There’s a new and effective way to avoid infection after surgeries involving implantable electronic devices, including pacemakers, according to research from the Cleveland Clinic.
Major infections were reduced by 40 percent with the use of dissolvable envelopes that wrap around devices and automatically release antibiotics, the study showed.
These results were presented Sunday at the American College of Cardiology Annual Scientific Session, and simultaneously published in the New England Journal of Medicine, the Clinic said. The study also will be presented at the European Heart Rhythm Association 2019 Congress.
The findings come at a time when concern about hospital infections is rising, said Dr. Khaldoun Tarakji, associate section head of cardiac electrophysiology at the Clinic.
“To be able to drop (the infection rate) by 40 percent was truly remarkable,” Tarakji said. He was co-senior author of the study, along with Dr. Bruce Wilkoff, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic.
Wilkoff and Tarakji are paid advisors for medical technology company Medtronic, which funded the study and manufactures the mesh envelope.
There’s a high risk of infection each time a patient undergoes surgery to replace or upgrade pacemakers, defibrillators or other implantable electronic devices, Tarakji said. Infection around the device can have serious consequences, such as additional surgery to remove the device and its surrounding hardware.
The study looked at a dissolvable envelope made of absorbable mesh, coated with two antibiotics, that encases the implanted device. The envelope, which received FDA approval in 2013, is fully absorbed in about two months. Researchers found no increase in complication rates.
This study is the first randomized control study of the mesh’s effectiveness, Tarakji said. The trial, which ran from 2015 to 2018, included nearly 7,000 patients at 181 medical centers in 25 countries, and followed patients for a year. The Clinic was among the medical centers that enrolled patients in the study.
“We never had a study of this magnitude before,” Tarakji said, adding that additional studies looking into more ways to reduce the infection rate are called for.