CLEVELAND, Ohio – The Cleveland Clinic has found a new and effective way to prevent post-surgical infections with implantable electronic devices, including cardiac pacemakers. Envelopes that wrap around devices and automatically release antibiotics, the study showed ,
These findings were presented on Sunday at the American College of Cardiology's Annual Scientific Session and simultaneously published in the New England Journal of Medicine, the clinic said. The study will also be presented at the 2019 European Heart Rhythm Association Congress.
The results come at a time when concern over hospital infections is rising, Dr. Khaldoun Tarakji, Head of Department of Cardiac Electrophysiology, Clinic at the Clinic. [1
Wilkoff and Tarakji are paid consultants for the medtech company Medtronic, which sponsored the study and manufacturers funded the network cladding.
There is a high risk of infection each time a patient undergoes surgery to replace or improve pacemakers, defibrillators, or other implantable electronic devices, Tarakji said. An infection around the device can have serious consequences, eg. For example, there is an additional operation to remove the device and its surrounding hardware.
The study examined a dissolvable sheath of resorbable mesh coated with two antibiotics that envelops the implanted device. The envelope, approved by the FDA in 2013, will be fully absorbed in approximately two months. The researchers found no increase in complication rates.
This study is the first randomized control study on the effectiveness of the network, Tarakji said. The study, which ran from 2015 to 2018, involved nearly 7,000 patients in 181 medical centers in 25 countries and followed patients for one year. The clinic was one of the medical centers where patients were enrolled in the study.
"We have never had a study of this magnitude," Tarakji said, adding that additional studies are needed to find more ways to reduce the infection rate. 19659011]