruce Wilcoff, director of the Department of Cardiac Arrhythmias and Arrhythmias at Cleveland Clinic and lead author of the study, said the incidence rates in this study were "generally very low compared to the studies of 39; other tests ", but stressed that the" envelope "" Given the risk of heart infections in patients, we strive to reduce infection rates as close to zero as possible. "
In addition, the study examined the safety of the antibiotic envelope and found no increase in the complication rate associated with the use of antibiotics. The envelope, manufactured by Medtronic, was approved by the US Food and Drug Administration in 2013 for use in electronic devices implanted in the heart.
Dr. Wilkov and Dr. Tarqji work as paid consultants at Medtronic, which funded the study. The Clinical Research Center at the Cleveland Clinic participated in the development of the study system, managed the data monitoring committee, and independently verified the results of the experiment.
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