Study Reveals Multiple, Previous Procedures as Predictor of Complications After ICD Replacement
Large, multicenter study published in the HeartRhythm Journal shows increased complication rates after ICD replacement

FOR IMMEDIATE RELEASE
Contact: Ann-Marie White
Heart Rhythm Society
(202) 464-3476
awhite@hrsonline.org

WASHINGTON, DC — New research reveals that patients with implantable cardioverter defibrillators (ICDs) who have had multiple, previous pocket procedures are at an increased risk of complications after ICD replacement. The new study published in the December 2008 edition of the HeartRhythm Journal, the official journal of the Heart Rhythm Society, further reports a higher than expected overall ICD replacement complication rate compared to findings from earlier studies.

The large, multicenter study, led by Andrew Krahn, MD, from the London Health Sciences Center in London, Ontario, involved participation from 12 of the largest ICD implanting centers in Canada. The purpose of the study was to identify predictors of ICD replacement complications and investigate those complications in order to determine what causes patients to be at a greater risk. The study proves that multiple, previous pocket procedures are a predictor of ICD replacement complications. Patients who have already had multiple pocket procedures are at a greater risk of complication.

“No prior research has investigated the potential risk factors associated with ICD replacement, more specifically, what makes some patients more at-risk than others,” stated author Andrew Krahn, MD. “Study findings will help physicians better understand complication risks for patients who may need ICD replacement, and ultimately provide better care for their patients.”

Among the 12 participating centers, 451 out of 2,635 advisory ICD devices were replaced between October 2004 and October 2005. Over a one-year follow-up period, results show that patients experience various levels of complications, both major and minor. Major complications can include serious infection requiring system removal, and bleeding or ICD malfunction necessitating reoperation, while minor complications can include minor infection or worsening of other medical conditions. Of the 451 patients who underwent ICD replacement:

• 41 (9.1%) experienced complications
• 27 (5.9%) required reoperation and included two deaths
• 14 patients (3.1%) experienced minor complications

For more information about this study, please visit www.heartrhythmjournal.com.

About HeartRhythm Journal
HeartRhythm, the official journal of the Heart Rhythm Society provides rapid publication of the most important science developments in the field of arrhythmias and cardiovascular electrophysiology (EP). As the official journal of the Heart Rhythm Society, HeartRhythm publishes both basic and clinical subject matter of scientific excellence devoted to the EP of the heart and blood vessels, as well as therapy. The journal is the only EP publication serving the entire electrophysiology community from basic to clinical academic researchers, private practitioners, technicians, industry and trainees. HeartRhythm has a new impact factor of 4.203 for 2007 and ranks 10th out of 72 cardiovascular medicine journals by the Institute for Scientific Information. Additionally, the journal ranks seventh in the Immediacy Index among cardiology publications. It is also the official publication of the Cardiac Electrophysiology Society.