Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients.

BACKGROUND: Although more than 150,000 implantable cardioverter defibrillators (ICDs) are implanted yearly worldwide, only few studies systematically examined complications of ICD therapy in large patient cohorts.
METHODS: We prospectively analyzed ICD-related complications in 440 consecutive patients who underwent first implantation of an ICD system for primary or secondary prevention of sudden cardiac death within the last 10 years at our institution. All study patients received pectoral nonthoracotomy ICD lead systems with the exception of one patient who had an artificial tricuspid valve.
RESULTS: During 46 +/- 37 months follow-up, 136 of 440 patients (31%) experienced at least one complication including implant procedure-related complications in 43 patients (10%), ICD generator-related complications in 28 patients (6%), lead-related complications in 52 patients (12%), and inappropriate shocks in 54 patients (12%). The most serious complications included one perioperative death due to heart failure (0.2%), two ICD system infections necessitating device removal (0.5%) and two perioperative cerebrovascular strokes (0.5%).
CONCLUSIONS: We conclude that more than one quarter of ICD patients experience complications during a mean follow-up of almost 4 years, although serious complications such as intraoperative death or ICD system infections are rare in patients with nonthoracotomy ICD systems. Recognition of these complications is the prerequisite for advances in ICD technology and management strategies to avoid their recurrence.