The global trial of nearly 7,000 patients also demonstrates the security of the envelope – ScienceDaily

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 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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