Addressing Device Failures and Problematic Lead Extractions
Heart & Vascular Institute Physician eNewsletter - Fall/Winter 2013
Any pacemaker or implantable cardioverter-defibrillator has the potential to fail from infection or lead-related side effects, requiring its removal. Infection alone is a serious concern, occurring in 2 percent of the 3 million patients with implanted devices. Cleveland Clinic is taking the lead in addressing this issue by organizing a consortium of electrophysiologists from 100 centers worldwide, who are interested in reducing device-related morbidity. This group, which represents a subset of electrophysiologists, has been exchanging ideas at annual symposia for years. Bruce Wilkoff, MD, Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic, felt it was time to formalize their relationship.
“Approaching these issues together will enable us to discover the best way to treat our patients and to communicate and implement changes in treatment protocol worldwide,” he says.
The group plans to tackle some difficult questions, including:
- How can device infections be prevented?
- How should device infections be treated?
- How should venous access be managed in a patient who needs dialysis?
- What is the volume of devices that need to be implanted in order to maintain competence and lower the rate of complications?
- Does a trained Lead Extraction Team reduce the rate of adverse events?
“These problems will only be solved by getting interested experts talking and challenging each other,” says Dr. Wilkoff.
Harnessing the power of passion
Because the subset of electrophysiologists committed to solving the problems of device failure and lead extraction is relatively small, many individuals operate virtually in isolation. The new working group, which Dr. Wilkoff prefers to call a collaborative community, provides an opportunity to share thoughts and ideas with others who share a similar passion.
“We are formalizing a grass-roots situation. Right now, we all handle these problems differently. Our goal is to coalesce around a particular protocol, which will then become the de facto standard of care,” he explains.
As a common project for collaboration, Dr. Wilkoff has organized an international clinical trial of a resorbable pouch that delivers antibiotics at the time of device change. The trial will begin enrolling 6,600 patients at centers in the U.S., Europe, Asia and Australia in 2014. A generous patient gift will enable Cleveland Clinic to move beyond coordinating the clinical trial to becoming the focal point for community coordination, education and communication.
“With new emphasis on measuring and reporting outcomes, both good and bad, you have to have strategies to measure what you are doing and make improvements,” says Dr. Wilkoff. “We hope this trial will lead to a method of preventing device-related infections and open the discussion for other exciting possibilities.”
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