Detect Long-term Complications After ICD Replacement: a Multicenter Italian Registry - DECODE Registry

Based on positive outcomes from numerous randomized, controlled trials, the implantable defibrillators have been included in the current European Society of Cardiology (ESC) and American College of Cardiology / American Heart Associations (ACC/AHA) guidelines as a standard of care in selected patients, and thus ICD use is currently increasing worldwide.

In the years after initial implantation, device replacement may become necessary for battery depletion or for upgrades to more complex multi-lead ICDs. The increase in generator or lead advisories and recalls contributes further to those patients considered for replacement.

The determination of procedural adverse events is complex, and requires monitoring of both short-term complications and long-term patient outcome.

Previous retrospective series have examined complications with ICD replacements. Moreover, the more recent REPLACE registry prospectively collected 6-month complication rates in patients undergoing pacemaker or ICD generator replacement at 72 private practice and academic sites in United States. This study examined a broad range of major and minor complications and found that ICD replacements were associated with a notable complication risk, particularly when a transvenous lead addition or revision was required.

Previous retrospective series have examined complications with ICD implantation in the Italian clinical practice, showing frequent interventions for system revision and demonstrating an association between adverse events and the complexity of the implanted device (i.e. Cardiac Resynchronization Therapy CRT-D versus single- or dual-chamber ICD). Moreover, it was shown that device replacement procedures are associated with significantly higher risk of infections.