Patients with implantable cardioverter defibrillators (ICDs) who have had multiple, previous pocket procedures are at an increased risk of complications after ICD replacement, according to a study published in the December edition of the Heart Rhythm Journal.
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.
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 showed 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 re-operation, while minor complications can include minor infection or worsening of other medical conditions.
Of the 451 patients who underwent ICD replacement:
- 41 experienced complications
- 27 required reoperation and included two deaths
- 14 patients experienced minor complications
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, Krahn said.
“No prior research has investigated the potential risk factors associated with ICD replacement, more specifically, what makes some patients more at-risk than others,” Krahn said. “Study findings will help physicians better understand complication risks for patients who may need ICD replacement, and ultimately provide better care for their patients.”