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EMBARGOED UNTIL 11:45 EST, March 17, 2019, NEW ORLEANS – A team of researchers led by a Cleveland Clinic discovered that the use of an antibiotic eluting resorbable shell when implanting cardiac devices such as pacemakers and defibrillators can reduce the rate of major infections by 40 percent.
The research was presented today at the 68th Annual Scientific Session of the American College of Cardiology and published concurrently in the New England Journal of Medicine. It will also be presented tomorrow at the 2019 congress of the European Rhythm Association.
Each year, approximately 1.7 million patients worldwide receive implantable electronic cardiac devices. These devices are used to correct abnormal heart rhythms and include pacemakers and implantable defibrillators. Although the devices are safe, there is a risk of infection, especially after a device replacement or other secondary procedures such as revisions of the pocket, changes in shunts and upgrades.
"Although the risk of major infections is low, when they occur, they can be devastating to patients, resulting in invasive procedures, withdrawal from the device, prolonged stays in the hospital and potentially death, "said Khaldoun Tarakji, MD, MPH, badociate head of cardiac electrophysiology section at the Cleveland Clinic and the lead author of the study. "Aside from the use of antibiotics just before the device's procedures, it is the first proven intervention to reduce the risk of infection in a randomized clinical trial." of this magnitude. "
The envelope consists of a resorbable mesh that envelops the defibrillator or pacemaker and is designed to stabilize the device when it is implanted in the body. It is covered with two antibiotics, minocycline and rifampin, which are continuously released into the device pocket for at least seven days. The envelope is fully absorbed after about nine weeks.
The global trial included 6,983 patients in 181 centers in 25 countries, receiving new defibrillators for cardiac resynchronization treatment or undergoing specific procedures on their implantable cardiac electronic devices, including pocket revisions, replacements or replacements. upgrades. They were randomized to receive the envelope or not and were followed for at least 12 months. All patients received standard preventive antibiotics before the operation to minimize the risk of infection. In the control group, 1.2% (42 patients) developed a major infection against 0.7% (25 patients) in the envelope group, a reduction of 40%. Among the main infections, 17 were endocarditis, an infection of the inner lining of the heart, and 50 were pocket infections. There were less pocket infections in the group of the envelope.
"The infection rates in our study were overall very low compared to those of other trials, and yet, we found that the envelope was still able to provide a significant benefit in terms of reduction. From the infection to the patients.According to the severity of heart infections, we strive to reduce infection rates as close to zero as possible, "said Bruce Wilkoff, MD, director of heart pacing and tachyarrhythmia at the Cleveland Clinic and lead author of the study.
The trial also examined the security of the envelope. The researchers found no increase in the rate of complications when the envelope was used. The envelope, manufactured by Medtronic, was approved by the FDA in 2013 for use in implantable cardiac electronic devices.
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Dr. Wilkoff and Dr. Tarakji are paid counselors for Medtronic. The study was funded by Medtronic. The Clinical Research Coordination Center at the Cleveland Clinic participated in the development of the study protocol, managed the data monitoring committee, and provided independent validation of test results.
About the Cleveland Clinic
The Cleveland Clinic is a multi-specialty, nonprofit academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with the goal of providing exceptional patient care, based on the principles of cooperation, compbadion and innovation. The Cleveland Clinic has pioneered many medical breakthroughs, including coronary bypbad surgery and the first face transplant in the United States. In its annual survey "America's Best Hospitals", the Cleveland Clinic is regularly designated by the US News & World Report as one of the country's top hospitals. Among Cleveland Clinic's 66,000 employees, there are more than 4,200 physicians and salaried researchers and 16,600 nurses, representing 140 specialties and medical specialties. The Cleveland Clinic's health system includes a 165-acre main campus near downtown Cleveland, 11 regional hospitals in northeastern Ohio, more than 180 outpatient care centers in northeastern Ontario. Ohio – including 18 full-service family health centers and three health and wellness centers – in southeastern Florida. ; Las Vegas, Nev .; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2018, there were 7.9 million total outpatient visits, 238,000 hospitalizations and observations and 220,000 surgical cases throughout the Cleveland Clinic's health care system. Patients came for treatment from each state and 185 countries. Visit us at clevelandclinic.org. Follow us on twitter.com/CCforMedia and twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.
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